Transcript Document

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
Introduction
How does EFSA work?
Receipt
of the
request
European Commission
European Parliament
Member States
EFSA (“self mandate”)
Examination
Acceptance
Allocation to
CEF Panel
Risk Assessment
Risk Communication
10 Scientific Panels
1 Scientific Committee
17 Scientific Units
Register of
questions
Food Contact
Materials,
Enzymes,
Flavorings
and
Processing
Aids (CEF)
Panel
Food
Additives and
Nutrient
Sources
Added to
Food (ANS)
Panel
Introduction: Scientific Panels/Committee
Mainly opinions on applications
Mainly generic opinions
• 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)
*) Since July 2008. Before Scientific Panel on food additives, flavourings, pocessing aids, and
materials in contact with food (AFC Panel)
Since 2003 >3,000 scientific outputs
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
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Toxicology – absorption, distribution, metabolism, excretion
(ADME) of substances (toxicokinetics and toxicodynamics), subchronic 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
Industry sends
aplications
to Member States
Data to be submitted:
-Identity and physico-chemical
properties, intended application
and technical function, existing
authorizations, migration studies
Reg. (EU) 10/2011Positive list*
Member State drafts mandate
EFSA (CEF Panel) evaluates
European Commission regulates
-Toxicological data
* 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://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:012:0001:0089:EN:PDF
Recycling processes
Plastic recycling
Used packages
Mechanical
recycling
90
applications
Food / Consumer safety? received in
2011
Pollutants?
What if
recovered bottles
contain traces of
petrol, urine,
pesticides …?
New packages
Food Enzymes
 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
6 applications received by now
CEF Panel work programme 2013
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
Food contact materinals
(plastic and active
andintelligent
packaging material
8+5=13
BPA
1
Flavourings: Reevaluation of FGE.19
and footnote 10
substances
16
Food enyzmes
0
Total:
data submission and new
exposure assessment)
50 outputs
Public consultation
10 work in progress
How the Panel works
 Working Groups of the CEF Panel
Resources available to
the CEF Panel for output
 EFSA staff: FIP Unit
delivery:
 Scientific procurement and grants
 Networks (FIP network)
The Panel, how it works in
practice: working groups
Request
Panel
Opinion
discussed,
modified,
adopted
Working Group
Draft
opinion
WG member
Panel Members
Hearing expert
The CEF Panel WGs in 2013
2012
Food Contact Material WG
Recycling plastics WG
Flavourings WG
Enzymes WG
BPA Exposure 2012 WG
BPA Toxicology 2012 WG
Genotox WG
Number of Mandates
43
Panel meetings
6
WG meetings/phone
conference calls
50
No. of meeting days
93
The Panel, how it works in practice:
FIP Unit and AppDesk Unit
FIP Unit
 Administrative support
meetings and travel
 Co-ordination of
workprogramme
 Scientific support to the
WGs/Panels
 Drafting of EFSA statements
and EFSA reports
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
AppDesk 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
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
The Panel, how it works in
practice: procurements and grants
http://www.efsa.europa.eu/en/calls.htm
 Data collection
 Preparatory work for scientific
opinions
 Other scientific and technical
assistance
 Flavourings: Danish Technical University (DTU), Copenhagen
 Food Contact Materials:
Non Toxicological Summary Data Sheets:
TNO, The Netherlands
Toxicological Summary Data Sheets: BfR Germany
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)
Establishment of the Woorking groups
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
Procurement:
BPA Exposure
Scientific literature review, from 20062013, through public call for tender
EFSA`s Call for data



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
Procurement:
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!
BPA: ”state of play” and future steps
 Draft opinion to be finalized by July 2013:
 Public consultation July-September 2013
 Stakeholder meeting foreseen in September 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!