EFSA Network of the Food Ingredients and Packaging (FIP) Unit on Food Contact Materials (FCM)

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Julianna Dennis
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1 EFSA Network of the Food Ingredients and Packaging (FIP) Unit on Food Contact Materials (FCM) Eric Barthelemy Scientific Oficer, coordinator of the FIP FCM network EFSA Advisory Forum - 9 March Parma, Italy

2 OUTLINE Mandate Meetings, discussions, topics Towards harmonisation 2

3 BACKGROUND FOR THE FIP NETWORK Advisory Forum agreed at its 49 th meeting in September 2013 with creation of the FIP Network for a 3 years period Mandate signed in October 2013 => until October

4 EFSA SCIENTIFIC NETWORK EFSA Scientific Networks aim to facilitate scientific cooperation between MS, EFTA, EU candidates and EFSA 4

5 OBJECTIVES OF THE FIP NETWORK About risk assessment activities and approaches To enhance cooperation between scientists To share the same level of information To avoid duplication of work and to possibly anticipate and prevent divergence of opinions To support and harmonise risk assessment practices 5

6 ABOUT THE FCM SUBGROUP FCM Network was set up in 2014 In February 2016, it gathers: 28 representative Member States (inc. Norway & Iceland) + Switzerland = 29 countries European Commission (DG SANTE + JRC) Council of Europe (CoE) CEF Panel (Chair of FCM WG) 6

FCM SUBGROUP MEETINGS Will have met 3 times since 2014 1 st meeting was held in November 2014 Main topic was non-plastics materials 2

7 FCM SUBGROUP MEETINGS Will have met 3 times since st meeting was held in November 2014 Main topic was non-plastics materials 2 nd meeting was held in July 2015 Main topic was draft guidances on safety evaluation of substances 3 rd meeting follows in May

NETWORK ACTIVITIES AND MEETINGS AGENDA Sharing and discussing information on: International and EU activities (CoE, EC,and EFSA) MS activities: cooperation between

8 NETWORK ACTIVITIES AND MEETINGS AGENDA Sharing and discussing information on: International and EU activities (CoE, EC,and EFSA) MS activities: cooperation between MSs; Projects & researches at national level; FCM type related risk assessment approaches (draft) Guidances for safety assessment Common challenges Also trainings 8

9 SHARING INTERNATIONAL AND EU ACTIVITIES CoE on worplan, resolutions, practical guide on metals and alloys (2013) EC DG SANTE on non-eu harmonised/regulated FCM such as roadmap project & baseline study EC JRC on migration testing projects (ceramics, plastic guidance for compliance) EFSA on former ESCO working group on nonplastics; on CEF Panel draft opinion on ground for revising SCF guidelines for safety assessment 9

10 SHARING MEMBER STATES ACTIVITIES Cooperations amongst MSs ANSES-DTU-BfR-RIVM workshop (2013) ANSES-DTU on Quantification and risk assessment of unknown contaminants migrating from Paper and Board (ongoing) BfR-FSVO(CH) on evaluation of printing inks Researches and projects BfR on migration from printing inks, from elastomers, release from metal and alloys ANSES on migration from elastomers Draft regulation DE & CH on printing inks, BE on coatings, etc. 10

11 SAFETY ASSESSMENT OF NON EU REGULATED FCM As part of MS activities, national safety assessment performed on Coatings, Paper and boards, Printing inks, Metal and alloys were presented (legislation, applications, requirements) It allows to identify who is doing safety assessment (e.g. DE, IT, NL for P&B) 11

12 SAFETY ASSESSMENT OF NON EU REGULATED FCM Reference to SCF/EFSA guidance for the submission of dossiers were highlighted along with special requirements, e.g. different migration methods Challenges and common issues are discussed: NIAS, oligomers, migration testing, readacross, database, ED 12

13 SAFETY ASSESSMENT OF NON EU REGULATED FCM MS representatives expressed the need for harmonization of the safety assessment This could be facilitated by sharing guidances such as EFSA draft opinion on the ground for revising the SCF guidelines and by cooperating on horizontal issues (e.g. NIAS, oligomers) 13

14 GUIDANCES ON SAFETY ASSESSMENT EFSA CEF Panel and safety assessment of substances: use of food consumption data welcomed by MS Need to harmonise the standards on food safety (mutual recognition) Could be applied to other FCMs with revisions NL guidance on NIAS for industry to perform its own risk assessment was welcomed (< 90 µg/kg food not expected of concern) gap with 0.15 µg/kg food, some limitations, further developments needed FR draft guidance on non-plastics (to follow) 14

15 TRAININGS On: Benchmark dose & Computational toxicology and modelling tools (EFSA training on advanced risk assessment):13 courses (+7) Use of the EFSA Comprehensive database (next network meeting) Use of the so called Belgium database on substances known by members of CoE to be used in FCM (next network meeting) 15

16 WHERE TO FIND THE INFORMATION? Conferences and conferences-like On EFSA website ( 16

17 TOWARDS HARMONISATION 1/4 It shows that safety assessment of non EU regulated FCMs is mostly based on the current SCF guidelines Consensus on the need for harmonisation of the safety assessment methodology Guidances for safety assessment Challenges such as NIAS and oligomers Migration testing may be FCM-type related 17

18 TOWARDS HARMONISATION 2/4 Further harmonisation of guidances could be (first step) on: Approach (tox. data tiered related, same tiers) Minimum tox. data requirement EU Food consumption data 18

19 TOWARDS HARMONISATION 3/4 It needs continuous cooperation amongst MSs on shared activities especially on migration testing with the aim to harmonise those testing specific to FCM type (e.g. paper and board, elastomer) There are already leader MSs for those non EU regulated FCMs Continue working together on challenges such as NIAS, oligomers 19

20 TOWARDS HARMONISATION 4/4 This requires willingness and decision Participation of right representants (authority should always be represented + experts/chair of Scientific Committee) Allocated time (FTE), meetings Continuing on training Medium term workprogram EC Mandate on harmonisation that drives people to better cooperate 20

21 THANK YOU FOR YOUR ATTENTION Any comments, questions? Let us cooperate together for a safe food

Food Contact Materials gaps to be addressed the roadmap excercise

Food Contact Materials gaps to be addressed the roadmap excercise The content of this lecture does not necessarily represent the position of the European Commission 1 ANEC, Brussels, 29.10.2013 Overview