Understanding Mutual Recognition Procedures for Biocidal Product Authorisation
Biocidal product (BP) approval works across Member States (MSs), following mutual recognition (MR) rules to prevent duplication. Two procedures exist: sequential MR (MRS), used with an existing authorization; and parallel MR (MRP), for initial national authorization (NA) and simultaneous MR applications.
Authorisation according to MRS/MRP should be granted under the same terms and conditions as the (initial) NA; however, in certain cases, the MSs concerned may propose to refuse to grant the authorisation or to adjust its terms and conditions.
The same rules as for a single BP also apply for a biocidal product family (BPF).
Settlement of disagreements
When any concerned MS disagrees with the product assessment report or SPC conclusions, it must provide detailed reasons to the reference MS. Other MSs and the applicant are included. Disagreements go to the Coordination Group (CG). The reference MS promptly involves the CG to reach agreement. The applicant can state its perspective. If the CG doesn’t agree in 60 days, the reference MS notifies the Commission (COM). COM makes a final decision via an implementing act. COM might consult ECHA for scientific opinions (BPC) or let the applicant comment (30 days) to finalize its decision.
