EU REQUIREMENTS FOR THIRD COUNTRIES EXPORTING FOOD TO THE EU

1. EU REQUIREMENTS FOR THIRD COUNTRIES EXPORTING FOOD TO THE EU CTA Briefing on Food Safety Standards Brussels 11/05/2009 Jacky Le Goslès

2. Scope of presentation • SPS agreement and equivalence • Requirements for third countries exporting food to the EU • Key components for a residue control system • Import controls • FVO inspections • BTFS programme

3. The European Union is the world’s largest importer of agricultural and fishery products

4. Sanitary & Phytosanitary Agreement

5. SPS Agreement • Art. 2.2.measures taken to protect public health…should be Science based and appropriate. • Art. 2.3. … should not be an unjustified barrier to trade. • Art. 3.1. … based on international standards, guidelines or recommendations, where they exist. • Art 3.2. ..higher level of SPS protection possible if there is scientific justification

6. SPS - equivalence • Art. 4.1. • Members shall accept SPS measures of other Members as equivalent... if the exporting Member objectively demonstrates … that its measures achieve the importing Member's appropriate level of SPS protection.

7. EU Food Law (Regulation (EC) No 178/2002) • Equivalence enshrined in Community Food Law • Articles 11 and 12: Food and feed imported to the Community shall complywith the relevant requirements of food law or conditions recognised by the Community to be at least equivalent with requirements contained therein Food shall not be placed on the market if it is unsafe

8. Requirements for third countries exporting food of animal origin to the EU • Every country wishing to export food of animal origin (FAO) to the EU must satisfy certain animal health, public health, veterinarycertification and residues requirements. • Appear on ‘lists of authorised third countries’ • Entire country or region • Authorised commodities • Approved establishments • Use of model certificates • Food produced in accordance with EU rules • NOT ON RESIDUES LIST = NO EXPORTS

9. Import of FAO From Third Countries Import control of products (BIP) specific requirements (e.g. control plan) control missions (FVO) country establishment Vessel ZV/FV Listing Specific listing general listing import general import & control legislation + product specific legislation Directive 97/78/EC imposes a veterinary control of food and feed products coming from third countries.

10. Official Journal Import FAO From Third Countries Request from the third Country Technical Documentation LISTING Decision No 1: Addition to the list of third countries Standing Committee on the Food Chain and animal health Decision No 2: Specific requirements Decision No 3: Health certificates (AH and PH) Adoption by college of Commissioners Decision No 4 List of establishments

11. Why does the EU require residues controls in FAO both from Member States and trading partners?

12. BECAUSE • Legislative requirement in EU • Public health - food safety • To detect and prevent abuse of drugs • To facilitate trade in animals and animal products • Equivalent standards expected from the EU’s trading partners: Art. 11, Directive 96/22/EC and Art. 29, Directive 96/23/EC)

13. FVO scrutiny Control system On-the-spot Desk study Elements of a residue control system Licensing and controls on use of veterinary medicines Residue Surveillance (Monitoring Plan) Border inspection posts in the EU Member States Residue testing Laboratories

14. For third countries • An approved residue plan is a prerequisite for export of food of animal origin to the EU. • Approved countries are listed in Commission Decision 2004/432/EC • Plans must be submitted to the Commission and approved annually

15. What food is tested for residues? • Food of animal origin • Laid down in Community law • Council Directive 96/23/EC • Member States test domestic and imported

16. Residue monitoring plan evaluation - outcome • Commission Decision 2004/432/EC revised twice in 2007 and twice in 2008 • In 2008 • 10 countries delisted for total of 15 commodities • 8 countries were newly listed or relisted for a total of 13 commodities • 83 countries now listed • Improved understanding by third countries of EU requirements

17. IMPORT CONTROLS IN EU BORDER INSPECTION POSTS (BIP) • BIPs are approved by the European Commission • BIPs are run by Member States • 3 fold control, identification (i), documentary (d) and physical (p) • All consignments should be (i) and (d) controlled. • For most of the authorised TC only for 20% of the consignments are submitted to (p) control • Samples are taken and relevant analyses carried out only randomly (consignments kept until analyses results) • Positive results :rejection or destruction and RASF information • Protective measures (e.g. Histamine analyses on 100% of tuna swordfish consignments)

18. http://ec.europa.eu/food/international/trade/guide_thirdcountries2006_en.pdfhttp://ec.europa.eu/food/international/trade/guide_thirdcountries2006_en.pdf All relevant Community legislation may be obtained from: http://europa.eu.int/eur-lex/lex/en/index.htm

19. FVO MISSION INSPECTION/AUDIT METHODS • METHOD: EVALUATION OF THE EFFECTIVENESS OF THE OFFICIAL CONTROL SYSTEM OF FAO EXPORTED TO THE EU (documented system ensuring the 2 above mentioned objectives) • EVALUATION OF THE CA CONTROL ACTIVITY IN ITS OFFICE, files of at least the visited farms, vessels and establishments • SAMPLE OF FARMS/VESSELS/ESTABLISHMENTS IN ORDER TO VERIFY CA CONTROL ACTIVITIES • SOME CHOSEN BY THE CA • SOME CHOSEN BY THE FVO: RASFF, FOLLOW UP OF A PREVIOUS MISSION OR TARGETTED MISSION • VERIFICATION IN SITU (FARMS/VESSELS, ESTABLISHMENTS)

20. E.G. MAIN FINDINGS RELATING TO FISHERY PRODUCTS EXPORTED TO THE EU • KNOWLEDGE, IMPLEMENTATION, CONTROL, ENFORCEMENT OF COMMUNITY REQUIREMENTS • CA EFFICIENCY, i.e. inspection frequency, scope, depth, follow-up, enforcement • BUDGET for CONTROLS/ANALYSES • LAB CAPACITIES/QUALITY OF ANALYSES • RESIDUE MONITORING PLAN FOR EXPORTED AQUACULTURE PRODUCTS

21. E.G. MAIN FINDINGS RELATING TO FISHERY PRODUCTS EXPORTED TO THE EU (cont.) • RUNNING/POTABLE/CLEAN WATER (ICE) • FRESHNESS OF FISH LANDED • HYGIENE OF OPERATIONS • COLD CHAIN • HYPER-CHLORINATED WATER USE • FP TRACEABILITY: • FROM VESSELS TO PLANTS • WITHIN PLANTS • RAW MATERIAL IMPORTED OR COMING FROM NON « EU APPROVED » VESSELS OR ESTABLISHMENTS • HACCP Plan inappropriate, inadequate/insufficient documentation • NUMBER OF OWN-CHECK ANALYSES AND OFFICIALANALYSES • ADDITIVES (crustaceans) • HEALTH STATUS OF STAFF

22. FOOD of VEGETAL ORIGINPrincipal results from reports • General • Lack of control by CA • Dependance on private standards • Poor performance in laboratories • No/poor controls at export

23. Principal Results • Pesticides • High frequency of use • Lack of control on GAP or on registered users • Lack of control in application or follow up • Variable MRLs • Poor equipment/analytical capability and poor quality control in laboratories

24. Principal Results • Phytosanitary Controls • Problems with understanding of community regulations • Monitoring and official controls limited • Lack of documentation/ tracability

25. HOW TO IMPROVE THE SITUATION • Pressure on TC: pre-listing on hold, appropriate and proportionate protective measures, action plans and follow-up (on-desk exercise and FVO missions) • CA official training: SANCO programmes, « Better Training for Safer Food » (Indonesia, Colombia and Senegal in 2006, Morocco, Mauritius, UAE, Chile and Viet Nam in 2007, Philippines and Jamaica in 2008) • technical assistance provided by Commission services (DEV, AIDCO, TRADE, SANCO) following TC requests

26. Import From Third Countries Import Control: reinforced measures • Listing of • countries • establishments Legislation and controls guarantee that exported products comply with EU legislation and consequently that their safety is not compromised Results significantly not conform and/or negative report from FVO • Test on each arrival/lot • Additional costs supported by importers Safegard clause Results significantly not conform De-listing

27. BTFS programme The programme started in 2005-2006. Commission Communication COM (2006) 519 has identified a long-term steady state of 6,000 participants and budget of €15million annually (around 2011-2012)

28. BTFS Evolution 2006-2008

29. BTFS Food hygiene and controls • 3 modules of 5 five-day courses on: • Meat and meat products • Milk and dairy products • Fishery products • 25 participants per workshop • Theoretical sessions, practical exercises, site visits, discussion as appropriate

30. BTFSHygiene and controls of fishery products (main subjects) • Organisation of official controls • Live Bivalve Molluscs: controls and applicable legislation • Controls of marine bio-toxins • Primary production • Hygiene requirements in freezers, vessels, processing establishments, fish farms and cold storage

31. Africa-EU Joint Strategy Capacity building activities in the SPS field in Africa 2009-2010 (€10M)

32. Activity 1 (OIE) Evaluation of Performance of Veterinary Services + follow-ups Activity 2 (OIE) Improvement of national / regional legal framework Activity 3 (OIE) Laboratory capacity (twinning) Activity 4 (OIE) Training of CVOs / National Focal Points Activity 5 (AESA Cons.) -12 five-day Regional ‘training of trainers’ workshops: -2 one-day (opening and closing) conferences Activity 6 (AESA Cons.) Sustained missions and ad hoc assistance (e.g. SMEs): 1,560 days / 12 experts / 6 Regions (~ 26 countries)

33. EU SPS rules for import of food of animal origin from Third Countries to the EUSUMMARY CTA Briefing on Food Safety Standards Brussels 11/05/2009 J. Le Gosles Adviser DG SANCO

34. Main Points to keep in mind • Food safety has become more important in the EU • EU first food importer in the world, e.g. More than 50% of fish consumed in EU are imported from TC/DC • Increase of establishments approved for export to the EU ( including freezer and factory vessels in TC) • More added value processed products imported

35. Main Points to keep in mind • EU rules based on SPS Agreement principles • Art. 2.2.measures taken to protect public health… should be Science based and appropriate. • Art. 2.3. … should not be an unjustified barrier to trade. • Art. 3.1. … based on international standards, guidelines or recommendations, where they exist. • Art 3.2. ..higher level of SPS protection possible if there is scientific justification • Art. 4.1. : Members shall accept SPS measures of other Members as equivalent... if the exporting Member objectively demonstrates … that its measures achieve the importing Member's appropriate level of SPS protection. • EU and EQUIVALENCE • Equivalence enshrinedin Community Food Law (Regulation (EC) No 178/2002) • Articles 11 and 12:Food and feed imported to the Community shallcomplywith the relevant requirements of food law orconditions recognised by the Community to be at least equivalentwith requirements contained therein

36. Main Points to keep in mind Import of FAO From Third Countries country establishment Vessel ZV/FV Listing control missions (FVO) Import control of products (BIP) specific requirements (e.g. residue monitoring programme) control missions (FVO) Specific listing general listing import general import & control legislation + product specific legislation Directive 97/78/EC imposes a veterinary control of food and feed products coming from third countries.

37. Official Journal Main Points to keep in mind Import of FAO From Third Countries Request from the third Country Technical Documentation LISTING Decision No 1: Addition to the list of third countries Standing Committee on the Food Chain and animal health Decision No 2: Specific requirements Decision No 3: Health certificates (AH and PH) Adoption by college of Commissioners Decision No 4 List of establishments

38. Main Points to keep in mind • A Competent Authority (or more but need for a very good cooperation/coordination) and laboratory capacities; • Official (documented) controls all along the FAO production chain, including primary production and sampling/analyses • Residue and environmental contaminant monitoring programme; • FBO Establishments • : Structures and equipment requirements, Good Hygiene Practices (SSOPs) and HACCP system in place • Ensuring the eligibility of the FAO exported to the EU (« sanitary » traceability) from primary production to exported consignments; • Better Training for Safer Food (BTFS) programme and Technical Assistance (TA )