France : New responsabilities for Anses from 1 July 2015

From 1 July 2015, in accordance with French legislation for agriculture, food and forestry of 13 October 2014, Anses is in charge of granting  approvals for plant protection products and adjuvants. The Ministry of Agriculture was previously in charge of it.

The décret No.2015-791 of 30 June 2015 on the conditions for the exercise by the Agency of these new missions  specifies the technical conditions of the transfer of the approval granting from the French Minister of Agriculture to Anses Managing Director.

Indeed, since 1 july 2015, Anses Managing Director has authority for approval granting and for  trial permit approval and parallel trade. It has to be noted that the French Ministry of Agriculture keeps the responsibility for the 120-day derogations as defined  in Article 53 of Regulation (EC) No.1107/2009.

The Decree also institutes a declaratory system replacing the prior approval system for some administrative changes of authorisations, to simplify procedures that do not require any assessment by the Agency.

In addition, the decree removes the separate deadlines for the evaluation by Anses and the approval management by the Ministry of Agriculture. Now, the overall timelines given in Regulation No.1107/2009 will apply. The allocation of time between evaluation and approval management now depends on the internal organisation of the Agency.

Finally, the text sets up a shorter procedure for the evaluation and authorisation of biocontrol products.

To ensure the functional separation between scientific assessment and approval granting, two distinct and independent  departments were created. The Department for approval (DAMM) and the Department for the assessment of regulatory products (DEPR, ex-DPR).

The newly formed DAMM consists of two units:

– the Administrative Unit, unique contact point for notifiers for contractual and administrative aspects with Anses, in charge of the dossier completeness check and the processing of administrative dossiers;

– the Approval Decision Unit, in charge of the preparation, follow-up and renewal of approval decisions.

All assessment conclusions and decisions will be published in the Register of authorisations and assessment conclusions.

For transparency, Anses decided to develop guidelines to clarify the principles adopted by the DAMM for the issue of approval decisions.

The draft guidelines were submitted electronically to public consultation from 12 May 2015 to 5 June 2015. The comments received during the public consultation have not challenged the principle of these guidelines. A note summarising the comments received and those taken into account was published by Anses on 1 July 2015.

The DAMM will also contribute to the implementation of the comparative assessment of products available on the market under the new provisions of EU regulation to come into force on 1 August 2015.

Furthermore, in accordance with the law, a Committee of Approvals monitoring will also be formed in autumn 2015. This advisory structure will provide to Anses management further insight to the scientific evaluation to ensure in particular that the risk management measures imposed as part of the authorisations are practicable and effective in a real situation, given the constraints of field practices.

Note, to preserve the independence of the Agency, a Charter on relations with the stakeholders is being developed.

Finally, since 1 July 2015, ANSES is also entrusted with the implementation of a monitoring system called ‘phytopharmacovigilance’ (PPV) of the effects of these products on human health, fauna, flora and environment. This system will strengthen current arrangements for post-authorisation monitoring.

If you have questions about the new missions of ANSES, please do not hesitate to contact us: +33 9 72 50 40 29.

We are also at your disposal for all your questions about the status of Anses opinions or informal appeals not solved by DGAl on 30 June 2015.