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2. Consumers, Health, Agriculture and Food Executive Agency SPECIFIC REGULATION ON IMPORT EU legislation addressing contaminants in food and feed in provenance from non-EU countries 2

3. Consumers, Health, Agriculture and Food Executive Agency Contents 3 1. EU Policy on Imports 2. Imports of non-animal origin 3. Reinforced border checks 4. Emergency measures 5. Approval of pre-export checks

4. Consumers, Health, Agriculture and Food Executive Agency EU Policy on Imports (1) 4 Art. 11 and 53 General Food Law Chapter V Reg. (EC) No 882/2004 Different regimes for:  live animals (Dir. 91/496/EEC)  food/feed of animal origin (Dir. 97/78/EC)  food/feed of non-animal origin (Art. 15 Reg. 882/04)  Plants and plants products (Dir. 2000/29/EC)

5. Consumers, Health, Agriculture and Food Executive Agency EU Policy on Imports (2) 5 IMPORT REQUIREMENTS IMPORT CONDITIONS IMPORT CONTROLS To be met prior to dispatch To be carried out at arrival in the EU

6. Consumers, Health, Agriculture and Food Executive Agency Imports of non-animal origin (1) 6 Risk-management instruments

7. Consumers, Health, Agriculture and Food Executive Agency Imports of non-animal origin (2) 7 From ' high ' to ' low ' risk – All countries/Sudan dyes

8. Consumers, Health, Agriculture and Food Executive Agency Imports of non-animal origin (3) 8 From ' low ' risk to ' high ' risk – Indian groundnuts/aflatoxins

9. Consumers, Health, Agriculture and Food Executive Agency Reinforced border checks (1) 9 Legal basis: Art. 15(5) Reg. 882/2004 Reg. (EC) 669/2009 Applicable as of 25 January 2010 Coordinated border controls on imports of feed and food of non-animal origin presenting a known or emerging risk List of imports subjects to quarterly reviews

10. Consumers, Health, Agriculture and Food Executive Agency Reinforced border checks (2) 10 Listed imports to be channelled through Designated Points of Entry (DPEs) Pre-notification via a Common Entry Document (CED); TRACES being used on a voluntary basis No further import conditions (e.g. health certificates) but only import controls! 100% documentary checks; identity and physical checks at lower control rates set in Annex I

11. Consumers, Health, Agriculture and Food Executive Agency Reinforced border checks (3) 11 MS designate DPEs and ensure their adequate equipment (Art. 4 and 5); until 08/2019, MS can use Control Points (CPs) inland (Art. 19) 2 working days for carrying out documentary checks; identity and physical checks 'as soon as technically possible‘ (Art. 8) Splitting of consignments possible only at the end of official controls (Art. 12) Custom clearance possible only if outcome of all required checks is ok (attested by completed CED) (Art. 10)

12. Consumers, Health, Agriculture and Food Executive Agency Reinforced border checks (4) 12 MS may allow onward transportation while results of physical checks are still pending (Art. 8 (2)) Special derogations for highly perishable foods, packaging with special characteristics and DPEs operating under geographical constraints (Art. 9) Non-compliances: rules of Reg. 882/04 apply Guidance document available at: http://ec.europa.eu/food/food/controls/increased_checks/docs/QandA_ paper_en.pdf

13. Consumers, Health, Agriculture and Food Executive Agency Reinforced border checks (5) 13 List of imports in Annex I Reg. 669/2009 Reviewed quarterly taking into account e.g. RASFF, FVO audits, EFSA scientific output, results of MS official controls (Art. 2). Adopted at Standing Committee PAFF level Several country/products/hazard combinations Most frequent contaminants: Aflatoxins, Ochratoxin A, but also pesticides and other residues, microbiological contamination etc. Any hazard can be included

14. Consumers, Health, Agriculture and Food Executive Agency Reinforced border checks (6) 14 Latest amendment of Annex I – Reg. (EU) No 2016/446 applicable as of 01/04/2016 Examples of imports currently listed: Sudan/Groundnuts/Aflatoxins (50% physical checks); USA/Pistachios/Aflatoxins (20%) etc. Annex I specifies if controls target food and/or feed; fresh, frozen and/or chilled etc. CN Codes facilitate product identification MS results published each year at: http://ec.europa.eu/food/food/controls/increased_checks/index_ en.htm

15. Consumers, Health, Agriculture and Food Executive Agency Emergency measures (1) 15 Legislative measures to tackle ‘serious risks’ in feed/food imported or produced within the EU Based on Art. 53 GFL and adopted at level of the Standing Committee PAFF Allow adoption of the most appropriate trade restrictions depending on the risk involved (e.g. suspension of import, special import conditions, reinforced checks etc. and any other interim measure) Evolution of the adopted measure closely followed

16. Consumers, Health, Agriculture and Food Executive Agency Emergency measures (2) 16 Art. 53 GFL vs Art. 15 (5) Reg. 882/2004  Art. 53 GFL allows introduction of a wide range of import requirements (e.g. health certificate, lab tests prior to dispatch, reinforced border controls at arrival in the EU etc.)  Art. 15(5) only reinforced checks at EU borders Art. 53 GFL vs Art. 48 Reg. 882/2004  Similar wording but Art. 48 used to a limited extent and generally for measures meant be long-term/permanent (ex. China/food contact materials)

17. Consumers, Health, Agriculture and Food Executive Agency Emergency measures (3) 17 Trigger elements

18. Consumers, Health, Agriculture and Food Executive Agency Emergency measures (4) 18 Regulation (EU) No 884/2014 – replaced Reg. 1152/2009 Special import requirements for certain feed/food presenting a high risk of aflatoxins Annex I lists products subject to import conditions: e.g. Iran/pistachios and derived products (50% physical checks); Egypt/groundnuts and derived products (20%) etc. Import list supplemented by Brazilian groundnuts, certain Indian spices and Indonesian nutmeg – Reg. (EU) 2016/24 (as of 2 Feb 2016)

19. Consumers, Health, Agriculture and Food Executive Agency Emergency measures (5) 19 Reg. (EU) No 884/2014: import conditions Consignments of relevant products must be:  accompanied by a valid health certificate (Art. 5) and analytical report (Art. 4) attesting compliance with maximum levels as well as performance of sampling and lab tests in conformity with EU legislation  fully traceable by means of an identification code that must appear on the consignment, on each individual bag and on the accompanying docs (Art. 6) – Not needed on all individual entities/packages of which the consignment consists of if many

20. Consumers, Health, Agriculture and Food Executive Agency Emergency measures (6) 20 Reg. (EU) No 884/2014: official controls DPEs located at EU borders Designated Points of Import (DPIs) at EU borders or inland But different roles also, as consignments must:  be pre-notified via CED to DPE (Art. 7) and there undergo 100% documentary checks (Art. 9 (2))  if necessary, authorised to be transferred to a DPI where identity/physical checks may take place as appropriate

21. Consumers, Health, Agriculture and Food Executive Agency Emergency measures (7) 21 Reg. (EU) No 884/2014: official controls Timeframe: 15 working days from when product is offered for import Splitting of consignment not allowed until official controls are completed (Art. 10) In case of non-compliance general rules of Reg. 882/04 apply (Art. 12) Custom clearance whenever results of controls are favourable (Art. 11)

22. Consumers, Health, Agriculture and Food Executive Agency Emergency measures (8) 22 Regulation (EU) No 175/2015 – repealed Reg. (EC) 258/2010 Import conditions for guar gum from India for PCP and dioxins Triggered in 2007 by a RASFF notification. Two FVO audits since then (2009 and 2011): improvements but contamination source still unknown + no investigation by competent authorities In 2014 alignment with other emergency measures following the import regime of Reg. (EC) No 669/2009

23. Consumers, Health, Agriculture and Food Executive Agency Emergency measures (9) 23 Reg. 175/2015: import conditions Consignments of guar gum and compound feed/food containing it must:  be accompanied by health certificate (Art. 4) and analytical report attesting compliance with MRL for PCP (0.01 mg/kg) and with EU sampling requirements (Dir. 2002/63/EC) (Art. 5)  be fully traceable by means of an identification code (Art. 6)

24. Consumers, Health, Agriculture and Food Executive Agency Emergency measure (10) 24 Reg. 175/2015: official controls Consignments must  be pre-notified via CED to DPEs (Art. 7)  undergo 100% documentary checks whilst identity and physical checks at 5% control rate (Art. 8) MS may allow for onward transportation

25. Consumers, Health, Agriculture and Food Executive Agency Emergency measure (11) 25 Regulation (EU) No 2016/6 – ‘Fukushima measure’ – Applicable as of 09/01/2016 and repealing Reg. (EU) 322/2014 March 2011: tsunami in Japan- Fukushima power plant released substantial amounts of radioactive materials Risk for public health: EU immediately adopted emergency measures subject to regular review January 2016: further relaxation of import requirements due to satisfactory compliance levels during 2013-2015

26. Consumers, Health, Agriculture and Food Executive Agency Emergency measure (12) 26 Reg. (EU) No 2016/6: Scope (Art. 1) Feed and food of animal & non-animal origin Originating or consigned from Japan Some exceptions: i.e. products harvested before 11/03/2011 and consignments for personal consumption

27. Consumers, Health, Agriculture and Food Executive Agency Emergency measure (13) 27 Reg. (EU) No 2016/6: import conditions (Artt. 4-7 + Annexes) Consignments of certain products (e.g mushrooms, fishery, rice, soybeans etc.) must be:  accompanied by a valid declaration (Annex III) signed by an authorised representative of Japanese authorities  for products from prefectures listed in Annex II also be accompanied by an analytical report showing compliance with MLs of caesium-134 and caesium-137 (Annex I)  fully traceable by means of an identification code that should appear on the declaration and all other accompanying documents (e.g. lab tests, CED/CVED)

28. Consumers, Health, Agriculture and Food Executive Agency Emergency measures (14) 28 Reg. (EU) No 2016/6: import controls (Artt. 8- 13) Relevant consignments must:  be pre-notified to DPEs/BIPs via CVED or CED  undergo 100% documentary checks; identity and physical checks at random - lab results to be available within 5 working days  be safely disposed of or returned to Japan if non-compliant

29. Consumers, Health, Agriculture and Food Executive Agency Approval of pre-export checks (1) 29 Art. 23 Reg. (EC) No 882/2004 - Approval of official controls conducted by a non-EU country immediately before products are dispatched to the EU EU approval subject to 2 conditions to be verified by a FVO audit:  imports meet EU requirements  controls in the country of origin efficient and effective enough to replace surveillance at import stage Approval results in a lower level of physical checks at EU borders (Art. 23 (2))

30. Consumers, Health, Agriculture and Food Executive Agency Approval of pre-export checks (2) 30 Instrument used to a relatively limited extent and mainly for imports of non-animal origin Regulation No (EU) 949/2015 recently adopted - June 2015 Formally approves pre-export checks for mycotoxins on:  almonds and peanuts from USA/aflatoxins  wheat and wheat flour from Canada/ochratoxin A

31. Consumers, Health, Agriculture and Food Executive Agency Approval of pre-export checks (3) 31 Relevant consignments must be:  accompanied by health certificate signed by relevant competent authorities and analytical report attesting compliance with relevant EU MRLs and sampling procedures  fully traceable by means of an identification code Official controls – Physical checks less than 1%

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