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
Health and
Consumers
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
Health and
Consumers
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
Health and
Consumers
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
Health and
Consumers
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
Health and
Consumers
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
Health and
Consumers
Interpretation issues
Negligible exposure
•
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
Health and
Consumers
Implementing measures
Endocrine Disruptors
•
Health and
Consumers
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
Health and
Consumers
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
Health and
Consumers
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
Health and
Consumers
Thank you very much
for your attention!
Health and
Consumers