Simplified authorisation of Biocidal Products

Optimizing Biocidal Product Approval: Streamlined Authorisation Procedure for Environmental and Health Benefits

The simplified authorisation (SA) procedure aims to encourage the use of biocidal products (BPs) that have . A more favourable environmental or human and animal health profile.

The procedure to apply for SA of a BP resembles national authorization, but with fewer information demands.

To apply for the SA procedure, the BP must be eligible according to Article 25 of the Biocidal Products Regulation ((EU) No 528/2012 (BPR)):

  • all the active substances contained in the BP appear in Annex I to the BPR and comply with the specified restrictions;
  • the BP does not contain any substance of concern;
  • the BP does not contain any nanomaterials;
  • the BP is sufficiently effective;
  • the handling of the BP and its intended use do not require personal protective equipment.

The evaluating Member State’s (MS) competent authority (CA) grants a BP’s SA, which remains valid for its approved terms.

Mutual recognition by other MSs is not needed for an SA. A notification to the relevant MS(s) before actually placing. The product on its territory is sufficient (derogations may apply) .

Simplified authorisation of Biocides