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The basic principle in the Biocidal Products Regulation ((EU) No 528/2012 (BPR)) is that a biocidal product (BP) must be authorised before it can be made available on the market or used in the European Union (EU)/European Economic Area (EEA). This takes place in two consecutive steps. As the first step, the active substance is evaluated and, provided the criteria are fulfilled, is then approved in a specified product-type (PT). The second step is the authorisation of each BP consisting of, containing or generating the approved active substance(s). This document concerns the second step, the authorisation of a BP.
The national authorisation (NA) of a BP is granted by the competent authority of the Member State (MSCA) where the BP will be made available on the market (receiving MS) and is only valid for the approved terms and conditions stated therein. To avoid duplication of the evaluation procedure, the product authorisation granted in one MS can be recognised in other MS through the mutual recognition procedure.
The same rules as for a single BP apply also for a biocidal product family (BPF).
Certain BPs may be authorised at Union level, without the need to obtain single NAs.
An application for NA can be made by, or on behalf of, the prospective authorisation holder (AH). The AH is the person/entity established within the EU/EEA who is responsible for the placing on the market of a BP in a particular MS.
The application for NA can, in general, be made at any time after the decision to approve the active substance has been adopted.
The BP authorisation application must be made by the date of approval of the active substance; otherwise the products must be removed from the market within 180 days of the active substance approval date. The use of existing stocks of that BP may continue until 365 days after the approval date. A product authorisation application can also be made at a later date but until it is granted the products must be removed from the market.
Where that BP contains more than one active substance for the same PT, the application for NA must be submitted no later than the date of approval of the last active substance for that PT. If the BP belongs to several PTs it is only necessary to apply for NA when the active substance(s) contained in it has/have been approved for all relevant PTs before the deadline of the last approved.
It is recommended that NA applications are made well ahead of the deadline to accommodate for possible rejection due to submission or payment failures before the applications are accepted for processing.