Health andConsumers

Health andConsumers

Commission view on the implementation of

Regulation (EC) No 1107/2009

ECPA/ECCA Brussels Regulatory Conference12-13 March 2014, Brussels, Belgium

Wolfgang Reinert

European Commission

Health and Consumers Directorate-General

Unit Chemicals, contaminants, pesticides

Health andConsumers

Health andConsumers

• 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 andConsumers

Health andConsumers

• 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 andConsumers

Health andConsumers

• 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

Implementing measures

New data requirements (DR)

Health andConsumers

Health andConsumers

• 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 andConsumers

Health andConsumers

• 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

Interpretation issues

Negligible exposure

Health andConsumers

Health andConsumers

• 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 andConsumers

Health andConsumers

•

Implementing measures

Endocrine Disruptors

Health andConsumers

Health andConsumers

• 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 andConsumers

Health andConsumers

• Module authorisation/ mutual recognition under development

• Recently updated:- Product management- Follow-up of application process- e-mail notifications- User management- User interface

Implementing measures

Authorisation Database

Health andConsumers

Health andConsumers

• 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 andConsumers

Health andConsumers

Thank you very muchfor your attention!