Since 1 July 2015, ANSES has been responsible for issuing marketing authorisations for plant protection products. The Agency was also given responsibility for establishing the phytopharmacovigilance scheme, and tasked with collecting all reports of adverse reactions related – or potentially related – to the use of a plant protection product.
Holders of marketing authorisations for plant protection products, manufacturers, as well as importers, distributors, professional users, advisers and trainers of users are required to report these adverse reactions to ANSES or to one of the organisations participating in the phytopharmacovigilance scheme.
To facilitate reporting and organise collection, the Agency has therefore put in place a specific system accessible from its website. Professionals engaging in any activity in connection with the use of plant protection products are thus invited to report any adverse reaction via this system (in French). Any other user of plant protection products can also report an adverse reaction via this new system or, if it concerns an adverse effect on human health, via the Adverse health event reporting portal of the Ministry of Social Affairs and Health.
Three questions for Françoise Weber, Deputy Director General for Regulated Products
Today, ANSES is launching an online system to facilitate the reporting of adverse reactions related to the use of plant protection products.Could you tell us about the phytopharmacovigilance scheme set up by ANSES?
Françoise Weber: The phytopharmacovigilance scheme aims to monitor the impact and effects of plant protection products on natural environments and on human, plant or animal health. It was set up by ANSES in late 2014 under the Act on the future of agriculture, food and forestry.
This Act gave ANSES competence in two new areas: one mission to issue marketing authorisations MAs) for plant protection products, and another to monitor the impact of these products on human health, ecosystems and living organisms.
ANSES relies on three tools to carry out this mission. Firstly, a surveillance network with around fifteen institutional partners, including poison control centres, the Agricultural Mutual Insurance Scheme (MSA), and several ministries and organisations specialising in the monitoring of environmental media and fauna, for example water, air and bees. These partners regularly supply data on the monitoring they conduct on environments, or on human, animal or plant health. The advantage of this network is that it enables ANSES to bring all these data together to perform across-the-board surveillance, so as to better detect the adverse effects of a substance and assess its impact. Secondly, ANSES also conducts studies to acquire missing knowledge or data for assessing the impact of plant protection products. And lastly, the reporting of adverse reactions supplements this scheme. This is mandatory for all professionals who market or use plant protection products, or advise on their use. The convergence and comparison of these different data sources thus give us every chance of being able to detect and analyse adverse reactions following the use of plant protection products as early as possible, and take the necessary decisions to prevent them. This could involve, for example, changing a product's conditions of use or even withdrawing it from the market.
What is the objective of the online reporting system launched today?
F.W.: Everyone needs to play a part in protecting human health and the environment, and ensuring that in the future, products are as safe as they are effective. Besides collecting data from the surveillance networks, the objective is also to use online reporting to gather information directly from the professionals in the field who use or sell the plant protection products, or who advise the users of these products. This is essential, in order to gather any signals relating to adverse reactions as early as possible. These field data will then be analysed and processed in conjunction with our partners. To facilitate the reporting of adverse reactions, we are launching an online reporting tool on our website.
What are the initial results of this scheme?
F.W.: First of all, the surveillance data from our network of partners are now taken into account in the assessments of active substances and plant protection products.
In some cases, this has led us to limit the uses or change the conditions of use of certain products, particularly as a result of contamination of environmental media such as water, or the observation of effects on human health.
For example, in 2016, MA holders reported a case of phytotoxicity affecting grape vines and a case in which the maximum residue limit was exceeded. Human poisoning cases have also been reported by the poison control centres, as well as a suspected cluster of paediatric cancers reported by an association. In fact, this last case led us to undertake specific studies on the exposure of local residents to plant protection products.
The phytopharmacovigilance scheme now gives ANSES a comprehensive and integrative view of the impact of plant protection products, throughout their life cycle, as well as the means to take action to prevent their adverse effects, in particular by adapting their marketing authorisations as necessary.
Phytopharmacovigilance is the latest complement to ANSES's existing missions of prior assessment of the risks associated with plant protection products, and the issuing and withdrawal of marketing authorisations. This scheme gives the Agency the means to anticipate, detect and analyse adverse reactions, thereby limiting the risks associated with the use of plant protection products. The analysis of the reports collected could in particular lead to changes in the conditions of use or the marketing authorisations of plant protection products.