1. The work of EFSA and of the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) Alina Lupu Scientific Officer, Food Ingredients and Packaging (FIP) Unit Focal Point Conference Warsaw, 16.04.2013

2. EFSA's mission EFSA is the European Union's scientific risk assessment body for food and feed safety, providing the scientific basis for risk management decisions in this area (Regulation (EC) 178/2002). Provide scientific and technical advice on all matters within these fields. Communicate all scientific outputs publicly (communication task is shared with EC/MS). EFSA: http://www.efsa.europa.eu

3. SCOPE: scientific advice on safety of food and feed throughout the food chain

4. How does EFSA work? Risk Assessment Risk Communication European Commission European Parliament Member States EFSA (“self mandate”) Register of questions Examination Allocation to CEF Panel Acceptance Receipt of the request 10 Scientific Panels 1 Scientific Committee 17 Scientific Units Introduction

5. Food Contact Materials, Enzymes, Flavorings and Processing Aids (CEF) Panel Food Additives and Nutrient Sources Added to Food (ANS) Panel

6. Introduction: Scientific Panels/Committee Food additives and nutrient sources (ANS) *) Food contact materials, enzymes, flavourings (CEF) *) Feed additives (FEEDAP) Genetically modified organisms (GMO) Nutrition (NDA) Animal health and welfare (AHAW) Biological hazards (BIOHAZ) Contaminants (CONTAM) Plant health (PLH) Plant protection products (PPR) Scientific Committee (SC) Mainly opinions on applicationsMainly generic opinions Since 2003 >3,000 scientific outputs *) Since July 2008. Before Scientific Panel on food additives, flavourings, pocessing aids, and materials in contact with food (AFC Panel)

7. The CEF Panel (2011-2014) PRATT Iona, Chair LECLERCQ Catherine, Vice-Chair MENNES Wim, Vice-Chair BECKMAN SUNDH Ulla, Member BINDERUP Mona-Lise, Member BOLOGNESI Claudia, Member BRIMER Leon, Member CASTLE Laurence, Member DI DOMENICO Alessandro, Member ENGEL Karl-Heinz, Member FRANZ Roland, Member GONTARD Nathalie, Member GUERTLER Rainer, Member HUSOY Trine, Member JANY Klaus-Dieter, Member KOLF-CLAUW Martine, Member MILANA Maria Rosaria, Member SVENSSON Kettil, Member TAVARES POCAS Maria de Fatima, Member TOLDRA Fidel, Member WÖLFLE Detlef, Member Toxicology – absorption, distribution, metabolism, excretion (ADME) of substances (toxicokinetics and toxicodynamics), sub- chronic and chronic toxicity (repeated dose studies), genotoxicity, developmental and reproductive toxicity, carcinogenicity, Chemistry – chemical reactivity of flavourings and of food contact substances, physico-chemistry, migration of food contact materials Dietary exposure assessment and quantitative risk assessment Food technology (manufacturing processes and use of processing aids) Food enzymes.

8. The CEF Panel mandate The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with questions on the safety of use of materials in contact with food, enzymes (including genetically modified), flavourings and processing aids, and also with questions related to the safety of processes (recycling of plastics and irradiation).

9. E.g.Authorization process for Food Contact plastics Plastics Reg. (EU) 10/2011- Positive list* Industry sends aplications to Member States Member State drafts mandate EFSA (CEF Panel) evaluates European Commission regulates * Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food: Union list of authorised monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids http://eur- lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:012:0001:0089:EN:PDF Data to be submitted: -Identity and physico-chemical properties, intended application and technical function, existing authorizations, migration studies -Toxicological data

10. New packages Mechanical recycling Food / Consumer safety? Pollutants? Used packagesUsed packages What if recovered bottles contain traces of petrol, urine, pesticides …? Recycling processes Plastic recycling 90 applications received in 2011

11.  Guidance of the CEF Panel on the Submission of a Dossier on Food Enzymes for Safety Evaluation adopted at the 23 July 2009 http://www.efsa.europa.eu/en/efsajournal/pub/1305.htm  Dossiers can be submitted as from September 2011 until March 2015  200 – 600 dossiers are expected Food Enzymes 6 applications received by now

12. CEF Panel work programme 2013 Total: 50 outputs AreaNumber of outputs other info New Guidelines for submission of an application for substances used as food contact material 1Public consultation ( draft: tiered toxicological data submission and new exposure assessment) Food contact materinals (plastic and active andintelligent packaging material 8+5=13 BPA1Public consultation Flavourings: Re- evaluation of FGE.19 and footnote 10 substances 16 Food enyzmes010 work in progress

13. How the Panel works  Working Groups of the CEF Panel  EFSA staff: FIP Unit  Scientific procurement and grants  Networks (FIP network) Resources available to the CEF Panel for output delivery:

14. Request Panel Working Group Opinion discussed, modified, adopted Draft opinion WG member Hearing expert Panel Members The Panel, how it works in practice: working groups

15. BPA Exposure 2012 WG BPA Toxicology 2012 WG Genotox WG Enzymes WG Flavourings WG Food Contact Material WG Recycling plastics WG The CEF Panel WGs in 2013 2012 Number of Mandates43 Panel meetings6 WG meetings/phone conference calls 50 No. of meeting days93

16. The Panel, how it works in practice: FIP Unit and AppDesk Unit Administrative support meetings and travel Co-ordination of workprogramme Scientific support to the WGs/Panels Drafting of EFSA statements and EFSA reports FIP Unit Acts as a support desk for applicants, Member States and other stakeholders (front office) Provides internal coordination (back office) on applications http://www.efsa.europa.eu/en/applicationshelpd esk.htm AppDesk Unit Scientific Assessement Support Unit Technical support in the field of statistics, modelling, data management and risk assessment Development and application of new or refined risk assessment approaches Dietary and Chemical Monitoring Unit Deals with the collection, collation and analysis of data on food consumption and chemical occurrence in food and feed for exposure assessments at European level

17.  Data collection  Preparatory work for scientific opinions  Other scientific and technical assistance The Panel, how it works in practice: procurements and grants  Flavourings: Danish Technical University (DTU), Copenhagen  Food Contact Materials:  Non Toxicological Summary Data Sheets: TNO, The Netherlands  Toxicological Summary Data Sheets: BfR Germany http://www.efsa.europa.eu/en/calls.htm EFSA’s priority: enhanced cooperation and networking in Europe – Article 36 grants

18. Food Enzymes:

19. Bisphenol A - self tasking of the CEF Panel 2012 BPA Mandate:  Full re-evaluation of BPA  Scientific Opinion on the risks to public health related to the presence of BPA in foodstuffs TOR 1.To evaluate the toxicity for humans, incl. vulnerable groups (e.g. pregnant women, infants and children, etc.); 2.To assess human exposure from dietary and non-dietary sources (incl. vulnerable groups); 3.To characterize the health risks for the general population and for vulnerable groups Deadline: November 2013 (incl. public consultation)

20.  WGs: BPA toxicology and BPA exposure started 2012 and worked in parallel.  13 members covering general tox, reprotox, immunotoxicity, toxicokinetics, epidemiology…  14 members covering dietary and non dietary exposure and biomonitoring  Since March 2013 WG TOX includes some members of exposure WG as this WG will finalise the draft opinion Establishment of the Woorking groups

21. BPA Exposure Procurement: Scientific literature review, from 2006- 2013, through public call for tender  Launched by EFSA in May 2012: addressed to Member States, research institutions, academia, food business operators, packaging business operators and other stakeholders  Aim: BPA occurrence in food and drinks, BPA migration from food contact materials and BPA occurrence data in food contacts materials.  1800 single data have been received EFSA`s Call for data

22. BPA Toxicology EFSA has outsourced the work on continuous “Review of scientific literature on BPA” through a contract with the University of Parma 1.First contract August 2010-July 2011 2.New contract August 2011-July 2014 About 30-40 new papers on BPA are published every month! Procurement:

23.  Stakeholder meeting foreseen in September 2013  Public consultation July-September 2013 BPA: ”state of play” and future steps  Draft opinion to be finalized by July 2013:

24. CEF Panel: Challenges for 2013  Re-evaluation of BPA – deadline November 2013  Finalisation of the safety assessment of Recycling processes – deadline December 2013  Many applications and short deadlines – 6 months

25. Thank you!