Biocidal products are substances or formulations intended to destroy, deter, render harmless, prevent the action of, or exert a controlling effect on any harmful organism by chemical or biological means. As part of the marketing authorisation applications for these products, ANSES has been mandated to assess biocidal active substances and the preparations that contain them. This assessment is guided by European regulations. Depending on the conclusions of this assessment, a decision is taken as to whether or not to allow the product to be placed on the market.
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Updated on 20/09/2016
Definition, regulatory framework and ANSES’s role
Keywords : Biocides
Biocidal products are substances or formulations intended to destroy, deter, render harmless, prevent the action of, or exert a controlling effect on, any harmful organism by chemical or biological means.
Biocidal active substances are chemicals or micro-organisms that have an action on or against harmful organisms.
Biocidal products are formulations that contain one or more active substances. They are presented in the form in which they are delivered to the user.
There are 22 types of biocidal products classified into four main groups:
- disinfectants (human or animal hygiene, disinfection of surfaces, disinfection of drinking water, etc.),
- preservatives (wood and building material preservatives, etc.),
- pest control products (rodenticides, insecticides, repellents, etc.),
- other biocidal products (embalming fluids, antifouling products, etc.).
Biocidal active substances and biocidal products are addressed in a European regulation (Regulation (EU) No 528/2012) that aims to harmonise the marketing authorisation and use of these products in Europe.
The main objective of this regulation is to ensure a high level of protection for humans, animals and the environment by limiting the marketing of biocidal products to those that have been proved effective and that do not present unacceptable risks.
The expert appraisal procedure
The assessment of biocidal active substances is carried out at the European level. For each active substance to be assessed, a reference Member State is designated. This Member State is responsible for producing an assessment report that is then discussed among all the Member States in order to come to a single decision regarding EU-level approval or non-approval of the substance.
The authorisation for biocidal products is issued at a national or European level. Marketing authorisation (MA) applications can only be submitted for biocidal products containing active substances on the “positive lists” or those in the process of being assessed.
Companies wishing to apply for marketing authorisation for a product must submit an MA application in the country in which they wish to market the product, via the European R4BP (Register for Biocidal Products) platform. The application dossier must include all the information enabling an assessment of the efficacy of the product for all of the intended uses, as well as the risks for humans and the environment linked to its use. Companies can submit an application for marketing authorisation using the mutual-recognition procedure if the product has already been assessed and authorised, in accordance with current European regulations, by another EU Member State.
In France, ANSES issues marketing authorisations for products, whereas the Ministry of Ecology is the competent authority for approving active substances at European level.
ANSES is in charge of coordinating national-level risk, safety and efficacy assessments of the biocidal active substances and biocidal products whose MA applications have been submitted in France. In this capacity, the Agency formulates assessment conclusions.
The examination of the MA application dossier enables an assessment of the risks for humans and the environment associated with each of the intended uses of the product in question, from its properties (physico-chemical, toxicity, environmental fate and ecotoxicity) and residue levels in food to an assessment of the efficacy of the product.
On the basis of the assessment conclusions, and where appropriate drawing on the support of MA Monitoring Committee (in French only), ANSES decides whether or not to issue marketing authorisations. It also manages any withdrawals of authorisation.