Definitions, regulatory framework and role of the Agency
There are 22 types of biocidal products (PTs), divided into four groups:
- disinfectants (human or animal hygiene, disinfection of surfaces, disinfection of drinking water, etc.);
- preservatives (for products during storage, for wood or construction materials, etc.);
- pest-control products (rodenticides, insecticides, repellents, etc.);
- other biocidal products (embalming fluids, antifouling products, etc.).
How are they regulated?
Biocidal products and the active substances they contain are covered by the European Regulation concerning the marketing and use of biocidal products (Regulation (EU) No 528/2012). This regulation aims to harmonise the marketing and use of these products within the European Union. Its main objective is to ensure a high level of protection for humans, animals and the environment by only placing on the market those biocidal products that are effective and do not present unacceptable risks.
According to this Regulation, biocides are assessed in two stages:
- biocidal active substances must first be approved at EU level for one or more specific product types from among the 22 defined by the Biocides Regulation (see above). A rapporteur Member State is appointed for each substance to be assessed. It is responsible for producing an assessment report that is then discussed with all the EU Member States;
- an application for marketing authorisation (MA) must be submitted for a product as soon as the active substances it contains have been approved for the product type in question. This MA can then be issued at national or European level. The MA application process includes an assessment of the biocidal product's efficacy and of the risks to humans and the environment associated with its use.
Companies wishing to apply for marketing authorisation for a biocidal product under Regulation (EU) No 528/2012 must submit a MA application in the EU state(s) where they wish to market the product. This is done via the European R4BP platform (Register for Biocidal Products). The MA application dossier must include all the information enabling an assessment of the product's efficacy for the intended uses, as well as of the risks to humans and the environment associated with its use.
What is ANSES's role?
ANSES is responsible for assessing the hazards, risks and effectiveness of biocidal active substances and products for which applications have been submitted in France. To carry out these assessments, like the other Member States, ANSES relies on harmonised European reference standards.
The product's MA application is examined in order to:
- assess the risks to humans and the environment associated with each of the product's intended uses through its properties (physico-chemical, toxicity, environmental fate and ecotoxicity), and the exposure resulting from use of the product;
- assess the product's effectiveness.
Based on the conclusions of the product assessment, and consulting where necessary its MA Monitoring Committee, ANSES decides whether or not to authorise biocidal products for the French market.
Have all commercially available biocidal products been authorised?
No, some biocidal products contain active substances that are still being assessed at European level. These products do not yet have a marketing authorisation according to Regulation (EU) No 528/2012. They can still be marketed, under a "transitional regime" provided for in the Regulation.
There are therefore two possible regimes for placing biocidal products on the market:
- the "transitional" regime: biocidal products currently on the market and containing active substances that are still being assessed at European level are subject to the existing specific rules of each Member State. In France, these products must comply with a certain number of rules, mainly in terms of reporting and labelling. There are additional provisions for certain specific uses. The companies marketing these products are responsible for proving their efficacy, and must be able to demonstrate it in the event of a control;
- the "regular" regime: this applies as soon as the active substances have been approved at European level. The products concerned must then undergo a full assessment by ANSES as part of the MA application process, in order to remain on the French market.
The list of biocidal active substances and their status, as well as the biocidal products authorised under Regulation (EU) No 528/2012, can be found on the ECHA website.
Does the authorisation procedure also apply to so-called natural or environmentally friendly products?
Just because a product is natural does not necessarily mean it is less hazardous. Products containing substances of natural or food origin, such as essential oils or vinegar, and claiming a biocidal effect are assessed and authorised in the same way as other biocidal products.
In addition, the Biocides Regulation considers that statements such as "low-risk biocidal product", "non-toxic", "not harmful to health", "natural", "environmentally friendly" or "animal friendly" are likely to mislead the user about the health and environmental risks and the efficacy of the product. They are therefore prohibited.
In order to encourage the use of biocidal products containing active substances with a profile that is more environmentally friendly or safer for human or animal health, a "simplified" authorisation procedure is provided for in Regulation (EU) No 528/2012: when a product meeting these criteria is authorised in one Member State, it becomes authorised throughout the European Union by simple notification, without having to go through a mutual recognition procedure. These products may be of natural or synthetic origin.