EU Pesticide Residue Monitoring and Rapid Alert System

1. The EU co-ordinated monitoring programme for cereals, fruits and vegetables and the EU rapid alert system 4th European Pesticide Residues Workshop - Rome May 28-31, 2002

2. PESTICIDE RESIDUES SANCO E.1 2 major components • Maximum residues levels (MRLs) • Monitoring in food

3. MaximumResidueLevel (MRL) legislation:- is “independent” of 91/414/EEC- dates from 1976- is a shared responsibility- applies to:- agricultural commodities - animal feed - processed food- is under continuous review http://europa.eu.int/comm/food/fs/ph_ps/pest/index_en.htm Pesticide Residue Legislation

4. 4 parent MRL Council Directives76/895/EEC: selected fruit & vegetables 86/362/EEC: cereals 86/363/EEC: foodstuffs of animal origin 90/642/EEC: certain products of plant origin including fruit & vegetables Amended by Dir 97/41 Pesticide Residue Legislation

5. 76/895/EEC: some fruit & vegetables Pesticide Residue Legislation For trade purposes MS could impose higher MRL but not lower MRLs under review - the directive will eventually become obsolete

6. 86/362/EEC; 86/363/EEC;90/642/EEC Pesticide Residue Legislation SANCO E.1 Trade, use, and human health addressed: • critical GAP: application rate; PHI  STMR • consumer intake models NEDI ADI/ARfD • MS transpose MRLs in National legislation • trade: conciliation procedure for disputes over unharmonized MRLs

7. Programme of Work Pesticide Residue Legislation SANCO E.1 • Set new MRLs for 91/414 Annex I inclusions • non-inclusions: LOD • inclusion: member states set provisional MRLs  Commission sets EU MRLs based on RMS recommendation - Respect Codex - analyse case-by-case, normally accept but reject if: based on obsolete data or obsolete EU uses, intake concerns

8. Programme of Work Pesticide Residue Legislation SANCO E.1 • CONSOLIDATE and AMEND the 4 Directives during 2002. • Proposal to Council and Parliament • Co-Decision • Based on SLIM recommendations

9. Monitoring of residues SANCO E.1 • National Monitoring programmes • Community Co-ordinated Monitoring Programme (started 1996) • Annual Commission Recommendation for following year • ‘5-year cycle’: assessment of actual intake for main European pesticide / commodity combination • Started ‘3-year cycle’ in 2001

10. Monitoring of residues SANCO E.1 Obligation in 86/362/EEC and 90/642/EEC (foodstuffs of plant origin) • National plans to Commission by 30 September • Commission: Co-ordinated plan to SCPH by 31 December (Monitoring Recommendation) • Results of national monitoring to Commission by 31 August of following year • Commission: Report of combined results and co-ordinated monitoring to SCPH by 30 September

11. Monitoring of Residues SANCO E.1 • Exceedences of MRLs • If MRL based on chronic intake: usually no health concern • More and more MRLs based on Acute intake: exceedence is immediate health concern • RASFF: guidance document

12. RASFF LEGAL BASIS Since 1978 (CD 84/133/EEC +amendments) Annex I to CD 92/59/EEC (SANCO unit D3) Scope: Food and industrial products but not feed REGULATION (EC) No 178/2002 of 28 January2002 (include feed sector and food imports from outside EU)

13. RASFF ARTICLE 50 OF REGULATION (EC) N° 178/2002RAPID ALERT SYSTEM Notification of a direct or indirect risk to human health from food or feed. Network involving member states, the Commission and the European Food Safety Authority (EFSA). The information from a member of the network shall be immediately notified to the Commission and then through the network. The EFSA may supplement the notification with any scientific or technical information.

14. RASFF ARTICLE 50 OF REGULATION (EC) N° 178/2002RAPID ALERT SYSTEM Member states shall immediately notify of: Any measures restricting the placing or forcing the withdrawal or the recall of food or feed. Any recommendation or agreement with professional operators aimed, on a voluntary or obligatory basis, at preventing, limiting or imposing specific conditions on the placing on the market. Any rejection at a border post of EU. The Commission shall immediately notify all border posts of EU.

15. RASFF ARTICLE 50 OF REGULATION (EC) N° 178/2002RAPID ALERT SYSTEM When a third country is concerned by a notification, the Commission shall provide this country with the appropriate information. Member States shall inform the Commission of the action implemented or measures taken. Participation may be opened up to applicant countries, third countries or international organizations on the basis of agreements

16. RASFF PRACTICAL FUNCTIONING Products covered by the RASSF: food and feed. Members of the RASSF: EU Member States + EEA. Product on the market of the EEA : Alert notification. Product rejected at an EEA Border post following import control: information notification.

17. RASFF PRACTICAL FUNCTIONING The information (notifications) received from MS and the EFTA surveillance authority (ESA) is transmitted to the 15 contact points and to the ESA and, when applicable, to third countries. Evaluation process: additional information or scientific advice may be requested.

18. RASFF Three levels of information: (i) Alert Notification (ii) Information Notification (iii) News

19. RASFF (i) Alert Notification Conditions - Food on the market - More than one MS - Immediate action is required

20. RASFF (i) Alert Notification Actions: Triggered by MS/EFTA (receive from Contact Points and evaluated by RASFF team in SANCO) - Withdrawal

21. RASFF (ii) Information Notification Conditions: - Not immediate action required - Provide useful information

22. RASFF (ii)Information Notification No Actions required

23. RASFF (iii)News Conditions: - Neither Alert nor information

24. CATEGORIES OF PRODUCTS NOTIFIED IN 2000 AS ALERT NOTIFICATIONS SANCO E.1

25. REASONS FOR ALERT NOTIFICATIONS IN 2000 SANCO E.1

26. CHEMICAL REASONS FOR ALERTNOTIFICATIONS IN 2000 SANCO E.1

27. CATEGORIES OF PRODUCTS NOTIFIED IN 2000 AS INFORMATION NOTIFICATIONS SANCO E.1

28. REASONS FOR INFORMATION NOTIFICATIONS IN 2000 SANCO E.1

29. RASFF CHEMICAL REASONS FOR INFORMATION NOTIFICATIONS IN 2000

30. RASFF HOW AND WHEN NOTIFY FACTS : Art 7 of CD86/362 and Art 4of CD 90/642 : in the case of infringement action to be taken without further specifications MRLs are not safety limits MRLs apply also to processed and composite foodstuffs MRLs are based on trials (correct applications rate and waiting time) Intake calculations: for various Consumers groups, for Acute and Chronic intakes

31. RASFF HOW AND WHEN NOTIFY If an MRL is exceeded, an additional calculation to establish whether the toxicological limit is exceeded Combine the toxicity ( the hazard ) and the exposure

32. RASFF HOWAND WHEN NOTIFY ADI and ARfD based on animal studies and safety factors List of international accepted ADIs and ARfD http://www.who.int/pcs/jmpr/jmpr.htm ECCO-peer review (CD91/414) National evaluations by EU MS

33. RASFF HOW AND WHEN NOTIFY Notification should not be issued if: intended for domestic market only already consumed food very minor in diet

34. RASFF HOW AND WHEN NOTIFY Pesticides with Acute toxicityPesticides without Acutetoxicity ARfD fixed No ARfD fixed ADI fixed No ADI Risk overestimation Alert Non Alert No Action