Biocidal Products protect humans, animals and materials against harmful organisms like bacteria. Biocidal product regulation (BPR) aims to ensure a high level of protection for humans and environment and improve the functioning of the Biocidal products’ market in the European Union (EU).
All Biocidal products must require authorization to enter the European market. Also, the active substances present in that Biocidal product must be previously approved. However, there are certain exceptions to this practice. For instance, Biocidal products with active substances within the Review Program are often made available on the market and are used subject to national laws. Similarly, products containing new active substances that are under assessment are allowed on the market if they have a granted provisional authorization.
For the convenience of Biocidal manufacturing companies, the European Commission has provided several authorization processes. Manufacturers can opt for any of these processes based on their product and the countries where they wish to launch their products.
- National Authorization and Mutual Recognition: To place the product only on a single market, authorization from that specific nation is sufficient.
- National Authorization and Mutual Recognition Renewal: For product authorization renewal, the authorization holder can apply to the Member State competent authority (MSCA). In case of mutual recognition authorization, the renewal application must be submitted to the reference MSCA and all concerned MSCAs.
- Union Authorization: A new alternative for companies to apply for a European Union (EU) wide authorization in one go.
- Simplified Authorization: For products that meet certain criteria defined in the regulation. For example, a product without any substances of concern.
- Same Biocidal Product Authorization: For products identical to an already authorized Biocidal product or to an authorization ongoing Biocidal product.
Henceforth, the Biocidal product manufacturers can choose any of the authorization processes to ensure a quick supply of their products in the EU region they would like to sell. For a comprehensive understanding of these Authorization processes in Europe, reach out to a Regulatory expert.