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EU criteria for endocrine disruptors – update

EU criteria for endocrine disruptors – update. Breakfast roundtable on regulation of endocrine disruptors - 11 July 2017. SCOPAFF meeting 4 July 2017 Formal vote taken Qualified majority* support obtained:

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EU criteria for endocrine disruptors – update

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  1. EU criteria for endocrine disruptors – update Breakfast roundtable on regulation of endocrine disruptors - 11 July 2017

  2. SCOPAFF meeting 4 July 2017 Formal vote taken Qualified majority* support obtained: - 21 Member states for: AT, BE, BG, CY, DE, EE, EL, ES, FI, FR, HR, IE, IT, LT, LU, MT, NL, PT, RO, SI, SK - 4 Member States abstained: HU, LV, PL, UK - 3 Member States against: CZ, DK, SE * Qualified majority requires: 55% of Member States (16 Member States), representing at least 65% of the EU population Current status

  3. Most recent version (4 July 2017) Overall no significant amendments made to core of criteria, still based on 3 elements of WHO/IPCS definition Inclusion of wording “known and presumed”- recital (4): “The determination of endocrine disrupting properties with respect to human health should be based on human and/or animal evidence, therefore allowing for the identification of both known and presumed endocrine disrupting substances.” Clarifications included to wording on exemption for substances with intended endocrine MOA (environmental target species) - recital (7) 6 month application period after entry into force 7 year review period Proposed technical amendment to derogation omitted from proposal (commitment from Commission to revisit after criteria formally adopted) Most recent version: rev4 (4 July 2017), available at: http://ec.europa.eu/health/sites/health/files/endocrine_disruptors/docs/20170530_ppp_draft_en.pdf Commission proposal

  4. Next steps & timelines Report Before 24 Jul 2017 Commission launch EP & Council Scrutiny Commission adoption, OJ publication (Nov-Dec 2017) Entry into Force Final criteria apply Plant Protection Products* 3 (+ 1) months 6 months 20 days Mid 2018 Commission adoption, OJ publication (Nov-Dec 2017) Sep2017 Commission launch EP & Council Scrutiny 17 Jul 2017 - BP Competent Authority meeting Entry into Force Final criteria apply Biocidal Products** ~6 months 2 (+ 2) months 20 days Mid 2018 * Regulatory Procedure with Scrutiny ** Delegated Act NB - EP & Council have VETO rights for both RPS measures & Delegated Acts

  5. Final criteria will apply to: New active substances submitted after the application date of the final criteria Renewals of active substances being re-authorised where a SCOPAFF approval vote has not yet taken place at the time the criteria apply Active substances with requirements related to providing confirmatory data related to ED properties Interim criteria In force up until final criteria officially apply Application of criteria

  6. ECPA position Criteria still limited to WHO/IPCS definition only No hazard characterisation (no potency) – essential to separate substances of concern from those of no concern Without hazard characterisation, many substances of low/no concern will be unnecessarily removed from farmer’s toolbox Concerned with principle of regulation by derogation – but amendment to derogation essential to ensure more workable criteria - Amendment should be re-tabled for voting by Member States EDsshould be managed by risk assessment (EFSA Scientific Committee opinion, 2013) Commission proposal

  7. THANK YOU

  8. Timelines 17 Oct 2016 - Commission sent official mandate to EFSA & ECHA to jointly prepare technical guidance for ED criteria, 14 Apr–3 May 2017 – First draft (chapters 4 & 5 only) available for comment by ED consultation group 17 Jul-31 Aug 2017 – Second draft (whole document) expected to be available for comment by ED consultation group Late 2017 – public consultation on final draft? SCOPAFF to formally “adopt” via Advisory Procedure” Technical guidance document will be critical to how final criteria are applied in practice Technical guidance document

  9. C & R categories CLP Carcinogenicity: Reg1272/2008 (CLP), Annex 1, section 3.6.2

  10. C & R categories CLP Reproductive toxicity: Reg1272/2008 (CLP), Annex 1, section 3.7.2

  11. EU Hazard Criteria and the setting of Import Tolerances

  12. Commission statement: The Commission informed the Committee that its Legal Service provided advice, which favoured the lowering to the LOD and the refusal of new ITs… only when this lowering of LODs is the consequence of an EU legal act, such as a Commission implementing Regulation non renewing the approval of an active substance and setting out the substance's hazard classification as a reason for the non renewal. The Legal Service advised that in this case the rejection should be made by the rapporteur Member State upon receipt of the IT request. Minutes of SCoPAFF Residues meeting; 12-12 June https://ec.europa.eu/food/sites/food/files/plant/docs/sc_phyto_20170612_ppr_sum.pdf Cut-off criteriaCan import tolerances be set?

  13. Industry viewImport tolerances for cut-off ASs Key points in ECPA letter: • Regulation 1107/2009 introduces hazard based criteria for EU approvals, not for the setting of MRLs/ITs • Hazard based restrictions on import tolerances would be • Contrary to the EU’s MRL legislation (Reg.396/2005) • Contrary to WTO SPS agreement • With substantial impact on international trade! • WTO requires that decisions are based on risk assessment – the EU must continue to comply with SPS principles Letter available on ECPA website: http://www.ecpa.eu/sites/default/files/document_policy/28234_Letter_to_European_Commission_Import_Tolerances_and_hazard_criteria%20-%20FINAL.pdf

  14. The main message …: • EU should set Import Tolerances: • Where necessary for trade • Where uses are safe for consumers (regardless of the EU’s hazard-based cut-off criteria)

  15. Substances potentially impacted by ‘wrong’ policy on import tolerances • Note: This is an indicative list only! • List based on substances that: • Trigger CMR (Cat.1)criteria • Potentially trigger ED (based on 2 published evaluations)

  16. Substances potentially impacted by ‘wrong’ policy on import tolerances • Indicative list, based on: • Trigger CMR criteria • Potentially trigger ED (based on 2 published evaluations) • Under current EU policy, import tolerances would be set at 0.01mg/kg These lists do not constitute evaluations of individual substances carried out under the Plant Protection products Regulation 1107/2009  and in no way prejudge future decisions on active substances

  17. European Residues Conference 2017 16th & 17th October 2017 Sheraton Airport Hotel, Brussels More details and registration to follow @ https://ecpa.events.idloom.com/residues2017

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