European regulation no. 528/2012 concerning biocidal products is designed to improve the market procedures for biocides within the EU while at the same time maintaining a high level of protection for the environment and public health. To be compliant with this regulation, all biocidal products destined to be marketed in Europe require authorisation, and the active substances which they contain must have received prior approval.
Marketing Authorisation for Biocides
Authorisation for biocidal products is granted at either a national or a European level. Only those biocidal products containing active substances which feature on the positive lists, or which are in the process of being evaluated, may be the subject of a Marketing Authorisation (MA).
Companies wishing to submit a MA (Marketing Authorisation) application for a product must submit an application dossier in the country in which they wish to market said product, via the Register for Biocidal Products or R4BP. Note that this submission procedure is not applicable to transitional MAs, that remain subject directly to the competent authority in the country concerned by the market authorisation.
The type of information required to complete an authorisation dossier depends not only on the type of MA but also, in the case of a transitional MA, on the competent national authorities concerned. Thus, a dossier for a long-term MA application will be more detailed and take a longer time to preprare, whereas a transitional MA dossier, for example, will be less onerous and will, in general, take less time to put together.
The various types of MA
There are 3 broad families for authorisation: transitional, provisional and long-term The long-term family of MAs comprises:
- The Union Authorisation MA
- The National & Mutual Recognition MA
- The Simplified MA
- The ‘Same’ Biocidal Product MA
- The Parallel Trade MA
Note that a long-term MA application may be submitted for a family of biocidal products (BP) or for just a single BP.
The transitional MA family groups together all the authorisations for the existing active substances (AS)* (as in the ECHA examination programme, listed in Annex II of the new Regulation (UE) No.1062/2014), those in the process of evaluation or those having been approved before the established cut-off date.
Finally, if a biocidal product contains one or more new ASs**, currently being evaluated, and if the competent evaluation authority submits a recommendation with a view to approve the new AS, the authorisation belongs to the family of provisional MAs.
*Existing active substances are those substances which were already present in the market as of 14th May 2000.
**New active substances are those substances which have appeared in the market after 14th May 2000.