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National transitional measures

At stage 6 of our Biocides decision tree we look at what is required if all of the biocides contained in (or generated by) your product aren’t approved under the EU BPR?

The Biocidal Products Regulation (BPR) covers the registration for sale and use of biocidal products. These are products used to protect people, animals and materials against harmful pests such as insects or bacteria via the action of an active substance in the product.

The EU BPR is an EU regulation, and as such it covers all EU member states. Not all biocidal products will fall under the remit of the BPR, or don’t yet. These may need to be registered or ‘notified’ under national registration routes – sometimes referred to as transitional rules.

Stage 6

This is a significant split in approach and completely changes the strategy required for bringing a biocidal product to market in the EU. You will have arrived at this ‘national transitional measures’ branch for three reasons, when the active substances contained in (or generated by) your product are:

  • Not approved under the EU BPR
  • Not listed in Annex I of the BPR
  • Listed under Art. 93 of the BPR

To understand when your product falls under the remit of the BPR or when it falls under the remit of national registration rules - the active substance, and its regulatory status, is key:

  • Where the active substance is approved for use as a biocidal active substance for the product type in question then the BPR applies 
  • Where the active substance is a part of the review programme but not yet reviewed and approved for a particular product type then national rules apply. 

The differences between the BPR registration requirements and those for national routes vary by member state with some states requiring more data than others. Regardless of which regulatory requirements apply to your biocidal product, it is also worth keeping in mind other regulations which also apply to biocidal products placed on the market such as CLP and REACH regulations.

To learn more about transitional measures and the BPR, look out for our soon to be published “Introduction to the Biocidal Products Regulation” eBook.

Stage 6 RHS

Contact

Enviresearch Ltd
34 Grainger Park Road
Newcastle upon Tyne NE4 8RY

Telephone: +44 (0)191 243 0687
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Further Information