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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.

ANSES : Public consultation on guidelines for the issue of approval decisions

As of next summer, ANSES, in addition to its role of scientific assessment, will also issue approvals for plant protection products, fertilisers and crop supports and adjuvants.

For transparency, ANSES has developed guidelines to clarify the principles applied by the Agency for issuing approval decisions. These guidelines are subject to public consultation from 12 May 2015 to 5 June 2015.

 

What can we learn?

  • Decisions taken by the Agency shall be notified to the applicant and will be published in the electronic register of decisions of ANSES, accessible on the Agency website as soon as possible. The conclusions of the assessment will be published in parallel on the same website.

Non-confidential parts of the zonal “Registration Report” (parts A and B), produced by ANSES, will also be made available on its website to provide access in much more detail to the results of the assessment.

  • In some cases, further assessment of the dossier by the DAMM may be required by the nature of the application and / or the result of the assessment, in order to prepare the draft decision. The cases identified are:
    • the case where all or part of the risk management measures associated with the results of the assessment raises questions in terms of feasibility and acceptability in practice to ensure its effectiveness;
    • the case where new data from either the assessment, including data subsequent to the renewal of approval of active substance, or of monitoring networks;
    • the case where data on sanitary and phytosanitary consequences of plant protection issues deserve to be taken into account in the decision process;
    • the case where the product contains an active substance leading to the implementation of comparative assessment and where a thorough analysis on practical / economic consequences of various possible alternatives is needed.
  • The comparative assessment of the product is made in compliance with European guidelines:
    • guidance document SANCO / 11507/2013 Rev.12, “Guidance Document on Comparative Assessment and Substitution of Plant Protection Products in according with Regulation (EC) No 1107/2009”, published by the European Commission dated 10 October 2014;
    • EPPO guidelines PP 1/271 (1), “Guidance on comparative assessment”, published in 2011 by the European and Mediterranean Plant Protection Organisation.

When it is implemented, comparative assessment will be a specific document showing responses at different stages of the process. This document will be attached to the conclusions of the assessment and made public with the conclusions of the assessment.

https://www.anses.fr/fr/documents/Lignes_directrices_PPP.pdf

 

ANSES : New responsibilities: granting approvals, control and inspection of products, monitoring

As part of future legislation for agriculture, food and forestry of 13 October 2014, the French government and the parliament decided to give new responsibilities to ANSES. These are:

Issuing authorisations of plant protection products, fertilisers, growing media and adjuvants, previously the responsibility of the Ministry of Agriculture.

Powers of control and inspection of these products, as regards the manufacture, packaging and labeling.

– The establishment of a monitoring plan for organising data collection on the impact of products on Human Health, flora, fauna, and the environment.

These new responsibilities will constitute an important development for the agency, whose mission fell far mainly in the field of scientific expertise.

 

The proposed new organisation is as follows:

DAMM  (Department for approvals)

  • Administrative Unit

→ contact point

→ dossiers completeness check

→ processing of administrative dossiers

  • Approvals decision Unit

→ preparation of approval decisions
→ Implementation of Comparative Assessment

Committee of
Approvals monitoring

→ technical support of DAMM

DEPR  (Department for the assessment of regulated products)

  • Coordination Unit

→ coordination of Assessment Units

  • Assessment Units

→ assessment of applications

→ comparative assessment of products

  • R&D and Scientific watch Unit

→ coordination of studies and research

→ scientific watch

Committee of
Specialised Experts

→ technical support of DEPR

PPV  (Pesticides Monitoring)
→ PPV data collection (Pesticides Residues Observatory, launching new studies, implementation of agreements…)→ analysis and interpretation of data→ transmission to DAMM and DEPR
PPVworking group→ support of PPV

https://www.anses.fr/fr/documents/Annexe-ModalitesdepriseenchargenouvellesMissions.pdf