1 EFSA establishment and legal basis

2 Creation of the European Food Safety Authority Creation of the European Food Safety Authority Succession of food scares (e.g. BSE, dioxins) Loss of consumer confidence in safety of food chain and damaged trust in public authorities Creation of agencies to handle food issues at national level Need to re-cast EU food safety system and policy

3 “General Food Law” General principles for food safety –Integrated approach –Responsibility of operators –Precautionary principle –Risk analysis Risk assessment Risk management Risk communication –Traceability Creation of the European Food Safety Authority Setting up a procedure for managing crises Regulation No 178/2002 of 28 January 2002

4 EFSA and Regulation No 178/2002 EFSA and Regulation No 178/2002 Provides the respective responsibilities risk assessment / risk management –EFSA in charge of risk assessment (RA) –Risk management (RM): Commission, MemberStates, European Parliament Scientific requests –Requested by the risk managers (COM/MS/EP) –Possibility of self tasking for EFSA

5 EFSA mission EFSA is the keystone of EU risk assessment regarding food and feed safety.EFSA is the keystone of EU risk assessment regarding food and feed safety. In co-operation with national authoritiesIn co-operation with national authorities Open consultation with its stakeholders,Open consultation with its stakeholders, Independent scientific adviceIndependent scientific advice TransparencyTransparency Clear communicationClear communication

6 EFSA’s tasks Risk assessment –Scientific opinions (art.29) : applications/generic –Technical or scientific assistance (art.31) –Technical guidelines Collection and study of information (art.33) Pre-evaluation for certain dossiers (Pesticides) Network /collaboration with other scientific organizations (e.g. ECDC) or assessment agencies in the Member States Participation in case of food safety crisis

7 EFSA structure and organisation

8 EFSA – Organisation and link with institutions and Member States EFSA – Organisation and link with institutions and Member States Management Board Executive Director Advisory Forum EFSA Structure Scientific Committee Scientific Panels Commission Council European Parliament MS EFSA

9 EFSA - Management Board Membership of 14 + Commission representative Lead EFSA’s strategy and future direction Exercise high level control on the authority Make sure that EFSA respects the key regulatory texts COMCouncil Parliament proposition of a list < 3 months to give suggestions appointment MB

10 EFSA - Advisory Forum Composed of representatives of similar bodies to EFSA in the Member States Role to ensure co-operation with Member States AF MS Propose representatives from org. similar to EFSA advises Exec. Dir. requests

11 EFSA Sc. Panels & Committee ( examples of questions )

12 EFSA 10 Scientific Panels and Scientific Committee 1.Animal health and welfare 2.Biological hazards 3.Contaminants 4.Plant health 5. Food additives and nutrient sources 6. Food contact materials, enzymes, flavourings 7. Feed additives 8. Genetically modified organisms 9. Nutrition 10. Plant protection products The Scientific Committee +

13 EFSA: Scientific Committee and Panels Independent scientists selected on basis of proven excellence in their fieldIndependent scientists selected on basis of proven excellence in their field Mandatory commitment of independenceMandatory commitment of independence Declaration of Interest (annual and per meeting)Declaration of Interest (annual and per meeting)

14 Scientific Committee Responsible for the provision of scientific advice on multi-sectorial issues On issues which do not fall within the competence of any of the Panels Responsible for the general co-ordination necessary to ensure the consistency in the scientific opinions of the different Panels

15 Some examples of the Scientific Committee’s activities  RA of Genotoxic and Carcinogenic Substances (2005)  Exposure Assessments in EFSA (2005)  Existing alternative approaches for animal testing (2009)  Application of the Benchmark Dose approach in RA (2009)  Animal Cloning (2008/2009)  Applications of Nanotechnology in food and feed (2009)  Human Health Risk Benefit Assessment of foods (2010)  Process-related transparency issues in RA (2006)  Science-related transparency issues in RA (2009)  Handling of urgent questions (2006)

16 ANS Panel Panel on food additives and nutrient sources added to food deals with questions of safety in the use of food additives, nutrient sources and other substances deliberately added to food, excluding flavourings and enzymes

17 ANS panel: example of how scientific opinion is used for policy measures Opinion on Calcium L-threonate for use as a source of calcium in food supplements Outcome: Regulation (EC) No 1170/2009 of 30 November 2009 amending Directive 2002/46/EC of the European Parliament and of Council and Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards the lists of vitamin and minerals and their forms that can be added to foods, including food supplements

18 CEF Panel Panel on food contact materials, enzymes, flavourings and processing aids deals with questions on the safety of use of materials in contact with food, enzymes, flavourings and processing aids, and also with questions related to the safety of processes.

19 AHAW Panel Panel on animal health and welfare deals with questions on all aspects of animal health and animal welfare, primarily relating to food producing animals including fish.

20 AHAW panel: example of how scientific opinion is used for policy measures Opinion on ‘Control and eradication of Classical Swine Fever in wild boar.’ Outcome: used by RM for developing ‘guidelines on surveillance/monitoring, control and eradication of CSF in wild boar’ (SANCO/7032/2010 rev4)

21 BIOHAZ Panel Panel on biological hazards deals with questions on biological hazards relating to food safety and food-borne disease, including food-borne zoonoses and transmissible spongiform encephalopathies, microbiology, food hygiene and associated waste management.

22 BIOHAZ Panel: example of how scientific opinion is used for policy measures BSE-TSE area: opinion on ‘Risk for human and animal health related to the revision of the BSE monitoring regime in some Member States’. Outcome: Commission Decision (EC) No 2008/908/EC Authorising EU-15 to revise its annual monitoring programme and to increase from 30 to 48 months as the new age limit for BSE testing.

23 CONTAM Panel Panel on contaminants in the food chain deals with questions on contaminants in food and feed, associated areas and undesirable substances such as natural toxicants, mycotoxins and residues on non authorised substances not covered by another Panel.

24 Contam panel: example of how scientific opinion is used for policy measures Melamine in infant milk and other milk products in China :Comm. Dec 2008/798 imposing special conditions governing the import of products containing milk or milk products originating in or consigned from China. More recent EFSA advice was used as basis for EU position at Codex meeting (July 2010), and once agreed, Commission will propose changed levels in legislation.

25 FEEDAP Panel Panel on additives and products or substances used in animal feed deals with questions on safety for the animal, the user/worker, the consumer of products of animal origin, the environment and with the efficacy of biological and chemical products/substances intended for deliberate addition/use in animal feed.

26 FEEDAP panel: example of how scientific opinion is used for policy measures Regulation 1831/2003 provides for authorisation of feed additives (technological, sensory, zootechnical, nutritional, coccidiostats/histomonostats) Authorisation dossier: Safety and efficacy of Bacillus subtilis PB6 (Bacillus subtilis) for chickens for fattening Outcome: authorised Reg. (EC) No 107/2010

27 GMO Panel Panel on genetically modified organisms deals with questions on genetically modified organisms as defined in Directive 2001/18/EC, such as micro-organisms, plants and animals, relating to deliberate release into the environment and genetically modified food and feed including their derived products.

28 GMOs panel: example of how scientific opinion is used for policy measures Regulation 1829/2003 provides for authorisation of GMOs) Authorisation dossier: for placing on the market of insect resistant and herbicide tolerant genetically modified maize MON89034 x NK603 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 Outcome: Authorisation decision adopted on 28 July 2010 (OJ L 197, ,p.15)

29 NDA Panel Panel on dietetic products, nutrition and allergies deals with questions related to dietetic products, human nutrition and food allergy as well as associated subjects such as novel foods.

30 PLH Panel Panel on plant health Numerous plant pests arrive in the European Union each year and can cause harm to plants, plant products or biodiversity. The brief for this Panel is to peer review and assess those specific risks in order to help secure the safety of the food chain. The Panel brings together a wide range of expertise in the various fields relevant to plant health.

31 PLH Panel: example of how scientific opinion is used for policy measures Opinion of the Scientific Panel on Plant Health on the pest risk analysis made by EPPO on Hydrocotyle ranunculoides L. f. (floating pennywort) PRA does not provide sufficient evidence that the organism can be considered harmful to plants: no listing in Council Directive 2000/29/EC

32 PPR Panel Panel on plant protection products and their residues deals with questions on the safety of plant protection products for the user/worker, the consumer of treated products, and the environment.

33 Scientific Co-operation and Assistance tasks Scientific Co-operation and Assistance tasks To support the scientific panels in the preparation of scientific opinions. To carry some specific tasks (i.e. zoonosis unit) To enhance risk assessment methodologies in Europa (in collaboration with the work of the scientific panels and scientific committee.)

34 Requests to EFSA Questions from the Commission –Majority (Legislation) –Authorisation procedures (including demands from MS) GMO, feed Additives, FCM… –Emergency procedure Questions from EP, MS Questions from EFSA itself

35 Elaboration of an opinion Attribution to a Panel –Nomination of a « rapporteur » –Discussion in Working Groups –Preparation of a draft opinion Final version –Discussion in plenary meeting (Panel) –Adoption, editing of the opinion –Publication (Website) –Communication (if necessary)

36 Risk communication: RA & RM OPINION MEASURES COMMUNICATION RA COMMUNICATION RM RISK COMMUNICATION RISK ASSESSMENT RISK MANAGEMENT