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Characteristics

The same biocidal product procedure results in an independent authorisation. These authorisations will have a different authorisation number from the reference product and can be changed, re-registered or cancelled independently of the reference product. It is possible to request certain administrative changes in comparison to the reference product when applying for a same biocidal product. These administrative changes are described in the appendix of Implementing regulation 354/2013.
Applications for same biocidal product need to be made, just like all other applications under BPR, through R4BP. ECHA provides a comprehensive manual on their website on how such an application is made.

See the ECHA website for ECHA’s Practical guide on BPR – Same biocidal product and the guidance on applications. Guidance on applications for a same biocidal product of an individual product of a biocidal product family is given in CA-March15-Doc.4.7-Final.

The legal basis

Same biocidal product authorisations find their legal basis in Commission Implementing Regulations (EU) 414/2013 and 1802/2016 and in Biocidal products Regulation 528/2012:

Application type criteria

  • The reference product or reference biocidal product family must be authorised in the member state in which you apply for the same biocidal product or a Union authorisation must have been granted
  • The reference product or reference biocidal product family needs to be in the process for national authorisation or Union authorisation
  • Only administrative changes according to Implementing Regulation (EU) No 354/2013 are allowed.
  • The same biocidal product(s) and/or biocidal product family need to have a different trade name than the reference biocidal product(s) (family).
  • The same biocidal product will have a different authorisation number than that of the reference product
  • Change of a same product or of a reference product shall be notified or applied for independently

Duration period product authorisation

When an authorisation is granted via the same biocidal product procedure, the expiry date will be identical to the expiry date of the reference authorisation.

Renewal (prolongation) of the same biocidal product

When the same biocidal product is identical to the reference product it is not necessary to send a renewal application. In this case you can refer in the prolongation application to the reference product, this is determined in CA-September21-Doc.4.12.

Is the same biocidal product not identical to the reference product, you have to send a full renewal application dossier. See information on Re-registration and renewals.