The Regulation on biocidal products requires all products to be authorised by a competent authority before they are placed on the market.
Authorities can only grant authorisation if the evaluation they carried out shows that the use of the product is safe for human and animal health, and the environment. The product must also be proven to be effective for its intended use(s).
Biocidal products are authorised through a two-step approach:
- The active substance (having the biocidal effect) must be approved at EU level. Its hazardous properties and possible risks to humans, animals and the environment are assessed.
- Every product containing that active substance must then be authorised for each specific formulation (e.g. liquid, spray, etc.), intended use (e.g. control of ticks or mosquitos) and user category (e.g. professional users or general public).
Who authorises the products?
Usually, the EU country where the biocidal products are to be placed on the market is responsible for authorising the product, in a process referred to as 'national authorisation'.
A mutual recognition process exists between EU countries, so that companies can obtain an authorisation of their products simultaneously in several countries (mutual recognition in parallel) or subsequently, if the product has been already authorised in one EU country (mutual recognition in sequence). This process allows quicker access to the market for companies and ensures harmonisation within the EU.
Some products can be authorised at EU level, allowing companies to place them on the EU market. In these cases, it is the European Commission that grants such authorisation. This process is referred to as 'Union authorisation'. Further information on how this works in practice is available in the following report.
The choice of the procedure for authorisation is left up to companies.
General principles for authorising biocidal products
- Annex V details the product types and their descriptions
- Article 23 sets out rules describing how a comparative assessment shall be carried out.
- Chapter VII outlines the harmonised procedures for the authorisation of biocidal products including national authorisation and mutual recognition
- Chapter VIII contains the authorisation procedures at Union level, how these should be submitted and how their benefits potentially outweigh mutual recognition. This guidance note sets out the similar conditions of use for biocidal products.
- Annex 1 provides a list of low-risk active substances and Chapter V outlines a simplified authorisation procedure for products containing such active substances
- Chapter IX relays changes to product authorisations (administrative, minor and major changes) which need to be approved by the Competent authorities before they can be implemented by authorisation holders
- The provision in Chapter X allows a company to import and place on the market of EU country B a product already authorised in EU country A, when an identical product is also authorised in EU country B (parallel trade).
- Articles 55-57 provide for derogations from general requirements, derogations for research and development, and exemption from registration under REACH legislation.
