Approval of Active Substances

All active substances, whether they are described as “existing” or “new” must be approved for a given product-type at EU level under the Biocidal Product Regulation (BPR). Approval is either by listing in the Union List of Approved Active Substances or Annex I of the BPR.

An application must be made in support of the active substance in the appropriate product-type with submission of a detailed technical dossier to a Member State who agrees to act as the Rapporteur Member State (RMS). The physical-chemical properties (including methods of analysis), efficacy, human and environmental toxicology and the environmental fate and behaviour of the active substance and representative biocidal product are assessed. Decisions on approval or non-approval of an active substance/product-type combination are made at the European Commission’s Standing Committee on Biocidal products. Approval may last for a maximum period of 10-years.

Application for approval of an “existing” active substance requires:

-          Submission of a detailed technical dossier via ECHA and the Register for Biocidal Products (R4BP)

-          Evaluation and peer review process by the RMS and ECHA, respectively

Application for approval of a “new” active substance requires:

-          Submission of a detailed technical dossier via ECHA and the Register for Biocidal Products (R4BP)

-          Evaluation and peer review process by the RMS and ECHA, respectively

Detailed guidance - Biocide Submission Manuals (BSM) – is provided by ECHA to assist applicants/industry. The manuals describe how to build IUCLID dossiers for the various BPR applications and how to submit and manage those applications in the R4BP.

An outline of the active substance approval process for biocidal active substances can be viewed on the website at the “About the Approval Process” section.

For further queries about the Department of Agriculture, Food and the Marine acting as a RMS and undertaking an active substance evaluation please contact us through the “Contact Us” section.


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