New EU clarifications on “similar use conditions” for Union authorisation of biocidal products

The European Commission has released a key guidance document for stakeholders seeking Union authorisation of biocidal products under Regulation (EU) No. 528/2012 (BPR). The document clarifies the meaning of “similar conditions of use throughout the Union”, a critical criterion for successfully applying for Union authorisation of biocidal products.

Under the BPR, biocidal products must be authorised before being placed on the market. As an alternative to national authorisations and subsequent mutual recognition, companies can apply for a single Union authorisation - provided that the product’s conditions of use are essentially the same across all Member States. However, certain product types (PTs) - such as PT 14 rodenticides, PT 15 avicides, PT 17 piscicides, PT 20 products for control of other vertebrates, and PT 21 antifouling products - as well as biocides containing active substances that are excluded under Article 5 of the BPR, are not eligible for this procedure.

Developed jointly with national competent authorities and the European Chemicals Agency (ECHA), the document defines “conditions of use” as all aspects relating to the application of the biocidal product, including:

• intended use and target organisms,
• application rates and usage instructions,
• risk mitigation measures,
• user categories (professional and non-professional),
• first aid instructions,
• emergency measures for environmental protection,
• shelf life,
• storage and disposal conditions.

Minor and justified differences - such as those due to national provisions or non-harmonised definitions - may be acceptable, as long as they do not require additional assessment. On the other hand, significant divergences (e.g. in dosage or target organisms) are generally considered incompatible with the Union authorization.

Applicants must include in their submission a structured and reasoned confirmation that the conditions of use are similar across the EU Member States; a generic statement will not suffice. The guidance also states that ECHA has made an official template available for this purpose, to support consistency in the evaluation process.

During the evaluation phase, the competent authority and ECHA’s Biocidal Products Committee will assess whether the criteria are met, taking into account the information provided and the applicant’s own data, including through direct engagement with national authorities.

This guidance applies to all new applications submitted from the date of its publication and serves as a key tool to promote transparency and harmonisation in the biocides market, ensuring alignment between regulatory requirements and technical assessments.

For companies intending to undertake this process, a thorough preliminary analysis of the conditions of use in the various Member States becomes crucial, supported by strong technical and regulatory oversight. In this context, the support of specialised consultants may be instrumental to the successful outcome of the procedure.