Union Authorisation

Under the Biocidal Products Directive, applications for authorisation were all submitted, and granted, at a national level. Where an organisation wished to make the product available on the market in a second Member State, a process of mutual recognition was used. In addition to this system, the BPR introduces a new process of Union authorisation which allows an organisation to make a single application to ECHA for a Union-wide authorisation to be granted. Certain conditions need to be fulfilled in order for a biocidal product to be granted a Union authorisation:

Firstly, the biocidal product must not contain any active substances fulfilling any of the criteria detailed in Article 5, i.e. those active substances:

• meeting the criteria for classification under the CLP Regulation as category 1A or 1B carcinogens, mutagens or reprotoxins;
• identified as having endocrine-disrupting properties;
• or meeting the criteria for being PBT or vPvB under the REACH Regulation.

Secondly, the biocidal product must have similar conditions of use throughout the Union.

Due to the different approaches to pest control across the European Union, the process of applying for Union authorisation is not open to all product types or all active substances. A Union authorisation will not be granted for biocidal products of product types 14, 15, 17, 20 or 21. For the remaining product types, in order to allow ECHA to manage the workload which will be generated, authorisations will be assessed and granted as per the table below:

Those biocidal products for which Union authorisation has been granted will be published on the ECHA website.

If the application for authorisation is for a biocidal product containing an active substance which is a candidate for substitution, then the evaluating Competent Authority will undertake a comparative assessment with other authorised products. If this assessment identifies other products which may be used in the specified application, and present a lower risk to health or the environment, the application for authorisation may not be approved. Such a comparative assessment will also be conducted at each renewal of an authorisation.