Authorisation, withdrawal and amendment of plant protection products: an ANSES mission since 1 July 2015
In compliance with the criteria defined by the European regulations, ANSES has been in charge of the appraisal of plant protection products, fertilisers and growing media, and adjuvants since 2006. Based on our scientific assessment of the risks and efficacy of these products, the Ministry of Agriculture issues marketing authorisations (MAs). Since 1 July 2015, in application of the French law on the future of agriculture, food and forestry of 13 October 2014, ANSES is in charge of issuing, withdrawing and amending MAs and permits for plant protection products, fertilisers and growing media, and adjuvants.
Since 1 July 2015, in application of the French law on the future of agriculture, food and forestry, ANSES, in addition to assessment of the efficacy of products and the risks linked to their uses, is now in charge of implementing the regulatory provisions related to the issuing, amending and withdrawal of marketing authorisations for plant protection products, fertilisers and growing media, and adjuvants.
The Agency, via its Market Authorisations Department (DAMM):
takes decisions on the issuing, amendment and withdrawal of authorisations prior to the marketing or experimentation of plant protection products, adjuvants, fertilisers and growing media, based on the findings of the scientific assessment of dossiers in a highly restrictive regulatory framework;
conducts inspection duties with regard to the manufacturing, formulation, packaging and labelling of plant protection products, adjuvants, fertilisers and growing media.
However, 120-day waiver authorisation decisions for plant protection products, referred to in Article 53 of regulation (EC) no.1107/2009, are issued by the Ministry of Agriculture.
The Agency bases its performance of these activities on:
- guidelines for enhanced transparency, clarity and fluidity in the decision-making process. These guidelines aim to set down clear criteria enabling the Agency to exercise its discretionary power based on the scientific assessment of MA application dossiers conducted in compliance with the regulations. They help to promote transparency by specifying cases that, in addition to dossier assessment work, may require further investigations, in particular with regard to risk management measures integrated into the MA decisions.
- an MA monitoring committee, as provided for by law, made up of figures with knowledge and experience in field practices and the difficulties of implementing MAs, and which may be solicited regarding the following questions:
- the conditions of applicability of risk management measures with regard to marketing authorisations;
- the safety of use of products with regard to human health and the environment;
- the agricultural and socio-economic interest of the various plant protection solutions available, with regard to compliance with agro-ecological principles, including biocontrol solutions;
- the use of data from the phytopharmacovigilance scheme;
- the identification of prioritary subjects for studies on the use of plant protection products and adjuvants, fertilisers andgrowing media;
- the identification of prioritary subjects in terms of production, formulation, packaging and labeling control for plant protection products and adjuvants, fertilisers and growing media.
- a memorandum of understanding with the departments of the ministries in charge of field control, to coordinate ministerial actions and those of ANSES in terms of product inspection and control.
To preserve the Agency's independence, a charter on relations with interest groups aims to ensure the traceability of exchanges with interested parties in contact with the Agency and to prevent risks that might call its independence into question.