New guidelines establishing “similar conditions of use across the Union” under the Biocidal Products Regulation (BPR) have been released by the European Commission. Simplifying Union authorizations for biocidal goods is the goal of this action.

For a single, EU-wide authorization, the “similar conditions of use” concept stipulates that the intended use and evaluation of a biocidal substance must be the same in every EU Member State. By permitting a single evaluation rather than several national ones, this simplifies the approval procedure.

Other applications must now clearly demonstrate comparable requirements, even if some items (those having active chemicals under Article 5 BPR and particular product categories as PTs 14, 15, 17, 20, 21) are excluded to inherent problems in harmonizing their usage. The guidelines stress that substantial variations based on local conditions would impede a Union authorization and define permissible minimal variances.

To get the information they need on current circumstances of use, applicants are encouraged to speak with national competent authorities (NCAs), review public national statistics, and draw on their own experience. This clarification reaffirms that getting a Union authorization requires essentially uniform authorization.

Why this is so important?

• Streamlined process: Using a single evaluation for the EU reduces administrative burden for applicants and regulatory authorities.
• Union Authorisation for biocidal products guarantees uniform regulatory framework and market access for biocidal goods in all Member States.

The guideline also tackles several non-harmonised concerns that can be addressed under Union approval, such as different definitions of user groups, national occupational exposure levels, national/local disposal requirements, and the provision of national poison centre information. Furthermore, it reinforces that Member States maintain the right to propose changes or non-application of Union authorization in their territory based on Article 37(1) BPR grounds, with information available on ECHA’s website and CIRCABC.

The European Commission’s new guideline guarantees that the Commission may efficiently manage and give a single, harmonized authorization based on a unified assessment, while adhering to the BPR’s stipulated timelines. Consequently, applicants are encouraged to propose conditions of use that are essentially consistent throughout all Member States, since a lack of such consistency will eventually impede the granting of a Union authorisation.