FERA and the role of the NRL Food contact materials and articles – analysis and migration testing

1. FERA and the role of the NRL Food contact materials and articles – analysis and migration testing Emma Bradley

2. Fera • Fera brought together: • Central Science Laboratory (CSL) • UK Government Decontamination Service (GDS) • Plant Health and Seeds Inspectorate (PHSI) • Plant Varieties and Seeds Division (PVS) • Plant Health Division (PHD)

3. Our role • Regulation • Policy and inspectorate functions for plant health, bee health and plant varieties and seeds • Research • Robust scientific research, analysis and evidence for government and commercial customers worldwide • Response • Advice, guidance and support as part of the UK’s capability to respond and recover in emergency situations

4. Our position Downstream Research Upstream Research Translational Research • End User: • Government • Industry • International Consumers • Blue Sky Science: • Global Challenges • Discoveries • Emerging Technologies solving practical problems rather than acquiring knowledge for knowledge's sake

5. Food safety Food Contaminants Food Authenticity Proficiency testing Environmental Contaminants Pesticides Mycotoxins National Reference Laboratory Veterinary medicines Testing Standards Chemical residues Packaging

6. Fera – NRL • FSA appointed FERA as NRL for: • Food contact materials and articles • Dioxins and PCBs in food an feed • Mycotoxins in food • PAHs in food • Trace elements in food • Also some vet drugs and pesticides • – VMD and CRD

7. Role of the NRL • NRLs are required (under 882/2004) to: • Collaborate with the EU-RL • Co-ordinate the activities of official control laboratories (Public Analysts) • Organise where appropriate comparative tests between the official control laboratories and ensure follow-up of such comparative testing • Ensure the dissemination to the competent authority and official national control laboratories of information that the EU-RL supplies • Provide scientific and technical assistance to the competent authority

8. Website http://www.fera.defra.gov.uk/scienceResearch/nationalReferenceLaboratory

9. Analysis and migration testing • What is migration and what factors influence it • Legislation • Migration testing

10. What is migration? • The mass transfer from an external source into food by sub-microscopic processes • May impact food in two ways • Safety – migration of harmful substances • Quality – migration of substances which impart taint or odour • Migration occurs from: • Food packaging • Materials and articles used in food manufacture, transport and storage • Materials and articles used in food preparation and consumption

11. Factors affecting migration • Migration is a diffusion and partitioning process that is dependent on: • The nature of the food contact material (FCM) • The nature and concentration of the migrating substance • The nature of the foodstuff • The nature, the extent and the type of contact between the food contact material/article and the foodstuff

12. EU legislation Framework Regulation (EC) No 1935/2004 (EC) No 2023/2006Good Manufacturing Practice 2007/42/EC Regeneratedcellulose film 84/500/EEC Ceramics,as amended 1895/2005/ECBADGE/BFDGE/ NOGE (EC) No 450/2009 Active and intelligent materials 93/11/EECNitrosamines and nitrosatable substances Plastics (EC) No 282/2008 Recycled plastics (EU) No 321/2011 restriction of use of Bisphenol A in plastic infant feeding bottles (EU) No 10/2011 Plastics Implementation Measure, as amended/corrected (EU) No 284/2011 polyamide and melamine plastic kitchenware Reproduced with the kind permission of Annette Schaefer (DG-SANCO, European Commission)

13. Framework Regulation • First step to harmonising legislation • Defines what is meant by ‘food contact materials and articles’ • Two general principles • Inertness • Safety • Article 3

14. EU legislation Framework Regulation (EC) No 1935/2004 (EC) No 2023/2006Good Manufacturing Practice 2007/42/EC Regeneratedcellulose film 84/500/EEC Ceramics,as amended 1895/2005/ECBADGE/BFDGE/ NOGE (EC) No 450/2009 Active and intelligent materials 93/11/EECNitrosamines and nitrosatable substances Plastics Regulation (EU) No 321/2011 restriction of use of Bisphenol A in plastic infant feeding bottles Regulation (EU) No 10/2011 – Plastics Implementation Measure, as amended/corrected Regulation (EU) No 284/2011 polyamide and melamine plastic kitchenware Reproduced with the kind permission of Annette Schaefer (DG-SANCO, European Commission)

15. Plastics • Principle of inertness • Overall migration limit (OML) • Principle of safety • Specific authorisation of substances • EFSA evaluation – risk assessment • Commission – risk management decision • Specific migration limit (SML) • Maximum permitted quantity in the material or article per unit area (QMA)

16. Non-intentionally added substances Nanoparticles Different toxicological properties Substances should be assessed on a case-by-case basis Risk assessment of the conventional particle size of a substance do not cover engineered nanoparticles Functional barrier Not CMR substances, not substances in nanoform Reduction factors Other aspects

17. How do we test? • Analysis of foods • Analysis of the material or article • Exposure to and analysis of food simulants • The material or article can be tested for its suitability before use by employing food simulants that are intended to mimic the migration properties of different categories of foods • Introduced in the early-1980’s along with the rules for using simulants

18. If the packaging material is already in contact with the foodstuff then the foodstuff itself should be analysed to test for compliance with the SML(s) The food should be removed from contact with the packaging before its expiration date or any date by which the manufacturer has indicated the product should be used for reasons of quality or safety If applicable food should be cooked in-pack prior to testing Analysis of the foodstuff

19. Analysis of the foodstuff • Not always possible • Some substances are ubiquitous and their presence does not necessarily mean migration from the material or article • Some migrants react with food components • Some materials and articles are sold for use with many different foodstuffs • Impossible to test each and every combination

20. Residual content The migration potential can be calculated based on the residual content of migratable substances determined in a complete extraction of the material or article If the total concentration of the extracted substances is less that the OML then compliance is demonstrated If the worst case concentration in the food (assuming 100% transfer from the material or article tested) is less that the SML then compliance is demonstrated Screening tests Solvent extraction (substitute test media) Migration modelling Analysis of the material or article

21. Migration into food simulants • Select simulant based on food type • Select exposure type • Select exposure conditions – time and temperature

22. Food simulants

23. Food simulants (*) simulant B can be omitted if the food has a pH of more than 4.5. (**) the testing in simulant D2 can be omitted if it can be demonstrated by means of an appropriate test that there is no `fatty contact’ with the plastic food contact material 3 = Simulant D-Reduction factor (updated based on scientific evidence)

24. For water Distilled water or equivalent For all foods Simulant A, Simulant B, and Simulant D2 For aqueous, alcoholic and milk Simulant D1 For aqueous, acetic and alcoholic up to 20% Simulant B and Simulant C Food simulants

25. Which exposure type? • Total immersion • Pouch • Reverse pouch • Article fill

26. Test conditions for overall migration

27. Test conditions for overall migration In case it is technically NOT feasible to perform OM7 with food simulant D2 the test can be replaced by test OM 8 or OM9

28. Test conditions for specific migration

29. Test conditions for specific migration Specific conditions Alternative 1 Exp -9627 * (1/T1-1/T2) T1 frozen/cold 278 K (5°C) T1 room temperature 298 K (25°C) Alternative 2 Frozen: 10 days 20°C Refrigerated: 10 days 40°C RT/6 months: 10 days 50°C RT all: 10 days 60°C Alternative 3 Equilibrium at 10 days 40°C

30. Defines simulants Testing rules for overall migration 7 standard test conditions 2 alternative test conditions Testing rules for specific migration Screening approaches for demonstration of compliance Verification for demonstration of non-compliance, mandatory for official control Rules for migration testing

31. The results of specific migration testing obtained in food shall prevail over the results obtained in food simulant The results of specific migration testing obtained in food simulant shall prevail over the results obtained by screening approaches (residual content/extraction solvents/migration modelling) Hierarchy of results

32. Combination of contact times and temperatures Repeated use Third test result used to demonstrate compliance First test when conclusive proof of no increase and compliant First test when non-detectable Specific migration testing

33. EU legislation – non-plastics Framework Regulation (EC) No 1935/2004 (EC) No 2023/2006Good Manufacturing Practice 2007/42/EC Regeneratedcellulose film 84/500/EEC Ceramics,as amended 1895/2005/ECBADGE/BFDGE/ NOGE (EC) No 450/2009 Active and intelligent materials 93/11/EECNitrosamines and nitrosatable substances Plastics (EC) No 282/2008 Recycled plastics (EU) No 321/2011 restriction of use of Bisphenol A in plastic infant feeding bottles (EU) No 10/2011 Plastics Implementation Measure, as amended/corrected (EU) No 284/2011 polyamide and melamine plastic kitchenware Reproduced with the kind permission of Annette Schaefer (DG-SANCO, European Commission)

34. Ceramics • Much less complicated • Limits for lead and cadmium release • Depend on article type • Only one simulant/test condition • 4% (v/v) acetic acid for 24 hours at 22°C • Test methods defined in the Directive

35. Regenerated cellulose film • RCF is a thin sheet material obtained from a refined cellulose derived from unrecycled wood or cotton • To meet technical requirements substances may be added • Specifications given on permitted content • RCF, softeners, additives • Lists of authorised softeners and additives • Regenerated cellulose film may be coated on one or both sides

36. Elastomer or rubber teats • The release of the N-nitrosamines and N-nitrosatable substances from elastomer or rubber teats and soothers is restricted by Directive 93/11/EEC

37. BADGE/BFDGE/NOGE • The restriction of use of certain epoxy derivatives in materials and articles intended to come into contact with food is given in Commission Regulation (EC) No 1895/2005 of 18 November 2005

38. Others? • Adhesives • Ion exchange resins • Printing inks • Silicones • Varnishes and coatings • Waxes • Paper and Board • Glass • Wood • Cork • Metals and alloys • Textiles

39. EU legislation – other recent developments Framework Regulation (EC) No 1935/2004 (EC) No 2023/2006Good Manufacturing Practice 2007/42/EC Regeneratedcellulose film 84/500/EEC Ceramics,as amended 1895/2005/ECBADGE/BFDGE/ NOGE (EC) No 450/2009 Active and intelligent materials 93/11/EECNitrosamines and nitrosatable substances Plastics (EC) No 282/2008 Recycled plastics (EU) No 321/2011 restriction on use of Bisphenol A in plastic infant feeding bottles (EU) No 10/2011 Plastics Implementation Measure, as amended/corrected (EU) No 284/2011 polyamide and melamine plastic kitchenware Reproduced with the kind permission of Annette Schaefer (DG-SANCO, European Commission)

40. Recent developments • Recycled materials • Active and intelligent food packaging

41. Recent developments • Baby bottles • Polyamide and melamine-ware imported from China and Hong Kong