The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms like pests or bacteria, by the action of the active substances contained in the biocidal product. This regulation aims to improve the functioning of the biocidal products market in the EU, while ensuring a high level of protection for humans and the environment.

All biocidal products require an authorisation before they can be placed on the market, and the active substances contained in that biocidal product must be previously approved. There are, however, certain exceptions to this principle. For example, biocidal products containing active substances in the Review Programme can be made available on the market and used (subject to national laws) pending the final decision on the approval of the active substance (and up to 3 years after). Products containing new active substances that are still under assessment may also be allowed on the market where a provisional authorisation is granted.

Authorization of Biocidal Products must meet the criteria of the BPR regulation and must be submitted under R4BP3 while the notification under transitional period must meet the specific requirements of each member state.

Since 1 September 2015, a biocidal product cannot be made available on the EU market unless either the substance supplier or the product supplier is included in the Article 95 list for the product type (PT) to which the product belongs. Applications for inclusion in the list of suppliers of active substances (Article 95 list) can only be submitted by a person established in the EU. However, companies outside the EU may be represented by a representative in the EU for the purposes of Article 95.

Support Services

YNB acts as a service provider for companies that intend to place their biocidal product in the EU market, in compliance with the BPR regulation requirements.

• Dossier preparation and submission in R4BP3 for Biocidal product authorization.
• To avoid the complexity that lies in the need for a specific regulatory approach in each country, we take care of preparing notifications for biocidal products under transitional period measures.
• We help active substance suppliers to prepare an application for inclusion in the Article 95 list.