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Commission view on the implementation of Regulation (EC) No 1107/2009

ECPA/ECCA Brussels Regulatory Conference 12-13 March 2014, Brussels, Belgium. Commission view on the implementation of Regulation (EC) No 1107/2009. Wolfgang Reinert European Commission Health and Consumers Directorate-General Unit Chemicals, contaminants, pesticides. Active substances.

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Commission view on the implementation of Regulation (EC) No 1107/2009

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  1. ECPA/ECCA Brussels Regulatory Conference 12-13 March 2014, Brussels, Belgium Commission view on the implementation of Regulation (EC) No 1107/2009 Wolfgang Reinert European Commission Health and Consumers Directorate-General Unit Chemicals, contaminants, pesticides

  2. Active substances first approval • 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

  3. Implementing measures Candidates for Substitution • 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

  4. Implementing measures New data requirements (DR) • 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 2013- because of non-peer-reviewed information in the a.s. dossier

  5. Implementing measures New data requirements (DR) • 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

  6. Interpretation issues Negligible exposure • Relates to points 3.6.3 – 3.6.5 and 3.8.2 of Annex II to Reg. 1107/2009:- Carc. and reprotox cat. 1A and 1B- Endocrine disruption • Element of exposure for hazard-oriented criteria

  7. Interpretation issues Negligible exposure • Dietaryexposure: legal thresholds (Reg. 396/2005) • Non-dietaryexposure: legislationleavesmarginofinterpretation • Guidancedocumentunderpreparation:- Discussionongoingbetween COM, MS and EFSA- stakeholderconsultationforeseen

  8. Implementing measures Endocrine Disruptors

  9. Implementing measures Zonal System • 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

  10. Implementing measures Authorisation Database • Module authorisation/ mutual recognition under development • Recently updated:- Product management- Follow-up of application process- e-mail notifications- User management- User interface

  11. Implementing measures Authorisation Database • 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

  12. Thank you very much for your attention!

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