Conditions of use in agriculture of plant protection products containing copper: understanding ANSES’s decisions
Why did ANSES re-assess the MAs for copper-based products?
ANSES examined the MA applications submitted by companies following the re-approval of copper compounds at European level in 2018. European Union legislation requires that products be re-assessed whenever an active substance has been re-approved. This re-assessment must include the new regulatory requirements and methodological developments that have occurred since the previous MA. As the competent authority for France, ANSES therefore examined each application for a new MA or the renewal of an MA on the basis of the dossiers provided by the submitting manufacturers.
Why have the conditions of use changed?
Some MAs were old, having been issued before ANSES was entrusted with issuing authorisations in 2015. The scientific and regulatory requirements governing the initial granting of MAs have changed significantly over the past decade or so. In addition, the 2018 European regulation on the approval of active substances imposes new conditions due to the risks posed by copper compounds to humans and the environment. Risk mitigation measures have been formulated for nearby residents, certain workers and the environment, particularly aquatic environments. The Agency took into consideration all these requirements before formulating its decisions.
Furthermore, for over ten years, copper compounds have been classified as “substances that are candidates for substitution” due to their persistence in soil and their toxicity to aquatic organisms. This status involves examining the alternative products available and raises the level of requirements applicable during assessments.
Why is there a discrepancy between certain conditions of use stipulated in the MA for agricultural workers and the needs in the field expressed by agricultural sectors?
ANSES assessed the MA applications for the uses, doses and number of product applications requested and documented in the dossier submitted by each company applying for an MA. ANSES did not, therefore, determine the doses and number of product applications specified in the MAs.
ANSES assessed each MA application against regulatory safety criteria, checking not only the risks but also the efficacy against each targeted pathogen. Following the assessments, ANSES issued authorisations allowing at least one authorised product to be available on the French market for all uses except hops. The authorisation for certain products in powder form has not been renewed because their safety was not demonstrated in the documentation provided. This type of formulation, which results in greater exposure for the applicator than other types of formulations, did not guarantee a level of safety that complies with current requirements for the applicator and the consumer.
How did ANSES consider the importance of copper for specific sectors, particularly organic farming?
The Agency is fully aware of the difficulties in replacing copper in the current agricultural model, particularly for organic production. It therefore sought solutions to ensure effective management measures to reduce risks while guaranteeing authorised uses.
It analysed possible risk management measures by examining the conditions of use in the authorisations set out in the MAs of other Member States. It also sought the opinion of the Marketing Authorisations Monitoring Committee (CSAMM), reporting to the Director of ANSES, on the impact and feasibility of the proposed risk control measures, such as the wearing of protective gloves when working among treated crops. The protection of wildlife was also assessed. Without the additional management measures, certain MAs could not have been granted in view of the risks.
Finally, aware of the needs of sectors dependent on copper, ANSES engaged in discussions with various stakeholders and presented its work on copper to participants of the platform for dialogue on plant protection products, including federations, agricultural unions and technical institutes.