Authorisation of biocidal products
National authorisation and mutual recognition
After the approval of an active substance, companies wishing to place biocidal products on the market in a Member State have to apply for product authorisation. This is done by submitting a dossier to that Member State, which then has to evaluate and take a decision on the authorisation within 365 days.
Once a first authorisation is granted by a Member State, the applicant can ask for the recognition of that authorisation by other Member States, either in sequence or in parallel. This is called mutual recognition. Disagreements regarding mutual recognition will be referred to the Coordination Group, which has 60 days to seek agreement. ECHA will provide the secretariat for this group. If an agreement cannot be reached, the matter is referred to the Commission which may ask ECHA for an opinion on the scientific or technical aspects of the case.
The authorisation granted, the assessment report and the summary of product characteristics will be available in R4BP, maintained by ECHA.
One of the new elements of the BPR is the possibility to have certain biocidal products authorised at Union level. This will allow companies to place these biocidal products on the market in the entire Union, without the need to obtain a national authorisation followed by mutual recognition.
This authorisation will give the same rights and obligations in all the Members States as those issued by the national authorisation.
Union authorisation will be granted to biocidal products with similar conditions of use across the Union, except those containing active substances meeting the exclusion criteria and certain product-types (14, 15, 17, 20 and 21). Depending upon the product types, Union authorisation will be available in three different stages:
- 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 onwards to the remaining products types 7, 8, 9, 10, 11, 12, 16 and 22.
The authorisation process starts with the submission of a dossier by a company to ECHA. The evaluating competent authority that has previously been chosen by the applicant, evaluates the dossier and forwards the result to ECHA's Biocidal Products Committee to prepare an opinion within 180 days. Finally, the European Commission takes a decision based upon ECHA's opinion.