Österreichisches Forschungsinstitut
www.ofi.at
für Chemie und Technik
Austrian Research Institut for Chemistry and Technology
COMMISSION REGULATION (EU) No 10/2011
of 14 January 2011
on
plastic materials and articles intended to
come into contact with food (FCM)
Dr. Johannes Bergmair
Plastic Implementation Measure (PIM)
www.ofi.at
Practical implementation for FCM
Overview:
 Scope of the commisson regulation (EU) No.
10/2011
 Regulation for plastic materials and articles to be
placed on the market
 Specific approach concerning the regulation (EU)
No. 10/2011
Scope of the regulation (EU) No. 10/2011
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Materials and articles (exclusively) of plastic
Article 2
Scope
1. This Regulation shall apply to materials and articles
which are placed on the EU market and fall under the
following categories:
(a) materials and articles and parts thereof consisting
exclusively of plastics;
with coating,
printed
a/o covered
(b) plastic multi-layer materials and articles held together
by adhesives or by other means;
(c) materials and articles referred to in points a) or b) that
are printed and/or covered by a coating;
(d) plastic layers or plastic coatings, forming gaskets in
caps and closures, that together with those caps and
closures compose a set of two or more layers of different
types of materials;
(e) plastic layers in multi-material multi-layer materials
and articles.
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Regulation (EU) No. 10/2011
Plastic materials & articles intended to come in contact with
food
NOT in the scope of Regulation (EU) No. 10/2011
 Ion exchange resin
 Rubbers
 Silicones
2007/42/EG
 Regenerated cellulose films (painted/ unpainted)
? Coatings made from paraffin wax
incl. synthetic paraffin wax a/o microcristalline wax
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Regulation (EU) No. 10/2011
Plastic materials & articles intended to come in contact with
food
Whereas.... (Preamble, Pt 6)
Printed or coated plastic materials and articles as well as those
held together by adhesives should be within the scope of the
Regulation.
Adhesives, coatings and printing inks are not necessarily
composed of the same substances as plastics. Regulation (EC)
No 1935/2004 foresees that for adhesives, coatings and
printing inks specific measures can be adopted. Therefore
plastic materials and articles that are printed, coated or held
together by adhesives should be allowed to contain in the
printing, coating or adhesive layer other substances than those
authorised at EU level for plastics.
Those layers may be subject to other EU or national rules.
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Regulation (EU) No. 10/2011
Plastic materials & articles intended to come in contact with
food
Article 19
Assessment of substances not included in the Union list
Compliance with Article 3 of Regulation (EC) No 1935/2004 of substances
referred to in Articles
6(1) (polymer production aids),
6(2) (colorants and solvents),
6(4) (non-intentionally added substances as well as aids to polymerisation),
6(5) (additives form the „provisional list“) as well as
14(2) (materials behind a functional barrier)
of this Regulation which are not covered by an inclusion in Annex I to this
Regulation shall be assessed in accordance with internationally recognised
scientific principles on risk assessment.
Regulation (EU) No. 10/2011
Placing on the market of plastic materials and articles
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Plastic materials and articles may only be placed on the market if they:
(Article 4)


comply with the relevant requirements set out in Article 3 of Regulation (EC) No
1935/2004 under intended and foreseeable use
- endanger human health
- bring about an unacceptable change in the composition of the food
- bring about a deterioration in the organoleptic characteristics
comply with the labelling requirements set out in Article 15 of Regulation (EC)
No 1935/2004; and

comply with the traceability requirements set out inArticle 17 of Regulation (EC)
No 1935/2004; and

are manufactured according to good manufacturing practiceas set out in
Commission Regulation (EC) No 2023/2006(1)

comply with the compositional and declaration requirementsset out in Chapters
II, III and IV of this Regulation.
FCM approved under food law
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Practical approach (1)
Formal inspection of composition
a) Are monomers, starting materials and additves listed and
approved in the regulation?
Regulation (EU) No. 10/2011
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Chapter II: Compositional requirements
Article 5 as well as Annex I:
Unionlist of authorised materials
 Monomers and other starting substances
 Additives exclusiv of colorants
 Polymer production aids excluding solvents
 Macromolecules obtained from microbial fermentation
Regulation (EU) No. 10/2011
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Chapter II: Compositional requirements
The following substances not included in the Union list
maybe present in the plastic layers of plastic materials or
articles:
(Article 6)

non-intentionally added substances („NIAS“)

aids to polymerisation
FCM approved under food law
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Evaluation of the composition
Attention should also be paid to...
...other material- a/o substance specific european
regulations/directives
 Regulation on epoxy derivatives
(EC No. 1895/2005)
 Regulation on plasticisers in gaskets in lids
(EC No. 372/2007)
(EC No. 597/2008)
 Directive on regenerated cellulose films (No. 2007/42/EG)
 Regulation on recycled plastic materials (EC No. 282/2008)
incl. EFSA-Guideline from May 2008
 Regulation on intelligent materials and articles (EC No.
450/2009) incl. EFSA-Guideline from July 2009
as well as applicable existing national regulations
FCM approved under food law
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Practical approach (2)
Formal inspection of composition
b) Are there migration limits for the single substances?
c) Are there certain specifications a/o restrictions?
EC No. 10/2011 Annex I, Tab. 1.:
?
?
?
?
Regulation (EU) No. 10/2011
Chapter II: Compositional requirements
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Article 10 as well as Annex II:
General restrictions on plastic materials and articles
Specific migration limits:
 Barium
1 mg/kg
 Cobalt
0,05 mg/kg
 Copper
5 mg/kg
 Iron
48 mg/kg
 Lithium
0,6 mg/kg
 Manganese
0,6 mg/kg
 Zinc
25 mg/kg
Release of (not listed) primary aromatic amines:
The detection limit is 0,01 mg of substance per kg of food or
food simulant.
Regulation (EU) No. 10/2011
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Chapter II: Compositional requirements
Specific migration limits: (Article 11)
 For substances for which no specific migration limit or other
restrictions are provided in Annex I, a generic specific migration
limit of 60 mg/kg shall apply.
 Special limitations for „dual additives“
Overall migration limit: (Article 12)
 Max. 10mg/dm²

plastic materials andarticles intended to be brought into contact with
food intendedfor infants and young children: max. 60 mg/kg
FCM approved under food law
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Practical approach (3)
Migration tests
a) Selection of necessary food simulants
Attention: Also for dry foodstuffs!
Regulation (EU) No. 10/2011
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Annex III: Food simulants
until now:
Aqua dest.
Acetic acid 3% (w/v)
new:
A
hydrophilic foodstuff (pH  4,5)
B
Ethanol 10 Vol.-%
Acetic acid 3 Gew.-%
hydrophilic foodstuff (pH < 4,5)
Ethanol 15% (v/v)
C
Ethanol 20 Vol.-%
alcohol. foodstuff ( 20% Alc.)
Ethanol 50% (v/v)
Vegetable oil
No tests intended
D
lipophilic foodstuff
E
dry foodstuff
D1: Ethanol 50 Vol.-%
D2: Vegetable oil
Tenax ®
Poly(2,6-Diphenyl-p-phenylenoxid)
FCM approved under food law
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Concrete approach (4)
Migration tests
b) Clarification of conditions of contacts when using food simulants
c) Conduction of appropriate test conditions

Check of overall migration

Check of specific migration
Regulation (EU) No. 10/2011 – Annex V
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
Compliance testing
CHAPTER 1:
Testing for specific migration of materials and articles already in
contact with food

CHAPTER 2:
Testing for specific migration of materials and articles not yet in
contact with food

CHAPTER 3:
Testing for overall migration

CHAPTER 4:
Correction factors applied when comparing migration test results with
migration limits
- Fat Reduction Factor (FRF)
- Correction of migration into food simulant D2
- Combination of correction factors 4.1 and 4.2.
Regulation (EU) No. 10/2011 – Annex V
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Testing for specific migration: Time/Temperature
„special conditions“:
t2 = t1 * Exp ((-Ea/R) * (1/T1-1/T2))
But max. 10 days/ 60°C
Ea...the worst case
activation energy 80kJ/mol
R...8,31 J/Kelvin/mol
Exp -9627 * (1/T1-1/T2)
T1...contact time
T2...testing time
Regulation (EU) No. 10/2011 – Annex V
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Testing for specific migration: Time/Temperature
For food simulants A, B, C or D1 the test may
be replaced by a test at 100 °C or at reflux
temperature for duration of four times the
time selected according to the conditions.
Regulation (EU) No. 10/2011 – Annex V
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Testing for specific migration: Time/Temperature
Time/ Temperature – Standard conditions

Testing for 10 days at 20 °C shall cover all storage times at frozen
condition.

Testing for 10 days at 40 °C shall cover all storage times at
refrigerated and frozen conditions including heating up to 70 °C/2 h,
heating up to 100 °C /15 min.

Testing for 10 days at 50 °C shall cover all storage time at
refrigerated and frozen conditions including heating up to 70 °C/2 h,
or heating up to 100 °C/15 min and storage times of up to 6 months at
room temperature.

Testing for 10 days at 60 °C shall cover long term storage above 6
months/room temperature and below including heating up to 70 °C/
2 h, or heating up to 100 °C/15 min.
Regulation (EU) No. 10/2011 – Annex V
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Testing for overall migration: Time/Temperature
Standardised testing conditions:
OM 5 covers OM1, OM2, OM3, OM4.‘worst case‘
conditions for all food simulants in contact with polyolefins.
OM1, OM2, OM3, OM4 and 5 covered!
`worst case`for non-polyolefines
OM1, OM2, OM3, OM4 and 5 covered! `worst case`for fatty
food simulants in contact with non-polyolefines
Regulation (EU) No. 10/2011 – Annex V
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Testing for overall migration: Time/Temperature
Substitute test for OM7 with food simulant D2 (2h/ 175 °C):
FCM approved under food law
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Practical approach (5)
Migration tests
a) Test performance
-
gravimetric
chromatographic
spectrometric
Abundance
TIC: HUND002.D
3.57
140000
5.96
6.21
3.51
130000
120000
4.18
110000
8.90
3.77
100000
90000
80000
11.15
70000
60000
4.87
50000 3.26
4.74
5.15
40000
7.19
7.29
5.06
9.78
12.74
30000
20000
10000
0
3.00
4.00
5.00
6.00
Time-->
Test with TENAX ®
Use of validated methods!
7.00
8.00
9.00
10.00
11.00
12.00
FCM approved under food law
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Practical approach (6)
Migration tests
e) Evaluation of results
f) Comparison with Regulation-requirements in accordance
of potential correction-factors
EC No. 10/2011 Annex I, Tab. 1; Annex II, Tab. 2:
?
?
FCM approved under food law
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Practical approach (8)
Sensory Evaluation/ Verification
a) Odor of packaging
b) Taste impairment (foodstuff, aquaeuos extract)
As well as....
…appropriate transfer of test results in the declaration of
conformity of the product of!
Regulation (EU) No. 10/2011
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Chapter IV: Declaration of compliance
Article 15 and Annex IV:
Content of declaration of compliance
Regulations substantially as previously (2002/72/EG)
Additionally:

Identity and address of the business issuing the Declaration of
compliance

Declaration of compliance for products from intermediate stages of
production

Sufficient information about the used materials or their degradation
products…(so far only adequate information on the substances used)

Information required in the presence of a functional barrier is now
required in all cases (so far only in functional barriers made of plastic)
Regulation (EU) No. 10/2011
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Chapter III: Specific product requirements
Plastic multi-layer materials and articles: (Article 13)

Option of using the 'functional barrier' - approach to individual plastic
layers, if

No direct foodstuff contact given

Limit violation and / or

Use of non-listed substances is given (except carcinogenic /
mutagenic / reproductive toxicity, nanomaterials)
Conditions

NO Migration of the substances into food or food simulant should be
detectable measured with statistical certainty by a method of analysis
with a limit of detection of 0,01 mg/kg = 10 ppb (for structurally or
toxicological related substances = Total limit)

Migration limit (OM, SML) observed in the total product
Thank you for your attention!
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Dr. Johannes Bergmair
T: +43 1 7981601 976
E: johannes.bergmair@ofi.at
ofi Austrian Research Institute
for Chemistry and Technology
Brehmstraße 14a
1110 Wien
Österreich
 +43-(0)1-798 16 01 - 0
 +43-(0)1-798 16 01 - 900
Packaging
Pharma & Medical Devices
Food & Feed analysis