REACH
Exemption from registration for recovered substances
26 April 2011
1.
Introduction
Under REACH (Regulation (EC) No 1907/2006 of the European Parliament and of the Council
of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of
Chemicals,
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1907:EN:NOT),
manufacturers of recovered substances can benefit from an exemption from registration if the
following conditions are met:
Art 2.7 (d) substances, on their own, in preparations or in articles, which have been
registered in accordance with Title II and which are recovered in the Community if:
(i) the substance that results from the recovery process is the same as the substance that
has been registered in accordance with Title II; and
(ii) the information required by Articles 31 or 32 relating to the substance that has been
registered in accordance with Title II is available to the establishment undertaking the
recovery.
Recovery operators should have the above information available and show it to competent
authorities if requested.
A recovered substance means a substance which is recovered from waste and which at the end
of the recovery operation ceases to be waste and thus becomes a product (end-of-waste).
Some cement companies recover eg waste gypsum, fly ash (has waste status in some
regions/Member States), blast furnace slag (also considered waste in some regions/MS) when
these materials are used for the production of cement. With the production of cement, the
recovery operation is completed and the waste materials change status to non-waste. This
means that these cement companies can benefit from the exemption from registration for the
recovered gypsum, fly ash or blast furnace slag (provided the conditions given in Art 2.7 (d) of
REACH are met).
The ECHA guidance document on waste and recovered substances gives further information
on how this exemption should be applied in practice (http://guidance.echa.europa.eu/public2/getdoc.php?file=waste_recovered_en). The document points out that industry associations
could play an important role in preparing standard information for their members.
It is sufficient that a registration has been filed for the substance by any registrant (in the same
supply chain leading to the waste generation or in another supply chain, p. 10 of the guidance
document). If the recovered substance does not need to originate from the same supply chain
as the originally registered substance, as a consequence, it is also irrelevant that the original
substance that ends up in waste that will be recovered in the EU, may have been manufactured
outside the EU and thus its original non-EU manufacturer may have never registered it in the
EU.
As a conclusion, the exemption from registration for recovered substances, provided
that the conditions (i) and (ii) from REACH Art 2.7 (d) are met, applies to substances
which are recovered from waste produced in the EU or recovered from waste imported
into the European Economic Area (EEA).
T17328/IC
1 of 8
26 April 2011
This exemption from registration does however not apply to substances which are recovered
outside the EEA and then imported into the EEA. As they cease to be waste outside the EEA,
they must be registered as “normal” substances when imported (Guidance document p. 9).
Please note that recovery operators have to make their own safety datasheet (if applicable) for
the (recovered) substance which they place on the market. Alternatively, a recovery operator
can agree with the original manufacturer that he can use the SDS of the original substance. If
the recovery operator does not get such an agreement, he cannot simply assume the SDS of
the original substance and use it as his own, as he would be violating property rights. Please
note that the above will most probably not apply to cement producers. In most cases, the
cement companies will not place the recovered substance on the market as such. The
recovered substances will most likely be placed on the market as a component in the mixture
cement and the cement companies will produce their own SDS for cement (see the
CEMBUREAU template for the SDS of cement, document T16580).
2.
Legitimate access to Art 31 or 32 information
The ECHA guidance document refers to the following as source for the Art 31 or Art 32
information:
“The recovery operator can use any available information, starting with the information on the
ECHA website and published in accordance with Article 119 of REACH, but must make sure
that he does not violate any property rights. When using an existing SDS, he should, therefore,
make sure that he has legitimate access to the information, and that the hazard profile of his
recovered substance is adequately covered by this existing SDS. The same applies to other
safety information, if required.”
According to a legal advice CEMBUREAU obtained from McKenna Long & Aldridge LLP on
5 May 2010, the below cited sources of information can be used.
Determination of the substance identity - sameness
From the Guidance on waste and recovered substances, these are the options to demonstrate
sameness:
 If the name is the same, the substance is the same unless available data shows the
contrary
 Same EINECS and CAS numbers are indicators
 Different percentages or nature of impurities are irrelevant for sameness if below 20%
(Comment: this leads to a problem for multiconstituent substances: already substances as
of 10% are main constituents in that case; so the percentage should be 10% at most, but
not 20%. Also, if components are present above 10% and would be considered main
constituents, then a different percentage or different component may well lead to another
substance).
Recommendations
 As a matter of practice, CEMBUREAU recommends that recovered substance
producers should rely on the substance identity agreed in the SIEF and should archive
the substance identity documents agreed in the SIEF (communication by the Lead
Registrant). They should also archive the Lead Registrant’s notice that the substance
will be registered, inviting SIEF members to participate in joint registration.
This can be used as evidence that the substance is registered, as SIEF members will
not per se receive the registration number. If this information is available, CEMBUREAU
will publish the substance identity information agreed in the SIEF to its Members.
 For sameness, the recovered substance producer can rely on the documentary
evidence above. In case of an inspection, he may have to test the substance and
provide laboratory results documenting sameness.
T17328/IC
2 of 8
26 April 2011
Evidence of registration
 Once a substance has been registered, it will appear on ECHA’s dissemination portal
(http://apps.echa.europa.eu/registered/registered-sub.aspx.). This is sufficient evidence of
the registration of a substance.
Note: Only when ECHA has finished checking the registration dossier and when the invoice
has been paid by the registrant (lead registrant), the substance is considered as registered.
Prior to that moment, the substance will not appear on the above cited webpage.
 Recovered substance producers do not need to have the registration number because that
number will vary slightly from producer to producer, whereas the recovered substance
producer must only show that “one” registration for that substance has been filed.
Availability of supply chain information
 Because ECHA will disseminate a lot of information pursuant to Art. 119 REACH and
confidentiality requests will be subject to extra fees and are therefore expected to be rare,
all supply chain info can in principle be retrieved for free from the ECHA-IT dissemination
tool
set
up
under
Art.
119
(see
the
dissemination
manual
http://echa.europa.eu/doc/reachit/dsm_15_dissemination_manual.pdf). This will include
information fitting into the sections of the SDS as well as the exposure scenarios and
guidance on safe use (p. 15 of dissemination manual).
Hence, unless confidentiality claims are made, it should not be necessary that
CEMBUREAU and/or its Members buy either supply chain information or small quantities of
products to obtain such info. As long as copyrights are not violated, all information on the
ECHA website can be used freely.
Once available, CEMBUREAU will consolidate the Art. 119 info and distribute it in its
membership.
 As regards information for which confidentiality claims are made and which is therefore not
available publicly under Art. 119 REACH, such information must be obtained from
registrants on a bilateral and contractual basis unless it can be obtained from public sources
(risk assessment reports; sector organisations). Not all consortia will produce harmonised
SDS and supply chain info - hence it may be difficult to purchase this information without a
customer/supplier relationship.
3.
Information on specific substances
The Annex provides information on substance identity, proof of registration and supply chain
information (Art 31 or 32 of REACH) for recovered substances of importance for cement
manufacturers:
 Gypsum
 Fly ash
 Blast furnace slag
 Converter slag
 Iron sulfate
4.
Information on REACH
More
information
on
REACH
http://echa.europa.eu/home_en.asp.
can
T17328/IC
3 of 8
be
found
on
ECHA’s
website
26 April 2011
REACH
Exemption from registration for recovered substances
Annex
26 April 2011
1.
Gypsum
Calcium sulfate is registered as an inorganic mono-constituent substance with the following
specifications:
Chemical
name
EINECS
CAS
Formula
Calcium
Sulphate
231-900-3
7778-18-9
CaSO4
Impurities
Clays:
Calcite, dolomite:
Silica:
Celestine:
pH 5-9
Typical
content %
(w/w)
87
Lower
Content %
(w/w)
70
Upper
Content %
(w/w)
100
0% - 30%
0% - 30%
0% - 10%
0% - 4%
CaSO4 containing impurities not identified in this specification, even if present in quantities
<0.1 %, can have an effect on the hazard classification of the substance. Companies need to
assess this.
The calcium sulfate consortium is of the opinion that the information published on the ECHA
website (http://apps.echa.europa.eu/registered/registered-sub.aspx, publically accessible) as
part of the registration dossier and the SDS prepared by the Consortium (contains registration
number without the four last digits) can be used freely and without written permission by any
company wishing to use the exemption from registration for recovered gypsum (calcium
sulfate).
Calcium sulfate is not hazardous.
Summary of Art 119 information – proof of registration
Please see: http://apps.echa.europa.eu/registered/data/dossiers/DISS-9ebe5c1d-2d61-3cd3e044-00144f67d031/DISS-9ebe5c1d-2d61-3cd3-e044-00144f67d031_DISS-9ebe5c1d-2d613cd3-e044-00144f67d031.html
And the SDS with ES in the Annex:
MSDS CaSO4 final AnnexI_ES_CaSO4_f
not hazardous.pdf
inal.pdf
Some useful information can also be found in the Substance Information sheet from the FGD
gypsum producers:
ECOBA
Master-SIS_FGD Gypsum_17.03.2011.pdf
T17328/IC
4 of 8
26 April 2011
2.
Fly ash
Fly ash is registered as an inorganic UVCB substance under the EC entry:
“Ashes (residues), coal”
EC number: 931-322-8
Ashes from coal fired power stations with and without co-combustion from secondary fuels.
Starting materials are hard coal and/or lignite with and without co-combustion of secondary
fuels. The thermal conversion takes place at least at a temperature from 1,100 up to 1,700 °C in
dry and wet bottom boilers.
Beside glass/amorphous material the following main minerals may be present: mullite, quartz,
magnetite, anhydrite, anorthite.
The following elements may be present (expressed as oxides): aluminium, calcium, iron,
magnesium, phosphorus, potassium, silicon, sodium, titanium and sulphur.
This entry covers both siliceous and calcareous fly ashes as well as bottom ash and boiler slag
from coal power plants.
The composition of the registered substance is as follows:
Chemical
name
EINECS
CAS
Glass, oxide,
chemicals
Mullite
Quartz
Magnetite
Anorthite
266-046-0
65997-17-3
215-113-2
238-878-4
215-169-8
1302-93-8
14808-60-7
1309-38-2
1302-54-1
Anhydrite
604-615-0
14798-04-0
Formula
Al6O5(SiO4)2
SiO2
Fe3O4
(Ca0.9-1Na0-0.1)(Si22.1Al1.9-2)O8
Ca(SO4)
Lower
Content %
(w/w)
30
Upper
Content %
(w/w)
100
0
0
0
0
35
35
15
15
0
15
To prove the “sameness” of the substance, companies will need to show by quantitative X-ray
diffraction that the amount of the major mineralogical elements (beside the glass content) is the
same.
Fly ash is not hazardous.
Summary of Art 119 information – proof of registration
Please see: http://apps.echa.europa.eu/registered/data/dossiers/DISS-a000ebe7-e6d4-0933e044-00144f67d031/DISS-a000ebe7-e6d4-0933-e044-00144f67d031_DISS-a000ebe7-e6d40933-e044-00144f67d031.html
Substance information sheets of siliceous and calcareous fly ash:
ARC_masterSIS_silic ARC_masterSIS_calc
eous fly ash_22.12.2010.pdf
areous fly ash_22.12.2010.pdf
T17328/IC
5 of 8
26 April 2011
3.
Blast furnace slag
Blast furnace slag (granulated and air-cooled) is registered as an inorganic UVCB under the
entry:
“Slags, ferrous metal, blast furnace”
EC number: 266-002-0
Composition:
Chemical name
EINECS
CAS
Formula
Slags, ferrous metal, blast furnace
266-002-0
65996-69-2
-
Typical
content %
(w/w)
100
Granulated and air cooled blast furnace slags are by-products of the manufacture of iron by
thermochemical reduction of iron oxides in a blast furnace. Blast furnace slag is formed in a
continuous process by the fusion of limestone (and/or dolomite) and other fluxes with the
residues from the carbon source and the non-metallic components of the iron bearing materials
(e.g. iron ore, iron sinter). Blast furnace slag is generated at temperatures above 1500°C.
Dependent on the way of cooling of the liquid slag it can be distinguished between crystalline
air-cooled blast furnace slag and glassy granulated blast furnace slag.
Blast furnace slag is not hazardous.
Summary of Art 119 information – proof of registration
Please see: http://apps.echa.europa.eu/registered/data/dossiers/DISS-9ff61f6f-a688-3c4de044-00144f67d031/DISS-9ff61f6f-a688-3c4d-e044-00144f67d031_DISS-9ff61f6f-a688-3c4de044-00144f67d031.html
Substance information sheet of blast furnace slag:
SDS GBS Granulated
blast furnace slag.pdf
T17328/IC
6 of 8
26 April 2011
4.
Converter slag
Converter slag (BOS) is registered as an inorganic UVCB under the entry:
“Slags, steelmaking, converter”
EC number: 294-409-3
Composition:
Chemical name
EINECS
CAS
Formula
Slags, steelmaking, converter
294-409-3
91722-09-7
-
Typical
content %
(w/w)
100
Converter slag is a by-product of the conversion of liquid iron (hot metal) into steel during a
batch process in a basic oxygen furnace. The slag is generated by the addition of fluxes, such
as limestone and/or dolomite, during blowing oxygen into the melt. Due to the oxidising
conditions some elements (like Fe and Mn) are partly oxidised and contribute to the formation of
the slag. Furthermore some components are either oxidised to gas (like carbon) or are
chemically bound in the slag (like silicon or phosphorus). The liquid slag which has tapping
temperatures of around 1600°C is air-cooled under controlled conditions in pits forming
crystalline slag.
Converter slag is not hazardous.
Summary of Art 119 information – proof of registration
Please see: http://apps.echa.europa.eu/registered/data/dossiers/DISS-9e9e461f-f4bf-4e9be044-00144f67d031/DISS-9e9e461f-f4bf-4e9b-e044-00144f67d031_DISS-9e9e461f-f4bf-4e9be044-00144f67d031.html
Substance information sheet of converter slag:
SDS BOS Steelmaking
slag converter.pdf
T17328/IC
7 of 8
26 April 2011
5.
Iron sulfate
Iron sulfate is registered as an inorganic mono-constituent substance under the entry:
“iron sulphate / / iron(2+) sulfate”
EC number: 231-753-5
Composition:
Chemical name
EINECS
CAS
Formula
Iron sulphate
Impurity: nickel(2+) sulfate
231-753-5
232-104-9
-
FeSO4
NiSO4
Typical
content %
(w/w)
87
13
Aqueous 12 % solution or granulated solid containing crystal water.
Classification (GHS):
Acute toxicity - oral
Skin corrosion/irritation
Serious eye damage/ eye irritation
Skin sensitisation
Acute Tox. 4
Skin Irrit. 2
Eye Irrit. 2
Skin Sens. 1
H302: Harmful if swallowed.
H315: Causes skin irritation.
H319: Causes serious eye irritation.
H317: May cause an allergic skin reaction.
Summary of Art 119 information – proof of registration
Please see: http://apps.echa.europa.eu/registered/data/dossiers/DISS-9eb2b09a-62a7-5d8ce044-00144f67d031/DISS-9eb2b09a-62a7-5d8c-e044-00144f67d031_DISS-9eb2b09a-62a75d8c-e044-00144f67d031.html
6.
Abbreviations
EINECS
ECHA
EEA
UVCB
REACH
MS
SDS
CAS
SIEF
FGD gypsum
ES
EC number
BOS slag
T17328/IC
European INventory of Existing Commercial chemical Substances
European Chemicals Agency
European Economic Area
Substances of Unknown or Variable composition, Complex reaction products or
Biological materials
Registration, Evaluation, Authorisation and Restriction of Chemicals
Member State
Safety Data Sheet
Chemical Abstracts Service
Substance Information Exchange Forum
Flue Gas Desulfurisation gypsum
Exposure Scenario
European Commission number
Basic Oxygen Steel slag
8 of 8
26 April 2011