Österreichisches Forschungsinstitutfür Chemie und Technik

Austrian Research Institut for Chemistry and Technology

www.ofi.at

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

www.ofi.at

Plastic Implementation Measure (PIM)

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

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Scope of the regulation (EU) No. 10/2011

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;

(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.

with coating,

printed

a/o covered

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Regulation (EU) No. 10/2011Plastic 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 waxincl. synthetic paraffin wax a/o microcristalline wax

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Regulation (EU) No. 10/2011Plastic 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. 10/2011Plastic 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.

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Regulation (EU) No. 10/2011Placing on the market of plastic materials and articles

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.

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FCM approved under food law

Practical approach (1)

Formal inspection of composition

a) Are monomers, starting materials and additves listed and

approved in the regulation?

BestNoodels

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Regulation (EU) No. 10/2011

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

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Regulation (EU) No. 10/2011

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

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FCM approved under food law

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

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FCM approved under food law

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.:Best

Noodels

? ? ? ?

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Regulation (EU) No. 10/2011

Chapter II: Compositional requirements

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.

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Regulation (EU) No. 10/2011

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

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FCM approved under food law

Practical approach (3)

Migration tests

a) Selection of necessary food simulants

Attention: Also for dry foodstuffs!Best

Noodels

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Regulation (EU) No. 10/2011

Annex III: Food simulants

Aqua dest. AAhydrophilic foodstuff (pH 4,5)

Ethanol 10 Vol.-%Ethanol 10 Vol.-%

Acetic acid 3% (w/v) BBhydrophilic foodstuff (pH < 4,5)

Acetic acid 3 Gew.-%Acetic acid 3 Gew.-%

Ethanol 15% (v/v) CCalcohol. foodstuff ( 20% Alc.)

Ethanol 20 Vol.-%Ethanol 20 Vol.-%

Ethanol 50% (v/v)D D

lipophilic foodstuff

D1: Ethanol 50 Vol.-% Ethanol 50 Vol.-%

Vegetable oil D2: Vegetable oil Vegetable oil

No tests intended EEdry foodstuff

TenaxTenax ® ®

Poly(2,6-Diphenyl-p-phenylenoxid)

until now: new:

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FCM approved under food law

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 BestNoodels

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Regulation (EU) No. 10/2011 – Annex V

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.

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Regulation (EU) No. 10/2011 – Annex V

Testing for specific migration: Time/Temperature

„special conditions“:

t2 = t1 * Exp ((-Ea/R) *

(1/T1-1/T2))

But max. 10 days/ 60°CEa...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

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Regulation (EU) No. 10/2011 – Annex V

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.

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Regulation (EU) No. 10/2011 – Annex V

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.

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Regulation (EU) No. 10/2011 – Annex V

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

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Regulation (EU) No. 10/2011 – Annex V

Testing for overall migration: Time/Temperature

Substitute test for OM7 with food simulant D2 (2h/ 175 °C):

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FCM approved under food law

Practical approach (5)

Migration tests

a) Test performance

- gravimetric

- chromatographic

- spectrometric

3.00 4.00 5.00 6.00 7.00 8.00 9.00 10.00 11.00 12.000

10000

20000

30000

40000

50000

60000

70000

80000

90000

100000

110000

120000

130000

140000

Time-->

Abundance

TIC: HUND002.D

3.26

3.51

3.57

3.77

4.18

4.74

4.87

5.06

5.15

5.96 6.21

7.19 7.29

8.90

9.78

11.15

12.74

Use of validated methods!Test with TENAX ®

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FCM approved under food law

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:

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FCM approved under food law

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!

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Regulation (EU) No. 10/2011 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)

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Regulation (EU) No. 10/2011 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

www.ofi.atThank you for your attention!

Packaging

Pharma & Medical Devices

Food & Feed analysis

Dr. Johannes BergmairT: +43 1 7981601 976E: 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