EU Official Control Regulations

1. EU Official Control Regulations • Food & Drug Administration • Bangkok, Thailand • 3rd April 2007 • Dorothy Guina-Dornan

2. Overview • New legislative framework • Part III • Regulation (EC) 882/2004: General official controls • Regulation (EC) 853/2004: Additional animal origin official controls • Supporting documentation • Key elements for the Food & Drug Administration

3. Animal Origin Hygiene Rules for Food of Animal Origin (853/2004) Hygiene of Foodstuffs (852/2004) Official Control on products of Animal Origin (854/2004) Official Control of Feed and Food (882/2004) Micro- criteria (2073/2005) 178/2002 General Food Law Official Control of Feed and Food (882/2004) Hygiene of Foodstuffs (852/2004) Repealing Directive (2004/41/EEC) Animal Health and Welfare (2002/99) Transitional measures (2076/2005) Implementing measures (2074/2005) Non-animal Origin

4. Imagine there’s no inspector !

5. Regulation 882/2004 • General Obligations • Member States must organise Official Controls on a regular basis using appropriate frequencies, taking into account • Identified risks • Experience and knowledge gained • Reliability of the food business operators own controls • Suspicion of non-compliance • Generally without prior warning

6. Control Activities, Methods & Techniques • Tasks related to official controls must be carried out using appropriate control methods and techniques including • Monitoring, surveillance, verification, audit, inspection, sampling and analysis • Verification of control systems in place • Inspection of businesses, premises, equipment etc • Checks on hygiene conditions • Assessment of procedures – HACCP, GMP, GHP, GGHP

7. Control Activities, Methods & Techniques • Examination of documents and records, etc • Interviews with Food Business Operators (FBO) and staff • Reading of values recorded by FBO equipment • Use of competent authority measuring equipment to verify measurements taken by the FBO • Any other activities required

8. Action in case of Non-compliance • Competent Authority must take action e.g., • Imposition of sanitation procedures • Restriction / prohibition of placing on the market • Recall, withdrawal, destruction • Suspension or closure • Withdrawal of approval, etc • Written notification of the decision and reasons • Right of appeal • Cost to be borne by the food business operator • Sanctions • Effective, proportionate and dissuasive, determined by Member States

9. Competent Authorities • Operational criteria • Staff training including CPD, multi-disciplinary working • Delegation of official control to regional or local level • Delegation of certain tasks but not responsibility to control bodies • Documented procedures • Ensure quality and consistency of official control, co-operation between control bodies

10. Operational criteria • Ensure impartiality, consistency and quality of official controls • Sufficient number of suitably qualified and experienced staff and adequate facilities • Legal powers • Operational contingency planning • Effective and efficient coordination and cooperation between central and local level • Internal and external audit subject to independent scrutiny and transparent

11. Relationship between central & local authorities Statement of Objectives Tasks responsibilities and duties of staff Control Methods & Techniques Monitoring & Surveillance Programmes Mutual Assistance Action to be taken following official control Co-operation with other services and departments Verification of appropriateness of methods of analysis and detection tests Any other activity or information required Documented Procedures

12. Delegation to Control Bodies • May delegate tasks but not responsibilities • May not delegate responsibility to take sanctions or impose penalties • Delegated bodies must operate to EN45004 • Delegated bodies must be audited • Notify the Commission

13. Staff Performing Official Controls • Received appropriate training for their area of competence • Regularly kept up to date • Continuing Professional Competence (CPD)

14. Import /Export Control • Import control extended to food of non animal origin (and organised under the national control plan) • Designated points of entry • Prior notification • Positive list of foods of known / emergent risk • Procedures for suspect food – detention, destruction, re-dispatch, special treatment

15. Import /Export Control • Product withdrawal – recall • Co – operation with Customs and Excise • Specific import conditions for certain feed and food • List of countries and establishments • Model certificates • Equivalency agreements

16. Laboratories • Official laboratories must be designated by the competent authority • Must be accredited to EN17025 • Community Reference Laboratories • Regulation (EC) No 776/2006 lists laboratories • National Reference Laboratories • Member States must designate NRLs for each CRL • Must notify the Commission, the relevant CRL and other Member States

17. Sampling & Analysis • Methods must comply with EU rules, if none then with internationally recognised protocols eg CEN or national legislation or • Other methods fit for the intended purpose or developed in accordance with scientific protocols • Criteria for methods of analysis established • Procedures to ensure right of food business operator to 2nd opinion • Supplementary opinion • Samples to be handled to ensure legal and analytical validity

18. Regulation 882/2004: Official Controls of Feed and Food • Financial Controls • Adequate resources to finance controls including through direct taxation / fees / charges • Fees for the registration / approval of establishments • Cost recovery for additional controls in the case of non-compliance

19. Regulation 882/2004: Official Controls of Feed and Food of non- animal origin • Registration / approval of food and feed establishments • Procedures for registration and approval / conditional approval, withdrawal and suspension • Lists of establishments • Administrative Assistance • 1 or more Liaison Body • EU and other MS involvement in administrative enquiries • Multi annual control plans and guidelines • Annual reports and guidelines

20. Regulation 882/2004: Official Controls of Feed and Food of non- animal origin • Community Activities • FVO missions • Verification of National Control Plans • Training of official control staff by EU • Assistance in third Country control of Member States • Co-Ordinated Control • Ad-hoc in addition to annual plan

21. Multi-Annual National Control Plan • Strategic Objectives • Designation of competent authorities and tasks • General Organisation and management of Official control systems at national, regional and local level- including official controls in individual establishments • Control systems applied to different sectors

22. Regulation 854/2004: Official Control of Foods of Animal Origin • These are in addition to Official Control of Feed and Food Regulations • Official controls on community establishments • Procedures concerning imports: lists of countries and establishments, equivalency • Revised ante and post mortem inspection requirements • HACCP throughout production – all principles • Science based risk assessment at slaughter • Promote visual inspection and reduce handling of meat

23. Multi-Annual National Control Plan • Methods used to ensure operational criteria are met • Training of control officials • Documented procedures • Organisation and operation of contingency plans for disease emergencies, food contamination incidents and other human health risks • Organisation of co-operation and mutual assistance

24. Regulation 854/2004: Official Control of Foods of Animal Origin • Establish frequency of inspection and actions for non compliance • Flexibility in small slaughterhouses to delegate some veterinary controls to trained staff • Detail veterinary qualifications and official duties • Applies to slaughterhouses, game handling establishments, cutting plants, harvesting and production areas for molluscs, landing points and markets for fish, and production and processing areas for milk and milk products

25. Regulation 882/2004 • EU Commission Guidelines on a number of key areas • Initially: • Audit Criteria (Decision 2006/677/EC) • Multi-Annual National Control Plan • Annual Report • Import Control (PONOA and POAO) • Official controls concerning microbiological sampling and testing of food • Better Training for Safer Food • Implementing measures – emerging risk, remote selling…