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!