To apply for active substance approval under the Biocidal Products Regulation, the applicant must submit a dossier for: the active substance, consisting of the information required by Annex II of the Regulation; and a biocidal product containing the active substance, consisting of the information required by Annex III of the Regulation. These dossiers must be compiled using a piece of software called IUCLID, and they must be submitted using the online hub R4BP. Both of these systems are free to use, and you can find the relevant links under the software section of our website.

Where the substance is an active substance of concern, the application must also provide evidence that one of the below conditions is met:

  • The risk to humans, animals or the environment, when incorporated into a biocidal product, is negligible under realistic worst-case conditions. For example, if the product is used in enclosed systems.
  • There is evidence that the active substance is essential to prevent or control a serious danger to human health, animal health or the environment.
  • The impact of not approving the active substance would be disproportionately negative on society when compared with the risk to human health, animal health or the environment.

Active substances of concern are those active substances:

  • meeting the criteria for classification under the CLP Regulation as category 1A or 1B carcinogens, mutagens or reprotoxins;
  • identified as having endocrine-disrupting properties; or
  • meeting the criteria for being PBT or vPvB under the REACH Regulation.

Evaluation of applications

Although submitted to ECHA, applications for the approval of an active substance are evaluated by the Competent Authorities of individual Member States. Prior to making a submission, therefore, the applicant must obtain written confirmation that the Member State they wish to evaluate their application agrees to do so. This written confirmation, along with the name of the Member State must be submitted with the application. Within 30 days of submitting the application, the applicant will be required to pay ECHA an application fee as stated in Regulation 564/2013. The application will not be deemed to be received until this payment is received. Once made, ECHA will inform both the applicant and the evaluating Competent Authority that the application has been accepted and the applicant will then be informed of the fees charged by the evaluating Competent Authority (as set by national legislation). The evaluating Competent Authority have a further 30 days to validate the application contains all the required information.

Following validation of the application, the evaluating Competent Authority will have a period of 365 days to send a report and conclusions of its evaluation to ECHA, during which time the applicant will have a 30-day commenting window. Once the conclusions of the evaluation have been submitted to ECHA, the Biocidal Products Committee (BPC) will have a further 270-day period during which to prepare an opinion and submit it to the European Commission. The Commission will then decide whether the active substance is approved, and prepare an implementing Regulation stating the conditions of that approval.