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Simplified authorisation procedure for Biocides: Updates on the living document

Revision of a living document on simplified biocidal product authorisation

Biocidal Product Regulation is implemented with a wide number of guidances and living documents. At the Competent Authority meeting in June 2021, an updated version of a living document concerning the simplified biocidal product authorisation was issued (check "Doc.4.10.b- CA-March16-Doc.4.6 Final.rev6").

In order to encourage the use of products with a more favourable environmental or animal health profile, simplified authorisation procedures are foreseen for those products. Once all conditions are fulfilled and a simplified authorisation has been granted, the biocidal product can be made available on the market in other Member States without the need for mutual recognition.

A number of guidances are available to indicate how to proceed, the most relevant are:

  • Practical guide on biocidal products Regulation on Simplified authorisation
  • CA-Sept13-Doc.6.2.e-Final: Handling of applications for product registration submitted under the BPD for which the evaluation has not been completed by 1 September 2013
  • CA-May14-Doc.5.5-Final: Consideration of storage stability, stability and shelf-life data in the context of applications for product authorisation under the simplified procedure (check corresponding document).
  • "Biocides Submission Manual; Application instructions: Simplified authorisations"

The latest update of the QA living document was issued to add the following question (Q) and answer (A):

Q: When a biocidal product family is authorised under the simplified authorisation procedure, and the authorisation holder notifies just one or more individual products of the family in other Member States, are the notified Member States entitled to raise formal referrals, in accordance with Articles 35 and 36 of the BPR, for products for which a notification was not received?

A: No, the notified MS is only entitled to raise referrals on those individual products of the family for which they have received the notification.

Do you need help on the Simplified Authorisation Procedure for your Biocides products? Please do not hesitate to contact our experienced knoell Biocides team.

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