1. Österreichisches Forschungsinstitut für 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

2. 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

3. www.ofi.at 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

4. www.ofi.at 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

5. www.ofi.at 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.

6. www.ofi.at 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.

7. www.ofi.at Regulation (EU) No. 10/2011 Placing 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.

8. www.ofi.at 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? Best Noodels

9. www.ofi.at 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

10. www.ofi.at 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

11. www.ofi.at 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

12. www.ofi.at 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 ??? ?

13. www.ofi.at 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.

14. www.ofi.at 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

15. www.ofi.at FCM approved under food law Practical approach (3) Migration tests a)Selection of necessary food simulants Attention: Also for dry foodstuffs! Best Noodels

16. www.ofi.at Regulation (EU) No. 10/2011 Annex III: Food simulants Aqua dest.A hydrophilic foodstuff (pH  4,5) Ethanol 10 Vol.-% Acetic acid 3% (w/v)B hydrophilic foodstuff (pH < 4,5) Acetic acid 3 Gew.-% Ethanol 15% (v/v)C alcohol. foodstuff (  20% Alc.) Ethanol 20 Vol.-% Ethanol 50% (v/v) D lipophilic foodstuff Ethanol 50 Vol.-% D1: Ethanol 50 Vol.-% Vegetable oil Vegetable oil D2: Vegetable oil No tests intendedE dry foodstuff Tenax ® Tenax ® Poly(2,6-Diphenyl-p-phenylenoxid) until now:new:

17. www.ofi.at 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 Best Noodels

18. www.ofi.at 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.

19. www.ofi.at 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°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

20. www.ofi.at 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.

21. www.ofi.at 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.

22. www.ofi.at 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

23. www.ofi.at Regulation (EU) No. 10/2011 – Annex V Testing for overall migration: Time/Temperature Substitute test for OM7 with food simulant D2 (2h/ 175 °C):

24. www.ofi.at FCM approved under food law Practical approach (5) Migration tests a)Test performance -gravimetric -chromatographic -spectrometric Use of validated methods! Test with TENAX ®

25. www.ofi.at 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:

26. www.ofi.at 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!

27. www.ofi.at 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)

28. www.ofi.at 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

29. www.ofi.at Thank you for your attention! Packaging Pharma & Medical Devices Food & Feed analysis 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