EUROPEAN COMMISSION
HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL
Directorate D – Food Safety: production and distribution chain
D3 – Chemicals, contaminants and pesticides
SANCO D3/AS D(2005)
File:SYNOPTIC DOCUMENT(2005.07.25)
“SYNOPTIC DOCUMENT”
PROVISIONAL LIST OF MONOMERS AND ADDITIVES NOTIFIED TO EUROPEAN COMMISSION AS
SUBSTANCES WHICH MAY BE USED IN THE MANUFACTURE OF PLASTICS OR COATINGS INTENDED
TO COME INTO CONTACT WITH FOODSTUFFS
(updated to June 2005)
-
-
Please read carefully the Explanatory Note to avoid any misunderstanding.
This document may also be found at the following internet address:
http://europa.eu.int/comm/food/food/chemicalsafety/foodcontact/synoptic_doc_en.pdf
1
NOTE FOR READER
1. Documents that explain the Community legislation on food contact materials and thus may
help the reader with interpretation of the “Synoptic Document” can be found at
http://europa.eu.int/comm/food/food/chemicalsafety/foodcontact/documents_en.htm.
2. The meaning of some abbreviations and words is explained in the document “List of the
abbreviations and explanations”.
3. If you notice mistakes, or you have suggestions, to improve this or the other documents
appearing on the website, e.g. addition of new sections and/or texts please send your
suggestions to European Commission (for the attention of Ms. Annette Schaefer) (for
address see document “EU and National Authorities”). The Commission may insert these
proposals in an updated version of this document or in the “Practical Guide”.
2
TABLE OF CONTENTS
CONTENT
PAGE
Note for reader
2
Table of contents
3
Warning
4
Explanatory Note
5
Appendix 1: General information or abbreviations of the main terms
7
Appendix 2: Definition of SCF lists
14
Appendix 3: Notes related to the column “Restrictions and/or Specifications
16
Table: Status of the substances
19
3
WARNING
If you notice a mistake in the document, please inform as soon as possible Ms A. Schaefer by email: Annette.Schaefer@cec.eu.int or by fax: +32.2.299.18.56.
1. Any information concerning the evaluation by the European Food Safety Authority (EFSA) and
the SCF should be addressed to EFSA/AFC Panel to Mr D. Spyropoulos (E-mail:
dimitrios.spyropoulos@efsa.eu.int) (see “EU and National Authorities” document).
2. It is recommended to consult the website of EFSA in order to know the results of the last meetings,
held after the date of the update of the Synoptic document:
http://www.efsa.eu.int/science/afc/afc_opinions/catindex_en.html.
3. An explanation of the columns is given in Appendix 1. The meaning of some numbers or asterisks,
which appear in the field “Restrictions and Specifications”, is explained in Appendix 3.
4. This document should be considered as a working document and not as a legal or binding document
and therefore it may be subject to relevant updates, changes or modifications.
4
EXPLANATORY NOTE
1.
This document contains all the monomers and additives (see an explanation of the terms in the
appendix 1 and 2) notified to the European Commission in view of their use in plastic materials
intended to come into contact with foodstuffs. It summarises the Community situation and the
evaluations of the listed substances carried out by a) the Scientific Committee on Food (SCF)
until May 2003 and b) the AFC Panel on food additives, flavourings, processing aids and
materials in contact with food of the European Food Safety Authority (EFSA), which replaced
the SCF, until 27 April 2005. This document should not be considered the appropriate
document to examine the legal situation of surface coatings even if a certain number of
substances that are used only in surface coatings appear in this document. The document
contains the monomers and additives listed in the inventory list of the Council of Europe
Resolution AP (2004) on coatings intended to come into food contact. However, not all
substances listed have been evaluated by the SCF or by EFSA.
2.
In principle, this document does not contain aids to polymerisation, colorants, inks, adhesives
and solvents, although some may be listed. Moreover, it must be stressed that the substances
appearing in this document shall not be considered, at this stage, as the only monomers and
additives legally used at Community level because the process of harmonisation of the national
lists is ongoing. To know whether or not a substance, which does not appear in the Community
directives, is authorised in the Member States, it is necessary to examine national laws or to
consult the national authorities, whose address can be found in the document “EU and
National Authorities”.
In conclusion this document should be considered as a working document
and not as a legal or binding document, and, therefore, it may be subject to
relevant modifications (integration, deletion and changes).
3.
The Commission services intend to include definitively in the future Community lists, if any,
only the substances classified into lists 0-4 by SCF or EFSA. The date when the list of
additives (see definition later) becomes a positive list will be fixed before 31 December 2007.
The persons interested in a substance classified into SCF lists 6-9, are invited to submit as
soon as possible and not later than 31 December 2006 the data requested by EFSA following
the recommendations of “Note for Guidance”, included in the website. The authorisation
procedure is described in the Framework Regulation (EC) No 1935/2004. For further
information on the list of additives see "Practical Guide", Chapter I, Section 3 Paragraph
3.2.
4.
At this stage, the Commission services are unable to specify whether the list will be extended
to aids to polymerisation ("substances which directly influence the formation of polymers"),
colorants, solvents, inks and adhesives. Therefore any extrapolation of the list to these
substances is premature. Moreover, the Commission services can only add a) that the
discussion on the type of rules to be applied to these substances will start after the Community
lists for monomers and additives for plastics and coatings are adopted and b) that they are
unable to specify any date on this matter.
5
5.
In principle the Commission services intend to update this document when the relevant number
of changes justifies an update (e.g. adoption of a Directive or EFSA opinion).
In order to know the last evaluations of the substances, see also the website of EFSA:
http://www.efsa.eu.int/science/afc/afc_opinions/catindex_en.html
Any information concerning the EFSA evaluation should be addressed to EFSA AFC Panel,
to Mr D. Spyropoulos (E-mail: dimitrios.spyropoulos@efsa.eu.int) (see “EU and National
Authorities” document).
6
APPENDIX 1
GENERAL INFORMATIONS OR ABBREVIATIONS OF THE MAIN TERMS
USED IN THIS DOCUMENT
Monomers and other starting substances
“Monomer and other starting substance", means any substance used in the manufacture of a
macromolecule, which constitutes the repeating unit of a polymer chain or polymer network of any
substance used in the manufacture of a plastic for food contact application. It also includes substances
used to modify existing natural or synthetic macromolecular substances. According to Directive
2002/72/EC, Annex 2, paragraph 1, the following substances are included in this definition:
"substances undergoing polymerisation, which include polycondensation, polyaddition or any
other similar process, to manufacture macromolecules;
natural or synthetic macromolecular substances used in the manufacture of modified
macromolecules, if the monomers or the other starting substances required to synthesise them
are not included in the list;
substances used to modify existing natural or synthetic macromolecular substances."
Although the definition and the examples seem very precise, some difficulties arise in the
identification of "monomers and other starting substances" in practice. Therefore, it is recommended to
read carefully the explanation given in Practical Guide, Chapter I, Section 3, paragraph 2.
Additives
See also paragraph 3 of the explanatory note of this document.
The list set out in the Table shall contain all the other substances not included in the definition of
monomers and other starting substances and not included in the definition of aids to polymerisation
(see below).
Therefore this list shall include:
a)
substances which are incorporated into plastics to achieve a technical effect in the finished
product; they are intended to be present in the finished articles ("additive");
b)
substances used to provide a suitable medium in which polymerisation occurs or substances
which directly influence the formation of polymers (conventionally these substances will called
"polymer production aids")
7
Therefore this list will include for example the following categories of substances:
"Category I"
-
antifoaming agents
-
antiskinning agents
-
antioxidants
-
antistatic agents
-
driers
-
emulsifiers
-
fillers
-
flame retardants
-
foaming agents
-
hardening agents
-
impact modifiers
-
lubricants
-
miscellaneous additives
-
optical brighteners
-
plasticizers
-
preservatives
-
protective colloids
-
reinforcements
-
release agents
-
solvents (see paragraph 2 of the Explanatory Note)
-
stabilizers
-
thickeners
-
UV absorbers
8
"Category II"
Polymer production aids
anti-foam reagents/de-gassing agents
-
blowing agents
-
buffering agents
-
build-up suppressants
-
dispersing aids
-
emulsifiers
-
flow control agents
-
nucleating agents
-
pH regulators
-
solvents (see paragraph 2 of the Explanatory Note)
-
surfactants
-
suspension agents
-
stabilisers
-
thickening agents
-
water treatment reagents
"Category III"
Aids to polymerisation
They are "Substances which directly influence the formation of polymers"
accelerators
-
catalysts
-
catalyst de-activators
-
catalyst supports
-
catalyst modifiers
-
chain scission reagents
-
chain transfer or extending agents
-
chain stop reagents
-
cross-linking agents
-
initiators and promoters
-
molecular weight regulators
-
polymerization inhibitors
-
redox agents
9
EXPLANATION OF THE COLUMNS
A short explanation of the fields and of some abbreviations is given below.
Column 1 ("REF_N")
This contains the substance reference numbers. Conventionally the following numbers have been
assigned:
Monomers:
10000-29999
Additives:
>30000
A substance listed as a monomer as well as an additive will be assigned two different REF.N. In some
cases, a cross-reference of the REF.N. is inserted in order to find a substance having a synonym,
commonly used.
Column 2 ("CAS_N")
This contains the CAS (Chemical Abstracts Service) registry number, if any. If the substance is a
mixture of substances, the CAS number refers to the mixture. Where an indent has been placed in the
column, it means that a research for CAS N. has been made, but that the result was negative. If the
result of the search was found to be doubtful or that the research has not yet been made, a question
mark appears in the column. Where there is inconsistency between the CAS number and the chemical
name, the chemical name shall take precedence over the CAS number. If there is inconsistency
between the CAS number reported in EINECS and the one in the CAS-Register, the CAS-number in
the CAS-Register shall apply.
Column 3 ("NAME")
This contains the chemical name attributed by the Commission services.
In some cases, a cross-reference of the REF.N. is inserted in order to find a substance having a
synonym, commonly used (see Column 4)
Column 4 ("SYNONIM")
This contains the REF.N. of a substance being a synonym, commonly used.
Column 5 ("DIR")
This indicates that a) the substance is included in the Commission Directive 2002/72/EC, relating to
plastic materials and articles intended to come into contact with foodstuffs (as amended by Directive
2004/1/EC and Directive 2004/19/EC); b) the substance is proposed to be inserted in the next
amendment to Directive 2002/72/EC (usually referred as 3rd amendment) or c) the substance was
mentioned in previous directives but it was later deleted for a particular reason. There are several
reasons why a substance is deleted. For example:
The substance appears under another more appropriate name
The substance is no longer requested by the petitioner
The individual substance can be covered under a generic name
The generic name has been deleted because the substances have been introduced individually
Deleted because considered as “basic polymer”. Basic polymers mean any polymeric substance, such as
plastic or polymer, which is capable of functioning as the main structural component of finished
materials and articles. They are not listed if their monomers are listed and they comply with Article 2 of
Framework Directive.
10
The following abbreviations appear in this column:
DIR = a) Substance included in the Directive 2002/72/EC of 6 of August 2002 (as last amended)
3AM = b) Substance proposed to be inserted in the 3rd amendment of the Directive 2002/72/EC
D = c) Substance previously mentioned in former directives but later deleted for a particular reason
Only the monomers and additives which are mentioned in the other document "EU SUBSTANCES"
(document available on the website) are considered substances approved at EU level. The other
appearing in the table below are substances which likely have been approved at national level but
which will not be included in the EU lists if the data requested by EFSA is not supplied on time (see
also paragraph 3 of the explanatory note of this document)
Column 6 ("RESTRICTIONS AND SPECIFICATIONS")
This column contains the restrictions and/or specifications for the use of the substance as they appear
in the Directive 2002/72/EC and amendments. See also Appendix 2 (definition of the SCF lists) and
Appendix 3 (notes related to the column “restrictions and/or specifications”).
It may include:
specific migration limit (SML),
maximum permitted quantity of the substance in the finished material or article (QM),
maximum permitted quantity of the substance in the finished material or article expressed as
mg per 6 dm2 of the surface in contact with foodstuffs (QMA),
other restriction specifically mentioned,
specifications related to the substance or to the polymer.
For some of the substances the Specific migration limits (SML) are specified. SML are obtained by the
Commission Services using the following conversions:
1) For substances with an ADI/TDI established - by multiplying the ADI/TDI values by a factor of 60.
This factor is derived from the convention that a person of 60 kg daily could ingest up to 1 kg of
foodstuffs in contact with a plastic article always containing the considered substance at a
concentration corresponding to the SML;
2) For substances where an ADI/TDI is not established – For these cases, restrictions can be
mentioned, frequently derived from reduced toxicity dossiers, leading directly to fixed migration limits
e.g. R=0.05 or R=5mg/kg food or food simulant. For these substances the SML generally corresponds
to the restriction (=R) which appears in the toxicological SCF/EFSA assessment.
Sometimes the QMA is mentioned. The relationship between the two restrictions SML and QMA is
QMA = SML*kg/6dm2. The value is derived from the SML by assuming a) that the substance migrates
completely (% of migration) and b) S/V report equal 6 dm²/1 liter.
For substances where the specific migration limits or other restrictions, are not indicated, the overall
migration limit of 60 mg/kg or 10 mg/dm2, according to the case, is applied.
For other abbreviations see explanation for column 8
11
Table: Relation between the SCF List, restriction and SML
SCF List
RESTRICTION
L0
In principle, no restriction
L1
SML = ADI x 60
L2
SML = TDI x 60
L3
SML = Restriction (=R) proposed by SCF/EFSA
L4
SML = not detectable, detection limit: 10 ppb or 20 ppb (when
analytical tolerance is included)
L5
Not authorised
L6A
Not authorised
L6B
Not authorised
Restriction (=R) proposed by SCF/EFSA may be indicated
L7
Not established – data needed
L8
Not established – data needed
L9
Not established – data needed
Note: Only substances classified in L0-L4 appear in the Directives.
Column 7 ("SCF_List")
This contains the number of the list in which the substance is classified by the EFSA, SCF or by SCFWG “FCM”. The meanings of the number or other abbreviations, which appear in this column, are
described in Appendix 2.
When letter “P” appears, this means “Postponed”. If a substance was already evaluated in the past, P
clarifies that the previous classification is not longer valable pending the examination of the new data
submitted to the SCF/EFSA and a re-evaluation of the substance.
Column 8 ("EFSA/SCF OP")
This contains the opinion of the SCF or EFSA updated to 27 April 2005.
As from September 2002, the SCF changed the format of the opinions. A more extensive and detailed
text summarises the historical background of the substances as well as the assessment given by the
SCF. Therefore, it has been decided to link the substance directly with the SCF opinion published on
Internet and no longer to repeat all the content of the SCF evaluation.
For EFSA opinions the proposed restrictions and the remarks for the Commission are indicated and the
link for the opinion published on the Internet is also provided.
When the substance was re-evaluated by EFSA, only the EFSA opinion is indicated. The link for the
previous SCF opinion is in some cases mentioned in the background of the opinion for information.
Other abbreviations which may appear in this Column:
Ac
Substances which is requested to be used only in coatings
ADI
Acceptable Daily Intake
DET
Detectable
DL
Limit of detection
FS
Food simulants
NCO
Isocyanate moiety
NS
Not specified
QM
Maximum permitted quantity of the "residual" substance in the material or article.
12
QMA
maximum permitted quantity of the substance in the finished material or article expressed
as mg per 6 dm² of the surface in contact with foodstuffs (QMA). The value is derived
from the SML by assuming a) that the substance migrates completely (100 % of migration)
and b) S/V report equal 6 dm²/1 liter.
QM (T) Maximum permitted quantity of the "residual" substance in the material or article
expressed as total of moiety/ substance(s) indicated.
SML
Specific migration limit in foods or in food stimulant.
SML (T) Specific migration limit in foods or in food simulant expressed as total of
moiety/substance(s) indicated. The number between brackets which appears after the
restriction refers to the Notes appearing in Annex VI of Directive 2002/72/EC.
TDI
Tolerable Daily Intake (this is a concept equivalent to the ADI, but applicable only to the
packaging sector and not to food additives).
Column 9 ("PL")
The sign + means that the substance was requested for plastics.
Column 10 ("CT")
The sign + means that the substance is listed in the inventory list of the Council of Europe Resolution
AP (2004) on coatings intended to come into food contact.
Other abbreviations which may appear in the Document:
W
when it appears in column "SCF_L", it refers to a "new substance". If it is alone, it means
that the substance is not yet evaluated. If it is followed by a number, this number indicates
the SCF-L."
?
Means that there is a doubt on the information given.
FP
Finished product (= material or article in finished state)
13
APPENDIX 2
DEFINITION OF THE SCF LISTS
Substances for which the Committee was able to express an opinion
List 0
Substances, e.g. foods, which may be used in the production of plastic materials and articles, e.g. food
ingredients and certain substances known from the intermediate metabolism in man and for which an
ADI need not be established for this purpose.
List 1
Substances, e.g. food additives, for which an ADI (=Acceptable Daily Intake), a t-ADI (=temporary
ADI), a MTDI (=Maximum Tolerable Daily Intake), a PMTDI (=Provisional Maximum Tolerable
Daily Intake), a PTWI (=Provisional Tolerable Weekly Intake) or the classification "acceptable" has
been established by this Committee or by JECFA.
List 2
Substances for which a TDI or a t-TDI has been established by this Committee.
List 3
Substances for which an ADI or a TDI could not be established, but where the present use could be
accepted.
Some of these substances are self-limiting because of their organoleptic properties or are volatile and
therefore unlikely to be present in the finished product. For other substances with very low migration,
a TDI has not been set, but the maximum level to be used in any packaging material or a specific limit
of migration is stated. This is because the available toxicological data would give a TDI which allows
that a specific limit of migration or a composition limit could be fixed at levels very much higher than
the maximum likely intakes arising from present uses of the additive.
LIST 4 (for monomers)
Section 4A
Substances for which an ADI or TDI could not be established, but which could be used if the
substance migrating into foods or in food simulants is not detectable by an agreed sensitive method.
Section 4B
Substances for which an ADI or TDI could not be established, but which could be used if the levels of
monomer residues in materials and articles intended to come into contact with foodstuffs are reduced
as much as possible.
LIST 4 (for additives)
Substances for which an ADI or TDI could not be established, but which could be used if the
substance migrating into foods or in food simulants is not detectable by an agreed sensitive method.
14
List 5
Substances which should not be used.
List 6
Substances for which there exist suspicions about their toxicity and for which data is lacking or is
insufficient.
The allocation of substances to this list is mainly based upon similarity of structure with that of
chemical substances already evaluated or known to have functional groups that indicate carcinogenic
or other severe toxic properties.
Section 6A: Substances suspected to have carcinogenic properties. These substances should not be
detectable in foods or in food simulants by an appropriate sensitive method for each substance.
Section 6B: Substances suspected to have toxic properties (other than carcinogenic). Restrictions may
be indicated.
List 7
Substances for which some toxicological data exist, but for which an ADI or a TDI could not be
established. The required additional information should be furnished.
List 8
Substances for which no or only scanty and inadequate data was available.
List 9
Substances and groups of substances which could not be evaluated due to lack of specifications
(substances) or to lack of adequate description (groups of substances).
Groups of substances should be replaced, where possible, by individual substances actually in use.
Polymers for which the data on identity specified in "SCF Guidelines" are not available.
List W
"Waiting list". Substances not yet included in the Community lists, as they should be considered "new"
substances, i.e. substances never approved at national level. These substances cannot be included in the
Community lists, lacking the data requested by the Committee.
In the substances used only for coatings this letter means that the substance is listed in the inventory
list of the Council of Europe Resolution AP (2004) on coatings intended to come into food contact and
are not evaluated by the SCF or EFSA.
List W7
Substances for which some toxicological data exists, but for which an ADI or a TDI could not be
established. The required additional information should be furnished.
List W8
Substances for which no or only scanty and inadequate data was available.
List W9
Substances and groups of substances which could not be evaluated due to lack of specifications
(substances) or to lack of an adequate description (groups of substances).
15
APPENDIX 3
NOTES RELATED TO THE COLUMN “RESTRICTIONS AND/OR SPECIFICATIONS
(1) Warning: there is a risk that the SML could be exceeded in fatty food simulants.
(2) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the
migration of the following substances mentioned as reference Nos: 10060 and 23920.
(3) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the
migration of the following substances mentioned as reference Nos: 15760, 16990, 47680, 53650
and 89440.
(4) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the
migration of the following substances mentioned as reference Nos: 19540, 19960 and 64800.
(5) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the
migration of the following substances mentioned as reference Nos: 14200, 14230 and 41840.
(6) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the
migration of the following substances mentioned as reference Nos: 66560 and 66580.
(7) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the
migration levels of the following substances mentioned as reference Nos: 30080, 42320, 45195,
45200, 53610, 81760, 89200 and 92030.
(8) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the
migration levels of the following substances mentioned as reference Nos: 38000, 42400, 64320,
67896, 73040, 85760, 85840, 85920 and 95725.
(9) Warning: there is a risk that the migration of the substance deteriorates the organoleptic
characteristics of the food in contact and then, that the finished product does not comply with the
second indent of Article 2 of Directive 89/109/EEC.
(10) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the
migration levels of the following substances mentioned as reference Nos: 30180, 40980, 63200,
65120, 65200, 65280, 65360, 65440 and 73120.
(11) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the
migration levels (expressed as Iodine) of the following substances mentioned as reference Nos:
45200, 64320, 81680 and 86800.
(12) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the
migration levels of the following substances mentioned as reference Nos: 36720, 36800, 36840
and 92000.
16
(13) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the
migration levels of the following substances mentioned as reference Nos: 39090 and 39120.
(14) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the
migration levels of the following substances mentioned as reference Nos: 44960, 68078, 82020
and 89170.
(15) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the
migration levels of the following substances mentioned as reference Nos: 15970, 48640, 48720,
48880, 61280, 61360 and 61600.
(16) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the
migration levels of the following substances mentioned as reference Nos: 49600, 67520 and
83599.
(17) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the
migration levels of the following substances mentioned as reference Nos: 50160, 50240, 50320,
50360, 50400, 50480, 50560, 50640, 50720, 50800, 50880, 50960, 51040 and 51120.
(18) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the
migration levels of the following substances mentioned as reference Nos: 67600, 67680 and
67760.
(19) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the
migration levels of the following substances mentioned as reference Nos: 60400, 60480 and
61440.
(20) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the
migration levels of the following substances mentioned as reference Nos: 66400 and 66480.
(21) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the
migration levels of the following substances mentioned as reference Nos: 93120 and 93280.
(22) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the
migration levels of the following substances mentioned as reference Nos: 17260, 18670, 54880
and 59280.
(23) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the
migration levels of the following substances mentioned as reference Nos: 13620, 36840, 40320
and 87040.
(24) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the
migration levels of the following substances mentioned as reference Nos: 13720 and 40580.
(25) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the
migration levels of the following substances mentioned as reference Nos: 16650 and 51570.
17
(26) QM(T) in this specific case means that the restriction shall not be exceeded by the sum of the
residual quantities of the following substances mentioned as reference Nos: 14950, 15700, 16240,
16570, 16600, 16630, 18640, 19110, 22332, 22420, 22570, 25210, 25240 and 25270.
(27) QMA(T) in this specific case means that the restriction shall not be exceeded by the sum of the
residual quantities of the following substances mentioned as reference Nos: 10599/90A,
10599/91, 10599/92A and 10599/93.
(28) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the
migration levels of the following substances mentioned as reference Nos: 13480 and 39680.
(29) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the
migration levels of the following substances mentioned as reference Nos: 22775 and 69920.
(30) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the
migration levels of the following substances mentioned as reference Nos: 86480, 86960 and
87120
(31) Compliance testing when there is a fat contact should be performed using saturated fatty food
simulants as simulant D.
(32) Compliance testing when there is a fat contact should be performed using isoctane as substitute of
simulant D (unstable).
(33) QMA(T) in this specific case means that the restriction shall not be exceeded by the sum of the
residual quantities of the following substances mentioned as reference Nos: 14800 and 45600.
(34) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the
migration levels of the following substances mentioned as reference Nos: 55200, 55280 and
55360.’
18
REF_N
CAS_N
NAME
SYNONIM
DIR
10030
000514-10-3 Abietic acid
DIR
10060
000075-07-0 Acetaldehyde
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
2
SML(T) = 6 mg/kg (2)
2
EFSA/SCF_OP
Group TDI: 1 mg/kg b.w.
90-day and 2-year oral rat studies.
(Ind Bio Test, 1962).
(SCF, 17th Report, 1986).
Group TDI = 0.1 mg/kg b.w. (calculated as
acetaldehyde (including 10060 and 23920)
PL
CT
+
+
+
+
+
+
+
+
Toxicity profiles similar to methaldehyde. A
2-year oral rat study and a 3-generation oral
rat study including teratogenicity with
methamethaldehide. The reports on nasal
carcinogenicity after inhalation were
considered without relevance for effects
from oral intake of smaller doses.
(adopted at 113rd SCF meeting)(17-18
September 1998)
10090
000064-19-7 Acetic acid
10120
000108-05-4 Acetic acid, vinyl ester
10150
000108-24-7 Acetic anhydride
Same 30280
DIR
2
10155
10160
10162
10180
000542-02-9
002206-94-2
010521-96-7
000556-08-1
Same 15280
D
D
D
D
8
6A
6A
8
Acetoguanamine
alpha-Acetoxystyrene
beta-Acetoxystyrene
p-(Acetylamino)benzoic
acid
Same 30000
DIR
DIR
1
SML = 12 mg/kg
19
2
http://europa.eu.int/comm/food/fs/sc/scf/out
16_en.html
Group ADI: not specified.
(SCF, 25th Series, 1990).
TDI: 0.2 mg/kg b.w.
90-day oral studies and metabolism studies
in mice and rats, teratogenicity studies in
rats and several mutagenicity studies
negative.
(Hazleton: 2146-51/4 January 1980; 251151/11-14 and 2195-51/6 & 7).
Group TDI: included in the ADI not
specified for acetic acid.
(SCF, 25th Series, 1990).
SCF_List 8
Needed data or information:
Data according to the new SCF-Guidelines.
See SCF evaluation in the website:
http://europa.eu.int/comm/food/fs/sc/scf/out
+
+
+
+
+
REF_N
CAS_N
NAME
10210
000074-86-2 Acetylene
10240
-
10270
-
10300
-
10330
-
10360
-
10390
-
10420
-
10450
-
10480
-
Acids, aliphatic,
dicarboxylic, esters with
alcohols, aliphatic,
monohydric
Acids, aliphatic,
dicarboxylic (C3-C12),
esters with alcohols,
unsaturated (C3-C18)
Acids, aliphatic,
dicarboxylic, saturated
(C4-C18)
Acids, aliphatic,
dicarboxylic, unsaturated
(C4-C12)
Acids, aliphatic,
dicarboxylic,
unsaturated, esters with
polyethyleneglycol
Acids, aliphatic,
dicarboxylic,
unsaturated, esters with
polypropyleneglycol
Acids, aliphatic, monoand dicarboxylic (C2C20), vinyl esters
Acids, aliphatic,
monocarboxylic (C3C12), esters with
alcohols, unsaturated
(C3-C18)
Acids, aliphatic,
monocarboxylic,
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
181_en.pdf
Residues of this gas in plastics are very
small. The gas has low toxic potential.
Migration into food will be toxicologically
negligible.
(NIOSH, Criteria for a recommended
standard, HEW Publ. n. 76-195).
PL
DIR
3
D
9
+
D
9
+
D
9
+
D
9
+
D
9
+
D
9
+
D
9
+
D
9
+
D
9
+
20
+
CT
REF_N
CAS_N
NAME
SYNONIM
saturated (C2-C24)
10510 Acids, aliphatic,
monocarboxylic,
unsaturated (C3-C24)
10540 Acids, aliphatic,
monocarboxylic,
unsaturated (C3-C8),
esters with alcohols,
aliphatic, monohydric,
saturated (C2-C12)
10570 Acids, aliphatic,
monocarboxylic,
unsaturated, esters with
polypropyleneglycol
10599/65 068955-98-6 Acids, fatty, saturated
(C16-C18) and
unsaturated (C18)
10599/70 ?
Acids, fatty,
unsaturated(C18)
10599/90 061788-89-4 Acids, fatty,
Same
unsaturated(C18), dimers 10599/90A
and
10599/91
10599/90A 061788-89-4 Acids, fatty, unsaturated
Same
(C18), dimers, distilled
10599/90
and
10599/91
10599/91 061788-89-4 Acids, fatty, unsaturated
(C18), dimers, non
Same
10599/90
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
D
9
+
D
9
+
D
9
+
W
+
D
9
+
D
D
+
DIR
DIR
QMA(T) = 0.05 mg/6
dm² (27)
QMA(T) = 0.05 mg/6
dm² (27)
21
3
3
CT
L3.
http://europa.eu.int/comm/food/fs/sc/scf/out
140_en.pdf
Group restriction: 0.05 mg/kg of food (for
10599/90A-10599/91-10599/92A and
10599/93).
Remark for Commission: only a method for
residual content is available. A QMA-limit
is applicable.
See SCF evaluation in the website:
http://europa.eu.int/comm/food/fs/sc/scf/out
come_en.html
opinions(SCF/CS/PM/GEN/M89)
Same references as 10599/90A.
http://europa.eu.int/comm/food/fs/sc/scf/out
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
distilled
10599/92 068783-41-5
10599/92A 068783-41-5
10599/93 068783-41-5
10600
-
10630
000079-06-1
10660
10690
and
10599/90A
Acids, fatty,
Same
unsaturated(C18),
10599/92A,
dimers, hydrogenated
10599/93
and 17190
Acids, fatty, unsaturated
Same
(C18), dimers,
10599/92,
hydrogenated, distilled
10599/93
and 17190
Acids, fatty, unsaturated
Same
(C18), dimers,
10599/92,10
hydrogenated, non
599/92A,171
distilled
90
Acids, linear, with an
even number of carbon
atoms (C8-C22), and the
dimers and trimers of the
unsaturated acids
Acrylamide
DIR
EFSA/SCF_OP
PL
CT
140_en.pdf
D
D
+
DIR
QMA(T) = 0.05 mg/6
dm² (27)
3
Same references as 10599/90A.
http://europa.eu.int/comm/food/fs/sc/scf/out
140_en.pdf
+
+
DIR
QMA(T) = 0.05 mg/6
dm² (27)
3
Same references as 10599/90A.
http://europa.eu.int/comm/food/fs/sc/scf/out
140_en.pdf
+
+
D
D
DIR
SML = ND (DL = 0.01
mg/kg)
015214-89-8 2-Acrylamido-2methylpropanesulphonic
acid
DIR
SML = 0.05 mg/kg
000079-10-7 Acrylic acid
DIR
4A
3
2
22
+
Neurotoxic for all 6 animal species tested.
Teratogenic in rats. Genotoxic in several
short term tests and carcinogenic in rats.
(RIVM doc. March 1991).
R = 0.05 mg/kg of food.
Available: Migration data and mutagenicity
tests. Considered non-genotoxic based on
the available studies (CS/PM/2083).
Group t-TDI: 0.1 mg/kg b.w. pending results
of ongoing teratogenicity studies on acrylic
acid.
Available: a 90-day oral rat study, an oral
reproduction study, 2- year oral rat and dog
studies with acrylic acid and an oral
teratogenicity study in rats with ethyl
acrylate, 3-year oral rat and dog studies with
acrylic acid, ethylene glycol monoester.
(NTP; Union Carbide report N. 43-529 (26
August 1980) and N. 43-528 (22 August
1980); RIVM report 65116008 (June 1984);
report Dow, 1967 and 1967; RIVM report
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
+
+
+
+
06-02-1990).
http://europa.eu.int/comm/food/fs/sc/scf/rep
orts/scf_reports_30.pdf
10720
10750
000999-55-3 Acrylic acid, allyl ester
002495-35-4 Acrylic acid, benzyl ester
10775
084100-23-2 Acrylic acid, 4-tertbutylcyclohexyl ester
000141-32-2 Acrylic acid, n-butyl
ester
10780
D
DIR
6A
2
D
8
DIR
2
Group TDI: 0.1 mg/kg bw (as acrylic acid).
Hydrolysis (complete) data allow to allocate
the same TDI as acrylic acid.
+
Group t-TDI: 0.1 mg/kg b.w. (as acrylic
acid).
See references for acrylic acid.
Group t-TDI: 0.1 mg/kg b.w. (as acrylic
acid).
See references for acrylic acid.
Group t-TDI: 0.1 mg/kg b.w. (as acrylic
acid).
See references for acrylic acid.
+
+
+
+
+
+
10810
002998-08-5 Acrylic acid, sec-butyl
ester
DIR
2
10840
001663-39-4 Acrylic acid, tert-butyl
ester
DIR
2
10870
002206-89-5 Acrylic acid, 2chloroethyl ester
Acrylic acid,
cyclohexylaminoethyl
ester
003066-71-5 Acrylic acid, cyclohexyl
ester
016868-13-6 Acrylic acid, cyclopentyl
ester
002156-96-9 Acrylic acid, decyl ester
050976-02-8 Acrylic acid,
dicyclopentadienyl ester
D
8
+
D
8
+
D
8
D
8
10900
10930
10960
10990
11000
11005
11010
012542-30-2 Acrylic acid,
dicyclopentenyl ester
024447-78-7 Acrylic acid, diester with
2,2-bis(4-hydroxy
phenyl)propane bis(2-
D
DIR
QMA = 0.05 mg/6 dm²
D
3AM
D
7
3
3
8
23
Available: hydrolysis data, but hydrolysis is
not complete.
+
+
+
Needed: hydrolysis data.
R = 0.05 mg/kg of food.
Available: Migration by worst case
calculation < 50 ppb, 3 mutagenicity tests
negative.
(RIVM/TNO/ISS SDS CS/PM/2743,
January 1996).
R = 0.05 mg/kg of food.
+
+
+
+
+
REF_N
CAS_N
NAME
hydroxyethyl) ether
Acrylic acid, diester with
1,3-butanediol
Acrylic acid, diester with
1,4-butanediol
Acrylic acid, diester with
diethyleneglycol
Acrylic acid, diester with
2,2-dimethyl-1,3propanediol
Acrylic acid, diester with
ethyleneglycol
Acrylic acid, diester with
1,6-hexanediol
Acrylic acid, diester with
polyethyleneglycol
Acrylic acid, diester with
tetraethyleneglycol
Acrylic acid, diester with
triethyleneglycol
Acrylic acid, diester with
tripropyleneglycol
11020
019485-03-1
11050
001070-70-8
11080
004074-88-8
11090
002223-82-7
11110
002274-11-5
11140
013048-33-4
11170
026570-48-9
11180
017831-71-9
11190
001680-21-3
11195
068901-05-3
and 04297866-5
002426-54-2 Acrylic acid, 2(diethylamino)ethyl ester
002439-35-2 Acrylic acid, 2(dimethylamino)ethyl
ester
002156-97-0 Acrylic acid, dodecyl
ester
11200
11230
11245
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
D
8
+
D
8
+
+
D
8
+
+
8
+
D
8
+
+
D
8
+
+
D
8
+
+
D
8
+
+
8
+
D
8
+
D
8
+
D
7
Needed: hydrolysis data.
+
+
3
R = 0.05 mg/kg of food.
Available: Migration data, 3 (negative)
mutagenicity studies.
(ISS/TNO SDS, March 1997 =
CS/PM/2996/11245).
+
+
DIR
SML = 0.05 mg/kg (1)
Remark: Since high migration into fat has
been demonstrated the WG recommends that
the Commission take the necessary measures
so that the restriction proposed is not
exceeded.
24
REF_N
11260
11290
11320
11350
11380
11390
11410
11425
11440
11470
11500
CAS_N
NAME
SYNONIM
000106-90-1 Acrylic acid, 2,3Same 16116
epoxypropyl ester
Acrylic acid, esters with
alcohols,
aliphatic,monohydric,
saturated (C1-C21)
Acrylic acid, esters with
alcohols, aliphatic,
monohydric, unsaturated
(C4-C18)
Acrylic acid, esters with
alcohols, aliphatic,
polyhydric (C2-C21)
Acrylic acid, esters with
etheralcohols
Acrylic acid, esters with
etheralcohols, aliphatic,
monohydric, saturated
(C1-C21)
Acrylic acid, esters with
glycolethers obtained
from mono- and/or
diglycols with alcohols,
aliphatic, monohydric
(C1-C18)
?
Acrylic acid, ester with
methoxydiethyleneglycol
044992-01-0 Acrylic acid, ester with
trimethylethanolammoni
um chloride
000140-88-5 Acrylic acid, ethyl ester
000103-11-7 Acrylic acid, 2ethylhexyl ester
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
+
D
6A
+
D
9
+
D
9
+
D
9
+
D
9
+
D
+
9
+
D
8
D
8
DIR
2
DIR
3
+
Group t-TDI: 0.1 mg/kg b.w. (as acrylic
acid).
See references for acrylic acid.
Restriction: 0.05 mg/kg of food
http://www.efsa.eu.int/science/afc/afc_opini
ons/675/afc_opinion20_ej109_list5_en1.pdf
http://europa.eu.int/comm/food/fs/sc/scf/out
62_en.pdf
25
+
+
+
+
+
+
REF_N
11505
11510
11520
11530
CAS_N
NAME
013402-02-3 Acrylic acid, hexadecyl
ester
000818-61-1 Acrylic acid,
hydroxyethyl ester
002918-23-2 Acrylic acid, 2hydroxyisopropyl ester
(= acrylic acid, 2hydroxy-1-methylethyl
ester)
000999-61-1 Acrylic acid, 2hydroxypropyl ester
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
W
Same 11830
DIR
DIR
+
See "Acrylic acid,
monoester with
ethyleneglycol"
D
QMA = 0.05 mg/6 dm²
for the sum of acrylic
acid, 2-hydroxypropyl
ester and acrylic acid,
2-hydroxyisoprpyl
ester and in compliance
with the specifications
laid down in Annex V.
CT
+
7
Needed: hydrolysis data.
+
3
R = 0.05 mg/kg of food (for the mixture).
Based on the reduced core set of
toxicological data according to the migration
level, see Appendix 2
+
+
+
Available: calculation of worst case
migration is < 0.05 mg/kg of food; gene
mutation assay in bacteria (negative);
chromosomal aberration assay in cultured
mammalian cells (positive); gene mutation
assay in cultured mammalian cells
(negative); micronucleus assay (negative).
RIVM/ISS/TNO SDS, July 2000 =
CS/PM/3117 REV. I/11530.
Remark for Commission:
- Only a residual Q method is available. A
QMA of 50 ug/6 dm2 is proposed.
(Adopted at the 126th SCF meeting, 28
February 2001)
http://europa.eu.int/comm/food/fs/sc/scf/out
84_en.pdf
11532
11560
11590
002761-08-2 Acrylic acid, 3hydroxypropyl ester
005888-33-5 Acrylic acid, isobornyl
ester
000106-63-8 Acrylic acid, isobutyl
ester
D
8
+
D
8
+
DIR
2
26
Group t-TDI: 0.1 mg/kg b.w. (as acrylic
acid).
See references for acrylic acid.
+
+
REF_N
11620
11650
11680
11695
11710
11740
11770
11800
11830
11860
11875
11890
11920
11950
11980
12010
12040
CAS_N
NAME
SYNONIM
001330-61-6 Acrylic acid, isodecyl
ester
029590-42-9 Acrylic acid, isooctyl
ester
000689-12-3 Acrylic acid, isopropyl
ester
003121-61-7 Acrylic acid, 2methoxyethyl ester
000096-33-3 Acrylic acid, methyl
ester
010095-13-3 Acrylic acid, monoester
with 1,3-butanediol
002478-10-6 Acrylic acid, monoester
with 1,4-butanediol
013533-05-6 Acrylic acid, monoester
with diethyleneglycol
000818-61-1 Acrylic acid, monoester
with ethyleneglycol
-
Acrylic acid, monoester
with propyleneglycol
004813-57-4 Acrylic acid, octadecyl
ester
002499-59-4 Acrylic acid, n-octyl
ester
005048-82-8 Acrylic acid,
phenylaminoethyl ester
000937-41-7 Acrylic acid, phenyl
ester
000925-60-0 Acrylic acid, propyl ester
040074-09-7 Acrylic acid, 2sulphoethyl ester
039121-78-3 Acrylic acid,
Same 11510
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
D
8
+
+
D
8
+
+
DIR
2
+
+
D
6B
+
+
DIR
2
+
+
D
7
D
8
D
7
Needed: hydrolysis data.
+
DIR
2
Group t-TDI: 0.1 mg/kg b.w. (as acrylic
acid).
See references for acrylic acid.
+
D
9
D
7
Needed: hydrolysis data.
+
+
DIR
2
Group t-TDI: 0.1 mg/kg b.w. (as acrylic
acid).
Hydrolysis (complete) data allow to allocate
the same TDI as acrylic acid.
+
+
D
8
D
7
Needed: hydrolysis data.
+
DIR
2
Group t-TDI: 0.1 mg/kg b.w. (as acrylic
acid).
See references for acrylic acid.
+
D
8
+
D
8
+
27
Group t-TDI: 0.1 mg/kg b.w. (as acrylic
acid).
See references for acrylic acid.
Group t-TDI: 0.1 mg/kg b.w. (as acrylic
acid).
See references for acrylic acid.
Needed: hydrolysis data.
+
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
sulphopropyl ester
Acrylic acid, triester with
glycerol tris(2hydroxypropyl) ether
Acrylic acid, triester with
1,1,1trimethylolpropane
tris(2-hydroxyethyl)
ether
Acrylic acid, vinyl ester
Acrylonitrile
12055
094160-26-6
12062
075577-70-7
12070
12100
002177-18-6
000107-13-1
12130
000124-04-9 Adipic acid
12160
12190
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
D
8
+
D
8
+
+
D
DIR
7
4A
Needed: hydrolysis data.
(SCF, 13th Series, 1982).
+
+
+
+
DIR
1
ADI: 5 mg/kg b.w.
(SCF, 25th Series, 1990).
+
+
002998-04-1 Adipic acid, diallyl ester Same 32200
000105-97-5 Adipic acid, di-n-decyl
Same 32320
ester
D
D
6A
8
12220
027178-16-1 Adipic acid, diisodecyl
ester
Same 32560
D
9
12250
000123-79-5 Adipic acid, di-n-octyl
ester
Same 32880
D
8
12265
004074-90-2 Adipic acid, divinyl ester
DIR
12280
002035-75-8 Adipic anhydride
DIR
Same 31730
SML = ND (DL
=0.020 mg/kg,
analytical tolerance
included)
QM = 5 mg/kg in FP.
For use only as comonomer.
3
2
28
Group R: 0.05 mg/kg b.w.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.050 mg/kg, peroxisome
proliferation study, too.
Group R: 0.05 mg/kg b.w.
Needed: in first instance specifications and
then on the specified substances
toxicological data depending on migration
level (see SCF guidelines) and, if migration
exceeds 0.050 mg/kg, peroxisome
proliferation studies too.
Group R: 0.05 mg/kg b.w.
Needed: toxicological data depending on
migration level (see SCFguidelines) and, if
migration exceeds 0.050 mg/kg, peroxisome
proliferation study too.
R = 0.5% (w/w) as co-monomer.
Hydrolysis data, inadequate. However
residue level very low.
(TNO SDS 1995-01-06).
Group TDI: 5 mg/kg b.w.
+
+
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
Included in group ADI for adipic acid.
12310
12340
-
12370
-
Albumin
Albumin, coagulated by
formaldehyde
12576
Alcohols, aliphatic,
monohydric, saturated,
primary, secondary or
tertiary (C4-C22)
Alcohols, aliphatic,
monohydric, saturated,
linear, primary (C4-C22)
Alcohols, aliphatic,
monohydric, unsaturated
(up to C18)
Alcohols, aliphatic,
polyhydric (up to C18)
Alcohols, cycloaliphatic,
mono- and/or
polyhydric, substituted
(up to C18)
Aldehydes (C4)
Alkadienes
n-Alkenes (up to C16)
068609-97-2 Alkyl(C12-C14)-2,3epoxypropyl ethers
Alkylphenols
12578
-
12375
12400
12430
12460
12490
12520
12550
12573
DIR
DIR
0
3
D
7
DIR
3
D
9
+
D
9
+
D
9
+
D
D
D
9
9
9
D
+
+
+
9
+
See also
12578
Alkyl(C1-C4)phenols
(consisting of a mixture
of mono, di, tri and tetra
alkyl substituted phenols
and up to 2% phenol)
5
29
Though albumin is a food component, it has
been modified by formaldehyde which is
classified in list 3 in 17th Series, SCF, 1986.
Needed: actual use, 28-day oral study of one
lower and one higher alcohol.
90-day oral studies, metabolic and/or
mutagenicity studies with some substances
out of the group.
Substance which should not be used.
Available: inadequate migration data, acute
toxicity data on several components of
mixture.
Evaluation is not possible from the data
provided. Sources for the mixture mentioned
do not exclude presence of toxic
components. Quantitative ranges are lacking
for many substances.
(RIVM/TNO SDS, February 1997 =
+
+
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
CS/PM/2993/12578).
12580
12610
12640
12650
12670
p-Alkyl(C4-C9)phenols
000107-18-6 Allyl alcohol
000106-92-3 Allyl 2,3-epoxypropyl
ether
Allyl ethers of mono-,
di-, or trimethylolphenol
002855-13-2 1-Amino-3Same 19145
aminomethyl-3,5,5trimethylcyclohexane
D
D
D
9
6A
6A
9
DIR
SML = 6 mg/kg
2
12700
000150-13-0 4-Aminobenzoic acid
D
8
12730
12760
000060-32-2 6-Aminocaproic acid
omega-Aminocarboxylic
acids, aliphatic, linear
(C6-C12)
000693-57-2 12-Aminododecanoic
acid
D
D
8
9
12761
12763
000141-43-5 2-Aminoethanol
Same 22337
and 67420
+
+
+
DIR
SML = 0.05 mg/kg
3
DIR
SML = 0.05 mg/kg.
Not for use in polymers
contacting foods for
which simulant D is
laid down in Directive
85/572/EEC and for
indirect food contact
only, behind the PET
layer
3
30
+
t-TDI: 0.1 mg/kg b.w.
Available: 13-week oral rat study, 2 negative
mutagenicity studies. (RIVM summary data,
April 1991)(CS/PM/921).
Needed: in-vitro chromosome aberration and
gene mutation in mammalian cells.
SCF_List 8
Needed data or information:
Data according to the new SCF-Guidelines.
See SCF evaluation in the website:
http://europa.eu.int/comm/food/fs/sc/scf/out
181_en.pdf
+
+
+
+
+
R = 0.05 mg/kg of food.
Mutagenicity tests are negative and
migration is low (less than 50 ppb).
(RIVM/TNO doc. CS/PM/2162).
R = 0.05 mg/kg of food.
Available: migration data from multilayer
bottle and residual content in polymer; gene
mutation assay in bacteria (negative);
chromosomal aberration assay in cultured
mammalian cells (negative); gene mutation
assay in cultured mammalian cells
(negative); in vitro cell transformation assay
(negative); toxicology summary on
reproductive toxicity; general toxicological
overview on MEA (made by the applicant).
RIVM/TNO SDS, August 1999 =
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
CS/PM/3337/22337.
Remark: substance evaluated only for the
requested use of indirect contact with nonfatty food.
12765
084434-12-8 N-(2-Aminoethyl)-betaalanine, sodium salt
Same 35180
DIR
SML = 0.05 mg/kg
3
(Adopted at the 121 SCF meeting (20 June
2000))
http://europa.eu.int/comm/food/fs/sc/scf/out
62_en.pdf
R = 0.05 mg/kg of food
http://europa.eu.int/comm/food/fs/sc/scf/out
61_en.pdf
+
Available: specific migration in 3% acetic
acid, 15% ethanol and 95% ethanol < 0.03
mg/kg food; gene mutation assay in bacteria
(negative); chromosomal aberration assay in
cultured mammalian cells (negative); gene
mutation assay in cultured mammalian cells
(negative)
RIVM/ISS/TNO SDS, November 1999 =
CS/PM/3352 REV. I/35180.
12771
000111-41-1 N-(2Same 35284
Aminoethyl)ethanolamin
e
12772
12775
000140-31-8 N-Aminoethylpiperazine
000124-68-5 2-Amino-2-methyl-1-
W7
8
8
31
Remark for Commission:
* Send a letter to the applicant, concerning
the "preparation" of the petition (poor
quality of the dossier)
* The commercial product (as 40% aqueous
solution) is tested in the mutagenicity assays
(Adopted at the 121 SCF meeting (20 June
2000))
Available: Mutagenicity tests, migration
data inadequate.
Needed: Validation of analytical methods, in
vitro chromosomal aberration study in
mammalian cells.
(RIVM Doc. CS/PM/2164).
+
+
+
REF_N
12786
CAS_N
NAME
propanol
000919-30-2 3Aminopropyltriethoxysil
ane
12788
002432-99-7 11-Aminoundecanoic
acid
12789
007664-41-7 Ammonia
12789/5
12790
12795
12820
12850
12880
12910
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
3AM
DIR
3
SML = 5 mg/kg
3
DIR
1
D
W
8
D
DIR
2
029602-44-6 Azelaic acid, bis(2hydroxyethyl) ester
000123-98-8 Azelaic acid dichloride
D
8
D
7
001732-10-1 Azelaic acid, dimethyl
ester
D
8
009037-22-3 Amylopectin
000080-46-6 p-tert-Amylphenol
Anhydrides of acids,
aliphatic,
monocarboxylic (C2C24)
000123-99-9 Azelaic acid
Same 35320
SCF
List
32
EFSA/SCF_OP
PL
Residual extractable content of 3aminopropyltriethoxysilane to be
less than 3 mg/kg filler.
Remark for the Commission: Used only for
the reactive surface treatment of inorganic
fillers.
http://www.efsa.eu.int/science/afc/afc_opini
ons/890/afc_op_ej201_fcm1.pdf
R: 5 mg/kg of foods.
Available: 3-month oral mouse and rat
study, 2-year oral mouse and rat studies,
several in vitro and in vivo mutagenicity
tests negative.
ADI: not specified.
(SCF, 25th Series, 1991).
+
CT
+
+
+
+
+
+
Group TDI: 3 mg/kg b.w.
A subacute oral rat study and absence of
mutagenicity in bacterial systems with
azelaic acid and a subacute oral rat study
with sebacic acid.
(Arch. f. Exp. Path. u. Pharmak., 197, 1941,
587-610).
+
+
Needed: hydrolysis and migration data.
Pending these results necessity for further
studies to be considered.
http://europa.eu.int/comm/food/fs/sc/scf/out
161_en.pdf
Group R : 0.05 mg/kg b.w.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
migration exceeds 0.050 mg/kg, peroxisome
proliferation studies too.
12940
12970
004080-88-0 Azelaic acid, diphenyl
ester
004196-95-6 Azelaic anhydride
12974
BADGE
Same
13510;
13610;
39700
D
8
DIR
2
According to
Commission Directive
2002/16/EC of 20
February 2002 on the
use of certain epoxy
derivatives in materials
and articles intended to
come into contact with
foodstuffs
33
2-3
+
Group TDI: 3 mg/kg b.w.
Included in the group TDI for azelaic acid.
On the basis of the available experimental
data, a TDI can be established for BADGE
and its hydrolysis products. Considering the
NOAEL of 15 mg/kg b.w./day observed in
the oral chronic toxicity/carcinogenicity
study in the rat with BADGE, and applying
an uncertainty factor of 100, a TDI of 0.15
mg/kg b.w. can be established for BADGE.
As BADGE is rapidly and extensively
metabolised in vivo into the corresponding
mono- and bis-diol derivatives, the Panel
includes these in the TDI.
For the other regulated BADGE reaction
products, i.e. the BADGE chlorohydrins
BADGE.2HCl, BADGE.HCl,
BADGE.HCl.H2O, in view of the lack of
genotoxicity, the Panel considers that the
current restriction of 1 mg/kg of food
remains appropriate.
The Panel is aware that other BADGE
reaction products, with undefined
toxicological properties
and chemical identity, may be found at low
levels in the migrate from epoxy coatings.
For the assessment of these, and in general
of minute amounts of unknown migrants
from food contact materials, a general
approach is currently under consideration by
the Panel.
EFSA opinion from 13 July 2004
http://www.efsa.eu.int/science/afc/afc_opini
ons/508/opinion_afc13_ej86_badge_v2_en1.
pdf
See the individual opinion on the substance
+
+
+
+
REF_N
12976
CAS_N
NAME
054208-63-8 BFDGE
12980
12983/1
13000
008015-74-5 Beechnut oil
Beechnut oil fatty acids
001477-55-0 1,3Benzenedimethanamine
13030
000539-48-0 1,4Benzenedimethanamine
000528-44-9 1,2,4Benzenetricarboxylic
acid
004422-95-1 1,3,5Benzenetricarboxylic
acid trichloride
13050
13060
SYNONIM
Same
13460;
39665
DIR
D
DIR
RESTRICTIONS
AND
SPECIFICATIONS
According to
Commission Directive
2002/16/EC of 20
February 2002 on the
use of certain epoxy
derivatives in materials
and articles intended to
come into contact with
foodstuffs
Can still be used in
heavy duty coatings
SML = 0.05 mg/kg
Same 37400
D
Same 25540
DIR
See "Trimellitic acid"
DIR
QMA = 0.05 mg/6
dm² measured as 1,3,5benzenetricarboxylic
acid.
SCF
List
7
3
3/D
3
EFSA/SCF_OP
(CS/PM/2812 Rev.1) which is reported in
the Internet website:
http://europa.eu.int/comm/food/fs/sc/scf/out
28_en.pdf
http://europa.eu.int/comm/food/fs/sc/scf/out
76_en.pdf
Food fat.
Constituents of food fats.
R: 0.05 mg/kg of food.
Mutagenicity tests are negative and
migration is very low (less than 5 ppb).
8
34
PL
CT
+
+
+
+
+
+
+
+
3
R = 0.05 mg/6 dm² measured as 1,3,5benzenetricarboxylic acid.
Available: Calculation of worst case
migration assuming 100% migration of
residual monomer, three (negative) in vitro
mutagenicity studies.
Remark for Commission: no method of
analysis is available for the enforcement of
an SML.
(RIVM/ISS/TNO SDS, October 1997 =
CS/PM/3075/13060)
(Adopted at 111th SCF meeting (18-19
March 1998)).
http://europa.eu.int/comm/food/fs/sc/scf/out
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
+
+
Group ADI: 5 mg/kg b.w.
(JECFA 27 M., 1983).
Needed: hydrolysis data.
Group ADI: 5 mg/kg b.w. in the ADI for
benzoic acid.
(SCF, 11th Series, 1981).
http://europa.eu.int/comm/food/fs/sc/scf/out
76_en.pdf
+
+
+
+
+
+
+
R = 0.05 mg/kg of food.
+
10_en.pdf
13075
000091-76-9 Benzoguanamine
Same 15310
DIR
13090
000065-85-0 Benzoic acid
Same 37600
DIR
1
13120
13150
000769-78-8 Benzoic acid, vinyl ester
000100-51-6 Benzyl alcohol
Same 38400
D
DIR
7
1
13160
039817-09-9 BFDGE and NOGE
(inserted for memo)
13180
000498-66-8 Bicyclo[2.2.1]hept-2-ene Same 22550
See:
12976;
13460;
39665;
22552;
68200
D
DIR
See "2,4-Diamino-6phenyl-1,3,5-triazine"
According to
Commission Directive
2002/16/EC of 20
February 2002 on the
use of certain epoxy
derivatives in materials
and articles intended to
come into contact with
foodstuffs.
Can still be used in
heavy duty coatings.
SML = 0.05 mg/kg
7
3
http://europa.eu.int/comm/food/fs/sc/scf/out
16_en.html
13210
001761-71-3 Bis(4Aminocyclohexyl)metha
DIR
SML = 0.05 mg/kg
35
3
Available: Adequate migration data;
adequate Ames test (negative); adequate
gene mutation assay in cultured mammalian
cells (negative); inadequate chromosomal
aberration assay in cultured mammalian
cells; adequate chromosomal aberration
assay in cultured mammalian cells
(negative).
(RIVM/ISS/TNO SDS, January 1998 =
CS/PM/2851 REV. I/13180).
(adopted at 113rd SCF meeting)(17-18
September 1998)
R = 0.05 mg/kg of food.
Available: Adequate migration data and
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
ne
13240
13250
13270
13300
13317
13323
003377-24-0 2,2-Bis(4aminocyclohexyl)propan
e
000101-77-9 Bis(4aminophenyl)methane
022287-56-5 4,4'-Bis(4chlorophenylsulphonyl)b
iphenyl
038050-97-4 1,4-Bis(4',4''dihydroxytriphenylmethy
l)benzene
132459-54-2 N,N'-Bis[4(ethoxycarbonyl)phenyl]
-1,4,5,8naphthalenetetracarboxy
diimide
000102-40-9 1,3-Bis(2hydroxyethoxy)benzene
EFSA/SCF_OP
PL
CT
analytical report, showing specific migration
of bis(4-aminocyclohexyl)methane is < 0.05
mg/kg food; inadequate report of gene
mutation test in bacteria; gene mutation
assay in bacteria (negative); chromosomal
aberration assay in cultured mammalian
cells (negative); gene
mutation assay in cultured mammalian cells
(negative).
(RIVM/ISS/TNO SDS, April 1998 =
CS/PM/ 2852 REV. I /13210).
(Adopted at 114th SCF meeting) (10
December 1998)
http://europa.eu.int/comm/food/fs/sc/scf/out
20_en.pdf
D
8
4A
D
+
Considered as genotoxic carcinogen.
Available: 2 oral carcinogenicity studies in
rats and mice, positive Ames test
(CS/PM/2009).
+
W8
+
D
8
+
3AM
3
DIR
SML = 0.05 mg/kg
36
3
Restriction: 0.05 mg/kg food
Remark for Commission: FRF is applicable
N,N'-Bis[4-(ethoxycarbonyl)phenyl]1,4,5,8naphthalenetetracarboxydiimide
(> 98.1 %) is requested as a co-monomer
(max. 4 %) for polyesters (like
PET, PBT).
http://www.efsa.eu.int/science/afc/afc_opini
ons/468/opinion11_afc_ej65_list4_en1.pdf
Restriction: 0.05 mg/kg of food.
http://europa.eu.int/comm/food/fs/sc/scf/out
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
+
+
140_en.pdf
13326
000111-46-6 Bis(2-hydroxyethyl)
ether
13328
000104-38-1 Bis(2-hydroxyethyl)
ether of hydroquinone
Bis(2-hydroxyethyl)ether
of hydroquinone and its
condensation products
with propylene oxide
001620-68-4 2,6-Bis(2-hydroxy-5methylbenzyl)-4methylphenol
000077-99-6 2,2-Bis(hydroxymethyl)- Same 25600,
1-butanol
39560 and
94960
000105-08-8 1,4Same 14880
Bis(hydroxymethyl)cycl
ohexane
004767-03-7 2,2Bis(hydroxymethyl)propi
onic acid
13330
13360
13380
13390
13395
13420
000843-55-0 1,1-Bis(4hydroxyphenyl)cyclohex
ane
Same
15760,39160
and 47680
DIR
See "Diethyleneglycol"
D
8
+
D
9
+
D
7
DIR
See "1,1,1-Trimethylol
propane"
DIR
DIR
Needed: 90-day oral study, migration data.
+
3
QMA = 0.05 mg/6
dm²
D
3
8
37
+
A limited 36-day oral rat study showed no
adverse effects at 50 mg/kg b.w./day.
(Eastman Kodak report, April 1966).
R: 0.05 mg/kg of food.
http://europa.eu.int/comm/food/fs/sc/scf/out
61_en.pdf
Available: calculation of worst case
migration based on extraction values;
analytical method for quantification in
aqueous simulants and in 95% ethanol is
properly described; gene mutation assay in
bacteria (negative); chromosomal aberration
assay in cultured mammalian cells
(negative); gene mutation assay in cultured
mammalian cells (negative).
RIVM/FR SDS, November 1999 =
CS/PM/3358 REV. I/13395.
Remark for Commission: No method of
analysis in olive oil is available. A QMA
would be indicated. (Adopted at the 121)
+
+
+
+
+
REF_N
13450
13453
CAS_N
NAME
SYNONIM
000125-13-3 3,3-Bis(4hydroxyphenyl)-2indolinone
001333-16- Bis(hydroxyphenyl)meth
0;087139ane, mixture of Bis(240and 4- and 2,4
0;002467hydroxyphenyl)methane
029;000620928;00246703-0
DIR
RESTRICTIONS
AND
SPECIFICATIONS
D
SCF
List
8
7
13455
002467-02-9 Bis(2hydroxyphenyl)methane
Same 13615
7
13457
000620-92-8 Bis(4hydroxyphenyl)methane
Same 39650
7
13460
054208-63-8 Bis(2Same 39665;
hydroxyphenyl)methane
12976
bis(2,3-epoxypropyl)
ether (=BFDGE)
13465
000126-00-1 4,4Same 16525
Bis(hydroxyphenyl)penta
noic acid
000080-05-7 2,2-Bis(4Same
hydroxyphenyl)propane 13607/3968
0/62540/400
13480
D
EFSA/SCF_OP
According to
Commission Directive
2002/16/EC of 20
February 2002 on the
use of certain epoxy
derivatives in materials
and articles intended to
come into contact with
foodstuffs.
Can still be used in
heavy duty coatings.
7
PL
+
SCF_list: 7.
Needed:
-A properly validated method including data
for the determination of Bisphenol F in a
typical final product
Or
A properly validated method including data
concerning the specific migration into food
simulants of Bisphenol F from a typical final
product.
http://europa.eu.int/comm/food/fs/sc/scf/out
172_en.pdf
SCF_list: 7.
See 13453.
http://europa.eu.int/comm/food/fs/sc/scf/out
172_en.pdf
SCF_list: 7.
See 13453.
http://europa.eu.int/comm/food/fs/sc/scf/out
172_en.pdf
http://europa.eu.int/comm/food/fs/sc/scf/out
76_en.pdf
+
+
+
+
+
+
8
DIR
SML(T) = 0.6 mg/kg
(28)
38
2
CT
+
See the specific opinion on this substances
adopted on 17, April 2002.
http://europa.eu.int/comm/food/fs/sc/scf/out
+
+
REF_N
CAS_N
NAME
13510
001675-54-3 2,2-Bis(4hydroxyphenyl)propane
bis(2,3-epoxypropyl)
ether (=BADGE)
13518
025036-25-3 2,2-bis(4-
SYNONIM
60/19255
Same
12974;
13610;
39700
DIR
DIR
RESTRICTIONS
AND
SPECIFICATIONS
According to
Commission Directive
2002/16/EC of 20
February 2002 on the
use of certain epoxy
derivatives in materials
and articles intended to
come into contact with
foodstuffs
SCF
List
2-3
W
39
EFSA/SCF_OP
128_en.pdf
On the basis of the available experimental
data, a TDI can be established for BADGE
and its hydrolysis products. Considering the
NOAEL of 15 mg/kg b.w./day observed in
the oral chronic toxicity/carcinogenicity
study in the rat with BADGE, and applying
an uncertainty factor of 100, a TDI of 0.15
mg/kg b.w. can be established for BADGE.
As BADGE is rapidly and extensively
metabolised in vivo into the corresponding
mono- and bis-diol derivatives, the Panel
includes these in the TDI.
For the other regulated BADGE reaction
products, i.e. the BADGE chlorohydrins
BADGE.2HCl, BADGE.HCl,
BADGE.HCl.H2O, in view of the lack of
genotoxicity, the Panel considers that the
current restriction of 1 mg/kg of food
remains appropriate.
The Panel is aware that other BADGE
reaction products, with undefined
toxicological properties
and chemical identity, may be found at low
levels in the migrate from epoxy coatings.
For the assessment of these, and in general
of minute amounts of unknown migrants
from food contact materials, a general
approach is currently under consideration by
the Panel.
EFSA opinion from 13 July 2004
http://www.efsa.eu.int/science/afc/afc_opini
ons/508/opinion_afc13_ej86_badge_v2_en1.
pdf
See the individual opinion on the substance
(CS/PM/2812 Rev.1) which is reported in
the Internet website:
http://europa.eu.int/comm/food/fs/sc/scf/out
28_en.pdf
PL
CT
+
+
+
REF_N
13520
CAS_N
NAME
SYNONIM
RESTRICTIONS
AND
SPECIFICATIONS
hydroxyphenyl)propane 2,2-bis(4hydroxyphenyl)propane
bis(2,3-epoxypropyl)
ether, copolymer
000116-37-0 2,2-Bis(4hydroxyphenyl)propane
bis(2hydroxypropyl)ether
038103-06-9 2,2-Bis(4Same 13614
hydroxyphenyl)propane,
bis(phthalic anhydride)
13540
002444-90-8 2,2-Bis(4hydroxyphenyl)propane,
disodium salt
129188-99-4 1,1-Bis(4hydroxyphenyl)-3,3,5trimethylcyclohexane
13550
000110-98-5 Bis(hydroxypropyl) ether
13560
005124-30-1 Bis(4-
SCF
List
3
13530
13545
DIR
DIR
SML = 0.05 mg/kg
3
EFSA/SCF_OP
PL
R: 0.05 mg/kg of food (only to be used in
the manufacture of adhesives).
Available: 3 mutagenicity studies, negative.
The worst case calculation as component of
an adhesive gives a maximum migration
value less than 50 ppb.
(RIVM doc. 1994-11-08 = CS/PM/2460).
R: 0.05 mg/kg of food.
1 month oral rat study, 3 mutagenicity tests
and migration data.
(Rivm doc. 90/678908/010).
+
D
W7
DIR
Same 15700
DIR
See
"Dipropyleneglycol"
See
40
CT
+
+
Available: specific migration data < 0.05
mg/kg food; gene mutation assay in bacteria
(negative); chromosomal aberration assay in
cultured mammalian cells (negative); gene
mutation assay in cultured mammalian cells
(negative); micronucleus assay (negative);
acute toxicity data; 90-day oral rat study;
reproduction study; teratogenicity study;
scientific statement provided by the
applicant.
Needed: test for endocrine activity in
accordance with US-EPA tiered approach.
RIVM/TNO SDS, February 2000 =
CS/PM/2644 REV.III/13545.
(Adopted at the 123rd SCF meeting, 19
October 2000)
http://europa.eu.int/comm/food/fs/sc/scf/out
76_en.pdf
+
+
+
+
+
REF_N
CAS_N
NAME
isocyanatocyclohexyl)me
thane
1,3 - bis(alphaisocyanatoisopropyl)ben
zene
1,3Bis(methoxymethyl)urea
3,3-Bis(3-methyl-4hydroxyphenyl)-2indolinone
Bisphenol A
13565
002778-42-9
13570
000141-07-1
13600
047465-97-4
13607
000080-05-7
13610
001675-54-3 Bisphenol A bis(2,3epoxypropyl)ether
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
"Dicyclohexylmethane4,4'-diisocyanate"
W
D
Same
13480/6254
0/40060/192
55/39680
Same
13510;
39700;
12974
+
8
DIR
SML = 1.8 mg/kg
DIR
See "2,2-Bis(4hydroxyphenyl)propan
e"
DIR
See "2,2-Bis(4hydroxyphenyl)propan
e bis(2,3epoxypropyl)ether"
41
2
2-3
+
TDI: 0.03 mg/kg b.w.
A 90-day oral rat study.
(Bayer Bericht Nr. 8086, January 3, 1979).
Under re-evaluation
http://europa.eu.int/comm/food/fs/sc/scf/out
128_en.pdf
+
+
+
On the basis of the available experimental
data, a TDI can be established for BADGE
and its hydrolysis products. Considering the
NOAEL of 15 mg/kg b.w./day observed in
the oral chronic toxicity/carcinogenicity
study in the rat with BADGE, and applying
an uncertainty factor of 100, a TDI of 0.15
mg/kg b.w. can be established for BADGE.
As BADGE is rapidly and extensively
metabolised in vivo into the corresponding
mono- and bis-diol derivatives, the Panel
includes these in the TDI.
For the other regulated BADGE reaction
products, i.e. the BADGE chlorohydrins
BADGE.2HCl, BADGE.HCl,
BADGE.HCl.H2O, in view of the lack of
genotoxicity, the Panel considers that the
current restriction of 1 mg/kg of food
remains appropriate.
The Panel is aware that other BADGE
reaction products, with undefined
toxicological properties
and chemical identity, may be found at low
levels in the migrate from epoxy coatings.
For the assessment of these, and in general
of minute amounts of unknown migrants
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
from food contact materials, a general
approach is currently under consideration by
the Panel.
EFSA opinion from 13 July 2004
http://www.efsa.eu.int/science/afc/afc_opini
ons/508/opinion_afc13_ej86_badge_v2_en1.
pdf
See the individual opinion on the substance
(CS/PM/2812 Rev.1) which is reported in
the Internet website:
http://europa.eu.int/comm/food/fs/sc/scf/out
28_en.pdf
13614
038103-06-9 Bisphenol A bis(phthalic Same 13530
anhydride)
13615
002467-02-9 Bisphenol F
Same 13455
13617
000080-09-1 Bisphenol S
Same 16090
13618
16068-37-4
13620
1,2Bis(triethoxysilyl)ethane
010043-35-3 Boric acid
Same 40320
DIR
See "2,2-Bis(4hydroxyphenyl)propan
e, bis(phthalic
anhydride)"
+
7
DIR
SCF_list: 7.
See 13453.
http://europa.eu.int/comm/food/fs/sc/scf/out
172_en.pdf
See "4,4'Dihydroxydiphenyl
sulphone"
+
+
W
DIR
SML(T) = 6 mg/kg
(23) (expressed as
Boron) without
prejudice to the
provisions of Directive
98/83/EC on water for
human consumption
(*).
42
2
+
+
Re-evaluation on the basis of an opinion of
the SCF in another context.
Group-TDI = 0.1 mg/kg b.w. (as B) (with
REF_n. 36840, 40320 and 87040).
The TDI is based on the No Adverse Effect
Level (NOAEL) of 9.6 mg/kg b.w./day for
effects on fetal body weight and skeletal
anomalies in the rat developmental study. A
Safety Factor (SF) of 100 is used.
“Opinion of the Scientific Committee on
Food on Arsenic, Barium, Fluoride, Boron
and Manganese in Natural Mineral Waters
(expressed on 13 December 1996, 105th
plenary meeting of the SCF, completed on
13 June 1997 at the 107th plenary meeting
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
13630
000106-99-0 Butadiene
DIR
13660
13690
000584-03-2 1,2-Butanediol
000107-88-0 1,3-Butanediol
D
DIR
13720
000110-63-4 1,4-Butanediol
Same 40580
DIR
RESTRICTIONS
AND
SPECIFICATIONS
QM = 1 mg/kg in FP or
SML =ND (DL =0.020
mg/kg, analytical
tolerance included)
SCF
List
4A
8
1
SML(T) = 0.05 mg/kg
(24)
3
EFSA/SCF_OP
of the SCF; 43rd Series of Reports of the
SCF, 2000”. This opinion is also available
on Internet.
(Adopted by the SCF at the 127th meeting,
30 May 2001)
http://europa.eu.int/comm/food/fs/sc/scf/out
86_en.pdf
Suspected of having carcinogenic potential
(NTP report 83-071, NIH publ. n. 84-2544,
1983).
ADI: 4 mg/kg b.w.
(JECFA 23 M., 1979).
5 mg/kg food
PL
CT
+
+
+
+
+
+
+
+
+
+
+
+
http://www.efsa.eu.int/science/afc/afc_opini
ons/675/afc_opinion20_ej109_list5_en1.pdf
http://europa.eu.int/comm/food/fs/sc/scf/out
86_en.pdf
13750
13780
000513-85-9 2,3-Butanediol
002425-79-8 1,4-Butanediol bis(2,3epoxypropyl) ether
13810
000505-65-7 1,4-Butanediol formal
D
DIR
Same 21821
DIR
QM = 1 mg/kg in FP
(expressed as Epoxy
group, Mw=43)
QMA = 0.05 mg/6 dm²
43
8
4A
3
Genotoxic similar to glycidylethers.
(CS/PM/2958).
R = 0.05 mg/kg of food.
http://europa.eu.int/comm/food/fs/sc/scf/out
76_en.pdf
Available: calculated (worst case) migration
is < 0.05 mg/kg of food; gene mutation
assay in bacteria (negative); chromosomal
aberration assay in cultured mammalian
cells (positive); gene mutation assay in
cultured mammalian cells (negative);
micronucleus assay (negative); in vivo UDS
assay (negative)
RIVM/ISS/TNO SDS, January 2000 =
CS/PM/2853 REV.I/13810.
Remark for Commission: only a method for
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
13840
000071-36-3 1-Butanol
Same 40590
13845
000075-65-0 tert-Butanol
Same 40594
13870
000106-98-9 1-Butene
DIR
3
13900
000107-01-7 2-Butene
DIR
3
13930
13932
006117-91-5 2-Buten-1-ol
000598-32-3 3-Buten-2-ol
Same 40610
DIR
SCF
List
3
3
D
DIR
QMA = ND (DL =
0.02 mg/6 dm²). To be
used only as a comonomer for the
preparation of
polymeric additive
44
8
4A
EFSA/SCF_OP
the residual quantity in the finished product
(FP) is available. A QMA is proposed.
(Adopted at the 123rd SCF meeting, 19
October 2000)
See references for "Alcohols, aliphatic,
monohydric, saturated, linear, primary (C4C22)" (PM/REF.N. 12375) in SCF list 3.
Residue in food less than 10 mg/kg.
(EHC,65).
Residues of this gas in plastics are very
small. The gas has low toxic potential.
Migration into food will be toxicologically
negligible. (Patty's Industrial Hygiene and
Toxicology, 3rd ed. 1981).
Residues of this gas in plastics are very
small. The gas has low toxic potential.
Migration into food will be toxicologically
negligible.
(Patty's Industrial Hygiene and Toxicology,
3rd ed. 1981).
n.d. (DL = 0.01 mg/kg)
Available: worst case migration of <= 0.008
mg/kg in the case of use as co-monomer of a
polymeric additive, made from less then
10% 1-buten-3-ol and used at less then 2.5%
in PVC; gene mutation assay in bacteria
(negative); chromosomal aberration assay in
cultured mammalian cells (positive); gene
mutation assay in cultured mammalian cells
(weakly positive).
RIVM/FR SDS, January 2000 =
CS/PM/3151 REV. III/13932.
Remark for Commission: only a method for
the determination of the residual content is
available.
(Adopted at the 121 SCF meeting (20 June
2000))
http://europa.eu.int/comm/food/fs/sc/scf/out
62_en.pdf
PL
CT
+
+
+
+
+
+
+
+
+
REF_N
13960
CAS_N
NAME
SYNONIM
14001
14002
001852-16-0 N(Butoxymethyl)acrylami
de
005153-77-5 N(Butoxymethyl)methacry
lamide
001320-16-7 tert-Butylbenzoic acid
000098-73-7 p-tert-Butylbenzoic acid
14005
14008
14020
000098-29-3 4-tert-Butylcatechol
Same 40640
000098-52-2 4-tert-Butylcyclohexanol
000098-54-4 4-tert-Butylphenol
Same 40850
14035
14050
14080
001746-23-2 4-tert-Butylstyrene
000111-34-2 Butyl vinyl ether
000926-02-3 tert-Butyl vinyl ether
14095
14110
000503-17-3 2-Butyne
000123-72-8 Butyraldehyde
13990
14140
14170
14185
14188/1
14200
000107-92-6
000106-31-0
008015-80-3
000105-60-2
Butyric acid
Butyric anhydride
Candlenut oil
Candlenut oil fatty acids
Caprolactam
Same 41840
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
D
6A
+
+
D
6A
+
+
8
7
D
DIR
SML = 0.05 mg/kg
8
8
3
D
D
D
6A
7
7
DIR
8
3
DIR
DIR
DIR
SML(T) = 15 mg/kg
45
0
3
8
8/D
2
+
+
Available: some data at RIVM.
Needed: migration and mutagenicity studies.
+
R = 0.05 mg/kg of food.
Available: Adequate migration data for
polycarbonate; calculation of worst-case
migration for epoxy systems and butylated
alkylphenolic resins; three (negative)
mutagenicity studies.
(RIVM/TNO SDS, March 1997 =
CS/PM/2991 /14020).
(Adopted at 111th SCF meeting (18-19
March 1998))
http://europa.eu.int/comm/food/fs/sc/scf/out
10_en.pdf
Needed: hydrolysis data.
Needed: provided hydrolysis can be
demonstrated, data on tert-butanol are
requested.
Occurs naturally in food. Used as flavour in
food at 0.1-10 mg/kg. Migration into food
would be self-limiting because of its taste.
Hydrolyses to corresponding acid.
Group TDI = 0.25 mg/kg b.w.
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
(5)
14230
002123-24-2 Caprolactam, sodium salt
14260
000502-44-3 Caprolactone
DIR
Same 41880
SML(T) = 15 mg/kg
(5) (expressed as
Caprolactam)
DIR
2
3
EFSA/SCF_OP
Two 90-day oral rat studies and 90-day oral
studies in mice and dogs.
(CIVO report 3489 June 1971 and NTP
Tech. Rep. Ser. 214, NTP 80-26).
Group TDI = 0.25 mg/kg b.w.
See references for caprolactam.
0.05 mg/kg food expressed as the sum of
caprolactone and 6-hydroxyhexanoic acid
PL
CT
+
+
+
+
+
+
+
+
+
+
+
+
http://www.efsa.eu.int/science/afc/afc_opini
ons/675/afc_opinion20_ej109_list5_en1.pdf
http://europa.eu.int/comm/food/fs/sc/scf/out
41_en.pdf
14290
14320
14350
14380
Caprolactone, substituted
000124-07-2 Caprylic acid
Same 41960
and 68560
000630-08-0 Carbon monoxide
000075-44-5 Carbonyl chloride
Same 23155
14390
14411
Cardura
008001-79-4 Castor oil
14440
14445
14450/1
14453
14470
14500
Same 42880
064147-40-6 Castor oil, dehydrated
Same 42960
Castor oil fatty acids
Castor oil fatty acids,
dehydrated
061790-39-4 Castor oil fatty acids,
hydrogenated
008001-78-3 Castor oil, hydrogenated Same 43120
009004-34-6 Cellulose
Same 43280
D
DIR
DIR
DIR
9
0
3
4A
Low migration.
Residues of this gas in plastics will be very
small. It is readily hydrolysed to CO2 and
HCl. Has a strong odour. Migration into
food would therefore be self-limiting.
DIR
3
D
3
3/D
3
SCF_List: 3
Restriction: none. In small doses
metabolised similarly to food fats
See SCF evaluation in the website:
http://europa.eu.int/comm/food/fs/sc/scf/out
181_en.pdf
Similar to food fats.
Constituents of food fats.
Identical with or similar to constituents of
food fats.
Identical with or similar to constituents of
food fats.
Similar to food fats.
QM = 1 mg/kg in FP
3
D
DIR
3
0
46
+
+
+
+
+
+
+
+
+
REF_N
14505
14508
CAS_N
NAME
SYNONIM
14527
14530
009004-35-7 Cellulose acetate
009004-36-8 Cellulose acetate
butyrate
009004-39-1 Cellulose acetate
propionate
008001-20-5 Chinawood oil
Chinawood oil fatty
acids
000115-28-6 Chlorendic acid
007782-50-5 Chlorine
14560
000126-99-8 2-Chloro-1,3-butadiene
14570
000106-89-8 1-Chloro-2,3Same 16750
epoxypropane
001204-28-0 4-(Chloroformyl)phthalic Same 13140
anhydride
and 25552
14512
14520
14523/1
14587
DIR
RESTRICTIONS
AND
SPECIFICATIONS
Same 43300
SCF
List
EFSA/SCF_OP
PL
3
3
Inert material, modified natural cellulose.
Inert material, modified natural cellulose.
+
+
3
Inert material, modified natural cellulose.
+
8
8/D
+
+
Same 18250
DIR
3
D
6A
DIR
Residues of this gas in plastics will be very
small. Migration into food would be selflimiting because of odour.
All data considered show that chloroprene is
hepatotoxic, teratogenic, mutagenic and
causes chromosomal abnormalities in
exposed workers. It affects testicular
function in man and animals.
See "Epichlorohydrin"
+
+
+
+
3
47
CT
QM = 0.05 mg/6 dm² for the chloride to be
measured as trimellitic acid.
Available: Hydrolysis data; calculation of
worst case migration assuming 100%
migration of residual trimellitic acid; two
Ames assays (negative); two in vitro
cytogenetic assays in Chinese hamster cells
(negative); two HPRT assys (negative);
acute oral toxicity data; subacute oral
toxicity in the rat (trimellitic acid);
inadequate subchronic oral toxicity in rat
and guinea pig; teratogenicity study in the
rat and guinea pig by inhalation; dermal
effects in rabbit (trimellitic acid); effect on
immune system by inhalation; eye irritation
study in rabbit (trimellitic acid); sensitisation
study in guinea pigs.
(RIVM/ISS/TNO SDS, October 1997 =
CS/PM3080/14587).
(Adopted at 111th SCF meeting (18-19
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
March 1998))
http://europa.eu.int/comm/food/fs/sc/scf/out
10_en.pdf
14590
14620
14650
000615-67-8 Chlorohydroquinone
057981-99-4 Chlorohydroquinone
diacetate
000079-38-9 Chlorotrifluoroethylene
14680
000077-92-9 Citric acid
14685
008001-31-8 Coconut oil
D
D
DIR
Same 44160
8
8
QMA = 0.5 mg/6 dm²
DIR
3
1
3
48
+
+
R = 0.5 mg/6 dm². Based on the reduced
core set of toxicological data according to
the migration level.
The substance is extremely volatile and the
toxicity data support an R = 0.05 mg/kg
food. However this is analytically not
enforceable due to the lack of a method for
an SML. The residual content QM = 0.05
mg/6dm2, assuming 100% migration, is
raised 10-fold as it has been demonstrated
that more than 95% of migrants appear in
the headspace because of the extreme
volatility of the additive.
Available: data on residual content of
chlorotrifluoroethylene (CTFE); poor
recovery of CTFE from food simulants;
liquid/vapour partitioning data of CTFE in
food simulants; gene mutation assay in
bacteria (negative); chromosomal aberration
assay in cultured mammalian cells
(negative); gene mutation assay in cultured
mammalian cells (negative); limited in vivo
SCE assay (negative).
RIVM/IT/TNO SDS, March 2001 =
CS/PM/2795 REV. II/14650.
(Adopted at the 128th SCF meeting, 12 July
2001)
http://europa.eu.int/comm/food/fs/sc/scf/out
97_en.pdf
Group ADI: not specified for citric acid and
its salts.
(SCF, 25th Series, 1990).
Food fat.
+
+
+
+
REF_N
14687
14693
14695/1
14698
14700/1
14710
CAS_N
NAME
008050-09-7 Colophony
008001-30-7
008001-29-4
000108-39-4
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
Same
24100,24130
,45055 and
83840
Corn oil
Corn oil fatty acids
Cottonseed oil
Cottonseed oil fatty acids
m-Cresol
DIR
3
3/D
3
3/D
3
14740
000095-48-7 o-Cresol
DIR
3
14770
000106-44-5 p-Cresol
DIR
3
14800
003724-65-0 Crotonic acid
14830
-
14836
Crotonic acid, esters with
alcohols, mono- and
polyhydric
000623-43-8 Crotonic acid, methyl
ester
014861-06-4 Crotonic acid, vinyl ester
14839
000623-68-7 Crotonic anhydride
14833
EFSA/SCF_OP
Same 45600
DIR
QMA(T) = 0.05
mg/6dm² (33)
3
Food fat.
Constituents of food fats.
Food fat.
Constituents of food fats.
28-day oral rat study showed no adverse
effects at 25 mg/kg b.w./day.
(Shell Report, April 1978).
28-day oral rat study showed no adverse
effects at 12 mg/kg b.w./day.
(Shell Report, April 1978).
28-day oral rat study showed no adverse
effect at 25 mg/kg b.w./day.
(Shell Report, April 1978).
SCF_list: 3
Restriction: 0.05 mg/kg of food.
Remark for Commission: A QMA is
proposed (QMA = 0.05 mg/6 dm2), because
only a method for the residual content is
available, however an SML is set for
REF_n. 18888.
See SCF evaluation in the website:
http://europa.eu.int/comm/food/fs/sc/scf/out
141_en.pdf
PL
CT
+
+
+
+
+
+
+
+
+
+
+
+
+
+
D
9
+
D
8
+
7?
6A
49
Needed: provided hydrolysis can be
demonstrated, data on crotonic acid are
requested.
http://europa.eu.int/comm/food/fs/sc/scf/out
161_en.pdf
Needed: information on crotonic acid.
+
+
REF_N
CAS_N
NAME
14841
000599-64-4 4-Cumylphenol
14860
14862
14863
14864
14875
010016-20-3
007585-39-9
017465-86-0
001687-30-5
14880
SYNONIM
DIR
DIR
Cycloalkenes
alpha-Cyclodextrin
same 46070
beta-Cyclodextrin
gamma-Cyclodextrin
1,2Same 18436
Cyclohexanedicarboxylic
acid
000105-08-8 1,4Same 13390
Cyclohexanedimethanol
RESTRICTIONS
AND
SPECIFICATIONS
SML = 0.05 mg/kg
D
DIR
14910
000108-94-1 Cyclohexanone
14920
14950
002842-38-8 2(Cyclohexylamino)ethan
ol
003173-53-3 Cyclohexyl isocyanate
DIR
14980
15010
15020
001631-25-0 N-Cyclohexylmaleimide
001131-60-8 p-Cyclohexylphenol
002182-55-0 Cyclohexyl vinyl ether
D
D
D
15030
000931-88-4 Cyclooctene
SCF
List
3
9
7
7
7
See "1,4Bis(hydroxymethyl)cyc
lohexane"
Same 45720
6A
D
DIR
EFSA/SCF_OP
R = 0.05 mg/kg of food.
Available: migration data, 3 mutagenicity
tests, negative.
(TNO SDS 1995-01-16, RIVM SDS 199405-31).
4A
6A
8
7
SML = 0.05 mg/kg.
For use only in
polymers contacting
foods for which
simulant A is laid
down in Directive
85/572/EEC.
50
3
CT
+
+
Under evaluation
Under evaluation
Under evaluation
+
+
+
+
+
Deleted because same as 13390.
+
Needed: adequate test for gene mutation and
chromosomal aberration.
(IARC (1989), 47, 151-169).
8
QM(T) = 1 mg/kg
(expressed as NCO)
(26).
PL
+
+
See references for 3,3'-dimethyl-4,4'diisocyanatobiphenyl.
Needed: provided hydrolysis can be
demonstrated, data on cyclohexanol are
requested.
R: 0.05 mg/kg of food; only for aqueous
foodstuffs.
Available: migration data from
polyoctenamer and from blends with
polypropylene in aqueous food simulants;
migration data from polyoctenamer in
HB307; three negative mutagenicity studies
performed with cyclooctene; acute toxicity
data.
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
(RIVM/TNO SDS, October 1998 =
CS/PM/2529 REV. III/15030).
(Adopted at 117th SCF meeting) (17 June
1999)
http://europa.eu.int/comm/food/fs/sc/scf/out
37_en.pdf
15040
15060
15070
000542-92-7 1,3-Cyclopentadiene
000142-29-0 Cyclopentene
001647-16-1 1,9-Decadiene
15095
15100
000334-48-5 Decanoic acid
000112-30-1 1-Decanol
15130
000872-05-9 1-Decene
15160
15190
000765-05-9 Decyl vinyl ether
Diamines, aliphatic,
linear (C2-C12)
000088-63-1 2,4Diaminobenzenesulphoni
c acid
000110-60-1 1,4-Diaminobutane
15220
15250
15260
15267
000646-25-3 1,10-Diaminodecane
000080-08-0 4,4'-Diaminodiphenyl
sulphone
D
D
DIR
Same 45940
Same 46050
SML = 0.05 mg/kg
DIR
DIR
DIR
8
8
3
0
3
SML = 0.05 mg/kg
D
D
3
7
9
R: 0.05 mg/kg of food.
5 negative mutagenicity tests, 28-day oral
study, bioaccumulation.
(CS/PM/2221).
Food constituent.
See references for "Alcohols
aliphatic,monohydric, saturated, linear,
primary (C4-C22)" (PM/REF.N 12375) in
SCF list 3.
R = 0,05 mg/kg of food.
Available: Migration data and 3
mutagenicity tests negative.
(RIVM/TNO/ISS SDS CS/PM/2744,
January 1996).
Needed: hydrolysis data.
D
DIR
2
D
8
7
4,4sulfonyldian
iline,
Benzeneami
ne, 4,4
51
+
+
+
+
+
+
+
+
+
+
+
+
TDI: 0.6 mg/kg b.w.
28- and 90-day oral rat studies, mutagenicity
tests.
(RIVM report 88/6788097003, 03-05-1988).
Under evaluation
+
+
+
REF_N
CAS_N
NAME
15270
15272
002783-17-7 1,12-Diaminododecane
000107-15-3 1,2-Diaminoethane
15274
000124-09-4 1,6-Diaminohexane
15280
000542-02-9 2,4-Diamino-6-methyl1,3,5-triazine
000373-44-4 1,8-Diaminooctane
000091-76-9 2,4-Diamino-6-phenyl1,3,5-triazine
15295
15310
15340
15355
000109-76-2 1,3-Diaminopropane
025513-64-8 Mixture of (40% w/w)
1,6-diamino-2,2,4trimethylhexane and
SYNONIM
Same 16960
and 53540
Same 18460
and 59240
DIR
D
DIR
DIR
Same 10155
D
Same 13075
D
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
8
See "Ethylenediamine"
See
"Hexamethylenediamin
e"
8
QMA = 5 mg/6 dm²
D
8
3
8
3
Same 22331
52
Data inadequate.
Restriction : 5 mg/kg of food. Based on the
reduced core set of toxicological data
according to the migration level.
Available : migration data on aqueous food
simulants and 50% ethanol ; log Po/w ; gene
mutation assay in bacteria (negative) ; gene
mutation assay in cultured mammalian cells
(slightly positive at only toxic doses) ;
chromosomal aberration assay in cultured
mammalian cells (positive) ; micronucleus
assay (equivocal) ; micronucleus assay with
extended sampling time (72h) and scoring of
at least 2000 PCE’s per animal (negative) ;
90-day oral rat study and 18 months oral
carcinogenicity studies in mice and rats
(limited studies due to too few animals and
the use of only 2 dose levels).
RIVM/ISS/FR/TNO SDS, October 2001 =
CS/PM/3469 REV. IV/15310.
Remark for Commission: primary amines
can react with oil constituents and therefore
a QMA seems an appropriate type of limit.
(Adopted at the 130th SCF meeting, 13
December 2001)
http://europa.eu.int/comm/food/fs/sc/scf/out
115_en.pdf
Re-evaluation to align this evaluation with
other evaluations done by the SCF.
R = 5 mg/6 dm2.
PL
CT
+
+
+
+
+
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
(60% w/w)1,6-diamino2,4,4-trimethylhexane
15370
003236-53-1 1,6-Diamino-2,2,4trimethylhexane
D
QMA = 5 mg/6 dm².
(Adopted by the SCF at the 127th meeting,
30 May 2001)
http://europa.eu.int/comm/food/fs/sc/scf/out
86_en.pdf
R = 5 mg/6dm2. Same references as for
REF_N. 15370
(Adopted by the SCF at the 127th meeting,
30 May 2001)
http://europa.eu.int/comm/food/fs/sc/scf/out
86_en.pdf
+
003236-54-2 1,6-Diamino-2,4,4trimethylhexane
D
15430
003749-77-7 4,4'Dicarboxydiphenoxybuta
ne
003753-05-7 4,4'-
D
8
+
D
8
+
53
3
Remark for Commission: A QM would be
indicated. The choice of a QM instead of
SML is due to the reactivity of the substance
with fat simulant.
Available: migration data; three negative
mutagenicity studies; 90-day oral rat study;
2-generation reproduction study (rat); two
teratogenicity studies (rat and rabbit).
RIVM/TNO SDS, November 2000 =
CS/PM/2914/15355.
(Adopted by the SCF at the 127th meeting,
30 May 2001)
http://europa.eu.int/comm/food/fs/sc/scf/out
86_en.pdf
R = 5 mg/6 dm2.
Remark for Commission: A QM would be
indicated. The choice of a QM instead of
SML is due to the reactivity of the substance
with fat simulant.
Available: migration data; three negative
mutagenicity studies; 90-day oral rat study;
2-generation reproduction study (rat); two
teratogenicity studies (rat and rabbit).
RIVM/TNO SDS, November 2000 =
CS/PM/2914/15355.
PL
15400
15460
QMA = 5 mg/6 dm²
3
EFSA/SCF_OP
+
CT
REF_N
CAS_N
NAME
Dicarboxydiphenoxyetha
ne
4,4'-Dicarboxydiphenyl
ether
4,4'-Dicarboxydiphenyl
sulphide
4,4'-Dicarboxydiphenyl
sulphone
1,4-Dichlorobenzene
15490
002215-89-6
15520
004919-48-6
15550
002449-35-6
15565
000106-46-7
15580
001653-19-6 2,3-Dichloro-1,3butadiene
000080-07-9 4,4'-Dichlorodiphenyl
sulphone
15610
15640
000156-59-2 cis-1,2-Dichloroethylene
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
D
8
+
D
8
+
D
8
+
DIR
SML = 12 mg/kg
D
DIR
2
TDI : 0.2 mg/kg bw.
A 4-week oral rat study, 3 and 6 month oral
rat and mouse studies, teratogenicity study,
mutagenicity studies not showing
genotoxicity. Oral carcinogenicity studies in
mice and rats indicate that there is limited
evidence of carcinogenic potential in
experimental animals.
(NTP report n. 319, NIH publ, 87-2575,
RIVM report 710401005 April 1991).
6A
SML = 0.05 mg/kg
D
3
8
54
+
CT
+
+
R = 0.05 mg/kg of food. Based on the
reduced core set of toxicological data
according to the migration level, see
Appendix 2
Available: migration data (< 0.05 mg/kg of
food); gene mutation assay in bacteria
(negative); two gene mutation assays in
cultured mammalian cells (one negative and
one positive); micronucleus assay (negative,
however substance did not reach the bone
marrow); in vitro/in vivo UDS assay
(negative).
RIVM/ISS SDS, May 2000 = CS/PM/3062
REV.I/15610.
(Adopted at the 126th SCF meeting, 28
February 2001)
http://europa.eu.int/comm/food/fs/sc/scf/out
84_en.pdf
+
+
+
REF_N
15670
15695
CAS_N
NAME
000156-60-5 trans-1,2Dichloroethylene
000461-58-5 Dicyanodiamide
15700
005124-30-1 Dicyclohexylmethane4,4'-diisocyanate
15730
15735
000077-73-6 Dicyclopentadiene
000111-42-2 Diethanolamine
15760
000111-46-6 Diethyleneglycol
15790
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
D
2
DIR
QM(T) = 1 mg/kg
(expressed as NCO)
(26).
DIR/D
4A
7
8
Same 47620
Same 13326,
39160 and
47680
EFSA/SCF_OP
8
Same 45670
and 47440
Same 13560
SCF
List
DIR
SML(T) = 30 mg/kg
(3)
2
000111-40-0 Diethylenetriamine
DIR
SML = 5 mg/kg
3
15820
000345-92-6 4,4'Difluorobenzophenone
DIR
SML = 0.05 mg/kg
3
15850
15880
000383-29-9 4,4'-Difluorodiphenyl
sulphone
000120-80-9 1,2-Dihydroxybenzene
Same 24051
DIR
SML = 6 mg/kg
2
15910
000108-46-3 1,3-Dihydroxybenzene
Same 24072
DIR
SML = 2.4 mg/kg
2
15940
000123-31-9 1,4-Dihydroxybenzene
Same 18867,
48620 and
DIR
SML = 0.6 mg/kg
2
PL
CT
+
TDI : 1 mg/kg b.w.
2 year oral rat and dog studies and Ames
tests.
(American Cyanamide report 1969).
See references for 3,3'-dimethyl-4,4'diisocyanatobiphenyl.
+
+
+
Under re-evaluation
Data inadequate.
R: contact with food containing nitrite
should be avoided.
Group TDI: 0.5 mg/kg b.w.
(SCF, 17th Series, 1986).
+
+
+
R: 5 mg/kg of food.
Available: 3-month oral rat study, several
mutagenicity studies negative.
(RIVM 90/678608/009).
R : 0.05 mg/kg in food.
Available: three mutagenicity tests negative,
very low migration.(Rivm report, April
1992).
+
+
+
+
+
55
TDI: 0.1 mg/kg b.w.
A 90-day oral rat study, negative in vitro and
in vivo mutagenicity tests, promoting effect
in mouse skin painting assay.
(SCC, 1983).
TDI: 0.04 mg/kg b.w.
A 90-day oral rat study 5 days a week,
metabolism in rabbit and man, several
negative in vitro mutagenicity tests and no
immunosuppressive action.
(Henkel report 29-01-1980).
TDI: 0.01 mg/kg b.w.
(SCF, 17th Series, 1986).
+
+
+
+
+
+
REF_N
CAS_N
NAME
15970
000611-99-4 4,4'Dihydroxybenzophenone
16000
000092-88-6 4,4'-Dihydroxybiphenyl
16030
001965-09-9 4,4'-Dihydroxydiphenyl
ether
002664-63-3 4,4'-Dihydroxydiphenyl
sulphide
000080-09-1 4,4'-Dihydroxydiphenyl
sulphone
16060
16090
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
SYNONIM
DIR
60060
Same 48720
DIR
SML(T) = 6 mg/kg
(15)
2
Same 48760
DIR
SML = 6 mg/kg
2
Same 13617
EFSA/SCF_OP
PL
Group TDI: 0.1 mg/kg b.w. (for 4,4'dihydroxybenzophenone; 2,2'-dihydroxy-4methoxybenzophenone;2-hydroxy-4hexoxybenzophenone;2-hydroxy-4-noctoxybenzophenone).
90-day oral rat studies (2,2'-dihydroxy-4methoxybenzophenone, 2-hydroxy-4methoxybenzophenone, 2-hydroxy-4-noctyloxybenzophenone) a 18-week oral dog
study (2-hydroxy-4-noctyloxybenzophenone) and 2-year rat and
dog studies (2-hydroxy-4-noctyloxybenzophenone), a reproduction
study (2-hydroxy-4-noctyloxybenzophenone) plus metabolism.
(J.Occup.Med. 1969, 11, 703, Food
Cosm.Tox. 1972, 10, 41-50, RIVM report
October 1972).
TDI: 0.1 mg/kg b.w.
90-day oral rat study and limited
mutagenicity studies.
(RIVM Doc/Tox 300/495 June 1984).
+
+
D
8
+
D
8
+
DIR
SML = 0.05 mg/kg
56
3
R = 0.05 mg/kg of food.
Available: the substance is used as a
comonomer for kitchen utensils, mainly
intended for repeated use, and for oven
cooking; migration has been tested upto 218
°C and is always below 0.05 mg/kg food
(aqueous simulants, HB307); gene mutation
assay in bacteria (negative); chromosomal
aberration assay in cultured mammalian
cells (positive); gene mutation assay in
cultured mammalian cells (negative);
micronucleus assay (negative).
RIVM/FR/ISS/TNO SDS, February 2000 =
CT
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
CS/PM/2854 REV. II/16090.
(Adopted at the 121 SCF meeting (20 June
2000))
http://europa.eu.int/comm/food/fs/sc/scf/out
62_en.pdf
16100
16119
16120
060793-35-3 1,4-Dihydroxy-2methylcyclohexane
025167-70-8 Diisobutene
000106-90-1 Glycidyl acrylate
Glycidyl ester of
trialkyl(C5-C15) acetic
acid
000106-91-2 Glycidyl methacrylate
000110-97-4 Diisopropanolamine
16150
000108-01-0 Dimethylaminoethanol
16180
005205-93-6 N(Dimethylaminopropyl)
methacrylamide
000121-69-7 N,N-Dimethylaniline
Same 49280
000616-38-6 Dimethyl carbonate
006864-37-5 3,3'-Dimethyl-4,4'diaminodicyclohexylmet
hane
16115
16116
16118
16190
16200
16210
8
+
8
D
D
Same 11260
Same 20590
Same 49065
D
Same 49235
DIR
D
8
SML = 18 mg/kg
2
D
6A
DIR
8
W8
3
SML = 0.05 mg/kg
(32). To be used only
in polyamides.
+
+
+
R: contact with food containing nitrite
should be avoided.
TDI: 0.3 mg/kg b.w.
A 90-day oral rat study, studies in other
species and observations in man.
(Arch. Ind. Hyg. Occup. Med., 4, 1951, 119122).
+
+
+
000091-97-4 3,3'-Dimethyl-4,4'diisocyanatobiphenyl
DIR
QM(T) = 1 mg/kg
(expressed as NCO)
(26).
57
4A
+
+
+
Data inadequate.
SCF_list:3
Restriction: 0.05 mg/kg of food.
+
+
Remark for Commission: substance is not
stable in fat simulant. Only to be used in
polyamides
16240
+
See SCF evaluation in the website:
http://europa.eu.int/comm/food/fs/sc/scf/out
142_en.pdf
(SCF, 17th Series, 1986).
+
REF_N
16252
16265
16270
16300
16330
16360
16363
16364
16390
CAS_N
NAME
SYNONIM
000110-03-2 2,5-Dimethyl-2,5hexanediol
156065-00-8 alpha-Dimethyl-3-(4'hydroxy-3'methoxyphenyl)propylsil
yloxy, omega-3dimethyl-3-(4'-hydroxy3'methoxyphenyl)propylsil
yl polydimethylsiloxane
000526-75-0 2,3-Dimethylphenol
Same 26377
000105-67-9 2,4-Dimethylphenol
Same 26375
000095-87-4 2,5-Dimethylphenol
Same 26379
000576-26-1 2,6-Dimethylphenol
000095-65-8 3,4-Dimethylphenol
000108-68-9 3,5-Dimethylphenol
000126-30-7 2,2-Dimethyl-1,3propanediol
Same 22437
DIR
RESTRICTIONS
AND
SPECIFICATIONS
D
SCF
List
8
W7
D
D
D
DIR
DIR
EFSA/SCF_OP
SML = 0.05 mg/kg
8
8
8
3
SML = 0.05 mg/kg
8
8
3
58
PL
CT
+
Under evaluation
R = 0.05 mg/kg of food.
Available: Migration data showing not
detectable at <0.012 mg/kg (3% acetic acid,
15% ethanol) or <0.020 mg/kg (olive oil)
under test conditions of 30 min. at 100°C
followed by 10 days at 40°C; Ames assy
(negative); in vitro chromosomal aberration
assay (positive); HPRT assay (negative) and
in vivo bone marrow cytogenetic assay
(negative)
(RIVM/DK/UK SDS, October 1997 =
CS/PM/3076/16360)
(Adopted at 111th SCF meeting (18-19
March 1998)).
http://europa.eu.int/comm/food/fs/sc/scf/out
10_en.pdf
R: 0.05 mg/kg of food.
Available: information on identity;
migration data with a coating made with
17% of the substance used as comonomer;
analytical method; data on residual content
(with 17% of the substance used as
comonomer), and corresponding analytical
method; 3 negative mutagenicity studies.
+
+
+
+
+
+
+
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
(RIVM/FR SDS, December 1998 =
CS/PM/3251/16390).
Remark: petitioner has to clarify the 40%
(weight) in the formulation.
(Adopted at 117th SCF meeting) (17 June
1999)
http://europa.eu.int/comm/food/fs/sc/scf/out
37_en.pdf
16420
16450
000123-91-1 Dioxane
000646-06-0 1,3-Dioxolane
Same 51160
D
DIR
16480
000126-58-9 Dipentaerythritol
Same 51200
DIR
2
16510
000138-86-3 Dipentene
Same 51300
D
8
16540
000102-09-0 Diphenyl carbonate
Same 51420
DIR
SML = 0.05 mg/kg
3
16570
004128-73-8 Diphenylether-4,4'diisocyanate
DIR
QM(T) = 1 mg/kg
(expressed as NCO)
4A
SML = 0.05 mg/kg
59
6A
3
Under re-evaluation
----------------------------------------------------R = 0.05 mg/kg of food.
Available: migration and usage data
showing exposure will be below 50 ppb,
adequate 14-day, inadequate 28-day and 7month oral toxicity studies, 3 inadequate
reproduction studies, adequate teratogenicity
study, several in vitro and in vivo
mutagenicity studies.
(CS/PM/2325, 1993-12-21).
Group TDI: 1 mg/kg b.w. (with
pentaerythritol).
(SCF, 17th Series, 1986).
Data made available for assessment of
chewing gum not available for this group.
SCF_List: 3
Restriction: 0.05 mg/kg of food Based on
the reduced core set of toxicological data
according to the migration level.
Remark for Commission: In the absence of
relevant information, the Fat (Consumption)
Reduction Factor should not be applied to
this substance
See SCF evaluation in the website:
http://europa.eu.int/comm/food/fs/sc/scf/out
180_en.pdf
See references for 3,3'-dimethyl-4,4'diisocyanatobiphenyl.
+
+
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
16600
005873-54-1 Diphenylmethane-2,4'diisocyanate
DIR
16630
000101-68-8 Diphenylmethane-4,4'diisocyanate
DIR
16650
000127-63-9 Diphenyl sulphone
16660
000110-98-5 Dipropyleneglycol
16670
034590-94-8 Dipropyleneglycol
monomethyl ether
001321-74-0 Divinylbenzene
16690
Same 51570
DIR
RESTRICTIONS
AND
SPECIFICATIONS
(26).
QM(T) = 1 mg/kg
(expressed as NCO)
(26).
QM(T) = 1 mg/kg
(expressed as NCO)
(26).
SML(T) = 3 mg/kg
(25)
DIR
SCF
List
QMA = 0.01 mg/6 dm²
or SML = ND (DL =
0.02 mg/kg, analytical
tolerance included) for
the sum of
Divinylbenzene and
Ethylvinylbenzene and
in compliance with the
specifications laid
down in Annex V
60
CT
See references for 3,3'-dimethyl-4,4'diisocyanatobiphenyl.
+
+
4A
See references for 3,3'-dimethyl-4,4'diisocyanatobiphenyl.
+
+
R = 3 mg/kg food (same reference as
REF_N. 51570).
Remark : the same substance was previously
evaluated as an additive (see Opinion on an
additional list of monomers and additives for
food contact materias expressed on 23
September 1999, at the 118th meeting of the
SCF) and the same evaluation is extended
now to its requested use as monomer.
(Adopted at the 128th SCF meeting, 12 July
2001)
http://europa.eu.int/comm/food/fs/sc/scf/out
97_en.pdf
t-TDI: 1.5 mg/kg b.w.
(SCF, 6th Series, 1978).
Data inadequate.
+
R = Not detectable. Sum of divinylbenzene
and ethylvinylbenzene (DL = 0.01 mg/kg).
Available: calculated worst case migration <
1.3 ug/kg food, based on the determination
of the residual content; two gene mutation
assays in bacteria (negative); mouse
inhalation study (shows weak clastogenic
activity); acute toxicity data; skin/eye
irritation study.
RIVM/ISS/TNO SDS, February 2001 =
CS/PM/2959 REV. III/16690.
Remark for Commission:
- Only a method for the determination of the
residual content is available
- Petition covers a mixture of substances of
divinylbenzene and ethylvinylbenzene
+
3
8
DIR
PL
4A
2
Same 51870
EFSA/SCF_OP
4A
+
+
+
+
REF_N
CAS_N
NAME
16697
000693-23-2 n-Dodecanedioic acid
16701
000112-53-8 1-Dodecanol
16704
000112-41-4 1-Dodecene
16719
003813-52-3 Endomethylenetetrahydr
ophthalic acid
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
DIR
SCF
List
3
Same 51975
3
DIR
SML = 0.05 mg/kg
D
3
8
61
EFSA/SCF_OP
(Adopted at the 128th SCF meeting, 12 July
2001)
http://europa.eu.int/comm/food/fs/sc/scf/out
97_en.pdf
Toxicologically acceptable.
Available: migration data in food simulants;
gene mutation assay in bacteria (negative);
gene mutation assay in cultured mammalian
cells (negative); micronucleus assay
(negative); 90-day oral rat study.
RIVM/DK/TNO SDS, November 2000 =
CS/PM/3793/16697.
Remark: A high log Po/w of 3.17 can
indicate the potential for accumulation but
as the substance is readily metabolised by
the normal fat metabolising route this is not
the case for DDDA. For this reason there is
also no reason for specifying a migration
limit.
(Adopted by the SCF at the 127th meeting,
30 May 2001)
http://europa.eu.int/comm/food/fs/sc/scf/out
86_en.pdf
See references for "Alcohols, aliphatic,
monohydric, saturated, linear, primary (C4C22)" (PM/REF.N. 12375) in SCF list 3.
R = 0.05 mg/kg of food.
Available: Adequate migration data,
showing specific migration of 1-dodecene is
<0.05 mg/kg food; three (negative)
mutagenicity studies.
(RIVM/ISS/TNO SDS, August 1997 =
CS/PM/3063/16704).
(Adopted at 111th SCF meeting (18-19
March 1998)).
http://europa.eu.int/comm/food/fs/sc/scf/out
10_en.pdf
PL
CT
+
+
+
+
+
REF_N
16720
CAS_N
NAME
SYNONIM
16750
000826-62-0 Endomethylenetetrahydr
ophthalic anhydride
000106-89-8 Epichlorohydrin
Same 14570
16778
000107-21-1 1,2-Ethanediol
16780
000064-17-5 Ethanol
16810
16840
-
Same 16990
and 53650
Same 52800
DIR
RESTRICTIONS
AND
SPECIFICATIONS
D
DIR
SCF
List
8
QM = 1 mg/kg in FP
4A
Highly toxic. Induces forestomach tumours
in rats after oral administration.
(Report from Nat. Inst. of Publ. Health,
Bilthoven 1982; International Program on
Chemical Safety, Series Environmental
Health Criteria, WHO, 33, 1984).
+
+
+
+
+
+
DIR
1
D
D
9
9
+
+
D
9
+
D
6A
+
16930
16950
000075-00-3 Ethyl chloride
000074-85-1 Ethylene
D
DIR
8
3
16955
000096-49-1 Ethylene carbonate
3AM
3
8
2
62
CT
+
2
16910
16925
16900
PL
D
Ether alcohols
Ethers of Nmethylolacrylamide
Ethers of Nmethylolmethacrylamide
013036-41-4 N(Ethoxymethyl)acrylami
de
000111-35-3 3-Ethoxy-1-propanol
009004-57-3 Ethylcellulose
Same 53280
16870
EFSA/SCF_OP
Acceptable.
(SCF, 11th Series, 1981).
+
+
Group TDI : not specified based on Group
ADI (=not specified) for certain modified
cellulose.
(JECFA 35 M., 1989).
Residues of this gas in plastics are very
small. The gas has low toxic potential.
Migration into food will be toxicologically
negligible.
(Patty's Industrial Hygiene and Toxicology,
3rd ed. 1981).
Restriction: Residual content of ethylene
carbonate: 5 mg/kg hydrogel at a
maximum ratio of 10 g hydrogel/kg food.
Ethylene glycol: SML= 30 mg/kg food
Remark for Commission: No method
available for specific migration; only a QM
method for the monomer and ethylene
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
+
+
+
+
glycol (hydrolysis product)
16960
000107-15-3 Ethylenediamine
Same 15272
and 53540
DIR
SML = 12 mg/kg
2
16990
000107-21-1 Ethyleneglycol
Same 16778
and 53650
DIR
SML(T) = 30 mg/kg
(3)
2
16993
000111-76-2 Ethyleneglycol
monobutyl ether
Same 53765
2
16996
000110-80-5 Ethyleneglycol
monoethyl ether
Same 53820
2
17005
000151-56-4 Ethyleneimine
Same 53950
17020
000075-21-8 Ethylene oxide
DIR
SML = ND (DL = 0.01
mg/kg).
4A
DIR
QM = 1 mg/kg in FP
4A
63
http://www.efsa.eu.int/science/afc/afc_opini
ons/190/opinion_afc_06_en1.pdf
http://europa.eu.int/comm/food/fs/sc/scf/out
141_en.pdf
TDI: 0.2 mg/kg b.w.
Two 90-day oral rat studies.
(ICI report, April 1975).
Group TDI = 0.5 mg/kg b.w. (with
diethyleneglycol).
See references for diethyleneglycol.
Group t-TDI : 0.05 mg/kg b.w. (with
15780=48050, 16993=53765, 16996=53820,
16999, 17002=53860, 30015, 30120, 30200,
48030).
See references for 16996.
Group t-TDI : 0.05 mg/kg b.w. (with
15780=48050, 16993=53765, 16996=53820,
16999, 17002=53860, 30015, 30120, 30200,
48030, 48050) pending evaluation of NTP
rat and mouse studies.
Several short term oral rat and dog studies,
reproduction and teratogenicity studies.
Carcinogenicity studies in mice and rats not
reported. Mutagenicity studies inadequate.
(RIVM summary, March 1991
(=CS/PM/922) and RIVM SDS, July 1996
(= CS/PM/2916).
Highly toxic by all exposure routes.
Carcinogenic for mice orally.
(IARC Monographs Vol 9, p. 37, Lyon
1975).
Strongly mutagenic in several studies.
Induces forestomach tumours in rats after
oral administration.
(Brit. J. Cancer, 1982, 46, 924; IARC
Monographs Vol. 11 and Suppl. 4, Lyon
1976 and 1982; Toxicity of ethylene oxide
and its relevance to man. ECETOC,
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
Same 54120
DIR
17040
000149-57-5 2-Ethylhexanoic acid
17050
000104-76-7 2-Ethyl-1-hexanol
17080
000103-44-6 2-Ethylhexyl vinyl ether
D
17110
016219-75-3 5Ethylidenebicyclo[2.2.1]
hept-2-ene
DIR
17111
17116
17118
17120
17121
17122
17140
17150
17160
038233-76-0 2-Ethylidene-1,4:5,8dimethano1,2,3,4,4a,5,8,8aoctahydronaphthalene
005877-42-9 4-Ethyl-1-octyn-3-ol
025429-37-2 Ethylphenol
000090-00-6 2-Ethylphenol
000620-17-7 3-Ethylphenol
000123-07-9 4-Ethylphenol
000109-92-2 Ethyl vinyl ether
000078-27-3 1-Ethynylcyclohexanol
000097-53-0 Eugenol
D
D
DIR
17170
061788-47-4 Fatty acids, coco
DIR
RESTRICTIONS
AND
SPECIFICATIONS
D
DIR
SCF
List
6B
SML = 30 mg/kg
1
7
QMA = 0.05 mg/6dm².
The ratio
surface/quantity of
food shall be lower
than 2 dm²/kg
3
EFSA/SCF_OP
Technical Report n. 5, 1982).
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg of food,
peroxisome proliferation studies too.
ADI: 0.5 mg/kg b.w.
(JECFA 41 M., 1993)
Needed: provided hydrolysis can be
demonstrated, data on 2-ethylhexanol are
requested.
SCF_L: 3
Restriction: 0.05 mg/kg of food. Based on
the reduced core set of toxicological data
according to the migration level.
Remark for Commission: Only a QM
method is available, therefore a QMA limit
is applicable.
(Adopted at the 136th SCF meeting, 5
March 2003)
http://europa.eu.int/comm/food/fs/sc/scf/out
172_en.pdf
PL
CT
+
+
+
+
+
+
+
+
D
SML = ND (DL = 0.02
mg/kg, analytical
tolerance included)
8
8
8
8
8
7
8
4A
3
64
+
+
+
+
+
Needed: hydrolysis data.
Metabolize into epoxyeugenol having
initiating activity.
(RIVM summary data, 12.05.1992
(cs/pm/1586)).
Equal to or similar to food fats.
+
+
+
+
+
REF_N
17175
17195
17200
17215
17230
17233
17245
17247/1
17260
CAS_N
NAME
SYNONIM
068938-15-8 Fatty acids, coco,
hydrogenated
091051-35-3 Fatty acids, peanut oil
068308-53-2 Fatty acids, soya
Same 88650
Fatty acids, sunflower oil
061790-12-3 Fatty acids, tall oil
Same
54710/0 and
54710/1
073138-53-1 Fatty acids, tall oil,
dimers
008016-13-5 Fish oil
Fish oil fatty acids
000050-00-0 Formaldehyde
Same 54880
17275
000064-18-6 Formic acid
Same 55040
17290
000110-17-8 Fumaric acid
Same 55120
17305
000141-02-6 Fumaric acid, bis(2ethylhexyl) ester
002807-54-7 Fumaric acid, diallyl
ester
000105-75-9 Fumaric acid, dibutyl
ester
002402-58-6 Fumaric acid, didodecyl
ester
000623-91-6 Fumaric acid, diethyl
ester
007283-70-7 Fumaric acid,
17320
17350
17365
17380
17392
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
3
W
3
3/D
3
DIR
DIR
EFSA/SCF_OP
PL
Toxicologically acceptable.
+
Equal to or similar to food fats.
Equal to or similar to food fats.
+
+
+
+
+
+
8
DIR
SML(T) = 15 mg/kg
(22)
3
3
3
1
+
Food fat.
Constituents of food fats.
Residues of this gas in plastics will be very
small. Formaldehyde is a normal
intermediate in human metabolism.
Carcinogenic for rats by inhalation at
concentrations irritant to the respiratory
tract.
(Final report on a chronic inhalation study in
rats and mice exposed to formaldehyde).
(Battelle Columbus Labs. Columbus, Ohio,
1981).
Group ADI : 3 mg/kg b.w. for formic acid
and ethyl formate.
(JECFA 17 M., 1973).
ADI: 6 mg/kg b.w.
(SCF, 25th Series, 1990).
+
1
D
8
+
D
6A
+
D
7
Needed: hydrolysis data.
+
7
Needed: hydrolysis data.
+
7
Needed: hydrolysis data.
+
7
Available: 100% hydrolysis in intestinal
+
65
+
+
+
+
DIR
D
CT
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
diisopropyl ester
17398
17410
17440
17470
17500
17505
17530
17560
17590
17620
17650
PL
CT
fluid within 30-40 minutes to monoisopropylester of fumaric acid and
isopropanol.
Needed: migration and toxicological data of
fumaric acid, diisopropyl ester according to
the guidelines.
(RIVM/TNO SDS, January 1999 =
CS/PM/3252/17392).
007283-68-3 Fumaric acid,
dioctadecyl ester
Fumaric acid, esters with
alcohols, aliphatic,
monohydric, saturated
(C1-C18)
Fumaric acid, esters with
alcohols, aliphatic,
monohydric, unsaturated
(C3-C18)
Fumaric acid, esters with
alcohols, polyhydric
000098-01-1 Furfural
000098-00-0 Furfurol
000050-99-7 Glucose
Glucosides obtained
from glucose and 1,3butanediol
Glucosides obtained
from glucose and 1,4butanediol
Glucosides obtained
from glucose and
diethyleneglycol
Glucosides obtained
EFSA/SCF_OP
(Adopted at 117th SCF meeting) (17 June
1999)
http://europa.eu.int/comm/food/fs/sc/scf/out
37_en.pdf
Needed: hydrolysis data.
D
7
D
9
+
D
9
+
D
9
+
D
7
DIR
D
8
0
7
Needed: hydrolysis data.
+
+
D
7
Needed: hydrolysis data.
+
D
7
Needed: hydrolysys data.
+
D
7
Needed: hydrolysis data.
+
Same 55160
66
Needed: 90-day oral study and mutagenicity
studies.
+
+
+
+
REF_N
17680
17710
17740
17770
17800
17830
17860
17890
17920
17950
17980
18010
18040
CAS_N
NAME
SYNONIM
from glucose and 2,2dimethyl-1,3propanediol
Glucosides obtained
from glucose and
ethyleneglycol
Glucosides obtained
from glucose and
glycerol
Glucosides obtained
from glucose and 1,6hexanediol
Glucosides obtained
from glucose and 1,2,6hexanetriol
Glucosides obtained
from glucose and
pentaerythritol
Glucosides obtained
from glucose and
polyethyleneglycol (Mw
> 200)
Glucosides obtained
from glucose and
polypropyleneglycol
(Mw > 400)
Glucosides obtained
from glucose and
propanediol
Glucosides obtained
from glucose and
sorbitol
Glucosides obtained
from glucose and sucrose
Glucosides obtained
from glucose and 1,1,1trimethylolpropane
000110-94-1 Glutaric acid
Same 55680
029733-18-4 Glutaric acid, diisodecyl Same 55760
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
D
7
Needed: hydrolysis data.
+
D
7
Needed: hydrolysis data.
+
D
7
Needed: hydrolysis data.
+
D
7
Needed: hydrolysis data.
+
D
7
Needed: hydrolysis data.
+
D
7
Needed: hydrolysis data.
+
D
7
Needed: hydrolysis data.
+
D
7
Needed: hydrolysis data.
+
D
7
Needed: hydrolysis data.
+
D
7
Needed: hydrolysis data.
+
D
7
Needed: hydrolysis data.
+
DIR
D
0
8
67
+
+
CT
REF_N
SYNONIM
DIR
18070
18100
ester
000108-55-4 Glutaric anhydride
000056-81-5 Glycerol
Same 55920
DIR
DIR
18115
031566-31-1 Glycerol monostearate
Same 57520
18120
18124
18126/1
18130
18150
18160
18190
18220
CAS_N
NAME
000107-22-2
008016-24-8
004371-64-6
Glyoxal
Same 58310
Hempseed oil
Hempseed oil fatty acids
1,1Heptadecanedicarboxylic
acid
000111-70-6 1-Heptanol
025339-56-4 Heptene
000592-76-7 1-Heptene
068564-88-5 NHeptylaminoundecanoic
acid
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
3
1
1
6A
3
3/D
8
D
3
D
D
DIR
SML = 0.05 mg/kg (1)
8
8
3
18250
000115-28-6 Hexachloroendomethyle Same 14527
netetrahydrophthalic acid
DIR
SML = ND (DL = 0.01
mg/kg)
4A
18280
000115-27-5 Hexachloroendomethyle
netetrahydrophthalic
anhydride
036653-82-4 1-Hexadecanol
Same 58790
DIR
SML = ND (DL = 0.01
mg/kg)
4A
18310
DIR
3
68
EFSA/SCF_OP
Hydrolises to corresponding acid.
Group ADI: not specified for glycerol,
glycerol diacetate, glycerol triacetate and
glycerol monoacetate.
(SCF, 11th Series, 1981).
ADI : not specified.
(JECFA 17 M., 1973).
PL
CT
+
+
+
+
+
+
+
Food fat.
Constituents of food fats.
+
See references for "Alcohols, aliphatic,
monohydric, saturated, linear, primary (C4C22)" (PM/REF_N. 12375) in SCF list 3.
R:= 0.05 mg/kg of food.
Available: migration into non-fat simulants,
5 negative mutagenicity studies, 90-day oral
rat study (CS/PM/2376).
Remark: since high migration into fat has
been demonstrated, the WG recommends
that the Commission take the necessary
measures so that the restriction proposed is
not exceeded.
Cancer in lung and liver of rats and mice,
positive in mutagenicity study in mouse
lymphoma cells.
(NTP techn. Rep. 304, NIH publ. 87-2560
April 1987).
Hydrolyses easily to acid known for
induction of lung cancer.
See references for "Alcohols, aliphatic,
+
+
+
+
+
+
+
+
REF_N
18340
18370
CAS_N
NAME
000822-28-6 Hexadecyl vinyl ether
000592-45-0 1,4-Hexadiene
18400
000592-42-7 1,5-Hexadiene
18430
000116-15-4 Hexafluoropropylene
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
D
DIR
7
7
D
DIR
SCF
List
7
SML = ND (DL = 0.01
mg/kg)
69
4A
EFSA/SCF_OP
monohydric, saturated,linear, primary (C4C22)" (PM/REF.N. 12375) in SCF list 3.
Needed: hydrolysis data.
Available: calculated worst case migration <
0.012 mg/kg food; gene mutation assay in
bacteria (negative); chromosomal aberration
assay in cultured mammalian cells
(positive); gene mutation assay in cultured
mammalian cells (positive); in vivo
micronucleus assay in rats by inhalation
(negative); acute toxicity data; two 4-hour
inhalation rat studies; 28-day inhalation rat
study; metabolism study.
Needed: in first instance an in vivo
micronucleus assay with an appropriate
route (other than inhalation) and if negative
an in vivo UDS assay should be performed.
RIVM/FR/TNO SDS, February 2000 =
CS/'PM/2421 REV. II/18370.
(Adopted at the 121 SCF meeting (20 June
2000))
http://europa.eu.int/comm/food/fs/sc/scf/out
62_en.pdf
Available: 4-week rat study by inhalation
and mutagenicity tests.
Needed: migration data and gene mutation
in mammalian cells in vitro. If migration
exceeds 0.05 mg/kg of food, additional
study according to SCF guidelines should
be supplied.
Not detectable.
Available: gene mutation assay in bacteria
(negative); chromosomal aberration assay in
cultured mammalian cells (positive); gene
mutation assay in cultured mammalian cells
(negative); micronucleus assay (positive);
UDS assay (negative).
RIVM SDS, October 2000 = CS/PM/923
REV. I/18430.
PL
CT
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
(Adopted by the SCF at the 127th meeting,
30 May 2001)
http://europa.eu.int/comm/food/fs/sc/scf/out
86_en.pdf
18436
18441
18444
18449
18460
18490
18520
18550
18580
18610
18640
001687-30-5 Hexahydrophthalic acid
000085-42-7 Hexahydrophthalic
anhydride
001076-97-7 Hexahydroterephthalic
acid
Same 14875
003089-11-0 N,N,N',N',N'',N''Hexakis(methoxymethyl)
-2,4,6-triamino-1,3,5triazine
000124-09-4 Hexamethylenediamine Same 15274
and 59240
015511-81-6 Hexamethylenediamine
adipate
038775-37-0 Hexamethylenediamine
azelate
Hexamethylenediamine
dodecanedicarboxylate
Hexamethylenediamine
heptadecanedicarboxylat
e
006422-99-7 Hexamethylenediamine
sebacate
000822-06-0 Hexamethylene
diisocyanate
D
D
8
8
7
+
+
(Adopted at 114th SCF meeting) (10
December 1998)
http://europa.eu.int/comm/food/fs/sc/scf/out
20_en.pdf
+
8
DIR
SML = 2.4 mg/kg
2
+
TDI: 0.04 mg/kg b.w.
A 28-day oral rat study.
(RIV report n. 48/80 March 1981).
+
D
8
D
7
D
8
+
D
8
+
D
8
+
DIR
18670
000100-97-0 Hexamethylenetetramine Same 59280
DIR
18700
000629-11-8 1,6-Hexanediol
DIR
+
+
Needed: hydrolysis data.
+
QM(T) = 1 mg/kg
(expressed as NCO)
(26).
SML(T) = 15 mg/kg
(22) (expressed as
Formaldehyde)
4A
See references for 3,3'-dimethyl-4,4'diisocyanatobiphenyl (PM/REF.N. 16240).
+
+
3
+
+
SML = 0.05 mg/kg
3
Formaldehyde liberator. Evaluated by
JECFA as a preservative for food. Amounts
of formaldehyde likely to migrate into food
are of no toxicological significance.
(JECFA 17 M., 1993)
SCF_list: 3
Restriction: 0.05 mg/kg of food.
+
+
70
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
+
+
+
+
+
+
+
See SCF evaluation in the website:
http://europa.eu.int/comm/food/fs/sc/scf/out
140_en.pdf
18730
18760
18780
002935-44-6 2,5-Hexanediol
000106-69-4 1,2,6-Hexanetriol
000111-27-3 1-Hexanol
18790
18820
025264-93-1 Hexene
000592-41-6 1-Hexene
18850
000107-41-5 Hexyleneglycol
18865
18867
003031-66-1 3-Hexyn-2,5-diol
000123-31-9 Hydroquinone
18875
151841-65-5 Hydroxy aluminium
bis[2,4,8,10-tetratert.butyl-6-hydroxy12h-dibenzo[d,g][1.3.2]dioxaphosphocin-6-oxide
000099-96-7 p-Hydroxybenzoic acid
18880
18888
080181-31-3 3-Hydroxybutanoic acid3-hydroxyopentanoic
acid, copolymer
D
D
D
DIR
Same 22072
and 59600
Same 15940,
48620 and
60060
34650
7
8
3
SML = 3 mg/kg
D
D
DIR
8
3
7
See references for "Alcohols, aliphatic,
monohydric, saturated, linear, primary (C4C22)" (PM/REF.N.12375) in SCF list 3.
R = 3 mg/kg of food.
Available: Migration data, 5 mutagenicity
studies negative, 28-day and inadequate 90day oral rat studies, 90-day inhalation rat
study, combined reproduction/development
toxicity screening study in rats,
bioaccumulation.
(TNO (Nov. 95) and Elias (Feb. 96) SDS
CS/PM/2742, and RIVM summary data, 1402-1991).
Needed: purity, physicochemical state,
migration data.
8
+
+
See "1,4Dihydroxybenzene"
3
DIR
DIR
2
In compliance with
specifications included
in Annex V
71
3
+
+
TDI: 10 mg/kg b.w.
The value of the TDI is based upon the
evaluation of the esters.
(JECFA 17 M., 1993)
SML = 0.05 mg/kg of food (for crotonic
acid).
Available: Extensive data on production
process and impurities; on copolymer, 28day and 90-day oral rat studies, and two
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
mutagenicity studies, negative; on the
impurity crotonic acid, two mutagenicity
tests, negative.
(CS/PM/1510 of 25.03.92; CS/PM/2317 and
2538 of 10.02.95).
Toxicologically acceptable provided the
following specifications are met:
STRUCTURAL FORMULA
CH3
CH3
O
CH2
O
[-0-CH-CH2-C-]m-[O-CH-CH2-C-]n
n/(m + n) greater than 0 and less or equal to
0.25
DESCRIPTION
These copolymers are produced by the
controlled fermentation of Alcaligenes
eutrophus using mixtures of glucose and
propanoic acid as carbon sources. The
organism used has not been genetically
engineered and has been derived from a
single wild-type organism Alcaligenes
eutrophus strain H16 NCIMB 10442.
Master stocks of the organism are stored as
freeze-dried ampoules. A
submaster/working stock is prepared from
the master stock and stored in liquid
nitrogen and used to prepare inocula for the
fermenter. Fermenter samples will be
examined daily both microscopically and for
any changes in colonial morphology on a
variety of agars at different temperatures.
The copolymers are isolated from heat
treated bacteria by controlled digestion of
the other cellular components, washing and
72
CT
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
drying. After isolation these copolymers are
in the form of a white to off-white powder.
These copolymers are normally offered as
formulated, melt formed granules containing
additives such as nucleating agents,
plasticisers, fillers, stabilisers and pigments
which all conform to the general and
individual specifications. These copolymers
are soluble in chlorinated hydrocarbons
such as chloroform or dichloromethane but
practically insoluble in ethanol, aliphatic
alkanes and water.
MOLECULAR WEIGHT
This copolymer must have a weight average
molecular weight which is not less than
150,000 Daltons as measured by gel
permeation chromatography.
PURITY
The migration of crotonic acid should not
exceed 0.05 mg/kg food.
Prior to granulation the raw material
copolymer powder must contain:
- not less than 98% poly(3-Dhydroxybutanoate-co-3-Dhydroxypentanoate) analysed after
hydrolysis as a mixture of 3-D-hydroxy
butanoic and 3-D-hydroxypentanoic acids;
- nitrogen content must be less than or equal
to 2500 micrograms per gram;
- zinc content must be less than or equal to
100 mg/Kg of plastic
- copper content must be less than or equal
to 5 mg/kg of plastic
- lead content must be less than or equal to
2 mg/kg of plastic
- arsenic content must be less than or equal
to 1 mg/kg of plastic - chromium content
must be less than or equal to 1 mg/kg of
73
PL
CT
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
18896
001679-51-2 4-(Hydroxymethyl)-1cyclohexene
DIR
SML = 0.05 mg/kg
3
18897
016712-64-4 6-Hydroxy-2naphthalenecarboxylic
acid
DIR
SML = 0.05 mg/kg
3
18898
000103-90-2 N-(4-Hydroxyphenyl)
acetamide
18900
000106-14-9 12-Hydroxystearic acid
DIR
SML = 0.05 mg/kg
Same 61840
3
3/0
74
EFSA/SCF_OP
plastic.
SCF_List: 3
Restriction: 0.05 mg/kg of food. Based on
the reduced core set of toxicological data
according to the migration level.
Remark for Commission: used in oxygen
scavenging polymer; no direct food contact
(except for dry foods).
See SCF evaluation in the website:
http://europa.eu.int/comm/food/fs/sc/scf/out
180_en.pdf
R = 0.05 mg/kg food
Available: migration data from monolayer in
direct contact with food simulants (SM <
0.046 mg/kg food); gene mutation assay in
bacteria (negative); chromosomal aberration
assay in cultured mammalian cells
(positive); gene mutation assay in cultured
mammalian cells (negative); in vivo
micronucleus assay (negative).
RIVM/TNO SDS, December 2000 =
CS/PM/3812/18897.
(Adopted at the 128th SCF meeting, 12 July
2001)
http://europa.eu.int/comm/food/fs/sc/scf/out
97_en.pdf
SCF_List: 3
Restriction: 0.05 mg/kg of food. Based on
the reduced core set of toxicological data
according to the migration level.
See SCF evaluation in the website:
http://europa.eu.int/comm/food/fs/sc/scf/out
180_en.pdf
SCF_List: 3
Restriction: none. In small doses
metabolised similarly to food fats
See SCF evaluation in the website:
http://europa.eu.int/comm/food/fs/sc/scf/out
181_en.pdf
PL
CT
+
+
+
+
REF_N
CAS_N
18905
18910
18940
18960
18970
002628-17-3
000288-32-4
000095-13-6
000089-65-6
000078-83-1
19000
000115-11-7 Isobutene
19030
016669-59-3 N(Isobutoxymethyl)acryla
mide
004548-27-0 N(Isobutoxymethyl)metha
crylamide
000109-53-5 Isobutyl vinyl ether
19045
19060
19090
19110
NAME
4-Hydroxystyrene
Imidazole
Indene
Isoascorbic acid
Isobutanol
000078-84-2 Isobutyraldehyde
004098-71-9 1-Isocyanato-3isocyanatomethyl-3,5,5trimethylcyclohexane
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
D
D
D
Same 62270
SCF
List
D
6A
8
8
W
8
DIR
3
D
6A
EFSA/SCF_OP
PL
+
+
+
Residue less than 1 mg/kg in food. No
mutagenicity and oral data.
(Directive 88/344/EEC).
Residues of this gas in plastics are very
small. The gas has low toxic potential.
Migration into food will be toxicologically
negligible.
(Patty's Industrial Hygiene and Toxicology,
3rd ed, 1981).
+
+
+
+
+
+
6A
DIR
Same 19147
D
DIR
QM = 5 mg/kg in FP
QM(T) = 1 mg/kg
(expressed as NCO)
(26).
75
3
8
4A
CT
+
R = 0.05 mg/kg of food.
Available: Hydrolysis data for isobutylvinylether, showing rapid total (100%)
hydrolysis of the monomer in simulated
gastric fluid into isobutanol and
acetaldehyde; calculated (worst case)
migration is <0.05 mg/kg food, assuming
100% migration of residual isobutylvinylether from a typical dispersion film;
three (negative) mutagenicity studies.
(RIVM/ISS/TNO SDS, October 1996 =
CS/PM/2907/19060).
(Adopted at 111th SCF meeting (18-19
March 1998)).
http://europa.eu.int/comm/food/fs/sc/scf/out
10_en.pdf
+
+
+
+
+
REF_N
CAS_N
NAME
19120
19130
19140
19145
19147
19150
025339-17-7
026896-18-4
026952-21-6
002855-13-2
004098-71-9
000121-91-5
Isodecanol
Isononanoic acid
Isooctanol
Isophorone diamine
Isophorone diisocyanate
Isophthalic acid
19180
000099-63-8 Isophthalic acid
dichloride
001459-93-4 Isophthalic acid,
dimethyl ester
19210
19240
19243
000744-45-6 Isophthalic acid,
diphenyl ester
000078-79-5 Isoprene
19255
000080-05-7 4,4'Isopropylidenediphenol
19270
19300
000097-65-4 Itaconic acid
002155-60-4 Itaconic acid, dibutyl
ester
000617-52-7 Itaconic acid, dimethyl
ester
007748-43-8 Itaconic acid, 2,3epoxypropyl diester
Itaconic acid, 2,3epoxypropyl monoester
Itaconic acid, esters with
alcohols, aliphatic,
19315
19330
19360
19390
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
D
D
D
Same 12670
Same 19110
DIR
SML = 5 mg/kg
D
DIR
DIR
8
8
8
D
D
3
7
SML = 0.05 mg/kg
D
Same 21640
SCF
List
3
EFSA/SCF_OP
PL
CT
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
http://europa.eu.int/comm/food/fs/sc/scf/out
128_en.pdf
+
+
Normal human metabolite.
Needed: hydrolysis data.
+
+
+
R = 5 mg/kg of food.
Available: Migration data, 7 mutagenicity
studies regarded as non-genotoxic, 28-day
inhalation and 90-day oral rat studies,
inhalation rat teratology study limited
absorption and excretion data (RIVM/TNO
SDS CS/PM/2757, January 96).
Needed: original data on migration and
genotoxicity.
R: 0.05 mg/kg in food.
Available: 3 mutagenicity tests, negative.
Migration data less than 0.050 mg/kg.
(Rivm summary data, May 1991,
CS/PM/969).
8
See "2-Methyl-1,3butadiene"
Same
13480/1360
7/62540/400
60/39680
DIR
D
0
7
8
+
D
6A
+
D
6A
+
D
9
+
76
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
D
9
19460
monohydric,
saturated(C1-C18)
Itaconic acid, esters with
alcohols, polyhydric
Itaconic acid, methyl
esters
Lactams of omegaaminocarboxylic acids,
aliphatic, linear (C7C12)
000050-21-5 Lactic acid
Same 62960
DIR
1
19470
19480
000143-07-7 Lauric acid
002146-71-6 Lauric acid, vinyl ester
DIR
DIR
0
3
19490
000947-04-6 Laurolactam
DIR
011132-73-3
000060-33-3
028290-79-1
008001-26-1
000110-16-7
DIR
19420
19435
19450
19510
19518
19526
19532
19534/1
19540
Lignocellulose
Linoleic acid
Linolenic acid
Linseed oil
Linseed oil fatty acids
Maleic acid
Same 63280
D
9
PL
SML = 5 mg/kg
DIR
SML(T) = 30 mg/kg
77
3
3
0
0
3
3/D
2
CT
+
9
Same 64015
Same 64150
Same 64160
Same 64800
EFSA/SCF_OP
+
+
ADI : not specified.
(SCF, 25th Series, 1990).
Complete hydrolysis in simulated intestinal
fluid to lauric acid and acetaldehyde
(CS/PM/2334).
Positive in gene mutation and chromosome
aberration studies in vitro, most likely due to
formation of acetaldehyde (CS/PM/2385).
R = 5 mg/kg of food.
Available: specific migration data; gene
mutation assay in bacteria (negative);
chromosomal aberration assay in cultured
mammalian cells (negative); gene mutation
assay in cultured mammalian cells
(negative); 90-day oral rat study.
(RIVM/TNO SDS, July 1999 =
CS/PM/2574 REV. II/19490).
(Adopted at the 119th SCF meeting) (2
December 1999)
http://europa.eu.int/comm/food/fs/sc/scf/out
50_en.pdf
Natural, non digestible fibre.
Food fat.
Constituents of food fats.
Group TDI = 0.5 mg/kg b.w. as maleic acid.
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
(4)
19570
19600
19630
19960
000999-21-3 Maleic acid, diallyl ester
000105-76-0 Maleic acid, dibutyl ester
071550-61-3 Maleic acid, diester with
1,2-propanediol
000141-05-9 Maleic acid, diethyl ester
014234-82-3 Maleic acid, diisobutyl
ester
001330-76-3 Maleic acid, diisooctyl
ester
000624-48-6 Maleic acid, dimethyl
ester
002915-53-9 Maleic acid, dioctyl ester
Maleic acid, esters with
alcohols, aliphatic,
saturated (C1-C18)
Maleic acid, esters with
alcohols, polyhydric
Maleic acid, ester with
1,3-butanediol
002424-58-0 Maleic acid, monoallyl
ester
000925-21-3 Maleic acid, monobutyl
ester
Maleic acid, monoesters
with alcohols, aliphatic,
monohydric,
unsaturated(C3-C18)
007423-42-9 Maleic acid, mono(2ethylhexyl) ester
003052-50-4 Maleic acid,
monomethyl ester
000108-31-6 Maleic anhydride
Same 64900
19972
000087-78-5 Mannitol
Same 65520
19975
000108-78-1 Melamine
Same 25420,
19660
19690
19720
19750
19780
19810
19840
19870
19900
19915
19930
19936
19945
EFSA/SCF_OP
PL
CT
+
+
(SCF, 17th Series, 1986).
D
D
D
6A
7
7
Under evaluation
Needed: hydrolysis data.
+
+
+
D
D
7
7
Needed: hydrolysis data.
Needed: hydrolysis data.
+
+
D
7
Needed: hydrolysis data.
+
D
7
Needed: hydrolysis data.
+
+
D
D
7
9
Needed: hydrolysis data.
+
+
+
D
9
D
7
D
6A
D
7
D
9
+
D
8
+
DIR
DIR
SML(T) = 30 mg/kg
(4) (expressed as
Maleic acid).
See "2,4,6-Triamino78
+
Needed: hydrolysis data.
+
Needed: hydrolysis data.
7
Needed : hydrolysis data.
2
Group TDI = 0.5 mg/kg b.w. as maleic acid.
(SCF, 6th Series, 1978).
1
ADI : acceptable.
(SCF, 16th Series, 1985).
See references for the same substance in
2
+
+
+
+
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
65360 and
93720
19977
19990
000060-24-2 2-Mercaptoethanol
000079-39-0 Methacrylamide
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
1,3,5-Triazine"
DIR
SML = ND (DL =0.02
mg/kg, analytical
tolerance included)
EFSA/SCF_OP
PL
CT
+
+
+
additive list.
8
4A
The classification is based on the decision
made on the structurally related compound
acrylamide classified in L4A and because it
is not detected in food/food simulants.
Available: migration data; Ames test;
dominant lethal assay; 2 generation
reproduction study; teratogenicity study in
mice
and three neurotoxicity studies.
(RIVM/TNO SDS, November 1996 =
CS/PM/2961).
20005
20020
20040
20045
20050
051410-72-1 Methacrylamidopropyltri
methylammonium
chloride
000079-41-4 Methacrylic acid
090551-76-1 Methacrylic acid,
alkyl(C12-C16) esters
090551-83-0 Methacrylic acid,
alkyl(C16-C18) esters
000096-05-9 Methacrylic acid, allyl
ester
6A
DIR
DIR
2
SML = 0.05 mg/kg
79
+
Group t-TDI: 0.1 mg/kg b.w. pending the
results of an adequate oral study.
Available: a 2-year oral rat study and several
other studies in several animal species with
methyl methacrylate.
(Tox. Appl. Pharmacol., 6, 1984, 29-36;
RIV doc. Tox. 300730, February 1983).
+
+
W
+
W
+
3
R : 0.05 mg/kg of food.
Available: Adequate migration data and
analytical method and stability data in food
simulants; three negative mutagenicity
studies.
(RIVM/DK/TNO SDS, June 1998=
CS/PM/3077/Rev.1/20050).
(Adopted at 114th SCF meeting) (10
December 1998)
http://europa.eu.int/comm/food/fs/sc/scf/out
20_en.pdf
+
+
REF_N
CAS_N
NAME
20080
002495-37-6 Methacrylic acid, benzyl
ester
20090
003775-90-4 Methacrylic acid, 2-(tertbutylamino)ethyl ester
046729-07-1 Methacrylic acid, 4-tertbutylcyclohexyl ester
000097-88-1 Methacrylic acid, butyl
ester
20095
20110
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
DIR
SCF
List
2
EFSA/SCF_OP
PL
CT
Group t-TDI: 0.1 mg/kg bw (as methacrylic
acid).
Hydrolysis (complete) data allow the
allocation of the same TDI as methacrylic
acid.
+
+
W
D
8
DIR
2
+
+
Group t-TDI: 0.1 mg/kg b.w. (as methacrylic
acid).
See references for methacrylic acid.
Group t-TDI: 0.1 mg/kg b.w. (as methacrylic
acid).
See references for methacrylic acid.
Group t-TDI: 0.1 mg/kg b.w. (as methacrylic
acid).
See references for methacrylic acid.
+
+
+
+
+
+
20140
002998-18-7 Methacrylic acid, secbutyl ester
DIR
2
20170
000585-07-9 Methacrylic acid, tertbutyl ester
DIR
2
20200
001888-94-4 Methacrylic acid, 2chloroethyl ester
Methacrylic acid,
cyclohexylaminoethyl
ester
000101-43-9 Methacrylic acid,
cyclohexyl ester
D
8
+
D
8
+
20230
20260
DIR
SML = 0.05 mg/kg
3
R = 0.05 mg/kg of food.
Remark for Commission: Method available
for the determination of specific migration
in aqueous and substitute food simulants
(iso-octane).
+
+
(Adopted at the 126th SCF meeting, 28
February 2001)
http://europa.eu.int/comm/food/fs/sc/scf/out
84_en.pdf
20290
20320
20350
016868-14-7 Methacrylic acid,
cyclopentyl ester
003179-47-3 Methacrylic acid, decyl
ester
Methacrylic acid, (ditert-butylamino)ethyl
D
8
D
7
D
8
80
+
Needed: hydrolysis data.
+
+
+
REF_N
20380
20410
CAS_N
NAME
ester
001189-08-8 Methacrylic acid, diester
with 1,3-butanediol
002082-81-7 Methacrylic acid, diester
with 1,4-butanediol
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
D
DIR
SCF
List
8
SML = 0.05 mg/kg
3
EFSA/SCF_OP
PL
CT
Available: hydrolysis study shows
incomplete hydrolysis.
R = 0.05 mg/kg of food.
Available: specific migration data in
aqueous simulants and in iso-octane; two
gene mutation assays in bacteria (negative);
chromosomal aberration assay in cultured
mammalian cells (positive); gene mutation
assay in cultured mammalian cells
(negative); in vivo micronucleus assay
(negative). acute toxicity test (LD50); three
sensitisation tests (two positive and one
negative);
RIVM/UK/TNO SDS, December 1998 =
CS/PM/3219 REV. I/20410.
+
+
+
+
(Adopted at the 121 SCF meeting (20 June
2000))
http://europa.eu.int/comm/food/fs/sc/scf/out
62_en.pdf
20425
20430
20440
20455
20470
20490
002358-84-1 Methacrylic acid, diester
with diethyleneglycol
001985-51-9 Methacrylic acid, diester
with 2,2-dimethyl-1,3propanediol
000097-90-5 Methacrylic acid, diester
with ethyleneglycol
006606-59-3 Methacrylic acid, diester
with 1,6-hexanediol
025852-47-5 Methacrylic acid, diester
with polyethyleneglycol
000109-17-1 Methacrylic acid, diester
with tetraethyleneglycol
DIR
SML = 0.05 mg/kg
8
+
8
+
3
SCF_List: 3
Restriction: 0.05 mg/kg of food. Based on
the reduced core set of toxicological data
according to the migration level.
See SCF evaluation in the website:
http://europa.eu.int/comm/food/fs/sc/scf/out
180_en.pdf
+
+
+
D
8
+
D
8
+
8
81
+
REF_N
20495
20500
20530
20560
20590
CAS_N
NAME
SYNONIM
000109-16-0 Methacrylic acid, diester
with triethyleneglycol
000105-16-8 Methacrylic acid, 2(diethylamino)ethyl ester
002867-47-2 Methacrylic acid, 2(dimethylamino)ethyl
ester
000142-90-5 Methacrylic acid,
dodecyl ester
000106-91-2 Methacrylic acid, 2,3epoxypropyl ester
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
W
D
DIR
D
Same 16119
DIR
+
8
SML = ND (DL = 0.02
mg/kg, analytical
tolerance included)
4A
7
QMA = 0.02 mg/6 dm²
4B
+
R = not detectable (detection limit = 10
ppb).
Remark for Commission:
* No method of analysis is available for the
enforcement of an SML.
* The substance hydrolyses readily at
neutral pH and above and so it will be
unstable in many foods. The substance is
stable in simulant B and will not hydrolyse
in simulant D.
(Adopted at 114th SCF meeting) (10
December 1998)
http://europa.eu.int/comm/food/fs/sc/scf/out
20_en.pdf
Needed: hydrolysis data.
QMA: 20 ug/6 dm².
Remark for Commission:
- Including the epoxide hydrolysis products
is not needed if the restriction is on a QM
basis.
- If a future application is made for a higher
restriction level, which could then permit
use as an additive in PVC organosols, then
chlorohydrin formation would need to be
considered.
+
+
+
+
+
+
(Adopted at 117th SCF meeting) (17 June
1999)
http://europa.eu.int/comm/food/fs/sc/scf/out
37_en.pdf
20620
-
Methacrylic acid, esters
with alcohols, aliphatic,
monohydric,
saturated(C1-C21)
D
9
82
CT
+
REF_N
CAS_N
NAME
20650
-
20680
-
20710
-
20740
039670-09-2
20770
-
20800
024493-59-2
20830
-
20860
005039-78-1
20875
002370-63-0
20890
000097-63-2
20920
000688-84-6 Methacrylic acid, 2ethylhexyl ester
002495-27-4 Methacrylic acid,
hexadecyl ester
000142-09-6 Methacrylic acid, hexyl
ester
20935
20940
Methacrylic acid, esters
with alcohols, aliphatic,
monohydric,
unsaturated(C4-C18)
Methacrylic acid, esters
with alcohols, polyhydric
(C2-C21)
Methacrylic acid, esters
with etheralcohols
Methacrylic acid, ester
with
ethoxytriethyleneglycol
Methacrylic acid, esters
with glycolethers
obtained from mono
and/or diglycols with
alcohols, aliphatic,
monohydric (C1-C18)
Methacrylic acid, ester
with
methoxytriethyleneglyco
l
Methacrylic acid, esters
with 1,2-propanediol
Methacrylic acid, ester
with
trimethylethanolammoni
um chloride
Methacrylic acid, 2ethoxyethyl ester
Methacrylic acid, ethyl
ester
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
D
9
+
D
9
+
D
9
+
D
8
D
9
+
D
8
+
D
8
+
+
D
8
+
+
Available: hydrolysis (incomplete) data.
+
8
DIR
2
D
8
83
+
+
Group t-TDI: 0.1 mg/kg b.w. (as methacrylic
acid).
See references for methacrylic acid.
+
+
+
+
7
Needed : hydrolysis data.
+
7
Needed : hydrolysis data.
+
REF_N
20945
20950
20965
20980
21010
21040
21070
21100
21115
21130
CAS_N
NAME
004664-49-7 Methacrylic acid, 2hydroxyisopropyl ester
(=methacrylic acid, 2hydroxy-1-methylethyl
ester)
000923-26-2 Methacrylic acid, 2hydroxypropyl ester
002761-09-3 Methacrylic acid, 3hydroxypropyl ester
007534-94-3 Methacrylic acid,
isobornyl ester
000097-86-9 Methacrylic acid,
isobutyl ester
029964-84-9 Methacrylic acid,
isodecyl ester
028675-80-1 Methacrylic acid,
isooctyl ester
004655-34-9 Methacrylic acid,
isopropyl ester
000816-74-0 Methacrylic acid,
methallyl ester
000080-62-6 Methacrylic acid, methyl
ester
21160
-
21170
000997-46-6
21190
000868-77-9
21220
032360-05-7
21250
002157-01-9
Methacrylic acid,
monoester with 1,3butanediol
Methacrylic acid,
monoester with 1,4butanediol
Methacrylic acid,
monoester with
ethyleneglycol
Methacrylic acid,
octadecyl ester
Methacrylic acid, n-octyl
ester
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
D
7
Needed: hydrolysis data.
+
D
8
Available: hydrolysis data. However no
significant hydrolysis has been measured.
+
D
8
+
D
8
+
+
DIR
2
+
+
D
8
+
+
D
8
+
DIR
2
D
6A
DIR
2
D
8
+
D
8
+
DIR
2
D
D
84
Group t-TDI: 0.1 mg/kg b.w. (as methacrylic
acid).
See references for methacrylic acid.
Group t-TDI: 0.1 mg/kg b.w. (as methacrylic
acid).
See references for methacrylic acid.
+
+
+
+
Group t-TDI: 0.1 mg/kg b.w. (as methacrylic
acid).
See references for methacrylic acid.
+
+
+
+
8
Group t-TDI: 0.1 mg/kg b.w. (as methacrylic
acid).
See references for methacrylic acid.
Hydrolysis negligible (CS/PM/1689).
+
+
7
Needed: hydrolysis data.
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
21280
002177-70-0 Methacrylic acid, phenyl
ester
DIR
2
21310
003683-12-3 Methacrylic acid,
phenylethyl ester
002210-28-8 Methacrylic acid, propyl
ester
D
8
DIR
2
4A
21340
EFSA/SCF_OP
PL
CT
Group t-TDI: 0.1 mg/kg bw. (as methacrylic
acid).
Hydrolysis (complete) data allow the
allocation of the same TDI as methacrylic
acid.
+
+
+
Group t-TDI: 0.1 mg/kg b.w. (as methacrylic
acid).
See references for methacrylic acid.
Restriction: Not detectable
Remark for Commission: Monomer is used
in coatings and a specific migration (SM)
method is not available. QMA restriction is
applicable in this case.
http://www.efsa.eu.int/science/afc/afc_opini
ons/190/opinion_afc_06_en1.pdf
http://europa.eu.int/comm/food/fs/sc/scf/out
180_en.pdf
SCF_List: 3
Restriction: R = 0.05 mg/kg food. Based on
the reduced core set of toxicological data
and on the very low migration.
See SCF evaluation in the website:
http://europa.eu.int/comm/food/fs/sc/scf/out
180_en.pdf
Needed : hydrolysis data.
+
+
+
+
+
+
21370
010595-80-9 Methacrylic acid, 2sulphoethyl ester
DIR
21400
054276-35-6 Methacrylic acid,
sulphopropyl ester,
potassium salt
DIR
21415
D
7
Needed: hydrolysis data.
+
+
21460
002549-53-3 Methacrylic acid,
tetradecyl ester
007779-31-9 Methacrylic acid, 3,3,5trimethylcyclohexyl ester
004245-37-8 Methacrylic acid, vinyl
ester
000760-93-0 Methacrylic anhydride
DIR
2
+
+
21490
000126-98-7 Methacrylonitrile
DIR
Group t-TDI: 0.1 mg/kg b.w. (as methacrylic
acid).
See references for methacrylic acid.
The chemical structure is similar to
acrylonitrile. Methacrylonitrile should be
treated in the same way as acrylonitrile.
+
+
21495
004203-89-8 3-[2(Methacryloxy)ethyl]-
21420
21430
QMA = 0.05 mg/6dm²
3
7
+
W
SML = ND (DL =
0.020 mg/kg, analytical
tolerance included)
4A
W
85
+
+
REF_N
21520
21540
21550
21580
CAS_N
NAME
SYNONIM
2,2spirocyclohexyloxazolidi
ne
001561-92-8 Methallylsulphonic acid,
sodium salt
006143-33-5 1,4-Methano-1,4,4a,9atetrahydro-9H-fluorene
000067-56-1 Methanol
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SML = 5 mg/kg
SCF
List
3
7
Same 65960
21615
21620
21630
21640
003644-11-9 N(Methoxymethyl)acryla
mide
003644-12-0 N(Methoxymethyl)methac
rylamide
000150-76-5 4-Methoxyphenol
Same 66030
000107-98-2 1-Methoxy-2-propanol
Same 66050
001187-59-3 N-Methylacrylamide
000078-79-5 2-Methyl-1,3-butadiene Same 19243
21670
000563-46-2 2-Methyl-1-butene
21610
DIR
DIR
3
D
EFSA/SCF_OP
PL
CT
R = 5 mg/kg of food.
Remark: since the substance is very soluble
in water and has no lipophilic structural
elements, the absence of accumulation can
be expected. No additional data concerning
the absence of accumulation are requested.
+
+
(Adopted at the 123rd SCF meeting, 19
October 2000)
http://europa.eu.int/comm/food/fs/sc/scf/out
76_en.pdf
Under evaluation
+
+
6A
+
+
D
6A
+
+
DIR
8
8
6A
4A
+
+
+
+
+
QM = 1 mg/kg in FP or
SML = ND (DL = 0.02
mg/kg, analytical
tolerance included)
D
8
86
The toxicity profile well known also from
intoxication of man. The potential migration
into food will not be of toxicological
significance.
(SCF, 6th Series, 1978).
+
N.D.
Remark for Commission: no method of
analysis is available. However, the CENmethod for butadiene can be adapted.
(Adopted at the 123rd SCF meeting, 19
October 2000)
http://europa.eu.int/comm/food/fs/sc/scf/out
76_en.pdf
+
REF_N
CAS_N
NAME
SYNONIM
DIR
SCF
List
PL
000513-35-9 2-Methyl-2-butene
000563-45-1 3-Methyl-1-butene
21733
000115-19-5 2-Methyl-3-butyn-2-ol
D
8
21736
002549-61-3 alpha-Methyl-epsiloncaprolactone
002549-60-2 beta-Methyl-epsiloncaprolactone
002549-58-8 delta-Methyl-epsiloncaprolactone
002549-59-9 epsilon-Methyl-epsiloncaprolactone
002549-42-0 gamma-Methyl-epsiloncaprolactone
000694-91-7 5Methylenebicyclo(2,2,1)
hept-2-ene
106246-33-7 4,4'-Methylenebis(3chloro-2,6diethylaniline)
D
8
+
D
8
+
D
8
+
D
8
+
D
8
+
D
8
+
21742
21745
21748
21760
21765
DIR
QMA = 0.006 mg/6
dm². For use only in
Polypropylene.
QMA = 0.05 mg/6 dm²
87
8
4B
EFSA/SCF_OP
21700
21730
21739
D
DIR
RESTRICTIONS
AND
SPECIFICATIONS
3
R = Only to be used in polypropylene at
maximum residue level 0.001 mg/dm² of
material.
Available: Analytical data and migration by
worst case calculation, 3 mutagenicity tests
of which gene mutation in bacterial cells and
in mammalian cells in vitro negative,
chromosome aberration test in mammalian
cells in vitro positive.
(RIVM/TNO/ISS CS/PM/2745, January
1996).
4-week oral rat study. Data inadequate.
(Bayer Rep. 12557, 1984-03-22).
R = 0.05 mg/kg of food.
http://europa.eu.int/comm/food/fs/sc/scf/out
76_en.pdf
Available: residual content; calculation of
worst case migration < 0.05 mg/kg food; log
Po/w; two gene mutation assays in bacteria
(negative); chromosomal aberration assay in
cultured mammalian cells (negative);
micronucleus assay (negative); in vivo UDS
assay (negative).
RIVM/IT/UK SDS, April 2000 =
CS/PM/3413/21765.
+
+
+
+
CT
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
+
+
+
+
+
Remark for Commission: only a method for
the residual quantity in the finished product
(FP) is available. A QMA is proposed.
(Adopted at the 123rd SCF meeting, 19
October 2000)
21790
21820
21821
21827
21837
21850
21880
21910
21940
21970
000110-26-9 Methylenebisacrylamide
013093-19-1 Methylenebiscaprolacta
m
000505-65-7 1,4Same 13810
(Methylenedioxy)butane
000078-93-3 Methyl ethyl ketone
Same 66655
001116-90-1 4-Methyl-1,4-hexadiene
000095-71-6 Methylhydroquinone
000717-27-1 Methylhydroquinone
diacetate
000814-78-8 Methyl isopropenyl
ketone
000924-42-5 N-Methylolacrylamide
D
D
DIR
6A
8
See "1,4-Butanediol
formal"
3
R: 5 mg/kg of food.
Same references as 66655.
+
Same 66680
D
D
D
6A
8
8
+
+
+
Same 66740
D
8
+
000923-02-4 NSame 66820
Methylolmethacrylamide
DIR
SML = ND (DL = 0.01
mg/kg)
DIR
4A
7
Genotoxic carcinogen.
(RIVM report 04-03-1991).
SCF_list: 7
Needed data or information: Analytical
proof of the residual content.
+
+
+
+
See SCF evaluation in the website:
http://europa.eu.int/comm/food/fs/sc/scf/out
140_en.pdf
22000
22030
22060
22090
22120
22150
001118-58-7
001115-08-8
000926-56-7
000763-29-1
000760-20-3
000691-37-2
2-Methyl-1,3-pentadiene
3-Methyl-1,4-pentadiene
4-Methyl-1,3-pentadiene
2-Methyl-1-pentene
3-Methyl-1-pentene
4-Methyl-1-pentene
22180
004461-48-7 4-Methyl-2-pentene
D
D
D
D
D
DIR
SML = 0.05 mg/kg
D
8
8
8
8
8
3
8
88
R: 0.05 mg/kg in food.
28- and 90-day oral rat studies. Ames test
negative, cytogenicity study doubtful.
(RIVM summary 1990-02-22).
+
+
+
+
+
+
+
REF_N
CAS_N
NAME
22190
002163-42-0 2-Methyl-1,3propanediol
22210
000098-83-9 alpha-Methylstyrene
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
3
DIR
3
EFSA/SCF_OP
R = 5 mg/kg of food.
Available: Worst case migration < 0.6
mg/kg food; log Po/w; three (negative)
mutagenicity studies; 14-day oral rat study;
90-day oral rat study.
(RIVM/ISS/TNO SDS, April 1997 =
CS/PM/2998/22190).
(Adopted at 111th SCF meeting (18-19
March 1998)).
http://europa.eu.int/comm/food/fs/sc/scf/out
10_en.pdf
0.05 mg/kg food
PL
CT
+
+
+
+
+
+
http://www.efsa.eu.int/science/afc/afc_opini
ons/675/afc_opinion20_ej109_list5_en1.pdf
http://europa.eu.int/comm/food/fs/sc/scf/out
10_en.pdf
22240
22242
000622-97-9 p-Methylstyrene
Same 26292
006144-04-3 alpha-Methylstyrene
dimer
22270 000107-25-5 Methyl vinyl ether
22300 000078-94-4 Methyl vinyl ketone
22330 001822-74-8 Methyl vinyl thioether
22330/50 Mixture of (80%) 2,4diamino-3,5diethyltoluene and (20%)
2,6-diamino-3,5diethyltoluene
22331
025513-64-8 Mixture of (35-45%
Same 15355
w/w) 1,6-diamino-2,2,4trimethylhexane and (5565% w/w)1,6-diamino2,4,4-trimethylhexane
D
6A
D
D
D
D
7
6A
6A
7
DIR
QMA = 5 mg/6 dm²
89
3
Needed: hydrolysis data.
SCF_list: 7
Needed data or information:
- an in vivo/in vitro rat liver UDS on a
representative batch
- an explanation for the contradictory results
observed in the Ames test.
See SCF evaluation in the website:
http://europa.eu.int/comm/food/fs/sc/scf/out
140_en.pdf
Re-evaluation to align this evaluation with
other evaluations done by the SCF.
R = 5 mg/6 dm2.
Remark for Commission: A QM would be
indicated. The choice of a QM instead of
SML is due to the reactivity of the substance
+
+
+
+
+
+
REF_N
22332
CAS_N
NAME
22333
Mixture of (40% w/w)
2,2,4-trimethylhexane1,6-diisocyanate and
(60% w/w) 2,4,4trimethylhexane-1,6diisocyanate
000079-11-8 Monochloroacetic acid
22337
000141-43-5 2-Aminoethanol
SYNONIM
-
DIR
DIR
RESTRICTIONS
AND
SPECIFICATIONS
QM(T) = 1 mg/kg
(expressed as NCO)
(26).
SCF
List
4A
3
Same 35170,
67420
3
90
EFSA/SCF_OP
PL
with fat simulant.
Available: migration data; three negative
mutagenicity studies; 90-day oral rat study;
2-generation reproduction study (rat); two
teratogenicity studies (rat and rabbit).
RIVM/TNO SDS, November 2000 =
CS/PM/2914/15355.
(Adopted by the SCF at the 127th meeting,
30 May 2001)
http://europa.eu.int/comm/food/fs/sc/scf/out
86_en.pdf
Not detectable
+
R = 0.05 mg/kg of food.
Available: migration data in water; two gene
mutation assays in bacteria (negative);
chromosomal aberration assay in cultured
mammalian cells (negative); gene mutation
assay in cultured mammalian cells
(equivocal); in vitro SCE assay (positive);
sex-linked recessive lethal assay in
Drosophila melanogaster (negative); 16-day
oral mouse and rat studies; 90-day oral
mouse and rat studies; 2-year oral mouse
and rat studies.
(RIVM/DE/TNO SDS, October 1998 =
CS/PM/3065 REV. II/22333).
(Adopted at 117th SCF meeting) (17 June
1999)
http://europa.eu.int/comm/food/fs/sc/scf/out
37_en.pdf
R = 0.05 mg/kg of food.
Available: migration data from multilayer
bottle and residual content in polymer; gene
mutation assay in bacteria (negative);
chromosomal aberration assay in cultured
CT
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
+
+
+
mammalian cells (negative); gene mutation
assay in cultured mammalian cells
(negative); in vitro cell transformation assay
(negative); toxicology summary on
reproductive toxicity; general toxicological
overview on MEA (made by the applicant).
RIVM/TNO SDS, August 1999 =
CS/PM/3337/22337.
Remark: substance evaluated only for the
requested use of indirect contact with nonfatty food.
22340
22350
000074-89-5 Monomethylamine
000544-63-8 Myristic acid
22360
001141-38-4 2,6Naphthalenedicarboxylic
acid
DIR
SML = 5 mg/kg
3
22390
000840-65-3 2,6Naphthalenedicarboxylic
acid, dimethyl ester
DIR
SML = 0.05 mg/kg
7
Same 67891
W8
1
DIR
91
(Adopted at the 121 SCF meeting (20 June
2000))
http://europa.eu.int/comm/food/fs/sc/scf/out
62_en.pdf
Data inadequate.
ADI: Not specified.
(SCF, 25th Series, 1989).
R: 5 mg/kg of food
Available: migration tests according to EU
directives; extraction tests according to
FDA; log Po/w; acute toxicity data; skin and
eye irritation studies; gene mutation assay in
bacteria (negative); two chromosomal
aberration assays in cultured mammalian
cells (one positive and one inadequate); gene
mutation assay in cultured mammalian cells
(negative); micronucleus assay (negative);
90-day oral rat study.
(RIVM/ISS/TNO SDS, April 1999 =
CS/PM/2220 REV. II/22360).
(Adopted at the 118th SCF meeting) (23
September 1999)
http://europa.eu.int/comm/food/fs/sc/scf/out
41_en.pdf
Available: specific migration < 0.024 mg/kg
food in water and 15% ethanol and <0.24
mg/kg food in 3% acetic acid and olive oil;
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
+
+
hydrolysis data; acute toxicity data; 90-day
oral rat study; gene mutation assay in
bacteria (negative); chromsomal aberration
assay in cultured mammalian cells
(negative); gene mutation assay in cultured
mammalian cells (negative); micronucleus
assay (negative).
Needed: information on the absence of
accumulation of the compound.
RIVM/TNO SDS, September 1999 =
CS/PM/3085 REV. I/22390.
22420
003173-72-6 1,5-Naphthalene
diisocyanate
22424
22437
026761-45-5 Neodecanoic acid, 2,3epoxypropyl ester
051000-52-3 Neodecanoic acid, vinyl
ester
000126-30-7 Neopentylglycol
22450
22465
22480
009004-70-0 Nitrocellulose
000112-05-0 Nonanoic acid
000143-08-8 1-Nonanol
22510
22535
22540
22550
027215-95-8
025154-52-3
000104-40-5
000498-66-8
Nonene
Nonylphenol
4-Nonylphenol
Norbornene
Same 68175
Same 68185
Same 13180
22552
-
Novolac glycidyl ethers
(=NOGE)
Same 68200
See 13160
22428
DIR
QM(T) = 1 mg/kg
(expressed as NCO)
(26).
D
4A
6A
Covered by 25360.
7/D
Deleted because covered by 25380.
Same 16390
DIR
Same 43330
Same 68150
DIR
D
DIR
3
8
3
D
8
9
8
D
D
DIR
D
(Adopted at the 121 SCF meeting (20 June
2000)
http://europa.eu.int/comm/food/fs/sc/scf/out
61_en.pdf
See references for 3,3'-dimethyl-4,4'diisocyanatobiphenyl.
See "2,2-Dimethyl-1,3Propanediol"
See
"Bicyclo[2.2.1]hept-2ene"
According to
Commission Directive
92
7
(SCF, 6th Series, 1978).
See references for "Alcohols, aliphatic,
monohydric, saturated, linear, primary (C4C22)" (PM/REF.N. 12375) in SCF list 3.
+
+
+
+
+
+
+
+
+
+
+
+
+
+
http://europa.eu.int/comm/food/fs/sc/scf/out
76_en.pdf
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
2002/16/EC of 20
February 2002 on the
use of certain epoxy
derivatives in materials
and articles intended to
come into contact with
foodstuffs.
Can still be used in
heavy coatings.
22555
000112-92-5 1-Octadecanol
22570
000112-96-9 Octadecyl isocyanate
DIR
22580
22585
22600
000930-02-9 Octadecyl vinyl ether
003710-30-3 1,7-Octadiene
000111-87-5 1-Octanol
D
D
DIR
7
8
3
22630
22660
025377-83-7 Octene (except 1-octene)
000111-66-0 1-Octene
D
DIR
8
2
22690
22720
001806-26-4 4-Octylphenol
000140-66-9 4-tert-Octylphenol
22750
22755
22757/1
22763
22766
22775
000929-62-4
008016-35-1
000112-80-1
Octyl vinyl ether
Oiticica oil
Oiticica oil fatty acids
Oleic acid
000143-28-2 Oleyl alcohol
000144-62-7 Oxalic acid
Same 68225
Same 68750
3
QM(T) = 1 mg/kg
(expressed as NCO)
(26).
SML = 15 mg/kg
D
Same 25185 DIR/D See "4-(1,1,3,3Tetramethylbutyl)phen
ol"
D
Same 69040
Same 69760
Same 69920
4A
8
D
DIR
7
8
8/D
1
DIR
3
2
SML(T) = 6 mg/kg
93
See references for "Alcohols, aliphatic,
monohydric, saturated, linear, primary (C4C22)" (PM/REF.N.12375) in SCF list 3.
See references for 3,3'-dimethyl-4,4'diisocyanatobiphenyl.
Needed: hydrolysis data.
See references for "Alcohols, aliphatic,
monohydric, saturated, linear, primary (C4C22)" (PM/REF.N. 12375) in SCF list 3.
t-TDI: 0.25 mg/kg b.w. pending results of
fertility and teratogenicity studies.
Available: a 90-day oral rat study and
mutagenicity studies.
(CIVO rep. V86.408/251091, 26 September
1986).
See REF.N°. 25185.
Needed: hydrolysis data.
Not food fat.
It is not an oil from food sources.
ADI : not specified.
(SCF, 25th Series, 1990).
Precursor of oleic acid.
TDI : 0.1 mg/kg b.w.
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
3
2-year oral rat study, observations in man.
(J. Am. Pharm. Ass. 1947, 36, 217-219,
Patty).
R = 0.05 mg/kg of food.
Remark for Commission: only a method for
the residual quantity in the finished product
(FP) is available. A QMA is proposed.
+
(29)
22778
007456-68-0 4,4'Oxybis(benzenesulphony
l azide)
DIR
22780
000057-10-3 Palmitic acid
22810
22811
22840
000504-60-9 1,3-Pentadiene
000591-93-5 1,4-Pentadiene
000115-77-5 Pentaerythritol
22842
22858
22861
22870
002590-16-1 Pentaerythritol diallyl
ether
005343-92-0 1,2-Pentanediol
000111-29-5 1,5-Pentanediol
000071-41-0 1-Pentanol
22900
000109-67-1 1-Pentene
DIR
QMA = 0.05 mg/6 dm²
(Adopted at the 123rd SCF meeting, 19
October 2000)
http://europa.eu.int/comm/food/fs/sc/scf/out
76_en.pdf
ADI: not specified.
(SCF, 25th Series, 1990).
Same 70400
DIR
1
Same 71600
D
D
DIR
8
8
2
D
6A
+
D
D
DIR
8
8
3
+
+
+
SML = 5 mg/kg
3
Group TDI: 1 mg/kg b.w. (with
dipentaerythritol).
See references for dipentaerythritol.
See references for "Alcohols, aliphatic,
monohydric, saturated, linear, primary (C4C22)" (PM/REF.N. 12375) in SCF list 3.
R: 5 mg/kg of food.
Available: migration data showing specific
migration < 0.05 mg/kg in food; log Po/w;
gene mutation assay in bacteria (negative);
chromosomal aberration assay in cultured
mammalian cells (negative); two gene
mutation assays in cultured mammalian cells
(one inadequate and one negative); 90-day
oral rat study.
RIVM/TNO/ISS SDS, October 1999 =
CS/PM/2855 REV. IV/22900.
(Adopted at the 121 SCF meeting (20 June
94
CT
+
+
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
2000))
http://europa.eu.int/comm/food/fs/sc/scf/out
61_en.pdf
22901
22912
22930
22932
000109-68-2 2-Pentene
000627-19-0 1-Pentyne
Perfluoroalkyl (C1-C3)
perfuorovinyl ethers
001187-93-5 Perfluoromethyl
perfluorovinyl ether
D
8
8
9
D
D
3AM
3
+
+
+
Restriction: 0.05 mg/kg food
Remark for Commission: QMA restriction
of 0.05 mg/6dm2 could be more appropriate
for enforcement purposes.
Only to be used for anti-stick coatings.
+
http://www.efsa.eu.int/science/afc/afc_opini
ons/675/afc_opinion20_ej109_list5_en1.pdf
22935
003823-94-7 Perfluoromethyl vinyl
ether
22937
001623-05-8 Perfluoropropyl
perfluorovinyl ether
22940
006996-01-6 Perfluoropropyl vinyl
ether
22960
000108-95-2 Phenol
22990
-
23020
23050
Phenols, mono- and
dihydric, alkoxylated or
hydrogenated
028994-41-4 alpha-Phenyl-o-cresol
000108-45-2 1,3-Phenylenediamine
D
DIR
7
SML = 0.05 mg/kg
3
D
7
DIR
2
D
9
D
DIR
SML = ND (DL = 0.02
95
8
4A
http://europa.eu.int/comm/food/fs/sc/scf/out
84_en.pdf
Needed: provided hydrolysis can be
demonstrated, data on perfluoromethanol are
requested.
R = 0.05 mg/kg of food.
Migration data and three mutagenicity
studies negative.
(RIVM SDS, May 1996 = CS/PM/2799).
Needed: provided hydrolysis can be
demonstrated, data on perfluoropropanol are
requested.
TDI: 1.5 mg/kg b.w.
90-day oral studies in mice and rats,
multigeneration studies oral in rats and 2year studies oral in mice and rats.
(NTP 80-15, NIH Tech. report 203, J.
Pharm. Exp. Ther. 184, 1973, 695).
+
+
+
+
+
+
+
Since the data on carcinogenicity by the oral
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
mg/kg , analytical
tolerance included)
23070
000102-39-6 (1,3Phenylenedioxy)diacetic
acid
DIR
QMA = 0.05 mg/6dm²
3
EFSA/SCF_OP
route were inadequate and the substance
demonstrated some genotoxic potential, it is
only acceptable for use provided there is no
detectable migration into food by an agreed
sensitive method.
SCF_list:3
Restriction: 0.05 mg/kg of food. .
Remark for Commission:
No method of analysis for specific migration
available. QMA= 0.05mg/6dm²
PL
CT
+
See SCF evaluation in the website:
http://europa.eu.int/comm/food/fs/sc/scf/out
142_en.pdf
23080
23110
23125
001079-21-6 Phenylhydroquinone
058244-28-3 Phenylhydroquinone
diacetate
000103-71-9 Phenyl isocyanate
D
D
23140
23155
000092-69-3 4-Phenylphenol
000075-44-5 Phosgene
Same 72320
Same 14380
D
DIR
23170
007664-38-2 Phosphoric acid
Same 72640
DIR
23173
001314-56-3 Phosphoric anhydride
23175
000122-52-1 Phosphorous acid,
triethyl ester
8
8
4A
DIR
Isocyanates can hydrolyse to corresponding
amines. Some aromatic amines are
carcinogenic.
8
See "Carbonyl
chloride"
1
1
Same 25525
+
+
QM = ND (DL = 1
mg/kg in FP)
96
3
MTDI: 70 mg/kg b.w. (as P).
(SCF, 25th Series, 1990).
MTDI : 70 mg/kg b.w. (as P).
(SCF, 25th Series, 1990).
QM = n.d. in the polymer (limit of detection
= 1 ppm).
Available: Adequate analytical method for
determination of the residual content;
calculation worst case migration; gene
mutation assay in bacteria (negative);
chromosomal aberration assay in cultured
mammalian cells (negative); gene mutation
assay in cultured mammalian cells
(positive); in vivo UDS assay in rat liver
(negative).
(RIVM/ISS/UK SDS, July 1998 =
+
+
+
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
CS/PM/3195/25525).
(Adopted at 114th SCF meeting) (10
December 1998)
http://europa.eu.int/comm/food/fs/sc/scf/out
20_en.pdf
23185
23187
-
23200
000088-99-3 o-Phthalic acid
23230
23380
000131-17-9 Phthalic acid, diallyl
ester
000088-95-9 o-Phthalic acid
dichloride
Phthalic acid,
halogenated derivatives
Phthalic acids,
hydrogenated
Phthalic acids,
hydrogenated,
substituted,
endosubstituted, and
their halogenated
derivatives
000085-44-9 Phthalic anhydride
23410
-
23260
23290
23320
23350
Phthalic acids
Phthalic acid
D
DIR
Same 74480
DIR
DIR
Same 76320
D
+
+
See "Terephtahalic
acid"
2
SML = ND (DL = 0.01
mg/kg)
4A
Group TDI: 1 mg/kg b.w.
Included in the group TDI for phthalic
anhydride.
Genotoxic carcinogen (mouse and rat).
(RIVM doc. 91/679112/001).
Needed: hydrolysis data.
+
+
+
+
D
7
D
9
+
D
9
+
D
9
+
DIR
2
Group TDI: 1 mg/kg b.w.
(SCF, 17th Series, 1986).
+
+
+
D
9
+
23440
23470
Phthalic anhydride,
hydrogenated
000111-16-0 Pimelic acid
000080-56-8 alpha-Pinene
D
DIR
8
3
+
+
+
23500
000127-91-3 beta-Pinene
DIR
3
+
+
97
Occurs naturally in food. Used as a flavour.
Migration into food would be self-limiting,
because of its taste.
(Fd Cosmetic Tox. 16, 1978 suppl. 1, 853).
Occurs naturally in food. Used as a flavour
up to 600 mg/kg of food. Migration into
food would be self-limiting because of its
taste.
REF_N
23530
23547
23560
23590
23592
23615
23620
23650
23651
23680
CAS_N
NAME
SYNONIM
025190-06-1 Poly(1,4Same 76570
butyleneglycol)(Mw>10
00)
009016-00-6 Polydimethylsiloxane
Same 76721
and 063148- (Mw> 6800)
62-9
-
Polyethers based on
ethylene oxide,
propylene oxide and/or
tetrahydrofuran,
containing free hydroxyl
groups
025322-68-3 Polyethyleneglycol
Same 76960
157567-90-3 Polyethyleneglycol
isotridecyl ether
methacrylate
029435-48-1 Polyhydroxybutyrate.to
be deleted here and
introduced in a special
annex if authorized.
Polyols derived from
phenols and bisphenols,
hydrogenated and/or
condensed with
epoxyalkanes and/or
arylepoxyalkanes
possibly halogenated,
alkoxylated, aryloxylated
025322-69-4 Polypropyleneglycol
Same 23651
(Mw>400)
and 80800
025322-69-4 Polypropyleneglycol
Same 23650
and 80800
009002-89-5 Polyvinylalcohols
Same 81280
DIR
RESTRICTIONS
AND
SPECIFICATIONS
D
DIR
SCF
List
7
In compliance with the
specifications laid
down in Annex V
2
D
9
DIR
2
EFSA/SCF_OP
(Food Cosmet. Toxicol. 16 (suppl.1) 1978,
859-861).
Needed: molecular weight distribution
curve.
See the SCF opinion for the substance
PM/REF.N. 76721.
(Adopted at 111th SCF meeting (18-19
March 1998)
PL
CT
+
+
+
+
Group TDI: 5 mg/kg b.w. (with
triethyleneglycol).
See references for triethyleneglycol.
(SCF, 6th Series, 1978).
+
W
+
+
D
+
D
9
+
D
3
Toxicologically acceptable.
+
DIR
3
Toxicologically acceptable.
+
+
D
D
+
+
98
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
D
SCF
List
23710
23730
23740
063148-65-2 Polyvinylbutyrals
008002-11-7 Poppyseed oil
000057-55-6 1,2-Propanediol
23770
000504-63-2 1,3-Propanediol
23800
000071-23-8 1-Propanol
Same 81880
DIR
3
23830
000067-63-0 2-Propanol
Same 62480
and 81882
DIR
1
23860
000123-38-6 Propionaldehyde
DIR
3
23890
000079-09-4 Propionic acid
DIR
1
23920
000105-38-4 Propionic acid, vinyl
ester
Same 81840
and 82065
DIR
DIR
Same 82000
9
3
1
DIR
SML = 0.05 mg/kg
SML(T) = 6 mg/kg (2)
(expressed as
Acetaldehyde)
99
3
2
EFSA/SCF_OP
Food fat.
ADI: 25 mg/kg b.w.
(JECFA 17 M., 1973).
R = 0.05 mg/kg of food.
Available: Adequate migration data; Ames
tests (negative); in vitro cytogenetic assay in
Chinese hamster cells (positive); HPRT
forward mutation assay in Chinese hamster
cells (negative); mouse bone marrow
micronucleus assay (negative);
teratogenicity study (segment II).
(RIVM/ISS/TNO SDS, August 1997 =
CS/PM/3066/23770).
(Adopted at 111th SCF meeting (18-19
March 1998)).
http://europa.eu.int/comm/food/fs/sc/scf/out
10_en.pdf
(SCF, 11th Series, 1981; JECFA 25 M.,
1981).
t-ADI: 1.5 mg/kg b.w.
(SCF, 11th Series, 1981)
Occurs naturally in food. Used as a flavour
up to 13 mg/kg of food. Migration into food
will be self-limiting because of its taste.
Group ADI: not specified.
(SCF, 1st Series, 1974).
Group-TDI = 0.1 mg/kg b.w. (included in
the group-TDI of acetaldehyde).
Available: Hydrolysis data for propionic
acid vinylester, showing total (100%
hydrolysis of the monomer in intestinal
fluid, after 1hr at 37 °C, into propionic acid
and acetaldehyde); calculation of (worst
case) migration is <0.5 mg/kg food,
assuming 100% migration of residual
propionic acid vinylester from a typical
dispersion film; a bacterial reversion assay
(negative); a test for chromosomal
PL
CT
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
23950
000123-62-6 Propionic anhydride
DIR
1
23980
000115-07-1 Propylene
DIR
3
24010
000075-56-9 Propylene oxide
DIR
24040
24045
24051
000764-47-6 Propyl vinyl ether
008016-49-7 Pumpkinseed oil
000120-80-9 Pyrocatechol
Same 15880
24055
000089-05-4 Pyromellitic acid
Same 13040
24057
000089-32-7 Pyromellitic anhydride
24070
073138-82-6 Resin acids and rosin
acids
000108-46-3 Resorcinol
24072
24073
000101-90-6 Resorcinol diglycidyl
ether
QM = 1 mg/kg in FP
D
DIR
4A
7
3
Same 83610
DIR
Same 15910
DIR
DIR
aberrations in vitro (positive).
Remark for the Commission: no method of
analysis is available for the enforcement of
an SML.
(RIVM/ISS/TNO SDS, January 1997 =
CS/PM/2909/23920).
(Adopted at 111th SCF meeting (18-19
March 1998)).
http://europa.eu.int/comm/food/fs/sc/scf/out
10_en.pdf
Group ADI: included in the ADI not
specified for propionic acid.(SCF, 1st
Report, 1974).
Residues of this gas in plastics are very
small. The gas has a low toxic potential.
Migration into food will be toxicologically
negligible.(Patty's Industrial Hygiene and
Toxicology, 3rd ed., 1981).
Mutagenic in several studies. Induces
forestomach tumours in rats after oral
administration.
(Brit. J. Cancer 1982, 46, 924).
Needed: hydrolysis data.
Food fat.
See "1,2Dihydroxybenzene"
SML = 0.05 mg/kg
(expressed as
Pyromellitic acid)
3
2
See "1,3Dihydroxybenzene"
QMA = 0.005 mg/6
dm² - Not for use in
100
PL
3
R: 0.05 mg/kg in food.
Same references as pyromellyitic anhydride.
R: 0.050 mg/kg in food.
Available data: 3 requested mutagenicity,
studies negative, no bioaccumulation,
migration less than 0.05 mg/kg in all food
simulants.
Group TDI: 1 mg/kg b.w.
(SCF, 17th Series, 1986).
R= 0.005 mg/kg of food; only to be used
behind the PET barrier.
CT
+
+
+
+
+
+
+
3
DIR
EFSA/SCF_OP
+
+
+
+
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
polymers contacting
foods for which
simulant D is laid
down in Directive
85/572/EEC and for
indirect food contact
only, behind the PET
layer.
24100
008050-09-7 Rosin
24115
24130
008050-31-5 Rosin, ester with
glycerol
008050-09-7 Rosin gum
24150
24160
24190
Rosin, polymerized
008052-10-6 Rosin tall oil
008050-09-7 Rosin wood
24220
24250
24260
24270
009006-03-5
009006-04-6
008001-23-8
000069-72-7
Rubber, chlorinated
Rubber, natural
Safflower oil
Salicylic acid
Same
14687,24130
,45055 and
83840
Same 84000
DIR
Same
14687,24100
,45055 and
83840
DIR
2
1
See "Rosin"
9
3
2
DIR
DIR
Same 84480
Same 84560
D
DIR
Same 84640
DIR
2-D
9
3
3
3
101
EFSA/SCF_OP
Available: data on residual content in PHAE
polymer, resulting in a worst case migration
of 0.001 mg/kg food; gene mutation assay in
bacteria (positive); chromosomal aberration
assay in cultured mammalian cells
(positive); micronucleus assay (negative)
(the target organ was not reached); 2-week
oral mouse and rat studies; 13-week oral
mouse and rat studies; mouse and rat
carcinogenicity studies; conclusions made in
other scopes.
RIVM/TNO SDS, August 1999 =
CS/PM/3338/24073.
Remark: Substance evaluated for the
requested use of indirect contact with non
fatty food.
(Adopted at the 121 SCF meeting (20 June
2000))
http://europa.eu.int/comm/food/fs/sc/scf/out
62_en.pdf
Group TDI: 1 mg/kg b.w.
(SCF, 17h Series, 1986).
ADI= 12.5 mg/kg b.w.
(SCF, 32nd Series, 1994).
Group TDI: 1 mg/kg b.w.
(SCF, 6th Series, 1978).
Group TDI: 1 mg/kg b.w.
(SCF, 6th Series, 1978).
Migration unlikely.
Food fat.
Naturally occurring in food in low
concentration.
PL
CT
+
+
+
+
+
+
+
+
+
+
+
+
+
+
REF_N
CAS_N
NAME
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
SYNONIM
DIR
Same 85030
DIR
2
24280
000111-20-6 Sebacic acid
24310
000111-19-3 Sebacic acid dichloride
D
7?
24340
002432-89-5 Sebacic acid, di-n-decyl
ester
D
8
24370
000106-79-6 Sebacic acid, dimethyl
ester
D
8
24400
D
8
24430
002918-18-5 Sebacic acid, diphenyl
ester
002561-88-8 Sebacic anhydride
DIR
2
24435
24440
008008-74-0 Sesame oil
009000-59-3 Shellac
24460
24475
24490
000124-41-4 Sodium methanolate
001313-82-2 Sodium sulphide
000050-70-4 Sorbitol
24520
008001-22-7 Soybean oil
24525
-
24540
24545
24550
Soybean oil fatty acids,
dimers
009005-25-8 Starch, edible
068412-29-3 Starch, hydrolysed
000057-11-4 Stearic acid
Same 85540
Same 85550
3
1
Same 88320
DIR
DIR
D
3
1
DIR
3
Same
88630/0 and
86630/1
EFSA/SCF_OP
PL
CT
Group TDI: 3 mg/kg b.w.
(SCF, 17th Series 1986).
Needed: migration and hydrolysis data.
Pending these results necessity for a 28-day
oral study and further studies to be
considered.
http://europa.eu.int/comm/food/fs/sc/scf/out
161_en.pdf
Group R: 0.05 mg/kg b.w.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.050 mg/kg, peroxisome
proliferation studies too.
Group R: 0.05 mg/kg b.w.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.050 mg/kg, peroxisome
proliferation studies too.
+
+
+
+
+
+
Group TDI : 3 mg/kg b.w.
Included in the group TDI for sebacic acid.
Food fat.
ADI: Acceptable.
(SCF, 26th Series, 1992).
Organoleptically self limiting.
Acceptable.
(SCF, 16th Series, 1985).
Food fat.
+
+
+
+
+
+
+
+
+
+
8/D
Same 88800
Same 88880
Same 89040
DIR
DIR
DIR
0
0
1
102
+
+
ADI: not specified.
(SCF, 25th Series, 1990).
+
+
+
+
+
REF_N
CAS_N
NAME
24560
24610
000111-63-7 Stearic acid, vinyl ester
000100-42-5 Styrene
24640
-
24760
Styrene substituted by
alkyl groups (alpha)
Styrene substituted in the
benzene ring
Styrene substituted by
halogens (alpha or beta)
Styrene substituted in the
vinyl group
026914-43-2 Styrenesulphonic acid
24790
24820
000505-48-6 Suberic acid
000110-15-6 Succinic acid
24670
24700
24730
SYNONIM
DIR
SCF
List
EFSA/SCF_OP
PL
CT
Hydrolysis negligible (CS/PM/1895).
Several oral studies performed: 6-month rat,
19-month dog, carcinogenicity in mice (3)
and in rats (4), 3-generation reproduction
and teratogenicity in rats. Mutagenicity
studies positive only with activation.
(RIVM doc. 1990-05-03 (CS/PM/428),
BGA doc. 1990-07-17 (CS/PM/475),
CS/PM/915).
NOTA BENE: the wg wishes to establish a
limit for styrene in food and asked the
Commission to provide migration data.
The wg of the SCF has the intention to
recommend to the Commission a ban for
styrene in oven ware due to unacceptably
high migration.
+
+
+
+
D
DIR
8
4B
D
9
+
D
9
+
D
9
+
D
9
+
DIR
Same 90960
RESTRICTIONS
AND
SPECIFICATIONS
SML = 0.05 mg/kg
D
DIR
3
8
1
103
R = 0.05 mg/kg of food.
Available: Adequate migration data in food
simulants up to and including 175 °C;
analytical method; four (negative) in vitro
mutagenicity studies; acute toxicity;
sensitisation study; eye irritation study.
(RIVM/TNO SDS, August 1997 =
CS/PM/2087 Rev I/24760).
(Adopted at 111th SCF meeting (18-19
March 1998)).
http://europa.eu.int/comm/food/fs/sc/scf/out
10_en.pdf
ADI: not specified.
(SCF, 25th Series, 1990).
+
+
+
+
+
REF_N
24835
24850
CAS_N
NAME
000106-65-0 Succinic acid, dimethyl
ester
000108-30-5 Succinic anhydride
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
Same 91135
SCF
List
7
Needed : hydrolysys data.
TDI : not specified based on ADI (=not
specified) for succinic acid.
Same 91170
DIR
2
24880
24887
000057-50-1 Sucrose
Same 91185
006362-79-4 5-Sulphoisophthalic acid,
monosodium salt
DIR
DIR
SML = 5 mg/kg
0
3
24888
003965-55-7 5-Sulphoisophthalic acid,
monosodium salt,
dimethyl ester
DIR
SML = 0.05 mg/kg
3
24895
24900
008001-21-6 Sunflower oil
Sunflower oil fatty acids,
dimers
068425-17-2 Syrups, hydrolysed
Polyglycitol
starch, hydrogenated
syrup
24903
3
D
3AM
3
24905
008002-26-4 Tall oil
3
24910
000100-21-0 Terephthalic acid
DIR
SML = 7.5 mg/kg
2
24940
000100-20-9 Terephthalic acid
dichloride
DIR
SML(T) = 7.5 mg/kg
(as Terephthalic acid)
2
24970
000120-61-6 Terephthalic acid,
DIR
2
104
EFSA/SCF_OP
R: 5 mg/kg in food.
90-day oral rat study, 3 mutagenicity studies
negative, bioaccumulation and migration
data.
(Rivm summary data, May 1992
(CS/PM/1590)).
R: 0.05 mg/kg in food.
Available: 3 mutagenicity tests, negative.
Migration data less than 0.05 mg/kg.
(Rivm summary data, August 1992
(cs/pm/1638)).
Food fat.
In compliance with the purity criteria for
maltitol syrup, E 965 (ii)
http://www.efsa.eu.int/science/afc/afc_opini
ons/675/afc_opinion20_ej109_list5_en1.pdf
Not a food oil but toxicologically
acceptable.
(SCF, 17th Series, 1986).
t-TDI: 0.125 mg/kg b.w.
Available: 3-month and 2-year oral rat
studies, mutagenicity test negative.
Needed: full reports from CIIT and ICI.
(CIIT, 1982)(UK document "Terephthalic
acid: proposed use in animal foodstuffs",
1984).
Group TDI: 0.175 mg/Kg b.w.(as
terephthalic acid)
Hydrolysis (complete) data allow the
allocation of the same TDI of terephthalic
acid.
TDI: 1 mg/kg b.w.
PL
CT
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
dimethyl ester
25000
25030
25035
25050
25060
25063
EFSA/SCF_OP
PL
CT
90-day oral mouse and rat studies and longterm studies in mice and rats not indicating
tumour induction.
(NCI Tech.report Series N. 121, 1979).
001539-04-4 Terephthalic acid,
diphenyl ester
016646-44-9 Tetra(allyloxy)ethane
013810-83-8 Tetrabromophthalic acid
25070
005593-70-4 Tetrabutyl titanate
000632-58-6 Tetrachlorophthalic acid
021635-90-5 Tetracyclo[4.4.0.12,5.1.7
,10]dodeca-3-ene
000112-72-1 1-Tetradecanol
Same 92300
25080
001120-36-1 1-Tetradecene
25090
000112-60-7 Tetraethyleneglycol
25105
25120
000112-57-2 Tetraethylenepentamine
000116-14-3 Tetrafluoroethylene
25150
000109-99-9 Tetrahydrofuran
D
8
+
D
6A
5
+
+
D
3
DIR
Same 92350
Same 92430
W
8
7
SML = 0.05 mg/kg
DIR
3
1
DIR
SML = 0.05 mg/kg
8
3
DIR
SML = 0.6 mg/kg
2
105
[Some organobromo compounds have a
bioaccumulation potential and 1,2dibromoethane is a category 2 carcinogen
(EC classification).]
+
Under evaluation
+
+
See references for "Alcohols, aliphatic,
monohydric, saturated, linear, primary (C24C22)" (PM/REF.N. 12375) in SCF list 3.
R = 0.05 mg/kg of food.
Available: Adequate migration data,
showing specific migration of 1-tetradecene
is < 0.05 mg/kg food; three (negative)
mutagenicity
studies.
(RIVM/ISS/TNO SDS, January 1997 =
CS/PM/2910/25080).
(Adopted at 111th SCF meeting (18-19
March 1998)).
http://europa.eu.int/comm/food/fs/sc/scf/out
10_en.pdf
ADI: 10 mg/kg b.w.
(JECFA 23 M., 1979).
+
+
+
+
+
+
R: 0.050 mg/kg in food.
Available 3 mutagenicity studies negative.
No migration data available.
(Summary data from RIVM, CS/PM/925).
TDI: 0.01 mg/kg b.w.
6-month oral studies in mice, rats and
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
rabbits.
(Gig. Sanit. 34, 1969, 114, EPA 560/11-80011, April 1980).
25158
25161
25163
25180
25185
000088-98-2 1,2,3,6Tetrahydrophthalic acid
000085-43-8 1,2,3,6Tetrahydrophthalic
anhydride
002426-02-0 3,4,5,6Tetrahydrophthalic
anhydride
000102-60-3 N,N,N,'N'-Tetrakis(2Same 92640
hydroxypropyl)ethylened
iamine
D
8
D
8
+
1-year oral rat study inadequate.
(Allied Chem. Corp. 1958).
+
8
DIR
2
000140-66-9 4-(1,1,3,3Same 22720 DIR/D
Tetramethylbutyl)phenol
6B
+
TDI: 1 mg/kg b.w.
A 90-day oral rat study.
(Hilltop Research Inst. Inc. January 3,
1956).
R= not detectable.
Available: Inadequate migration data,
inadequate mutagenicity studies, acute
tox.data, 28-day oral rat study, two 90-day
oral rat studies, reproduction study (special
design), excretion study, skin and eye
irritation studies, two oestrogenic studies.
Needed: Confirmation of the claim of nondetectability at 5 ppb level; information on
the composition of the test samples
(particularly the amount of 4-(1,1,3,3tetramethylbutyl)phenol used in the
polycondensation process should be
indicated); reasons for deviation from
standard test conditions in migration
experiments; a more extensive description of
the method of determination (preferably
according to the standard format) and
sufficient information to allow evaluation of
the data provided; detailed data on the level
of 4-tert.octylphenol in the recovery
experiments. In vitro chromosomal
aberration assay in cultured mammalian
cells; dependent of the outcome of the
106
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
25208
026471-62-5 Toluene diisocyanate
25210
000584-84-9 2,4-Toluene diisocyanate
DIR
25240
000091-08-7 2,6-Toluene diisocyanate
DIR
25270
026747-90-0 2,4-Toluene diisocyanate
dimer
DIR
25300
25330
000088-19-7 o-Toluenesulphonamide
000070-55-3 p-Toluenesulphonamide
D
D
25360
-
Trialkyl(C5-C15)acetic
acid, 2,3-epoxypropyl
ester
DIR
QM = 1 mg/kg in FP
(expressed as Epoxy
group, Mw=43)
25380
-
Trialkyl acetic acid (C7C17), vinyl esters
(=vinyl versatate)
DIR
QMA = 0.05 mg/6 dm²
25385
000102-70-5 Triallylamine
SCF
List
4A
DIR
QM(T) = 1 mg/kg
(expressed as NCO)
(26).
QM(T) = 1 mg/kg
(expressed as NCO)
(26).
QM(T) = 1 mg/kg
(expressed as NCO)
(26).
4A
107
migration studies a one-generation
reproduction study (special attention to be
given to effects on male reproductive
organs) may be needed.
(RIVM/LST/TNO SDS, November 1996 =
CS/PM/2793).
See references for 3,3'-dimethyl-4,4'diisocyanatobiphenyl.
See references for 3,3'-dimethyl-4,4'diisocyanatobiphenyl.
PL
+
+
+
See references for 3,3'-dimethyl-4,4'diisocyanatobiphenyl.
+
4A
See references for 3,3'-dimethyl-4,4'diisocyanatobiphenyl.
+
4A
3
3
Needed: mutagenicity and reproduction
studies on the commercial mixture to be
specified.
Available: a 5-week oral rat study and
mutagenicity tests.
(Summary data only (CS/PM/932)).
Structural similarity taken into account.
R = 0.05 mg/kg of food.
Remark for Commission: only a method for
the residual quantity in thin films is
available. A QMA is proposed.
(Adopted at the 123rd SCF meeting, 19
October 2000)
http://europa.eu.int/comm/food/fs/sc/scf/out
76_en.pdf
R = 40 mg/kg hydrogel at a ratio of 1 kg
food to a max of 1.5 g hydrogel. Only to be
used in hydrogels intended for non-direct
food contact use.
Available: adequate data on residual content
CT
+
4A
8
7
In compliance with the
specifications laid
down in Annex V
EFSA/SCF_OP
+
+
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
+
of triallylamine in hydrogel; calculated
migration; five in vitro (one positive) and in
vivo mutagenicity tests. Although the one
negative in vivo mutagenicity study is not
enough to rule out the genotoxic potential
completely, the risk is thought to be very
low, if at all, based on the technical
information (i.e. no migration) and the
restriction for use. The WG therefore does
not require a further in vivo mutagenicity
study.
(RIVM/TNO/ISS SDS CS/PM/2856, June
1996).
25390
25405
25420
000101-37-1 Triallyl cyanurate
001025-15-6 Triallyl isocyanurate
000108-78-1 2,4,6-Triamino-1,3,5triazine
25450
026896-48-0 Tricyclodecanedimethan
ol
D
Same 19975,
65360 and
93720
DIR
SML = 30 mg/kg
DIR
SML = 0.05 mg/kg
6A
6A
2
3
TDI: 0.5 mg/kg b.w.
(SCF, 17th Series, 1986).
+
+
+
+
R = 0.05 mg/kg of food. Based on the
reduced core set of toxicological data
according to the migration level, see
Appendix 2
+
+
+
+
+
+
Available: adequate information on the
identity of the substance; incomplete
specific migration data in ethanol instead of
olive oil; gene mutation assay in bacteria
(negative); chromosomal aberration assay in
cultured mammalian cells (negative); gene
mutation assay in cultured mammalian cells
(negative).
RIVM/FR SDS, July 2000 = CS/PM/3253
REV. II/25450
http://europa.eu.int/comm/food/fs/sc/scf/out
84_en.pdf
25480
000102-71-6 Triethanolamine
25510
000112-27-6 Triethyleneglycol
Same 25922
and 94000
Same 94320
D
8
DIR
2
108
Group TDI: 5 mg/kg b.w. (with
polyethyleneglycol).
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
(SCF, 17th Series, 1986).
25520
25525
25540
000112-24-3 Triethylenetetramine
000122-52-1 Triethylphosphite
000528-44-9 Trimellitic acid
Same 23175
Same 13050
DIR
QM(T) = 5 mg/kg in
FP.
8
D
3
+
Restriction: 5 mg/kg of food
Remark for Commission: Group restriction
together with the trimellitic anhydride REF
No 25550
+
+
+
+
+
http://www.efsa.eu.int/science/afc/afc_opini
ons/468/opinion11_afc_ej65_list4_en1.pdf
25550
000552-30-7 Trimellitic anhydride
DIR
QM(T) = 5 mg/kg in
FP (expressed as
Trimellitic acid).
3
http://europa.eu.int/comm/food/fs/sc/scf/out
10_en.pdf
Restriction: 5 mg/kg of food, expressed as
trimellitic acid
Remark for Commission: Group restriction
together with the trimellitic acid REF No
25540
http://www.efsa.eu.int/science/afc/afc_opini
ons/468/opinion11_afc_ej65_list4_en1.pdf
http://europa.eu.int/comm/food/fs/sc/scf/out
10_en.pdf
25561
25570
25573
25574
25595
25600
25630
002768-02-7 (Trimethoxy)vinylsilane
000067-48-1 Trimethylethanolammoni
um chloride
016938-22-0 2,2,4-Trimethylhexane1,6-diisocyanate
015646-96-5 2,4,4-Trimethylhexane1,6-diisocyanate
000077-85-0 Trimethylolethane
000077-99-6 1,1,1Trimethylolpropane
037275-47-1 1,1,1Trimethylolpropane
diacrylate
Same 26320
Same 94880
Same 13380,
39560 and
94960
D
8
D
DIR
SML = 6 mg/kg
D
4A
+
4A
+
9
2
+
+
7
109
+
+
TDI: 0.1 mg/kg b.w.
A 90-day oral rat study.
(Report Perstorp, Sweden).
Needed: hydrolysis data.
+
+
REF_N
25645
25660
25690
25720
25750
25780
25810
25840
CAS_N
NAME
000682-09-7 1,1,1Trimethylolpropane
diallyl ether
019727-16-3 1,1,1Trimethylolpropane
dimethacrylate
1,1,1Trimethylolpropane
maleates
007024-08-0 1,1,1Trimethylolpropane
monoacrylate
007024-09-1 1,1,1Trimethylolpropane
monomethacrylate
025723-16-4 1,1,1Trimethylolpropane,
propoxylated
015625-89-5 1,1,1Trimethylolpropane
triacrylate
003290-92-4 1,1,1Trimethylolpropane
trimethacrylate
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
D
6A
D
7
D
8
D
7
Needed: hydrolysis data.
+
D
7
Needed: hydrolysis data.
+
D
8
D
8
DIR
SML = 0.05 mg/kg
3
+
Needed: hydrolysis data.
+
+
+
+
Available: hydrolysis only to the diacrylate
and acrylic acid (CS/PM/2156). Known
sensitiser.
(Food Chem. Tox. 23, 124, 1985).
Needed: in addition to data according to
SCF guidelines, information on potential for
sensitisation to plastics made from this
monomer.
Restriction : 0.05 mg/kg of food. Based on
the reduced core set of toxicological data
according to the migration level.
Available : migration data ; 2 gene mutation
assays in bacteria (one negative, however no
experimental details given (publication), one
weak positive) ; chromosomal aberration
assay in cultured mammalian cells (positive)
; 2 gene mutation assays in cultured
mammalian cells (one positive, however no
experimental details given (publication), one
negative) ; in vivo micronucleus assay
110
CT
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
(negative) ; in vivo/in vitro UDS assay in rat
liver (negative).
RIVM/FR/DE SDS, October 2001 =
CS/PM/3440 REV. III/25840.
(Adopted at the 130th SCF meeting, 13
December 2001)
http://europa.eu.int/comm/food/fs/sc/scf/out
115_en.pdf
25870
25900
000107-39-1 2,4,4-Trimethyl-1pentene
000110-88-3 Trioxane
25910
024800-44-0 Tripropyleneglycol
25915
000090-72-2 2,4,6Same 95400
Tris((Dimethylamino)me
thyl)phenol
000102-71-6 Tris(2Same 25480
hydroxyethyl)amine
and 94000
027955-94-8 1,1,1-Tris(4hydroxyphenyl)ethane
25922
25927
25930
001067-53-4 Tris(2methoxyethoxy)vinylsila
ne
D
DIR
8
SML = 0.05 mg/kg
DIR
3
2
+
Under re-evaluation.
R = 0.05 mg/kg of food.
(Adopted at 117th SCF meeting) (17 June
1999)
http://europa.eu.int/comm/food/fs/sc/scf/out
37_en.pdf
Group TDI: 1.5 mg/kg b.w. (with
polypropyleneglycol and
dipropyleneglycol).
See references for dipropylenglycol.
+
+
+
+
8
D
DIR
+
D
QM = 0.5 mg/kg in FP.
For use only in
polycarbonates.
D
3
6A
111
+
R = 0.5 mg/kg in finished product
(polycarbonate).
Available: calculated worst case migration;
Ames /E. Coli assay; in vitro chromosomal
aberration assay; two in vivo micronucleus
assays; in vivo UDS assay; acute toxicity
assay.
(RIVM/TNO SDS, December 1996 =
CS/PM/2911).
+
+
REF_N
25960
25980
CAS_N
NAME
25990
25995
26020
26050
000057-13-6 Urea
Versatic acid (=acids,
aliphatic,
monocarboxylic,
saturated, branched(C5C15)
000689-97-4 Vinylacetylene
Vinyl alcohol
001484-13-5 N-Vinylcarbazole
000075-01-4 Vinyl chloride
26080
-
SYNONIM
DIR
Same 95630
DIR
D
D
D
DIR
See 10120
RESTRICTIONS
AND
SPECIFICATIONS
See Council Directive
78/142/EEC
26110
Vinyl ethers of alcohols,
aliphatic, monohydric,
saturated (C2-C18)
000075-35-4 Vinylidene chloride
D
DIR
26140
000075-38-7 Vinylidene fluoride
DIR
QM = 5 mg/kg in FP or
SML = ND (DL = 0.05
mg/kg)
SML = 5 mg/kg
26155
001072-63-5 1-Vinylimidazole
DIR
QM = 5 mg/kg in FP
SCF
List
PL
CT
0
D
+
+
+
6A
+
+
+
+
6A
4A
EFSA/SCF_OP
(SCF, 1st Series, 1975).
9
4B
3
3
+
(SCF 13th Series, 1982).
+
+
R: 5 mg/kg of food.
Many inhalation studies, 1-year oral rat
study, carcinogenicity studies by inhalation
in mice and rats negative, mutagenicity
studies negative, reproduction study
negative.
(RIVM report 1992-10-29).
R = 0.05 mg/kg of food.
Available: Adequate analytical method for
determination of residual 1-vinylimidazole
in terpolymer; calculated worst case
migration is < 0.17 ppb into food; three
negative mutagenicity
studies.
(RIVM/TNO SDS, April 1998 =
CS/PM/3158 /95805).
+
+
+
+
REMARK for Commission: Only a method
for the determination for the residual content
is available.
(Adopted at 114th SCF meeting) (10
112
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
December 1998).
http://europa.eu.int/comm/food/fs/sc/scf/out
20_en.pdf
R = 2 mg/kg in finished product.
Available: 5 mutagenicity studies considered
to be non-genotoxic, physical-chemical data
on VIMA; adequate analytical data and
method for the residual content of VIMA in
final product; calculation of worst case
migration assuming 100% migration of
residual monomer.
(RIVM SDS, May 1994 = CS/PM/2371 and
TNO SDS, August 1996 = CS/PM/2857).
PL
CT
003195-78-6 N-Vinyl-Nmethylacetamide
DIR
26200
002867-48-3 N-Vinyl-Nmethylformamide
000100-69-6 2-Vinylpyridine
000100-43-6 4-Vinylpyridine
000088-12-0 Vinylpyrrolidone
D
6A
+
DIR
6A
6A
4A
+
+
+
+
+
+
+
+
+
+
+
Same 95810
3
EFSA/SCF_OP
26170
26215
26217
26230
QM = 2 mg/kg in FP
SCF
List
SCF_list: 4A
Restriction: n.d. by an agreed sensitive
method.
Remark for Commission: only to be used in
adhesives for paper and board and QMA <
10 µg/6dm².
+
See SCF evaluation in the website:
http://europa.eu.int/comm/food/fs/sc/scf/out
140_en.pdf
26260
26290
001184-84-5 Vinylsulphonic acid
025013-15-4 Vinyltoluene
26292
26320
000622-97-9 p-Vinyltoluene
002768-02-7 Vinyltrimethoxysilane
D
D
Same 22240
Same 25561
D
DIR
6A
7
QM = 5 mg/kg in FP
D
3
Needed: migration data and on that basis
decide on indication for a 28/90 day oral
study.
R = 0.05 mg/kg of food.
Remark: Given the data on rapid and
complete hydrolysis no further questions
concerning genotoxicity are raised.
Remark for Commission: Complete and
rapid hydrolysis in aqueous foodstuff and
113
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
+
+
+
+
food simulants.
26340
26345/1
26360
008024-09-7 Walnut oil
Walnut oil fatty acids
007732-18-5 Water
Same 95855
26370
001330-20-7 Xylene
Same 95945
26375
26377
26379
30000
000105-67-9
000526-75-0
000095-87-4
000064-19-7
Same 16300
Same 16270
Same 16330
Same 10090
30045
In compliance with the
Directive 98/83/EC.
3
D
D
D
DIR
D
D
D
1
000123-86-4 Acetic acid, butyl ester
DIR
1
30060
30080
000071-48-7 Acetic acid, cobalt II salt
004180-12-5 Acetic acid, copper salt
DIR
30100
000111-55-7 Acetic acid, diester with
ethyleneglycol
000111-15-9 Acetic acid, 2ethoxyethyl ester
7
?
30120
30130
30140
m-Xylenol
o-Xylenol
p-Xylenol
Acetic acid
DIR
3
3/D
0
Acetic acid,
ethoxypropyl ester
000141-78-6 Acetic acid, ethyl ester
SML(T) = 30 mg/kg
(7) (expressed as
Copper)
W
2
114
Group ADI: not specified.
(SCF, 25th Series, 1991).
t-ADI: 6 mg/kg bw.
(SCF, 25th Series, 1991).
+
+
+
+
+
+
+
+
+
For Copper, R = 5 mg/person based on
http://europa.eu.int/comm/food/fs/sc/
scf/out176_en.pdf.
Needed: hydrolysis data.
+
+
9
Group t-TDI : 0.05 mg/kg b.w. (with
15780=48050, 16993=53765, 16996=53820,
16999, 17002=53860, 30015, 30120, 30200,
48030)
R : 0.05 mg/kg of food.
1
ADI: not specified.
+
2
DIR
(Adopted at 116th SCF meeting) (24 March
1999)
http://europa.eu.int/comm/food/fs/sc/scf/out
27_en.pdf
Food fat.
Constituents of food fats.
Specification: Impurity levels not to exceed
those set in the Drinking water Directive.
R: 0.02 mg/kg bw (with
95945,95947,95949,95951) based on
allowing 1/10 of TDI for food contact
materials.
2-year oral rat study, mutagenicity test
negative.
(WHO draft, Geneva, September
1992)(CS/PM/1712).
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
(SCF, 11th Series, 1981).
30160
30165
30180
see 30180
000108-21-4 Acetic acid, isopropyl
ester
002180-18-9 Acetic acid, manganese
salt
D
7
DIR
SML(T) = 0.6 mg/kg
(10) (expressed as
Manganese)
1-2
Needed: hydrolysis data.
L2 for Manganese.
Group TDI: 0.01 mg/kg b.w. (as Mn).
Recommended daily allowance 2-3 mg/day.
Average daily intake 10 mg.
(Manganese. Environmental Health Criteria
17, WHO, Geneva 1981).
+
+
+
L1 for acetic acid.
Group ADI: Not specified.
(SCF, 25th Series, 1991).
30190
30225
30240
30245
30280
see 30280
000628-63-7 Acetic acid, pentyl ester
see 30330
000109-60-4 Acetic acid, propyl ester
000108-24-7 Acetic anhydride
30295
000067-64-1 Acetone
30320
30330
see 30370
Acetone-nonylphenolthiodipropionic acid
didodecyl ester,
copolymer
330198-91-9 12-(Acetoxy)stearic acid,
2,3-bis(acetoxy)propyl
ester
30340
Same 10150
DIR
D
7
D
7
2
DIR
3
Needed: hydrolysis data.
Needed: hydrolysis data.
Group TDI: included in the ADI not
specified for acetic acid.
(SCF, 25th Series, 1991).
Residue in food less than 5 mg/kg.
(SCF, 11th Series, 1981).
D
9
3AM
3
+
+
+
+
+
+
+
+
+
Restriction: None
Remark for Commission: FRF is applicable
+
http://www.efsa.eu.int/science/afc/afc_opini
ons/675/afc_opinion20_ej109_list5_en1.pdf
http://europa.eu.int/comm/food/fs/sc/scf/out
172_en.pdf
30345
001118-84-9 Acetylacetic acid, allyl
ester
W
115
+
REF_N
30350
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
PL
30370
30385
30400
DIR
DIR
0
8
1
30401
-
3AM
1
ADI: not specified.
(SCF, 7th report, 1978).
ADI: not specified.
7
Needed: hydrolysis data.
+
DIR
D
3
Toxicologically acceptable.
+
+
+
DIR
3
Toxicologically acceptable.
+
+
30480
30560
30610
30612
30620
30640
30720
30725
30800
+
+
+
+
+
9
+
9
+
9
+
7
9
116
Needed: hydrolysis data.
CT
000141-97-9 Acetylacetic acid, ethyl
ester
Acetylacetic acid, salts
000123-54-6 Acetylacetone
Acetylated diglycerides
Acetylated mono- and
diglycerides of fatty
acids
000140-04-5 Acetylricinoleic acid,
butyl ester
see 30620
Acids C2-C24 aliphatic,
linear, monocarboxylic
from natural oils and fats
and their mono-, di- and
triglycerol esters
(branched fatty acids at
naturally occurring levels
are included).
Acids C2-C24 aliphatic,
linear, monocarboxylic,
synthetic and their
mono-, di- and
triglycerol esters
Acids, aliph. monocarb.
(C6-C24)
Acids, aliph., monocarb.
(C8-C22), sec-butyl and
oleyl esters
Acids, aliph., monocarb.
(C8-C22), compounds
with diethanolamine
068603-38-3 Acids, aliph., monocarb.
(C16-C18), compounds
with diethanolamine
Acids, aliph., monocarb.
(more than C5), esters
with mannitol
7
EFSA/SCF_OP
Same references as 39280.
+
+
REF_N
CAS_N
30880
-
30960
-
31040
-
31120
-
31200
-
31280
-
31302
-
31304
085566-24-1
31306
092797-30-3
31307
095912-87-1
31328
-
31330
-
31350
125109-79-7
NAME
SYNONIM
Acids, aliph., monocarb.
(more than C5), esters
with pentaerythritol
Acids, aliph., monocarb.
(C6-C22) esters with
polyglycerol
Acids, aliph., monocarb.,
hydroxylated (C12-C20)
and their sulphonated
and acetylated
derivatives
Acids, aliph., monocarb.
(C6-C24), Li, Mn and Sn
salts
Acids, aliph., monocarb.,
sat.(more than C7),
esters with alcohols,
aliph. monoh.
Acids, aliph., monocarb.
(C8-C22), compounds
with triethanolamine
Acids carboxylic, esters
with alcohols (for memoto be del.later)
Acids, fatty (C14-C18), Same 30490
alkyl (C14-C18) esters
Acids, fatty (C14-C22),
alkyl (C16-C24) esters
Acids, fatty (C16-C18),
alkyl (C12-C18) esters
Acids, fatty from animal
or vegetable food fats
and oils
Acids, fatty from animal
or vegetable fats and
oils, methyl esters
Acids, fatty (C14-C22),
esters with
pentaerythritol
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
9
DIR
1
DIR
PL
+
Group ADI: 25 mg/kg b.w.
(SCF, 7th Series, 1978).
+
9
+
9
+
9
+
9
+
D
+
8
+
9
+
9
+
3/D
Constituent of food fats.
117
+
+
9
9
CT
+
+
REF_N
31352
31360
31382
31384
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
085116-93-4 Acids, fatty (C16-C18),
esters with
pentaerythritol
see 31470
Acids, fatty,
unsaturated(C18),
dimers, hydrogenated adipic acid2ethylhexanol-1,2propanediol, copolymer
-
31440
31455
31470
-
31490
-
31492
-
31495
-
Acids, fatty,
unsaturated(C18),
dimers, hydrogenatedadipic acid-1,2propanediol, copolymer
see 31490
Acids, fatty, dimerized
Acids, sat., linear (C5C10), esters with
dipentaerythritol
Acids, substituted (C9C20), and their trietha
Nolamine salts
Acrylamide-acrylic acidethyl acrylateethyleneglycol
methacrylatepolyethyleneglycol
(EO=5) dodecylaminetoluene diisocyanate,
copolymer (Mw= 500015000)
Acrylamide-acrylic acidmethacrylic acidpolyethyleneglycol(EO=
5 and 15)dodecylamine,
SCF
List
EFSA/SCF_OP
PL
9
+
D
7
+
+
7?
Available: Molecular mass distribution and
hydrolysis in simulated gastric juice (no
hydrolysis). 3 mutagenicity tests with the
dimeric acids were negative.
Needed: Information on items 2 and 3 in the
SCF guidelines in first instance (see page
50-51 of the "Practical Guide N.1").
(RIVM/TNO SDS, CS/PM/2648).
Available: Same text as 31382.
+
Needed: Same text as 31382.
118
D
9
9
+
+
+
9
+
7?
Available: molecular weight distribution
curve.
Needed: chemical structure, migration and
toxicity data for the polymer according to
SCF guidelines. Chemical structure of and
and 3 mutagenicity tests for
polyethyleneglycol (EO=5) dodecylamine.
+
7
Needed: molecular weight distribution
curve. Chemical structure of
the polymer. Chemical structure of and 3
mutagenicity tests for methacrylic acid ester
+
CT
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
copolymer (Mw=1000020000)
31497
31500
-
Acrylamide-acrylic acidmethacrylic acidpolyethyleneglycol
(EO=50)nonylphenyl
ether, copolymer (Mw=
10000-20000)
025134-51-4 Acrylic acid, acrylic
acid, 2-ethylhexyl ester,
copolymer
7
EFSA/SCF_OP
PL
with polyethylenglycol (EO=15)
dodecylamine and with methacrylic acid
polyethyleneglycol (EO=5) dodecylamine.
Available: Use and average molecular mass.
+
CT
Needed: Structure of the polymer and
molecular mass distribution in first instance.
(CS/PM/2632).
3AM
3
Group restriction 6mg/kg food for acrylic
acid and 0.05 mg/kg food for acrylic acid, 2ethylhexyl ester.
+
http://www.efsa.eu.int/science/afc/afc_opini
ons/675/afc_opinion20_ej109_list5_en1.pdf
http://europa.eu.int/comm/food/fs/sc/scf/out
142_en.pdf
31505
-
31520
061167-58-6
31530
123968-25-2
31532
048076-38-6
31534
025135-39-1
31536
009010-77-9
Acrylic acid, acrylic
esters of alcohols,
monohydric, primary,
linear (C1-C18),
copolymers
Acrylic acid, 2-tertbutyl-6-(3-tert-butyl-2hydroxy-5methylbenzyl)-4methylphenyl ester
Acrylic acid, 2,4-di-tertpentyl-6-[1-(3,5-di-tertpentyl-2hydroxyphenyl)ethyl]phe
nyl ester
Acrylic acid, eicosyl
ester
Acrylic acid-ethyl
acrylate-methyl
methacrylate, copolymer
Acrylic acid-ethylene,
copolymer
D
DIR
SML = 6 mg/kg
2
DIR
SML = 5 mg/kg
3
119
+
TDI: 0.1 mg/kg b.w.
3-month oral rat study. Mutagenicity studies.
Migration data.
No bioaccumulation in fish.
(RIVM 90/678608/007; CS/PM/926).
R = 5 mg/kg food.
3-month oral rat study, 3 mutagenicity tests,
negative, migration data.
(TNO 1994-08-08).
+
+
+
W
+
W
+
W
+
REF_N
31540
31542
CAS_N
NAME
Acrylic acid-maleic
anhydride, copolymer
(Mw= 5000-20000)
174254-23-0 Acrylic acid, methyl
ester, telomer with 1dodecanethiol, C16-C18
alkyl esters
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
-
Same 81960
3AM QM=0.5% w/w in final
article
SCF
List
EFSA/SCF_OP
PL
7?
Needed: migration and toxicity data for the
polymer according to SCF guidelines.
+
3
Restriction: Maximum quantity 0.5% w/w in
the final article
Remark for Commission: Restriction on
maximum quantity (QM) is proposed to
control migration of dodecylmercaptane if
any.
+
CT
http://www.efsa.eu.int/science/afc/afc_opini
ons/768/afc_fcm_op_list6_2004.12.171.pdf
31545
31550
31560
31580
31595
31600
31605
31610
025322-25-2 Acrylic acid-methyl
methacrylate, copolymer
(average Mw=1000-2000
dalton)
Acrylic acid-methyl
methacrylateethyleneglycol
monomethacrylate
phosphate, copolymer
(Mw= 5000-20000)
7?
http://www.efsa.eu.int/science/afc/afc_opini
ons/195/opinion_afc_01_en1.pdf
Needed: migration and toxicity data
according to SCF guidelines on the
polymeric additive itself.
7?
Available: Use.
025085-34-1 Acrylic acid-styrene,
copolymer
Acrylic acidvinylpyrrolidone,
copolymer
Acrylic polymers
see 31700
009003-18-3 Acrylonitrile-butadiene,
copolymer
009010-81-5 Acrylonitrile-butadienemethacrylic acid,
copolymer
D
+
9
+
9
D
D
+
+
+
+
+
Needed: Mw distribution curve, 3
mutagenicity tests for ethylenglycol
monomethacrylate phosphate monomer. The
need for further mutagenicity tests is under
discussion.
(CS/PM/2632).
W
120
+
+
REF_N
31620
CAS_N
NAME
SYNONIM
31730
009010-94-0 Acrylonitrile-butadienemethyl methacrylatestyrene, copolymer
009003-56-9 Acrylonitrile-butadienestyrene, copolymer
009003-54-7 Acrylonitrile-styrene,
copolymer
see 31730
068411-97-2 N-Acylsarcosines where
the acyl group is derived
from the fatty acids of
coconut oil
000124-04-9 Adipic acid
Same 12130
31760
-
31640
31660
31680
31700
31840
31920
Adipic acid, alkyl,
primary (C4-C13) esters
025805-74-7 Adipic acid-1,3and 025718- benzenedimethanamine,
70-1
copolymer (=adipic acid,
m-xylylenediamine,
copolymers)
000103-23-1 Adipic acid, bis(2ethylhexyl) ester
DIR
RESTRICTIONS
AND
SPECIFICATIONS
DIR
SCF
List
D
+
D
+
D
8
+
+
+
ADI: 5 mg/kg b.w.
(SCF, 25th Series, 1991).
Group R= 0.05 mg/kg b.w.
+
+
Available: Range of numerical molecular
mass (Mn): 14.000 - 21300 D.
+
7?
2
32000
000105-96-4 Adipic acid, bis(6methylheptyl) ester
8
32080
000110-29-2 Adipic acid, n-decyl noctyl ester
8
32160
068515-75-3 Adipic acid, dialkyl
esters (C7-C9)
9
121
CT
+
1
SML = 18 mg/kg (1)
PL
D
9
DIR
EFSA/SCF_OP
Needed: Mw distribution curve.
(CS/PM/2632).
Statement on a new intake study.
CS/PM/3276 REV.I/31920.
http://europa.eu.int/comm/food/fs/sc/scf/rep
orts/scf_reports_36.pdf
Group R: 0.05 mg/kg b.w.
Needed : toxicological data depending on
migration level (see SCF guidelines) and if
migration exceeds 0.05 mg/kg peroxisome
proliferation studies too.
Group R: 0.05 mg/kg b.w.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, peroxisome
proliferation studies too.
Group R: 0.05 mg/kg b.w.
Available: 90-day oral rat study.
Needed: in first instance specifications.
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
Toxicological data depending on migration
level (see SCF guidelines) and, if migration
data exceeds 0.05 mg/kg, peroxisome
proliferation study of the specified
substances.
32200
32240
002998-04-1 Adipic acid, diallyl ester Same 12160
000105-99-7 Adipic acid, dibutyl ester
32320
000105-97-5 Adipic acid, di-n-decyl
ester
32395
025212-19-5 Adipic aciddiethylenetriamineepichlorohydrin,
copolymer
7
32400
072088-98-3 Adipic aciddiethylenetriamineepichlorohydrinethyleneimine,
copolymer
000141-04-8 Adipic acid, diisobutyl
ester
D
32480
32560
027178-16-1 Adipic acid, diisodecyl
ester
6A
8
Same 12190
8
7
Same 12220
9
122
Group R: 0.05 mg/kg b.w.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, peroxisome
proliferation study too.
Group R: 0.05 mg/kg b.w.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, peroxisome
proliferation study too.
Available: Molecular mass distribution
curve, data on use, impurities, residual
amounts of starting substances.
Needed: In first instance, information on
identity of the fraction below 1000 D.
DE/TNO SDS, June 1998 = CS/PM/3163
REV.1/32395).
(Adopted at 114th SCF meeting) (10
December 1998)
http://europa.eu.int/comm/food/fs/sc/scf/out
20_en.pdf
+
+
+
+
+
Group R: 0.05 mg/kg b.w.
Available: inadequate 2-year oral rat study.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, peroxisome
proliferation study too.
Group R: 0.05 mg/kg b.w.
Needed: in first instance specifications and
+
+
CT
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
32640
033703-08-1 Adipic acid, diisononyl
ester
9
32720
001330-86-5 Adipic acid, diisooctyl
ester
9
32760
000627-93-0 Adipic acid, dimethyl
ester
8
32800
000151-32-6 Adipic acid, di-n-nonyl
ester
8
32840
001119-74-0 Adipic acid, di-noctadecyl ester
8
32880
000123-79-5 Adipic acid, di-n-octyl
ester
Same 12250
8
123
EFSA/SCF_OP
then on the specified substances
toxicological data depending on migration
level (see SCF guidelines) and, if migration
exceeds 0.05 mg/kg, peroxisome
proliferation studies too.
Group R: 0.05 mg/kg b.w.
Available: 90-day oral rat and dog studies
and two mutagenicity studies.
Needed: in first instance specifications, test
for chromosome aberrations in mammalian
cells in vitro and then the remaining
toxicological tests depending on migration
level (see SCF guidelines) and, if migration
exceeds 0.05 mg/kg, peroxisome
proliferation studies too.
Group R: 0.05 mg/kg b.w.
Needed: in first instance specifications and
then on the specified substances provide
toxicological data depending on migration
level (see SCF guidelines) and, if migration
exceeds 0.05 mg/kg, peroxisome
proliferation study too.
Group R: 0.05 mg/kg b.w.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, peroxisome
proliferation study too.
Group R: 0.05 mg/kg b.w.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, peroxisome
proliferation study too.
Group R: 0.05 mg/kg b.w.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, peroxisome
proliferation studies too.
Group R: 0.05 mg/kg b.w.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
PL
CT
+
+
+
+
+
+
REF_N
32920
32960
33040
33105
33120
CAS_N
NAME
Adipic acid, esters with
diols from C2-C6
Adipic acid, mixed esters
with 1,2-propyleneglycol
and alcohols,
monoh.,sat., linear (C8C10)
094109-12-3 Adipic acid, mono-noctadecyl ester, calcium
salt
146340-15-0 Alcohols C12-C14
secondary.beta.-(2hydroxyethoxy)ethoxylated
Alcohols, aliph, monoh.,
sat., linear, primary (C4C24)
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
-
33200
-
33280
-
33320
-
SCF
List
9
W9
7
W7
DIR
3
Alcohols, aliph, monoh.,
sat., linear or
secondary(C4-C22)
Alcohols, aliph., monoh.,
unsat., linear, (C16-C22)
(except oleyl alcohol)
EFSA/SCF_OP
migration exceeds 0.05 mg/kg, peroxisome
proliferation study too.
Group R: 0.05 mg/kg b.w.
+
Needed: hydrolysis data.
+
Evaluated in EFSA-AFC and classified in
List7.
http://www.efsa.eu.int/science/afc/afc_opini
ons/195/opinion_afc_01_en1.pdf
90-day oral studies, metabolic and/or
mutagenicity studies with some substances
out of the group.
(SCF, 17th Series, 1986).
+
+
+
Needed: toxicological data on two
representatives of the group according SCF
guidelines.
N.B. The evaluation is not applicable to
oleyl alcohol.
9
+
33350
Alcohols, cycloaliph.,
monoh.(up to C18), and
substituted
009005-32-7 Alginic acid
33360
-
Alginic acid, salts
D
33440
-
9
+
33460
-
Alkanes (b.p.up to 100
degrees celsius)
Alkanes, n, and iso,(C4C14)
9
+
DIR
1
124
+
ADI: not specified.
(JECFA, 39M., 1992).
ADI: 50 mg/kg b.w.
(JECFA 17 M., 1973).
CT
+
Group R: 0.05 mg/kg bw.
Provide informations on identity.
9
8
PL
+
+
+
REF_N
33520
33535
33540
33550
33565
33600
33680
33760
33800
33801
33820
33840
33920
34000
CAS_N
NAME
n-Alkenes (C2-C14)
152261-33-1 alpha-Alkenes(C20C24)maleic anhydride-4amino-2,2,6,6tetramethylpiperidine,
polymer
068439-57-6 alpha-Alkene(C14C16)sulphonic acid,
sodium salt
Alkenylnorborneneethylene, copolymer
Alkenylnorborneneethylene-propylene,
copolymer
C-alkenyl(C12-C18)
succinalkyl(C12-C18)
imide
Alkyl(C8C20)arylsulphonic acid
Alkyl(C8C18)arylsulphuric acid
Alkyl(C10C13)benzenesulphonic
acid
n-Alkyl(C10C13)benzenesulphonic
acid
093062-35-2 Alkyl(C8-C14)benzenesulphonic acid, sodium
salt
Alkyl(C11C14)bis(hydroxyethyl)su
lphonium bisulphate
Alkyl(C11C14)bis(hydroxyethyl)su
lphonium glycolsulphate
n-Alkyl(C11C15)bis(hydroxyethyl)su
lphonium sulphate
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
9
W
PL
+
+
W
DIR
SML = 30 mg/kg
125
+
D
+
9
+
9
+
9
+
9
+
9
+
2
CT
TDI = 0.5 mg/kg b.w. based on TDI for
52000.
+
D
+
9
+
9
+
9
+
+
REF_N
34015
34080
34160
34165
34180
34195
34225
34230
CAS_N
NAME
Alkyl caprolactone
phosphate
n-Alkyl(C11C14)hydroxyethyl
sulphide
see 34230
Alkyl(C8C18)phenoxybenezenedi
sulphonic acid, salts
Alkyl(C14C29)poly(ethyleneglycol
)glycolic acid
Alkyl(C8C18)poly(ethyleneand/or propylene-and/or
butyleneglycol)glycolic
acid
068037-49-0 Alkyl(C10C18)sulphonic acids
Alkyl(C8-C22)sulphonic
acids
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
-
34231
-
34240
-
n-Alkyl(C8C22)sulphonic acids
Alkyl(C10C20)sulphonic acid,
esters with phenols
DIR
SML = 6 mg/kg
D
SCF
List
EFSA/SCF_OP
9
+
9
+
D
9
+
9
+
9
+
W9
+
2
+
2
TDI: 0.1 mg/kg b.w.
1- and 2-year oral rat studies (Bayer report
1960).
TDI: 0.1 mg/kg bw based on TDI for 34230.
7
SCF_List: 7
+
Needed data or information:
Chromosomal aberration assay in vitro
according to prevailing guidelines,
controlling the effects of test article on pH
and osmolality of the medium, and
providing historical data on spontaneous
aberration frequencies in the test system.
Data to demonstrate the absence of potential
for accumulation in man.
(Adopted at the 136th SCF meeting, 5
March 2003)
http://europa.eu.int/comm/food/fs/sc/scf/out
126
PL
+
CT
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
172_en.pdf
34241
-
34245
085711-69-9
34250
085711-70-2
34275
085586-07-8
34280
-
34281
-
34290
-
34292
068585-47-7
34295
085586-07-8
34297
073296-89-6
34300
068955-20-4
34400
-
34415
-
Alkyl(C10C20)sulphonic acid
esters with cresols or
cresols and phenols
Alkyl(C13-C17sec)sulphonic acid,
sodium salts
Alkyl(C14-C18sec)sulphonic acid,
sodium salts
Alkyl(C12Same 34295
C14)sulphuric acid, salts
Alkyl(C8-C22)sulphuric
acids
Alkyl(C8-C22)sulphuric
acids, linear, primary,
with an even number of
carbon atoms
Alkyl(C16C18)sulphuric acid, salts
Alkyl(C10C16)sulphuric acid,
sodium salt
Alkyl(C12Same 34275
C14)sulphuric acid,
sodium salt
Alkyl(C12C16)sulphuric acid,
sodium salts
Alkyl(C16C18)sulphuric acid,
sodium salt
Alkyl(C12C16)trimethylammonium
bromide
Alkyl(C1-C12) vinyl
ethers-allyl alcohol,
copolymers
9
DIR
+
W
+
W
+
9
Look at 34281.
+
9
Look at 34281.
+
3
Toxicologically acceptable.
(CS/PM/2472 = Elias SDS 1994-11-24).
+
9
Look at 34281.
+
D
Covered by 34280.
+
D
Covered by 34275.
+
W
D
127
+
+
+
Covered by 34290.
+
8
+
9
+
REF_N
CAS_N
NAME
34430
-
34445
-
34452
-
34470
-
34475
-
34480
-
34560
021645-51-2 Aluminium hydroxide
34640
013170-05-3 Aluminium hydroxide
bis(4-tert-butylbenzoate)
34650
151841-65-5 Aluminium hydroxybis
[2,2’-methylenebis (4,6di-tert.butylphenyl)
phosphate
SYNONIM
Alkyl(C1-C12) vinyl
ethers - maleic acid or
allyl alcohol, copolymer
Alkyl(C1-C12) vinyl
ethers-maleic acid,
copolymers
Allyl alcohol-vinyl
acetate, copolymer
Aluminium calcium
hydrophosphite
Aluminium calcium
hydroxide phosphite,
hydrate
Aluminium fibers, flakes
and powders
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
+
9
+
9
+
D
+
DIR
2-3
DIR
2
DIR
2
DIR
SML = 5 mg/kg
128
PL
9
W8
18875
EFSA/SCF_OP
3
For Aluminium
L2.
Group TDI= 1mg/kg b.w. based on PTWI
for Al of 7 mg/kg b.w. (SCF, 25th Series,
1991).
For phosphite.
L3.
Phosphite easily oxidised to phosphate.
Available: migration data, 28-day oral rat
study, 4 mutagenicity studies.
(RIVM SDS, August 1994).
TDI : 1 mg/kg b.w. (as Al) based on PTWI=
7 mg/kg (as Al)
(SCF, 25th Series, 1991).
TDI: 1 mg/kg bw (as Al) based on PTWI: 7
mg/kg b.w. (as Al).
(SCF, 25th Series, 1991).
L2 for Al.
TDI: 1 mg/kg bw (as Al) based on PTWI: 7
mg/kg bw (as Al).
(SCF, 25th Series, 1991).
W8 for bis(4-tert.butylbenzoate).
SCF_List: 3
Restriction: 5 mg/kg of food. Based on the
reduced core set of toxicological data
according to the migration level.
(Opinion adopted by the SCF at the 136th
meeting, 5 march 2003)
http://europa.eu.int/comm/food/fs/sc/scf/out
CT
+
+
+
+
+
+
+
REF_N
34690
CAS_N
NAME
34720
011097-59-9 Aluminium magnesium
carbonate hydroxide
001344-28-1 Aluminium oxide
34750
-
34790
015306-17-9 Aluminium tris(ethyl
acetylacetate)
Amides of acids, aliph.,
monocarb. (C6-C22)
143925-92-2 Amines,
bis(hydrogenated tallow
alkyl) oxidised
SYNONIM
Same 64480
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
DIR
3
DIR
2
Aluminium silicate,
silanated
9
EFSA/SCF_OP
172_en.pdf
Inert material.
TDI: 1 mg/kg bw (as (Al) based on PTWI: 7
mg/kg b.w. (as Al).
(SCF, 25th Series, 1991).
L2 for Al.
TDI: 1 mg/kg bw based on PTWI: 7 mg/kg
bw (as Al).
(SCF, 25th Series 1991).
PL
CT
+
+
+
+
L9 for "silanated".
34800
34850
34875
34880
34895
omega-Aminoacids (C6C12)
Aminoacids, salts
000088-68-6 2-Aminobenzamide
W
+
9
DIR
QM = For use only :
(a) in PO at 0.1%
(w/w) but not in LDPE
when it is in contact
with foods for which
the Dir. 85/572
establishes a RF< 3; (b)
in PETat 0.25 % (w/w)
in contact with foods
other of those for
which simulant D is
laid down in
Dir.85/572
-
3
+
SCF_List: 3
Restriction: Only to be used:
·in polyolefins at 0.1 % (w/w) and not for
fatty food with a simulant D Reduction
Factor less than 3
·in PET at 0.25% (w/w) and only for food
for which simulant D is not required.
Remark for Commission: To make sure that
also for the migration of Bis(hydrogenated
tallow, C16-C18, alkyl) nitrones and
(Hydrogenated tallow, C16-C18, alkyl)
oximes into fatty foods a sufficient safety
margin to the NOEL in the subchronic oral
rat study exists the following restriction is
proposed: Qm 0,1 % in polyolefins, not for
fatty foods with a Reduction Factor < 3.
See SCF evaluation in the website:
http://europa.eu.int/comm/food/fs/sc/scf/out
180_en.pdf
9
DIR
SML = 0.05 mg/kg. To
129
9
3
+
+
SCF_List: 3
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
be used only for PET
for water and
beverages.
EFSA/SCF_OP
PL
Restriction: 0.05 mg/kg of food. Based on
the reduced core set of toxicological data
according to the migration level.
Remark for Commission: only requested in
contact with water and beverages. Substance
may be reactive with fat components,
therefore authorisation should be restricted
to requested application (PET for water and
beverages).
(Opinion adopted by the SCF at the 136th
meeting, 5 March 2003)
http://europa.eu.int/comm/food/fs/sc/scf/out
172_en.pdf
34925
34940
34960
35040
35120
35160
061789-40-0 3-Amino-N(carboxymethyl)-N,N,dimethyl-1propanaminium, N-coco
acyl derivatives
hydroxides, inNer salt
014205-40-4 3-Aminocrotonic acid,
diester with
ethyleneglycol
3-Aminocrotonic acid,
esters with
butyleneglycol
3-Aminocrotonic acid,
esters with mono- or
dihydric alcohols
013560-49-1 3-Aminocrotonic acid,
diester with thiobis (2hydroxyethyl) ether
W8
-
006642-31-5 6-Amino-1,3dimethyluracil
+
8
Available: summary on 90-day study,
migration into oil (< 0.25 ppm).
+
7
Available: 90-day oral rat study, inadequate
migration data (CS/PM/ 2034).
Needed: 3 mutagenicity studies, physicochemical and migration data, analytical
method.
+
9
Same 92820
DIR
DIR
2
SML = 5 mg/kg
3
+
t-TDI: 5 mg/kg b.w. pending results of
mutagenicity studies.
Available: 28-day and 90-day oral rat
studies, metabolism, very low migration.
R = 5 mg/kg of food.
Remark for Commission: 6-amino-1,3dimethyl-uracil hydrolyses in acetic acid.
130
+
+
CT
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
+
+
(Adopted at the 119th SCF meeting) (2
December 1999)
http://europa.eu.int/comm/food/fs/sc/scf/out
50_en.pdf
35170
000141-43-5 2-Aminoethanol
35180
084434-12-8 N-(2-Aminoethyl)-betaalanine, sodium salt
Same
674201276322337
DIR
SML = 0.05 mg/kg.
Not for use in polymers
contacting foods for
which simulant D is
laid down in Directive
85/572/EEC and for
indirect food contact
only, behind the PET
layer
Same 12765
3
D
Available: specific migration in 3% acetic
acid, 15% ethanol and 95% ethanol < 0.03
mg/kg food; gene mutation assay in bacteria
(negative); chromosomal aberration assay in
cultured mammalian cells (negative); gene
mutation assay in cultured mammalian cells
(negative)
RIVM/ISS/TNO SDS, November 1999 =
CS/PM/3352 REV. I/35180.
+
Remark for Commission:
* PM/REF No. should be changed
* Send a letter to the applicant, concerning
the "preparation" of the petition (poor
quality of the dossier)
* The commercial product (as 40% aqueous
solution) is tested in the mutagenicity assays
http://europa.eu.int/comm/food/fs/sc/scf/out
61_en.pdf
35200
35280
35284
034730-59-1 N-(2-Aminoethyl)-2aminoethanesulphonic
acid, sodium salt
N-(2-Aminoethyl)-3aminopropanesulphonic
acid, salts
000111-41-1 N-(2-
Same 12771
DIR
SML = 0.05 mg/kg.
131
8
+
8
+
3
R = 0.05 mg/kg of food.
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
Aminoethyl)ethanolamin
e
35288
35320
093820-52-1 N-(2-Aminoethyl)-N-(2hydroxyethyl)-betaalanine,N-coco
acylderivatives,
monosodium salts(+)
090268-48-7 4-Amino-4-oxo-2sulfobutyric acid, Ntallow alkyl derivatives,
disodium salts
007664-41-7 Ammonia
35340
35440
001066-33-7 Ammonium bicarbonate
012124-97-9 Ammonium bromide
35520
012125-02-9 Ammonium chloride
35600
001336-21-6 Ammonium hydroxide
35680
001314-60-9 Antimony pentoxide
35760
001309-64-4 Antimony trioxide
35294
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
Not for use in polymers
contacting foods for
which simulant D is
laid down in Directive
85/572/EEC and for
indirect food contact
only, behind the PET
layer.
Same12789
W8
+
W8
+
DIR
D
1
1/D
1
6B
SML = 0.02 mg/kg
(expressed as
Antimony and
analytical tolerance
included)
132
CT
(Adopted at the 121 SCF meeting (20 June
2000))
http://europa.eu.int/comm/food/fs/sc/scf/out
62_en.pdf
1
DIR
PL
Remark: substance evaluated only for the
requested use for indirect contact with nonfatty food.
DIR
DIR
EFSA/SCF_OP
3
ADI: not specified.
(SCF, 25th series, 1991).
Group ADI: 1 mg/kg b.w. (as Br) as
pesticide residue.
(JMPR "Pesticide residues in food", 1988,
paper 93/2).
ADI: not specified.
(SCF, 25th Series, 1991).
ADI: not specified.
(SCF, 25th Series, 1991)
R : 0.01 mg/kg (as Sb) in food.
Very low EEC limit for drinking water: 0.01
mg/1.
Needed: actual use.
Restriction 0.04 mg/kg of food (as Sb)
Remark for Commission: Migration limit
might be exceeded at very high temperature.
http://www.efsa.eu.int/science/afc/afc_opini
ons/190/opinion_afc_06_en1.pdf
+
+
+
+
+
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
0
0
9
+
+
+
+
+
9
5
+
+
http://europa.eu.int/comm/food/fs/sc/scf/out
50_en.pdf
35840
35845
35880
35920
35960
000506-30-9 Arachidic acid
007771-44-0 Arachidonic acid
Aromatic sulphonic
acids-formaldehyde,
copolymer
Arylsulphonic acid
001332-21-4 Asbestos
Same 12810
Same 12813
DIR
DIR
36000
000050-81-7 Ascorbic acid
DIR
1
36080
000137-66-6 Ascorbyl palmitate
DIR
1
36160
010605-09-1 Ascorbyl stearate
DIR
1
36240
-
Azelaic acid, alkyl,
primary(C1-C12) esters
000103-24-2 Azelaic acid, bis(2ethylhexyl) ester
9
36400
000106-03-6 Azelaic acid, bis(6methylheptyl) ester
8
36480
000109-31-9 Azelaic acid, di-n-hexyl
ester
7
36320
7
133
[There is well-known occupational hazard
and the disposal of materials containing
asbestos may constitute an environmental
hazard.]
Acceptable.
(SCF, 22th Series, 1989).
Acceptable.
(SCF, 22th Series, 1989).
Acceptable.
Covered by the assessment for ascorbyl
palmitate.
Group R: 0.05 mg/kg b.w.
Group R: 0.05 mg/kg b.w.
Available: inadequate 90-day study.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, peroxisome
prn_
Group R: 0.05 mg/kg b.w.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, peroxisome
proliferation study too.
Group R: 0.05 mg/kg b.w.
Available: 90-day and 2-year oral rat, 1-year
oral dog studies.
Needed: toxicological data depending on
migration level (see SCF guidelines) and if
migration exceeds 0.05 mg/kg peroxisome
+
+
+
+
+
+
+
+
REF_N
CAS_N
NAME
36560
002064-80-4 Azelaic acid, di-n-octyl
ester
36640
000123-77-3 Azodicarbonamide
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
8
DIR
See Commission
Directive 2004/1/EC
‘For use only as
blowing agent. Use
prohibited as from 2
August 2005.’
3
EFSA/SCF_OP
proliferation studies too.
Group R: 0.05 mg/kg b.w.
Needed: toxicological data depending on
migration level (see SCF g uidelines) and, if
migration exceeds 0.05 mg/kg, peroxisome
proliferation study too.
SCF_List: 3
Restriction: Only as a blowing agent and not
for materials intended for contact with
alcoholic beverages.
http://www.efsa.eu.int/science/afc/afc_opini
ons/1005/afc_op_ej219_semicarbazide_en1.
pdf.
PL
CT
+
+
http://www.efsa.eu.int/science/afc/afc_docu
ments/364/p_afc_doc_03_en11.pdf
http://www.efsa.eu.int/science/afc/afc_docu
ments/525/semicarbazide_afc_state02_1oct_
en1.pdf
http://www.efsa.eu.int/science/afc/afc_docu
ments/365/p_afc_doc_0111.pdf
36720
017194-00-2 Barium hydroxide
DIR
SML(T) = 1 mg/kg
(12) (expressed as
Barium)
3
36800
010022-31-8 Barium nitrate
DIR
SML(T) = 1 mg/kg
(12) (expressed as
Barium)
2-3
36840
012007-55-5 Barium tetraborate
DIR
SML(T) = 1 mg/kg
134
2-3
See SCF evaluation in the website:
http://europa.eu.int/comm/food/fs/sc/scf/out
181_en.pdf
R: 1 mg/kg (as Ba) in food
(Rivm doc. May 1992 (CS/PM/1584)).
List 2 for nitrate
TDI: 3 mg/kg bw (for nitrate) based on ADI
= 5 mg/kg bw on sodiumnitrate.
(SCF, 26 Series, 1992).
List 3 for Barium
R: 1 mg/kg (as Ba) in food.
(Rivm doc., May 1992 (CS/PM/1584)).
Re-evaluation on the basis of an opinion of
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
expressed as Barium
(12) and SML(T) = 6
mg/kg (23) (expressed
as Boron) without
prejudice to the
provisions of Directive
98/83/EC on water for
human consumption
(OJ L 330, 5.12.1998,
p.32).
36880
36960
37040
37120
37200
37240
37280
37360
37440
008012-89-3
003061-75-4
000112-85-6
-
Beeswax
Behenamide
Behenic acid
Same 12990
Behenic acid, esters with
pentaerythritol
053161-46-9 Behenic acid,
monoesters with
pentaerythritol
Behenic acid, salts
001302-78-9 Bentonite
000100-52-7 Benzaldehyde
DIR
DIR
DIR
0
3
0
7
In compliance with
note 9 in Annex VI
000080-17-1 Benzenesulphonic acid
hydrazide
D
3
1
6A
135
PL
CT
+
Needed: hydrolysis data.
+
+
+
+
Needed: hydrolysis data.
+
the SCF in another context.
List 3 for Barium.
R = 1 mg/kg (as Ba in food).
RIVM SDS, May 1992 = CS/PM/1584.
List 2 for Borate.
Group-TDI = 0.1 mg/kg b.w. (as B) (with
REF_n. 36840, 40320 and 87040).
The TDI is based on the No Adverse Effect
Level (NOAEL) of 9.6 mg/kg b.w./day for
effects on fetal body weight and skeletal
anomalies in the rat developmental study. A
Safety Factor (SF) of 100 is used.
“Opinion of the Scientific Committee on
Food on Arsenic, Barium, Fluoride, Boron
and Manganese in Natural Mineral Waters
(expressed on 13 December 1996, 105th
plenary meeting of the SCF, completed on
13 June 1997 at the 107th plenary meeting
of the SCF; 43rd Series of Reports of the
SCF, 2000”. This opinion is also available
on Internet.
(Adopted by the SCF at the 127th meeting,
30 May 2001)
http://europa.eu.int/comm/food/fs/sc/scf/out
86_en.pdf
7
DIR
DIR
EFSA/SCF_OP
Metabolized to ammonia and behenic acid
Inert material.
Group ADI = 5 mg/kg b.w. as benzoic acid.
(JECFA 11 M., 1967)
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
37520
002634-33-5 1,2-Benzisothiazolin-3one
7
37530
?
37600
111337-53-2 1,2-Benzisothiazolin-3one, lithium salt
000065-85-0 Benzoic acid
37680
000136-60-7 Benzoic acid, butyl ester
37760
-
37840
37920
38000
Benzoic acid, esters with
1,2-propanediol
000093-89-0 Benzoic acid, ethyl ester
000136-36-7 Benzoic acid, 3hydroxyphenyl ester
000553-54-8 Benzoic acid, lithium salt
Same 13090
DIR
1
DIR
2
EFSA/SCF_OP
PL
CT
Under re-evaluation
Microbiological data missing.
t-TDI: 0.02 mg/kg bw.
Under re-evaluation
+
+
Group ADI: 5 mg/kg b.w.
(JECFA 27 M., 1983).
Group TDI: 5 mg/kg b.w. as benzoic acid
for butyl-, ethyl-, methyl-, propylbenzoate
on the basis of the Group ADI for benzoic
acid.
(JECFA 27 M., 1983)
+
D
DIR
2
7
DIR
SML(T) = 0.6 mg/kg
(8) (expressed as
Lithium)
1-2
38080
000093-58-3 Benzoic acid, methyl
ester
DIR
2
38160
002315-68-6 Benzoic acid, propyl
ester
DIR
2
136
+
+
+
Group TDI: 5 mg/kg b.w. as benzoic acid
for butyl-, ethyl-, methyl-, propylbenzoate
on the basis of the Group ADI for benzoic
acid.
(JECFA 27 M., 1983).
Needed: hydrolysis data.
+
L1 for benzoic acid.
Group ADI: 5 mg/kg b.w..
(JECFA 27M., 1983).
+
L2 for Lithium.
Group TDI: 0.01 mg/kg b.w. (as Li).
Available: 90-day oral rat studies,
mutagenicity data, therapeutic use of Li
salts.
(Rivm summary, Sept. 1991).
Group TDI: 5 mg/kg b.w. as benzoic acid
for butyl-, ethyl-, methyl-, propylbenzoate
on the basis of the Group ADI for benzoic
acid.
(JECFA 27 M., 1983).
Group TDI: 5 mg/kg b.w. as benzoic acid
for butyl-, ethyl-, methyl-, propylbenzoate
on the basis of the Group ADI for benzoic
acid.
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
38240
000119-61-9 Benzophenone
DIR
SML = 0.6 mg/kg
2
38320
005242-49-9 4-(2-Benzoxazolyl)-4'(5-methyl-2benzoxazolyl)stilbene
000056-93-9 Benzyltrimethylammoni
um chloride
066822-60-4 Betaine type methacrylic Same 65920
polymer (Nmethacrylolylethyl-N,Ndimethylammonium alpha-Nmethylcarboxylate,octad
ecyl methacrylate,ethyl
methacrylate,cyclohexyl
methacrylate,n-vinyl-2pyrrolidone,copolymers
351870-33-2 cis-endoBicyclo[2.2.1]heptane2,3-dicarboxylic acid,
disodium salt
DIR
In compliance with the
specifications laid
down in Annex V
3
38480
38500
38505
3AM
(JECFA 27 M., 1983).
Group TDI: 0.01 mg/kg b.w.
90-day oral rat study and metabolism study
(CIVO report R 3301, 1970).
R = Maximum amount to be used 0.05%
(w/w).
PL
+
+
8
+
D
+
3
137
EFSA/SCF_OP
Restriction: 5 mg/kg of food (based on a
daily consumption of 1 kg of packaged food
per person. This restriction would
correspond to a maximum intake of 0.1 mg
cis-endo-bicyclo[2.2.1]heptane-2,3dicarboxylic acid, disodium salt /kg b.w./day
Such figure is at least two orders of
magnitude lower than the NOAEL which
can be extrapolated from the results on the
most sensitive species.)
Remark for Commission: Not to be used
with polyethylene in contact with acidic
foods
Hydrophilic substance (based on logPo/w,
and on highest migration into acidic foods)
The purity of the substance tested was >=
98.8%
The petitioner applies only for
polypropylene (all food types) and
polyethylene (non acidic foods)
http://www.efsa.eu.int/science/afc/afc_opini
+
CT
REF_N
38510
38515
CAS_N
NAME
SYNONIM
136504-96-6 1,2-Bis(3aminopropyl)ethylenedia
mine, polymer with Nbutyl-2,2,6,6tetramethyl-4piperidinamine and
2,4,6-trichloro-1,3,5triazine
001533-45-5 4,4'-Bis(2benzoxazolyl)stilbene
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
DIR
SML = 5 mg/kg
3
DIR
SML = 0.05 mg/kg (1)
3
EFSA/SCF_OP
ons/190/opinion_afc_06_en1.pdf
R: 5 mg/kg of food.
R: 0.05 mg/kg food.
Available: 3 mutagenicity tests, negative and
migration data.
(RIVM SDS of 1994-10-25 and 1996-05-03
= CS/PM/2463 and CS/PM/2791).
PL
CT
+
+
+
+
+
+
+
Remark: since high migration into fat has
been demonstrated with the exception of
PET, the WG recommends that the
Commission take the necessary measures so
that the restriction proposed is not exceeded.
38530
38560
38565
38580
032509-66-3 Bis(3,3-bis(4-hydroxy-3- Same 53670
tert-butylphenyl)butanoic
acid), ester with
ethyleneglycol
007128-64-5 2,5-Bis(5-tert-butyl-2benzoxazolyl)thiophene
D
DIR
SML = 0.6 mg/kg
090498-90-1 3,9-Bis[2-(3-(tert.butyl4-hydroxy-5methylphenyl)propionylo
xy)-tert.butyl]-2,4,8,10tetraoxaspiro[5.5]undeca
ne
2
W7
TDI: 0.01 mg/kg b.w.
90-day oral dog and rat studies, 1-year (+
0.5-year recovery) study in mice showed
accumulation in tissues by fluorescence.
(RIVM, doc. tox. 300/277, June 1981).
Available: Migration data, 3-month oral rat
study; 3 (negative) in vitro mutagenicity
studies, high bioaccumulation potential.
+
Needed: data demonstrating absence of
bioaccumulation in vivo, especially in liver
and fat.
(RIVM SDS, = CS/PM/2994/38565).
057569-40-1 Bis(2-tert-butyl-4Same 92205
methyl-6-(3-tert-butyl-5methyl-2-
D
138
+
REF_N
CAS_N
38600
000078-63-7
38615
002212-81-9
38625
002781-00-2
38640
38700
063397-60-4
38720
38750
38780
38800
38810
NAME
SYNONIM
hydroxybenzyl)
phenyl)terephthalate
2,5-Bis(tertbutylperoxy)-2,5dimethylhexane
1,3-Bis(tertbutylperoxyisopropyl)be
nzene
1,4-Bis(tertbutylperoxyisopropyl)be
nzene
see 38700
Bis(2carbobutoxyethyl)tinbis(isooctyl
mercaptoacetate)
105350-68-3 2,2-Bis[4-(2-(3,5-di-tertbutyl-4-hydroxyhydro
cinnamoyloxy))ethoxyph
enyl]-propane
000118-82-1 Bis(3,5-di-tert-butyl-4Same 66320
hydroxyphenyl)methane
023128-74-7 N,N'-Bis(3-(3,5-di-tert- Same 59120
butyl-4hydroxyphenyl)propiony
l)hexamethylenediamine
032687-78-8 N,N'-Bis(3-(3,5-di-tertbutyl-4hydroxyphenyl)propiony
l)hydrazide
080693-00-1 Bis(2,6-di-tert-butyl-4methylphenyl)pentaeryth
ritol diphosphite
DIR
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SML = 18 mg/kg
SCF
List
EFSA/SCF_OP
9
Specification for use.
+
9
Specification for use.
+
9
Specification for use.
+
D
2
t-TDI: 0.3 mg/kg b.w. pending additional
mutagenicity studies.
Available: 28-day in young rats and 90-day
oral rat studies and Ames test.
(RIVM report 89/678608/003, 1989-04-04).
CT
+
+
W
+
D
+
D
+
+
+
+
DIR
SML = 15 mg/kg
2
DIR
SML = 5 mg/kg (sum
of phosphite and
phosphate)
3
TDI: 0.25 mg/kg b.w.
3 month oral rat study, mutagenicity studies.
Migration data.
(RIVM, September 1990).
R = 5 mg/kg of food (sum of phosphite and
phosphate).
Remark for Commission: only migration
data of the additive from polypropylene into
food simulants are available.
(Adopted at 111th SCF meeting (18-19
March 1998)).
139
PL
+
REF_N
38820
38840
CAS_N
NAME
026741-53-7 Bis(2,4-di-tertbutylphenyl)
pentaerythritol
diphosphite
154862-43-8 Bis(2,4dicumylphenyl)pentaeryt
hritol-diphosphite
38879
135861-56-2 Bis(3,4dimethylbenzylidene)sor
bitol
38880
38885
see 38820
002725-22-6 2,4-Bis(2,4dimethylphenyl)-6-(2hydroxy-4octyloxyphenyl)-1,3,5triazine
see 38950
110675-26-8 2,4Bis(dodecylthiomethyl)6-methylphenol
38920
38940
38950
079072-96-1 Bis(4ethylbenzylidene)sorbitol
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
DIR
SML = 0.6 mg/kg
2
DIR
SML = 5 mg/kg (as
sum of the substance
itself, its oxidised form
bis(2,4dicumylphenyl)pentaer
ythritol-phosphate and
its hydrolysis product
(2,4-dicumylphenol)).
3
DIR
2
EFSA/SCF_OP
http://europa.eu.int/comm/food/fs/sc/scf/out
10_en.pdf
TDI: 0.01 mg/kg b.w.
90-day oral rat and 4-month oral dog studies
and Ames test.
(RIVM, Doc. Tox. 300/335, June 1982).
R =5 mg/kg of food (assigned to Doverphos
S-9228 including the stabiliser itself, its
oxidised form bis (2,4-dicumylphenol)
pentaerythritol-phosphate and its hydrolysed
product (2,4-dicumylphenol).
(Adopted at the 126th SCF meeting, 28
February 2001)
http://europa.eu.int/comm/food/fs/sc/scf/out
84_en.pdf
Group TDI = 1 mg/kg bw (with 39760 and
38920).
Available: 3 mutagenicity studies negative,
3 months oral rat study, bioaccumulation
and migration data.
(RIVM report 1995-08-22, CS/PM/2650).
PL
+
+
+
D
W7
+
+
3AM
D
3
+
+
DIR
2
140
Restriction: Group restriction of 5 mg/kg
food as sum of 2,4bis(dodecylthiomethyl)-6-methylphenol and
2,4-bis(octylthiomethyl)-6-methylphenol
Remark for Commission: FRF is applicable
http://www.efsa.eu.int/science/afc/afc_opini
ons/768/afc_fcm_op_list6_2004.12.171.pdf
Group TDI: 1 mg/kg b,w. (with bis(4ethylbenzylidene) sorbitol,
bis(methylbenzylidene) sorbitol and
+
CT
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
dibenzylidene sorbitol).
Several 90-day mouse and rat studies,
several mutagenicity tests negative.
(RIVM Doc. 88/678608/008, 1 Nov. 1988;
RIVM Doc. Tox 300/425, May 1983, RIVM
15 Nov. 1989).
38960
38970
39010
39025
39040
39045
39060
39090
035958-30-6 2,2-Ethylidene-bis-(4,6di-t-butylphenol)
N,N-Bis-(2ethylhexyl)glycine,
sodium salt
000088-24-4 Bis(2-hydroxy-3-tertbutyl-5ethylphenyl)methane
000119-47-1 Bis(2-hydroxy-3-tertbutyl-5methylphenyl)methane
see 39090
004066-02-8 Bis(2-hydroxy-3cyclohexyl-5methylphenyl)methane
035958-30-6 1,1-Bis(2-hydroxy-3,5di-tertbutylphenyl)ethane
-
N,N-Bis(2hydroxyethyl)alkyl(C8C18)amine
Same 39060
D
+
8
+
Same 66400
D
+
Same 66480
D
+
Same 66560
D
D
+
+
Same 38960
DIR
SML = 5 mg/kg
3
DIR
SML(T) = 1.2 mg/kg
(13)
2
141
R: 5 mg/kg in food.
Available: 3-month oral rat and dog studies,
reproduction study and tests for
mutagenicity negative.
(RIVM doc. February 1992).
Nota bene
Substance evaluated in the past (Additional
List of Monomers and Additives Evaluated
by the WG "Food Contact Materials" of the
SCF During the 69th-70th Meetings
(adopted during the 107th SCF meeting of
12 and 13 June 1997 see
http://europa.eu.int/comm/food/fs/sc/oldcom
m7/out12_en.html ) Only a clarification of
the expression "free amine" appearing in the
SCF restrictions of the substance 39120 (see
below) was requested to the SCF. Therefore,
this is not a re-evaluation of the substance
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
39120
-
39140
000136-26-5 N,N-Bis(2hydroxyethyl)decanamid
e
000111-46-6 Bis(2-hydroxyethyl)
Same
ether
15760,13326
and 47680
006200-40-4 Bis(2-hydroxyethyl)-2hydroxypropyl-3(dodecyloxy)methylamm
onium chloride
000120-40-1 N,N-Bis(2Same 63560
hydroxyethyl)lauramide
39160
39200
39280
N,N-Bis(2hydroxyethyl)alkyl(C8C18)amine
hydrochlorides
DIR
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SML(T) = 1.2 mg/kg
(13) expressed as
tertiary amine
(expressed excluding
HCl)
SCF
List
2
7?
EFSA/SCF_OP
because of new data.
Group t-TDI = 0.02 mg/kg b.w. (with REFn. 39120).
Needed: three in vitro mutagenicity studies
according to guidelines on either REF_N.
39090 or 39120.
Remark: on the basis of the available studies
it remains included in the group t-TDI
pending the results of the required
mutagenicity studies. If negative it will be
classified in L3 with a restriction of 5 mg/kg
of food.
NOTE: both substances are covered when
the mutagenicity studies are submitted.
(Adopted by the SCF at the 127th meeting,
30 May 2001)
http://europa.eu.int/comm/food/fs/sc/scf/out
86_en.pdf
Group t-TDI = 0.02 mg/kg b.w. expressed as
tertiary amine (expressed excluding HCl)
(with REF_n. 39090).
(Adopted by the SCF at the 127th meeting,
30 May 2001)
http://europa.eu.int/comm/food/fs/sc/scf/out
86_en.pdf
Same references as 39280.
D
DIR
SML = 1.8 mg/kg
2
7?
142
PL
+
+
+
TDI: 0.03 mg/kg b.w.
90-day oral rat study.
(CIVO report R2491 September. 1967 and
2628 February 1968).
Available: 3-month oral rat and dog studies
with different diethanolamides of fatty acids.
Three mutagenicity studies, negative.
Migration data.
+
+
CT
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
Needed: Reason for the choice of test
sample (polymer and concentration of
additive) for migration test, stability of
additive in food simulants under the test
conditions applied, physical-chemical data
including Po/w and data on use.
(RIVM SDS May 1996 = CS/PM/2801).
39360
-
39440
058767-50-3
39480
000093-83-4
39520
000093-82-3
39560
000077-99-6
39600
000077-62-3
39665
054208-63-8
N,N-Bis(2hydroxyethyl)octadecyla
mine, N(2-hydroxyethylNoctadecylglycine(monos
odium salt/and N,N'bis(hydroxyethyl)-N(carboxymethyl)
octadecanaminium
hydroxide (inNer salt)
compon. mixt. of
reaction as maJor
components of mixture
prepared by reac
N,N-Bis(2hydroxyethyl)-N-(noctyl)-Nmethylammonium 4toluenesulphonate
N,N-Bis(2hydroxyethyl)oleamide
N,N-Bis(2hydroxyethyl)stearamide
2,2-Bis(hydroxymethyl)- Same 13380,
1-butanol
25600 and
94960
Bis(2-hydroxy-3-(1Same 66580
methylcyclohexyl)-5methylphenyl)methane
Bis(2Same 13460;
hydroxyphenyl)methane
12976
bis(2,3-epoxypropyl)
ether (=BFDGE)
D
According to
Commission Directive
2002/16/EC of 20
February 2002 on the
143
9
+
8
+
7?
Same references as 39280.
+
7?
Same references as 39280.
+
D
+
D
+
7
http://europa.eu.int/comm/food/fs/sc/scf/out
76_en.pdf
+
+
REF_N
CAS_N
NAME
39680
000080-05-7 2,2-Bis(4hydroxyphenyl)propane
39700
001675-54-3 2,2-Bis(4hydroxyphenyl)propane
bis(2,3-epoxypropyl)
ether (=BADGE)
SYNONIM
Same
13480/1360
7/62540/400
60/19255
Same
12974
13510;
13610;
DIR
DIR
DIR
RESTRICTIONS
AND
SPECIFICATIONS
use of certain epoxy
derivatives in materials
and articles intended to
come into contact with
foodstuffs.
Can still be used in
heavy duty coatings.
SML= 0.6 mg/kg (28)
According to
Commission Directive
2002/16/EC of 20
February 2002 on the
use of certain epoxy
derivatives in materials
and articles intended to
come into contact with
foodstuffs
144
SCF
List
EFSA/SCF_OP
PL
2
http://europa.eu.int/comm/food/fs/sc/scf/out
128_en.pdf
+
2-3
On the basis of the available experimental
data, a TDI can be established for BADGE
and its hydrolysis products. Considering the
NOAEL of 15 mg/kg b.w./day observed in
the oral chronic toxicity/carcinogenicity
study in the rat with BADGE, and applying
an uncertainty factor of 100, a TDI of 0.15
mg/kg b.w. can be established for BADGE.
As BADGE is rapidly and extensively
metabolised in vivo into the corresponding
mono- and bis-diol derivatives, the Panel
includes these in the TDI.
For the other regulated BADGE reaction
products, i.e. the BADGE chlorohydrins
BADGE.2HCl, BADGE.HCl,
BADGE.HCl.H2O, in view of the lack of
genotoxicity, the Panel considers that the
current restriction of 1 mg/kg of food
remains appropriate.
The Panel is aware that other BADGE
reaction products, with undefined
toxicological properties
and chemical identity, may be found at low
levels in the migrate from epoxy coatings.
For the assessment of these, and in general
of minute amounts of unknown migrants
from food contact materials, a general
approach is currently under consideration by
the Panel.
+
CT
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
EFSA opinion from 13 July 2004
http://www.efsa.eu.int/science/afc/afc_opini
ons/508/opinion_afc13_ej86_badge_v2_en1.
pdf
See the individual opinion on the substance
(CS/PM/2812 Rev.1) which is reported in
the Internet website:
http://europa.eu.int/comm/food/fs/sc/scf/out
28_en.pdf
39715
39730
39750
39760
39815
025036-25-3 2,2-Bis(4hydroxyphenyl)propane 2,2-bis(4hydroxyphenyl)propane
bis(2,3-epoxy-propyl)
ether, copolymer
025068-38-6 2,2-Bis(4hydroxyphenyl)propaneepichlorohydrin
copolymer
025265-71-8 Bis(hydroxypropyl) ether Same 51760
and 00011098-5
see 39890
182121-12-6 9,9Bis(methoxymethyl)fluor
ene
W
DIR
QMA = 0.05 mg/6 dm²
145
+
9
+
D
+
+
D
3
+
+
+
R: 0.05 mg/kg of food.
Available: Maximum worst case migration
is calculated to be 0.034 mg/kg; Ames assay
(negative); in vitro chromosomal aberration
assay (positive); in vitro mammalian cell
gene mutation
assay (negative); mouse bone marrow
micronucleus assay (negative); rat bone
marrow chromosome analysis (negative); in
vivo UDS in rat liver (negative).
(RIVM/ISS/UK SDS, October 1997 =
CS/PM/ 3081/39815).
(adopted at 113rd SCF meeting)(17-18
September 1998)
http://europa.eu.int/comm/food/fs/sc/scf/out
16_en.html
REF_N
CAS_N
NAME
39890
087826-41-3 Bis(methylbenzylidene)
and 069158- sorbitol
41-4 and
054686-974/08154112-0
39920
000085-60-9 1,1-Bis(2-methyl-4hydroxy-5-tertbutylphenyl)butane
39925
129228-21-3 3,3-Bis(methoxymethyl)2,5-dimethylhexane
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
DIR
SCF
List
2
Same 40770
7?
DIR
SML = 0.05 mg/kg
3
EFSA/SCF_OP
PL
CT
Group TDI: 1 mg/kg b.w. (with bis(4ethylbenzylidene)sorbitol and
bis(methylbenzylidene) sorbitol).
28- and 90-day oral rat studies, one in-vitro
mutagenicity study.
See references for bis(4ethylbenzylidene)sorbitol.
Available: data from 30- and 90-day oral rat
studies inadequate.
Needed: in first instance migration and
mutagenicity data.
+
+
R: 0.05 mg/kg of food.
Available: worst case migration levels based
on compositional analysis and assumption
of 1000% migration from 250 um layer
thickness; gene mutation assay in bacteria
(negative); chromosomal aberration assay in
cultured mammalian cells (negative); two
gene mutation assays in cultured mammalian
cells (positive); in vivo UDS assay in rat
liver (negative); in vivo micronucleus assay
(negative).
(RIVM/ISS/UK SDS, November 1998 =
CS/PM/3223 REV. I/39925).
+
+
Remark for Commission: No method of
analysis for the determination of an SML is
available.
(Adopted at 116th SCF meeting) (24 March
1999)
http://europa.eu.int/comm/food/fs/sc/scf/out
27_en.pdf
39980
40000
-
Bis(N,N'-methyl-betahydroxyethyl)hexamethylenebisurea
000991-84-4 2,4-Bis(octylmercapto)6-(4-hydroxy-3,5-di-tertbutylanilino)-1,3,5-
8
DIR
SML = 30 mg/kg
146
2
+
TDI: 0.5 mg/kg b.w.
90-day oral rat and dog studies.
(RIVM monograph 300/211, December
+
+
REF_N
40020
40040
40060
40080
40120
CAS_N
NAME
SYNONIM
triazine
110553-27-0 2,4Bis(octylthiomethyl)-6methylphenol
013259-35-3 Bis(pentaerythritol)
adipate
000080-05-7 Bisphenol A
013879-32-8 Bis(phenoxyethyl)formal
Bis(polyethyleneglycol)h
ydroxymethylphosphonat
e
DIR
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SML(T) = 5 mg/kg
(41) with 38940
SCF
List
2
EFSA/SCF_OP
1980).
TDI: 0.1 mg/kg b.w.
Available: 1- and 3-month oral rat studies
and teratogenicity studies in rats.
Bioaccumulation and mutagenicity studies
and migration data. (RIVM
90/6786008/008).
9
Same
13480/1360
7/19255//39
680/62540
D
DIR
SML = 0.6 mg/kg
8
3
CT
+
+
+
http://europa.eu.int/comm/food/fs/sc/scf/out
128_en.pdf
R = 0.6 mg/kg food
Available: migration data (< 0.1 mg/kg);
gene mutation assay in bacteria (negative);
chromosomal aberration assay in cultured
mammalian cells (negative); gene mutation
assay in cultured mammalian cells
(negative); 90-day oral rat study.
Remark: no accumulation is expected.
RIVM SDS, November 2000 =
CS/PM/3813/40120.
Remark (reasoning for calculating the
restriction):
Current approach is not setting a TDI based
on abovementioned data-package.
The restriction is calculated based on the
“LOAEL” of 5 mg/kg b.w. (90-day study;
change in thymus weight and liver changes)
and making use of a safety factor of 500 (10
for intraspecies; 10 for interspecies and 5 for
LOAEL to NOAEL). Body weight of 60 kg
is used in the calculation.
(Adopted at the 128th SCF meeting, 12 July
2001)
147
PL
+
+
+
REF_N
40160
CAS_N
NAME
SYNONIM
061269-61-2 N,N'-Bis(2,2,6,6tetramethyl-4piperidyl)hexamethylene
diamine-1,2dibromoethane,
copolymer
40240
-
40320
010043-35-3 Boric acid
DIR
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SML = 2.4 mg/kg
SCF
List
2
EFSA/SCF_OP
PL
http://europa.eu.int/comm/food/fs/sc/scf/out
97_en.pdf
t-TDI: 0.04 mg/kg b.w.
+
CT
Available: 90-day oral rat study, rat
teratogenicity study and mutagenicity study.
(HRC reports MTI 135/85733/ST, 24
Sept.1985 and MTI 133/85540, 14 August
1985 plus Farmitalia report 6 March 1985).
Bis(triethyleneglycol)
hydroxymethylphosphon
ate
D
Same 13620
DIR
SML(T) = 6 mg/kg
(23) (expressed as
Boron) without
prejudice to the
provisions of Directive
98/83/EC on water for
human consumption*.
148
2
Needed: Usage data, results of mutagenicity
study in eukaryotic cells.
(CS/PM/2632).
t-TDI: 0.01 mg/kg b.w.
Available: 90-day oral rat study and
migration < 0.1 ppm.
(RIVM doc. Oct. 1970).
Needed: mutagenicity studies.
Re-evaluation on the basis of an opinion of
the SCF in another context.
Group-TDI = 0.1 mg/kg b.w. (as B) (with
REF_n. 36840, 40320 and 87040).
The TDI is based on the No Adverse Effect
Level (NOAEL) of 9.6 mg/kg b.w./day for
effects on fetal body weight and skeletal
anomalies in the rat developmental study. A
Safety Factor (SF) of 100 is used.
“Opinion of the Scientific Committee on
Food on Arsenic, Barium, Fluoride, Boron
and Manganese in Natural Mineral Waters
(expressed on 13 December 1996, 105th
plenary meeting of the SCF, completed on
13 June 1997 at the 107th plenary meeting
of the SCF; 43rd Series of Reports of the
SCF, 2000”. This opinion is also available
on Internet.
(Adopted by the SCF at the 127th meeting,
30 May 2001)
http://europa.eu.int/comm/food/fs/sc/scf/out
86_en.pdf
+
+
+
REF_N
SYNONIM
DIR
DIR
40560
40570
40580
010043-11-5 Boron nitride
000052-51-7 2-Bromo-2-nitro-1,3propanediol
007166-19-0 2-Bromo-2-nitrostyrene
009041-40-1 Butadienedivinylbenzene,
copolymer
Butadienedivinylbenzene-methyl
methacrylate-styrene,
copolymer
009052-84-0 Butadienedivinylbenzene-styrene,
copolymer
Butadiene-methacrylic
esters of alcohols,
aliphatic, monohydric,
saturated (C1-C18)styrene, copolymers
Butadiene-2-methyl-1,3butadiene, copolymer
Butadiene-2-methyl-1,3butadiene-styrene,
copolymer
025053-09-2 Butadiene-methyl
methacrylate-styrene,
copolymer
009003-55-8 Butadiene-styrene,
copolymer
see 40630
000106-97-8 Butane
000110-63-4 1,4-Butanediol
Same 13720
40590
000071-36-3 1-Butanol
40400
40460
40480
40490
40500
40510
40520
40530
40535
40545
40555
CAS_N
NAME
DIR
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
3
8
SML(T) = 0.05 mg/kg
(24)
Same 13840
Inert, insoluble material.
PL
+
+
+
9
+
9
+
9
+
9
+
9
+
D
+
D
+
D
3
3
CT
+
8
9
3
149
EFSA/SCF_OP
Volatile compound.
Same reference as 13720.
(Adopted by the SCF at the 127th meeting,
30 May 2001)
http://europa.eu.int/comm/food/fs/sc/scf/out
86_en.pdf
See references for "Alcohols, aliphatic,
monohydric, saturated, linear, primary (C4C24)" (PM/REF.N. 33120) in SCF list 3.
+
+
+
+
+
+
REF_N
CAS_N
NAME
40592
40594
000078-92-2 2-Butanol
000075-65-0 tert-Butanol
40597
025895-47-0 1-Butene-ethylenepropylene, copolymer
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
Same 13842
Same 13845
SCF
List
8
3
3
EFSA/SCF_OP
Residue in food less than 10 mg/kg.
(SCF, 11th Series, 1981; EHC 65).
Specifications: copolymer with average
molecular weight about 58000 Daltons, max.
% of use = 2% in finished product.
PL
CT
+
+
+
+
Toxicologically acceptable.
(RIVM SDS 1995-01-24).
40600
-
40618
40621
005131-66-8
025767-47-9
40624
028185-36-6
40630
40632
002782-40-3
004299-07-4
Butene-ethylenepropylene-vinyl estersunsaturated aliphatic
acids (inCluding their
salts and esters),
copolymers
1-Butoxy-2-propanol
Butyl acrylate-styrene,
copolymer
Butyl acrylatevinylpyrrolidone,
copolymer
N-Butylbenzamide
2-Butylbenzo[d]isothiazolin-3one
D
+
8
W
150
+
+
9
+
8
7
+
+
Available: calculation of maximum
migration assuming 100% migration of the
additive over lifetime of the FCM; analytical
method for the determination of 2-butylbenzo[d]isothiazolin-3-one in PVC; log
Po/w; gene mutation assay in bacteria
(negative); chromosomal aberration assay in
cultured mammalian cells (positive); gene
mutation assay in cultured mammalian cells
(negative); in vivo micronucleus assay
(negative; however no indication that the
substance reached the bone marrow); in vivo
UDS assay (negative); 90-day oral rat study.
Needed:
. "Evidence of absence of any preservative
effect with the food"
. Migration data and a well-described
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
method.
RIVM/TNO SDS, August 2000 =
CS/PM/3132 REV. I/40632.
Remark: discussion with WG-FMH on the
method/details (will be determined later on).
(Adopted by the SCF :
http://europa.eu.int/comm/food/fs/sc/scf/out
16_en.html )
40640
40700
40720
40770
40800
40820
40830
40840
40865
40880
40960
40980
41000
41010
000098-29-3 4-tert-butylcatechol
000075-91-2 tert-Butyl hydroperoxide
025013-16-5 tert-Butyl-4hydroxyanisole (=BHA)
000085-60-9 4,4'-Butylidenebis(6-tertbutyl-m-cresol)
013003-12-8 4,4'-Butylidene-bis(6tert-butyl-3methylphenyl-ditridecyl
phosphite)
009011-53-4 Butyl methacrylateisobutyl methacrylate,
copolymer
025608-33-7 Butyl methacrylatemethyl methacrylate,
copolymer
001638-22-8 4-Butylphenol
050696-71-4 tert-Butylphenol
disulphide
015666-29-2 Butylthiostannoic acid
026935-10-4 Butylurethaneformaldehyde,
copolymer
019664-95-0 Butyric acid, manganese
salt
Same 14005
DIR
SML = 30 mg/kg
Same 39920
8
W
1
+
+
t-ADI: 0.5 mg/kg b.w.
(SCF, 22th Series, 1989).
D
DIR
SML = 6 mg/kg
2
+
+
TDI: 0.1 mg/kg b.w.
90-day oral rat study.
(CIVO report 5254, February 1977).
+
W
+
W
+
Same 47120
8
D
See '47210'.
Same 40635
D
D
+
+
2
L0 for butyric acid.
+
DIR
SML(T) = 0.6 mg/kg
(10) (expressed as
Manganese)
000096-48-0 gamma-Butyrolactone
?
Calcium aluminium
L2= 0.01 mg/kg b.w. (as Mn).
TDI: 0.01 mg/kg (as Mn).
See references for 30180 in L2 in this report.
8
D
151
+
+
+
+
REF_N
CAS_N
NAME
41040
41120
hydroxyphosphite, basic
065140-91-2 Calcium bis(3,5-di-tertbutyl-4-hydroxybenzylmonoethyl)phosphonate
005743-36-2 Calcium butyrate
010043-52-4 Calcium chloride
41200
41280
007789-75-5 Calcium fluoride
001305-62-0 Calcium hydroxide
41360
41440
010101-39-0 Calcium metasilicate
Calcium 2methoxybenzoate
001305-78-8 Calcium oxide
41020
41520
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
Same 46880
SCF
List
D
DIR
DIR
0
1
DIR
7?
1
7?
8
DIR
1
DIR
2
41680
012004-14-7 Calcium
and 037293- sulphoaluminate
22-4
000076-22-2 Camphor
41760
41800
008006-44-8 Candelilla wax
000142-62-1 Caproic acid
DIR
41840
000105-60-2 Caprolactam
41920
-
41600
41960
42000
epsilon-Caprolactoneethyleneimine-lauric
acid, copolymer
000124-07-2 Caprylic acid
063438-80-2 (2-Carbobutoxyethyl)tintris(isooctyl
mercaptoacetate)
DIR
Same 18770
and 59360
Same 14200.
DIR
In compliance with
note 9 in Annex VI
SML(T) = 15 mg/kg
(5)
DIR
DIR
ADI: not specified.
(SCF, 25th Series, 1991)
Needed: migration data.
ADI: not specified.
(SCF, 25th Series, 1991)
Needed: migration data.
152
CT
+
+
+
+
+
+
+
+
+
+
+
+
3
D
Natural wax. Purity to be specified.
+
+
2
Group TDI: 0.25 mg/kg b.w.
Two 90-day oral rat studies and 90-day oral
studies in mice and dogs.
(CIVO report 3489 June 1971 and NTP tech.
Rep. Ser. 214, NTP 80-26).
In first instance provide information on
identity.
+
3
0
SML = 30 mg/kg
PL
ADI: not specified.
(SCF, 25th Series, 1991)
TDI: 1 mg/kg bw (as Al) based on PTWI= 7
mg/kg bw (as Al).
(SCF, 25th Series, 1991).
Natural compound with strong flavour.
W9
Same 14320
and 68560
EFSA/SCF_OP
2
+
+
+
+
+
+
t-TDI: 0.5 mg/kg b.w. pending additional
mutagenicity studies
Available: 35-day in young and 90-day oral
rat studies and Ames test.
(RIVM report 89/678608/002, 1989-04-04).
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
42080
001333-86-4 Carbon black
3
42160
000124-38-9 Carbon dioxide
DIR
42240
42320
Carbon fibers
007492-68-4 Carbonic acid, copper
salt
DIR
42360
42400
010290-71-8 Carbonic acid, iron salt
010377-37-4 Carbonic acid, lithium
salt
42480
000584-09-8 Carbonic acid, rubidium
salt
DIR
42500
-
Carbonic acid, salts
DIR
42560
-
Carbon vegetable
42640
009000-11-7 Carboxymethylcellulose
42680
42720
42800
42880
003401-73-8 N-(3-Carboxy-2sulphopropionyl)-Noctadecyl-l-aspartic acid,
tetrasodium salt
008015-86-9 Carnauba wax
009000-71-9 Casein
008001-79-4 Castor oil
Same 14411
DIR
DIR
DIR
3
0
3
42960
064147-40-6 Castor oil, dehydrated
DIR
3
DIR
1
SML(T) = 30 mg/kg
(7) (expressed as
Copper)
SML(T) = 0.6 mg/kg
(8) (expressed as
Lithium)
SML = 12 mg/kg
9
2
D
2
2
1
1/D
DIR
Same 14440
2
EFSA/SCF_OP
Under re-evaluation.
---------------------------------------------------Criteria purity shall be established. Carbon
black should be free from aromatic
hydrocarbons (CS/PM/2041).
ADI: not specified.
(JECFA 23rd M., 1980).
For Copper. Same as Ref.No 30080.
Group TDI: 0.01 mg/kg b.w. (as Li).
See references for benzoic acid, lithium salt.
TDI: 0.2 mg/kg b.w.
90-day oral rat study on diet low in K+.
Normal food may contain up to 140 mg/kg,
average daily intake for man 1-4 mg.
(RIVM 617601002, 1981).
ADI: not specified for carbonate.
(SCF, 25th Series, 1991)
Food grade acceptable.
(SCF, 4th Series, 1977).
Group TDI: not specified based on Group
ADI (=not specified) for certain modified
celluloses.
(JECFA 35 M, 1989).
W8
153
PL
CT
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
Natural wax. Purity to be specified.
Same as 14411
http://europa.eu.int/comm/food/fs/sc/scf/out
181_en.pdf
Similar to fats food.
+
+
+
+
+
+
+
REF_N
43040
43120
43200
43201
43230
43232
CAS_N
NAME
Castor oil, epoxidized
(oxirane less than 5%,
iodine Number less than
6)
008001-78-3 Castor oil, hydrogenated Same 14470
Castor oil, mono- and
diglycerides
Castor oil fatty acids
mono- and diglycerides
43330
43360
43390
43410
43440
009012-09-3 Cellulose triacetate
008001-75-0 Ceresin
008001-75-0 Ceresin
43480
064365-11-3 Charcoal, activated
43280
43300
DIR
RESTRICTIONS
AND
SPECIFICATIONS
-
008002-33-3 Castor oil, sulphated
068187-76-8 Castor oil, sulphated,
sodium salt
Castor oil, sulphonated,
sodium salt
009004-34-6 Cellulose
009004-36-8 Cellulose acetate
butyrate
009004-70-0 Cellulose nitrate
068442-85-3 Cellulose, regenerated
43265
SYNONIM
SCF
List
EFSA/SCF_OP
8
DIR
PL
+
3
3
Identical with or similar to food fat.
Toxicologically acceptable.
+
+
+
3
SCF_List: 3
Restriction: none. In small doses
metabolised similarly to food fats
See SCF evaluation in the website:
http://europa.eu.int/comm/food/fs/sc/scf/out
181_en.pdf
+
+
9
W
Same 14500
Same 14508
Same 43440
Same 43410
+
+
8
+
DIR
DIR
0
3
+
+
DIR
D
2
DIR
9
D
3
3AM
3
Same 22450
154
CT
Inert material, modified natural cellulose.
Group TDI: not specified based on Group
ADI (=not specified) for certain modified
cellulose.
(JECFA 35 M., 1989).
Refined, natural, crystalline wax. Purity to
be specified.
Restriction: Only to be used in polyethylene
terephthalate (PET) at a maximum
amount of 10 mg/kg polymer.
Purity criteria: in compliance with vegetable
carbon (E 153), except for the ash content
which can be up to 10%.
http://www.efsa.eu.int/science/afc/afc_opini
ons/675/afc_opinion20_ej109_list5_en1.pdf
+
+
+
+
+
+
+
+
REF_N
43490
43495
43515
CAS_N
NAME
SYNONIM
001332-58-7 China clay (=natural
Same 62720
aluminium silicate)
066402-68-4 China clay, calcined
Chlorides of choline
Same 54660
esters of coconut oil fatty and 63400
acids
DIR
DIR
RESTRICTIONS
AND
SPECIFICATIONS
QMA = 0.9 mg/6 dm²
SCF
List
EFSA/SCF_OP
PL
D
+
D
3
+
+
R : to be used at a maximum amount of
0.015 g/m² (150 ug/dm²).
Available: Method for determination of
residual content; three (negative)
mutagenicity studies (performed with
lauroyl choline chloride); 28-day and 90-day
oral rat studies (on coconut fatty acid esters
of choline chloride, the largest component of
which is lauric acid ester of choline
chloride); bioaccumulation study (in Zebra
fish).
Remark: change name into 'Fatty acids of
coconut oil, esters with choline chloride'.
Remark: Given the physical/chemical data,
there is no need for asking further data on
possible accumulation.
Remark: If hydrolysis data are provided
(showing complete hydrolysis), then the
restriction may be deleted.
(RIVM/ISS/TNO SDS, April 1997 =
CS/PM/2999/63400).
CT
+
REMARK for Commission: No method of
analysis is available for the enforcement of
an SML.
(Adopted at 113th SCF meeting)(17-18
September 1998)
http://europa.eu.int/comm/food/fs/sc/scf/out
16_en.html
43520
43590
43600
-
Chlorides of choline
esters of linear natural
monocarb.acids
000079-07-2 Chloroacetamide
004080-31-3 1-(3-Chloroallyl)-3,5,7triaza-1azoniaadamantane
chloride
9
DIR
SML = 0.3 mg/kg
155
W
2
+
+
TDI: 0.005 mg/kg b.w.
Two 90-day oral rat and a dog studies and
teratogenicity studies in rats and rabbits and
negative mutagenicity studies.
+
REF_N
CAS_N
NAME
43650
000075-68-3 1-Chloro-1,1difluoroethane
43680
000075-45-6 Chlorodifluoromethane
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
W7?
DIR
SML = 6 mg/kg and in
compliance with the
specifications laid
down in Annex V.
2
EFSA/SCF_OP
(RIVM doc. December 1983).
Available: semichronic and chronic
inhalation studies in rats, 2 inhalation
teratogenicity studies in rats, several Ames
tests and two in vivo mutagenicity studies,
migration data.
Needed: reproduction study.
TDI: 0.1 mg/kg b.w. (based on
teratogenicity study).
Specification: content of
chlorofluoromethane less than 1 ppm.One
year oral rat study. Several inhalation studies
in several animal species, including
teratogenicity in rabbits. Mutagenicity tests
in-vitro and in-vivo.
N.B. The Committee has not considered the
environmental implications of the use of the
solvent in food technology, but recognises
that environmental considerations may take
precedence over its own evaluations on this
occasion.
90-day oral rat and dog studies.
Reproduction and teratogenicity studies in
rabbits, 3 mutagenicity studies.
(RIVM Doc.Tox.300/430 May 1979,
September 1983, June 1984). Very potent
sensitizer.
PL
+
+
43760
026172-55-4 5-Chloro-2-methyl-4isothiazolin-3-one
7
43820
-
D
+
43840
015659-56-0
8
+
43920
015242-96-3
9
+
43980
44000
001308-38-9
001333-82-0
Chromic chloride
complex with linear
sat.monocarb.acids (C16
and above)
Chromic chloride
myristate
Chromic chloride
stearate
Chromium (III) oxide
Chromium trioxide
9
5
156
CT
+
+
+
Cr(VI) is a genotoxic carcinogen (IARC
monograph 1980, vol. 23).
+
REF_N
CAS_N
NAME
44080
000104-55-2 Cinnamaldehyde
44160
000077-92-9 Citric acid
44240
-
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
+
9
(Adopted at 111th SCF meeting (18-19
March 1998)).
http://europa.eu.int/comm/food/fs/sc/scf/out
10_en.pdf
Group ADI: not specified for citric acid and
its salts.
(SCF, 25th Series, 1990).
Group R: 0.05 mg/kg b.w.
D
See PM/REF.N. 95725.
+
7
Needed: hydrolysis data and reports from
Duel et al., (1951).
Needed: hydrolysis data and reports from
Duel et al., (1951).
Group R: 0.05 mg/kg b.w.
Needed: toxµ$icological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, peroxisome
proliferation study too.
ADI: 20 mg/kg b.w.
(JECFA 28 M., 1984).
Group R: 0.05 mg/kg b.w.
Needed: toxicological data depending on
migration level (see SCF guidelines) and if
migration exceeds 0.05 mg/kg peroxisome
proliferation study too.
Group R: 0.05 mg/kg b.w.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, peroxisome
proliferation study too.
L2 for Al.
TDI: 1 mg/kg bw (as Al) based on PTWI: 7
mg/kg bw (as Al).
(SCF, 25th Series, 1991).
+
8
Same 14680
DIR
1
44560
Citric acid, alkyl,
primary (C2-C12), esters
110638-71- Citric acid, lithium salt, Same 95725
6*
reaction product with
vermiculite
001321-57-9 Citric acid,
monoisopropyl ester
001323-66-6 Citric acid, mono-noctadecyl ester
000077-94-1 Citric acid, tributyl ester
44640
000077-93-0 Citric acid, triethyl ester
44720
007775-50-0 Citric acid, tri-noctadecyl ester
8
44800
007147-34-4 Citric acid, tris(2ethylhexyl) ester
8
44880
001333-88-6 Cobalt aluminate
2-3
44300
44320
44400
7
8
DIR
1
L3 fo Co.
R: 0.05 mg/kg of food (as Co).
157
+
CT
+
+
+
+
+
+
+
+
+
+
REF_N
CAS_N
NAME
44960
011104-61-3 Cobalt oxide
44980
44985
061788-46-3 Cocoalkylamines
061791-14-8 Cocoalkylamines,
ethoxylated
061791-63-7 NCocoalkyltrimethylenedi
amines
061790-63-4 Coconut oil fatty acids
68603-42-9 diethanolamide (add
and
cas_N = 68440-04-0)
008050-09-7 Colophony
44995
45040
45055
45060/0
008002-13-9 Colza oil
45075
-
45105
-
45120
-
SYNONIM
DIR
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SML(T) = 0.05 mg/kg
(14) (expressed as
Cobalt)
SCF
List
3
Condensation products
of ethylene oxide with
alkyl- and dialkylamines
(C1-C20)
Copolymers of acrylic or
methacrylic esters with
vinylpyrrolidone
Copolymers of
acrylic,fumaric,itaconic,
maleic and methacrylic
acids with butadiene,
butene, divinylbenzene,
esters of these acids with
sat. monoh. aliph.
alcohols(C1-C18),
ethylene, ethylene oxide,
158
(Rivm, summary data, October
1992)(CS/PM/1707).
L3 for Cobalt.
R: 0.05 mg/kg of food (as Co).
(RIVM, summary data, October
1992=CS/PM/1707).
PL
CT
+
W
W
+
+
W
+
7?
Same
14687,24100
,24130 and
83840
Same
45060/1,835
80/0 and
83580/1
EFSA/SCF_OP
Same references as 39280.
+
D
+
D
+
9
+
9
+
9
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
45195
etC..
Copolymer of 1-alkenes
(C20-C24) and diesters
of maleic acid and tallow
alcohol (C16-C18)
containing max 13%
tallow alcohol and max
5% 1-alkenes (C20-C24)
Copolymers of linear or
branched 1-alkenes(C3C38) and mono- or
diesters of maleic acid
with linear or branched
alcohols (C2-C36),
ethoxylated alcohols
(C1-C36) with
ethoxylation degree
between 2-36
007787-70-4 Copper bromide
DIR
45200
001335-23-5 Copper iodide
DIR
45280
45360
45440
Cotton fibers
008001-29-4 Cottonseed oil
Cresols, butylated,
styrenated
DIR
45130
45165
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SML(T) = 30 mg/kg
(7) (expressed as
Copper)
SML(T) = 30 mg/kg
(7) (expressed as
Copper) and SML = 1
mg/kg (11) (expressed
as Iodine)
SML = 12 mg/kg
SCF
List
EFSA/SCF_OP
PL
7?
Needed: Migration data and also 3
mutagenicity tests on 1-alkenes, unless the
industry confirms that they have straight
chain.
+
9
Look at 45130.
+
2
For Copper. Same as Ref.No 30080.
+
2
For Copper. Same as Ref.No 30080.
+
Inert, insoluble material.
Equal to or similar to food fats.
t-TDI: 0.2 mg/kg b.w.
+
+
+
3
3/D
2
CT
Available: 3-month oral rat and 2-year oral
rat and dog studies, rat reproduction study.
(Food Drug Research Lab. 1964).
Needed: specification and Mw distribution
curve, in first instance.
45450
068610-51-5 p-Cresol-
DIR
SML = 5 mg/kg
159
3
(to be confirmed by SCF)
SCF_list: 3
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
dicyclopentadieneisobutylene, copolymer
EFSA/SCF_OP
PL
CT
+
+
+
+
Restriction: 5 mg/kg of food.
See SCF evaluation in the website:
http://europa.eu.int/comm/food/fs/sc/scf/out
140_en.pdf
45520
45560
45600
p-Cresol, styrenated
014464-46-1 Cristobalite
003724-65-0 Crotonic acid
45610
025609-89-6 Crotonic acid-vinyl
acetate, copolymer
005232-99-5 2-Cyano-3,3diphenylacrylic acid,
ethyl ester
45640
45650
006197-30-4 2-Cyano-3,3diphenylacrylic acid, 2ethylhexyl ester
45670
000461-58-5 Cyanoguanidine
Same 14800
DIR
DIR
QMA(T) = 0.05
mg/6dm² (33)
9
3
3
Inert material.
Same references as 14800
http://europa.eu.int/comm/food/fs/sc/scf/out
141_en.pdf
9
DIR
DIR
SML = 0.05 mg/kg
SML = 0.05 mg/kg
Same 15695
and 47440
3
3
D
160
+
SCF_list:3
Restriction: 0.05 mg/kg of food.
See SCF evaluation in the website:
http://europa.eu.int/comm/food/fs/sc/scf/out
142_en.pdf
R = 0.05 mg/kg food.
Available: migration data (< 0.05 mg/kg
food); gene mutation assay in bacteria
(negative); chromosomal aberration assay in
cultured mammalian cells (negative); gene
mutation assay in cultured mammalian cells
(negative); micronucleus assay (negative);
acute toxicity data; 90-day oral rat study;
teratogenicity study with rats.
RIVM/TNO SDS, January 2001 =
CS/PM/3818/45650.
Remark: If data on the absence of potential
for accumulation were available then a
restriction of 5 mg/kg food could be
assigned to this substance.
(Adopted at the 128th SCF meeting, 12 July
2001)
http://europa.eu.int/comm/food/fs/sc/scf/out
97_en.pdf
+
+
+
+
REF_N
45680
CAS_N
NAME
SYNONIM
45710
45720
Cycloalkanes (0-100
degrees celsius)
000291-64-5 Cycloheptane
000110-82-7 Cyclohexane
166412-78-8 1,2Hexahydrop
Cyclohexanedicarboxylic hthalic acid,
acid, diisononyl ester
diisononyl
ester
000108-93-0 Cyclohexanol
Same 14905
000108-94-1 Cyclohexanone
Same 14910
45760
000108-91-8 Cyclohexylamine
45840
-
45690
45700
45705
45841
45842
45880
45920
DIR
RESTRICTIONS
AND
SPECIFICATIONS
-
Cyclopentadienecyclopentenedicyclopentadiene-2pentene-2-methyl-2butene-1,3-pentadiene,
copolymers,
hydrogenated or Not
Cyclopentadienecyclopentenedicyclopenbtadiene-2pentene-2-methyl-2butene-1,3-pentadiene,
copolymers
Cyclopentadienecyclopentenedicyclopentadiene-2pentene-2-methyl-2butene-1,3-pentadiene,
copolymers,
hydrogenated
000287-92-3 Cyclopentane
009000-16-2 Dammar
SCF
List
+
8
8
7
+
+
+
2
Under re-evaluation
Needed: adequate test for gene mutation and
chromosomal aberration.
(IARC (1989), 47, 151-169).
TDI: 1 mg/kg b.w. calculated with reference
to the ADI for cyclamic acid of 11 mg/kg
b.w.
(JECFA 26 M., 1982).
DIR
161
+
+
+
7?
Needed: Mw distribution curve, 3
mutagenicity tests on monomers not in L 04, in first instance.
+
8
Needed: data according to SCF guidelines
on polymeric additives.
+
8
3
CT
+
9
Same
15065,45925
PL
9
8
6A
DIR
EFSA/SCF_OP
Natural wax. Purity to be specified.
+
+
REF_N
CAS_N
NAME
SYNONIM
and 45930
Same 15065,
45920 and
45930
Same 15065,
45920 and
45925
Same 15095
45925
009000-16-2 Damar resin
45930
009000-16-2 Damar wax
45940
46000
46070
46080
46160
46440
46480
000334-48-5 n-Decanoic acid
see 46070
010016-20-3 alpha-Dextrin
007585-39-9 beta-Dextrin
Dialkyl or alkyl (more
than C8) phosphate
Dialkyldithiocarbamic
acid, salts
Dialkyl(C8-C20)ketones
061790-53-2 Diatomaceous earth
Same 62880
068855-54-9 Diatomaceous earth,
Same 62885
soda ash flux-calcined
000120-78-5 Dibenzothiazyl
disulphide
000094-36-0 Dibenzoyl peroxide
032647-67-9 Dibenzylidene sorbitol
46560
000106-93-4 1,2-Dibromoethane
46640
000128-37-0 2,6-Di-tert-butyl-p-cresol
(=BHT)
5,7-di-tert-Butyl-3-(3,4- Same 67170
and 2,3-dimethylphenyl)3H-benzofuran-2-one
46240
46320
46375
46380
46400
46700
DIR
RESTRICTIONS
AND
SPECIFICATIONS
DIR
SCF
List
+
D
+
Food constituent.
9
9
3
3
DIR
DIR
8
2
5
DIR
SML = 3.0 mg/kg
1
DIR
SML = 5 mg/kg
3
162
+
+
+
+
+
CT
+
+
+
+
+
Inert material.
Inert material.
8
DIR
PL
D
0
D
0
0
9
DIR
DIR
EFSA/SCF_OP
+
+
+
+
+
Group TDI: 1 mg/kg b.w. (with bis(4ethylbenzylidene)sorbitol and
bis(methylbenzylidene) sorbitol).
Several 90-day oral mouse and rat studies,
several mutagenicity studies negative.
See references for bis(4-ethylbenzylidene)
sorbitol.
[Some organobromo compounds have a
bioaccumulation potential and 1,2dibromoethane is a category 2 carcinogen
(EC classification).]
ADI: 0.05 mg/kg b.w.
(SCF, 22th Series, 1989).
R = 5 mg/kg of food.
http://europa.eu.int/comm/food/fs/sc/scf/out
20_en.pdf
+
+
+
+
+
+
+
+
REF_N
46720
46750
46790
46800
46870
46880
46960
CAS_N
NAME
SYNONIM
containing: a) 5,7-di-tertbutyl-3-(3,4dimethylphenyl)-3Hbenzofuran-2-one (80 to
100% w/w) and b) 5,7di-tert-butyl-3-(2,3dimethylphenyl)-3Hbenzofuran-2-one (0 to
20% w/w)
004130-42-1 2,6-Di-tert-butyl-4ethylphenol
000088-58-4 2,5-Di-tertbutylhydroquinone
004221-80-1 3,5-Di-tert-butyl-4hydroxybenzoic acid,
2,4-di-tert-butylphenyl
ester
067845-93-6 3,5-Di-tert-butyl-4hydroxybenzoic acid,
hexadecyl ester
DIR
RESTRICTIONS
AND
SPECIFICATIONS
DIR
QMA = 4.8 mg/6 dm²
SCF
List
3
EFSA/SCF_OP
R: 0.8 mg/dm².
Available: 3 negative mutagenicity studies,
90-day oral rat and dog studies,
bioaccumulation, calculation of the worst
case as well as analytical method.
(RIVM 93/6/3330/001, 1993-0126=CS/PM/2011, TNO 1995-0403=CS/PM/2580).
PL
+
W
+
Same 47200
DIR
2
TDI: 2 mg/kg bw.
90-day oral rat study.
(RIVM report May 1973).
+
Same 58800
DIR
2
+
003135-18-0 3,5-Di-tert-butyl-4Same 49760
hydroxybenzylphosphoni
c acid, dioctadecyl ester
065140-91-2 3,5-Di-tert-butyl-4Same 41020
hydroxybenzylphosphoni
c acid, monoethyl ester,
calcium salt
DIR
2
TDI: 2.5 mg/kg b.w.
90-day oral rat and dog studies, reproduction
study in rats, mutagenicity studies.
(RIVM doc. 88/678608/001, 1 November
1988).
TDI: 1 mg/kg bw.
A 90-day oral rat study.
(CIBA-GEIGY report, 14 February 1970).
TDI = 0.1 mg/kg b.w.
A 4+4 week, a 13+4 week and a two year
oral rat studies.
(Ciba-Geigy reports CBG 174/78110, 10-071978 and CBG 192/781233, 22-03-1979,
CBG 261/821163, 4 April 1984).
DIR
SML = 6 mg/kg
030947-30-9 3,5-Di-tert-butyl-4hydroxybenzylphosphoni
c acid, monoethyl ester,
2
8
163
CT
+
+
+
+
+
REF_N
CAS_N
47040
034137-09-2
47080
47120
000110-05-4
050696-71-4
47200
004221-80-1
47210
026427-07-6
47215
47220
47280
47360
47380
000683-18-1
000077-58-7
002782-57-2
000075-71-8
068611-44-9
47440
47500
47520
NAME
SYNONIM
nickel salt
3,5-Di-tert-butyl-4hydroxyhydrocinnamic
acid, triester with 1,3,5tris(2-hydroxyethyl)1,3,5- triazine-2,4,6(1h,3h,5h)trione
Di-tert-butyl peroxide
Di(tert-butylphenol)
Same 40865
disulphide
2,4-Di-tert-butylphenyl Same 46790
3,5-di-tert-butyl-4hydroxybenzoate
Dibutylthiostannoic acid
Same as
polymer [= thiobis(butyl40880
tin sulphide), polymer]
Dibutyltin dichloride
Dibutyltindilaurate
Dichlorocyanuric acid
Dichlorodifluoromethane
Dichlorodimethylsilane,
reaction products with
silica
000461-58-5 Dicyanodiamide
Same 15695
and 45670
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
8
EFSA/SCF_OP
Available: 90-day oral rat and dog studies
and a reproduction study were inadequate.
8
8
D
DIR
in compliance with the
specifications laid
down in Annex V.
2
W
8
D
7
W
DIR
2
153250-52-3 N,N'-Dicyclohexyl-2,6naphthalene
dicarboxamide
Dicyclopentadieneindene-styrenealpha.methylstyrenevinyltoluene-isobutylene,
copolymer, hydrogenated
3
3
164
PL
CT
+
+
+
TDI: 2 mg/kg b.w.
90-day oral rat study.
(RIVM report May 1973).
t-TDI: 25 mg/kg b.w.
Available: 70- and 90-day and 2-year oral
rat studies, observations in man and
migration data.
Needed: mutagenicity studies.
+
+
+
+
+
Needed: migration data and specifications.
+
+
+
TDI: 1 mg/kg b.w.
2-year oral rat and dog studies and Ames
tests.
(American Cyanamid report 1969).
Restriction: 5 mg/kg food
http://www.efsa.eu.int/science/afc/afc_opini
ons/960/afc_op_ej218_8thlist_en1.pdf
R: 5 mg/kg of food. Specifications to be
added (range of percentage of comonomers,
percentage with Mw < 1000 Daltons)?
Toxicologically acceptable.
Available: migration data, 5 Ames tests and
an in vivo mutagenicit y study (negative)
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
and a 3-month oral rat study.
(RIVM February 1993, CS/PM/855).
Remark: since high migration into fat has
been demonstrated, the WG recommends
that the Commission take the necessary
measures so that the restriction proposed is
not exceeded.
47535
47540
007173-51-5 Didecyldimethylammoni
um chloride
027458-90-8 Di-tert-dodecyl
disulphide
47550
47600
002123-19-5 Didodecyl ketone
084030-61-5 Di-n-dodecyltin
bis(isooctyl
mercaptoacetate)
47620
000111-42-2 Diethanolamine
W8
DIR
DIR
SML = 0.05 mg/kg
3
SML = 12 mg/kg
8
3
Same 15735
W8
165
+
R = 0.05 mg/kg of food.
Available: migration data; gene mutation
assay in bacteria (negative); chromosomal
aberration assay in cultured mammalian
cells (negative); gene mutation assay in
cultured mammalian cells (negative); acute
toxicity studies with di-tert-dodecyl
trisulfide (TPS20) and di-tert-dodecyl
pentasulfide (TPS32); 4-week oral rat study
with di-tert-dodecyl pentasulfide (TPS32);
skin and eye irritation studies performed
with TPS20 and TPS32; sensitisation studies
performed with TPS20 and TPS32.
(RIVM/TNO SDS, September 1999 =
CS/PM/2964 REV. II/47540).
(Adopted at the 119th SCF meeting) (2
December 1999)
http://europa.eu.int/comm/food/fs/sc/scf/out
50_en.pdf
Restriction: 0.05 mg/kg food (as sum of
mono-n-dodecyltin tris(isooctyl
mercaptoacetate), di-n- dodecyltin
bis(isooctyl mercaptoacetate),
monododecyltin trichloride and didodecyltin dichloride) expressed as the sum
of mono- and di-dodecyltin chloride.
http://www.efsa.eu.int/science/afc/afc_opini
ons/960/afc_op_ej218_8thlist_en1.pdf
Data inadequate.
+
+
+
+
+
REF_N
47630
CAS_N
NAME
SYNONIM
48460
000143-00-0 Diethanolamine dodecyl Same 52400
sulphate
027027-16-3 3-Diethylaminoethyl
methacrylate-methyl
methacrylate, copolymer
000111-46-6 Diethyleneglycol
Same
13326,15760
and 39160
000120-55-8 Diethyleneglycol
dibenzoate
021209-30-3 Diethyleneglycol
dioleate
068818-39-3 Diethyleneglycol
dipalmitate
074356-18-6 Diethyleneglycol
diricinoleate
000109-30-8 Diethyleneglycol
distearate
000106-12-7 Diethyleneglycol
monooleate
036381-62-1 Diethyleneglycol
monopalmitate
005401-17-2 Diethyleneglycol
monoricinoleate
000106-11-6 Diethyleneglycol
monostearate
000100-37-8 Diethylethanolamine
Same 48400
000100-37-8 Diethylhydroxyethylami Same 48370
ne
000075-37-6 1,1-Difluoroethane
48470
029658-26-2 4,4'-
47660
47680
47720
47760
47840
47920
48000
48080
48160
48240
48320
48370
48400
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
D
EFSA/SCF_OP
Restriction: contact with nitrite containing
food should be avoided.
Same as 52400.
D
DIR
SML(T) = 30 mg/kg
(3)
2
Group TDI = 0.5 mg/kg b.w.
(SCF, 17th Series, 1986).
+
+
Needed: hydrolysis data.
+
7
Needed: hydrolysis data.
+
7
Needed: hydrolysis data.
+
7
Needed: hydrolysis data.
+
7
Needed: hydrolysis data.
+
7
Needed: hydrolysis data.
+
7
Needed: hydrolysis data.
+
7
Needed: hydrolysis data.
+
8
D
9
166
+
7
3
CT
+
W
DIR
PL
+
Toxicologically acceptable.
Available: Migration data, 2 gene mutation
tests in bacteria and 1 in Drosophila, chronic
toxicity/carcinogenicity rat inhalation study,
rat inhalation teratology study.
(RIVM/TNO SDS CS/PM/2747, November
95).
+
+
+
+
+
REF_N
CAS_N
48480
48500
48520
48560
059113-36-9
000504-53-0
022986-69-2
036265-41-5
48590
086088-85-9
48620
000123-31-9
48640
000131-56-6
48720
NAME
SYNONIM
Difluorobenzophenonehydroquinone,
copolymer
Diglycerol
Same 15855
Di-n-heptadecyl ketone
Di-n-hexadecyl ketone
1,4-Dihydro-2,6dimethyl-3,5dicarbododecyloxypyridi
ne
4,5-Dihydro-1-methyl-2Nortallow alkyl-3-(2tallow amidoethyl)imidazolium, methyl
sulphate
1,4-Dihydroxybenzene Same 15940,
18867 and
60060
2,4Dihydroxybenzophenone
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
8
8
8
8
EFSA/SCF_OP
Available: oral studies in rats and dogs were
inappropriate.
W8
PL
+
+
+
+
+
DIR
SML = 0.6 mg/kg
2
TDI: 0.01 mg/kg b.w.
(SCF, 17th Series, 1986).
+
DIR
SML(T) = 6 mg/kg
(15)
2
+
000611-99-4 4,4'Same 15970.
Dihydroxybenzophenone
DIR
SML(T) = 6 mg/kg
(15)
2
48800
000097-23-4 2,2'-Dihydroxy-5,5'dichlorodiphenylmethane
DIR
SML = 12 mg/kg
2
48880
000131-53-3 2,2'-Dihydroxy-4methoxybenzophenone
DIR
SML(T) = 6 mg/kg
(15)
2
48960
000120-87-6 9,10-Dihydroxystearic
acid
7
Group TDI: 0.1 mg/kg b.w.
See references for 4,4'dihydroxybenzophenone in list 2.
Group TDI: 0.1 mg/kg b.w.
See references for 4,4'dihydroxybenzophenone in list 2.
TDI: 0.2 mg/kg b.w.
2-week and 13-week oral rat studies and
observations in man from its therapeutic use.
(J. Am. Leather. Chemists Assoc. 1944, 39,
203-209; J. Pharmacol. Exper. Therap.
1949, 96, 238-249).
Group TDI: 0.1 mg/kg b.w.
See references for 4,4'dihydroxybenzophenone in list 2.
Evaluated in EFSA-AFC and classified in
list7.
http://www.efsa.eu.int/science/afc/afc_opini
ons/195/opinion_afc_01_en1.pdf
49040
001115-01-1 9,10-Dihydroxystearic
acid, methyl ester
8
167
+
+
+
+
+
CT
REF_N
49050
49055
49065
49120
49160
49200
49202
49235
49280
49330
49340
49360
49465
49472
49485
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
000108-83-8 Diisobutyl ketone
027213-90-7 Diisobutylnaphthalenesul
phonic acid, sodium salt
000110-97-4 Diisopropanolamine
Same 16120
8
9
Available: no adequate oral data, Ames test.
No data are available.
+
+
8
+
003271-22-5 2,4-Dimethoxy-6-(1pyrenyl)-1,3,5-triazine
000127-19-5 Dimethylacetamide
Dimethylalkyl(C8C18)benzylammonium
chloride
068391-01-5 Dimethylalkyl(C12C18)benzylammonium
chloride
000108-01-0 Dimethylaminoethanol
7
R: contact with food containing nitrite
should be avoided.
Needed: information on tissue accumulation.
Suspected embryotoxicity/teratogenicity.
Existing data are not available to the SCF.
Provide them.
+
+
CAS_N
NAME
SYNONIM
DIR
6B
9
9
Same 16150
2
000121-69-7 N,N-Dimethylaniline
Same 16190
001879-09-0 2,4-Dimethyl-6-tert.butylphenol
061789-71-7 Dimethyl(cocoalkyl)benz
ylammonium chloride
Dimethyldialkyl(C8C18)ammonium chloride
000068-12-2 Dimethylformamide
8
8
095009-13-5 N,N-Dimethyl-2hydroxy-N-(2hydroxypropyl)-1propanaminium, diester
with vegetable oil fatty
acids methyl sulphate
134701-20-5 2,4-Dimethyl-6-(1methylpentadecyl)phenol
9
TDI: 0.3 mg/kg b.w.
See references for same substance
(PM/REF. 16150) in monomer report.
SML = 1 mg/kg
168
3
+
+
+
Existing data are not available to the SCF.
Provide them.
+
+
+
Suspected of embryotoxicity/teratogenicity.
(EHC 114).
W8
DIR
+
+
9
6B
CT
+
+
R = 1 mg/kg of food.
Available: Adequate migration data showing
specific migration into aqueous food
simulants is < 0.05 mg/kg food and into
olive oil < 0.12-0.48 mg/kg food; three
(negative) mutagenicity studies; 28-day oral
rat study; 90-day oral rat study (relatively
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
low NOAEL + effects still observed after
the recovery period); log Po/w; ADME
study.
Remark: Based on the hepatotoxic effects
observed in both the 28-day and 90-day oral
rat studies which resulted in the same low
NOAEL of 10 mg/kg b.w., the SCF used a
safety factor of 500 and a 60 kg person to
establish a restriction of 1 mg/kg of food.
(RIVM SDS, February 1998 = CS/PM/2917
REV. I/49485).
(adopted at 113rd SCF meeting)(17-18
September 1998)
http://europa.eu.int/comm/food/fs/sc/scf/out
16_en.html
49510
49520
49540
49580
49595
-
alpha,omegaDimethylpoly(obutyl(polypropyleneglyc
ol)(polyethyleneglycol)(
polydimethylsiloxane)
see 49580
000067-68-5 Dimethyl sulphoxide
Same 16410
029351-51-7 Dimethylthianthrene
057583-35-4 Dimethyltin
bis(ethylhexyl
mercaptoacetate)
see 49600
9
DIR
D
3
3AM
8
2
169
+
DMSO is used as carrier of drugs to
facilitate skin penetration.
L2 for tin
Isooctyl refers to industrial mixture
including substances with a branched chain
of 8 atoms of carbon. Usually, x-methyl-C7,
x,y-dimethyl-C6 are the major components
of an isooctyl “mixture” (more than 90%).
x-ethyl-C6 are present but not in a large
quantities (less than 10%). The composition
of this mixture could be slightly different
according the oil feedstock used for the
synthesis of it and of the process used for the
“oxo” reaction..
In contrast, ethylhexyl (ethyl-C6) refers
usually to 2-ethylhexyl structure which is
perfectly defined chemically.
+
+
+
+
REF_N
CAS_N
NAME
49600
026636-01-1 Dimethyltin bis(isooctyl
mercaptoacetate)
49680
000093-46-9 N,N'-Di-(2-naphthyl)-pphenylenediamine
2,4-Dinonylphenyl bis(4-monononylphenyl)
phosphite
003135-18-0 Di-n-octadecyl 3,5-ditert-butyl-4hydroxybenzyl
phosphonate
002500-88-1 Dioctadecyl disulphide
49720
49760
49840
49920
50000
50080
SYNONIM
DIR
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SML(T) = 0.18 mg/kg
(16) (expressed as Tin)
SCF
List
2
7
EFSA/SCF_OP
In the scope of organotin compounds for
which the toxicity is related to organic tin,
studies done either with the “isooctyl” or the
“ethylhexyl” could be used for evaluation of
branched C8 organotin compounds.
Group TDI: 0.003 mg/kg b.w. (as Sn) (with
67520 and 83599).
See references for 83599 in list 2.
Needed: purity specification especially on
presence of beta-naphthylamine
D
Same 46870
2/D
DIR
SML = 3 mg/kg
020297-71-6 Dioctadecyl 3-methyl-4hydroxy-5-tert-butyl
benzylmalonate
001844-09-3 Dioctadecyl
monosulphide
003806-34-6 Dioctadecyl
pentaerythritol
diphosphite
2
CT
+
+
+
TDI: 1 mg/kg b.w.
A 90-day oral rat study.
(Ciba-Geigy report 14 February 1970).
+
TDI: 0.05 mg/kg b.w.
A 90-day oral rat study.
(Hoechst report 1967).
+
8
+
8
+
W7
170
PL
Available: Acute toxicity data; 90-day oral
rat study (IBT study);
90-day oral dog study (IBT study); review of
the IBT rat and dog studies; neurotoxicity
study in the hen.
Needed: Migration data (on the phosphite
and phosphate); three in vitro mutagenicity
studies and data to demonstrate the absence
of potential for accumulation.
(RIVM SDS, August 1996 = CS/PM/2903/
50080).
(Adopted at 111th SCF meeting (18-19
March 1998)).
http://europa.eu.int/comm/food/fs/sc/scf/out
+
+
REF_N
CAS_N
NAME
50160
-
50240
010039-33-5 Di-n-octyltin bis(2ethylhexyl maleate)
50320
SYNONIM
Di-n-octyltin bis(nalkyl(C10-C16)
mercaptoacetate)
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
DIR
SML(T) = 0.04 mg/kg
(17) (expressed as Tin)
2
DIR
SML(T) = 0.04 mg/kg
(17) (expressed as Tin)
2
015571-58-1 Di-n-octyltin bis(2ethylhexyl
mercaptoacetate)
DIR
SML(T) = 0.04 mg/kg
(17) (expressed as Tin)
2
50360
-
DIR
SML(T) = 0.04 mg/kg
(17) (expressed as Tin)
2
50400
033568-99-9 Di-n-octyltin bis(isooctyl
maleate)
DIR
SML(T) = 0.04 mg/kg
(17) (expressed as Tin)
2
50480
026401-97-8 Di-n-octyltin bis(isooctyl
mercaptoacetate)
DIR
SML(T) = 0.04 mg/kg
(17) (expressed as Tin)
2
Di-n-octyltin bis(ethyl
maleate)
Same 64840
EFSA/SCF_OP
10_en.pdf
Group-TDI: 0.0006 mg/kg bw (as Sn) for all
di-n-octyltin derivatives.
See references for 50480.
http://europa.eu.int/comm/food/fs/sc/scf/out
41_en.pdf
Group-TDI: 0.0006 mg/kg bw (as Sn) for all
di-n-octyltin derivatives.
See references for 50480.
http://europa.eu.int/comm/food/fs/sc/scf/out
41_en.pdf
Group-TDI: 0.0006 mg/kg bw (as Sn) for all
di-n-octyltin derivatives.
See references for 50480.
http://europa.eu.int/comm/food/fs/sc/scf/out
41_en.pdf
Group-TDI: 0.0006 mg/kg bw (as Sn) for all
di-n-octyltin derivatives.
See references for 50480.
http://europa.eu.int/comm/food/fs/sc/scf/out
41_en.pdf
Group-TDI: 0.0006 mg/kg bw (as Sn) for all
di-n-octyltin derivatives.
See references for 50480.
http://europa.eu.int/comm/food/fs/sc/scf/out
41_en.pdf
Group-TDI: 0.0006 mg/kg bw (as Sn) for
dioctyltin stabilisers (REF_N 50480)
Group-TDI = 0.02 mg/kg b.w. (as Sn) for
monooctyltin stabilisers (REF_N 67760)
Available: migration data; several subacute
studies in rats and dogs (performed with
MOTTG, DOTTG, MOTC, DOTC and
formulation of MOTC and DOTC); several
semichronic studies in rats and dogs
(performed with MOTTG, DOTTG and
formulation of MOTTG and DOTTG); 2year rat and dog studies (performed with
DOTTG and formulation of MOTC and
171
PL
+
+
+
+
+
+
CT
REF_N
CAS_N
50560
-
50640
50720
NAME
Di-n-octyltin 1,4butanediol
bis(mercaptoacetate)
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
DIR
SML(T) = 0.04 mg/kg
(17) (expressed as Tin)
2
003648-18-8 Di-n-octyltin dilaurate
DIR
SML(T) = 0.04 mg/kg
(17) (expressed as Tin)
2
015571-60-5 Di-n-octyltin dimaleate
DIR
SML(T) = 0.04 mg/kg
2
172
EFSA/SCF_OP
DOTC); gene mutation assays in bacteria
(negative) (performed with MOTC, DOTC
and formulation of MOTTG and DOTTG);
gene mutation assays in cultured mammalian
cells (negative) (performed with MOTC and
DOTC); in vitro UDS assay (negative)
(performed with DOTC); in vitro covalent
DNA binding assay (negative) (performed
with DOTC); micronucleus assays
(negative; however, it was noted that no
cytotoxicity was observed when performed
with MOTC) (negative with formulation
with MOTTG and DOTTG); in vivo SCE
assay (negative) (performed with DOTC); 2generation reproduction study in rats
(performed with formulation of MOTTG
and DOTTG); teratogenicity study in rats
(performed with formulation of MOTTG
and DOTTG); teratogenicity study in rabbits
(performed with formulation of MOTTG
and DOTTG).
(RIVM SDS, October 1998 =
CS/PM/3255/50480/67760).
Remark for Commission: no analytical
method is available.
(Adopted at the 118th SCF meeting) (23
September 1999)
http://europa.eu.int/comm/food/fs/sc/scf/out
41_en.pdf
Group-TDI: 0.0006 mg/kg bw (as Sn) for all
di-n-octyltin derivatives.
See references for 50480.
http://europa.eu.int/comm/food/fs/sc/scf/out
41_en.pdf
Group-TDI: 0.0006 mg/kg bw (as Sn) for all
di-n-octyltin derivatives.
See references for 50480.
http://europa.eu.int/comm/food/fs/sc/scf/out
41_en.pdf
Group-TDI: 0.0006 mg/kg bw (as Sn) for all
PL
+
+
+
CT
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
(17) (expressed as Tin)
50800
-
Di-n-octyltin dimaleate,
esterified
DIR
SML(T) = 0.04 mg/kg
(17) (expressed as Tin)
2
50880
-
Di-n-octyltin dimaleate,
polymers (n=2-4)
DIR
SML(T) = 0.04 mg/kg
(17) (expressed as Tin)
2
50960
069226-44-4 Di-n-octyltin
ethyleneglycol
bis(mercaptoacetate)
DIR
SML(T) = 0.04 mg/kg
(17) (expressed as Tin)
2
51040
015535-79-2 Di-n-octyltin
mercaptoacetate
DIR
SML(T) = 0.04 mg/kg
(17) (expressed as Tin)
2
51120
-
DIR
SML(T) = 0.04 mg/kg
(17) (expressed as Tin)
2
51160
000123-91-1 Dioxane
Di-n-octyltin
thiobenzoate 2ethylhexyl
mercaptoacetate
Same 16420
6A
173
EFSA/SCF_OP
di-n-octyltin derivatives.
See references for 50480.
http://europa.eu.int/comm/food/fs/sc/scf/out
41_en.pdf
Group-TDI: 0.0006 mg/kg bw (as Sn) for all
di-n-octyltin derivatives.
See references for 50480.
http://europa.eu.int/comm/food/fs/sc/scf/out
41_en.pdf
Group-TDI: 0.0006 mg/kg bw (as Sn) for all
di-n-octyltin derivatives.
See references for 50480.
Evaluated in accordance with the previous
guidelines. Decision endorsed despite lack
of compliance with recent guidelines, in the
light of the very low group t-TDI.
(CS/PM/2632).
http://europa.eu.int/comm/food/fs/sc/scf/out
41_en.pdf
Group-TDI: 0.0006 mg/kg bw (as Sn) for all
di-n-octyltin derivatives.
See references for 50480.
http://europa.eu.int/comm/food/fs/sc/scf/out
41_en.pdf
Group-TDI: 0.0006 mg/kg bw (as Sn) for all
di-n-octyltin derivatives.
See references for 50480.
http://europa.eu.int/comm/food/fs/sc/scf/out
41_en.pdf
Group-TDI: 0.0006 mg/kg bw (as Sn) for all
di-n-octyltin derivatives.
See references for 50480.
http://europa.eu.int/comm/food/fs/sc/scf/out
41_en.pdf
IARC evaluation: group IIb carcinogen. EU
classification: Category 3 carcinogen.
Primarily to be evaluated as monomer, also
used as additive, hence cross reference. As
contaminant (e.g. 46720) in finished
products, dioxane should not be detectable
PL
+
+
+
+
+
+
CT
REF_N
CAS_N
NAME
SYNONIM
51200
000126-58-9 Dipentaerythritol
Same 16480
51300
000138-86-3 Dipentene
Same 16510
51440
015647-08-2 Diphenyl 2-ethylhexyl
phosphite
007144-65-2 o-Diphenyl glycidyl
ether
000102-06-7 Diphenylguanidine
026401-27-4 Diphenyl isooctyl
phosphite
000127-63-9 Diphenyl sulphone
51470
51500
51520
51570
DIR
RESTRICTIONS
AND
SPECIFICATIONS
DIR
2
8
Same 72560
Same 16650
SCF
List
DIR
SML(T) = 3 mg/kg
(25)
EFSA/SCF_OP
in food or food simulants by an appropriate
sensitive method.
Group TDI: 1 mg/kg b.w. (with
pentaerythritol).
(SCF, 17th Series, 1986).
Data made available for assessment of
chewing gum not available for this group.
PL
+
+
8
+
D
+
D
8
+
+
3
R: 3 mg/kg of food
Available: migration data; log Po/w; gene
mutation assay in bacteria (negative);
chromosomal aberration assay in cultured
mammalian cells (negative); gene mutation
assay in cultured mammalian cells
(negative); 4-week oral rat study; 3-months
oral rat study.
(RIVM/TNO SDS, April 1999 =
CS/PM/2651 REV. II/51570).
+
(Adopted at the 118th SCF meeting) (23
September 1999)
http://europa.eu.int/comm/food/fs/sc/scf/out
41_en.pdf
51600
51680
51700
003375-11-9 Diphenylsulphone-3,3'disulphonylhydrazide
000102-08-9 N,N'-Diphenylthiourea
147315-50-2 2-(4,6-Diphenyl-1,3,5triazin-2-yl)-5(hexyloxy)phenol
Same 91400
6A
DIR
SML = 3 mg/kg
2
DIR
SML = 0.05 mg/kg
3
174
+
TDI: 0.05 mg/kg b.w.
28-day, 1-year and 2-year oral rat studies.
(RIVM January 1967 and May 1973).
R = 0.05 mg/kg of food.
Available: Adequate migration data, three in
vitro mutagenicity assays.
(RIVM/ISS/TNO SDS, November 1996 =
CS/PM/2748).
+
+
CT
REF_N
51760
51840
51870
51900
51920
51930
51932
51933
51935
51938
51940
51950
51975
CAS_N
NAME
025265-71-8 Dipropyleneglycol
and 00011098-5
027138-31-4 Dipropyleneglycol
dibenzoate
SYNONIM
DIR
Same 39750
DIR
RESTRICTIONS
AND
SPECIFICATIONS
034590-94-8 Dipropyleneglycol
Same 16670
monomethyl ether
028519-02-0 Disodium dodecyl
Same 52240
diphenylether
disulphonate
007558-79-4 Disodium hydrogen
phosphate
055963-33-2 Distarch phosphate
(=E1412)
068130-14-3 Distarch phosphate (=
E1414)
064741-88-4 Distillates (petroleum),
solvent-refined heavy
paraffinic
064741-89-5 Distillates (petroleum),
solvent-refined light
paraffinic
068131-89-5 Distillates (petroleum),
steam cracked, polymers
with ethylene-manuf,-byproduct piperylene-cut
alkenes
000540-09-0 Diundecyl ketone
Diurethans arising from
hexamethylene
diisocyanate and
alcohols aliph., monoh.,
sat. (C2-C20)
000112-53-8 1-Dodecanol
Same 16701
SCF
List
EFSA/SCF_OP
CT
+
2
t-TDI: 1,5 mg/kg b.w.
(SCF, 6th Series, 1978).
+
7?
Available: 3 month oral rat and dog studies
(inadequate), metabolism, Ames test and
migration data.
(RIVM 06-09-88; Velsicol 14-09-1988).
Needed: 3 month oral rat study chromosome
aberration in vitro, gene mutation in
mammalian cells.
Data inadequate.
+
8
+
8/D
+
D
+
W
+
W
+
W
+
W
+
W
+
8
9
3
175
PL
+
+
See references for the same substance in
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
monomer list.
51985
52000
52080
52160
52210
52240
52320
52400
52480
52560
52565
52640
52645
009002-92-0 alpha-n-DodecanolSame 77737
omegaand 77920
hydroxypoly(oxyethylen
e)
027176-87-0 Dodecylbenzenesulphoni
c acid
026264-05-1 Dodecylbenzenesulphoni
c acid, isopropylamine
salt
025155-30-0 Dodecylbenzenesulphoni
c acid, sodium salt
000112-55-0 n-Dodecylmercaptan
028519-02-0 Dodecylphenoxybenzene Same 51900
disulphonic acid,
and 86880
disodium salt
052047-59-3 2-(4Dodecylphenyl)indole
000143-00-0 Dodecylsulphuric acid,
diethanolamine salt
004722-98-9 Dodecylsulphuric acid,
monoethanolamine salt
Dodecylsulphuric acid,
salts
000151-21-3 Dodecylsulphuric acid,
sodium salt
016389-88-1 Dolomite
010436-08-5 cis-11-Eicosenamide
9/D
DIR
SML = 30 mg/kg
2
+
TDI: 0.5 mg/kg b.w.
Two 2-year oral rat studies, mutagenicity
studies.
(RIVM Summary report March 1965).
+
8
+
D
+
W
+
DIR
SML = 0.06 mg/kg
Same 47630
2
8
Same 67460
DIR
DIR
176
TDI: 0.001 mg/kg b.w.
A 90-day oral rat study.
(Inst. f. Biol. Forsch. Koln, report 1976).
For dodecylsulphuric acid
L3. Toxicologically acceptable.
Same references as for 34281.
+
+
+
+
+
D
For diethanolamine
L8. Not in contact with food containing
nitrite.
Covered by 67441.
+
D
Covered by 34295.
+
+
D
Covered by 34281.
+
+
3
3
Inert material. Purity to be specified.
Hydrolyses to innocuous substances.
Available: specific migration in 3% acetic
acid and 15% ethanol < 0.04 mg/kg, in olive
oil maximum 2.8 mg/kg into food;
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
comparable with oleamide and erucamide
and thus complete hydrolysis to be expected
in intestinal fluid in fatty acid and ammonia;
gene mutation assay in bacteria (negative).
(RIVM/TNO SDS, March 1999 =
CS/PM/3269/52645).
(Adopted at the 118th SCF meeting) (23
September 1999)
http://europa.eu.int/comm/food/fs/sc/scf/out
41_en.pdf
52650
52660
52720
52730
000112-79-8 Elaidic acid
Epichlorohydrinpolyamide, copolymer
029564-58-7 2,3-Epoxypropyl
methacrylate-methyl
methacrylate- styrene,
copolymers
000112-84-5 Erucamide
000112-86-7 Erucic acid
52780
-
52800
000064-17-5 Ethanol
52880
023676-09-7 4-Ethoxybenzoic acid,
ethyl ester
52960
035001-51-5 2-Ethoxy-5-tert-butyl-2'-
52700
8
9
(Adopted at 111th SCF meeting (18-19
March 1998)
9
Same 16775
DIR
DIR
3
3
Esters of 12hydroxystearic and
stearic acid with C20guerbet alcohols
7?
Same 16780
DIR
DIR
1
SML = 3.6 mg/kg
2
8
177
+
+
+
See the references for 68960.
Occurs in small amounts in some vegetable
oils.
Available: 2 mutagenicity studies (negative)
and 4-week oral rat study (insufficient for
the substances to be used for food contact
materials).
Needed: detailed information on the method
of analysis and on decomposition
products, gene mutation in mammalian cells,
3-month oral rat study, bioaccumulation,
information on decomposition products from
high temperature usage.
(RIVM 1994-10-25 = CS/PM/2581).
Acceptable.
(SCF, 11th Series, 1981).
t-TDI: 0.06 mg/kg b.w.
Available: 28-days oral rat study and 3
mutagenicity tests.
(RIVM, 17th March 1987).
Needed: 90-day oral study.
+
+
+
+
+
+
+
+
+
REF_N
53040
53080
53120
53200
53230
53232
53235
53238
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
ethyl-4'-tert-butyloxalic
acid bisanilide
035001-52-6 2-Ethoxy-5-tert-butyl-2'ethyloxalic acid
bisanilide (=2-ethoxy-5tert-butyl-2'ethyloxanilide)
Ethoxycarbonylmethyl
diethylphosphonate
065816-20-8 N-(4Ethoxycarbonylphenyl)N'ethyl-N'phenylformamidine
023949-66-8 2-Ethoxy-2'ethyloxanilide
SCF
List
EFSA/SCF_OP
8
7
SML = 30 mg/kg
-
Ethyl acrylate-ethylenemethyl acrylate-methyl
methacrylate-vinyl
acetate and/or vinyl
benzoate, copolymers
026376-86-3 Ethyl acrylate-2ethylhexyl acrylate,
copolymer
Ethyl acrylatemethacrylic acidethyleneglycol
monomethacrylatepolyethyleneglycol
(EO=50) nonyl phenyl
ether-toluene
diisocyanate, copolymer
(Mw=50000-500000)
Ethyl acrylatemethacrylic acidpolyethyleneglycol
(EO=25) alkyl(C32)
ether, copolymer (Mw=
2
Available: migration data, 4-week oral rat
study, 2 mutagenicity studies negative.
Needed: 90-day oral study, gene mutation in
mammalian cells. (CS/PM/1709)
+
+
TDI: 0.5 mg/kg b.w.
90-day and 2-year oral rat studies.
(Sandoz reports 1973 and 1975).
9
+
+
Available: Uses (as coating additive).
+
Needed: Structure of the polymer, Mw
distribution curve, toxicity testing in
accordance with the guidelines on polymeric
additives (version updated to 15 December
1995, CS/PM/2632).
(Adopted at 111th SCF meeting (18-19
March 1998)
D
178
+
+
W
7?
CT
+
W8
DIR
PL
+
REF_N
53240
53255
CAS_N
NAME
DIR
RESTRICTIONS
AND
SPECIFICATIONS
100000-500000)
072275-83-3 Ethyl acrylatemethacrylic acidpoly(ethyleneglycol)lauryl methacrylate
ether, terpolymer
000100-41-4 Ethylbenzene
53270
037205-99-5 Ethylcarboxymethylcellu
lose
53280
009004-57-3 Ethylcellulose
53310
-
53360
000110-31-6
53440
005518-18-3
53520
000110-30-5
53540
000107-15-3
53570
027014-42-2 Ethylenediamineand 025214- ethylene oxide and/or
63-5
propylene oxide,
copolymer
000060-00-4 Ethylenediaminetetraacet
ic acid
53600
SYNONIM
Ethylene-acrylic acid
and/or maleic anhydride
and/or vinyl acetate,
copolymers
N,N'Ethylenebisoleamide
N,N'Ethylenebispalmitamide
N,N'Ethylenebisstearamide
Ethylenediamine
SCF
List
7?
3
Same 16925
DIR
2
DIR
2
EFSA/SCF_OP
PL
Needed: In first instance, information on the
nature of the residue.
(TNO, SDS, 1992 = CS/PM/2582 /53240.
(Adopted at 111th SCF meeting (18-19
March 1998)
R: 0.01 mg/kg b.w. based on allowing 1/10
of TDI (= 1 mg/kg.b.w.) for food packaging
uses.
Available: 6-month rat inhalation study,
mutagenicity studies.
Group TDI: not specified based on group
ADI (=not specified) for certain modified
celluloses.
(JECFA 35 M., 1989).
Group TDI: not specified based on Group
ADI (=not specified) for certain modified
celluloses.
(JECFA 35M., 1989).
+
D
+
+
Chemically similar to 53520 in list 3.
+
DIR
3
+
DIR
3
90-day oral monkey study. Chemically
similar to N'N-ethylene bisstearammide.
Two inadequate 2-year oral rat studies and
low migration (Hoechst report 13/05, 1963).
TDI: 0.2 mg/kg b.w.
Two 90-day oral rat studies.
(ICI report, April 1975).
9
DIR
2
179
+
+
3
2
+
+
DIR
Same 15272
and 16960
CT
+
+
+
+
+
TDI: 2.5 mg/kg b.w. as calcium disodium
salt on the basis of JECFA ADI for calcium
disodium EDTA.
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
53610
054453-03-1 Ethylenediaminetetraacet
ic acid, copper salt
53650
000107-21-1 Ethyleneglycol
53670
032509-66-3 Ethyleneglycol bis [3,3- Same 38530
bis(3-tert-butyl-4hydroxyphenyl)butyrate]
2
53680
53685
53760
53820
see 53610
000624-04-4 Ethyleneglycol dilaurate Same 63360
see 53670
000110-80-5 Ethyleneglycol
Same 16996
monoethyl ether
D
D
D
2
53840
53845
see 54005
004219-48-1 Ethyleneglycol
monolaurate
000109-86-4 Ethyleneglycol
monomethyl ether
Same 63440
D
D
Same 17002
2
53860
Same 16990
and 16778
DIR
SML(T) = 30 mg/kg
(7) (expressed as
Copper)
2
DIR
SML(T) = 30 mg/kg
(3)
2
180
EFSA/SCF_OP
(JECFA 17 M., 1973; SCF 4th Series, 1977)
R= 5 mg/person (as Copper).
based on (a) for copper same references as
30080 and (b) for calcium disodium EDTA
(=2.5 mg/kg.bw, SCF, 4th Series, 1977).
Group TDI = 0.5 mg/kg b.w. (with
diethyleneglycol).
(SCF, 17th Series, 1986).
TDI = 0.1 mg/kg b.w.
Available: acute oral toxicity data; 90-day
oral rat study; 16-week oral rat study (after
in utero exposure); 90-day oral dog study; 2year oral dog study; 2.5 year oral rat study
(combined chronic/ carcinogenicity study);
one-generation reproduction study with rats;
three negative mutagenicity studies.
(RIVM SDS, January 1998 = CS/PM/3157/
53670).
REMARK for Commission: No method of
analysis is available for the enforcement of
an SML.
(Adopted at 114th SCF meeting) (10
December 1998)
http://europa.eu.int/comm/food/fs/sc/scf/out
20_en.pdf
Group t-TDI : 0.05 mg/kg b.w. (with
15780=48050, 16993=53765, 16996=53820,
16999, 17002=53860, 30015, 30120, 30200,
48030).
See references for 16996.
PL
+
+
+
+
+
+
+
+
+
+
+
+
+
Group t-TDI : 0.05 mg/kg b.w. (with
15780=48050, 16993=53765, 16996=53820,
16999, 17002=53860, 30015, 30120, 30200,
CT
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
48030).
(See references for 16996)
53900
53920
53930
53950
53970
53985
54000
54005
54020
54040
54060
54080
54085
54100
54120
050586-59-9 Ethyleneglycoltrimethylolpropane,
copolymer
see 54120
025038-37-3 Ethylene-1,4-hexadienepropylene, copolymer
000151-56-4 Ethyleneimine
Same 17005
009006-26-2 Ethylene-maleic
anhydride, copolymer
009010-79-1 Ethylene oxidevinylpyrrolidone,
copolymer
see 54170
005136-44-7 Ethylene-Npalmitamide-N'stearamide
Ethylene-propylene,
copolymer
Ethyleneureaformaldehydeisophthalic acid diamide,
copolymer
024937-78-8 Ethylene-vinyl acetate,
copolymer
see 54260
Ethylene-vinyl benzoate,
copolymer
Ethylene-vinyl esters of
sat., aliph., monocarb.,
acids (C2-C18),
copolymer
000149-57-5 2-Ethylhexanoic acid
Same 17040
9
+
D
D
+
+
4
DIR
+
D
+
9
+
D
3
+
+
Chemically similar to 53520 in list 3.
D
+
9
+
D
+
D
9
+
+
9
+
6B
181
See references for same substance in
monomer report.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg of food,
peroxisome proliferation study too.
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
54130
024593-34-8 2-Ethylhexanoic acid,
cerium salt
6B
54140
000136-52-7 2-Ethylhexanoic acid,
cobalt(II) salt
6B
EFSA/SCF_OP
PL
L6B for 2-ethylhexanoic acid
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg of food,
peroxisome proliferation study too.
L8 for cerium.
L3 for Cobalt.
R: 0.05 mg/kg of food (as Co).
(RIVM, summary data, 0ctober
1992=CS/PM/1707).
CT
+
+
+
L6B for 2-ethylhexanoic acid.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg of food,
peroxisome proliferation study too.
54160
54170
54190
54220
see 54300
093777-46-9 2-Ethylhexanoic acid,
decyl ester
D
6B
015956-58-8 2-Ethylhexanoic acid,
manganese salt
6B
022464-99-9 2-Ethylhexanoic acid,
zirconium salt
6B
L0 for n-decanoic acid.
L6B for 2-ethylhexanoic acid.
Needed: toxicological data depending on
migration level (SCF guidelines) and, if
migration exceeds 0.05 mg/kg of food,
peroxisome proliferation study too.
L2 for the Mn.
Group TDI: 0.01 mg/kg b.w. (as Mn).
See references for 30180 in L2 in this report.
L6B for 2-ethylhexanoic acid.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg of food,
peroxisome proliferation study too.
L6B for 2-ethylhexanoic. Needed: same as
17040.
L7 for zirconium.
Available: Oral life span study in mice and
rats and oral studies in rabbits and dogs
182
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
(reports not seen).
Needed: migration data and toxicity data
according to SCF guidelines.
(RIVM doc; (CS/PM/2091)).
54240
54245
54260
see 54380
2-Ethylhexyl maleatevinyl acetate copolymer
009004-58-4 Ethylhydroxyethylcellulo
se
D
9
DIR
2
54270
-
Ethylhydroxymethylcellu
lose
DIR
2
54280
-
Ethylhydroxypropylcellu
lose
DIR
2
54300
118337-09-0 2,2'-Ethylidenebis(4,6di-tert-butyl phenyl)
fluorophosphonite
54320
54380
54400
54420
see 54420
008047-99-2 NEthyltoluenesulphonami
de
035835-94-0 Ethyltriphenylphosphoni
um acetate
see 54450
000121-32-4 Ethylvanillin
54450
-
54480
-
54395
Fats and oils, from
animal or vegetable food
sources
Fats and oils,
hydrogenated, from
animal or vegetable food
DIR
SML = 6 mg/kg
2
+
+
Group TDI: not specified based on Group
ADI (=not specified) for certain modified
celluloses.
(JECFA 35 M., 1989).
Group TDI : not specified based on Group
ADI (=not specified) for certain modified
celluloses.
(JECFA, 35 M., 1989).
Group TDI : not specified based on group
ADI (=not specified) for certain modified
celluloses.
(JECFA, 35 M., 1989).
TDI = 0.1 mg/kg b.w.
3 month oral dog and 3 month combined
oral fertility study in rats. Mutagenicity tests
negative.
(doc. CS/PM/841)
D
8
+
+
+
+
+
+
8
D
1
+
DIR
3
ADI : 5 mg/kg b.w.
(JECFA 35 M., 1990).
Food fat.
DIR
3
Similar to food fats.
183
+
+
+
+
+
+
+
REF_N
54560
54640
54650
54660
54710/1
54720
54730/1
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
sources
Fats and oils, refined,
arising from bones, with
unsaponifiable matter up
to 1%
Fats and oils, sulphated,
derived from animal or
vegetable sources
Fats and oils,
sulphonated, derived
from animal or vegetable
sources
Fatty acids of coconout Same 43515
oil, esters with choline
and 63400
chloride
061790-12-3 Fatty acids, tall oil
Same 17230
and 54710/0
see 54650
Fatty acids, tall oil,
cobalt salts
SCF
List
EFSA/SCF_OP
PL
9
+
9
+
9
+
D
http://europa.eu.int/comm/food/fs/sc/scf/out
16_en.html
+
3
D
3
CT
+
+
+
L3 for fatty acids tall oil.
+
L3 for Cobalt.
R: 0.05 mg/kg of food (as Co).
(RIVM, summary data, October
1992=CS/PM/1707).
54766
54840
54860
54880
115438-43-2 Fatty acids, tallow,
hydrogenated, 2ethylhexylester
064755-02-8 Fatty acids, tallow,
lithium salts
see 54860
Fibers, natural, synthetic
or metallic
007782-41-4 Fluorine
016961-83-4 Fluorosilicic acid
000050-00-0 Formaldehyde
Same 17260.
54900
009017-33-8 Formaldehyde-
54768
54800
54820
9
+
+
DIR
SML(T) = 15 mg/kg
(22)
D
D
+
+
W
7
3
+
+
+
+
+
+
9
184
Needed: use levels, migration data.
See references for the same substance in
monomer list.
(SCF, 17th Series, 1986).
REF_N
54930
54960
CAS_N
NAME
SYNONIM
naphthalenesulphonic
acid, copolymer
025359-91-5 Formaldehyde-1Same 80330
naphthol copolymer
[=poly(1hydroxynaphthylmethane
)]
DIR
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SML = 0.05 mg/kg
3
55040
Formaldehydetoluenesulphonamide,
copolymer
Formaldehyde-2,4,6triamino-1,3,5-triazine,
copolymer
009011-05-6 Formaldehyde-urea,
copolymer
000064-18-6 Formic acid
Same 17275
DIR
1
55120
000110-17-8 Fumaric acid
Same 17290
DIR
1
55160
55190
55200
000098-00-0 Furfurol
Same 17505
029204-02-2 Gadoleic acid
Same 17510
001166-52-5 Gallic acid, dodecyl ester
DIR
DIR
8
0
1
55280
001034-01-1 Gallic acid, octyl ester
DIR
SML(T) = 30 mg/kg
(34)
1
55360
000121-79-9 Gallic acid, propyl ester
DIR
SML(T) = 30 mg/kg
(34)
1
55440
55520
55600
55630
55680
009000-70-8
000526-95-4
000110-94-1
DIR
DIR
DIR
54970
55030
001338-51-8
and 02503571-6
009003-08-1
SCF
List
Gelatin
Glass fibers
Glass microballs
Gluconic acid (= E574)
Glutaric acid
Same 18010
SML(T) = 30 mg/kg
(34)
185
PL
Available: Adequate migration data;
mutagenicity studies on the polymeric
additive itself (negative); mutagenicity data
on the
monomer 1-naphthol (negative).
(RIVM/TNO SDS, October 1997 = CS/PM/
3086/54930).+
+
9
+
D
+
D
+
0
3
3
W
0
DIR
EFSA/SCF_OP
Group ADI: 3 mg/kg b.w. for formic acid
and ethyl formate.
(JECFA 17 M., 1973).
ADI: 6 mg/kg b.w.
(SCF, 25th Series, 1990).
Group ADI: 0.5 mg/kg b.w. for gallic acid,
octyl ester and gallic acid, propyl ester.
(SCF, 22th Series, 1989).
Group ADI: 0.5 mg/kg b.w. for gallic acid,
dodecyl ester and gallic acid, propyl ester.
(SCF, 22th Series, 1989).
Group ADI: 0.5 mg/kg b.w. for gallic acid,
dodecyl ester and gallic acid, octyl ester.
(SCF, 22th Series, 1989).
Inert material.
Inert material.
+
CT
+
+
+
+
+
+
+
+
+
+
+
+
REF_N
55760
CAS_N
NAME
SYNONIM
55920
029733-18-4 Glutaric acid, diisodecyl Same 18040
ester
028880-25-3 Glutaric acid, diisooctyl
ester
000056-81-5 Glycerol
Same 18100
56000
025395-31-7 Glycerol diacetate
56020
56040
56055
56070
56080
099880-64-5
027638-00-2
053563-63-6
025637-84-7
Glycerol dibehenate
Glycerol dibutyrate
Glycerol dilaurate
Glycerol dimyristate
Glycerol dioleate
56120
56160
56240
56320
026657-95-4
026402-29-9
027902-24-5
001323-83-7
Glycerol dipalmitate
Glycerol dipropionate
Glycerol diricinoleate
Glycerol distearate
56360
-
55840
56400
56480
56485
56486
Glycerol esters with
acetic acid
Glycerol, esters with
acids, aliph., monocarb.
(more than C6)
Glycerol, esters with
acids, aliph., monocarb.,
hydroxylated (C12-C20)
091052-28-7 Glycerol, esters with
acids, aliph.,sat.(C14C18) and acids, aliph.
unsat (C16-C18)
Glycerol, esters with
acids, aliph.,sat., linear
with an even number of
DIR
RESTRICTIONS
AND
SPECIFICATIONS
DIR
SCF
List
+
8
+
1
3
3
3
3
1
3
3
3
1
Same 89240
Group ADI: not specified for glycerol,
glycerol diacetate, glycerol triacetate and
glycerol monoacetate.
(SCF, 11th Series, 1981).
Group ADI: not specified for glycerol,
glycerol diacetate, glycerol triacetate and
glycerol monoacetate.
(SCF, 11th Series, 1981).
Toxicologically acceptable.
Toxicologically acceptable.
Toxicologically acceptable.
Toxicologically acceptable.
ADI: not specified.
(JECFA 17 M., 1973).
Toxicologically acceptable.
Toxicologically acceptable.
Toxicologically acceptable.
ADI: not specified.
(JECFA 17 M., 1973).
DIR
DIR
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
9
+
9
+
Toxicologically acceptable.
CT
+
9
3
186
PL
8
1
DIR
EFSA/SCF_OP
+
+
REF_N
CAS_N
56487
-
56490
-
56495
-
56500
-
56510
-
56520
-
56535
-
56540
-
56550
-
56560
56565
-
56570
-
56580
-
56585
-
56600
NAME
SYNONIM
carbon atoms (C14-C18)
and with acids aliph.,
unsat., linear, with an
even number of carbon
atoms (C16-C18)
Glycerol esters with
butyric acid
Glycerol, esters with
erucic acid
Glycerol esters with 12hydroxystearic acid
Glycerol, esters with
lauric acid
Glycerol, esters with
linoleic acid
Glycerol, esters with
myristic acid
Glycerol, esters with
nonanoic acid
Glycerol, esters with
oleic acid
Glycerol, esters with
palmitic acid
see 56600
Glycerol, esters with
Same 56535
pelargonic acid
Glycerol, esters with
propionic acid
Glycerol, esters with
ricinoleic acid
Glycerol, esters with
stearic acid
026446-35-5 Glycerol monoacetate
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
DIR
PL
CT
+
+
+
DIR
3
Toxicologically acceptable.
+
DIR
3
Toxicologically acceptable.
+
DIR
3
Toxicologically acceptable.
+
+
DIR
3
Toxicologically acceptable.
+
+
DIR
3
Toxicologically acceptable.
+
+
DIR
3
Toxicologically acceptable.
+
+
DIR
3
Toxicologically acceptable.
+
+
DIR
3
Toxicologically acceptable.
+
+
D
D
D
+
+
+
+
+
+
+
+
+
+
+
+
DIR
DIR
3
SCF_List: 3
Restriction: none. In small doses
metabolised similarly to food fats.
See SCF evaluation in the website:
http://europa.eu.int/comm/food/fs/sc/scf/out
181_en.pdf
DIR
1
187
Group ADI: not specified for glycerol,
glycerol diacetate, glycerol triacetate and
glycerol monoacetate.
REF_N
CAS_N
56610
56640
56720
56760
030233-64-8
026999-06-4
026402-23-3
001323-43-9
56780
56800
027215-38-9
030899-62-8
56840
56880
56960
027214-38-6
026402-26-6
025496-72-4
57040
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
PL
CT
3
3
3
3
(SCF, 11th Series, 1981).
Toxicologically acceptable.
Toxicologically acceptable.
Toxicologically acceptable.
Toxicologically acceptable.
+
+
+
+
+
+
+
3
3
Toxicologically acceptable.
Chemically similar to natural fats.
+
+
+
+
+
+
+
+
+
3
Toxicologically acceptable.
Toxicologically acceptable.
ADI: not specified.
(JECFA 17 M., 1973).
Group TDI: not specified. Similarity with
the citric acid esters.
(JECFA 17 M., 1973).
ADI: not specified for citric and fatty acid
esters of glycerol.
(SCF, 7th Series, 1978).
Toxicologically acceptable.
Group TDI= not specified. Similarity with
the citric acid esters.
(JECFA 17 M., 1973)
ADI: not specified for citric and fatty acid
esters of glycerol.
(SCF, 7th Series, 1978).
Toxicologically acceptable.
+
+
3
Toxicologically acceptable.
+
+
1
ADI: not specified.
(JECFA 17 M., 1973).
Group TDI= not specified. Similarity with
the citric acid esters.
(JECFA 17 M., 1973).
ADI: not specified for citric and fatty acid
esters of glycerol.
(SCF, 7th Series, 1978).
+
+
Glycerol monobehenate
Glycerol monobutyrate
Glycerol monohexanoate
Glycerol mono(12hydroxystearate)
Glycerol monolaurate
Glycerol monolaurate
diacetate
Glycerol monomyristate
Glycerol monooctanoate
Glycerol monooleate
DIR
DIR
3
3
1
-
Glycerol monooleate,
ester with ascorbic acid
DIR
2
57120
-
Glycerol monooleate,
ester with citric acid
DIR
1
57150
57200
026657-96-5 Glycerol monopalmitate
Glycerol monopalmitate,
ester with ascorbic acid
DIR
3
2
57280
-
DIR
1
57360
57520
026894-50-8 Glycerol
monopropionate
001323-38-2 Glycerol
monoricinoleate
031566-31-1 Glycerol monostearate
57600
-
Glycerol monostearate,
ester with ascorbic acid
DIR
2
57680
-
Glycerol monostearate,
ester with citric acid
DIR
1
57440
DIR
DIR
Glycerol monopalmitate,
ester with citric acid
Same 18115
188
EFSA/SCF_OP
+
+
+
+
+
+
+
+
REF_N
CAS_N
NAME
57760
000102-76-1 Glycerol triacetate
57800
57840
57880
58240
58300
018641-57-1 Glycerol tribehenate
000060-01-5 Glycerol tributyrate
Glycerol, triesters with
acids, aliph., monocarb.
(more than C6)
000620-67-7 Glycerol triheptanoate
000538-24-9 Glycerol trilaurate
068476-38-0 Glycerol trimontanate
000555-45-3 Glycerol trimyristate
000555-44-2 Glycerol tripalmitate
000139-45-7 Glycerol tripropionate
000139-44-6 Glycerol tris(12hydroxystearate)
000555-43-1 Glycerol tristearate
Glycine, salts
58310
58320
58400
000107-22-2 Glyoxal
007782-42-5 Graphite
009000-30-0 Guar gum
58480
009000-01-5 Gum arabic
58560
58600
58640
Gums, natural
012173-47-6 Hectorite
015655-33-1 2-Heptadecyl-4,4'bis(methylene stearate)1,3- oxazoline
000142-82-5 n-Heptane
000111-14-8 Heptanoic acid
025637-99-4 Hexabromocyclododecan
e
57920
57960
58000
58040
58060
58080
58160
58680
58720
58770
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
Same 93695
SCF
List
1
EFSA/SCF_OP
PL
CT
Group ADI: not specified for glycerol,
glycerol diacetate, glycerol triacetate and
glycerol monoacetate.
(SCF, 11th Series, 1981).
Toxicologically acceptable.
Toxicologically acceptable.
+
+
+
+
+
+
+
DIR
3
3
9
DIR
3
3
7
3
3
3
3
Toxicologically acceptable.
Toxicologically acceptable.
Needed: hydrolysis data.
Toxicologically acceptable.
Toxicologically acceptable.
Toxicologically acceptable.
Toxicologically acceptable.
+
+
+
+
+
+
+
+
+
Toxicologically acceptable.
ADI: acceptable.
(SCF, 25th Series, 1991).
+
+
+
DIR
3
1
D
3
1
+
+
+
+
DIR
DIR
DIR
1
+
+
Same 93810
Same 95260
Same 62040
Same 18120
9
W
7
8
3
5
DIR
189
Inert material.
ADI: not specified.
(SCF, 7th Series, 1978).
ADI: not specified.
(JECFA, 35 M., 1989).
+
+
+
+
+
Needed: report of 90-day oral study
(BIBRA).
Fatty acid from food.
[Some organobromo compounds have a
bioaccumulation potential and 1,2dibromoethane is a category 2 carcinogen
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
(EC classification).]
58800
58840
58880
58960
59040
59080
59120
59200
067845-93-6 Hexadecyl 3,5-di-tertSame 46800
butyl-4-hydroxybenzoate
029316-77-6 Hexadecyl methacrylateoctadecyl methacrylate,
copolymer
000123-03-5 Hexadecylpyridinium
chloride
000057-09-0 Hexadecyltrimethylamm Same 18330
onium bromide
009011-17-0 Hexafluoropropylenevinylidene fluoride,
copolymer (Mw>70.000)
166412-78-8 Hexahydrophthalatic
1,2acid, diisononyl ester
cyclohexane
dicarboxylic
acid, diison
023128-74-7 1,6-HexamethyleneSame 38780
bis(3-(3,5-di-tert-butyl4hydroxyphenyl)propiona
mide)
035074-77-2 1,6-Hexamethylenebis(3-(3,5-di-tert-butyl-4hydroxyphenyl)propionat
e)
59240
000124-09-4 Hexamethylenediamine
59280
000100-97-0 Hexamethylenetetramine Same 18670.
59330
59332
59360
000110-54-3 n-Hexane
Hexane (isomers)
000142-62-1 Hexanoic acid
D
W
+
8
DIR
SML = 6 mg/kg
2
3
+
TDI: 0.1 mg/kg b.w.
400-day oral rat study.
(RIVM report, September 1978).
Average Mw above 70000.
7
+
+
+
DIR
SML = 45 mg/kg
2
TDI: 0.75 mg/kg b.w.
2-year and 90-day oral rat studies,
teratogenicity studies in mice, rats, rabbits.
(RIVM report 88/678608/010, 1989-01-24).
+
+
DIR
SML = 6 mg/kg
2
TDI: 0.1 mg/kg b.w.
90-day oral rat and dog (plus 4-week
recovery period) studies and a 2-year oral
study.
(RIVM July 1975, report CBG 182/80928, 5
april 1982).
TDI: 0.04 mg/kg b.w.
See references for the same substance in
monomer report.
See references for the same substance in
monomer list.
+
+
Same 15274
and 18460
Same 18770
and 41800
+
2
DIR
SML(T) = 15 mg/kg
(22) (35)(expressed as
Formaldehyde)
3
8
9
0
DIR
190
+
+
+
+
+
+
+
REF_N
59440
59520
59600
59760
59815
59816
59817
59818
59819
59825
59840
59841
59842
59920
59935
59950
59980
59990
CAS_N
NAME
SYNONIM
2,8,14,18,24,30Hexaoxa-6,10,22,26tetrathio-7,9,23,25tetrastanna7,7,9,9,23,23,25,25-octa(n-dodecyl)spiro(15,15)hentriaconta
ne-3,13,19,29-tetraoxide
002425-77-6 2-Hexyldecanol
000107-41-5 Hexyleneglycol
Same 18850
and 22072
019569-21-2 Huntite
Hydrocarbon resins (for
memo.to be deleted later)
267233-58-9 Hydrocarbon resins,
aliphatic
267233-95-4 Hydrocarbon resins,
aromatic
267233-62-5 Hydrocarbon resins,
cyclodiene
267233-74-9 Hydrocarbon resins,
hydrogenated
Hydrocarbons, aliphatic
up to C8
Hydrocarbons, aliphatic,
(C10-C14) (b.p. 180-260
°C)
see 59935
see 59950
see 59980
Hydrocarbons (b.p. 180260 °C, hydrogenated)
Hydrocarbons (b.p. 180260 °C, conventional)
Hydrocarbon wax,
oxidized
007647-01-0 Hydrochloric acid
DIR
RESTRICTIONS
AND
SPECIFICATIONS
-
SCF
List
EFSA/SCF_OP
8
8
7
DIR
3
D
DIR
CT
+
Needed: purity, physicochemical state,
migration data.
Inert, insoluble material.
+
+
+
+
W
+
W
+
W
+
W
+
9
+
9
+
D
D
D
9
+
+
+
+
D
+
9
+
1
191
PL
ADI: not specified.
(SCF, 25th Series, 1991)
+
+
REF_N
60005
60020
60030
60060
CAS_N
NAME
Hydrochloric acid, salts
010026-04-7 Hydrochloric acid,
tetrasilicon salt
012072-90-1 Hydromagnesite
000123-31-9 Hydroquinone
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
PL
D
D
Deleted because the acid appears in the list.
+
+
DIR
3
D
Inert material. Purity to be specified.
+
+
Inert, insoluble material.
Group ADI: 10 mg/kg b.w. for ethyl, methyl
and propyl esters.
(SCF, 1st Series, 1975).
Group-TDI: 10 mg/kg bw based on group
ADI = 10 mg/kg bw for ethyl, methyl and
propyl esters.
Group ADI: 10 mg/kg b.w. for ethyl, methyl
and propyl esters.
(SCF, 1st Series, 1975).
Group ADI: 10 mg/kg b.w. for ethyl, methyl
and propyl esters.
(SCF, 1st Series, 1975).
TDI: 0.025 mg/kg b.w.
90-day oral rat study, 3 mutagenicity
studies.
(RIVM doc. 27 October 1987).
Group TDI: 0.5 mg/kg b.w. for 2-(2'hydroxy-3,5'-di-tert.butylphenyl)-5-chlorobenzotriazole and 2-(2'-hydroxy5'methylphenyl)benzotriazole.
Group TDI: 0.5 mg/kg b.w. for 2-(2'hydroxy-3'-tert.butyl-5'-methylphenyl)-5chlorobenzotriazole and 2-(2'-hydroxy-5'methyl phenyl)benzotriazole.
Group TDI: not specified based on Group
ADI (=not specified) for certain modified
celluloses.
(JECFA 35 M., 1989).
+
+
Same 15940,
18867 and
48620
60080
60160
012304-65-3 Hydrotalcite
000120-47-8 4-Hydroxybenzoic acid,
ethyl ester
DIR
DIR
3
1
60180
004191-73-5 4-Hydroxybenzoic acid,
isopropyl ester
DIR
2
60200
000099-76-3 4-Hydroxybenzoic acid,
methyl ester
DIR
1
60240
000094-13-3 4-Hydroxybenzoic acid,
propyl ester
DIR
1
60320
070321-86-7 2-[2-Hydroxy-3,5bis(1,1dimethylbenzyl)phenyl]b
enzotriazole
003896-11-5 2-(2'-Hydroxy-3'-tertbutyl-5'-methylphenyl)5-chlorobenzotriazole
DIR
SML = 1.5 mg/kg
2
DIR
SML(T) = 30 mg/kg
(19)
2
60480
003864-99-1 2-(2'-Hydroxy-3,5'-ditert-butylphenyl)-5chlorobenzotriazole
DIR
SML(T) = 30 mg/kg
(19)
2
60560
009004-62-0 Hydroxyethylcellulose
DIR
60640
000150-39-0 N-(2Hydroxyethyl)ethylenedi
aminetriacetic acid
60400
EFSA/SCF_OP
2
8
192
CT
+
+
+
+
+
+
+
+
+
+
+
+
+
REF_N
60800
60880
60960
61040
61055
61120
61200
61280
61340
61360
CAS_N
NAME
SYNONIM
065447-77-0 1-(2-Hydroxyethyl)-4hydroxy-2,2,6,6tetramethyl piperidinesuccinic acid, dimethyl
ester, copolymer
009032-42-2 Hydroxyethylmethylcell
ulose
Hydroxyethyloctadecyla
mine
000111-58-0 N-(2Same 69500
Hydroxyethyl)oleamide
000122-99-6 2-Hydroxyethyl phenyl
ether
009005-27-0 Hydroxyethyl starch
DIR
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SML = 30 mg/kg
DIR
-
070198-29-7 1-(2-Hydroxyethyl)2,2,6,6-tetramethyl-4hydroxypiperidine/succin
ic acid,copolymer
003293-97-8 2-Hydroxy-4-nhexyloxybenzophenone
000149-44-0 Hydroxymethanesulphini Same 70160
c acid, sodium salt
000131-57-7 2-Hydroxy-4methoxybenzophenone
DIR
SCF
List
EFSA/SCF_OP
PL
CT
2
TDI : 0.5 mg/kg b.w.
90-Day oral rat and dog studies, 2-year oral
rat study.
(HRC report CBG 237/92271, 10 May 1983)
+
+
2
Group TDI: not specified based on Group
ADI (=not specified) for certain modified
celluloses.
(JECFA 35 M., 1989).
+
+
8
+
8
+
8
+
2
Group TDI: not specified.
(JECFA 26 M., 1982).
9
DIR
SML(T) = 6 mg/kg
(15)
2
+
Group TDI: 0.1 mg/kg b.w.
See references for 4,4'dihydroxybenzophenone in list 2.
8
DIR
61390
037353-59-6 Hydroxymethylcellulose
DIR
61440
002440-22-4 2-(2'-Hydroxy-5'methylphenyl)benzotriaz
ole
DIR
SML(T) = 6 mg/kg
(15)
2
2
SML(T) = 30 mg/kg
(19)
193
2
+
Group TDI: 0.1 mg/kg b.w.
See references for 4,4'dihydroxybenzophenone in list 2.
Group TDI: not specified based on Group
ADI (=not specified) for certain modified
celluloses.
(JECFA 35 M., 1989).
Group TDI: 0.5 mg/kg b.w. for 2-(2'hydroxy-3'-tert.butyl-5'-methylphenyl)-5chlorobenzotriazole, 2-(2'-hydroxy-3,5'-ditert.butylphenyl)-5-chloro-benzotriazole and
2-(2'-hydroxy-5'methylphenyl)benzotriazole.
+
+
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
Several 90-day oral rat and dog studies and a
2-year oral rat study and 3-4 month oral
dosing of man.
(HRC report CBG 161/78164).
61480
61520
61600
-
Hydroxymethyl-1phospha-2,6,7trioxybicyclo(2.2.2)octan
e-3-(3,5-di-tert-butyl-4hydroxyphenyl)
propionate
004710-34-3 2Hydroxyoctadecanesulph
onic acid, sodium salt
001843-05-6 2-Hydroxy-4-noctyloxybenzophenone
DIR
61680
009004-64-2 Hydroxypropylcellulose
61760
009004-65-3 Hydroxypropylmethylcel Same 66700
lulose
61800
009049-76-7 Hydroxypropyl starch
61840
000106-14-9 12-Hydroxystearic acid
61880
078616-19-0 12-Hydroxystearic acid,
diester with glycerol
12-Hydroxystearic acid3-dimethylaminopropyl
amine, copolymer
12-Hydroxystearic acid,
esters with glycerol
61920
62000
SML(T) = 6 mg/kg
(15)
DIR
Same 18900
D
+
8
+
2
2
D
DIR
1
DIR
3
3
Group TDI: 0.1 mg/kg b.w.
See references for 4,4'dihydroxybenzophenone in list 2.
Group TDI: not specified based on Group
ADI (=not specified) for certain modified
celluloses.
(JECFA 35 M., 1989).
Group TDI: not specified based on Group
ADI (=not specified) for certain modified
celluloses.
(JECFA 35 M., 1989).
ADI: not specified.
(SCF, 13th Series 1982).
SCF_List: 3
Restriction: none. In small doses
metabolised similarly to food fats.
See SCF evaluation in the website:
http://europa.eu.int/comm/food/fs/sc/scf/out
181_en.pdf
Toxicologically acceptable.
W9
D
194
+
+
+
+
+
+
+
+
+
+
+
+
Toxicologically acceptable.
+
REF_N
CAS_N
NAME
SYNONIM
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
62080
-
62095
056780-58-6
62110
007681-52-9
62140
62160
006303-21-5
007681-53-0
62175
62220
010025-82-8
010045-89-3
62230
62240
020344-49-4 Iron hydroxide oxide
001332-37-2 Iron oxide
DIR
W
2
62245
012751-22-3 Iron phosphide
3AM
3
62250
62270
000089-65-6 Isoascorbic acid
000078-83-1 Isobutanol
62280
09003-29-6
62295
62320
62400
62405
62415
12-Hydroxystearic acid3-dimethylaminopropyl
amine- dimethyl
sulphate, copolymer
2-Hydroxy-3(trimethylammonio)prop
yl starch chloride
Hypochlorous acid,
sodium salt
Hypophosphorous acid
Hypophosphorous acid,
sodium salt
Indium trichloride
Iron(ii) diammonium
bisulphate
DIR
Isobutylene-butene
copolymers
Isobutene-2-methyl-1,3butadiene, copolymer
see 62435
see 62450
031807-55-3 Isododecane
097259-92-2 Isononanoic acid, butyl
ester
W9
EFSA/SCF_OP
In first instance provide information on
identity.
PL
+
W
6A
DIR
3
3
8
3
W
8
Same 18970
Similar to
76520
7
195
CT
+
Positive in several mutagenicity studies.
(RIVM doc. CS/PM/2093).
Easily oxidized to phosphoric acid.
Easily oxidized to phosphorous acid.
+
+
+
+
+
+
Iron maximum provisional tolerable daily
intake 0.8 mg/kg bw.
(27th M, JECFA, 1983).
ADI: not specified.
(SCF, 1st Series 1975).
Restriction: None (Inert, insoluble material)
Remark for Commission: It is requested
only for use in PET polymers and copolymers.
http://www.efsa.eu.int/science/afc/afc_opini
ons/768/afc_fcm_op_list6_2004.12.171.pdf
Residue less than 1 mg/kg in food. No
mutagenicity or oral data.
(Directive 88/344/EEC)
Under evaluation
+
+
+
+
+
+
+
+
D
+
D
D
9
W
+
+
+
+
REF_N
CAS_N
62420
62435
62450
62480
025103-52-0
011087-88-0
000078-78-4
000067-63-0
62500
-
62540
62560
62640
62720
NAME
isooctanoic acid
Isooctyl epoxystearate
Isopentane
Isopropanol
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
Same 19135
8
6A
3
D
DIR
Same 23830
and 81882
1,1(Isopropylidenebis(pphenyleneoxy))-bis(3-(p(2,3-epoxypropoxy)alpha,alphadimethylbenzyl)phenoxy
))2-propanol
000080-05-7 4,4'Same
Isopropylidenediphenol 13480/1360
7/40060/192
55/39680
092908-32-2 4,4'Isopropylidenediphenylal
kyl(C12-C15)phosphites
008001-39-6 Japan wax
001332-58-7 Kaolin
Same 43490
SCF
List
Volatile.
6A
D
3
1
DIR
3
D
D
62960
Kaolin, calcined
061790-53-2 Kieselguhr
Same 46375
068855-54-9 Kieselguhr, soda ash flux Same 46380
calcined
000050-21-5 Lactic acid
Same 19460
DIR
1
63040
000138-22-7 Lactic acid, butyl ester
DIR
2
63120
63200
007100-07-4 Lactic acid, iron salt
051877-53-3 Lactic acid, manganese
salt
DIR
D
1-2
SML(T) = 0.6 mg/kg
(10) (expressed as
Manganese)
http://europa.eu.int/comm/food/fs/sc/scf/out
128_en.pdf
CT
+
+
+
+
+
+
Refined, natural wax. Purity to be specified.
ADI: not specified.
(SCF, 25th Series, 1990).
Inert material.
ADI: not specified.
(SCF, 25th Series, 1990).
Group TDI= not specified.
Similarity with lactic acid, ethyl ester for
which an ADI not specified was established
by JECFA 26 M., 1982.
L1 for lactic acid.
ADI: not specified.
(SCF, 25th Series, 1991).
L2 for Manganese.
Group TDI: 0.01 mg/kg bw (as Mn)
196
PL
+
9
DIR
DIR
62800
62880
62885
EFSA/SCF_OP
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
See references for acetic acid, manganese(II)
salt (PM/REF.N. 30180) in list 2.
63240
63260
63280
63360
63400
63440
63480
63520
63560
63600
63680
63760
63840
63880
63920
63940
008006-54-0 Lanolin (pharmacopeia
grade)
091079-06-0 Lard oil, sulphated,
ammonium salt
000143-07-7 Lauric acid
000624-04-4 Lauric acid, diester with
ethyleneglycol
025234-60-0 Lauric acid, ester with
choline chloride
004219-48-1 Lauric acid, monoester
with ethyleneglycol
001338-39-2 Lauric acid, monoester
with sorbitan
001793-68-6 Lauric acid, monoester
with triethanolamine
000120-40-1 Lauric diethanolamide
000097-78-9 N-Lauroylsarcosine
001344-40-7 Lead phosphite, dibasic
008002-43-5 Lecithin
000123-76-2 Levulinic acid
Light petroleum
hydrocarbons, odorless
000557-59-5 Lignoceric acid
008062-15-5 Lignosulphonic acid
0
Same 19470
Same 53685
DIR
+
9
+
0
7
+
+
+
+
Needed: hydrolysis data.
Same as
43515 and
54660
Same 53845
D
http://europa.eu.int/comm/food/fs/sc/scf/out
16_en.html
+
7
Needed: hydrolysis data.
+
Same 87600
D
Same 39280
DIR
DIR
7
Needed: hydrolysis data.
+
D
8
D
1
Same references as 39280.
+
+
+
+
0
9
DIR
3AM
0
3
197
+
ADI: not specified.
(JECFA 17 M., 1973).
+
+
Specifications on identity.
R = 0.04 mg/dm² = 0.24 mg/kg of food for
the requested use, i.e. as dispersant for
plastics dispersions.
Available: molecular mass distribution
curve; calculation of worst case migration
assuming 100% transfer into food; gene
mutation assay in bacteria (negative) and 16week oral rat study.
(RIVM/DE SDS, May 1999 = CS/PM/3284
REV. I/63940).
Remark for Commission: No analytical
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
8
0
9
+
+
+
+
0
3
7
+
+
+
+
+
+
method is available.
(Adopted at the 118th SCF meeting) (23
September 1999)
http://europa.eu.int/comm/food/fs/sc/scf/out
41_en.pdf
64000
64015
64080
64150
64160
64240
003999-01-7 Linoleamide
000060-33-3 Linoleic acid
Same 19518
Linoleic acid, esters with
alcohols, aliph., monoh.
028290-79-1 Linolenic acid
Same 19526
008001-26-1 Linseed oil
Same 19532
008016-11-3 Linseed oil, epoxidized
(oxirane less than
10%,iodine Number less
than 6)
64300
001310-65-2 Lithium hydroxide
64320
010377-51-2 Lithium iodide
64400
001345-05-7 Lithopone
64480
011097-59-9 Magnesium aluminium
hydroxide carbonate
Lysine, salts
64500
DIR
DIR
2
DIR
SML(T) = 1 mg/kg
(11) (expressed as
Iodine) and SML(T) =
0.6 mg/kg (8)
(expressed as Lithium)
2
3
Same 34690
D
DIR
0
198
Food fat.
Available: inadequate 20 week oral rat
study, Ames test said to be negative (no
report supplied)(CS/PM/1517).
Needed: data according to SCF guidelines.
(N.B. Epoxidised linseed oil cannot be
covered by data on epoxidised soya bean
oil).
Group TDI: 0.01 mg/kg b.w. (as Li).
See references for 38000 in list 2.
L2 for I.
Group-TDI based on PMTDI: 0.017 mg/kg
b.w. (as I).
(JECFA 33 M., 1988).
L2 for Li.
Group TDI: 0.01 mg/kg bw (as Li).
90-day oral rat studies and metabolism and
human use of lithium salts in therapy.
(RIVM tox 105/76 July 1976, tox 204/78,
November 1978, tox 126/79 October 1979).
For Li see references for benzoic acid,
lithium salt in list 2.
Free from water soluble barium. Insoluble,
inert material.
Inert, insoluble material.
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
64560
007786-30-3 Magnesium chloride
64640
001309-42-8 Magnesium hydroxide
DIR
1
64720
001309-48-4 Magnesium oxide
DIR
1
64800
000110-16-7 Maleic acid
64820
000142-16-5 Maleic acid, bis(2ethylhexyl) ester
010039-33-5 Maleic acid, di-n-octyltin Same 50240
bis (2-ethylhexyl) ester
Maleic acid, esters with
pentaerythritol
Maleic acid,
monohexadecyl ester,
potassium salt
000108-31-6 Maleic anhydride
Same 19960
Maleic anhydride-butene
and/or ethylene and/or
propylene, copolymers
Maleic anhydrideethylene or styrene or
methyl vinyl ether,
copolymer
025119-65-7 Maleic anhydride-methyl
methacrylate, copolymer
see 65020
Maleic anhydride-methyl
vinyl ether, copolymer
028133-65-5 Maleic anhydride methyl
vinyl ether, copolymer,
sodium salt (Mw>70000)
W
025722-45-6 Maleic anhydride-
9
64840
64860
64880
64900
64920
64940
64955
64960
64970
64972
64985
1/D
Same 19540.
DIR
SML(T) = 30 mg/kg
(4)
2
D
EFSA/SCF_OP
ADI: not specified.
(SCF, 25th Series, 1991)
ADI: not specified.
(SCF, 25th Series, 1991)
ADI: not specified.
(SCF, 25th Series, 1991)
Group TDI: 0.5 mg/kg b.w. as maleic acid.
(SCF, 17th Series, 1986).
+
+
+
+
+
Same references as 50240.
+
+
Needed: hydrolysis data.
+
D
D
+
+
9
+
D
+
D
9
+
+
7
199
CT
+
9
7
PL
Needed: In first instance, Mw distribution
curve of the polymer (maleic anhydride
methyl vinyl ether, copolymer, sodium salt).
Remark: Monomer, i.e. methyl vinyl ether
(PM/REF No. 22270) not yet evaluated
(provide hydrolysis data).
(Adopted at 111th SCF meeting (18-19
March 1998)
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
65020
propylene, copolymer
025736-61-2 Maleic anhydridestyrene, copolymer,
sodium salt
Maleic anhydride-vinyl
esters, copolymers
006915-15-7 Malic acid
65040
65120
000141-82-2 Malonic acid
007773-01-5 Manganese chloride
65200
012626-88-9 Manganese hydroxide
DIR
65280
010043-84-2 Manganese
hypophosphite
DIR
64990
65000
RESTRICTIONS
AND
SPECIFICATIONS
3AM
SCF
List
3
EFSA/SCF_OP
PL
Restriction: None
http://www.efsa.eu.int/science/afc/afc_opini
ons/768/afc_fcm_op_list6_2004.12.171.pdf
+
D
Same 19965
DIR
Same 19968
DIR
DIR
65360
011129-60-5 Manganese oxide
DIR
65440
-
DIR
Manganese
pyrophosphite
65520
000087-78-5 Mannitol
Same 19972
65630
000108-78-1 Melamine
Same
19975,25420
and 93720
65768
000149-30-4 2-Mercaptobenzothiazole
1
SML(T) = 0.6 mg/kg
(10) (expressed as
Manganese)
SML(T) = 0.6 mg/kg
(10) (expressed as
Manganese)
SML(T) = 0.6 mg/kg
(10) (expressed as
Manganese)
SML(T) = 0.6 mg/kg
(10) (expressed as
Manganese)
SML(T) = 0.6 mg/kg
(10) (expressed as
Manganese)
DIR
3
2
2
2-3
2
2-3
200
+
ADI: not specified.
(SCF, 25th Series, 1990).
Occurs in plants.
Group TDI: 0.01 mg/kg b.w. (as Mn).
(Environmental Health Criteria 17, WHO
1981).
Group TDI: 0.01 mg/kg b.w. (as Mn).
See references for acetic acid, manganese(II)
salt in list 2.
L2 for manganese
Group TDI: 0.01 mg/kg b.w. (as Mn).
See references for acetic acid, manganese(II)
salt in list 2.
L3 for hypophosphite.
Hypophosphite easily oxidised tp
phosphoric acid.
Group TDI: 0.01 mg/kg b.w. (as Mn).
See references for acetic acid, manganese(II)
salt.
L2 for manganese.
Group TDI: 0.01 mg/kg b.w. (as Mn).
See references for acetic acid, manganese(II)
salt in list 2.
D
L3 for pyrophosphite.
Easily oxidized to pyrophosphoric acid.
ADI: acceptable.
(SCF, 16th Series, 1985).
See "2,4,6-triamino-1,3,5-triazine".
6A
Statement on 2-Mercaptobenzothiazole
1
CT
+
+
+
+
+
+
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
(MBT)
The Committee has received a request to
comment on the safety of the proposed CEN
extraction limit for MBT from rubber
materials used for soothers and teats.
- Considering that on the basis of wellconducted genotoxicity studies the
previously expressed concern of possible
carcinogenic effects related to the migration
of low amounts of MBT from finished
products can now be discounted.
- Considering that based on the limit of 8 mg
MBT/kg rubber extracted over 24 hours as
proposed by CEN, a worst case exposure to
MBT was calculated not to exceed 22 ug/kg
b.w. for a baby weighing 2 kg, fed 8 times a
day using a new teat of 5 g at each occasion
and
- In view of the existing toxicological
studies, albeit insufficient for establishing a
TDI, which show a NOAEL of 94 mg/kg
b.w. from a 90-day oral mouse study leading
to a margin of safety of around 4200,
The Committee concludes that the potential
oral exposure to MBT resulting from
materials in compliance with the proposed
CEN limit of 8 mg/kg rubber extracted over
a 24 hour period does not constitute a health
hazard.
However, the Committee is aware that MBT
has been reported, primarily in occupational
settings, to induce sensitisation after dermal
contact. As this issue is not related to food
safety it is considered to be outside the remit
of the Committee.
Therefore the SCF recommends that the
Commission seeks appropriate advice to
consider whether direct contact exposure to
MBT, through teats and soothers, constitutes
a sensitisation hazard.
201
PL
CT
REF_N
65770
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
002492-26-4 2Mercaptobenzothiazole,
sodium salt
SCF
List
6A
202
EFSA/SCF_OP
Available: inadequate migration data and
worst case calculations; gene mutation
assays in bacteria (negative); chromosomal
aberration assay in cultured mammalian
cells (positive); gene mutation assays in
cultured mammalian cells (one assay
negative and one assay weakly positive);
SCE assay in vitro (positive); mouse bone
marrow micronucleus assay (negative); in
vivo rat liver UDS assay (negative); limited
in vivo DNA binding assay (negative); three
16-day oral mouse and rat studies (one
inadequate); two 90-day oral mouse and rat
studies; 2 carcinogenicity studies (mouse
and rat); two teratogenicity studies (rat);
metabolism study; skin and eye irritation
studies; sensitisation study; human data
concerning sensitisation.
RIVM/DK/ISS/TNO SDS, March 2000 =
CS/PM/3224 A+B REV.IV/65768/65770.
(Adopted at the 123rd SCF meeting, 19
October 2000
http://europa.eu.int/comm/food/fs/sc/scf/out
76_en.pdf
Statement on 2-Mercaptobenzothiazole
(MBT)
The Committee has received a request to
comment on the safety of the proposed CEN
extraction limit for MBT from rubber
materials used for soothers and teats.
- Considering that on the basis of wellconducted genotoxicity studies the
previously expressed concern of possible
carcinogenic effects related to the migration
of low amounts of MBT from finished
products can now be discounted.
- Considering that based on the limit of 8 mg
MBT/kg rubber extracted over 24 hours as
proposed by CEN, a worst case exposure to
PL
+
CT
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
MBT was calculated not to exceed 22 ug/kg
b.w. for a baby weighing 2 kg, fed 8 times a
day using a new teat of 5 g at each occasion
and
- In view of the existing toxicological
studies, albeit insufficient for establishing a
TDI, which show a NOAEL of 94 mg/kg
b.w. from a 90-day oral mouse study leading
to a margin of safety of around 4200,
The Committee concludes that the potential
oral exposure to MBT resulting from
materials in compliance with the proposed
CEN limit of 8 mg/kg rubber extracted over
a 24 hour period does not constitute a health
hazard.
However, the Committee is aware that MBT
has been reported, primarily in occupational
settings, to induce sensitisation after dermal
contact. As this issue is not related to food
safety it is considered to be outside the remit
of the Committee.
Therefore the SCF recommends that the
Commission seeks appropriate advice to
consider whether direct contact exposure to
MBT, through teats and soothers, constitutes
a sensitisation hazard.
Available: inadequate migration data and
worst case calculations; gene mutation
assays in bacteria (negative); chromosomal
aberration assay in cultured mammalian
cells (positive); gene mutation assays in
cultured mammalian cells (one assay
negative and one assay weakly positive);
SCE assay in vitro (positive); mouse bone
marrow micronucleus assay (negative); in
vivo rat liver UDS assay (negative); limited
in vivo DNA binding assay (negative); three
16-day oral mouse and rat studies (one
inadequate); two 90-day oral mouse and rat
203
PL
CT
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
65800
068039-13-4 Methacrylamidopropyltri
methylammonium
chloride, polymer (Mw=
10000-100000)
W7
65805
-
W7
65830
000109-16-0
65905
007779-31-9
65910
002530-85-0
65920
066822-60-4
Methacrylamidopropyltri
methylammonium
chloridetrimethylethanolammoni
um chloride
methacrylate, copolymer
(Mw=10000-100000)
Methacrylic acid, diester
with triethyleneglycol
Methacrylic acid, 3,3,5trimethylcyclohexyl ester
[3(Methacryloxy)propyl]
trimethoxysilane
[NSame 38500
MethacryloyloxyethylN,N-dimethyl-Ncarboxymethylammoniu
m chloride, sodium salt octadecyl methacrylateethyl methacrylatecyclohexyl methacrylateN-vinyl-2-pyrrolidone,
copolymers
EFSA/SCF_OP
studies; 2 carcinogenicity studies (mouse
and rat); two teratogenicity studies (rat);
metabolism study; skin and eye irritation
studies; sensitisation study; human data
concerning sensitisation.
RIVM/DK/ISS/TNO SDS, March 2000 =
CS/PM/3224 A+B REV.IV/65768/65770.
(Adopted at the 123rd SCF meeting, 19
October 2000
http://europa.eu.int/comm/food/fs/sc/scf/out
76_en.pdf
Needed: Mw distribution curve; three
mutagenicity studies with the monomer
(which is now listed in L6A).
(Adopted at 111th SCF meeting (18-19
March 1998)
Needed: Mw distribution curve; three
mutagenicity tests with the monomers
(which are listed in L6A or in L8).
(Adopted at 111th SCF meeting (18-19
March 1998)
+
+
+
W
+
2
204
CT
W
8
DIR
PL
+
TDI: 1 mg/kg b.w.
90-day oral rat study. Mutagenicity data not
needed for this polymer.
(RIVM doc. Tox 300/482 March 1984).
+
REF_N
CAS_N
NAME
66000
-
66030
66080
66160
000150-76-5
000613-93-4
016515-58-5
66200
037206-01-2
66240
009004-67-5 Methylcellulose
66270
66320
000096-37-7 Methylcyclopentane
000118-82-1 4,4'-Methylenebis(2,6di-tert-butylphenol)
085209-93-4 2,2'-Methylenebis(4,6di-tert-butylphenyl)
lithium phosphate
66350
SYNONIM
3'-Methoxy-4'hydroxyphenyl-2-indole
4-Methoxyphenol
Same 21615
N-Methylbenzamide
7-(5'-Methyl-6'-nbutoxybenzotriazole(2))-3phenylcoumarin
Methylcarboxymethylcel
lulose
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
8
DIR
2
DIR
2
3
66360
085209-91-2 2,2'-Methylene bis(4,6di-tert-butylphenyl)
sodium phosphate
DIR
SML = 5 mg/kg
3
66400
000088-24-4 2,2'-Methylene bis(4Same 39010
ethyl-6-tert-butylphenol)
DIR
SML(T) = 1.5 mg/kg
(20)
2
66480
000119-47-1 2,2'-Methylene bis(4methyl-6-tertbutylphenol)
DIR
SML(T) = 1.5 mg/kg
(20)
2
205
CT
+
+
+
Group TDI: not specified based on Group
ADI (= not specified) for certain modified
celluloses.
(JECFA 35 M., 1989).
Group TDI: not specified based on Group
ADI (=not specified) for certain modified
celluloses.
(JECFA 35 M., 1989).
8
8
3AM
PL
+
8
8
8
Same 38750
Same 39025
EFSA/SCF_OP
+
+
+
+
Restriction: 5 mg/kg food.
Remark for the Commission: Lithium:
Group restriction of 0.6 mg/kg food.
http://www.efsa.eu.int/science/afc/afc_opini
ons/890/afc_op_ej201_fcm1.pdf
R: 5 mg/kg in food.
Available: 3-month oral rat study,
mutagenicity tests negative, migration data.
(RIVM doc. 15 Oct. 1991).
Group TDI: 0.025 mg/kg b.w.(with 66480).
Available for 66480: two 90-day oral rat
studies, 4-month oral dog study and
mutagenicity studies.
(RIVM Doc/Tox 300/418 April 1983 and
CS/PM/171).
Group TDI: 0,025 mg/kg b.w.(with 66400).
Available: two 90-day oral rat studies, 4month oral dog study, mutagenicity studies.
(RIVM doc./Tox 300/418 April 1983 and
CS/PM/171).
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
66560
004066-02-8 2,2'-Methylenebis(4methyl-6cyclohexylphenol)
Same 39045
DIR
SML(T) = 3 mg/kg (6)
2
66580
000077-62-3 2,2'-Methylenebis(4methyl-6-(1-methylcyclohexyl) phenol)
Same 39600
DIR
SML(T) = 3 mg/kg (6)
2
66600
66620
026545-58-4 Methylenebis(naphthalen
esulphonic acid),
disodium salt
000075-09-2 Methylene chloride
66640
009004-59-5 Methylethylcellulose
66655
000078-93-3 Methyl ethyl ketone
66675
?
66680
66695
EFSA/SCF_OP
PL
TDI = 0.05 mg/kg b.w. (with 66580).
Available for 66580 short-term oral rat and
dog study, 90-day oral dog study and 2-year
oral rat and dog study.
(RIVM doc. CS/PM/2205).
Group TDI = 0.05 mg/kg b.w. (with 66560).
Available: short-term oral rat and dog study,
90-day oral dog study and 2-year oral rat
and dog study (RIVM doc. CS/PM/2205).
+
8
3
DIR
2
+
+
R: 0.05 mg/kg of foods.
(SCF, 29th Series, 1992).
Group TDI: not specified based on Group
ADI (=not specified) for certain modified
celluloses.
(JECFA, 35 M., 1989).
R: 5 mg/kg of food.
Available: 3 and 6 month inhalation studies
in rats, teratogenicity studies by inhalation in
mice and rats, mutagenicity tests.
(RIVM doc. CS/PM/2098),(SCF, 29th
Series, 1992).
+
+
Same 21827
3
Methylheptadecanoic
acid
000095-71-6 Methylhydroquinone
Same 21850
Methylhydroxymethylcel
lulose
D
+
DIR
8
2
+
+
DIR
2
66700
009004-65-3 Methylhydroxypropylcel Same 61760
lulose
66715
66720
66725
000693-98-1 2-Methylimidazole
see 66755
000108-10-1 Methyl isobutyl ketone
8
D
3
206
CT
Group TDI: not specified based on group
ADI (= not specified) for certain modified
celluloses.
(JECFA 35 M., 1989).
Group TDI: not specified based on group
ADI (= not specified) for certain modified
celluloses.
(JECFA 35M., 1989).
R: 5 mg/kg of food.
Available: 3 month oral rat study and 3
+
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
month inhalation studies mice, rats, dogs
and monkeys, teratogenicity studies by
inhalation in mice and rats , mutagenicity
tests.
(WHO Env. Health Crit. n. 117 (1990)
Geneva).
66740
66745
66755
66800
66820
000814-78-8 Methyl isopropenyl
Same 21910
ketone (=2-methyl-2penten-4-one)
Methyl isopropenyl
ketone-styrene,
copolymer
002682-20-4 2-Methyl-4-isothiazolin3-one
DIR
SML = ND (DL = 0.02
mg/kg, analytical
tolerance included)
8
+
9
+
4A
See references for 43760 in list 4.
+
D
7
L8
+
66840
66860
66880
66905
000139-99-1 Methyl oleate, sulphated
000923-02-4 NSame 21970
Methylolmethacrylamide
000107-83-5 2-Methylpentane
000108-11-2 4-Methyl-2-pentanol
Same 22080
see 66950
000872-50-4 N-Methylpyrrolidone
3AM
8
8
D
2
66930
068554-70-1 Methylsilsesquioxane
3AM
3
Same 86426
+
+
Restriction: None.
Used as solvent.
http://www.efsa.eu.int/science/afc/afc_opini
ons/890/afc_op_ej201_fcm1.pdf
Residual monomer in methylsilsesquioxane:
< 1 mg methyltrimethoxysilane /kg of
methylsilsesquioxane
+
+
+
http://www.efsa.eu.int/science/afc/afc_opini
ons/468/opinion11_afc_ej65_list4_en1.pdf
66940
-
alpha-Methylstyrene-Noctadecylmaleimide-N(2,2,6,6-tetramethyl-4piperidyl)maleimide,
copolymer
W7
207
+
http://europa.eu.int/comm/food/fs/sc/scf/out
114_en.pdf
Available: Inadequate migration data, Mw,
Mn, mutagenicity studies on the polymeric
additive itself.
Needed: Mw distribution,additional
information on overall migration in olive oil
+
+
+
REF_N
66950
66960
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
-
alpha-Methylstyrenestyrene, copolymer,
hydrogenated
068441-38-3 alpha-Methylstyrenevinyltoluene, copolymer,
hydrogenated
SCF
List
3
3
EFSA/SCF_OP
and on specific migration, 3 mutagenicity
tests on each of the starting substances not
on List 0-4
(RIVM 1994-09-06).
R: 5 mg/kg of food.
See the opinion for PM/REF.N. 66960.
R: 5 mg/kg of food.
Available: molecular weight distribution
curve and migration data showing high
migration in fat simulants. Mutagenicity
data (from 47520), 3-month oral rat and dog
studies.
(TNO 1995-05-22 = CS/PM/2594)(Elias
CS/PM/838).
PL
CT
+
+
+
+
Remark: since high migration into fat has
been demonstrated the WG recommends that
the Commission take the necessary measures
so that the restriction proposed is not
exceeded.
67040
67120
67155
67160
014295-72-8 1(4Methylsulphonylphenyl)3-(4-chlorophenyl)-delta2-pyrazoline
012001-26-2 Mica
Mixture of 4-(2Benzoxazolyl)-4'-(5methyl-2benzoxazolyl)stilbene,
4,4'-bis(2-benzoxazolyl)
stilbene and 4,4'-bis(5methyl-2benzoxazolyl)stilbene)
Mixt.of:60% alkyl(C11C14)bis(hydroxyethyl)sulpho
nium
glycolsulphate;17.9%
alkyl(C11-C14)-
8
DIR
3AM
3
3
D
208
+
Inert silicate.
R = Maximum amount to be used 0.05%
(w/w).
+
+
+
+
REF_N
67161
67162
67165
67170
CAS_N
NAME
SYNONIM
bis(hydroxyethyl)sulpho
nium sulphate;2,6%
alkyl (C11C14)bis(hydroxyethyl)su
lphonium bisulphate;19.5
% alkyl etC.
068439-49-6 Mixture of a)fatty
Same 77895
alcohols(C16C18)(approx. 48%);
b)ethyleneglycol
monoalkyl(C16C18)ether(approx.24%);
c)polyethyleneglycol(e0
=2-6)monoalkyl(C16C18)ether(approx. 28%)
Mixture of lauric and
myristic alcohol with
their polyethyleneglycol
ethers (1-10EO)
Mixture of:a)40-100%
react.product of 2mercaptoethyl oleate
with dimethyltin
dichloride,methyltin
trichloride and sodium
sulphide;b)0-40% 2mercaptoethyl
oleate;c)0-5% 2mercaptoethanol;d)040% paraffin etC.
Mixture of (80 to 100% Same 83598
w/w) 5,7-di-tert-butyl-3(3,4-dimethylphenyl)2(3H)-benzofuranone
and (0 to 20% w/w)5,7di-tert-butyl-3-(2,3dimethylphenyl)-2(3H)benzofuranone
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
D
7
+
Needed: Migration and toxicity data on
polyethyleneglycol ethers.
D
D
SML = 5 mg/kg
209
3
PL
+
+
R = 5 mg/kg of food.
Available: Adequate migration data; log
Po/w; three negative mutagenicity studies;
90-day oral rat study (including examination
of the activity of the peroxisome associated
enzymes); metabolism study (in vitro and in
vivo) in rats; in vitro gene mutation assay in
bacteria with the dimer (CG33-0941); ADE
study.
(RIVM/TNO SDS, March 1998 =
+
CT
REF_N
CAS_N
NAME
67180
-
67185
67280
028679-16-5 Mixture of (40% w/w)
Same 22332
2,2,4-trimethylhexane1,6-diisocyanate and
(60% w/w) 2,4,4trimethylhexane-1,6diisocyanate
001317-33-5 Molybdenum disulphide
023850-94-4 Monobutyltin tris(2ethylhexanoate)
000108-90-7 Monochlorobenzene
67355
-
67200
67240
67360
Mixture of (50% w/w)
phthalic acid n-decyl noctyl ester, (25% w/w)
phthalic acid di-n-decyl
ester, (25% w/w)
phthalic acid di-n- octyl
ester.
SYNONIM
Mono-, di- and
trialkyl(C4-C18)phenyl
ethers of poly(ethyleneand/or propylene- and/or
butyleneglycol)acetic
acid
067649-65-4 Mono-n-dodecyltin
tris(isooctyl
mercaptoacetate)
Same 75850
DIR
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SML = 5 mg/kg (1)
SCF
List
3
D
DIR
EFSA/SCF_OP
CS/PM/2965 REV. I/67170).
(Adopted at 114th SCF meeting) (10
December 1998)
http://europa.eu.int/comm/food/fs/sc/scf/out
20_en.pdf
R = 5 mg/kg of food or food simulant.
Available: 3 mutagenicity studies negative,
3 months oral rat study, test on liver
peroxisome proliferation, migration in
aqueous food simulants only.
Remark: high migration into fatty food is
likely.
(RIVM report 1995-09-04 (=CS/PM/2655)).
Not detectable
3
W
Inert, insoluble material.
2
TDI: 0.6 mg/kg b.w.
90-day oral rat study, 2 year oral mouse and
rat studies, Ames list negative, in vitro
mutagenicity test positive.
(Appendix to RIVM report 758701004
March 1990).
SML = 24 mg/kg
210
3
CT
+
+
+
+
9
DIR
PL
+
+
Restriction: 0.05 mg/kg food (as sum of
mono-n-dodecyltin tris(isooctyl
mercaptoacetate), di-n- dodecyltin
bis(isooctyl mercaptoacetate),
monododecyltin trichloride and didodecyltin dichloride) expressed as the sum
+
REF_N
67420
CAS_N
NAME
000141-43-5 Monoethanolamine
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
Same 12763
and 35170
SCF
List
3
EFSA/SCF_OP
PL
of mono- and di-dodecyltin chloride.
http://www.efsa.eu.int/science/afc/afc_opini
ons/960/afc_op_ej218_8thlist_en1.pdf
R = 0.05 mg/kg of food.
+
Available: migration data from multilayer
bottle and residual content in polymer; gene
mutation assay in bacteria (negative);
chromosomal aberration assay in cultured
mammalian cells (negative); gene mutation
assay in cultured mammalian cells
(negative); in vitro cell transformation assay
(negative); toxicology summary on
reproductive toxicity; general toxicological
overview on MEA (made by the applicant).
RIVM/TNO SDS, August 1999 =
CS/PM/3337/22337.
Remark: substance evaluated only for the
requested use of indirect contact with nonfatty food.
67440
-
67441
-
Monoethanolamine alkyl
sulphate
Monoethanolamine
alkyl(C8-C22)sulphate,
linear, primary, even
numbered
D
8
(Adopted at the 121 SCF meeting (20 June
2000))
Partially covered by 67441.
L3 and L8.
For alkyl(C8-C22)sulphuric acids, linear,
primary, even numbered.
+
+
L3. Toxicologically acceptable.
Same references as for 34281.
For monoethanolamine.
67442
67515
090583-16-7 Monoethanolamine
alkyl(C12-C14)sulphate
057583-34-3 Monomethyltin
tris(ethylhexyl
D
see 67520
3AM
2
211
L8.
Partially covered by 67441.
L2 for tin
Isooctyl refers to industrial mixture
+
+
CT
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
mercaptoacetate)
054849-38-6 Monomethyltin
tris(isooctyl
mercaptoacetate)
DIR
SML(T) = 0.18 mg/kg
(16) (expressed as Tin)
2
67600
-
DIR
SML(T) = 1.2 mg/kg
(18) (expressed as Tin)
2
DIR
SML(T) = 1.2 mg/kg
(18) (expressed as Tin)
2
DIR
SML(T) = 1.2 mg/kg
(18) (expressed as Tin)
2
67680
67760
PL
including substances with a branched chain
of 8 atoms of carbon. Usually, x-methyl-C7,
x,y-dimethyl-C6 are the major components
of an isooctyl “mixture” (more than 90%).
x-ethyl-C6 are present but not in a large
quantities (less than 10%). The composition
of this mixture could be slightly different
according the oil feedstock used for the
synthesis of it and of the process used for the
“oxo” reaction..
In contrast, ethylhexyl (ethyl-C6) refers
usually to 2-ethylhexyl structure which is
perfectly defined chemically.
67520
Mono-n-octyltin
tris(alkyl(C10-C16)
mercaptoacetate)
027107-89-7 Mono-n-octyltin tris(2ethylhexyl
mercaptoacetate)
026401-86-5 Mono-n-octyltin
tris(isooctyl
mercaptoacetate)
EFSA/SCF_OP
In the scope of organotin compounds for
which the toxicity is related to organic tin,
studies done either with the “isooctyl” or the
“ethylhexyl” could be used for evaluation of
branched C8 organotin compounds.
Group TDI: 0.003 mg/kg bw (as Sn) (with
49600 and 83599).
See references for 83599 in list 2.
.
Group-TDI: 0.02 mg/kg bw (as Sn) with
67680 and 67760.
See references for 67760
Group-TDI: 0.02 mg/kg bw (as Sn)(with
67760 and 67600).
See references for 67760 in list 2.
Group-TDI: 0.02 mg/kg bw (as Sn) for
monooctyltin stabilisers (REF_N 67760)
Group-TDI: 0.0006 mg/kg bw (as Sn) for
dioctyltin stabilisers (REF_N 50480)
Available: migration data; several subacute
studies in rats and dogs (performed with
MOTTG, DOTTG, MOTC, DOTC and
formulation of MOTC and DOTC); several
semichronic studies in rats and dogs
212
+
+
+
+
CT
REF_N
67840
67850
67870
CAS_N
-
NAME
Montanic acids and/or
their esters with
ethyleneglycol and/or
with 1,3-butanediol
and/or with glycerol
008002-53-7 Montan wax
000110-91-8 Morpholine
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
DIR
3
DIR
3
5
213
EFSA/SCF_OP
(performed with MOTTG, DOTTG and
formulation of MOTTG and DOTTG); 2year rat and dog studies (performed with
DOTTG and formulation of MOTC and
DOTC); gene mutation assays in bacteria
(negative) (performed with MOTC, DOTC
and formulation of MOTTG and DOTTG);
gene mutation assays in cultured mammalian
cells (negative) (performed with MOTC and
DOTC); in vitro UDS assay (negative)
(performed with DOTC); in vitro covalent
DNA binding assay (negative) (performed
with DOTC); micronucleus assays
(negative; however, it was noted that no
cytotoxicity was observed when performed
with MOTC) (negative with formulation
with MOTTG and DOTTG); in vivo SCE
assay (negative) (performed with DOTC); 2generation reproduction study in rats
(performed with formulation of MOTTG
and DOTTG); teratogenicity study in rats
(performed with formulation of MOTTG
and DOTTG); teratogenicity study in rabbits
(performed with formulation of MOTTG
and DOTTG).
(RIVM SDS, October 1998 =
CS/PM/3255/50480/67760).
Remark for Commission: no analytical
method is available.
(Adopted at the 118th SCF meeting) (23
September 1999)
http://europa.eu.int/comm/food/fs/sc/scf/out
41_en.pdf
3-4 month oral dog, 3 month rat and 2-year
rat studies plus negative Ames tests.
(RIVM report 05-03-1990).
Inert compound, specifications needed.
[Possibility of the formation of carcinogenic
PL
CT
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
67878
-
Morpholine, its salts of
acids, aliph., monocarb.,
sat., more than C7
5
67882
-
Morpholine, its salts of
acids, aliph., monocarb.,
unsat., more than C7
5
67891
000544-63-8 Myristic acid
67895
025263-97-2 Myristic acid, isobutyl
ester
020336-96-3 Myristic acid, lithium
salt
67896
67898
67910
67912
67918
67921
67930
Same 22350
DIR
1
7
DIR
SML(T) = 0.6 mg/kg
(8) (expressed as
Lithium)
000544-64-9 Myristoleic acid
Same 67898
000085-47-2 1-Naphthalenesulphonic
acid
000120-18-3 2-Naphthalenesulphonic
acid
001338-24-5 Naphthenic acids
061789-36-4 Naphthenic acids,
calcium salts
061789-51-3 Naphthenic acids, cobalt
salts
1-2
EFSA/SCF_OP
N-nitrosomorpholine in nitrite-containing
foodstuffs, as well as from nitrite in saliva.
To a minor extent this nitrosamine can also
be formed from N-substituted morpholines.]
[Possibility of the formation of carcinogenic
N-nitrosomorpholine in nitrite-containing
foodstuffs, as well as from nitrite in saliva.
To a minor extent this nitrosamine can also
be formed from N-substituted morpholines.]
[Possibility of the formation of carcinogenic
N-nitrosomorpholine in nitrite-containing
foodstuffs, as well as from nitrite in saliva.
To a minor extent this nitrosamine can also
be formed from N-substituted morpholines.]
ADI: NS
(SCF, 25th Series, 1989).
Needed: hydrolysis data.
Based on the above-mentioned data the
substance is classified:
SCF_List: L1 for myristic acid (ADI: Not
specified).
SCF_List: L2 for lithium (Group-TDI = 0.01
mg/kg bw. (as Li))
http://europa.eu.int/comm/food/fs/sc/scf/out
172_en.pdf
+
+
+
+
+
+
+
8
+
9
CT
+
8
8
W
W
214
PL
+
+
L3 for Cobalt.
R: 0.05 mg/kg of food (as Co).
(RIVM, summary data, October
1992=CS/PM/1707).
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
L9 for napthenic acids.
67936
67946
001338-02-9 Naphthenic acids, copper
salts
001336-93-2 Naphthenic acids,
manganese salt
W
9
+
L9 for naphthenic acids.
+
L2 for the Mn.
Group TDI: 0.01 mg/kg b.w.
See references for 30180 in L2 in this report.
68000
68001
68002
68040
68050
68070
68078
-
Naphthenic mineral oil
Naphthenic mineral oil
(hydrogenated)
Naphthenic mineral oil
(conventional)
003333-62-8 7-(2H-Naphtho-(1,2D)triazol-2-yl)-3phenylcoumarin
026896-20-8 Neodecanoic acid
052270-44-7 Neodecanoic acid, cobalt
(ii) salt
027253-31-2 Neodecanoic acid, cobalt
salt
DIR
+
+
D
+
2
W
3/D
Similar to
68078
Similar to
68070
9
D
DIR
SML(T) = 0.05 mg/kg
(expressed as
Neodecanoic acid) and
SML(T) = 0.05 mg/kg
(14) (expressed as
Cobalt). Not for use in
polymers contacting
foods for which
simulant D is laid
down in Directive
215
3
TDI: 1 mg/kg b.w.
90-day oral rat and dog studies, two
mutagenicity tests.
(RIVM 300/234 Tox/75, July 1981).
+
L3 for neodecanoic acid.
R: 0.05 mg/kg of food for neodecanoic acid.
Not for fatty foods.
Available: 3 negative mutagenicity tests and
migration data for non-fatty foods for
neodecanoic acid.
+
+
L3 for Cobalt.
R: 0.05 mg/kg of food (as Co).
(RIVM, summary data, October
1992=CS/PM/1707).
List 3 for neodecanoic acid.
R: 0.05 mg/kg of food for neodecanoic acid.
Not for fatty foods.
Available: 3 negative mutagenicity tests and
migration data for non-fatty foods for
neodecanoic acid.
List 3 for Cobalt.
R: 0.05 mg/kg of food (as Co).
(RIVM, summary data, October
1992=CS/PM/1707)."
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
85/572/EEC.
68080
68112
68125
68140
see 68040
027253-29-8 Neodecanoic acid, zinc
salt
037244-96-5 Nepheline syenite
007697-37-2 Nitric acid
68145
080410-33-9 2,2',2"-Nitrilo[triethyl
tris(3,3',5,5'-tetra-tertbutyl-1,1'-bi-phenyl-2,2'diyl)phosphite]
68150
68180
68185
68200
000112-05-0 Nonanoic acid
see 68125
000104-40-5 4-Nonylphenol
Novolac glycidyl ethers
(=NOGE)
68210
032536-52-0 Octabromodiphenyl
ether
68225
000112-92-5 1-Octadecanol
EFSA/SCF_OP
DIR
3
2
SML = 5 mg/kg (sum
of phosphite and
phosphate)
Same 22465
Same 22540
same 22552
See 13160
D
According to
Commission Directive
2002/16/EC of 20
February 2002 on the
use of certain epoxy
derivatives in materials
and articles intended to
come into contact with
foodstuffs.
Can still be used in
heavy coatings.
3
8
D
8
7
5
Same 22555
3
216
CT
(Adopted at the 126th SCF meeting, 28
February 2001)
http://europa.eu.int/comm/food/fs/sc/scf/out
84_en.pdf
D
W
DIR
PL
+
+
Inert material.
TDI: 3 mg/kg bw based on ADI= 5 mg/kg
bw on sodium nitrate.
(SCF, 38th Series, 1997)
R = 5 mg/kg of food (covering the sum of
phosphite and phosphate).
Available: adequate migration data, three in
vitro mutagenicity studies; 90-day oral rat
study, acute delayed neurotoxicity study; log
Po/w.
(RIVM/TNO SDS, November 1996 =
CS/PM/2749).
+
+
+
+
+
+
+
http://europa.eu.int/comm/food/fs/sc/scf/out
76_en.pdf
+
[Some organobromo compounds have a
bioaccumulation potential and 1,2dibromoethane is a category 2 carcinogen
(EC classification).]
See references for same substance in
monomer report.
+
+
+
REF_N
CAS_N
NAME
68240
68320
000124-30-1 Octadecylamine
002082-79-3 Octadecyl 3-(3,5-di-tertbutyl-4hydroxyphenyl)propionat
e
68400
010094-45-8 Octadecylerucamide
68480
016545-53-2 Octadecyl (4-hydroxy3,5dimethylbenzyl)merca
ptoacetate
000124-07-2 n-Octanoic acid
68560
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
DIR
SML = 6 mg/kg
8
2
DIR
SML = 5 mg/kg
3
Same 14320
and 41960
+
+
+
+
D
+
+
+
+
8
68650
006700-85-2 n-Octanoic acid, cobalt
salt
3
0-2
217
CT
+
007435-02-1 n-Octanoic acid, cerium
salt
016577-52-9 n-Octanoic acid, lithium
salt
TDI: 0.1 mg/kg b.w.
Several oral rat studies (3-weeks to 3months), 2-year oral studies in mice and rats,
two-generation and teratogenicity studies,
mutagenicity tests.
(RIVM doc. 31-03-92).
R: 5 mg/kg of food
Available: specific migration in aqueous
food simulants <0.4 mg/kg, in HB307 1.8
mg/kg; gene mutation assay in bacteria
(negative); chromosomal aberration assay in
cultured mammalian cells (negative); gene
mutation assay in cultured mammalian cells
(negative); 90-day oral rat study (no
NOAEL established).
(RIVM/UK/TNO SDS, May 1999 =
CS/PM/3273 REV. I/68400).
(Adopted at the 118th SCF meeting) (23
September 1999)
http://europa.eu.int/comm/food/fs/sc/scf/out
41_en.pdf
PL
8
68640
68680
EFSA/SCF_OP
LO for n-octanoic acid.
L8 for cerium.
L3 for Cobalt.
R = 0.05 mg/kg of food (as Co)
(RIVM, summary data, October
1992=CS/PM/1707).
L0 for n-octanoic acid.
L2 for the Lithium.
Group TDI : 0.01 mg/kg b.w. (as Li).
See references for 38000 in L2 in this report.
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
68690
006535-19-9 n-Octanoic acid,
manganese salt
2
68720
68730
see 68775
018312-04-4 Octanoic acid, zirconium
salt
D
9
EFSA/SCF_OP
PL
L0 for n-octanoic acid.
L2 for the Mn.
Group TDI: 0.01 mg/kg b.w. (as Mn).
See references for 30180 in L2 in this report.
CT
+
L0 for n-octanoic acid.
+
L9 for octanoic acid.
+
L7 for zirconium.
See references for 54220.
68775
68800
68840
68860
005333-42-6
000106-84-3
000111-88-6
004724-48-5
2-Octyldodecanol
Octyl epoxystearate
n-Octylmercaptan
n-Octylphosphonic acid
68880
68960
000992-55-2 2-n-Octylthio-4,6-bis(4hydroxy-3,5-di-tertbutylphenoxy)-1,3,5triazine
000301-02-0 Oleamide
69040
000112-80-1 Oleic acid
Same 70040
DIR
SML = 0.05 mg/kg
8
6A
8
3
R = 0.05 mg/kg of food. Based on the
reduced core set of toxicological data
according to the migration level.
Available : migration data (SM < 15 ppb) ;
gene mutation assay in bacteria (negative) ;
chromosomal aberration assay in cultured
mammalian cells (negative) ; gene mutation
assay in cultured mammalian cells
(negative).
RIVM/TNO SDS, June 2001 = CS/PM/3847
REV. I/68860.
(Adopted at the 130th SCF meeting, 13
December 2001)
http://europa.eu.int/comm/food/fs/sc/scf/out
114_en.pdf
8
Same 22763
DIR
3
DIR
1
218
+
+
+
+
+
Hydrolyses to innocuous substances.
Available: Migration data, Ames test,
hydrolysis tests.
(RIVM doc. 1990-09-12, CS/PM/2434).
ADI: not specified.
+
+
+
+
REF_N
69120
69160
CAS_N
NAME
SYNONIM
000142-77-8 Oleic acid, butyl ester
014666-94-5 Oleic acid, cobalt salt
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
7
3
3AM
EFSA/SCF_OP
(SCF, 25th Series, 1990).
Needed: hydrolysis data.
SCF_List: 3 -Restriction : 0.05 mg/kg for
cobalt
SCF_List: 1 for oleic acid ; food additive
"ADI not specified"
Remark for Commission: Intended to be
used in active packaging.
PL
CT
+
+
+
http://www.efsa.eu.int/science/afc/afc_opini
ons/195/opinion_afc_01_en1.pdf
69200
-
69280
69360
69440
000111-62-6
042254-63-7
022393-86-8
69500
000111-58-0
69520
69560
69600
69680
69760
69840
032953-65-4
003687-45-4
000142-57-4
000110-25-8
000143-28-2
016260-09-6
69848
69900
Organopolysiloxanes
000122-51-0 Orthoformic acid,
triethyl ester
000144-62-7 Oxalic acid
69920
Oleic acid, esters with
alcohols aliph., monoh.
Oleic acid, ethyl ester
Oleic acid, heptyl ester
Oleic acid, hexadecyl
ester
Oleic acid,
monoethanolamide
Oleic acid, octyl ester
Oleic acid, oleyl ester
Oleic acid, pentyl ester
N-Oleoylsarcosine
Oleyl alcohol
Oleylpalmitamide
Same 61040
Same 22766
+
7
7
7
Needed: hydrolysis data.
Needed: hydrolysis data.
Needed: hydrolysis data.
+
+
+
D
DIR
DIR
SML = 5 mg/kg
7
7
7
8
3
3
+
Needed: hydrolysis data.
Needed: hydrolysis data.
Needed: hydrolysis data.
Precursor of oleic acid.
R: 5 mg/kg of food.
Available: 3-month oral rat study,
mutagenicity studies negative, migration
data.
(RIVM doc. 17.03.92).
9
D
Same 94160
Same 22775
7
http://europa.eu.int/comm/food/fs/sc/scf/out
180_en.pdf
Needed: hydrolysis data.
DIR
SML(T) = 6 mg/kg
(29)
219
2
+
+
+
+
+
+
+
+
+
TDI: 0.1 mg/kg b.w.
2-year oral rat study, observations in man.
+
+
REF_N
70000
70040
70080
70160
70240
70320
70400
70480
70560
70640
70720
70760
70780
70800
70870
70880
70960
71020
71040
71100
CAS_N
NAME
SYNONIM
070331-94-1 2,2'-Oxamidobis[ethyl-3(3,5-di-tert-butyl-4hydroxyphenyl)propionat
e]
000106-84-3 Oxiraneoctanoic acid, 3- Same 68800
octyl, octyl ester
000080-51-3 4,4'-Oxybis(benzene
sulphonyl hydrazide)
000149-44-0 Oxymethanesulphinic
acid, sodium salt
012198-93-5 Ozokerite
000629-54-9 Palmitamide
000057-10-3 Palmitic acid
DIR
RESTRICTIONS
AND
SPECIFICATIONS
DIR
2
6A
(J. Am. Pharm. Ass. 1947, 36, 217-219,
Patty).
TDI: 10 mg/kg b.w.
90-day oral rat and dog studies, 2-generation
rat study, 2 mutagenicity tests.
(RIVM 85/627915/128 November, 1985).
3
8
1
DIR
Waiting for an answer to the letter from
EEC (CS/PM/374) to the interested industry
using RIVM conclusions in CS/PM/366.
Mineral wax. Purity to be specified.
7
7
7
7
Needed: hydrolysis data.
D
Needed: hydrolysis data.
+
+
+
+
+
+
+
+
+
+
7
Needed: hydrolysis data.
+
7
7
Needed: hydrolysis data.
Needed: hydrolysis data.
+
+
5
+
+
0
8
220
+
+
W8
DIR
CT
+
ADI: not specified.
(SCF, 25th Series, 1990).
Needed: hydrolysis data.
Needed: hydrolysis data.
Needed: hydrolysis data.
7
PL
+
D
DIR
000111-06-8 Palmitic acid, butyl ester
000628-97-7 Palmitic acid, ethyl ester
026718-83-2 Palmitic acid, heptyl
ester
000540-10-3 Palmitic acid, hexadecyl
ester
020259-32-9 Palmitic acid, iron (III)
salt
000110-34-9 Palmitic acid, isobutyl
ester
059231-33-3 Palmitic acid, isodecyl
ester
002598-99-4 Palmitic acid, octadecyl
ester
016958-85-3 Palmitic acid, octyl ester
031148-31-9 Palmitic acid, pentyl
ester
000373-49-9 Palmitoleic acid
Same 22785
017281-74-2 Palmitoylbenzoylmethan
e
063449-39-8 Paraffins, chlorinated
EFSA/SCF_OP
D
Same 61340
Same 22780
SCF
List
+
+
[IARC (1989; volume 48) has classified
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
9
D
+
+
+
+
D
+
+
chlorinated paraffins of average carbonchain length C12 and average degree of
chlorination approximately 60% as possibly
carcinogenic to humans (group 2B).]
71120
71121
71122
71150
71200
71201
71202
71280
71281
71282
71283
71300
71360
71440
71470
008012-95-1 Paraffin oil
Paraffin oil
(hydrogenated)
Paraffin oil
(conventional)
068188-18-1 Paraffin oils,
chlorosulphonated,
saponified
Paraffin, synthetic
Paraffin, synthetic
(hydrogenated)
Paraffin, synthetic
(conventional)
008002-74-2 Hydrocarbon waxes,
and 063231- paraffin and
60-7
microcrystalline
008002-74-2 Hydrocarbon waxes,
and 063231- paraffin and
60-7
microcrystalline
(hydrogenated)
Hydrocarbon waxes,
paraffin and
microcrystalline
(conventional)
063231-60-7 Paraffin wax and
hydrocarbon waxes,
microcrystalline
064742-51-4 Paraffin waxes
(petroleum),
hydrotreated
008002-03-7 Peanut oil
009000-69-5 Pectin
W
+
9
D
+
+
+
+
D
+
+
9
+
+
D
+
+
D
+
+
D
+
+
W
3
1
DIR
032534-81-9 Pentabromodiphenyl
ether
5
221
+
Food fat.
ADI: not specified.
(SCF, 7th Series, 1978).
[Some organobromo compounds have a
bioaccumulation potential and 1,2-
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
dibromoethane is a category 2 carcinogen
(EC classification).]
71520
71600
71625
71635
71645
71660
71670
000117-97-5 Pentachlorothiophenol,
zinc salt
000115-77-5 Pentaerythritol
054381-53-2 Pentaerythritol
dimyristate
025151-96-6 Pentaerythritol dioleate
068818-38-2 Pentaerythritol
monomyristate
010332-32-8 Pentaerythritol
monooleate
178671-58-4 Pentaerythritol tetrakis
(2-cyano-3,3diphenylacrylate)
8
Same 22840
DIR
2
Group TDI: 1 mg/kg b.w. (with
dipentaerythritol).
(SCF, 17th Series, 1986).
Needed: hydrolysis data.
+
+
7
R = 0.05 mg/kg food.
Available: migration data, 3 mutagenicity
tests, not regarded as genotoxic.
Remark: Since high migration into fat has
been demonstrated, the SCF recommends
that the Commission take the necessary
measures, so that the restriction proposed is
not exceeded.
(RIVM SDS, October 1994= CS/PM/2465).
(adopted at 113rd SCF meeting)(17-18
September 1998)
http://europa.eu.int/comm/food/fs/sc/scf/out
16_en.html
Needed : hydrolysis data.
7
Needed : hydrolysis data.
+
3
R = 0.05 mg/kg food.
Available: migration data (< 0.05 mg/kg
food); gene mutation assay in bacteria
(negative); chromosomal aberration assay in
cultured mammalian cells (negative); gene
mutation assay in cultured mammalian cells
(negative); acute toxicity data; 4-week oral
rat study.
RIVM/TNO SDS, January 2001 =
CS/PM/3819/71670.
(Adopted at the 128th SCF meeting, 12 July
2001)
http://europa.eu.int/comm/food/fs/sc/scf/out
97_en.pdf
+
7
DIR
DIR
SML = 0.05 mg/kg.
Not for use in polymers
contacting foods for
which simulant D is
laid down in Directive
85/572/EEC.
SML = 0.05 mg/kg
222
+
3
+
+
+
REF_N
SYNONIM
DIR
71680
006683-19-8 Pentaerythritol
Same 92655
tetrakis[3-(3,5-di-tertbutyl-4- hydroxyphenyl)propionate]
DIR
71686
007575-23-7 Pentaerythritol
tetrakis(3mercaptopropionate)
000115-83-3 Pentaerythritol
tetrastearate
000098-77-1 Pentamethyleneammoniu
mpentamethylenedithiocar
bamate
000109-66-0 Pentane
see 71686
see 71710
see 71720
007601-89-0 Perchloric acid, sodium
salt monohydrate
71695
71710
71720
71760
71840
71920
71935
71960
72000
72001
72002
72046
72048
72060
CAS_N
NAME
003825-26-1 perfluorooctanoic acid,
ammonium salt
see 72060
see 72061
see 72062
007727-54-0 Persulphuric acid,
ammonium salt
007727-21-1 Persulphuric acid,
potassium salt
008009-03-8 Petrolatum
RESTRICTIONS
AND
SPECIFICATIONS
2
DIR
DIR
SCF
List
SML = 0.05 mg/kg
(31)
EFSA/SCF_OP
PL
CT
TDI: 3 mg/kg b.w.
Oral studies for 3 months and 2 years in rats,
3 and 4 months in dogs, lifetime in mice,
reproduction and teratogenicity in mice and
rats and mutagenicity studies.
(RIVM report 89/678608/013, 1989-06-13).
+
+
8
+
D
+
8
+
3
D
D
D
3
Volatile.
SCF_list:3
Restriction: 0.05 mg/kg of food.
Remark for Commission: for fatty food
method only applicable with saturated fatty
food simulant (e.g. HB307, Mygliol).
See SCF evaluation in the website:
http://europa.eu.int/comm/food/fs/sc/scf/out
142_en.pdf
+
+
+
+
+
8
+
+
D
D
D
8
+
+
+
+
+
+
8
Same 72062
and 95695
D
223
+
+
+
REF_N
72061
72062
72080
72081
CAS_N
NAME
Petrolatum
(hydrogenated)
008009-03-8 Petrolatum
(conventional)
Petroleum hydrocarbon
resins
Petroleum hydrocarbon
resins (hydrogenated)
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
-
Same 72060
and 95695
72135
72160
Petroleum hydrocarbon
resins (conventional)
Phenols and/or cresolsstyrene and/or alphamethylstyrene and/or
(C3-C12) olefins,
copolymers
000092-84-2 Phenothiazine
000948-65-2 2-Phenylindole
72240
000090-43-7 2-Phenylphenol
72105
PL
CT
D
+
+
D
+
9
+
7
72081/10 088526-47-0 Petroleum hydrocarbon
resins (hydrogenated)
72082
SCF
List
7
-
DIR
SML = 15 mg/kg
Available: molecular weight and molecular
weight distribution curve; residual amounts
of monomers, hydrogenated monomers
and catalysts; three (negative) mutagenicity
studies (performed
with the hydrogenated hydrocarbon resin).
Needed: In first instance, migration data on
the polymeric additive; explanation why the
residual amount of the hydrogenated
monomers and unpolymerizable components
are rather high (in the product), because the
WG expressed its concern for the lack of
toxicity data; more information on
specification, i.e. information on
hydrogenation, purification and viscosity of
final product.
(RIVM/DE SDS, October 1997 =
CS/PM/3082/72081).
Under re-evaluation
http://europa.eu.int/comm/food/fs/sc/scf/out
172_en.pdf
+
+
9
+
9
+
8
2
D
224
EFSA/SCF_OP
+
TDI: 0.25 mg/kg b.w.
1 and 2-year oral rat studies, migration data.
(Arch. Toxicol. 1964, 20, 220-225).
+
+
REF_N
72320
72400
72480
72560
72620
72640
72650
72710
72720
CAS_N
NAME
SYNONIM
000092-69-3 4-Phenylphenol
Same 23140
000132-27-4 2-Phenylphenol, sodium
salt
003645-61-2 4-Phenylphenol, sodium
salt
007144-65-2 3-(2-Phenyl)phenoxySame 51470
1,2-epoxypropane
Phosphonic acid, esters
007664-38-2 Phosphoric acid
Same 23170
DIR
RESTRICTIONS
AND
SPECIFICATIONS
003138-43-0 Phosphoric acid, di-nnonyl ester
72800
001241-94-7 Phosphoric acid,
diphenyl 2-ethylhexyl
ester
Deleted. Covered by 72240.
+
+
D
Deleted. Covered by 72320.
+
9
1
DIR
SML = 2.4 mg/kg
225
CT
+
MTDI: 70 mg/kg b.w. (as P).
(SCF, 25th Series, 1990).
+
+
+
W
+
W
+
6B
DIR
PL
8
D
6B
Same 72910
EFSA/SCF_OP
6A
068515-98-0 Phosphoric acid,
alkyl(C3-C9) esters
000107-66-4 Phosphoric acid, dibutyl
ester
002197-63-9 Phosphoric acid, di-nhexadecyl esters
72760
SCF
List
2
Group R: 0.05 mg/kg b.w.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, peroxisome
proliferation studies and neurotoxicity
studies too.
Group R: 0.05 mg/kg b.w.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, peroxisome
proliferations studies and neurotoxicity
studies too.
TDI: 0.04 mg/kg b.w. (based on a 90-day
study).
The entire profile of this substance allows to
allocate a TDI.
Available: Acute toxicity data; two 90-day
oral rat studies; inadequate 2-year oral rat
and dog studies; one-generation
reproduction study using rats; teratogenicity
study; Ames assay (negative); gene mutation
assay in mouse lymphoma cells (negative);
in vivo bone marrow cytogenetic assay
(negative); neurotoxicity study; peroxisome
proliferation study.
+
+
+
+
REF_N
72880
72910
72915
72940
72960
73040
73120
73160
CAS_N
NAME
SYNONIM
097489-40-2 Phosphoric acid,
ethanolamine hexyl
branched and linear ester
001241-94-7 Phosphoric acid, 2Same 72800
ethylhexyl diphenyl ester
012645-31-7 Phosphoric acid, 2ethylhexyl ester
010402-24-1 Phosphoric acid, iron salt
007446-27-7 Phosphoric acid, lead (II)
salt
013763-32-1 Phosphoric acid, lithium
salts
010124-54-6 Phosphoric acid,
manganese salt
-
Phosphoric acid, monoand di-n-alkyl (C16 and
C18) esters
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
9
EFSA/SCF_OP
PL
(RIVM SDS, June 1996 =
CS/PM/2858/72800).
Remark for Commission: no method of
analysis is available for the enforcement of
an SML.
(Adopted at 111th SCF meeting (18-19
March 1998)).
http://europa.eu.int/comm/food/fs/sc/scf/out
10_en.pdf
Group R: 0.05 mg/kg b.w.
+
D
+
W
+
D
D
DIR
DIR
DIR
SML(T) = 0.6 mg/kg
(8) (expressed as
Lithium)
SML(T) = 0.6 mg/kg
(10) (expressed as
Manganese)
SML = 0.05 mg/kg
226
1-2
1-2
3
CT
+
+
L2 for lithium.
Group TDI: 0.01 mg/kg b.w. (as Li).
See references for benzoic acid, lithium salt.
L1 for phosphoric acid.
MTDI: 70 mg/kg bw (as P).
(SCF, 25th Series, 1991).
L2 for Manganese.
Group TDI: 0.01 mg/kg b.w. (as Mn).
See references for acetic acid, manganese(II)
salt.
L1 for Phosphoric acid.
MTDI: 70 mg/kg bw. (as P)
(SCF, 25th Series, 1991)
All 4 constituents of the mixture are
allocated in List 3 with R = 0.05 mg/kg of
food.
The four constituents of the mixture are:
- Phosphoric acid, mono-octadecyl ester
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
(CAS no. 2958-09-9)
- Phosphoric acid, di-octadecyl ester (CAS
no. 3037-89-6)
- Phosphoric acid, mono-hexadecyl ester
(CAS no. 3539-43-3)
- Phosphoric acid, di-hexadecyl ester (CAS
no. 2197-63-9)
73200
73280
73360
73440
73480
73520
73600
73680
Phosphoric acid, monoand diesters with
alcohols, aliph. (C9C18), diethanolamine
salt
Phosphoric acid, mono
and diesters with
alcohols, aliph. (C9C18), salts
003539-43-3 Phosphoric acid, monon-hexadecyl ester
9
(Adopted at the 126th SCF meeting, 28
February 2001)
http://europa.eu.int/comm/food/fs/sc/scf/out
84_en.pdf
Group R : 0.05 mg/kg b.w.
9
Group R: 0.05 mg/kg bw.
+
3
R: 0.05 mg/kg of food.
+
003900-04-7 Phosphoric acid, monon-hexyl ester
Phosphoric acid, nonyl
ester, sodium salt
039471-52-8 Phosphoric acid,
octadecyl esters
000078-51-3 Phosphoric acid,
tributoxyethyl ester
7
Based on data for 73160.
Needed: hydrolysis data.
+
9
Group R: 0.05 mg/kg b.w.
+
D
Group R: 0.05 mg/kg bw.
+
6B
Group R: 0.05 mg/kg b.w.
Available: Ames test, 14-day and 18-week
oral rat studies.
Needed: Full report of 18 week oral rat
study by Monsanto (1987) and tests for gene
mutation and chromosome aberration in
mammalian cells in vitro in the first
instance.
Group R: 0.05 mg/kg b.w.
Available: Ames test and several subchronic
+
-
000126-73-8 Phosphoric acid, tributyl
ester
6B
227
+
+
CT
REF_N
CAS_N
NAME
73720
000115-96-8 Phosphoric acid,
trichloroethyl ester
73760
-
73840
SYNONIM
DIR
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SML = ND (DL = 0.02
mg/kg, analytical
tolerance included)
Phosphoric acid,
triethanol ester
000126-71-6 Phosphoric acid,
triisobutyl ester
SCF
List
4A
9
6B
73920
000115-86-6 Phosphoric acid,
triphenyl ester
6B
74000
000078-42-2 Phosphoric acid, tris(2ethylhexyl) ester
6B
74010
145650-60-8 Phosphorous acid,
bis(2,4-di-tert.-butyl-6methylphenyl) ethyl ester
74080
DIR
SML = 5 mg/kg (sum
of phosphite and
phosphate)
025448-25-3 Phosphorous acid,
3
6B
228
EFSA/SCF_OP
oral rat studies.
Needed: remaining toxicological data
depending on migration level (see SCF
guidelines) and, if migration exceeds 0.05
mg/kg, peroxisome proliferation studies and
neurotoxicity studies too.
Carcinogenic to rats.
(NTP Tech. Rep. Ser. N. 391, May 1991).
PL
+
Group R: 0.05 mg/kg b.w.
+
Group R: 0.05 mg/kg bw.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg peroxisome
proliferation studies and neurotoxicity
studies too.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, neurotoxicity
studies too.
Group R: 0.05 mg/kg b.w.
Available: Ames test, 90-day and 2-year oral
mouse and rat studies.
Needed: remaining toxicological data
depending on migration level (see SCF
guidelines) and, if migration exceeds 0.05
mg/kg, peroxisome proliferation studies and
neurotoxicity studies too.
R = 5 mg/kg of food (covering the sum of
phosphite and phosphate).
+
Available: migration data, three in vitro
mutagenicity tests, Ames/E. coli test with
the oxidation product, 28-day oral rat study,
90-day oral rat study, "limited" delayed
neurotoxicity study in hens.
(RIVM/TNO SDS, October 1996 =
CS/PM/2916).
Group R: 0.05 mg/kg b.w.
CT
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
triisodecyl ester
74160
013423-78-4 Phosphorous acid, tris-2(cyclohexylphenyl) ester
74240
031570-04-4 Phosphorous acid,
tris(2,4-di-tertbutylphenyl) ester
74320
039865-35-5 Phosphorous acid,
tris((3-ethyl-3-oxetanyl)methyl) ester
74400
-
74455
-
74480
74560
74640
Phosphorous acid,
tris(nonyl-and/or
dinonylphenyl) ester
Phthalate mixture of the
ethyl- or butylester of
glycolic acid with aliph,
monoh, alcohols (C1-C4)
000088-99-3 o-Phthalic acid
Same 23200
6B
DIR
2
6B
DIR
SML = 30 mg/kg
2
EFSA/SCF_OP
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, peroxisome
proliferation studies and neurotoxicity
studies too.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, neurotoxicity
studies too.
TDI: 1 mg/kg b.w.
90-day and 2-year oral rat studies, 2generation study in rats and mutagenicity
studies.
(HRC report CBG 167/76339, 18 Aug.1976,
LSR 80/CIA 015/111, 21 Oct. 1980, CibaGeigy 82 0873 Feb. 1985).
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, neurotoxicity
studies too.
TDI: 0.5 mg/kg b.w.
90-day oral rat and 2-year oral rat and dog
studies, 3 generation oral rat reproduction
study, 3 negative mutagenicity studies.
(RIVM 08-1-1990).
D
DIR
2
000085-68-7 Phthalic acid, benzyl
butyl ester
000117-81-7 Phthalic acid, bis(2ethylhexyl) ester
2
2
229
PL
CT
+
+
+
+
+
+
+
Group TDI: 1 mg/kg b.w.
Included in the group TDI for phthalic
anhydride.
Under re-evaluation
+
+
+
Under re-evaluation
------------------------------------------------TDI: 0.05 mg/kg b.w.
(see the individual report, CS/PM/2161
FINAL).
+
+
REF_N
74720
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
000117-82-8 Phthalic acid, bis(2methoxyethyl) ester
SCF
List
8
EFSA/SCF_OP
PL
Due to the lack of data according to new
SCF guidelines, the substance is transferred
from List 6B to List 8. In first instance more
data on the migration and use are needed in
order to judge if further toxicity data are also
needed.
+
CT
R: 0.05 mg/kg of food (by analogy with
53860). Suspected of
embriotoxicity/teratogenicity.
Available: some studies, but inadequate.
74800
068515-42-4 Phthalic acid, dialkyl
(C7-C11) esters
7
http://www.efsa.eu.int/science/afc/afc_docu
ments/469/statement01_afc_phthalates_en1.
pdf
Due to the lack of data according to new
SCF guidelines, the substance is transferred
from List 6B to List 7. In first instance more
data on the migration and use are needed in
order to judge if further toxicity data are also
needed.
+
Group R: 0.05 mg/kg b.w.
Needed: in first instance specifications on
identity.
Toxicological data depending on migration
level (see SCF guidelines) and, if migration
exceeds 0.05 mg/kg, peroxisome
proliferation studies on specified substances.
74880
000084-74-2 Phthalic acid, dibutyl
ester
2
230
http://www.efsa.eu.int/science/afc/afc_docu
ments/469/statement01_afc_phthalates_en1.
pdf
Under re-evaluation.
-----------------------------------TDI = 0.1 mg/kg b.w.
Available: acute oral toxicity data; skin- and
eye irritation data; ADME data; 3-week oral
rat study; 4-week oral rat study; 13-week
oral rat studies; peroxisome proliferation
+
+
REF_N
74960
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
000084-61-7 Phthalic acid,
dicyclohexyl ester
SCF
List
7
EFSA/SCF_OP
studies; metabolism study; two-generation
reproduction study in rats; two teratogenicity
studies in rats (one is limited); mutagenicity
data; human data; 90-day mouse and rat
studies; 2-generation reproduction study; 5
teratogenicity studies with rats; placental
transfer study; androgen-regulated
developmental study; peroxisome
proliferation study; estrogenicity studies;
conclusion of other scopes (a.o. CSTEE
opinion).
RIVM SDS, July 2000 = CS/PM/853 REV.
I/74880.
NOTE: The TDI is based on the LOAEL of
52 mg/kg b.w. from the 2-generation rat
study with a continuous breeding protocol.
Making use of an uncertainty factor of 500
(10 for interspecies; 10 for intraspecies and
5 for extrapolating from a LOAEL to a
NOAEL), a TDI of 0.1 mg/kg b.w. is
derived.
Remark: no long-term/carcinogenicity study
is available: not considered necessary.
(To be adopted by the SCF)
Due to the lack of data according to new
SCF guidelines, the substance is transferred
from List 2 to List 7. In first instance more
data on the migration and use are needed in
order to judge if further toxicity data are also
needed.
t-TDI: 0.1 mg/kg b.w.
Available: three 90-day oral rat studies,
limited in vitro mutagenicity studies (RIVM
1988).
Needed: reproduction and teratogenicity
studies, tests for gene mutation and
chromosome aberrations in mammalian cells
in vitro.
http://www.efsa.eu.int/science/afc/afc_docu
231
PL
+
CT
REF_N
75040
75100
75105
75120
CAS_N
-
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
Phthalic acid, diesters
with hexadecanol and/or
octadecanol
SCF
List
7
-
Phthalic acid, diesters
with primary, saturated
C8-C10 branched
alcohols, more than 60%
C9.
Phthalic acid, diesters
with primary, saturated
C9-C11 branched
alcohols more than 90%
C10
000084-66-2 Phthalic acid, diethyl
ester
2
EFSA/SCF_OP
ments/469/statement01_afc_phthalates_en1.
pdf
Due to the lack of data according to new
SCF guidelines, the substance is transferred
from List 2 to List 7. In first instance more
data on the migration and use are needed in
order to judge if further toxicity data are also
needed.
Group t-TDI : 0.15 mg/kg bw (with 76120).
Available: 3 months oral rat study,
teratogenicity study and Ames test negative.
(RIVM doc. 1990-09-11, CS/PM/529).
Needed: reproduction study, peroxisome
proliferation, gene mutation and
chromosome aberration in mammalian cells
in vitro.
http://www.efsa.eu.int/science/afc/afc_docu
ments/469/statement01_afc_phthalates_en1.
pdf
Under re-evaluation.
http://europa.eu.int/comm/food/fs/sc/scf/out
50_en.pdf
CT
+
+
+
2
Under re-evaluation.
http://europa.eu.int/comm/food/fs/sc/scf/out
50_en.pdf
+
+
7
Due to the lack of data according to new
SCF guidelines, the substance is transferred
from List 2 to List 7. In first instance more
data on the migration and use are needed in
order to judge if further toxicity data are also
needed.
+
+
t-TDI: 0.2 mg/kg b.w.
Available: a 3-month oral rat study, in vitro
mutagenicity studies, i.p. teratogenicity
232
PL
REF_N
75200
75280
75360
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
003648-21-3 Phthalic acid, di-n-heptyl
ester
SCF
List
7
000084-69-5 Phthalic acid, diisobutyl
ester
8
026761-40-0 Phthalic acid, diisodecyl
D
233
EFSA/SCF_OP
studies and peroxisome proliferation studies.
(Fd. Cosm. Toxicol. 1978, 16, 415-422,
RIVM 1986, June).
Needed: reproduction and teratogenicity
study.
http://www.efsa.eu.int/science/afc/afc_docu
ments/469/statement01_afc_phthalates_en1.
pdf
Due to the lack of data according to new
SCF guidelines, the substance is transferred
from List 6B to List 7. In first instance more
data on the migration and use are needed in
order to judge if further toxicity data are also
needed.
Group R: 0.05 mg/kg b.w.
Available: Ames test.
Needed: remaining toxicological data
depending on migration level (see SCF
guidelines) and, if migration exceeds 0.05
mg/kg, peroxisome proliferation studies too.
http://www.efsa.eu.int/science/afc/afc_docu
ments/469/statement01_afc_phthalates_en1.
pdf
Due to the lack of data according to new
SCF guidelines, the substance is transferred
from List 6B to List 8. In first instance more
data on the migration and use are needed in
order to judge if further toxicity data are also
needed.
Group R: 0.05 mg/kg b.w.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, peroxisome
proliferation studies too.
http://www.efsa.eu.int/science/afc/afc_docu
ments/469/statement01_afc_phthalates_en1.
pdf
This item is changed into a new item (see
PL
CT
+
+
+
+
REF_N
75440
75520
75600
75680
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
ester
028553-12-0 Phthalic acid, diisononyl
ester
027554-26-3 Phthalic acid, diisooctyl
ester
SCF
List
D
8
000131-11-3 Phthalic acid, dimethyl
ester
7
000084-76-4 Phthalic acid, di-n-nonyl
ester
8
EFSA/SCF_OP
75105).
This item is changed into a new item (see
75100).
Due to the lack of data according to new
SCF guidelines, the substance is transferred
from List 9 to List 8. In first instance more
data on the migration and use are needed in
order to judge if further toxicity data are also
needed.
Group R: 0.05 mg/kg b.w.
http://www.efsa.eu.int/science/afc/afc_docu
ments/469/statement01_afc_phthalates_en1.
pdf
Due to the lack of data according to new
SCF guidelines, the substance is transferred
from List 6B to List 7. In first instance more
data on the migration and use are needed in
order to judge if further toxicity data are also
needed.
Group R: 0.05 mg/kg b.w.
Available: limited oral rat chronic
toxicity/carcinogenicity study, oral
teratogenicity studies in rats and mice, Ames
test.
Needed: gene mutation and chromosome
aberration in mammalian cells in vitro and
migration data in the first instance.
http://www.efsa.eu.int/science/afc/afc_docu
ments/469/statement01_afc_phthalates_en1.
pdf
Due to the lack of data according to new
SCF guidelines, the substance is transferred
from List 6B to List 8. In first instance more
data on the migration and use are needed in
order to judge if further toxicity data are also
needed.
Group R: 0.05 mg/kg b.w.
234
PL
CT
+
+
+
+
+
REF_N
75760
75840
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
014117-96-5 Phthalic acid, di-noctadecyl ester
SCF
List
8
000117-84-0 Phthalic acid, di-n-octyl
ester
7
EFSA/SCF_OP
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, peroxisome
proliferation studies too.
http://www.efsa.eu.int/science/afc/afc_docu
ments/469/statement01_afc_phthalates_en1.
pdf
Due to the lack of data according to new
SCF guidelines, the substance is transferred
from List 6B to List 8. In first instance more
data on the migration and use are needed in
order to judge if further toxicity data are also
needed.
Group R: 0.05 mg/kg b.w.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, peroxisome
proliferation studies too.
http://www.efsa.eu.int/science/afc/afc_docu
ments/469/statement01_afc_phthalates_en1.
pdf
Due to the lack of data according to new
SCF guidelines, the substance is transferred
from List 6B to List 7. In first instance more
data on the migration and use are needed in
order to judge if further toxicity data are also
needed.
Group R: 0.05 mg/kg b.w.
Available: Ames test, peroxisome
proliferation study, oral mouse reproduction
study, inadequate oral rat 90-day study,
inadequate oral rat chronic
toxicity/carcinogenicity study.
Needed: gene mutation and chromosome
aberration study in mammalian cells in vitro
and migration data in the first instance.
http://www.efsa.eu.int/science/afc/afc_docu
ments/469/statement01_afc_phthalates_en1.
235
PL
CT
+
+
+
REF_N
75850
75920
76000
CAS_N
-
NAME
Phthalic acid, di-n-octyl
and/or di-n-decyl and/or
n-decyl n-octyl esters
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
Same 67180
7
000119-06-2 Phthalic acid, di-ntridecyl ester
-
SCF
List
7
Phthalic acid, mixed
esters with butyl
glycolate and alcohols,
aliph.,monoh., (C1-C4)
8
236
EFSA/SCF_OP
pdf
Due to the lack of data according to new
SCF guidelines, the substance is transferred
from List 3 to List 7. In first instance more
data on the migration and use are needed in
order to judge if further toxicity data are also
needed.
R: 5 mg/kg of food or food simulant.
Available: 3 mutagenicity studies negative,
3 months oral rat study, test on liver
peroxisome proliferation, migration in
aqueous food simulants only.
Remark: high migration into fatty food is
likely.
(RIVM report 1995-09-04 (=CS/PM/2655)).
http://www.efsa.eu.int/science/afc/afc_docu
ments/469/statement01_afc_phthalates_en1.
pdf
Due to the lack of data according to new
SCF guidelines, the substance is transferred
from List 6B to List 7. In first instance more
data on the migration and use are needed in
order to judge if further toxicity data are also
needed.
Group R: 0.05 mg/kg b.w.
Available: Ames test.
Needed: remaining toxicological data
depending on migration level (see SCF
guidelines) and, if migration exceeds 0.05
mg/kg, peroxisome proliferation studies too.
http://www.efsa.eu.int/science/afc/afc_docu
ments/469/statement01_afc_phthalates_en1.
pdf
Due to the lack of data according to new
SCF guidelines, the substance is transferred
from List 9 to List 8. In first instance more
data on the migration and use are needed in
order to judge if further toxicity data are also
PL
+
+
+
CT
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
needed.
76005
76080
76085
000085-70-1 Phthalic acid, mixed
esters with butyl
glycolate and butanol
-
7
Phthalic acid, mixed
esters with ethyl
glycolate and alcohols,
aliph.,monoh., (C1-C4)
8
000084-72-0 Phthalic acid, mixed
esters with ethyl
glycolate and ethanol
7
237
Group R: 0.05 mg/kg b.w.
http://www.efsa.eu.int/science/afc/afc_docu
ments/469/statement01_afc_phthalates_en1.
pdf
Due to the lack of data according to new
SCF guidelines, the substance is transferred
from List 6B to List 7. In first instance more
data on the migration and use are needed in
order to judge if further toxicity data are also
needed.
Group R: 0.05 mg/kg b.w.
Available: 30-day and 1-year oral rat studies
and mutagenicity studies all inadequate.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg peroxisome
proliferation studies too.
http://www.efsa.eu.int/science/afc/afc_docu
ments/469/statement01_afc_phthalates_en1.
pdf
Due to the lack of data according to new
SCF guidelines, the substance is transferred
from List 9 to List 8. In first instance more
data on the migration and use are needed in
order to judge if further toxicity data are also
needed.
Group R: 0.05 mg/kg b.w.
http://www.efsa.eu.int/science/afc/afc_docu
ments/469/statement01_afc_phthalates_en1.
pdf
Due to the lack of data according to new
SCF guidelines, the substance is transferred
from List 6B to List 7. In first instance more
data on the migration and use are needed in
order to judge if further toxicity data are also
needed.
+
+
+
CT
REF_N
76160
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
001240-18-2 o-Phthalic acid, n-pentyl
benzyl ester
SCF
List
8
EFSA/SCF_OP
Group R: 0.05 mg/kg b.w.
Available: 4-month and 2-year rat and 1year dog studies all inadequate.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, peroxisome
proliferation studies too.
http://www.efsa.eu.int/science/afc/afc_docu
ments/469/statement01_afc_phthalates_en1.
pdf
Due to the lack of data according to new
SCF guidelines, the substance is transferred
from List 6B to List 8. In first instance more
data on the migration and use are needed in
order to judge if further toxicity data are also
needed.
PL
CT
+
Group R: 0.05 mg/kg b.w.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, peroxisome
proliferation studies too.
http://www.efsa.eu.int/science/afc/afc_docu
ments/469/statement01_afc_phthalates_en1.
pdf
76240
76320
068389-55-9 o-Phthalic acid-2,2triethyleneglycol
benzoate, copolymer
000085-44-9 Phthalic anhydride
76400
007681-93-8 Pimaricin
76415
019455-79-9 Pimelic acid, calcium
salt
9
Same 23380
DIR
2
D
Same as
23440
3AM
3
238
+
Group TDI: 1 mg/kg b.w.
(SCF, 17th Series, 1986).
Postponed. Waiting for an answer to the
circular letter from EEC (CS/PM/324)
asking informations on technological
function of the substance. Date limit:
30.6.90.
Restriction: None (the substance is a
metabolite of a non toxic fatty acid)
http://www.efsa.eu.int/science/afc/afc_opini
ons/190/opinion_afc_06_en1.pdf
+
+
+
+
REF_N
76455
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
-
SCF
List
EFSA/SCF_OP
PL
D
76460
76461
Polyacrylates and/or
polymethacrylates, salts
009003-01-4 Polyacrylic acid
009003-01-4 Polyacrylic acid
76480
-
Polyamides (Mw>6000)
D
76500
-
D
+
76510
76513
009003-17-2
-
D
9
+
+
76516
76520
76540
76560
76640
76660
76665
009003-29-6
009003-49-0
Polyamides made by
reacting acids,
dicarboxylic, linear (C2C4) with diamines (C2C4)
Polybutadiene
Polybutadiene,
maleimidised
Polybutadiene, silylated
Polybutene
Same 62280
Polybutyl acrylate
see 76670
see 76690
Polycarbonates
Poly(cyclooctene)
9
D
9
D
D
D
7
+
+
+
+
+
+
+
025267-51-0
9
7
+
Look at 76461.
Under re-evaluation
-----------------------------------------------(Restriction 5mg/kg)
In first instance, specify the nature of
starting substances and provide the MW
distribution curve.
Awaiting data on the monomer with
PM/REF.No 15030.
+
+
-
Polycyclopentadiene,
D
239
Remark: Migration of this polymeric
additive is covered by the limit for global
migration. No need for bioaccumulation
data, since no effects were seen in the
lymphonodes and Kupfer cells in the 90-day
study.
(Adopted at 111th SCF meeting (18-19
+
+
Needed: Migration of monomer from
relevant plastic materials.
(RIVM/TNO SDS, February 1997 =
CS/PM/2995/76665).
76670
CT
+
+
REF_N
76680
76681
CAS_N
SYNONIM
hydrated
068132-00-3 Polycyclopentadiene,
hydrogenated
-
76685
-
76690
-
76720
NAME
DIR
DIR
Polycyclopentadiene,
hydrogenated
RESTRICTIONS
AND
SPECIFICATIONS
SML = 5 mg/kg (1)
3AM Old 76680
Poly 1-decene,
homopolymer,
hydrogenated
Polydienic resin
synthetic, (m.w. about
1000)
009016-00-6 Polydimethylsiloxane
and 06314862-9
SCF
List
3
3
7
EFSA/SCF_OP
March 1998)
R: 5 mg/kg of food.
Toxicologically acceptable.
Available: migration data, mutagenicity
studies in vitro and in vivo negative, 3month oral rat and dog studies, 2 generation
and
teratogenicity oral rat studies and
bioaccumulation.
(RIVM, March 1995 = CS/PM/2585).
Remark: since high migration into fat has
been demonstrated, the WG recommends
that the Commission take the necessary
measures so that the restriction proposed is
not exceeded.
R: 5 mg/kg of food
Toxicologically acceptable.
Available: migration data, mutagenicity
studies in vitro and in vivo negative, 3month oral rat and dog studies, 2 generation
and
teratogenicity oral rat studies and
bioaccumulation.
(RIVM, March 1995 = CS/PM/2585).
Remark: since high migration into fat has
been demonstrated, the WG recommends
that the Commission take the necessary
measures so that the restriction proposed is
not exceeded.
Specifications: Average ponderal Mw <
10000 Daltons.
Available: 3-month oral rat study and
mutagenicity data on 1-decene, negative.
Needed: migration data in first instance.
9
Same 49525
and 23547.
D
2
240
PL
CT
+
+
+
+
+
TDI = 1.5 mg/kg b.w. based on ADI of 1.5
mg/kg bw. Specification of Mw > 6800.
(JECFA 37 M).
+
+
REF_N
76721
76730
76750
CAS_N
NAME
009016-00-6 Polydimethylsiloxane
and 063148- (Mw> 6800)
62-9
Polydimethylsiloxane,
gammahydroxypropylated
SYNONIM
Same 49525
and 23547
DIR
DIR
DIR
RESTRICTIONS
AND
SPECIFICATIONS
In compliance with the
specifications laid
down in Annex V.
SML = 6 mg/kg
2
2
EFSA/SCF_OP
(Adopted at 111th SCF meeting (18-19
March 1998)
TDI = 1.5 mg/kg b.w. based on ADI of 1.5
mg/kg bw. Specification of Mw > 6800.
(JECFA 37 M).
TDI: 0.1 mg/kg b.w.
90-day oral rat study, in-vitro and in-vivo
mutagenicity tests.
(RIVM report, 1990-04-26).
PL
+
9
+
9
+
76790
-
Polyester of adipic acid
with 1,3- and/or 1,4butanediol and/or 1,2propanediol, with free
hydroxyl groups
acetylated
2
76800
76805
-
D
9
+
+
76810
-
see 76940
Polyester of adipic acid
with 1,3-butanediol and
1,6-hexanediol
Polyesters produced by
reacting adipic acid,
9
+
76780
2
241
Group-TDI: 0.5 mg/kg .b.w. (with PM/REF
Nos. 76790, 76865 and 80820).
Same references as 76865.
(Adopted at 114th SCF meeting) (10
December 1998)
http://europa.eu.int/comm/food/fs/sc/scf/out
20_en.pdf
Group-TDI: 0.5 mg/kg .b.w. (with PM/REF
Nos. 76780, 76865 and 80820).
Same references as 76865.
(Adopted at 114th SCF meeting) (10
December 1998)
http://europa.eu.int/comm/food/fs/sc/scf/out
20_en.pdf
CT
+
Polyesters of acrylic and
methacrylic acids with
alcohols, aliphatic,
monohydric, saturated
(C1-C18)
Polyesters of adipic acid
and/or azelaic acid with
1,2-propanediol, 1,3- and
1,4-butanediol or 1,6hexanediol
024937-93-7 Polyester of adipic acid
with 1,3-butanediol
76760
-
SCF
List
+
+
+
REF_N
CAS_N
76815
-
76820
-
76824
-
NAME
SYNONIM
glycerol, and acids,
aliphatic,
monocarboxylic,
saturated, linear (C6C22)
Polyester of adipic acid
with glycerol or
pentaerythritol, esters
with even numbered,
unbranched C12-C22
fatty acids
Polyester of adipic acid
with propanediol
Polyester of adipic acid
with 1,2-propanediol, noctanol, n-decanol
DIR
RESTRICTIONS
AND
SPECIFICATIONS
3AM
SCF
List
3
EFSA/SCF_OP
PL
Restriction: Specifications: Fraction with
Mw <1000D less than 5%.
http://www.efsa.eu.int/science/afc/afc_opini
ons/768/afc_fcm_op_list6_2004.12.171.pdf
+
8
7
+
Specifications : Average ponderal Mw<1000
Daltons.
+
Available: 3-months oral rat study and
mutagenicity data on 1-decene, negative.
76830
76840
76845
-
Polyester formed from
adipic,azelaic,decanedicarboxylic,glutaric,malei
c,phthalic,sebacic,succini
c acids with one or more
diols (C2C6),glycerol,mannitol,2,
2-bis(4hydroxyphenyl)propane,
pentaerythritol sorbitol,
the terminal group may
be ester.…
Polyesters of azelaic acid
with n-hexanol and 2ethylhexanol
031831-53-5 Polyester of 1,4Polycaprolac
butanediol with
tone diol
caprolactone
7
Needed: migration data, in first instance.
Same as 76790; 76790 is covered by 76865.
Needed: Specification of the polyesters in
actual use, migration and toxicity data on
representative esters based on other acids
than adipic acid.
(Adopted at 114th SCF meeting) (10
December 1998)
http://europa.eu.int/comm/food/fs/sc/scf/out
20_en.pdf
9
3AM
3
242
+
+
Restriction: none.
Remark for the Commission: The restriction
for caprolactone (REF No 14260) and 1,4butanediol (REF No 13720) shall be
+
CT
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
respected.
http://www.efsa.eu.int/science/afc/afc_opini
ons/890/afc_op_ej201_fcm1.pdf
76850
76860
76865
76866
76868
76870
-
Polyester of
pentaerythritol with
adipic acid and oleic acid
Polyester of
pentaerythritol with
adipic acid and
unsubstituted aliph.,
monocarb. acids (C16C22)
Polyesters of 1,2propanediol and/or 1,3and/or 1,4-butanediol
and/or
polypropyleneglycol
with adipic acid, also
end-capped with acetic
acid or fatty acids C10C18 or n-octanol and/or
n-decanol
Polyesters of 1,2Same 76865
propanediol and/or 1,3and/or 1,4-butanediol
and/or
polypropyleneglycol
with adipic acid, also
end-capped with acetic
acid or fatty acids C12C18 or n-octanol and/or
n-decanol
026222-20-8 Polyester of 1,2propanediol with sebacic
acid
Polyesters prod.by
reacting 5 moles of
pentaerythritol with 4
m.of adipic acid and 12
m.of oleic acid and/or
9
+
9
+
D
SML = 30 mg/kg
2
http://europa.eu.int/comm/food/fs/sc/scf/out
20_en.pdf
+
DIR
SML = 30 mg/kg
2
Group-TDI = 0.5 mg/kg .b.w. (with
PM/REF Nos. 76780, 76790
and 80820). Remark: The group TDI is
based on analytical and toxicological
studies carried out with different polyesters
covered by the
general description of PM Ref. N. 76865.
http://europa.eu.int/comm/food/fs/sc/scf/out
20_en.pdf
+
W
9
243
+
+
+
REF_N
CAS_N
NAME
76930
76940
76945
76950
polyester prod.by
reacting 7 m.of
pentaerythritol with 6
m.of adipic acid and 16
m.of sat. etC.
see 76950
Polyesters of terephthalic
acid
Polyesters, unsaturated
Polyether ether ketone
Polyetherpolyols
009002-88-4 Polyethylene
76951
-
76880
76920
Polyethylene and
polyethylene wax
76954
064754-90-1 Polyethylene, chlorinated
with a chlorine content
up to 56%
76960
025322-68-3 Polyethyleneglycol
76980
024938-37-2 Poly(ethyleneglycoladipa
te)
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
Similar to
80000
Same
76950/8000
0
SCF
List
+
+
D
9
W
D
+
+
D
DIR
2
7
244
PL
D
D
7
Same 23590
EFSA/SCF_OP
CT
+
Deleted because covered by 76951.
+
Available: migration data from PE, PS and
PVC (samples do not contain the maximum
indicated concentration of the additive).
+
Needed:
- characterisation of the type of PE material
used in the migration test;
- migration data into olive oil or a suitable
alternative fatty food simulant.
RIVM/DE SDS, June 2000 =
CS/PM/3787/76951.
Needed: Mw distribution curve; migration of
the low molecular weight range; identity of
the migrants, if not possible then
information on the carbon chain length and
the degree of chlorination.
(TNO SDS, September 1995 =
CS/PM/2662)
(Adopted at 111th SCF meeting (18-19
March 1998)
Group TDI: 5 mg/kg b.w. (with
triethyleneglycol).
See references for triethyleneglycol.
(SCF, 6th Series, 1978).
Needed: hydrolysis data.
+
+
+
+
+
+
REF_N
CAS_N
77020
-
77022
-
77025
-
77030
068891-38-3
77035
068891-38-3
77040
77070
068954-91-6
77072
068815-56-5
77105
068410-69-5
77120
-
77200
061791-14-8
77280
009005-02-1
77320
-
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
Polyethyleneglycol
alkyl(C3-C18) ether
Polyethyleneglycol
(EO=25) alkyl(C32)
ether (Mw=1500-3000)
SCF
List
EFSA/SCF_OP
PL
9
W7
Polyethyleneglycol
(EO=25) alkyl(C32)
ether monomethacrylate
(Mw=1500-3000)
Polyethyleneglycol
Same 77035
alkyl(C12-C14) ether
sodium sulphate
Polyethyleneglycol
Same 77030
(EO=2-3) alkyl(C12C14)ether sodium
sulphate
see 76980
Polyethyleneglycol
alkyl(C10-C12) ether
sulphosuccinate,
disodium salt
Polyethyleneglycol
alkyl(C10-C16) ether
sulphosuccinate,
disodium salt
Polyethyleneglycol
bis(tallow acyl amido
ethyl)methyl ammonium
methosulphate
Polyethyleneglycol tertbutyl ether
Polyethyleneglycol
cocoamine
Polyethyleneglycol
dilaurate
W7
Needed: In first instance, Mw distribution
curve and structure of the C32 alcohol.
(Adopted at 111th SCF meeting (18-19
March 1998)
Needed: In first instance, Mw distribution
curve and structure of the C32 alcohol.
(Adopted at 111th SCF meeting (18-19
March 1998)
+
+
+
+
8
+
+
D
9
+
+
+
D
+
+
W8
+
9
+
9
+
2
245
+
9
2
Polyethyleneglycol
dimyristate
CT
Group TDI: 10 mg/kg bw for all PEG esters
of food fatty acids.
(CS/PM/1656).
Group TDI: 10 mg/kg bw for all PEG esters
of food fatty acids.
+
+
REF_N
CAS_N
NAME
77360
009005-07-6 Polyethyleneglycol
dioleate
77370
070142-34-6 Polyethyleneglycol-30
dipolyhdroxystearate
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
2
Same 77850
3AM
3
EFSA/SCF_OP
(CS/PM/1656).
Group TDI: 10 mg/kg bw for all PEG esters
of food fatty acids.
(CS/PM/1656).
Restriction: none
PL
CT
+
+
http://www.efsa.eu.int/science/afc/afc_opini
ons/675/afc_opinion20_ej109_list5_en1.pdf
77440
-
77480
-
77500
77520
Polyethyleneglycol
diricinoleate
Polyethyleneglycol
dodecyl ether
009014-92-0 Polyethyleneglycol
dodecylphenyl ether
061791-12-6 Polyethyleneglycol ester Same 77522
of castor oil
and 77521
77521
-
77522
061791-12-6 Polyethyleneglycol (EO
= 20-40) ester of castor
oil
Polyethyleneglycol
esters of (C6-C22) fatty
acids
061788-85-0 Polyethyleneglycol ester
of hydrogenated castor
oil
Polyethyleneglycol ester
of hydrogenated castor
oil fatty acids
061788-85-0 Polyethyleneglycol (EO
= 40) ester of
hydrogenated castor oil
77570
77600
77601
77602
DIR
SML = 42 mg/kg
9
+
+
W
DIR
SML = 42 mg/kg
Polyethyleneglycol ester Same 77520
of castor oil fatty acids
2
2
Same 77520
Same 77602
and 77601
2
http://europa.eu.int/comm/food/fs/sc/scf/out
142_en.pdf
TDI: 0.7 mg/kg bw based on TDI for castor
oil.
(SCF, 7th Series, 1978)(CS/PM/1656).
DIR
+
TDI: 0.7 mg/kg bw based on TDI for castor
oil.
(SCF, 7th Series, 1978)(CS/PM/1656).
TDI: 0.7 mg/kg bw based on TDI for castor
oil.
(SCF, 7th Series, 1978)(CS/PM/1656).
+
+
9
+
D
+
3
L3. Based on TDI for 77520 and L3 for
14470.
+
Same 77600
3
L3. Based on TDI for 77520 and L3 for
14470.
+
Same 77600
D
246
+
+
+
REF_N
77660
CAS_N
NAME
SYNONIM
Polyethyleneglycol
esters of natural fatty
acids
77680
see 77710
77702 Polyethyleneglycol
esters of aliph.
monocarb. acids (C6C22) and their
ammonium and sodium
sulphates
77705 Polyethyleneglycol(>2O
EO)ethers of alkyl
phenols, sodium
sulphates
77708 09002-92Polyethyleneglycol (EO=
0;09004-95- 1-50) ethers of primary
9;09043-30- linear and branched C85;09002-92- C22 alcohols
0;68439-496;etc
77708/10 069013-19-0 Polyethyleneglycol
ethers of C8-C22
alcohols
77710 Polyethyleneglycol
ethers of C10-C20
alcohols
77710/5 068439-54-3 Polyethyleneglycol
ethers of C11-C13branched alcohols
77711 068439-50-9 Polyethyleneglycol
ethers of C12-C14
alcohols
77712 068213-23-0 Polyethyleneglycol
ethers of C12-C18
alcohols
77713 009005-00-9 Polyethyleneglycol(EO= Same 78140
2) ethers of C18 alcohols and 78550
77720 Polyethyleneglycol ether
of benzylphenol, and
DIR
RESTRICTIONS
AND
SPECIFICATIONS
-
SCF
List
2
D
2
DIR
EFSA/SCF_OP
Group TDI: 10 mg/kg bw for all PEG esters
of food fatty acids.
(CS/PM/1656).
Group TDI: 10 mg/kg bw for all PEG esters
of food fatty acids.
(CS/PM/1656).
9
7
Under re-evaluation
D
9
PL
+
+
+
+
+
+
+
+
+
Look also at 67162.
+
W
247
CT
+
+
D
+
+
D
+
+
9
+
9
+
REF_N
CAS_N
77732
-
77733
-
77735
059269-54-4
77737
009002-92-0
77740
009014-90-8
77747
058853-83-1
77750
053694-15-8
77760
061791-28-4
77775
-
77790
009004-95-9
77800
068071-98-7
77840
068951-50-8
77850
070142-34-6
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
their sulphates and/or
their sodium and
ammonium sulphonates
Polyethyleneglycol
(EO=1-30, typically 6)
ether of butyl 2-cyano-3(4-hydroxy-3methoxyphenyl)acrylate
Polyethyleneglycol
(EO=1-30, typically 5)
ether of butyl 2-cyano-3(4hydroxyphenyl)acrylate
Polyethyleneglycol ether
of dodecylphenol,
sodium sulphate
Polyethyleneglycol ether Same 51985
of dodecylalcohol
and 77920
Polyethyleneglycol ether Same 78460
of nonylphenol, sodium
sulphate
Polyethyleneglycol ether
of octylphenol, sodium
sulphate
Polyethyleneglycol ether
of sorbitol
Polyethyleneglycol ether
of tallow fatty alcohol
Polyethyleneglycol ether
of trimethylolpropane
Polyethyleneglycol
hexadecyl ether
Polyethyleneglycol
hydrogenated tallow
amine ethylsulphate
Polyethyleneglycol
hydroxymethylphosphon
ate
Polyethyleneglycol 12-
SCF
List
EFSA/SCF_OP
7
Under re-evaluation.
+
7
Under re-evaluation.
+
9
+
9
+
D
+
9
+
9
+
D
+
9
+
9
+
9
+
D
+
W7-D SCF_list: 7
248
PL
+
CT
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
hydroxystearate
77880
77890
77895
009043-30-5 Polyethyleneglycol
isotridecyl ether
Polyethyleneglycol
isotridecyl ether
sulphate, salts
068439-49-6 Polyethyleneglycol
(EO=26)monoalkyl(C16-C18)
ether
EFSA/SCF_OP
PL
CT
Needed data or information:
- Molecular weight distribution curve
(differential and cumulative)
- Details on MS spectra
- Clarification of the inconsistency in the
data from the petitioner in respect to the
solubility of the test compound in various
solvents.
See SCF evaluation in the website:
http://europa.eu.int/comm/food/fs/sc/scf/out
142_en.pdf
Same 67161
DIR
SML = 0.05 mg/kg and
in compliance with the
specifications laid
down in Annex V
249
8
+
8
+
3
R = 0.05 mg/kg of food.
Available: Adequate migration data;
inadequate gene mutation assay in bacteria;
incomplete chromosomal aberration assay in
cultured mammalian cells (missing odd
pages of the report); gene mutation assay in
bacteria (negative); gene mutation assay in
cultured mammalian cells (negative);
chromosomal aberration assay in
mammalian cells (negative).
(RIVM/ISS/TNO SDS, April 1998 =
CS/PM/2859 REV.II/77895).
(Adopted at 114th SCF meeting) (9-10
December 1998)
REMARK: The sum of all components
present in Marlipal 1618/1 was determined
in the migration experiments. A shift of the
quantitative composition of the components
migrated into the food simulants related to
the initial composition of Marlipal 1618/1
was observed. The method is suitable to
determine the sum of free fatty alcohol and
the homologues of ethylene glycol ethers.
REMARK :The toxicity studies were
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
performed with Marlipal 1618/1
(commercial product with the specifications
as given in the dossier).
Adopted at 114th SCF meeting)(10
December 1998)
http://europa.eu.int/comm/food/fs/sc/scf/out
20_en.pdf
77920
78000
78080
009002-92-0 Polyethyleneglycol
monododecyl ether
052019-36-0 Polyethyleneglycol
monodecyl phosphate
009004-81-3 Polyethyleneglycol
monolaurate
78120
-
78140
009005-00-9 Polyethyleneglycol
monooctadecyl ether
009004-96-0 Polyethyleneglycol
monooleate
78160
78190
78240
78320
78360
78400
78440
Same 51985
and 77737
+
9
+
2
Polyethyleneglycol
monomyristate
009004-98-2 Polyethyleneglycol
monooleyl ether
009004-94-8 Polyethyleneglycol
monopalmitate
009004-97-1 Polyethyleneglycol
monoricinoleate
9
2
Same 77713
and 78550
Group TDI : 10 mg/kg bw for all PEG esters
of food fatty acids.
(CS/PM/1656).
Group TDI: 10 mg/kg bw for all PEG esters
of food fatty acids.
(CS/PM/1656).
8
2
DIR
SML = 42 mg/kg
009004-99-3 Polyethyleneglycol
monostearate
009016-45-9 Polyethyleneglycol
nonylphenyl ether
026027-38-3 Polyethyleneglycol,4nonylphenyl ether
2
Group TDI: 10 mg/kg bw for all PEG esters
of food fatty acids.
(CS/PM/1656).
+
+
Group TDI: 10 mg/kg b.w. for all PEG
esters of food fatty acids.(CS/PM/1656).
TDI: 0.7 mg/kg bw based on TDI for castor
oil.
(SCF, 7th Series, 1978)(CS/PM/1656).
+
+
D
+
P
+
+
+
+
W7
250
+
+
9
2
+
Needed: in the first instance, information on
the composition of the substances used.
RIVM doc. CS/PM/2223 (in CS/PM/2223
change title to "4-nonylphenylpolyethyleneglycol ethers
(PM/REF.N.78440)").
REF_N
78460
78480
78520
78550
78555
78560
78640
78720
78800
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
009014-90-8 Polyethyleneglycol
Same 77740
nonylphenyl ether,
sodium sulphate
051811-79-1 Polyethyleneglycol
nonylphenyl phosphate
009040-38-4 Polyethyleneglycol
and 067999- nonylphenyl
57-9
sulphosuccinate,
disodium salt
009005-00-9 Polyethyleneglycol
Same 77713
(EO=2) octadecylether
and 78140
062362-49-6 Polyethyleneglycol
(EO=2) octadecyl ether
phosphate
009002-93-1 Polyethyleneglycol
and 009036- octylphenyl ether
19-5
Polyethyleneglycol
and/or
polypropyleneglycol
esters of aliph.,
monocarb.,acids (C6C22) and their
ammonium and sodium
sulphates
Polyethyleneglycol
and/or
polypropyleneglycol
ethers of aliph.,
monoh.,alcohols (C8C20) and their
ammonium and sodium
sulphates
Polyethyleneglycol
and/or
polypropyleneglycol
ethers of alkylphenols
and their ammonium and
sodium sulphates
SCF
List
PL
CT
P
+
+
9
+
+
9
+
+
7
Available: Toxicological review.
Needed : migration data in first instance.
+
W
+
9
+
D
+
9
9
251
EFSA/SCF_OP
Confirmed.
Remark: some individual compounds are
listed.
(Adopted at 111th SCF meeting (18-19
March 1998)
+
+
+
+
+
REF_N
78880
78960
79040
CAS_N
NAME
Polyethyleneglycol
and/or
polypropyleneglycol
ethers of
trimethylolpropane
and/or sorbitol
Polyethyleneglycol
sorbitan
009005-64-5 Polyethyleneglycol
sorbitan monolaurate
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
-
SCF
List
PL
9
+
9
+
DIR
1
79120
009005-65-6 Polyethyleneglycol
sorbitan monooleate
DIR
2
79200
009005-66-7 Polyethyleneglycol
sorbitan monopalmitate
DIR
1
79280
009005-67-8 Polyethyleneglycol
sorbitan monostearate
DIR
1
79360
009005-70-3 Polyethyleneglycol
sorbitan trioleate
DIR
2
79440
009005-71-4 Polyethyleneglycol
sorbitan tristearate
DIR
1
252
EFSA/SCF_OP
Group ADI: 10 mg/kg b.w. for
polyethyleneglycol sorbitan monooleate,
polyethyleneglycol sorbitan monopalmitate,
polyethyleneglycol sorbitan monostearate,
polyethyleneglycol sorbitan tristearate.
(SCF, 15th Series, 1985).
Group TDI: 10 mg/kg b.w. for
polyethylenglycol sorbitan monolaurate,
polyethyleneglycol sorbitan monooleate,
polyethyleneglycol sorbitan monostearate,
polyethyleneglycol sorbitan tristearate.
(SCF, 15th Series 1985).
Group ADI: 10 mg/kg b.w. for
polyethyleneglycol sorbitan monooleate,
polyethyleneglycol sorbitan monolaurate,
polyethyleneglycol sorbitan monostearate,
polyethyleneglycol sorbitan tristearate.
(SCF, 15th Series, 1985).
Group ADI: 10 mg/kg b.w. for
polyethyle~eglycol sorbitan monooleate,
polyethyleneglycol sorbitan monopalmitate,
polyethyleneglycol sorbitan monolaurate,
polyethyleneglycol sorbitan tristearate.
(SCF, 15th Series, 1985).
Group TDI: 10 mg/kg b.w. based on the
group ADI 10 mg/kg b.w. for
polyethyleneglycol sorbitan monolaurate
and other polyethyleneglycol sorbitan esters.
(SCF, 15th Series, 1985).
Group ADI: 10 mg/kg b.w. for
polyethyleneglycol sorbitan monooleate,
polyethyleneglycol sorbitan monopalmitate,
+
CT
+
+
+
+
+
+
+
+
REF_N
CAS_N
NAME
79520
-
79550
009014-85-1 Polyethyleneglycol
2,4,7,9-tetramethyl-5decyN-4,7-diol ether
79600
009046-01-9 Polyethyleneglycol
tridecyl ether phosphate
79680
026913-06-4 Polyethyleneimine
and 00900298-6
Polyethyleneimine,
79720
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
Polyethyleneglycol
stearate
SCF
List
2
3
3AM
3
253
EFSA/SCF_OP
polyethyleneglycol sorbitan monostearate,
polyethyleneglycol sorbitan monolaurate.
(SCF, 15th Series, 1985).
Group TDI: 10 mg/kg bw for all PEG esters
of food fatty acids.
(CS/PM/1656).
Only to be used for no-stick
polytetrafluoroethane (PTFE) coatings
manufactured by sintering.
Available: information on the nature of the
decomposition residue of the substance (S440); calculated worst case migration is
0.002 mg residue/dm2 from the final PTFE
coating, assuming 100% migration of the
solid residue; gene mutation assay in
bacteria (negative); chromosomal aberration
assay in cultured mammalian cells
(negative); gene mutation assay in cultured
mammalian cells (negative); acute toxicity
data; limited 28-day range-finding study;
inadequate 90-day oral rat study; inadequate
one-generation reproduction study.
RIVM/TNO SDS, January 2001 =
CS/PM/2906 REV. I/79550.
(Adopted at the 128th SCF meeting, 12 July
2001)
http://europa.eu.int/comm/food/fs/sc/scf/out
97_en.pdf
Restriction: 5 mg/kg
Remark for Commission: Specifications:
Polyethyleneglycol (EO <=11) tridecyl ether
phosphate (mono- and dialkyl
ester) with a maximum 10% content of
polyethyleneglycol (EO<=11) tridecyl ether
http://www.efsa.eu.int/science/afc/afc_opini
ons/768/afc_fcm_op_list6_2004.12.171.pdf
PL
CT
+
+
+
W9-D
+
D
+
REF_N
CAS_N
NAME
-
79840
-
79841
103479-08-9 Polyethyleneimine,
modified
114133-44-7 Polyethyleneimine,
modified
009003-11-6 Poly(ethylene propylene)
and 106392- glycol
12-5
Poly(ethylene
propyleneglycol)(>20
EO and >20 P0)
Poly(ethylene and/or
propyleneglycol)- aliph.,
monoh., alcohols (C8C20),copolymers and
their ammonium and
sodium sulphates
111905-54-5 Poly(ethylene
propylene)glycol alkyl
(C13-C15)ethers
067167-17-3 Poly(ethylene
propylene)glycol
dioleate
79920
79930
79950
79960
79965
DIR
RESTRICTIONS
AND
SPECIFICATIONS
modified with adipic
acid, diethylenetriamine,
and epichlorohydrin
Polyethyleneimine,
butylated
79760
79842
SYNONIM
SCF
List
2
Polyethyleneimine,
modified
9
PL
TDI: 0.1 mg/kg b.w.
Specification for ethyleneimine (R= 0.010
mg/kg).
90-day oral rat study, mutagenicity studies
negative.
(RIVM report 90/678608/002 February
1990).
In principle List 9.
Some substances covered by 79840 have
been identified:
(polymin (R) SN (CAS N. 103479-08-9)(see
CS/PM 330) but documentation is
inadequate. The substances must be listed
individually and assessed accordingly. L8.
+
+
D
+
Under re-evaluation
+
9
+
D
+
D
9
Same as 79968.
CT
+
D
7
254
EFSA/SCF_OP
+
+
+
REF_N
79967
79968
79969
80000
CAS_N
NAME
055126-40-4 Poly(ethylene
propylene)glycol
distearate
069227-21-0 Poly(ethylene propylene)
and 111905- glycol ethers of C13-C15
54-5
alcohols
037251-69-7 Poly(ethylene
propylene)glycol
nonylphenyl ether
009002-88-4 Polyethylene wax
SYNONIM
Similar to
76950
DIR
RESTRICTIONS
AND
SPECIFICATIONS
3AM
SCF
List
+
8
+
P
+
80077
068441-17-8 Polyethylene, oxidized
80080
80240
068441-17-8 Polyethylene waxes,
oxidized
037349-34-1 Polyglycerol
monostearate
029894-35-7 Polyglycerol ricinoleate
80320
009009-32-9 Polyglycerol stearate
1
80330
025359-91-5 Poly(1Same 54930
hydroxynaphthylmethane
)(=formaldehyde-1naphtalenol copolymer)
D
80160
7
Restriction: None
http://www.efsa.eu.int/science/afc/afc_opini
ons/11/opinion_afc_07_en1.pdf
http://europa.eu.int/comm/food/fs/sc/scf/out
86_en.pdf
Needed data or information:
-In first instance, mutagenicity tests on a
well characterised (GPC profile, content of
epoxy groups, content of peroxide groups
and oxygen) low molecular weight fraction.
-If the migration data stand, then the full
core set of the toxicity data will be needed.
-If a SML has to be allocated there will also
be a need for an in house validated method
for the determination in food simulants.
http://europa.eu.int/comm/food/fs/sc/scf/out
86_en.pdf
D
1
DIR
1
255
PL
9
3
Similar to
80077
EFSA/SCF_OP
ADI: 25 mg/kg b.w.
(SCF, 7th Series, 1978).
ADI: 7.5 mg/kg b.w.
(SCF, 7th Series, 1978).
ADI: 25 mg/kg b.w.
(JECFA 26 M., 1982).
See 54930.
CT
+
+
+
+
+
+
+
+
+
REF_N
80340
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
027924-99-8 Poly(12-hydroxystearic
acid)
SCF
List
7
Needed: Mw distribution curve and adequate
migration data.
Under re-evaluation
80360
009003-27-4 Polyisobutene
7
80365
80380
026335-74-0 Poly(isobutyl acrylate)
009003-04-7 Polymer of acrylic acid,
sodium salt
see 80340
Polymers of dioctyltin
bis(2-ethylhexyl
maleate)
Polymers of dioctyltin
bis(2-ethylhexyl
mercaptoacetate)
Polymers of di-n-octyltin
dimaleate
025087-26-7 Polymethacrylic acid
Polymethacrylic acids,
salts
082451-48-7 Poly(6-morpholino1,3,5,-triazine-2,4,-diyl)[(2,2,6,6,-tetramethyl-4piperidyl)imino]hexamethylene-[(2,2,6,6tetramethyl-4-piperidyl)imino]
Polyolefins (low
molecular weight)
068410-99-1 Polyolefins, chlorinated
9
D
+
+
D
9
+
+
9
+
9
+
D
D
+
+
80440
80460
80470
80480
80550
80560
+
+
7
Under re-evaluation.
+
9
Look also at 76685.
+
9
256
Available: contradictory information on Mw
distribution.
Needed: migration of products on the market
with low average Mw.
CT
+
058128-22-6 Poly(12-hydroxystearic
acid) stearate
80425
W7
Available: Ames test + micronucleus test
with 2 commercial product s; inadequate
migration data.
PL
80345
80400
80410
octadecanoic
acid, 12hydroxy-,
homopoly
EFSA/SCF_OP
+
+
REF_N
CAS_N
NAME
with a chlorine content
of up to 56%
Polyoxyalkyl(C2C4)dimethylpolysiloxane
80640
-
80670
80720
Polyphenylene oxide
008017-16-1 Polyphosphoric acids
80760
80765
009003-07-0 Polypropylene
Polypropylene and
polypropylene wax
025322-69-4 Polypropyleneglycol
80800
SYNONIM
80820
025101-03-5 Polypropyleneglycol
adipate
80845
029408-67-1 Polypropyleneglycol
azelate (end-capped with
stearic acid)
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
DIR
3
DIR
D
1
D
D
Same 23650
and 23651
DIR
EFSA/SCF_OP
Available: average MW ~7600, 2 negative
mutagenicity tests, 90-day oral rat study
(RIVM doc. CS/PM/91, 1987).
MTDI: 70 mg/kg b.w. (as P).
(JECFA 26 M., 1982).
Look at 80765.
PL
CT
+
+
+
+
+
+
+
3
Toxicologically acceptable.
+
D
Deleted. Covered by 76865.
http://europa.eu.int/comm/food/fs/sc/scf/out
20_en.pdf
Needed: data according to SCF guidelines
on polymeric additives.
+
W8
+
Remark: name need eventually be modified,
add: end-capped with stearic acid.
80850
-
80880
80890
-
80895
-
80930
-
80940
-
Polypropyleneglycol
butyl ether
see 80820
Polypropyleneglycol
esters with acids, aliph.,
monocarb., sat. (C12C20)
Polypropyleneglycol
esters of
aliph.,monocarb.,acids(C
6-C22) and their
ammonium and sodium
sulphates
Polypropyleneglycol
ether of
trimethylolpropane
Polypropyleneglycol
laurate
9
257
+
D
D
+
+
9
+
9
+
9
+
REF_N
80950
80960
80970
80985
81000
81015
81030
81040
81060
81080
81100
81120
81122
81123
CAS_N
NAME
Polypropyleneglycol
octadecyl phosphate
see 80950
Polypropyleneglycol
oleate
Polypropyleneglycol
oleate butyl ether
009003-11-6 Polypropyleneglycol
polyoxyethylated
Polypropyleneglycol
ricinoleate
Polypropyleneglycol
stearate
see 81100
009003-07-0 Polypropylene wax
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
-
SCF
List
EFSA/SCF_OP
PL
W9
+
D
9
+
+
9
Same 80765
009003-53-6 Polystyrene
068441-35-0 Polystyrene,
hydrogenated
Polyterpenes
Polyterpenes,
hydrogenated
Polyterpenes,
hydrogenated
+
D
+
9
+
9
+
D
3
3AM
Restriction: None
http://www.efsa.eu.int/science/afc/afc_opini
ons/11/opinion_afc_07_en1.pdf
http://europa.eu.int/comm/food/fs/sc/scf/out
86_en.pdf
D
D
258
CT
+
+
+
+
+
9
9
Confirmed.
+
+
7
Available: Migration data, 3 mutagenicity
studies on the polymeric additive itself
negative, unacceptable 90-day oral rat study
(unvalidated IBT study).
Needed: Information on whether the
substance tested is representative of other
brands of polyterpene, hydrogenated resins.
In first instance , explanation of presence of
unhydrogenated monomer (100 ppm) in the
polymeric additive (if presence is confirmed,
3 mutagenicity tests on unhydrogenated
monomer will be required) as well a 90-day
oral rat study on the polymeric additive
itself.
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
+
+
+
+
(RIVM/TNO SDS CS/PM/2750, January
96).
81160
81200
81215
81220
81230
81245
81260
009002-84-0 Polytetrafluoroethylene
071878-19-8 Poly[6-[(1,1,3,3tetramethylbutyl)amino]1,3,5-triazine-2,4-diyl][(2,2,6,6-tetramethyl-4piperidyl)imino]hexamethylene[(2,
2,6,6-tetramethyl-4piperidyl)imino]
065447-77-0 Poly/(2,2,6,6Same 91150
tetramethylpiperidine1,4diyl)ethyleneoxysuccinyl
oxyl
192268-64-7 Poly-[[6-[N-(2,2,6,6tetramethyl-4piperidinyl)-nbutylamino]-1,3,5triazine-2,4diyl][(2,2,6,6tetramethyl-4piperidinyl)imino]-1,6hexanediyl[(2,2,6,6tetramethyl-4piperidinyl)imino]]alpha-[N,N,N',N'tetrabutyl-N"-(2,2,6,6tetramethyl-4piperidinyl)-N
DIR
DIR
SML = 3 mg/kg
SML = 5 mg/kg
Polyurethanes
009003-20-7 Polyvinyl acetate
Polyvinyl acetate,
partially hydrolyzed
D
2
D
Same as 60800.
+
3
R = 5 mg/kg of food
Available: molecular mass distribution
curve, specifications; specific migration;
gene mutation assay in bacteria (negative);
chromosomal aberration assay in cultured
mammalian cells (negative); gene mutation
assay in cultured mammalian cells
(negative); 28-day oral rat study; gene
mutation assay with two migrating byproducts (negative).
(RIVM/DE SDS, September 1999 =
CS/PM/3272 REV. I/81220).
(Adopted at the 119th SCF meeting) (2
December 1999)
http://europa.eu.int/comm/food/fs/sc/scf/out
50_en.pdf
+
+
+
+
+
+
9
D
7
259
TDI: 0.05 mg/kg b.w.
3-month oral dog and 3- and 6-month oral
rat studies, mutagenicity studies.
(RIVM rep.89/678608/006 1989-04-11).
Available: molecular weight distribution
curve.
Needed: migration data and toxicity data
according to SCF guidelines on the
compound with the highest concentration of
REF_N
CAS_N
NAME
81280
009002-89-5 Polyvinyl alcohols
81310
81325
009002-86-2 Polyvinyl chloride
025498-06-0 Polyvinylcyclohexane
81360
81390
81440
81460
025104-37-4
024937-79-9
-
81475
81485
81500
81515
Polyvinylethers
Poly(vinyl ethyl ether)
Polyvinylidene fluoride
Poly-N-vinyl-Nmethylacetamide
Poly-N-vinyl-Nmethylformamide
(m.w.>40.000)
025035-84-1 Polyvinyl propionate
009003-39-8 Polyvinylpyrrolidone
087189-25-1 Poly(zinc glycerolate)
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
Same 23680
SCF
List
7
D
W7
DIR
Available: 3-mutagenicity tests on the
polymer, negative and migration data, Ames
test on the monomer. Molecular weight
distribution curve.
Needed: remaining mutagenicity studies
according to the SCF guidelines on the
monomer.
(RIVM-TNO 1995-04-10 = CS/PM/2587)
CT
+
+
+
+
+
+
+
+
9
+
9
9
2-3
+
+
+
007758-02-3 Potassium bromide
DIR
1
81600
001310-58-3 Potassium hydroxide
DIR
1
81680
007681-11-0 Potassium iodide
DIR
260
the low molecular weight fraction.
Needed: migration data on the compound
with the highest concentration of the low
molecular weight fraction.
PL
9
9
D
9
81520
SML(T) = 1 mg/kg
(11) (expressed as
Iodium)
EFSA/SCF_OP
1
L3.
Toxicologically acceptable.
(TNO, 1995-04-11 = CS/PM/2588)
L2 for Zinc
Same as for 96180
Group ADI: 1 mg/kg b.w. (as Br) as
pesticide residue.
See references for ammonium bromide in
list 2.
ADI: not specified.
(SCF, 25th Series, 1991)
PMTDI: 0.017 mg/kg b.w. (as I).
(JECFA 33 M., 1988).
+
+
+
+
+
+
REF_N
SYNONIM
DIR
Powders, flakes and
fibers of brass, bronze,
copper, stainless steel,
tin and alloys of copper,
tin and iron
Powders, flakes and
fibres of chromium,
molybdenum, nickel and
their alloys
120498-03-5 1,3Same 38510
Propanediamine,N,N"1,2
-ethanediylbis-,polymer
with N-butyl-2,2,6,6tetramethyl-4piperidinamine and
2,4,6-trichloro-1,3,5triazine
DIR
81840
000057-55-6 1,2-Propanediol
DIR
81880
000071-23-8 1-Propanol
Same 23740
and 82065
Same 23800
81882
000067-63-0 2-Propanol
Same 23830
and 62480
DIR
81920
005520-20-7 1-Propanol,3-[1,3,3,3tetramethyl-1-[(trimethyl
silyl) oxy] disiloxanyl],hydrogen sulphate,
compound with 2propanamine(1:1)
174254-23-0 2-Propenoic acid, methyl Same 31542
ester, telomer with 1dodecanethiol, C16-18
alkylesters (name to be
checked)
000079-09-4 Propionic acid
Same 23890
81760
81761
81820
81960
82000
CAS_N
NAME
-
RESTRICTIONS
AND
SPECIFICATIONS
SML(T) = 30 mg/kg
(7) (expressed as
Copper); SML = 48
mg/kg (expressed as
Iron)
SCF
List
For Copper. Same as Ref.No 30080.
+
7
Needed: Migration data and justification of
use.
+
3
R: 5 mg/kg of food.
Available: Specific migration is 0.1-0.6
mg/kg food; three negative mutagenicity
studies; acute toxicity data; 90-day rat
gavage study (no NOAEL); skin/eye
irritation studies; 90-day oral rat study.
(RIVM/TNO SDS, March 1998 =
CS/PM/2805 REV. I/81820).
(Adopted at 114th SCF meeting) (10
December 1998)
http://europa.eu.int/comm/food/fs/sc/scf/out
20_en.pdf
ADI: 25 mg/kg b.w.
(JECFA 17 M., 1973).
See references for same substance in
monomer report.
t-ADI : 1.5 mg/kg b.w.
(SCF, 11th Series, 1981).
+
3
1
+
+
+
D
+
Group ADI: not specified.
(SCF, 1st Series, 1974).
CT
+
+
W
1
261
PL
2
1
DIR
EFSA/SCF_OP
+
+
+
REF_N
82020
CAS_N
NAME
SYNONIM
019019-51-3 Propionic acid, cobalt
salt
DIR
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SML(T) = 0.05 mg/kg
(14) (expressed as
Cobalt)
SCF
List
1-3
EFSA/SCF_OP
L3 for Cobalt.
R: 0.05 mg/kg of food (as Cobalt).
(RIVM, summary data, October 1992=
CS/PM/1707).
PL
+
L1 for propionic acid.
See references for propionic acid.
82065
000057-55-6 1,2-Propyleneglycol
82080
009005-37-2 1.2-Propyleneglycol
alginate
1,3-Propyleneglycol
alginate
022788-19-8 1,2-Propyleneglycol
dilaurate
82160
82240
82320
82400
82480
82560
1,3-Propyleneglycol
dilaurate
000105-62-4 1,2-Propyleneglycol
dioleate
Same 23740
and 81840
D
DIR
1
Group ADI: 25 mg/kg b.w.
(JECFA 17 M., 1973).
8
DIR
1
-
000821-69-2 1,3-Propyleneglycol
dioleate
033587-20-1 1,2-Propyleneglycol
dipalmitate
+
+
Group ADI: 25 mg/kg b.w. (as
propyleneglycol) for 1,2-propyleneglycol
esters of fatty acids.
(JECFA 17 M., 1973).
8
DIR
1
1
82640
056414-56-3 1,2-Propyleneglycol
diricinoleate
7?
82720
006182-11-2 1,2-Propyleneglycol
distearate
DIR
1
82800
027194-74-7 1,2-Propyleneglycol
monolaurate
DIR
1
262
+
+
Group ADI: 25 mg/kg b.w. (as
propyleneglycol) for 1,2-propyleneglycol
esters of fatty acids.
(JECFA 17 M., 1973).
8
DIR
+
+
+
Group ADI: 25 mg/kg b.w. (as
propyleneglycol) for 1,2-propyleneglycol
esters of fatty acids.
(JECFA 17 M., 1973).
Needed: hydrolysis and migration data.
http://europa.eu.int/comm/food/fs/sc/scf/out
161_en.pdf
Group ADI: 25 mg/kg b.w. (as
propyleneglycol) for 1,2-propyleneglycol
esters of fatty acids.
(JECFA 17 M., 1973).
Group ADI: 25 mg/kg b.w. (as
propyleneglycol) for 1,2-propyleneglycol
esters of fatty acids.
+
+
+
+
CT
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
(JECFA 17M., 1973).
82880
82960
83040
83120
83200
83280
-
1,3-Propyleneglycol
monolaurate
001330-80-9 1,2-Propyleneglycol
monooleate
8
DIR
1,3-Propyleneglycol
monooleate
029013-28-3 1,2-Propyleneglycol
monopalmitate
1
-
1,3-Propyleneglycol
monopalmitate
026402-31-3 1,2-Propyleneglycol
monoricinoleate
+
Group ADI: 25 mg/kg b.w. (as
propyleneglycol) for 1,2-propyleneglycol
esters of fatty acids.
(JECFA 17 M., 1973)
8
DIR
1
-
+
Group ADI: 25 mg/kg b.w. (as
propyleneglycol) for 1,2-propyleneglycol
esters of fatty acids.
(JECFA 17 M., 1973)
8
Same 83775
7?
83300
001323-39-3 1,2-Propyleneglycol
monostearate
DIR
1
83320
-
Propylhydroxyethylcellul
ose
DIR
2
83325
-
Propylhydroxymethylcell
ulose
DIR
2
83330
-
Propylhydroxypropylcell
ulose
DIR
2
83360
83440
see 83300
002466-09-3 Pyrophosphoric acid
DIR
D
1
83455
83460
013445-56-2 Pyrophosphorous acid
012269-78-2 Pyrophyllite
DIR
DIR
3
3
263
+
+
+
Needed: hydrolysis and migration data.
http://europa.eu.int/comm/food/fs/sc/scf/out
161_en.pdf
Group ADI: 25 mg/kg b.w. (as
propyleneglycol) for 1,2-propyleneglycol
esters of fatty acids.
(JECFA 17 M., 1973)
TDI: not specified based on group ADI
(=not specified) for certain modified
celluloses.
(JECFA 35M., 1989).
Group TDI: not specified based on group
ADI (=not specified) for certain modified
celluloses.
(JECFA 35M., 1989).
Group TDI: not specified based on group
ADI (=not specified) for certain modified
celluloses.
(JECFA 35M., 1989).
MTDI: 70 mg/kg b.w. (as P).
(JECFA 26 M., 1982).
Easily oxidized to phosphoric acid.
Inert material.
+
+
+
+
+
+
+
+
+
+
REF_N
83470
83475
83480
83510
83520
83530
83535
83555
CAS_N
NAME
014808-60-7 Quartz
121888-66-2 Quaternary ammonium
compounds,
benzylbis(hydrogenated
tallow alkyl)methyl,
benzoate lauryl sulphate,
salts with bentonite
121888-67-3 Quaternary ammonium
compounds,
benzylbis(hydrogenated
tallow alkyl)methyl,
bis(hydrogenated tallow
alkyl)dimethylammoniu
m salt with hectorite
121888-68-4 Quaternary ammonium
compounds,
benzyl(hydrogenated
tallow alkyl)dimethyl,
chlorides, compounds
with bentonite and
sodium stearate
see 83610
071011-24-0 Quaternary ammonium
compounds,
benzyl(hydrogenated
tallow alkyl)dimethyl,
chlorides, compounds
with bentonite
068989-03-7 Quaternary ammonium
compounds, coco alkyl
bis(hydroxyethyl)methyl, ethoxylated
methyl sulphate
071011-27-3 Quaternary ammonium
compounds,
bis(hydrogenated tallow
alkyl)dimethyl,
chlorides, compounds
with hectorite
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
DIR
SCF
List
3
W
Inert material.
PL
CT
+
+
+
9
+
9
+
D
9
+
9
+
W
264
EFSA/SCF_OP
+
+
REF_N
83560
83565
83580/0
83580/1
83595
83598
83599
CAS_N
NAME
SYNONIM
068953-58-2 Quaternary ammonium
compounds,
bis(hydrogenated tallow
alkyl)dimethyl, salts with
bentonite
093572-63-5 Quaternary ammonium
compounds N,N,N'tris(hydroxyethyl)-N,N'dimethyl-N'-tallow
alkyltrimethylene di,bis(methyl sulphates),
salts
008002-13-9 Rapeseed oil (food grade
Same
quality)
45060/0,450
60/1,and
83580/1
008002-13-9 Rapeseed oil
Same
45060/0,450
60/1 and
83580/0
119345-01-6 Reaction product of ditert-butylphosphonite
with biphenyl, obtained
by condensation of 2,4di-tert-butylphenol with
Friedel Craft reaction
product of phosphorus
trichloride and biphenyl
181314-48-7 Reaction prod.of 3Same 67170
hydroxy-5,7-ditert.butylbenzofuran-2one with o-xylene
consisting of 5,7-ditert.butyl-3-(2,3dimethylphenyl)-(3h)benzofuran-2-one and 57-di-tert.butyl-3-(3,4dimethylphenyl)-(3h)benzof.
068442-12-6 Reaction products of
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
9
DIR
SML = 18 mg/kg and
in compliance with the
specifications
mentioned in Annex V.
+
W9
+
D
+
+
3
Food fat.
+
+
2
TDI: 0.3 mg/kg b.w.
90-day oral rat study and mutagenicity
studies.
(Sandoz report 1979).
+
+
D
DIR
SML(T) = 0.18 mg/kg
265
CT
2
+
Group-TDI: 0.003 mg/kg b.w. (as Sn) (with
+
REF_N
CAS_N
NAME
SYNONIM
DIR
oleic acid, 2mercaptoethyl ester, with
dichlorodimethyltin,
sodium sulphide and
trichloromethyltin
83600
83610
83650
see 83690
073138-82-6 Resin acids and rosin
acids
009008-34-8 Resin acids and rosin
acids, manganese salts
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
(16) (expressed as Tin)
Same 24070
PL
2
Group TDI: 1 mg/kg b.w.
(SCF, 17th Series, 1986)
L2 (= 1 mg/kg b.w.) for resin acids.
+
+
+
L2 for the Mn.
Group TDI: 0.01 mg/kg b.w. (as Mn).
See references for 30180 in L2 in this report.
83680
83690
83700
see 83700
035732-94-6 Ricinoleamide
000141-22-0 Ricinoleic acid
83760
-
Same 24075
DIR
SML = 42 mg/kg
Ricinoleic acid, esters
with alcohols, aliph.,
monoh.
D
8
3
9
266
CT
49600 and 67520).
Available: migration data from PVC;
hydrolysis in gastric fluid; two bacterial
reversion assays; a mouse bone marrow
micronucleus assay; with methyltin
compounds two bacterial reversion assays; a
mammalian cell gene mutation assay; an in
vitro chromosomal aberration assay; a
mouse bone marrow micronucleus test; an in
vivo/in vitro UDS in rat liver; acute toxicity
data; a subacute oral rat study; 90-days oral
rat studies on 3 representative mixtures of
methyltin stabilisers, on methyltin chlorides
and on mercaptoethyloctadecenoic.
(RIVM/ISS/TNO October
1996,=CS/PM/2908)
(Adopted at 111th SCF meeting (18-19
March 1998)).
http://europa.eu.int/comm/food/fs/sc/scf/out
10_en.pdf
D
2
DIR
EFSA/SCF_OP
SCF_List: 3
Restriction: none. In small doses
metabolised similarly to food fats.
See SCF evaluation in the website:
http://europa.eu.int/comm/food/fs/sc/scf/out
181_en.pdf
+
+
+
+
REF_N
83775
83840
83880
83920
84000
84080
84090
84095
84100
84210
84240
84320
84400
CAS_N
NAME
026402-31-3 Ricinoleic acid, esters
with 1,2-propanediol
008050-09-7 Rosin
009010-69-9 Rosin acids, zinc salt
Rosin derivatives
008050-31-5 Rosin, ester with
glycerol
008050-26-8 Rosin, ester with
pentaerythritol
065997-04-8 Rosin, fumarated
068201-58-1 Rosin, fumarated,
polymer with
formaldehyde
065997-11-7 Rosin, fumarated,
polymer with
pentaerythritol
065997-06-0 Rosin, hydrogenated
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
Same 83280
SCF
List
D
Same
14687,24100
,24130 and
45055
Same 96280
DIR
2
Same 24115
DIR
D
9
1
DIR
2
Same 84420
EFSA/SCF_OP
CT
+
Group TDI: 1 mg/kg b.w.
(SCF, 17th Series, 1986).
ADI= 12.5 mg/kg b.w.
(SCF, 32th Series, 1992).
Group TDI= 1 mg/kg b.w.
Included in the group TDI for colophony of
1 mg/kg b.w.
(SCF, 6th Series, 1978) also including rosins
(SCF, 17th Series, 1986).
+
+
+
+
+
+
+
W
W
+
+
W
+
DIR
2
065997-13-9 Rosin, hydrogenated,
ester with glycerol
008050-15-5 Rosin, hydrogenated,
ester with methanol
DIR
3
DIR
2
064365-17-9 Rosin, hydrogenated,
ester with pentaerythritol
DIR
2
267
PL
Group TDI: 1 mg/kg bw.
Included in the TDI for
24070/24130/24190/83610/83840/84080/
84320/84400/84420.
(SCF, 17th Series, 1986).
Toxicologically acceptable.
+
+
+
+
Group TDI= 1 mg/kg b.w.
Included in the group TDI for colophony of
1 mg/kg b.w.
(SCF 6th, Series 1978) also including rosins
(SCF, 17th Series, 1986).
Group TDI= 1 mg/kg b.w.
Included in the group TDI for colophony of
1 mg/kg b.w.
(SCF, 6th Series 1978) also including rosins
(SCF, 17th Series, 1986).
+
+
+
REF_N
CAS_N
NAME
SYNONIM
84410
84420
008050-28-0 Rosin, maleated
065997-06-0 Rosin, partially
hydrogenated
84425
065997-07-1 Rosin, polymer with
formaldehyde
068475-37-6 Rosin, polymerised, ester
with glycerol
083137-13-7 Rosin, reaction products
with acrylic acid
009006-03-5 Rubber, chlorinated
Same 24220
009006-04-6 Rubber, natural
Same 24250
Rubber, synthetic
000069-72-7 Salicylic acid
Same 24270
84430
84435
84480
84560
84570
84640
84720
84800
84880
84960
85030
85040
85120
85200
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
W
2
Same 84210
000118-58-1 Salicylic acid, benzyl
ester
000087-18-3 Salicylic acid, 4-tertbutylphenyl ester
000119-36-8 Salicylic acid, methyl
ester
000118-55-8 Salicylic acid, phenyl
ester
000111-20-6 Sebacic acid
Sebacic acid, alkyl (C6C12) esters
000122-62-3 Sebacic acid, bis(2ethylhexyl) ester
DIR
DIR
Group TDI: 1 mg/kg bw.
Included in the TDI for
24070/24130/24190/83610/83840/84080/84
210 84320/84400.
(SCF, 17th series, 1986).
+
+
W
+
SML = 12 mg/kg
2
DIR
SML = 30 mg/kg
1
Migration unlikely.
Naturally occurring in food in low
concentration.
Needed: hydrolysis data.
7
TDI: 0.2 mg/kg b.w.
2-year oral rat study.
(RIVM March 1972).
ADI: 0.5 mg/kg b.w.
(JECFA 11 M., 1967).
Needed: hydrolysis data.
D
9
Group R: 0.05 mg/kg b.w.
7
8
268
+
W
DIR
027214-90-0 Sebacic acid, bis(6methylheptyl) ester
CT
+
7
Same 24280
PL
W
9
3
9
3
DIR
EFSA/SCF_OP
Group R: 0.05 mg/kg b.w.
Available: Ames test and 3-week oral rat
study.
Needed: remaining toxicological data
depending on migration level (see SCF
guidelines) and, if migration exceeds 0.05
mg/kg, peroxisome proliferation studies too.
Group R: 0.05 mg/kg b.w.
Needed: toxicological data depending on
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
REF_N
85280
85360
CAS_N
NAME
SYNONIM
052829-07-9 Sebacic acid, bis(2,2,6,6tetramethyl-4-piperidyl)
ester
000109-43-3 Sebacic acid, dibutyl
ester
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
7
DIR
85440
000106-79-6 Sebacic acid, dimethyl
ester
85520
002432-87-3 Sebacic acid, di-n-octyl
ester
85550
009000-59-3 Shellac
Same 24440
85580
85600
007631-86-9 Silica
Silicates, natural
Same 86240
85601
-
Same 85600
85610
-
Silicates, natural (with
the exception of
asbestos)
Silicates, natural,
DIR
3
Same 24370
8
8
1
D
D
3
DIR
3
DIR
3
269
EFSA/SCF_OP
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg peroxisome
proliferation studies too.
Available: 4 mutagenicity studies.
Needed: migration data, use, stability during
production and use.
Toxicologically acceptable (hydrolyses in
intestinal fluid to sebacic acid and butanol).
Available: migration data in olive oil;
hydrolysis data; inadequate semichronic oral
rat and chronic oral rat and reproduction
study; inadequate Ames test; inadequate
Drosophila study; inadequate micronucleus
assay; three adequate in vitro mutagenicity
studies; peroxisome proliferations study.
(RIVM/TNO July 1996,=CS/PM/2860)
Group R: 0.05 mg/kg b.w.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg peroxisome
proliferation studies too.
Group R: 0.05 mg/kg b.w.
Available: "data inadequate"(extract from
Lefaux book".
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, peroxisome
proliferation studies too.
ADI: acceptable.
(SCF, 26th Series, 1992).
Inert material. Some specific silicates have
been allocated an ADI, not specified.
(SCF, 25th Series, 1991)
PL
CT
+
+
+
+
+
+
+
+
+
+
Inert material.
+
+
REF_N
85680
85760
CAS_N
NAME
silanated (with the
exception of asbestos)
001343-98-2 Silicic acid
012068-40-5 Silicic acid, lithium
aluminium salt(2:1:1)
SYNONIM
DIR
See also
85980/8642
7
DIR
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
2
SML(T) = 0.6 mg/kg
(8) (expressed as
Lithium)
2-3
EFSA/SCF_OP
PL
CT
TDI: not specified based on ADI: not
specified for silicon dioxide.
(SCF, 25th Series, 1991)
L2 for Li
Group TDI: 0.01 mg/kg b.w. (as Li).
See references for 38000 in L2 in this report.
+
+
+
L2 for Al
TDI: 1 mg/kg bw (as Al) based on PTWI: 7
mg/kg bw (as Al).
(SCF, 25th Series, 1991).
85840
85920
85950
053320-86-8 Silicic acid, lithium
magnesium sodium salt
012627-14-4 Silicic acid, lithium salt
037296-97-2 Silicic acid, magnesiumsodium-fluoride salt
DIR
DIR
SML(T) = 0.6 mg/kg
(8) (expressed as
Lithium)
SML(T) = 0.6 mg/kg
(8) (expressed as
Lithium)
3AM
2-3
2-3
3
270
L2 for silicic acid.
TDI: not specified, based on ADI: not
specified for silicon dioxide and several
silicates.
(SCF, 25th Series, 1990)
Group TDI = 0.01 mg/kg b.w. (as Li).
See references for benzoic acid, lithium salt.
L2 for silicic acid.
TDI: not specified, based on ADI: not
specified for silicon dioxide and several
silicates.
(SCF, 25th Series, 1990)
Group TDI: 0.01 mg/kg b.w. (as Li).
See references for benzoic acid, lithium salt.
L2 for silicic acid.
TDI: not specified, based on ADI: not
specified for silicon dioxide and several
silicates.
(SCF, 25th Series, 1990)
Restriction: 0.15 mg fluoride/kg food
Remark for Commission: This is a Group
Restriction. No direct contact intended.
Restriction may include this condition of use
if necessary.
+
+
+
REF_N
CAS_N
NAME
85980
-
86000
86030
Silicic acid, silylated
004766-57-8 Silicic acid, tetrabutyl
ester
000078-10-4 Silicic acid, tetraethyl
ester
068412-37-3 Silicic acid (H4SiO4),
tetraethyl ester,
hydrolysed
010101-52-7 Silicic acid, zirconium
salt
86050
86052
86080
Silicic acid, salts
86160
86240
000409-21-2 Silicon carbide
007631-86-9 Silicon dioxide
86260
-
86280
86285
86300
86320
86360
86380
86400
Silicon dioxide
amorphous, fluorinated
Silicon dioxide
amorphous, silanated
Silicon dioxide, silanated
063148-62-9 Silicone oils
Silicones
158061-44-0 Siloxanes and silicones,
alkyl(C24-C28) methyl
133101-81-2 Siloxanes and silicones,
dimethyl, ethoxy methyl,
ethoxy phenyl, polymers
with methyl
silsesquioxanes and
phenyl silsesquioxanes,
ethoxy-terminated
Siloxanes and silicones,
dimethyl, ethyl
SYNONIM
85680/8642
7
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
D
2
DIR
3
8
EFSA/SCF_OP
http://www.efsa.eu.int/science/afc/afc_opini
ons/675/afc_opinion20_ej109_list5_en1.pdf
TDI: not specified, based on ADI: not
specified for silicon dioxide.
(SCF, 25th Series, 1991)
Inert material.
8
PL
CT
+
+
+
+
+
+
W
7
Same 85580
DIR
DIR
3
1
+
L3 for silicic acid.
L7 for zirconium.
See references for 54220.
Inert material.
ADI: not specified.
(SCF, 25th Series, 1991)
8
DIR
+
+
+
+
3-D
Inert material.
+
3
9
9
W
Inert material.
+
271
+
+
+
+
W
9
+
+
+
+
+
REF_N
CAS_N
86401
189354-75-4
86402
068037-78-5
86404
-
86405
151662-01-0
86405/5
068938-54-5
86406
068937-54-2
86408
068937-55-3
86408/5
128192-17-6
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
hydrogen, reaction
products with
polyethyleneglycol
monoallyl ether
Siloxanes and silicones,
dimethyl, hexadecyl
methyl, 3-hydroxypropyl
methyl, ethoxylated
propoxylated
Siloxanes and silicones,
dimethyl,
hexadecylmethyl, methyl
octadecyl
Siloxanes and silicones,
dimethyl,
hexadecylmethyl,
octadecyl methyl, 11methoxy-11oxoundecylmethyl
Siloxanes and silicones,
dimethyl, 3hydroxypropyl groupterminated, ethoxylated
propoxylated
Siloxanes and silicones,
dimethyl, 3hydroxypropyl methyl,
ethers with
polyethyleneglycol
monomethyl ether
Siloxanes and silicones,
dimethyl, 3hydroxypropyl methyl,
ethoxylated
Siloxanes and silicones,
dimethyl, 3hydroxypropyl methyl,
ethoxylated propoxylated
Siloxanes and silicones,
dimethyl, 3-
SCF
List
EFSA/SCF_OP
PL
W
+
9
+
9
+
+
W
+
W
+
9
+
+
9
+
+
W
272
CT
+
REF_N
CAS_N
86409
070131-67-8
86410
129893-29-4
86411
155490-71-4
86412
067762-96-3
86414
064365-23-7
86416
067762-83-8
86418
068554-66-5
86420
068554-67-6
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
hydroxypropyl methyl,
3-hydroxypropyl groupterminated, ethoxylated
propoxylated
Siloxanes and silicones,
dimethyl, hydroxyterminated
Siloxanes and silicones,
dimethyl, hydroxyterminated, ethers with
polyethylenepolypropyleneglycol
monobutyl ether
Siloxanes and silicones,
dimethyl, hydroxyterminated, ethers with
polyethylenepolypropyleneglycol
monomethyl ether
Siloxanes and silicones,
dimethyl, hydroxyterminated, ethers with
polypropyleneglycol
monobutyl ether
Siloxanes and silicones,
dimethyl, hydroxyterminated, ethoxylated
propoxylated
Siloxanes and silicones,
dimethyl,
methyloctadecyl
Siloxanes and silicones,
dimethyl, polymers with
methylsilsesquioxanes,
ethoxy-terminated
Siloxanes and silicones,
dimethyl, polymers with
methylsilsesquioxanes,
hydroxy-terminated
SCF
List
EFSA/SCF_OP
PL
W
9
+
+
W
273
CT
+
+
9
+
+
9
+
+
9
+
+
9
+
+
9
+
+
REF_N
86422
86424
86424/5
86425
86426
86426/5
CAS_N
NAME
068554-65-4 Siloxanes and silicones,
dimethyl, polymers with
methylsilsesquioxanes
and polyethylenepolypropyleneglycol
monobutyl ether
068554-64-3 Siloxanes and silicones,
dimethyl, polymers with
methylsilsesquioxanes
and polypropyleneglycol
monobutyl ether
155419-55-9 Siloxanes and silicones,
dimethyl, polymers with
phenylsilsesquioxanes,
ethoxy-terminated
067762-90-7 Siloxanes and silicones,
dimethyl, reaction
products with silica
068554-70-1 Silsesquioxanes, methyl
86427
133101-85-6 Silsesquioxanes, phenyl,
ethoxy-terminated
001318-02-1 Silver alumino silicate
86432
-
86432/10 86434 -
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
Same as
66930
SCF
List
EFSA/SCF_OP
PL
CT
9
+
+
9
+
+
W
+
W
+
D
+
W
replaced by
95995
+
D
Silver-containing glass
(Silver-magnesiumcalcium-phosphateborate)
3
Silver in glass
Silver sodium hydrogen
zirconium phosphate
3
+
Restriction: Group restriction of 0.05 mg
Ag/kg of food.
Remark for Commission: It is a surface
biocide
http://www.efsa.eu.int/science/afc/afc_opini
ons/468/opinion11_afc_ej65_list4_en1.pdf
Restriction: Group restriction of 0.05 mg
Ag/kg of food.
Remark for Commission: It is a surface
biocide
http://www.efsa.eu.int/science/afc/afc_opini
ons/468/opinion11_afc_ej65_list4_en1.pdf
http://europa.eu.int/comm/food/fs/sc/scf/out
274
+
+
+
REF_N
86437
CAS_N
NAME
-
Silver zeolite A (silver
zinc sodium ammonium
alumino silicate), silver
content 2- 5 %
86437/50 -
Silver-zinc- aluminium boron - phosphate glass,
mixed with 5-20%
barium sulphate, silver
content 0.35-0.6%
86438
-
Silver zinc zeolite A (
silver-zinc sodium
alumino silicate calcium
metaphosphate), silver
content 1-1.6%
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
Same
95995/1
SCF
List
3
3
Similar to
86437 and
86438/50
3
275
EFSA/SCF_OP
62_en.pdf
Group restriction: 0.05 mg Ag/kg food,
based on the human NOEL of about 10 g of
silver for a total lifetime oral intake
allocated by WHO (WHO, 2004) for
drinking water.
Maximum content in polymer: 10% (w/w)
of silver zeolite A containing ≤ 5% silver.
Only for repeated use articles made from
polyolefins
(up to 40°C for contact times below 1 day)
and for poly(alkylene terephthalate) based
polymers (up to 99°C for contact times
below 2 hours)
Remark for the Commission: It is a biocide
http://www.efsa.eu.int/science/afc/afc_opini
ons/890/afc_op_ej201_fcm1.pdf
Group restriction: 0.05 mg Ag/kg food,
based on the human NOAEL of about 10 g
of silver for a total lifetime oral intake
allocated by WHO (WHO, 2004) for
drinking water.
Group restriction: 1 mg Ba/kg food
Group restriction: 6 mg B/kg food
Maximum content in plastic: 1% (w/w)
Remark for Commission: It is a biocide
http://www.efsa.eu.int/science/afc/afc_opini
ons/890/afc_op_ej201_fcm1.pdf
Group restriction: 0.05 mg Ag/kg of food,
based on the human NOAEL of about 10 g
of silver for a total lifetime oral intake
allocated by WHO (WHO, 2004) for
drinking water.
Remark for Commission: It is a biocide
The Commission is advised to specify:
- the maximum amount of additive (1%) and
- the max. amount of silver in the additive
(1.6%) or in the final food contact material
http://www.efsa.eu.int/science/afc/afc_opini
ons/890/afc_op_ej201_fcm1.pdf
PL
+
+
+
CT
REF_N
CAS_N
86438/50 -
NAME
Silver zinc zeolite A (
silver-zinc sodium
magnesium alumino
silicate calcium
phosphate), silver
content 0.34-0.54%
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
Similar to
86437 and
86438
SCF
List
3
86440
?
Sodium aluminate
2
86480
007631-90-5 Sodium bisulphite
DIR
86560
007647-15-6 Sodium bromide
DIR
86640
009004-32-4 Sodium
carboxymethylcellulose
D
86655
-
9
86670
86720
Sodium
dialkylsulphonimides
007775-14-6 Sodium dithionite
001310-73-2 Sodium hydroxide
DIR
86800
007681-82-5 Sodium iodide
DIR
86840
86880
007681-57-4 Sodium metabisulphite
Sodium monoalkyl
dialkylphenoxybenzened
isulphonate
DIR
SML(T) = 10 mg/kg
(30) (expressed as
SO2)
1
1
8
1
SML(T) = 1 mg/kg
(11) (expressed as
Iodine)
SML = 9 mg/kg
276
1
W
2
EFSA/SCF_OP
Group restriction: 0.05 mg Ag/kg of food,
based on the human NOAEL of about 10 g
of silver for a total lifetime oral intake
allocated by WHO (WHO, 2004) for
drinking water.
Remark: It is a biocide
The Commission is advised to specify:
- the maximum amount of additive (1%) and
- the max. amount of silver in the additive
(1.6%) or in the final food contact material
http://www.efsa.eu.int/science/afc/afc_opini
ons/890/afc_op_ej201_fcm1.pdf
TDI: 1 mg/kg bw (as Al) based on PTWI : 7
mg/kg b.w. (as Al).
(SCF, 25th Report, 1991).
Group ADI: 0.7 mg/kg b.w. as SO2
(JECFA 27 M., 1983).
Group ADI: 1 mg/kg b.w. (as Br) as
pesticide residue.
See references for ammonium bromide in
list 2.
Group TDI not specified for natural,
regenerated and modified cellulose (SCF 7th
Report, 1978 and JECFA 17 M., 1973 and
followin g).
PL
CT
+
+
+
+
+
+
+
ADI: not specified.
(SCF, 25th Series, 1991)
PMTDI: 0.017 mg/kg b.w. (as I)
(JECFA 33 M., 1988).
t-TDI: 0.15 mg/kg b.w. pending
reproduction and teratogenicity studies.
Available: 2-year oral rat and dog studies.
+
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
86920
007632-00-0 Sodium nitrite
DIR
SML = 0.6 mg/kg
3
86960
007757-83-7 Sodium sulphite
DIR
1
87040
001330-43-4 Sodium tetraborate
DIR
SML(T) = 10 mg/kg
(30) (expressed as
SO2)
SML(T) = 6 mg/kg
(23) (expressed as
Boron) without
prejudice to the
provisions of Directive
98/83/EC on water for
human consumption
(OJ L 330,
5.12.1998,p.32)
87120
007772-98-7 Sodium thiosulphate
DIR
SML(T) = 10 mg/kg
(30) (expressed as
SO2)
1
87200
000110-44-1 sorbic acid
DIR
1
87280
029116-98-1 Sorbitan dioleate
DIR
2
87360
-
87440
Sorbitan, esters with
acids, aliph., monocarb.
(more than C5)
071902-01-7 Sorbitan isostearate
277
2
EFSA/SCF_OP
PL
CT
R: 0.01 mg/kg bw based on allowing 1/10 of
t-TDI for food packaging uses.
(SCF, 26th Series, 1992).
Group ADI: 0.7 mg/kg b.w. as SO2
(JECFA 27 M., 1983).
+
+
+
+
Re-evaluation on the basis of an opinion of
the SCF in another context.
Group-TDI = 0.1 mg/kg b.w. (as B) (with
REF_n. 36840, 40320 and 87040).
The TDI is based on the No Adverse Effect
Level (NOAEL) of 9.6 mg/kg b.w./day for
effects on fetal body weight and skeletal
anomalies in the rat developmental study. A
Safety Factor (SF) of 100 is used.
“Opinion of the Scientific Committee on
Food on Arsenic, Barium, Fluoride, Boron
and Manganese in Natural Mineral Waters
(expressed on 13 December 1996, 105th
plenary meeting of the SCF, completed on
13 June 1997 at the 107th plenary meeting
of the SCF; 43rd Series of Reports of the
SCF, 2000”.
(Adopted by the SCF at the 127th meeting,
30 May 2001)
http://europa.eu.int/comm/food/fs/sc/scf/out
86_en.pdf
Group ADI: 0.7 mg/kg b.w. as SO2.
Included in the group ADI for sulphites.
(JECFA 27 M., 1983).
ADI: 25 mg/kg b.w.
(SCF, 6th Series, 1978).
Group TDI: 5 mg/kg b.w. based on the
group ADI 5 mg/kg b.w. for sorbitan esters
of lauric and oleic acids.
(SCF, 7th Series, 1978).
+
+
+
+
+
+
+
9
+
9
+
REF_N
CAS_N
NAME
87520
062568-11-0 Sorbitan monobehenate
87560
87600
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
DIR
2
054392-26-6 Sorbitan monoisostearate
001338-39-2 Sorbitan monolaurate
Same 63480
DIR
8
1
87680
001338-43-8 Sorbitan monooleate
DIR
1
87760
026266-57-9 Sorbitan monopalmitate
DIR
1
87840
001338-41-6 Sorbitan monostearate
DIR
1
87920
061752-68-9 Sorbitan tetrastearate
DIR
2
88000
88080
054392-27-7 Sorbitan triisostearate
026266-58-0 Sorbitan trioleate
DIR
9
2
88160
054140-20-4 Sorbitan tripalmitate
DIR
2
88240
026658-19-5 Sorbitan tristearate
DIR
1
88320
000050-70-4 Sorbitol
DIR
1
88400
-
Same 24490
Sorbitol, esters with
9
278
EFSA/SCF_OP
PL
CT
Group TDI= 5 mg/kg b.w. based on the
group ADI 5 mg/kg b.w., for sorbitan esters
of lauric and oleic acids.
(SCF, 7th Series, 1978).
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
Group ADI: 5 mg/kg b.w. for sorbitan
monolaurate and sorbitan monooleate.
(SCF, 7th Series, 1978).
Group ADI: 5 mg/kg b.w. for sorbitan
monolaurate and sorbitan monooleate.
(SCF, 7th Series, 1978).
Group ADI: 25 mg/kg b.w. for sorbitan
monostearate, sorbitan monopalmitate and
sorbitan tristearate.
(SCF, 7th Series, 1978).
Group ADI: 25 mg/kg b.w. for sorbitan
monostearate, sorbitan monopalmitate and
sorbitan tristearate.
(SCF, 7th Series, 1978).
Group TDI: 5 mg/kg b.w. based on the
group ADI 5 mg/kg b.w. for sorbitan esters
of lauric and oleic acids.
(SCF, 7th Series, 1978).
Group TDI: 5 mg/kg b.w. based on the
group ADI 5 mg/kg b.w. for sorbitan esters
of lauric and oleic acids.
(SCF, 7th Series, 1978).
Group TDI: 5 mg/kg b.w. based on the
group ADI 5 mg/kg b.w. for sorbitan esters
of lauric and oleic acids.
(SCF, 7th Series, 1978).
Group ADI: 25 mg/kg b.w. for sorbitan
monostearate, sorbitan monopalmitate and
sorbitan tristearate.
(SCF, 7th Series, 1978).
Acceptable.
(SCF, 16th Series, 1985).
+
REF_N
88480
88560
88600
88630/1
88640
88650
88680
88720
88770
88780
88800
CAS_N
NAME
SYNONIM
acids, aliph., monocarb.
(more than C5)
Sorbitol, esters with
acids, hydroxylated,
monocarb. (C12-C20)
see 88600
026836-47-5 Sorbitol monostearate
008001-22-7 Soybean oil
DIR
RESTRICTIONS
AND
SPECIFICATIONS
DIR
Same 24520
and 88630/0
008013-07-8 Soybean oil, epoxidized
068308-53-2 Soybean oil fatty acids, Same 17200
polymerized
008002-23-1 Spermaceti wax
Sperm oil, hydrogenated
009045-28-7 Starch acetate (= E1420)
009057-06-1 Starch carboxymethyl
ether
009005-25-8 Starch, edible
Same 24540
DIR
In compliance with the
specifications laid
down in Annex V.
SCF
List
+
D
2
+
+
3
TDI= not specified based on the ADI for
sorbitol.
(SCF, 17th Series, 1986).
Food fat.
2
Restriction for baby food:
CT
+
+
+
+
http://www.efsa.eu.int/science/afc/afc_opini
ons/467/opinion_afc10_ej64_epox_soyoil_e
n1.pdf
--------------------------------------TDI: 1 mg/kg b.w.
Available: 15-week and 2-year oral rat
studies and 1-year oral dog study,
reproduction and teratogenicity studies.
ADI's and TDI's are allocated in the light of
life long average exposure and allowing for
sporadic intakes above the set limits. For the
infants, however, the actual consumption
pattern surveys have revealed intakes for
prolonged periods of time which may
exceed the TDI.
(Bibra report n. 515/86; summary report
prepared by UK January 1988).
8
8
W
W
0
279
PL
9
D
DIR
EFSA/SCF_OP
+
+
+
+
+
+
+
REF_N
88880
88920
CAS_N
NAME
88950
88960
89040
068412-29-3 Starch, hydrolysed
066829-29-6 Starch octenylsuccinate,
sodium salt (= E1450)
065996-62-5 Starch, oxidised (=
E1404)
011120-02-8 Starch phosphate (=
E1410)
039316-70-6 Starch succinate
000124-26-5 Stearamide
000057-11-4 Stearic acid
89120
89170
000123-95-5 Stearic acid, butyl ester
013586-84-0 Stearic acid, cobalt salt
88930
88940
SYNONIM
DIR
Same 24545
DIR
Same 24550
DIR
DIR
Same 89165
DIR
89200
007617-31-4 Stearic acid, copper salt
89240
89280
001323-83-7 Stearic acid, diglyceride Same 56320
005303-25-3 Stearic acid, dodecyl
ester
Stearic acid, esters with
alcohols, aliph.(C4-C22)
Stearic acid, esters with
ethyleneglycol
008045-34-9 Stearic acid, esters with
pentaerythritol
000111-61-5 Stearic acid, ethyl ester
022047-49-0 Stearic acid, 2ethylhexyl ester
026739-53-7 Stearic acid, guanidine
salt
024466-84-0 Stearic acid, heptyl ester
001190-63-2 Stearic acid, hexadecyl
89360
89440
89520
89600
89680
89760
89840
89920
DIR
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
0
W
SML(T) = 30 mg/kg
(7) (expressed as
Copper)
SML(T) = 30 mg/kg
(3)
+
+
+
+
W
+
7
1-3
Same references as 68960.
ADI: not specified.
(SCF, 25th Series, 1990).
Needed: hydrolysis data.
L3 for Cobalt.
R: 0.05 mg/kg of food (as Co).
(RIVM, summary data, October
1992=CS/PM/1707).
+
+
+
+
L1 for stearic acid.
See references for stearic acid.
For Copper. Same as Ref.No 30080.
+
D
D
Needed: hydrolysis data.
+
+
7
Needed: hydrolysis data.
+
2
+
7
TDI = 0.5 mg/kg b.w.
(SCF, 6th Series, 1978).
Needed: hydrolysis data.
7
7
Needed: hydrolysis data.
Needed: hydrolysis data.
+
+
2
D
7
7
280
CT
W
W
3
1
SML(T) = 0.05 mg/kg
(14) (expressed as
Cobalt)
PL
+
+
Needed: hydrolysis data.
Needed: hydrolysis data.
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
ester
Stearic acid, hexyl ester
Stearic acid, iron salt
Stearic acid, isobutyl
ester
Stearic acid, isodecyl
ester
Stearic acid, isotridecyl
ester
Stearic acid, lead
(dibasic) salt
Stearic acid, lead salt
Stearic acid, nonyl ester
Stearic acid, octadecyl
ester
Stearic acid, octyl ester
Stearic acid, pentyl ester
Stearic acid, 2stearamidoethyl ester
Stearic acid, tridecyl
ester
Stearoylbenzoylmethane
89950
89970
90000
003460-37-5
005136-76-5
000646-13-9
90080
031565-38-5
90120
031565-37-4
90160
052652-59-2
90240
90305
90320
007428-48-0
028084-19-7
002778-96-3
90400
90480
90560
000109-36-4
006382-13-4
014351-40-7
90640
031556-45-3
90720
058446-52-9
90800
90880
90930
90960
005793-94-2 Stearoyl-2-lactylic acid, Same 90840
calcium salt
005793-94-2 2-(2Same 90800
Stearoyloxypropionyl)ox
y)propionic acid,
calcium salt
000142-48-3 N-Otearoylsarcosine
Styrene copolymers
000110-15-6 Succinic acid
Same 24820
91040
028801-70-9 Succinic acid, diisodecyl
90840
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
7
D
7
EFSA/SCF_OP
Needed: hydrolysis data.
Needed: hydrolysis data.
8
PL
CT
+
+
+
+
+
W
+
D
+
D
9
7
Needed: hydrolysis data.
+
+
+
7
7
7
Needed: hydrolysis data.
Needed: hydrolysis data
Needed: hydrolysis data.
+
+
+
7
Needed: hydrolysis data.
+
DIR
2
+
DIR
1
TDI: 1.5 mg/kg b.w.
30-day oral rat, 90-day oral dog, 2generation oral rat studies, mutagenicity and
migration data.
(RIVM report June 1979).
ADI: 20 mg/kg b.w.
(SCF, 7th Series, 1978).
DIR
D
+
8
9
1
+
+
+
8
281
+
ADI: not specified.
(SCF, 25th Series, 1990).
+
+
REF_N
CAS_N
NAME
SYNONIM
ester
Succinic acid, diisooctyl
ester
Succinic acid, dimethyl Same 24835
ester
Succinic acid, dimethyl Same 81215
ester-(4-hydroxy-2,2,6,6tetramethyl
piperidyl)ethanol,
copolymer
Sucrose acetate
isobutyrate
Sucrose esters of
monocarb. Acids
Sucrose octaacetate
3,3'-SulphonylSame 51600
bis(benzenesulphonic
acid)dihydrazide
Sulphoricinic acid, salts
Sulphosuccinic acid
Sulphosuccinic acid,
alkyl(C4-C20) esters,
salts
Sulphosuccinic acid,
alkyl(C12-C18) esters,
disodium salt
Sulphosuccinic acid,
bis(1,3-dimethylbutyl)
ester, sodium salt
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
91120
028880-24-2
91135
000106-65-0
91150
065447-77-0
91200
000126-13-6
91280
-
91360
91400
000126-14-7
003375-11-9
91440
91520
91540
005138-18-1
-
91545
090268-36-3
91560
002373-38-8
91570
010041-19-7 Sulphosuccinic acid,
bis(2-ethylhexyl)ester
8
91572
000577-11-7 Sulphosuccinic acid,
bis(2-ethylhexyl)ester,
sodium salt
D
EFSA/SCF_OP
8
7
1
Needed: hydrolysis data.
3
D
9
8
9
ADI: 10 mg/kg bw.
(SCF, 25th Series, 1991)
282
+
+
+
Bitter taste.
Group R: 0.05 mg/kg bw.
D
8
+
+
9
DIR
CT
+
D
DIR
PL
+
+
+
+
+
+
Group R: 0.05 mg/kg b.w.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, peroxisome
proliferation studies.
Group R: 0.05 mg/kg b.w.
Needed: toxicological data depending on
migration level (see SCF guidelines) and if
migration exceeds 0.05 mg/kg peroxisome
proliferation studies too.
+
+
+
+
+
REF_N
91580
91600
91630
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
023386-52-9 Sulphosuccinic acid,
dicyclohexyl ester,
sodium salt
see 91540
003006-15-3 Sulphosuccinic acid,
dihexyl ester, sodium salt
SCF
List
PL
8
+
D
8
+
+
91650
000127-39-9 Sulphosuccinic acid,
diisobutyl ester, sodium
salt
8
91665
029857-13-4 Sulphosuccinic acid,
diisodecyl ester, sodium
salt
8
91672
055184-72-0 Sulphosuccinic acid,
diisotridecyl ester,
sodiium salt
8
91680
001639-66-3 Sulphosuccinic acid,
dioctyl ester, sodium salt
8
91720
000922-80-5 Sulphosuccinic acid,
dipentyl ester, sodium
salt
8
91760
002673-22-5 Sulphosuccinic acid,
ditridecyl ester, sodium
salt
8
283
EFSA/SCF_OP
Group R: 0.05 mg/kg b.w.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, peroxisome
proliferation studies too.
Group R: 0.05 mg/kg bw.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg bw,
peroxisome proliferation studies too.
Group R: 0.05 mg/kg bw.
Needed: toxicological data depending on
migration level(see SCF guidelines) and, if
migration exceeds 0.05 mg/kg peroxisome
proliferation studies too.
Group R: 0.05 mg/kg bw.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg peroxisome
proliferation studies too.
Group R: 0.05 mg/kg bw.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, peroxisome
proliferation studies too.
Group R: 0.05 mg/kg bw.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg peroxisome
proliferation studies too.
Group R: 0.05 mg/kg bw.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, peroxisome
proliferation studies too.
CT
+
+
+
+
+
+
+
+
+
+
REF_N
91780
91800
CAS_N
NAME
SYNONIM
DIR
067893-42-9 Sulphosuccinic acid, 4[2-[(12-hydroxy-1oxooleyl)amino]ethyl]ester,
disodium salt
037294-49-8 Sulphosuccinic acid,
isodecyl ester, disodium
salt
8
007704-34-9 Sulphur
007664-93-9 Sulphuric acid
DIR
DIR
92000
007727-43-7 Sulphuric acid, barium
salt
DIR
010124-44-4 Sulphuric acid, copper
salt
SCF
List
EFSA/SCF_OP
W8
91840
91920
92030
RESTRICTIONS
AND
SPECIFICATIONS
DIR
3
1
SML(T) = 1 mg/kg
(12) (expressed as
Barium)
SML(T) = 30 mg/kg
(7) (expressed as
Copper)
3
2
PL
CT
+
Group R: 0.05 mg/kg bw.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg peroxisome
proliferation studies too.
Inert material.
ADI: not specified.
(SCF, 25th Series, 1991)
L3 for Barium.
R: 1 mg/kg (as Ba) in food or in food
simulant.
(Rivm doc., May 1992 (CS/PM/1584)).
L3 for the compound.
Insoluble material.
L1 for sulphuric acid.
ADI = not specified.
See references for sulphuric acid in list 1.
+
+
+
+
+
+
+
+
For copper(II).
Same as Ref.No 30080.
92040
92080
92100
92120
012202-17-4 Sulphuric acid, lead (triand 052732- and tetrabasic) salt
72-6
014807-96-6 Talc
D
DIR
92150
061789-97-7 Tallow
Tallow, sulphated,
ammonium, potassium,
or sodium salt
001401-55-4 Tannic acids
DIR
92160
000087-69-4 Tartaric acid
DIR
1
3
9
According to the
JECFA specifications
3
1
284
+
ADI: not specified.
(SCF, 25th Series, 1991)
Toxicologically acceptable.
+
Toxicologically acceptable with JECFA
specifications.
(Doc. 1995-02-01 = CS/PM/2536)
ADI: 30 mg/kg b.w.
+
+
+
+
+
+
REF_N
92180
92195
92205
92240
92280
92320
CAS_N
NAME
000087-92-3 Tartaric acid, dibutyl
ester
Taurine, salts
057569-40-1 Terephthalic acid, diester Same 38580
with 2,2'methylenebis(4-methyl6-tert-butylphenol)
see 92180
see 92205
Tetradecylpolyethyleneglycol(EO=
3-8) ether of glycolic
acid
92350
000112-60-7 Tetraethyleneglycol
92400
000097-77-8 N.N'-Tetraethylthiuram
disulphide
000109-99-9 Tetrahydrofuran
92430
92450
92480
92560
SYNONIM
000097-99-4 Tetrahydrofurfurol
Tetrakis(2,4-di-tertbutylphenyl)-2,4'biphenylylene
diphosphonite
038613-77-3 Tetrakis(2,4-di-tertbutyl-phenyl)-4,4'biphenylylene
diphosphonite
Same 25090
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
7
DIR
DIR
0
2
DIR
D
D
2
SML = 15 mg/kg
DIR
1
EFSA/SCF_OP
(SCF, 25th Series, 1991)
Needed: hydrolysis data.
TDI: 1 mg/kg b.w.
A 90-day oral rat study.
(CIVO report 5569, December 1977).
t-TDI: 0.25 mg/kg b.w.
Available: 28- and 90-day oral rat studies.
(CIVO/TNO 3108 October 1970, 3287
October 1970).
Needed: mutagenicity data on polymeric
additive itself and specify monomer
content.
Remark: after verification, name to be
changed into "tetradecylpolyethyleneglycol [E0= 3-8] ether of
glycolic acid"
ADI : 10 mg/kg b.w.
(SCF, 17th Series, 1986).
8
Same 25150.
2
8
7
DIR
SML = 18 mg/kg
285
2
PL
+
+
+
+
+
+
+
+
TDI: 0.01 mg/kg b.w.
See references for same substance in
monomer report.
Needed: neurotoxicity study in hens.
TDI: 0.3 mg/kg b.w.
90-day oral rat study and mutagenicity
studies.
(Sandoz report 1979).
+
+
+
+
CT
REF_N
92640
92655
92700
92720
92740
92760
92800
92820
92840
92880
92900
CAS_N
NAME
SYNONIM
DIR
000102-60-3 N.N.N.'N'-Tetrakis(2Same 25180
hydroxypropyl)ethylened
iamine
006683-19-8 Tetrakis[methylene(3,5- Same 71680
di-tert-butyl-4hydroxy)hydrocinnamate
]methane
078301-43-6 2,2,4,4-Tetramethyl-20(2,3-epoxypropyl)-7oxa-3,20diazadispiro[5.1.11.2]heneicosan-21-one,
polymer
DIR
000137-26-8 N.N'-Tetramethylthiuram
disulphide
011067-82-6 Tetrapropylene benzene
sulphonic acid, sodium
salt
000096-69-5 Thiobis(6-tert-butyl-mcresol)
000096-69-5 4,4'-Thiobis(6-tert-butyl3-methylphenol)
Same 92800
and 92840
Same 92760
and 92840
013560-49-1 Thiobis(ethyleneglycol
Same 35120
3-aminoCrotonate)
000096-69-5 Thiobis(2-methyl-4Same 92760
hydroxy-5-tertand 92800
butyl)benzene
041484-35-9 Thiodiethanol bis(3-(3,5- Same 92900
di-tert-butyl-4-hydroxy
phenyl) propionate)
041484-35-9 Thiodiethylenebis(3,5di-tert-butyl-4-
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
2
EFSA/SCF_OP
TDI: 1 mg/kg b.w.
(SCF, 17th Series, 1986).
D
DIR
SML = 5 mg/kg
3
PL
CT
+
+
R = 5 mg/kg of food.
+
+
Available: adequate migration data; acute
toxicity data; 90-day oral study (Hostavin
N30); three in vitro mutagenicity studies
(Hostavin N30) and three in vitro
mutagenicity studies (Hostavin N20).
(RIVM/TNO SDS, July 1996 =
CS/PM/2861).
DIR
DIR
SML = 0.48 mg/kg
SML = 2.4 mg/kg
Same 92880
8
+
8
+
D
+
2
+
D
+
D
+
2
D
286
t-TDI: 0.008 mg/kg b.w. pending results of
ongoing 2-year and reproduction studies.
Available: 28- and 90-day oral rat studies,
one in-vitro mutagenic test.
(RIVM doc. 88/678608/007, 1 November
1988).
TDI: 0.04 mg/kg b.w.
90-day oral rat study, mutagenicity studies.
Desirable: migration data.
(RIVM report 88/678608/009, 1989-01-24).
+
+
+
REF_N
92930
92960
93040
93120
CAS_N
NAME
hydroxyhydrocinnamate)
120218-34-0 Thiodiethanolbis(5methoxycarbonyl-2-6dimethyl-1,4dihydropyridine-3carboxylate)
000111-17-1 Thiodipropionic acid
Thiodipropionic acid,
dibehenyl ester
000123-28-4 Thiodipropionic acid,
didodecyl ester
SYNONIM
DIR
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SML = 6 mg/kg
SCF
List
2
8
8
DIR
SML(T) = 5 mg/kg
(21)
287
3
EFSA/SCF_OP
TDI = 0.1 mg/kg b.w.
90-day oral rat study, mutagenicity tests
negative, absence of bioaccumulation.
(CS/PM/305,336,358,460).
Group R: 0.05 mg/kg bw.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, peroxisome
proliferation studies too.
Group R: 5 mg/kg of food (with
thiodipropionic acid, dioctadecyl
ester=93280)
Available: Adequate migration data from
PVC and ABS; acute toxicity data; 28-day
oral rat study; 90-day oral rat study;
inadequate data on long-term toxicity; three
oral teratogenicity studies using mice,
hamsters and rabbits; studies on absorption,
distribution, metabolism and excretion;
peroxisome proliferation
study (this study deviated from the SCF
guidelines on peroxisomal
proliferation); two Ames assays (negative);
in vitro chromosomal
aberration assay (negative); gene mutation
assay in mouse limphoma cells (negative).
Remark: Data insufficient for allocating a
TDI (no reproduction
study and no long-term study). The WG
decided not to ask for a new peroxisome
proliferation study, since the 90-day study
showed only increased liver weights (no
morphological changes) at very high doses
(1000 mg/kg b.w.). In view of the structure
of the compound and the metabolism data
provided there is no need for demonstration
of the absence of potential for accumulation.
PL
CT
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
93200
003287-12-5 Thiodipropionic acid,
dihexadecyl ester
8
93280
000693-36-7 Thiodipropionic acid,
dioctadecyl ester
93360
016545-54-3 Thiodipropionic acid,
ditetradecyl ester
8
93420
007646-78-8 Tin(iv) chloride
1
93440
013463-67-7 Titanium dioxide
DIR
1
93520
DIR
1
93540
000059-02-9 alpha-Tocopherol
and 01019141-0
000108-88-3 Toluene
93585
93680
000104-15-4 p-Toluenesulphonic acid
009000-65-1 Tragacanth gum
DIR
SML(T) = 5 mg/kg
(21)
Same 25205
3
3
8
1
DIR
288
EFSA/SCF_OP
No need for a long-term toxicity study, since
myocarditis was not seen after the recovery
period of the 90-day study.
(RIVM/TNO SDS, May 1996 =
CS/PM/2862/93120).
(adopted at 113rd SCF meeting)(17-18
September 1998)
http://europa.eu.int/comm/food/fs/sc/scf/out
16_en.html
Group R: 0.05 mg/kg bw.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, peroxisome
proliferation studies too.
Group R: 5 mg/kg of food (with 93120=
dilauryl thiodipropionate) based on data
available for 93120.
(adopted at 113rd SCF meeting)(17-18
September 1998)
http://europa.eu.int/comm/food/fs/sc/scf/out
16_en.html
Group R: 0.05 mg/kg bw.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, peroxisome
proliferation studies too.
PTWI: 14 mg/kg b.w.
(JECFA, 33M., 1989).
Acceptable.
(SCF, 1st Series, 1975).
Acceptable.
(SCF, 22th Series, 1989).
R: 1.2 mg/kg of food.
See references for the same substance (PM
REF. 25205) in monomer report.
PL
CT
+
+
+
+
+
+
+
+
+
+
+
ADI: not specified.
(SCF, 21th Series, 1989).
+
REF_N
CAS_N
NAME
93695
93720
000102-76-1 Triacetin
000108-78-1 2,4,6-Triamino-1,3,5triazine
93730
2,4,6-Triamino-1,3,5triazine resins
000077-90-7 Tri-n-butyl acetyl citrate
93760
SYNONIM
Same 57760
Same 19975,
25420 and
65360
DIR
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SML = 30 mg/kg
SCF
List
D
2
EFSA/SCF_OP
TDI: 0.5 mg/kg b.w.
(SCF, 17th Series, 1986).
9
PL
CT
+
+
+
+
New studies on-going.
-----------------------------------------------------R = 5 mg/kg of food.
Available: specific migration values in 3%
acetic acid and olive oil ranging from 9.028.2 mg/6 dm2; 14-day range-finding rat
study; 90-day rat study; 2-generation
reproduction study using rats; gene mutation
assay in bacteria (negative); two
chromosomal aberration assays in cultured
mammalian cells (both negative); two gene
mutation assays in cultured mammalian cells
(one negative and one positive); in vivo
UDS assay (negative); metabolism study
(rat); skin and eye irritation studies (only
summaries available); sensitisation study.
RIVM/ISS/TNO SDS, January 2000 =
CS/PM/2966 REV.II/93760.
Remark for Commission: since high
migration into fat has been demonstrated
with the exception of PET, it was
recommended that the Commission take the
necessary measures so that the restriction
proposed is not exceeded.
+
http://europa.eu.int/comm/food/fs/sc/scf/out
10_en.pdf
93810
93840
93870
93872
93900
000060-01-5
000087-90-1
000071-55-6
000079-00-5
000079-01-6
Tributyrin
Trichlorocyanuric acid
1,1,1-Trichloroethane
1,1,2-Trichloroethane
Trichloroethylene
Same 57840
D
D
D
D
D
289
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
93920
93930
000075-69-4 Trichlorofluoromethane
003380-34-5 2,4,4'-Trichloro-2'hydroxydiphenyl ether
7
3
93970
-
7
94000
94040
94060
94080
94081
Tricyclodecanedimethan
ol
bis(hexahydrophthalate)
000102-71-6 Triethanolamine
Same 25480
and 25922
085665-45-8 Triethanolamine
alkyl(C8-C14)sulphate
090583-18-9 Triethanolamine
alkyl(C12-C14)sulphate
Triethanolamine
alkylsulphuric acids,
salts
Triethanolamine
alkyl(C8-C22)sulphuric
PL
Needed: migration data and specifications.
Restriction: 5 mg/kg of food
Remark for Commission:
- Migration could exceed 5 mg/kg of food
- The use of this substance should not lead to
a lowering of hygienic standards in food
handling
- The Fat (consumption) Reduction Factor is
not applicable despite log Po/w = 4.8,
because migration in aqueous simulants
maybe higher than 10 % of the SML
allocated to this substance,i.e. 5 ppm.
- Concerning efficacy, none of the data
submitted demonstrated whether there is a
significant effect on microbial numbers
under in-use conditions of triclosan and to
what extent the substance might contribute
to reduce cross contamination.
- The Panel noted that no data were
submitted to demonstrate activity against
common food pathogens such as
Campylobacter spp.
http://www.efsa.eu.int/science/afc/afc_opini
ons/11/opinion_afc_07_en1.pdf
http://europa.eu.int/comm/food/fs/sc/scf/out
62_en.pdf
Under re-evaluation.
http://europa.eu.int/comm/food/fs/sc/scf/out
86_en.pdf
+
+
+
D
+
D
+
D
+
For alkyl(C8-C22)sulphuric acids, linear,
primary, even numbered.
CT
+
8
8
290
EFSA/SCF_OP
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
acids, linear, primary,
even numbered and its
salts
94100
EFSA/SCF_OP
PL
CT
L3. Toxicologically acceptable.
Same references as for 34281.
002717-15-9 Triethanolamine oleate
8
For triethanolamine.
L8.
L8 for triethanolamine.
+
L1 for oleic acid.
ADI : not specified.
(SCF, 25th Series, 1990).
94160
94240
94320
000122-51-0 Triethoxymethane
000077-89-4 Triethyl acetylcitrate
000112-27-6 Triethyleneglycol
94400
036443-68-2 Triethyleneglycol bis[3(3-tert-butyl-4-hydroxy 5-methylphenyl)
propionate]
94480
94560
026523-64-8 Trifluorotrichloroethane
000122-20-3 Triisopropanolamine
94640
-
94720
94800
Same 69900
Same 25510
8
8
2
DIR
DIR
SML = 9 mg/kg
2
DIR
SML = 5 mg/kg
7
3
1,3,5Triisopropylbenzene-2,4polycarbodiimide
068515-60-6 Trimellitic acid,
trialkyl(C7-C9) ester
003319-31-1 Trimellitic acid, tris(2ethylhexyl) ester
Group TDI: 5 mg/kg b.w. (with
polyethyleneglycol).
(SCF 17th Series, 1986).
SCF_list: 2
TDI = 0.15 mg/kg b.w.
See SCF evaluation in the website:
http://europa.eu.int/comm/food/fs/sc/scf/out
140_en.pdf
Needed: migration data and specification.
R: 5 mg/kg of food.
Available: migration, 3 negative
mutagenicity tests, 90-day oral rat and dog
studies.
(CS/PM/2324).
Hydrophilic so no data on bioaccumulation
required.
8
W9
+
+
+
+
+
+
+
Group R: 0.05 mg/kg bw.
W6B Group R: 0.05 mg/kg b.w.
Available: Ames test and indication of
peroxisome proliferation.
Needed: peroxisome proliferation study and
tests for gene mutation and chromosome
291
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
aberrations in mammalian cells in vitro.
94880
94960
95000
95040
95120
95200
000067-48-1 Trimethylethanolammoni Same 25570
um chloride
000077-99-6 1,1,1Same 13380,
Trimethylolpropane
25600 and
39560
028931-67-1 Trimethylolpropane
trimethacrylate-methyl
methacrylate copolymer
001462-84-6 2,3,6-Trimethylpyridine
000108-75-8 2,4,6-Trimethylpyridine
001709-70-2 1,3,5-Trimethyl-2,4,6tris(3,5-di-tert-butyl-4hydroxybenzyl)benzene
8
DIR
SML = 6 mg/kg
+
2
TDI = 0.1 mg/kg b.w.
(SCF, 17th Series, 1986).
+
DIR
3
Toxicologically acceptable.
Available : data on use; data on residual
monomers and the fraction with molecular
mass < 1000 D.
Remark: the two monomers (starting
substances) have been evaluated by the SCF
in the past and classified in list 2 and list 3,
respectively. The two monomers are:
? Methyl methacrylate (REF_N. 21130); list
2 with a group t-TDI = 0.1 mg/kg b.w. (as
methacrylic acid) (Reference: Scientific
Committee for Food 42nd series of reports
of the SCF, 2000)
? Trimethylolpropane trimethacrylate
(REF_N. 25840); list 3 with a restriction of
0.05 mg/kg of food. (Reference: Opinion of
the Scientific Committee on Food on the
16th additional list of monomers and
additives for food contact materials, adopted
by the SCF on 13/12/2001)
RIVM/DE SDS, April 2001 = CS/PM/3324
REV. I/95000.
(Adopted at the 131st SCF meeting, 27
February 2002)
http://europa.eu.int/comm/food/fs/sc/scf/out
124_en.pdf
+
DIR
8
8
2
292
t-TDI: 1 mg/kg b.w. pending check of the
reports.
2-year oral studies in rats and dogs and oral
carcinogenicity studies in mice and rats.
(Shell reports n. TLGR 0023.68. March
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
1969, TLGR. 0024.68, Sept. 1968, TLGR.
0019.69, March 1969).
95260
95265
000139-45-7 Tripropionin
227099-60-7 1,3,5-Tris(4benzoylphenyl) benzene
95270
161717-32-4 2,4,6-Tris(tertbutyl)phenyl-2-butyl-2ethyl-1,3-propanediol
phosphite
95280
95360
95400
95440
95520
Same 58080
040601-76-1 1,3,5-Tris(4-tert-butyl-3hydroxy-2,6dimethylbenzyl)-1,3,5triazine2,4,6(1H,3H,5H)-trione
027676-62-6 1,3,5-Tris(3,5-di-tertbutyl-4-hydroxybenzyl)1,3,5-triazine2,4,6(1H,3H,5H)-trione
D
3
3AM
DIR
SML = 2 mg/kg (as
sum of phosphite,
phosphate and the
hydrolysis product =
TTBP)
3
DIR
SML = 6 mg/kg
2
DIR
SML = 5 mg/kg
3
000090-72-2 2,4,6Same 25915
Tris[(dimethylamino)met
hyl]phenol
000144-15-0 Tris(2-ethylhexyl)
acetylcitrate
8
068958-97-4 1,1,3-Tris(2-methyl-4ditridecyl phosphite-5-
8
8
293
Restriction: 0.05 mg/kg food
http://www.efsa.eu.int/science/afc/afc_opini
ons/675/afc_opinion20_ej109_list5_en1.pdf
http://europa.eu.int/comm/food/fs/sc/scf/out
180_en.pdf
R = 2 mg/kg food (sum of phosphite,
phosphate and the hydrolysis product
(TTBP))
Remark for Commission: in aqueous food
simulants to be measured as 2,4,6-tri-tertbutylphenol.
(Adopted at the 119th SCF meeting) (2
December 1999)
http://europa.eu.int/comm/food/fs/sc/scf/out
50_en.pdf
t-TDI: 0.1 mg/kg b.w.
Available: 90-day oral rat and dog studies.
(RIVM document, June 1989).
Needed: mutagenicity and migration data,
impurities to be specified.
R: 5 mg/kg of food
Available: 3-month oral rat study,
mutagenicity studies negative, migration
data.
(RIVM doc. February 1992).
+
+
+
+
+
+
+
Group R: 0.05 mg/kg b.w.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.050 mg/kg, peroxisome
proliferation studies too.
+
+
REF_N
CAS_N
NAME
SYNONIM
95600
tert-butylphenyl) butane
001843-03-4 1,1,3-Tris(2-methyl-4hydroxy-5-tertbutylphenyl) butane
95630
95645
95680
000057-13-6 Urea
Urea resins
000121-33-5 Vanillin
Same 25960
95695
008009-03-8 Vaseline
Same 72060
and 72062
95710
-
95720
95725
95726
95728
Vegetable oils, from
food sources,
hydrogenated or not
Vegetable oils, inedible
110638-71-6 Vermiculite, reaction
product with citric acid,
lithium salt
DIR
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SML = 5 mg/kg
SCF
List
3
D
D
1
PL
R: 5 mg/kg of food
Available: adequate migration data (SM
0.003-1.8 mg/dm2); log Po/w; acute toxicity
data; inadequate 90-day oral dog study;
inadequate 12-week oral rat study; 13-week
oral rat study; gene mutation assay in
bacteria (negative); chromosomal aberration
assay in cultured mammalian cells
(negative); gene mutation assay in cultured
mammalian cells (negative); excretion
studies.
(RIVM/TNO SDS, April 1999 =
CS/PM/2905 REV. I/95600).
(Adopted at the 118th SCF meeting) (23
September 1999)
http://europa.eu.int/comm/food/fs/sc/scf/out
41_en.pdf
+
ADI: 10 mg/kg b.w.
(JECFA 11 M., 1967).
D
3
Same 44300
EFSA/SCF_OP
DIR
SML(T) = 0.6 mg/kg
(8) (expressed as
Lithium)
025213-24-5 Vinyl acetate-vinyl
alcohol, copolymer
025086-48-0 Vinyl acetate-vinyl
alcohol, vinyl chloride,
294
D
2
+
+
+
CT
+
+
Food fats or similar to food fats.
Group TDI = 0.01 mg/kg b.w. as Li (see
references for 38000).
Available: Migration data, 28-day oral rat
study, Ames test, in vivo micronucleus test.
No further data needed in view of its mineral
nature.
(RIVM SDS CS/PM/2423).
+
+
+
W
+
W
+
REF_N
CAS_N
95730
009003-22-9
95735
009005-09-8
95740
-
95755
025086-89-9
95760
95761
95762
95770
-
95780
025853-89-8
95800
-
95810
000088-12-0
95820
-
95830
95835
95840
95855
NAME
copolymer
Vinyl acetate-vinyl
chloride, copolymer
Vinyl acetate-vinyl
chloride-maleic acid,
copolymer
Vinyl acetate-vinyl
chloride-vinyl
propionate, copolymer
Vinyl acetatevinylpyrrolidone,
copolymers
see 95880
see 95881
see 95882
Vinyl chloride-vinyl
esters of sat., aliph.,
monocarb., acids (C2C18),copolymers
Vinyl chloride-vinyl
propionate, copolymer
Vinylidene chloride
copolymers
Vinylpyrrolidone
Vinylpyrrolidonemethacrylic acid, esters
with alcohols
aliph.,monoh.,sat.(C1C18), copolymers
Vinylpyrrolidone-vinyl
acetate and/or vinyl
propionate, copolymers
003039-83-6 Vinylsulphonic acid,
sodium salt
see 95905
007732-18-5 Water
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
D
PL
CT
+
+
W
+
9
+
9
Same 26230
+
D
D
D
9
+
+
+
+
9
+
9
+
4A
Same references as 26230
http://europa.eu.int/comm/food/fs/sc/scf/out
140_en.pdf
+
9
+
9
+
W
Same 26360
DIR
In compliance with the
295
D
0
+
+
+
Specification: Impurity levels not to exceed
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
Directive 98/83/EC.
95857
-
95859
-
95860
95870
95880
95881
008042-47-5
-
95882
95883
95890
95905
95920
Waxes=mineral
hydrocarbons (only for
documents allocation)
Waxes, refined, derived
from petroleum based or
synthetic hydrocarbon
feedstocks
Waxes, natural
Wheat protein
White mineral oil
White mineral oil
(hydrogenated)
008042-47-5 White mineral oil
(conventional)
White mineral oils,
paraffinic, derived from
petroleum based
hydrocarbon feedstocks
95921
95935
008002-74-2 White soft paraffin
013983-17-0 Wollastonite
Wood flour and fibers,
untreated
Wood flour and fibers
011138-66-2 Xanthan gum
95945
001330-20-7 Xylene
EFSA/SCF_OP
In compliance with the
specifications laid
down in Annex V.
Same 95882
Same 95880
DIR
In compliance with the
specifications laid
down in Annex V.
2
+
D
0
9
D
+
+
+
+
+
D
+
2
D
3
3
DIR
9
1
3
296
+
+
DIR
DIR
Same 26370
CT
those set in the Drinking Water Directive.
D
DIR
PL
Group ADI = 20 mg/kg bw for waxes
conforming to the following specification:
Viscosity not less than 11 centiStokes at
100°C;
Carbon number not less than 25 at the 5%
boiling point.
Average molecular weight not less than 500.
(SCF, 37th Series, 1997)
+
+
Group ADI = 4 mg/kg bw for oils
conforming to the following specifications:
Viscosity: not less than 8.5 centiStokes at
100xC;
Carbon number: not less than 25 at the 5%
boiling point;
Average molecular weight: not less than
480.
(SCF, 37th Series, 1997)
Inert material.
Inert material.
Confirmed.
ADI : not specified.
(JECFA, 30M., 1986).
Group R: 0.02 mg/kg bw (with
95947,95949,95951) based on
allowing 1/10 of TDI for food contact
+
+
+
+
+
+
+
+
+
+
+
REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
materials.
2-year oral rat study, mutagenicity test
negative.
(WHO draft, Geneva, September
1952)(CS/PM/1712).
95995
95995/1
96000
001318-02-1 Zeolites
Zeolite A, silver
96180
Zinc
alkylaryldithiocarbamate
Zinc
dialkyldithiocarbamate
000136-23-2 Zinc
dibutyldithiocarbamate
Zinc dust
96190
96200
020427-58-1 Zinc hydroxide
055799-16-1 Zinc hydroxyphosphite
96080
96160
Ex 86427
Same as
86437
-
W
+
+
9
+
9
+
8
+
2
DIR
2
2-3
Group TDI= 1 mg/kg b.w.(as Zn) based on
JECFA PMTDI= 1 mg/kg b.w. (as
Zn)(JECFA, 26M, 1982).
Same as for 96180.
L2 for Zn
For Zinc the same reference as for 96180.
+
+
+
+
+
+
+
+
+
+
L3 for phosphite.
Phosphite easily oxidised to phosphate.
96220
96240
96280
96320
96400
000557-09-5
001314-13-2
009010-69-9
001314-98-3
053801-45-9
Zinc octanoate
Zinc oxide
Zinc salt of resinic acids Same 83880
Zinc sulphide
Zirconium oxide
D
2
D
2
7
DIR
DIR
****** THE END ******
297
Same as for 96180.
Same as for 96180.
L7 for zirconium.
See references for 54220.
+
+