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1. Risk assessment on non-harmonized FCM atthenationallevel - experience and conclusionsfromthe ESCO Working Group of CEF Panel Jitka Sosnovcová, M.Sc, MPH National Institute of Public Health, Prague NRL for FCM EFSA meeting 16/04/ 2013 Warsaw, Poland

2. Website: www.szu.cz

3. Introduction • Food Contact Materials (FCM) • Regulatory background, harmonized and non-harmonized area • Examples of „food crises“ caused by FCM • Risk assessment of FCM • Creation and mandate of ESCO Working Group on non-plastic FCM • Main aims, general approach and methodology of its work • Final Report, findigs and outcomes of ESCO Working Group on non-plastic FCM • Conclusion

4. Food Contact Materials – a huge area • FCM made ofdifferenttypesof materials (plastic and non-plastic) + many chemicals • FCM mayreleasechemicalsinto food products and beverageswhich are in contactwiththem Criticalissue: • limited official control, limited numberofanalyticalmethods + many problems

5. What is food contact materials? • some examples Industry equipment Food packaging Active packaging ?

6. Food packaging Different materials: plastics, paper, glass…. Multilayer Printing inks, adhesives…

7. Machinery – utensils - equipment

8. DIFFERENT TYPE OF MATERIALS • Glass, • Ceramics • Laquers • Metals/alloys • Paper/board • Plastics (PE, PP, PVC, PA, PS, PET, ABS, SAN, copolymers….) • Printing inks • Rubber • Silicone • Surface coatings • Woods, cork, stones, texilesetc • Combinations and active and intelligent packaging • Recycledmaterials

9. Existing EU legislation

10. EU FRAMEWORK REGULATION (1935/2004) General requirements and definitions Specific legislation Declaration of compliance Supporting documents Supporting documents Supporting Supporting documents

11. Existing EU legislation Regulation EC No.1935/2004istheframework EU legislationthatcoversall food contactmaterials and articles Itdefines FCM and sets basic requirements: • FCM shall not beendangerhumanhealth • FCM shall not bringaboutanunacceptablechanges in thecompositionofthe food • FCM shall not bringaboutdeterioration in theorganolepticcharacteristics

12. Structure of existing legislation on FCM For all type FCM REGULATION EU No. 1935/2004 REGULATION EC No. 2023/2008 on GMP SPECIFIC LEGISLATION on materials or individual substances (REGULATIONS, DIRECTIVES, NATIONAL PROVISIONS AND REGULATIONS OR RECOMMENDATIONS) ↓ ↓ Harmonised at the EU level National provisions • Regenerated cellulose film All others materials as are: • Plastics Elastomers, Silicons • Ceramics Paper and Board • Recycled plastics Rubber, Coatings, • Active and intelligent FCM Metals and Aloys Individual chemical substances Printing inks, Colorants or groups (e.g. BADGE, BFDGE, NOGE,..)

13. In recent years, Competent Authorities of MSs and the European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM.

14. Safety of Food Contact Materials depends on: Selection of suitable raw materials (chemicals), additives, colorants… Compliance with good manufacture practice Comliance with proper use of a product for the corresponding conditions for application of FCM according to the type of materials, (temperature, time, type of foodstuffs ) transportation, storage Safe and complient food contact material or final article means = reduced risk of migration or transition of harmful substances into foods

15. The first example:Migration of semicarbazide and ESBO or other plasticizers (phtalates, adipates ) from closure gaskets of baby jars Semicarbazide H2N-NH-CO-NH2 Semi area with food contact

16. Chain of producing packed food in jars with closures PVC lid gasket food packaging plasticizers

17. Plasticizers found in lids

18. The second example:The need for urgent actions on ink components/mainly photoinitiators/ used for printing paperboard and for multilayer packaging found in food( ITX isopropylthioxanthone, benzophenone, 4-methylbenzophenone, alkylbenzenes, 1-hydroxycyclohexyl-1phenylketone, …

19. The third example Releasing of heavy metals (Pb and Cd) from glass and cups /drinking rims/ or from coatings

20. Risk analysis

21. Food crises – the need to perform the Risk Assessment Wehave to followprinciples and methodsforthe Risk AssessmentofChemicals in Food as a scientificallybasedprocessconsistingofthefollowingfoursteps: • 1. Hazard identification • 2. Hazard characterization • 3. Exposureassessment • 4. Risk characterization

22. Components in risk assessment Toxicokinetics (ADME) Hazard identification Toxicodynamics (Effects) Critical effect Hazardcharacterisation Dose x response relationship Health based intake threshold Concentration in food Exposure assessment Intake of food Conclusion on hazard characterisation and exposure assessment Risk characterization

23. Toxicokinetics - What the body does to the chemical • Absoprption • Distribution • Metabolism • Excretion Toxicodynamics - What the chemical does to the body Effects: Change in the morphology, physiology, growth, development, reproduction or life span of an organism Adverse effects: • Cancer • Damage on organs (liver, kidney, lung, heart....etc) • Damage on the central nervous system (neurotoxicity) • Damage on the reproductive systemetc.

24. Toxicodynamics • Studies in experimental animals • In vitro studies (on bacteria and cells) • Human data (Epidemiolgical studies) • Non-testing data ( based on structural data e.g. QSAR

25. Exposure • Concentration in food x Consumption of food for all • Consumption for specific groups of consumers • (children, eaters, older people, etc.)

26. Definition of hazard and risk Hazard is the inherent property of an agent having the potential to cause adverse effects in an organism exposed to the agent. Risk is the probability of an adverse effect in an organism caused under specified circumstances by exposure to an agent.

27. ESCO Working Group on non-plastic FCM 2009 Internal Mandate proposed by EFSA to the CEF Panel for the creation and management of an EFSA Scientific Cooperation (ESCO) Working Group The initiative for the establishment of the ESCO WG has been given by the Advisory Forum of the EFSA in 2009 with the aim to collect relevant information on the evaluation status of non plastic substances of FCM and articles.

28. ESCO Working Group on non-plastic FCM The main aims: • to collect the relevant information on the evaluation status of non plastic parts of Food Contact Materials • to highlight gaps and propose priorities for future actions

29. ESCO Working Group on non-plastic FCM General approach and methodology • to collectinformationavailable in MemberStates on theevaluationofsubstancesfor FCM otherthanplastics • to prepare inventorylistsofevaluatedsubstancesfordifferent FCMs including information of date used and type of evaluation • to classify the substances according to the way they were evaluated (risk assessment background)

30. ESCO Working Group on non-plastic FCM General approach and methodology • to identify the gaps and strengths in different approaches • to establish the principles of setting the priorities for further evaluations • to organize a workshop with stakeholders to discuss findings, outcomes and the draft ESCO report

31. ESCO Working Group on non-plastic FCM Work activities started by comparing the various legislative requirements and recommendations in Member States Findings: The scope and structure of the national requirements are usually different: Positive lists of substances, requirements on impurities, requirements on final products (migration limits, concentration in mass of products,.. ) Also safety evaluations (risk assessment background) differs

32. National legislation on non plastic FCM (EU Member States only) Paper and board (Belgium, Czech Republic, France, Germany, Greece, Italy, Latvia, Lithuania,Netherlands, Poland, Slovakia, Slovenia) Adhesives (Germany, Slovenia, Spain) Printing inks(Czech Republic, Rumania, Spain) Varnish coatings (Belgium, Czech Republic, France, Greece,Italy, Netherlands, Slovakia, Slovenia, Spain Silicone (Czech Republic, Germany, Hungary, Italy, Netherlands, Spain

33. National legislation (non plastics) Rubber (The Czech Republic, France, Germany, Hungary, Italy, The Netherlands, Romania, Slovakia, Slovenia, Spain Cork (The Czech Republic, The Netherlands, Slovakia) Wax (Germany, The Netherlands) Ion-exchange resins (Spain) No national provisions: Austria, Bulgaria, Cyprus, UK, Denmark, Estonia, Finland, Ireland, Luxembourg, Malta, Portugal, Sweden

34. ESCO WORKING GROUP ON NON PLASTIC FOOD CONTACT MATERIALS MEETING WITH THE STAKEHOLDERS • A meeting withstakeholderswasorganised in Milan (Italy) in 2011 • AlsoEuropeanprofessionalorganisationsactive in thefieldof FCM wereinvitated

35. European professional organisations Paper and board: ACE (TheAllianceforBeverageCartons and theEnvironment) CEPI (ConfederationofEuropeanPaperIndustries) CITPA (International ConfedarationofPaper and BoardConvertors) FEFCO (EuropeanFederationofCorrugatedBoardManufacturers) Printinginks: EuPIA (EuropeanPrintingInkAssociation) Adhesives: FEICA (AssociationofEuropeanAdhesives and SealantsManufacturers)

36. European professional organisations Rubber: ETRMA (European Tyre & Rubber Manufactuters Association) IISRP (International Institute of Synthetic Rubber Producers European Section Secretary Varnishes and coatings: CEPE: (European Council of Paint, Printing Ink and Artists´colours Industry) Metals and alloys: APEL (Association of European Producers of Steel for Packaging) EMPAC (Empac Food Contact Commission) Food contact additives: CEFIC-FCA (CEFIC . Food Contact Additives)

37. Topics for discussion • Subjects of discussion: • crisis prevention, • increase the consumer confidence into packaged foods, positive lists for non plastic materials, • if migration data of substances used in non plastic FCM are available /analytical methods, • identification of gaps…… • Discussion the draft ESCO final report • Expected results (outputs) collection of the information about • Follow up activities in the future

38. What we did • Collect informationavailable in Member States on the evaluation of substances for FCM other than plastics: • - Collecting the evaluations available in Member States • - Preparing inventory lists of evaluated substances including information of the data used and the outcome of the evaluation • - Identifying the most knowledgeable experts in the field, who could be mobilized in case of further need • Analyze the information collected: • - Classifying the substances according to the way they were evaluated (guidelines, risk assessment background). • - Identifying the gaps and strengths in different approaches and underlying guidelines. • - Establish the principles of setting the priorities for further evaluations

39. Report of ESCO WG on non-plastic FCM • Final Report was issued • This external report is not produced by EFSA. It is published here to help keep the public informed of developments related to EFSA's scientific work. EFSA reserves its rights, view and position as regards the issues addressed and conclusions reached in the present document, without prejudice to the rights of the authors. • Report • Annex I

40. Report of ESCO WG on non-plastic FCM • - Inventory listwith 2800 entries*: substances used for manufacture of non-plastic FCM (*list A: 230 substances evaluated according SCF Guidelines) • - Other evaluations for prioritization: Threshold of Toxicological Concern (TTC) • - Dietary exposure: • based on uses and concentration in FCM

41. Annex I of ESCO WG on non-plastic FCMThe lists contain the following columns: • A. PM/REF N°:Commission PM reference number; • B. CAS RN: CAS Registry Number; • C. NAME: name of the substance ( and C.I. name, only for pigments and dyes); • D. SCF list: the classification into an SCF list, if available; • E. Regulation/Recommendation: the national Regulation or Recommendations where the substance is listed, if available; • F. Restriction: the restrictions contained in the national Regulations or Recommendations; • G. Substance in positive list(y/n): if the substance is included in the MS positive list or not; • H. MS: Member State; • I. Safety Evaluation by MS: this column contains A or B, • A means that the evaluation was done after 1991 (when the first version of the SCF guidelines was published), • Bmeans that the evaluation was done before 1991; • J. Remarks: any other relevant information related to the substance, e.g. technological function, reaction products etc.

42. For more detailed information:Please, look at the Final Report of ESCO WG on non-plastic FCM on the website of EFSA

43. tHANK YOU VERY MUCH FOR your KIND ATTENTION !