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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
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
SCOPE: scientific advice on safety of food and feed throughout the food chain
How does EFSA work?
Risk AssessmentRisk Communication
European Commission
European Parliament
Member States
EFSA (“self mandate”)
Register of questionsExaminati
on
Allocation to CEF Panel
Acceptance
10 Scientific Panels1 Scientific Committee 17 Scientific Units
Introduction
Food Contact
Materials, Enzymes, Flavorings
and Processing Aids (CEF)
Panel
Food Additives
and Nutrient Sources Added to
Food (ANS) Panel
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 applications Mainly 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)
The CEF Panel (2011-2014)
PRATT Iona, ChairLECLERCQ Catherine, Vice-ChairMENNES Wim, Vice-ChairBECKMAN SUNDH Ulla, MemberBINDERUP Mona-Lise, MemberBOLOGNESI Claudia, MemberBRIMER Leon, MemberCASTLE Laurence, MemberDI DOMENICO Alessandro, MemberENGEL Karl-Heinz, MemberFRANZ Roland, MemberGONTARD Nathalie, MemberGUERTLER Rainer, MemberHUSOY Trine, MemberJANY Klaus-Dieter, MemberKOLF-CLAUW Martine, MemberMILANA Maria Rosaria, MemberSVENSSON Kettil, MemberTAVARES POCAS Maria de Fatima, MemberTOLDRA Fidel, MemberWÖLFLE 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 .
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).
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
New packages
Mechanicalrecycling
Food / Consumer safety?
Pollutants?
Used packages
What if recovered bottlescontain traces ofpetrol, urine,pesticides …?
Recycling processes
Plastic recycling
90 applications received in
2011
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
CEF Panel work programme 2013
Total: 50 outputs
Area Number of outputs other info
New Guidelines for submission of an application for substances used as food contact material
1 Public consultation(draft: tiered toxicological data submission and new exposure assessment)
Food contact materinals (plastic and active andintelligent packaging material
8+5=13
BPA 1 Public consultation
Flavourings: Re-evaluation of FGE.19 and footnote 10 substances
16
Food enyzmes 0 10 work in progress
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:
Request
Panel Working Group
Opinion discussed, modified, adopted
Draft opinion
WG member
Hearing expertPanel Members
The Panel, how it works in The Panel, how it works in practice: working groupspractice: working groups
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 Mandates
43
Panel meetings 6
WG meetings/phone conference calls
50
No. of meeting days 93
The Panel, how it works in The Panel, how it works in practice: FIP Unit and AppDesk practice: FIP Unit and AppDesk UnitUnit 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/applicationshelpdesk.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
Data collection Preparatory work for
scientific opinions Other scientific and technical assistance
The Panel, how it works in The Panel, how it works in practice: procurements and practice: procurements and grantsgrants
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
Food Enzymes:
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)
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
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
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 20112. New contract August 2011-July 2014
About 30-40 new papers on BPA are published every month!
Procurement:
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:
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
Thank you!