Biocidal Product Regulation

VCI position on deadlines after authorisation has been granted for a biocidal product with existing active substances

Biocidal products containing so called existing active substances are allowed to be placed on the market without authorisation according to transitional measurements. In the case where an authorisation is granted for a biocidal product which is already available on the market according to the transitional provisions (Article 89), it is in the view of VCI not clear what deadline applies to end the transitional measures. The VCI describes in its position the various scenarios leading to the end of the transitional period and proposes a pragmatic solution.

Legal Basis / Background

The Biocidal Product Regulation (EU) No 528/2012 (BPR) governs the making available on the market and the use of biocidal products, based on a two-tier assessment scheme. The first step in this system is the approval of the active substances, followed by the authorisation of the biocidal products that contain them.

According to Article 89 BPR, under the transitional measures the biocidal products containing so-called existing active substances can temporarily continue to be made available on the market without authorisation, i.e. according to the “old” provisions. When the application for authorisation of a biocidal product has been submitted before to the date of approval of the active substance used therein, then this biocidal product, can continue to be placed on the market during the authorisation process. The transitional rules for such biocidal products available on the market cease to apply with certain deadlines for the following scenarios:

  • Active substance used is not approved
  • No application for authorisation is submitted in due course
  • The application for authorisation was submitted but
    • the application was rejected,
    • the authorisation is not granted or
    • conditions for the authorisation are imposed making it necessary to change the product.

Unclear Situation

In the case where an authorisation is granted for a biocidal product which is already available on the market according to the transitional provisions (Article 89), there are, in the opinion of VCI, no EU-wide sufficiently binding rules what deadline applies to end the transitional measures.

The VCI's VIewpoint

The VCI is very interested in finding an appropriate solution harmonised throughout Europe. It is essential for such a solution to take into account the real practice in companies (including trade structures) – in order to prevent legal uncertainty and unnecessary work, cost and waste.

The VCI's position paper describes its proposal for a solution in detail. Please find it in the download section at the top of this page (so-called "Langfassung"; size: 4 pages).

For questions or suggestions, please feel free to contact us.

Contacts

Dr. Evelyn Roßkamp

E-Mail: rosskamp@vci.de