Simplified authorisation procedure for a biocidal product

The simplified procedure for the authorisation of biocidal products means that a Member State evaluates the product in accordance with different, less extensive data requirements than usual.

To be eligible for the simplified authorisation procedure the product must comply with all of the following conditions:

  • All the active substances contained in the biocidal product appear in Annex I of the Biocidal Products Regulation and comply with the specified restrictions.
  • The biocidal product does not contain any substance of concern.
  • The biocidal product does not contain any nanomaterials.
  • The biocidal product is sufficiently effective.
  • The handling of the biocidal product and its intended use do not require personal protective equipment.

Please note that Annex I of the Biocidal Products Regulation does not contain the same information as Annex I of the Biocidal Products Directive.

Where a simplified authorisation is granted, the biocidal product may be made available on the market in other Member States without the need for mutual recognition. The authorisation holder, however, needs to notify each relevant Member State 30 days before placing the product on its territory. The product must also be labelled and must have a user manual in the national official language of the Member State.

In Sweden, one such product will have the registration number specified by the evaluating Member State that has authorised the product. Therefore such products may have a registration number in a different format than the biocidal products been authorised in Sweden.

Last published 12 August 2022