The skilled partner for regulatory guidance in complex EU regulation for biocides

A substance can only be used for this if certain conditions are met:

• The substance must be assessed and formally approved based on a scientific evaluation performed by European Chemicals Agency (ECHA) and the EU Member States. An active substance dossier includes comprehensive data on the substance’s identity, physicochemical properties, (eco-))toxicological profile, environmental fate, and intended uses.

• The assessment must demonstrate that the substance is effective for the intended biocidal purpose and no unacceptable risks to human health, animal health, or the environment are found.

• Once approved, the substance is included in the Union list of approved active substances, published by ECHA.

Only after these steps can a substance be eligible for use in the EU. CEHTRA’s expert team have a proven track record of preparing and submitting active substance dossiers (new approvals, renewals, Annex I inclusions, etc.) and supporting companies until successful approval is established.

To place a biocidal product or a biocidal product family (BPF) on the market in the EU, companies must prepare and submit a comprehensive dossier according to the criteria set by the Biocidal Products Regulation (BPR). These dossiers typically include data on physicochemical properties, efficacy, (eco-)toxicological hazard profiles and risk assessments. The submission can be made through national schemes or via the EU central authorisation process (ie. BPR procedure), dependent on the EU status.

With deep expertise and knowledge in the BPR framework, CEHTRA can assist in the entire process from dossier preparation, designing testing strategies, and managing the dossier until the successful authorization reached, allowing market access for biocidal products in EU and national markets.

The main goal of the Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) is to ensure a high level of protection for humans, animals, and the environment, by harmonizing the process via an EU-procedure that allows improving the functioning of the market for biocidal products such as disinfectants, wood preservatives, pest control products, and antifouling products.

To sell these products within EU, companies must meet strict BPR requirements. Approval of active substances used in the products and biocidal product authorisations are mandatory before going to the market.

The complexity of EU requirements for biocidal products, including active substances used in these products, requires a dedicated understanding of the Regulation (EU) 528/2012. At CEHTRA, our experienced regulatory team is able to guide you in selecting the right steps towards full BPR compliance.