Active substance approval
To gain authorisation to place a biocidal product on the market in Great Britain (GB) under the GB Biocidal Products Regulation (GB BPR) the active substance(s) in the product must first be approved for the relevant product type(s) and included on the GB List of Active Substances or the GB Simplified Active Substances List.
Check the status and regulatory process
Before considering supporting an active substance for approval in GB, you should check the status of the active substance in the relevant product type(s) on the GB List of Active Substances. It may be:
- already ‘approved’
- ‘under review’
- ‘under assessment’
- ‘not approved’
If the active substance is still under review or under assessment, it may be possible to contact the current Review Programme participant or active substance supporter and discuss the option of data sharing.
If the active substance is not on the GB List of Active Substances, it may be a ‘new active substance’ – one that was not on the market on 14 May 2000 as an active substance of a biocidal product for purposes other than scientific or product and process-orientated research and development.
Supporting an active substance
Supporting an active substance through to approval requires a substantial financial commitment, therefore we encourage you to contact us to set up a pre-submission meeting to discuss the dossier submission requirements before submitting your application.
- Find out how much a pre-submission meeting may cost
- Find out how to apply for active substance approval
Some active substances (those that do not give rise to concern in accordance with Article 28(2) of GB BPR) may be eligible for inclusion on the GB Simplified Active Substances List. Find out if your active substance is eligible and how to support a simplified active substance.
It may be possible to take over the role of participant in supporting an active substance that is included in the GB Review Programme if the current participant withdraws their support or the active substance is redefined during the assessment. When this happens, HSE will publish an open invitation for companies to notify their support for the active substance. Find out how to notify your support for an active substance with an open invitation.
It may be possible to notify an active substance / product type combination for inclusion in the GB Review Programme if you meet the criteria given in points 1a or 1b and 2a or 2b and 3a or 3b below.
- You have placed a product on the GB market either:
- before 1 January 2021, based on published guidance or written advice from the EU Commission, and EU Competent Authority or HSE
- after 31 December 2020, based on published guidance or written advice from HSE
- That guidance or advice stated that either:
- the product was excluded from the scope of EU/GB BPR
- the relevant active substance/product type combination was one which was already notified
- That guidance or advice has subsequently been reviewed by either:
- new guidance published by the EU Commission before 1 January 2021, or HSE after 31 December 2020
- a decision published in accordance with Article 3 (3) of EU BPR prior to 01 January 2021, or Article 3 (3) of GB BPR after 31 December 2020
Where there is no GB-specific guidance, HSE will use relevant technical guidance for the EU Biocidal Products Regulation (EU BPR), as the two sets of legislation are very similar. The European Chemicals Agency (ECHA) has published the following guidance documents to support the EU BPR:
- guidance on information requirements for active substances and biocidal products – applicants should use this document when preparing dossiers for active substance approval
- Biocides Submission Manual (BSM) series - describes how to build IUCLID dossiers with detailed and illustrative technical assistance
- guidance and training on IUCLID – please note that HSE is unable to provide support on IUCLID
Calculating the actual costs
When you submit your application, we will estimate how much it may cost (“initial estimated fee”) to process the application based on the information provided. As HSE operates on a cost recovery basis, at the end of the assessment we will calculate the actual cost for evaluating the application based on the total time spent. If the total cost has gone beyond the initial estimated fee, a top-up fee will be requested. Alternatively, if the cost is less than the initial estimated fee, an appropriate refund will be given.
Please note if a top if fee is required it must be paid prior to the active substance receiving the appropriate approval decision and the publication of any associated GB legal documents.