Health and Consumers Health and Consumers Commission view on the implementation of Regulation (EC) No 1107/2009 ECPA/ECCA Brussels Regulatory Conference March 2014, Brussels, Belgium Wolfgang Reinert European Commission Health and Consumers Directorate-General Unit Chemicals, contaminants, pesticides

Health and Consumers Health and Consumers New Active substances (Reg. 188/2011) - about finished - 3 substances still in the peer-review New Active substances (Reg. 1107/2009) - No major problems flagged - Progress made in the integration of CLP-process into review Active substances first approval

Health and Consumers Health and Consumers List according to article 80 (7) under finalisation Covering a.s. approved until Jan 2013 Regulatory framework under consultation Apply comparative assessment as from 1 January 2015 List to be completed by that date GD comparative assessment on agenda of SCFCAH in March Implementing measures Candidates for Substitution

Health and Consumers Health and Consumers New data requirements published in April 2013 Apply to all a.s. and PPP dossiers as from 1 January 2016 Transitional measures create problems for: - PPP dossier submissions after 1 January 2016, containing - a.s. of AIR2, or - new a.s. submitted before 31 December because of non-peer-reviewed information in the a.s. dossier Implementing measures New data requirements (DR)

Health and Consumers Health and Consumers Possible solution: old DR exceptionally continue to apply to a.s. dossiers in PPP submissions containing a.s. to which the old DR still apply (new a.s., AIR2) No problems with applying new data requirements for PPP dossier in all cases as foreseen Amended GD and draft Reg. to be presented to SCFCAH in March Implementing measures New data requirements (DR)

Health and Consumers Health and Consumers Relates to points – and of Annex II to Reg. 1107/2009: - Carc. and reprotox cat. 1A and 1B - Endocrine disruption Element of exposure for hazard-oriented criteria Interpretation issues Negligible exposure

Health and Consumers Health and Consumers Dietary exposure: legal thresholds (Reg. 396/2005) Non-dietary exposure: legislation leaves margin of interpretation Guidance document under preparation: - Discussion ongoing between COM, MS and EFSA - stakeholder consultation foreseen Interpretation issues Negligible exposure

Health and Consumers Health and Consumers Implementing measures Endocrine Disruptors

Health and Consumers Health and Consumers Recent analyses from industry and MS on the functioning System is not yet working according to desire Yet, no thorough analysis: figures presented too divergent Complexity of the zonal vs. national authorisation: - Failure to comply with deadlines - Resource problems - Lack of streamlining in the procedure COM dedicated to the principle of mutual recognition and keen to enhance the functioning Implementing measures Zonal System

Health and Consumers Health and Consumers Module authorisation/ mutual recognition under development Recently updated: - Product management - Follow-up of application process - notifications - User management - User interface Implementing measures Authorisation Database

Health and Consumers Health and Consumers Second user acceptance testing before summer 2014 Publication planned second semester 2014 What next? - Expand existing EPPO codes - Implement other modules (amendment of authorisation, minor uses…) - Incorporate existing entries from MS databases - Publish catalogue of EU authorisations Implementing measures Authorisation Database

Health and Consumers Health and Consumers Thank you very much for your attention!