1. Health and Consumers Health and Consumers 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 1

2. Health and Consumers Health and Consumers Overview Legislation – MRL setting and review programme International dimension Control and 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 2

3. Health and Consumers Health and Consumers 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 3

4. Health and Consumers Health and Consumers 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 4

5. Health and Consumers Health and Consumers 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) 5

6. Health and Consumers Health and Consumers 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) 6

7. Health and Consumers Health and Consumers 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 7

8. Health and Consumers Health and Consumers Control and Enforcement – Coordinated EU multiannual programme Dual purpose: a) Check for compliance with MRLs and b) dietary exposure assessment 2015 – 2017 programme voted in February 2014 Adoption in second half of 2014 Basis for national monitoring programmes of the Member States 8

9. Health and Consumers Health and Consumers Control and Enforcement – Food and Veterinary Office FVO audits on pesticide controls in Member States: Audit series on pesticide residues controls from 2007-2011: Overview Report published on SANCO homepage 2012-2014: audit series on controls for marketing and use of plant protection products (PPP); follow-up on recommendations for pesticide residues 9

10. Health and Consumers Health and Consumers Control and Enforcement – Food and Veterinary Office FVO audits on pesticide conrols in Third Countries: Audits to countries with identified risk: High trade volume RASFF notifications Member State control data via EFSA Examples of audits in 2013: Morocco, Turkey, China, Kenya New focus on herbs and spices 10

11. Health and Consumers Health and Consumers 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 11

12. Health and Consumers Health and Consumers 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 12

13. Health and Consumers Health and Consumers 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…" 13

14. Health and Consumers Health and Consumers 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…" 14

15. Health and Consumers Health and Consumers 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, … 15

16. Health and Consumers Health and Consumers 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 16

17. Health and Consumers Health and Consumers 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 17

18. Health and Consumers Health and Consumers 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 18

19. Health and Consumers Health and Consumers 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 19

20. Health and Consumers Health and Consumers New areas and challenges Endocrine disruptors and cut-off criteria COM is developing criteria to identify endocrine disruptors, as required by Reg. 1107/2009 on plant protection products and by Reg. 528/2012 on biocides Criteria may impact MRL and import tolerance setting 20

21. Health and Consumers Health and Consumers 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 21

22. Health and Consumers Health and Consumers 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 22

23. Health and Consumers Health and Consumers 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 23

24. Health and Consumers Health and Consumers 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 24

25. Health and Consumers Health and Consumers New areas and challenges- Review of Reg. 396/2005 Items for consideration: Alignment with Reg. 1107/2009, e.g. cut-off criteria, procedural alignments Lisbonisation Biocides? Addressing legal gaps and clarifications e.g. dual use substances, presence from other sources than PPP use, Art. 12 procedures, Consolidation of Annexes, need for t-MRLs, etc. 25

26. Health and Consumers Health and Consumers Questions? Contact: Almut. Bitterhof@ec.europa.eu 26