Authorisation of biocidal products

Biocidal products must be authorised in accordance with BPR before making available on the market or before use. An authorisation must be applied for products containing active substances already on the market once all the active substances of the product are approved in accordance with BPR. The active substances have to be approved for the concerned product-type.  For products containing new active substances an authorisation must have been granted before placing on the market (for the first time) just as under Directive 98/8/EU. An authorisation may be subject to an individual product or a product family. The IT tool for submission of applications is the Register for Biocidal Products (R4BP). The details of product authorisation will be clarified by technical guidance notes provided by the Commission.

 

A Union authorisation can be applied for from 1 September 2013 onwards for certain biocidal products. An EU-wide authorisation will be granted to products with similar conditions of use across the Union.  The company applying for Union authorisation submits the application and necessary information to the European Chemicals Agency (ECHA). The applicant chooses in advance the evaluating national competent authority who will assess the data. ECHA’s Biocidal Product Committee prepares an opinion based on the evaluation results and the European Commission makes the authorisation decision.


The Union authorisation will be available at different stages depending on the product-type for products containing active substances already on the market as follows:

 

  • from 1 September 2013 for product-types 1, 3, 4, 5, 18 and 19
  • from 1 January 2017 for product-types 2, 6 and 13
  • from 1 January 2020 for the remaining product-types 7, 8, 9, 10, 11, 12, 16 and 22.

 

The Union authorisation is not available for product-types 14, 15, 17, 20 and 21, or if the product contains active substances which meet the general exclusion criteria (e.g. substances in CMR categories 1A and 1B).

 

A Union authorisation can applied for products containing new active substances from 1 September 2013 onwards, unless the product contains active substances which meet the general exclusion criteria (e.g. substances in CMR categories 1A and 1B) or unless it falls under product-type 14, 15, 17, 20 or 21.

 

A national authorisation can be applied for any biocidal product under BPR. The application is assessed and the authorisation granted by a competent authority. In Finland, the competent authority is Tukes. Applications are provided directly to the national authority using the Register for Biocidal Products (R4BP) as the submission tool.

 

During the transitional period of BPR, a national authorisation before placing on the market is needed for certain biocidal products, i.e. wood preservatives, slimicides in pulp and paper industry, antifouling products, rodenticides, insecticides, acaricides and pest control repellents. This applies until application for authorisation is to be made in accordance with the regulation.. Information about the national authorisation and application procedures can be found under "National procedures".

 

Mutual recognition of an authorisation continues under BPR. Mutual recognition in parallel is a new feature. It means that mutual recognition of an authorisation for a biocidal product which is not yet authorised in any member state can be applied while the application for first authorisation is being processed. The other option is mutual recognition in sequence which means that an authorisation is applied for a product which already has been given the first authorisation in another country.

 

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