ECPA/ECCA Regulatory conference on 12-13 March 2014

1. ECPA/ECCA Regulatory conference on 12-13 March 2014 Developments in the area of pesticide residues – Commission update Almut Bitterhof, head of sector pesticides residues, European Commission DG Health and Consumers, Unit E.3

2. Overview • Legislation – MRL setting and review programme • International dimension • Controland Enforcement • New areas and challenges • Cumulative risk assessment • Revision of the IESTI equation • Endocrine disruptors • Biocides • Evaluation and possible review of Regulation (EC) No 396/2005

3. Legislation – Routine MRL setting • Reg. (EC) No. 396/2005, Art. 10 • Evaluation of new applications to set or modify specific MRLs (Art. 10), including import tolerances • Management of unforeseen situations: residues arising from dual use substances or from other sources than plant protection product use

4. Legislation – Review of existing MRLs - Reg. 396/2005 Art. 12 • Priority for DG SANCO to speed up the review that is much delayed • Review of complete set of existing MRLs for more than 300 substances (Art.12 review) • Scientific input: EFSA reasoned opinions and advice of EU Reference Laboratories on analytical aspects • In 2013 MRLs for about 50 substances were reviewed

5. Revision of Annex 1 to Regulation (EC) No 396/2005 • Annex I setting the food commodities for which MRLs apply was recently reviewed • Proposal voted in February 2014 • Application date: 1st January 2015 • Introduction of 2 parts, Part A and Part B • Part A: Products of plant and animal origin referred to in Article 2(1) to which MRLs apply • Part B: Other products referred to in Article 2(1)

6. International dimension • Codex Alimentarius • Presenting EU positions in Codex Committee on pesticides residues (CCPR) • Active participation in electronic working groups • Implementation of CXLs in EU legislation annually (second half of each year)

7. Control and Enforcement • Coordinated EU multiannual programme • Follow up of the Rapid Alert System on Food and Feed • Art. 15(5) of Regulation 882/2004 – updating the list of pesticides in food/feed of non-animal origin with increased level of official control at point of entry • FVO audits- input into mission programme

8. Control and Enforcement – Coordinated EU multiannual programme • Dual purpose: a) Check forcompliancewith MRLs andb) dietaryexposureassessment • 2015 – 2017 programmevoted in February 2014 • Adoption in secondhalf of 2014 • Basis for national monitoringprogrammesofthe Member States

9. Control and Enforcement – Food and Veterinary Office • FVO audits on pesticidecontrols in Member States: • Audit series on pesticideresiduescontrolsfrom 2007-2011: Overview Report published on SANCO homepage • 2012-2014: auditseries on controlsformarketinganduseof plant protectionproducts (PPP); follow-up on recommendationsforpesticideresidues

10. Control and Enforcement – Food and Veterinary Office • FVO audits on pesticideconrolsin Third Countries: • Audits to countries withidentifiedrisk: High tradevolume • RASFF notifications • Member State controldata via EFSA • Examplesofaudits in 2013: Morocco, Turkey, China, Kenya • New focus on herbsandspices

11. New areas and challenges- Cumulative risk assessment (CRA) • Why do we need CRA? • Effects from active substances with similar mode of action may add up • Strong concerns from citizens and European Parliament as cumulative efects are not considered so far • CRA will enable COM to respond to such concerns

12. New areas and challenges- Cumulative risk assessment (CRA) • Legal basis for CRA: • Art. 14 and 36 of Regulation (EC) No 396/2005 on maximum residue levels, Recital (6) • Art. 4 of Reg. (EC) No 1107/2009 on the placing on the market of PPPs

13. CRA in Reg. (EC) No. 396/2005 • Art. 14 (Decision on applications concerning MRLs) • "…account shall be taken of: • (a) the scientific knowledge available • (b) the possible presence of pesticide residues arising from other sources than current plant protection uses of active substances, and their known cumulative and synergistic effects, when the methods to assess such effects are available…"

14. CRA in Reg. (EC) No. 396/2005 • Rationale for Art. 14 in Recital (6): • "It is also important to carry out further work to develop a methodology to take into account cumulative and synergistic effects. In view of human exposure to combinations of active substances and their cumulative and possible aggregate and synergistic effects on human health, MRLs should be set after consultation of the European Food Safety Authority…"

15. CRA in Reg. (EC) No. 1107/2009 • Art. 4 (Approval criteria for active substances): • The residues of plant protection products …. shall not have any harmful effects on human health, including that of vulnerable groups, …,taking into account known cumulative and synergistic effects where the scientific methods accepted by the Authority to assess such effects are available, …

16. Current Status of CRA (1) • Close collaboration between EFSA and DG SANCO established • EFSA: 2 cumulative assessment groups (CAGs) established focussing on effects on thyroid and nervous system • EFSA work is ongoing • Cumulative risk assessment carried out as pilot project in EFSA monitoring report

17. Current Status of CRA (2) • SANCO established en electronic WG for risk managers of the Member States • RTD funded project (ACROPOLIS) finalised (FP 7) – follow up being discussed

18. Considerations for future implementation of CRA in risk management • When? • Once all the Cumulative risk assessment groups have been established by EFSA • How? • Define detailed procedures • Evaluate impact of change of methodology • Consideration of international trade • Define communication strategy

19. Revision of the IESTI equation • Recent SCOFCAH identified the need to take up earlier discussions on the revision of the IESTI equation • The approach to be taken currently discussed internally in DG SANCO • Close collaboration between risk assessors and risk managers needed, discussion at international level needed

20. New areas and challenges • Endocrinedisruptorsandcut-off criteria • COM isdevelopingcriteriatoidentifyendocrinedisruptors, asrequiredby Reg. 1107/2009 on plant protectionproductsandby Reg. 528/2012 on biocides • Criteriamayimpact MRL andimporttolerancesetting

21. New areas and challenges – Biocides • Legislation and responsibilities: • Legislation is managed by DG ENV • If MRL need to be set, this will be SANCO responsibility

22. New areas and challenges – Biocides • Next steps (1): • Define a strategy to identify biocides for which MRLs are necessary • BfR workshop on 18-19 March 2014 • Define the legal framework under which MRLs should be set in case appropriate • Interplay between legislation for dual use substances

23. New areas and challenges – Biocides • Next steps (2): • Possible legal frameworks: • Regulation 315/1993 on contaminants • Dir. 2002/32 undesirable substances in feed • Reg. 396/2005 on pesticides residues • Reg. 470/2009 on veterinary medicinal products • Define procedural aspects between 3 different agencies (ECHA, EMA and EFSA) and 2 Commission DGs

24. New areas and challenges- Review of Reg. 396/2005 • Way forward: • As a first step: Evaluation study for Reg. 396/2005 planned for 2015 • Depending on the outcome further steps • No immediate review of Reg. 396/2005

25. New areas and challenges- Review of Reg. 396/2005 • Items forconsideration: • Alignmentwith Reg. 1107/2009, e.g. cut-off criteria, proceduralalignments • Lisbonisation • Biocides? • Addressing legal gapsandclarifications • e.g. dual usesubstances, presencefromothersourcesthan PPP use, Art. 12 procedures, Consolidationof Annexes, needfor t-MRLs, etc.

26. Questions? • Contact: Almut. Bitterhof@ec.europa.eu