1. Canice Nolan, 12 April 20081 Shared healthcare challengesFood Safety in the European Union - Seattle, 12 April 2008 - Canice Nolan - EC Delegation to the USA

2. Canice Nolan, 12 April 20082 The EU 27+ countries 490+ million consumers Educated, informed With high expectations for: - Safety - Quality - Choice - Availability - Price - Convenience - Taste Worlds’ largest importer of food

3. Canice Nolan, 12 April 20083 Response to crises Separate the promotional aspects of agriculture from food safety – SANCO Separate risk assessment from risk management - EFSA Enhance risk communication

4. Canice Nolan, 12 April 20084 Level EU ploughing field Uniformity of application (defragment market): Move from Directives to Regulations Train the auditors/trainers Domestic vs imported meet same standards Don’t let market penalise those with higher standards Harmonise and improve standards: Include a regulatory impact assessment Equivalence vs compliance Help where necessary: SMEs Developing countries – Aid for Trade R&D International engagement: Codex, IPPC, FAO, OIE, WHO World Bank

5. Canice Nolan, 12 April 20085 General Food Law  General principles (definitions)  Risk analysis  EFSA  Traceability  Precautionary principle  RASFF Regulation (EC) N ˚ 178/2002

6. Canice Nolan, 12 April 20086 General Food Law Article 17 – Liability Operators at all stages shall ensure food and feed is safe Article 18 – Traceability All food, feed and animals: one step up, one step down Article 11 - Imports Food and feed imported into the Community shall comply with the food law or conditions recognised as equivalent Article 12 - Exports Food and feed exported shall comply with the food law, unless otherwise requested by importing authorities

7. Canice Nolan, 12 April 20087 HYGIENE 1 EP and Council Reg. (EC) N. 852/2004 Requirements for all food : Registration of establishments for all food business and production; Objectives : safety of foodstuffs “from farm to fork”; to facilitate controls at all stages of production, distribution, export. Means : primary responsibility rests with food business operators; mark applied directly to the product, the wrapping or packaging, or printed on a label affixed to the product/or a non-removable tag food operators other than at the level of primary production shall apply the HACCP introduced by the Codex Alimentarius; MS shall encourage the development of national GMPs by food operators; Microbiological criteria and temperature controls.

8. Canice Nolan, 12 April 20088 HYGIENE 2 EP and Council Reg. (EC) N. 853/2004 Requirements for food of animal origin : Approval of establishments; A health mark by veterinary authorities; An identification mark by companies; Animals must be clean; (Simplified) requirements for slaughterhouses and cutting plants; Emergency slaughter. Objectives : safety of foodstuffs “from farm to fork”; to facilitate controls.

9. Canice Nolan, 12 April 20089 HYGIENE 3 EP and Council Reg. (EC) N. 854/2004 Characteristics : Official Controls Quantitative assessment of risks determining the ante and post-mortem examinations; Food business operator is still responsible; Verification by competent authority; Goal more important than the means. Major changes: ( compared to 64/433/EC and 71/118/EEC) Actions if animals are not clean; Food chain information; Visual inspection; Use of company staff.

10. Canice Nolan, 12 April 200810 FOOD RECALL Obligation for a business operator to inform consumers on the reasons of a withdrawal and, if necessary, recall the food when: A food is considered as not being in compliance with the food safety requirements (unsafe food) and The food in question is on the market and has left the immediate control of the food business and The consumer has access to this food

11. Canice Nolan, 12 April 200811 NOTIFICATION Article 19.3 requires immediate information to the competent authorities of a potential risk and action taken to prevent it when a food placed on the market may be considered injurious to health Added value: Facilitates a global prevention of risks by enabling the competent authorities to receive early warnings or to identify potential (possibly emerging risks) in order to ensure the most efficient and proportionate ways to manage them

12. Canice Nolan, 12 April 200812 Criteria for notification Prohibited substances or ingredients Unauthorised substances or ingredients Exceeding of legal limits Unauthorised establishment for food of animal origin Unauthorised novel food / GM food Physical risk (foreign bodies) Incorrect labelling implying health risk Other risk based on risk assessment

13. Canice Nolan, 12 April 200813 RASFF The RASFF is: a network for the notification of direct or indirect risks to human health deriving from food or feed. The RASFF involves: the Member States, the European Commission and the Authority (EFSA). Each of them designates a contact point, which is a member of the network. The Commission is responsible for managing the network.

14. Canice Nolan, 12 April 200814 European Food Safety Authority European Commission EFTA Surveillance Authority Contact point in each Member Country AustriaGreecePolandIceland BelgiumHungaryPortugalNorway CyprusIrelandSlovakiaLiechstenstein Czech RepublicItalySlovenia DenmarkLatviaSweden EstoniaLithuaniaSpain FinlandLuxembourgUnited Kingdom FranceMaltaRomania GermanyNetherlandsBulgaria RASFF Members

15. Canice Nolan, 12 April 200815 RASFF Notifications Alert notifications (Year/Number)  Food or feed for which a risk has been identified  Product is on the market  Immediate action is required by members of the network Information notifications (Year/Letter code)  Food or feed for which a risk has been identified  Product has not reached the market  Immediate action is not required by members of the network News notifications Information related to the safety of food/feed Not communicated as an ‘alert’ or an ‘information’ But is judged interesting for the control authorities

16. Canice Nolan, 12 April 200816 MEMBER COUNTRY NOTIFICATION RASFF ASSESSMENT FEEDBACK FROM MEMBER COUNTRIES RASFF TRANSMISSION MEMBER COUNTRIES THIRD COUNTRY CONCERNED Business / Consumer FEEDBACK FROM THIRD COUNTRY CONCERNED WEEKLY OVERVIEW ANNUAL REPORT Border Control Market Control Third country / Media Media

17. Procedure for requesting guarantees after repetitive notifications MISSION THIRD COUNTRY THIRD COUNTRY COMPETENT AUTHORITY MEMBERS STATES CONTACT POINTS LETTER FROM THE DIRECTOR GENERAL +COPIES OF NOTIFICATIONS GUARANTEES RASFF

18. Canice Nolan, 12 April 200818 Evolution of the number of notifications

19. Canice Nolan, 12 April 200819 Type of control

20. Canice Nolan, 12 April 200820 Product origin

21. Canice Nolan, 12 April 200821 Notifications for US exports to EU GM RiceAflatoxin almonds

22. Canice Nolan, 12 April 200822 Third countries ? Participation in the rapid alert system may be opened up to: applicant countries, third countries, or international organisations. Conditions: there must be an agreement concluded for this purpose, between the EU and the country or international organisation concerned reciprocity must be granted confidentiality measures equivalent to those applicable in the EU must be in place.

23. WWRASFF RASFF TRAINING NATIONAL RASFF EU confidentiality agreement and reciprocity REGIONAL RASFF WWRASFF 2007 2011 2013 2015 Seminars Call for tender Third Countries projects Call for tender Regional projects

24. Canice Nolan, 12 April 200824 Closing thought on foodborne disease…