Shared healthcare challenges

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

2. 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 Canice Nolan, 12 April 2008

3. Response to crises • Separate the promotional aspects of agriculture from food safety – SANCO • Separate risk assessment from risk management - EFSA • Enhance risk communication Canice Nolan, 12 April 2008

4. 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 Canice Nolan, 12 April 2008

5. General Food Law Regulation (EC) N˚ 178/2002 • General principles (definitions) • Risk analysis • EFSA • Traceability • Precautionary principle • RASFF Canice Nolan, 12 April 2008

6. 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 Canice Nolan, 12 April 2008

7. 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. Canice Nolan, 12 April 2008

8. 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. Canice Nolan, 12 April 2008

9. 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. Canice Nolan, 12 April 2008

10. 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 Canice Nolan, 12 April 2008

11. 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 Canice Nolan, 12 April 2008

12. 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 Canice Nolan, 12 April 2008

13. 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. Canice Nolan, 12 April 2008

14. RASFF Members • Contact point in each Member Country Austria Greece Poland Iceland Belgium Hungary Portugal Norway Cyprus Ireland Slovakia Liechstenstein Czech Republic Italy Slovenia Denmark Latvia Sweden Estonia Lithuania Spain Finland Luxembourg United Kingdom France Malta Romania Germany Netherlands Bulgaria European Food Safety Authority European Commission EFTA Surveillance Authority Canice Nolan, 12 April 2008

15. RASFF Notifications Alert notifications (Year/Number) • Food or feed for which a risk has been identified • Product is on the market • Immediate action isrequired 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 Canice Nolan, 12 April 2008

16. WEEKLY OVERVIEW FEEDBACK FROM MEMBER COUNTRIES FEEDBACK FROM THIRD COUNTRY CONCERNED Market Control MEMBERCOUNTRY NOTIFICATION Media Border Control Third country / Media Business / Consumer RASFF ASSESSMENT ANNUAL REPORT RASFF TRANSMISSION THIRD COUNTRY CONCERNED MEMBERCOUNTRIES Canice Nolan, 12 April 2008

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

18. Evolution of the number of notifications Canice Nolan, 12 April 2008

19. Type of control Canice Nolan, 12 April 2008

20. Product origin Canice Nolan, 12 April 2008

21. Notifications for US exports to EU Aflatoxin almonds GM Rice Canice Nolan, 12 April 2008

22. 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. Canice Nolan, 12 April 2008

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

24. Closing thought on foodborne disease… Canice Nolan, 12 April 2008