1. SANCO-D-4 International Questions (bilateral) The Safety of Imported Foods in general and the particular rules for casings - EU Perspective Cairo May 2011 Wolf Maier, DG Health and Consumers, EU Commission

2. SANCO-D-4 International Questions (bilateral) Scope of the presentation nThe Single Market, risks and risk management nGeneral rules for domestic and imported foods  The General Food Law  The main pillars of the food safety legislation  Official controls and certification nSources of Information

3. SANCO-D-4 International Questions (bilateral) The European Union The EU is a Success Story 60 years peace, shared values, compromise Single Market with 500 Million citizens Economic stability, 70% of trade intra-EU Harmonisation of rules and standards The EU is a nightmare 27 countries, 21 Languages, Diverse traditions expectations and economies, 100.000s food businesses, By far the biggest importer and exporter of food worldwide Risks must be managed

4. SANCO-D-4 International Questions (bilateral) The single market The Single European Market stands for the free movement of people, goods, services and capital: ‘The four freedoms’. On a practical level, it means the possibility for EU citizens to live, work, study and do business throughout the EU as well as to enjoy a wide choice of competitively priced goods and services.

5. SANCO-D-4 International Questions (bilateral) A Single Market for goods Member States may restrict the free movement of goods only in exceptional cases, for example when there is a risk resulting from issues such as public health, environment, or consumer protection. Approximately half of the trade in goods within the EU is covered by harmonised regulations, while the other half is accounted for by the ‘non- harmonised’ sector, which is either regulated by national technical regulations or not specifically regulated at all. Once allowed into the EU, food commodities and animal products in particular, can be sold in any Member State

6. SANCO-D-4 International Questions (bilateral) Risks to be managed: Contagious animal and plant disease FMD, Avian Flu, Carnal Bunt, Citrus Canker Zoonoses Salmonella, Listeria, BSE, Tb General hygiene Enterobacteria, histamine Contaminants Pharmaceuticals, pesticides, heavy metals Fraud

7. SANCO-D-4 International Questions (bilateral) 7 How does it work? Harmonized legal framework Efficient risk management Transparency, information exchange Constant scrutiny at all levels

8. SANCO-D-4 International Questions (bilateral) European Parliament Council of the EU European Commission Economic & Social Committee Committee of the Regions European Court of Justice European Court of Auditors Advisory Committees Legal Framework: Institutional Triangle Interpretation of law Financial control

9. SANCO-D-4 International Questions (bilateral) Legal Framework (2): The European Commission Promoting the common interest The European Commission represents and upholds the interests of Europe as a whole. It is independent of national governments. It has the right of initiative, i.e. to propose new European laws, which it presents to Parliament and Council. It implements EU laws and policies with the help of Regulatory Committees. It can enforce EU laws via infraction procedures against Member States and it can bring cases to the European court.

10. SANCO-D-4 International Questions (bilateral) European Food Law What is food? Food of animal origin Raw products (meat, fish, etc) Processed products (ham, smoked fish etc) Food of non-animal origin Fruits, vegetables, cereals, tubers Drinks Others (e.g. table salt)

11. SANCO-D-4 International Questions (bilateral) The main pillars (1): General Food Law Regulation 178/2002 Article 17 – Liability All operators must ensure safety of food and feed. Article 18 – Traceability All food, feed and animals: One step up, one step down. Article 20 – Recall All recalls must be reported to authorities. Article 11 - Imports Food and feed imported into the Community complies with food law or conditions recognised as equivalent. Article 12 - Exports Food and feed exported shall comply with the food law.

12. SANCO-D-4 International Questions (bilateral) The main pillars (2): Animal Health Main, horizontal legislation Live animals For example, for bovine species Council Directive 64/432 and Dir. 2004/68 for imports Identification For example, Regulation (EC) 1760/2000. Germplasm For example, Council Dir. 88/407 for bovine semen Council Directive 89/556 for bovine ova and embryos Products of animal origin For example, for fresh meat or poultry meat Council Directive 2002/99 Meat products Council Directive 72/462

13. SANCO-D-4 International Questions (bilateral) The main pillars (3): Animal Health Main, horizontal legislation Animal welfare Council Directive 98/58 for farming purposes Specific rules Specific rules for animal diseases For example, FMD, avian infuenza Specific animal welfare rules For example, Regulation 1099/2009 for animal protection during slaughter Implementing rules

14. SANCO-D-4 International Questions (bilateral) The main pillars (4): Plant Health Main, horizontal legislation Authorisation of plant protection products Pesticide residues Regulation (EC) No 396/2005 Harmful organisms Directive 2002/29 Seeds and propagating material Implementing rules (example) Decision 2004/4 on potatoe diseases - emergency measures against the dissemination of Pseudomonas solanacearum

15. SANCO-D-4 International Questions (bilateral) The main pillars (5): Zoonoses Main, horizontal legislation Contol of Salmonella and other zoonotic agents: Regulation 2160/2003 Bovine spongiform encephalitis Regulation 999/2001 Implementing rules Decision 2007/843 on Salmonella control programs in breeding flocks Decision 2007/848 for laying hens

16. SANCO-D-4 International Questions (bilateral) The main pillars (6): Hygiene Main, horizontal legislation General hygiene for all food and feed Regulation 852/2004 HACCP-based self controls in all businesses Hygiene for products of animal origin Regulation 853/2004 Specific requirements for high risk foods Inspection and control practices Regulation 854/2004 Implementing rules Microbial criteria Regulation 2073/2005 Testing methods Reg. 2074/2005

17. SANCO-D-4 International Questions (bilateral) The main pillars (7): Contaminants Main, horizontal legislation Council Regulation 315/93 for contaminants in food Residues of veterinary drugs Council Regulation (EC) 2377/90 Hormone ban Directive 96/22/EC Implementing rules (Dir. 96/23) Residue monitoring plan; Reviewed by FVO.

18. SANCO-D-4 International Questions (bilateral) The main pillars (8): Additives, flavourings, contact materials Main, horizontal legislation Regulation (EC) No 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings Food contact materials Regulation 1935/2004

19. SANCO-D-4 International Questions (bilateral) The main pillars (9): Labelling Main Legislation Directive 2000/13 Labelling of foods Directive 90/496 Nutritional labelling Specific rules for dietary foods and special needs New rules in preparation

20. SANCO-D-4 International Questions (bilateral) The main pillars (10): Official Controls Regulation 882/2004 Coherent principles for all authorities: Adequate staff, resource, training. Accredited labs, international standards. Risk-based controls in all sectors based on multi-annual plans. delegation of official inspection is possible. pre-export inspection is possible.

21. SANCO-D-4 International Questions (bilateral) 21 Summary: EU food law in a nutshell All Member States: Credible inspection and control system. All food and feed: Liability, Traceability, Reporting. General hygiene rules. HACCP-based self controls. Notification, risk based controls. High risk foods (foods of animal origin) Specific hygiene rules. Pre-market authorization and inspection.

22. SANCO-D-4 International Questions (bilateral) 22 EU oversight – the FVO The mission of the Food and Veterinary Office is, through its audits, inspections and related activities, to: Check compliance with the EU food law within the European Union and in countries exporting to the EU, Contribute to the development of EU policy in food safety, animal health and welfare and plant health, Contribute to the development and implementation of effective control systems, Inform stakeholders of the outcome of its audits and inspections.

23. SANCO-D-4 International Questions (bilateral) 23 EU oversight – the FVO The single market is built on scrutiny, not trust. 200 inspections per year, 160 in Member States. Back-to-office reports within 24 hours. SANCO ‘Task Force’ convened if necessary for crisis management or immediate safeguard measures. Full transparency: Reports discussed with Member States and published on the Internet. Agreed dispute settlement mechanisms.

24. SANCO-D-4 International Questions (bilateral) Food Imports - Same Principles Food of animal origin Lists of eligible countries and businesses. Country listing after inspection by FVO. Regular country audits on risk basis. Approval based on compliance or equivalence. Food of non-animal origin No country listing. Importer is liable for safety (general food law). Some specific rules apply for high-risk foods (potatoes, nuts, citrus).

25. SANCO-D-4 International Questions (bilateral) Country Listing: Food of animal origin Competent Veterinary Authority in-line with Regulation 882/2004. Animal health/zoonoses requirements met. Approved businesses meet EU hygiene requirements and are regularly inspected. Monitoring system for residues in place. Confirmatory inspection of the FVO. Official Certification agreed. Member States agree.

26. SANCO-D-4 International Questions (bilateral) Food businesses listing (animal origin) Country listing establishes a relationship of trust: Exporting country can list further businesses after inspection by own control services; 4 weeks commenting period, then automatic inclusion on list of approved establishments and eligibility for imports; FVO re-inspects risk-based or ‘for reason’. Entry via designated Border Inspection Posts.

27. SANCO-D-4 International Questions (bilateral) Plants, Fruit, Vegetables No country listing Plant Health requirements. Residue tolerances must be met. Entry via any border post. For composite foods all components of animal origin must be EU eligible, even if the product is exempt from certification. Importer is responsible and liable.

28. SANCO-D-4 International Questions (bilateral) Certification Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products Rules to be observed in issuing certificates Certifying officers must not certify data of which they have no personal knowledge or which cannot be ascertained by them. Certifying officers must not sign certificates relating to products which they have not inspected or which have passed out of their control. Where a certificate is signed on the basis of another certificate or attestation, the certifying officer shall be in possession of that document before signing. The competent authorities shall take all necessary steps to ensure the integrity of certification. Certifying officers have a status which ensures their impartiality and have no direct commercial interest.

29. SANCO-D-4 International Questions (bilateral) In consequence: Adherence to rules must be enforced by risk-based, official inspections by a designated, competent authority. Certification requires a cleraly established, transparent information flow.

30. SANCO-D-4 International Questions (bilateral) It does not matter whether or not a country is part of the EU No discrimination: The food law either applies directly, or it must be complied with. No short cuts: There cannot be a compromise on safety standards. But flexibility is there: Objectives must be met, no overly detailed prescriptions. And technical assistance is offered: Regulatory allignment and Neighbourhood Policy, Better Training for Safer Food initiative, Bilateral and regional programs.

31. SANCO-D-4 International Questions (bilateral) Bottom Line: Fortress Europe? Market access conditions are complex and not easy to meet, but … One negotiation – 500 Mio consumers; Fully harmonised import conditions for all food and feed, in-line with international standards; No discrimination. Transparent rules, aids for capacity building. It works: EU is by far the biggest importer of food worldwide - also from developing and least developed countries;

32. SANCO-D-4 International Questions (bilateral) SPS requirements for market access Contaminants MonitoringHygiene Animal Health Fruit +-(+)- Potatoes + Plant health By-products +-(+) Fresh fish +-(+)- Aquaculture ++++ Meat prod.+++++ Fresh meat++++ Milk prod.++++ Animals++(+)+++ There are many opportunities!

33. SANCO-D-4 International Questions (bilateral) Documentation on the web General Information: http://ec.europa.eu/food/index_en.htm http://ec.europa.eu/food/index_en.htm Food and Veterinary Office: http://ec.europa.eu/food/fvo/index_en.html http://ec.europa.eu/food/fvo/index_en.html European Food Safety Authority http://efsa.europa.eu And please feel free to contact: wolf-martin.maier@ec.europa.eu wolf-martin.maier@ec.europa.eu