Produits Phytopharmaceutiques

Assessment of plant protection products

Plant protection products are formulations intended to protect plants and plant products.These products must obtain authorisation before they can be placed on the market, on the basis of a scientific assessment. Find out what these products are, how they are regulated and whats is Anses's mission.

Whats are plant protection products?

They are preparations intended to protect plants and also their products after harvesting. They are considered as pesticides, a group which also include biocides and antiparasitics for human and veterinary use.

The use of plant protection products is intended to:

  • protect plants against all harmful organisms or prevent their action;
  • act on the life processes of plants (insofar as they are not nutrients);
  • ensure the storage of plant products;
  • destroy undesirable plants;
  • destroy parts of plants, inhibit or prevent undesired growth of plants.

Each formulation consists of one or more active substances responsible for the properties of the plant protection product and substances called co-formulants. These co-formulants give the product a form suitable for its application. They include anti-foaming agents, diluents and wetting agents.

What are the issues of the assessment of plant protection products?

Having products that are safe, and whose performance has been assessed and conditions of use specified (taking into account progress in knowledge, diversity and any specific aspects of crop situations) is a major issue for farmers, consumers, industry and the environment. The use of plant protection products may cause direct or indirect risks to humans, whether this be the user or the general population, as well as to ecosystems. Assessing pesticides before they can be placed on the market, and monitoring them post-authorisation, are vital to public and environmental health.

The regulatory framework

Plant protection products must obtain authorisation before they can be placed on the market, on the basis of a scientific assessment whose criteria are laid down in specific European Union regulations. The active substances contained in these products must first go through a scientific assessment and approval process at European level.Commercial products containing these substances are then assessed by geographical zone containing several countries, before marketing authorisation can finally be granted at the level of each Member State. In France, ANSES has been responsible for this task since 2015.

Assessment and authorisation in 5 points

  • Before a plant protection pro-duct can be marketed in France, the active substance it contains must first have been approved at European level. If this is the case, the manufacturer must then submit a marketing autho-risation application to ANSES, including the studies required by the regulations and any rele-vant scientific publications. The studies must have been carried out with the formulated product as it will be used, in order to take into account the effect of all the components: active substance(s) already approved by Europe as well as co-formulants.
  • The Market Authorisations Department at ANSES checks the administrative admissibility of the application dossiers, then forwards them to the department responsible for evaluating these products, for a scientific assess-ment of the data provided and their compliance with regulatory requirements.
  • ANSES assesses the products’ effectiveness and the risks asso-ciated with their use for applicators, workers, residents and people in the vicinity of application sites, as well as for consumers, the envi-ronment, fauna and flora. To do this, the Agency calls on teams of scientific assessors specialising in different disciplines (chemistry, toxicology, ecotoxicology, etc.) and is supported by an independent expert committee. The assess-ment takes into account data from the scientific literature and from surveillance schemes.
  • On the basis of this assess-ment, which is shared with the other Member States in Europe’s South zone, decisions to grant or refuse authorisation are issued for each use of the product and for a defined period of time. The decisions define the conditions of use and, if necessary, restric-tions on use according to any risks identified.
  • ANSES authorises the sale and use of each product through this marketing authorisation. However, the authorisation, which allows products that have been tested for effectiveness and the absence of any harmful effects to be made available for a given use, does not constitute a prescription for use. ANSES supports the principle of the lowest possible use of these products in circumstances where there is no alternative to their use to protect crops. Authorisations may be restricted or withdrawn at any time if justified by new scientific or surveillance data.

The regulation of pesticides and exposure of local residents

The European regulations currently provide for the exclusion of CMR (carcinogenic, mutagenic or reprotoxic) Category 1 plant protection substances. Concerning all products, especially those containing a CMR Category 2 substance, a risk assessment must be carried out before they are placed on the market. This may lead to specific measures being taken to limit the exposure of local residents and susceptible population groups such as children, in particular by establishing buffer zones. General regulatory provisions aimed at protecting local residents must also be complied with, such as restrictions on use near places frequented by schoolchildren and near structures housing vulnerable people (the elderly, sick people, etc.).

Read the note on buffer zones for the protection of local residents in French only