GB Review Programme for existing biocidal active substances
The GB Review Programme is the system of evaluating existing biocidal active substances in Great Britain (England, Scotland and Wales).
Existing active substance - the active substance was 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.
A list of active substances that are being or have been evaluated as part of the Review Programme can be found on the GB List of Active Substances by filtering the Regulatory process column and selecting Review Programme for existing active substances.
The rules and procedures of the GB Review Programme are provided by the GB Review Regulation.
Adding active substances
Under the GB Review Regulation, additional active substance / product type combinations may be eligible to be included in the GB Review Programme, if the criteria given in points 1 (a or b) and 2 (a or b) and 3 (a or b) below can be met.
- You have placed a product on the GB market either:
- prior to 01 January 2021, based on published guidance or written advice from the EU Commission, and EU Competent Authority or HSE; or
- after 31 December 2020, based on published guidance or written advice from HSE
AND
- That guidance or advice stated that either:
- the product was excluded from the scope of EU / GB BPR; or
- the relevant active substance / product type combination was one which was already notified
AND
- That guidance or advice has subsequently been reviewed by either:
- new guidance published by the EU Commission prior to 01 January 2021, or HSE after 31 December 2020; or
- 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
Joining or replacing participants
Under the GB Review Regulation, the role of participant - the person, company or taskforce supporting the active substance - may be:
- shared between a new and existing participant
- taken over by a new participant
In either case:
- both parties must agree to the proposed course of action
- the new participant must have the right to refer to the full active substance dossier submitted or referred to by the existing participant
If you wish to join or replace a participant, both parties should jointly inform HSE in writing at [email protected], and include all relevant letters of access.
Withdrawing support
Participants may also withdraw their support for an active substance in the GB Review Programme without having a new participant to replace them.
If you are intending to withdraw your support, you should inform HSE in writing at[email protected].
When a participant informs HSE that they are withdrawing support for an active substance, HSE will publish an open invitation for companies to take over the role of participant, providing:- the support was withdrawn before the draft Competent Authority Report (dCAR) was submitted to the applicant for comment
- the role of participant has not previously been taken over for that active substance / product type combination under GB BPR
Find out how to notify your support for an active substance following an open invitation.
If an open invitation is published, the original participant will remain on the GB Article 95 list (as a 'former Review Programme participant') until either one of the following is confirmed:
- a new participant has taken over that active substance / product type combination
- that active substance / product type combination is no longer supported in the GB Review Programme
Therefore, we advise that suppliers who are intending to withdraw support also inform their customers who will need to find an alternative supplier to remain compliant.
Redefinition
During the evaluation of an active substance it may become clear that the identity of the substance being evaluated does not entirely match the identity of the substance that was initially supported. Therefore, it may not be appropriate to apply the conclusions of such an evaluation to the substance as it was initially identified.
In such cases, the GB Review Regulation allows HSE, after consultation with the applicant, to establish a new identity for the substance.
When this happens, HSE will publish an open invitation for companies to take over the role of participant for the 'old' substance as originally identified.
Find out how to notify your support for an active substance following an open invitation.
Essential use derogations
Active substances in the GB Review Programme may be given non-approval decisions because of either:
- the conclusions of the evaluation
- the substance no longer being supported
Where an existing active substance is given a non-approval decision, it may be granted an essential use derogation if either:
- evidence shows that the active substance is essential to prevent or control a serious danger to human health, animal health or the environment
- not approving the active substance would have a disproportionate negative impact on society when compared with the risk to human health, animal health or the environment
Applications for essential use derogations for active substances must be made by HSE to the Secretary of State or a Devolved Authority within 18 months of the decision not to approve the active substance. If you have any information about a serious need for an essential use derogation, please contact us.