Biocidal Active Substance Approval & Renewal
Active Substance Approval and Renewal
Approval of an active substance is a fundamental part of the regulation of biocidal products. Under both the EU and GB Biocidal Products Regulations, an active substance generally needs to be approved for the relevant product type before biocidal products containing it can be authorised.
Active substance approvals are granted for a defined period. Maintaining approval can therefore require organisations supporting an active substance to prepare for renewal, assess new scientific and regulatory evidence and consider whether the conclusions and conditions supporting the existing approval remain valid.
For some substances, renewal can also raise wider questions about hazard classification, exclusion or substitution criteria, the availability of alternatives and the consequences of different regulatory outcomes. Addressing these issues may require regulatory, scientific and socio-economic evidence to be considered together.
Active substance approval under the BPR
Approval applies to a specific active substance and product type combination.
Under the EU Biocidal Products Regulation (EU BPR), an application for active substance approval is evaluated by an evaluating competent authority. The assessment is subsequently considered by ECHA’s Biocidal Products Committee (BPC), which adopts an opinion that forms the basis for the European Commission’s decision on approval.
The assessment considers whether the active substance meets the applicable requirements of the BPR. This includes consideration of the risks associated with representative uses and, where relevant, whether the substance meets the BPR’s exclusion criteria or criteria for identification as a candidate for substitution.
Approval is granted for a defined period and may be subject to specific conditions.
Further information is available from ECHA – Approval of active substances.
When does an active substance approval need to be renewed?
Active substance approvals are time limited.
Where an organisation wishes to continue supporting an active substance for a particular product type beyond its existing approval period, a renewal application must be submitted within the applicable regulatory deadline.
Under EU BPR, the application must be submitted to ECHA at least 550 days before the approval expires. Where an application covers more than one product type with different expiry dates, it must be submitted at least 550 days before the earliest relevant expiry date.
The same minimum 550-day period applies under GB BPR, with renewal applications submitted to the Health and Safety Executive (HSE).
The applicable approval status, expiry date and renewal deadline should therefore be established well in advance. The timetable can have implications for evidence generation, regulatory planning, consortium decisions and the resources needed to support renewal.
Current EU renewal information is available from ECHA – Renewal of active substances.
For Great Britain, HSE maintains BPR active substance lists for GB and Northern Ireland, including approval status and relevant dates.
What evidence is required for renewal?
Renewal is not simply an administrative extension of an existing approval.
Under EU BPR, applicants must submit relevant data required under Article 20 that have been generated since the initial approval or previous renewal. The applicant must also assess whether the conclusions of the previous assessment remain valid and provide supporting information.
The renewal process therefore provides an opportunity to consider whether new information affects the basis on which the active substance was previously assessed.
Depending on the substance and regulatory issues involved, this may require consideration of developments in areas such as:
- scientific knowledge and available evidence;
- hazard classification;
- exposure and use information;
- human health and environmental risk assessment;
- efficacy;
- regulatory requirements and assessment approaches;
- conditions attached to the existing approval; and
- alternatives and substitution, where relevant.
The evidence required will depend on the active substance, product type, uses and issues identified during the regulatory assessment.
From 1 July 2026, applications to renew active substance approvals under EU BPR must contain the relevant approval data in IUCLID format, including approval data from the original active substance application.
Further information is available from ECHA – Renewal of active substances.
Active substance renewal under GB BPR
For active substances used in biocidal products placed on the market in England, Scotland and Wales, renewal is governed by the GB Biocidal Products Regulation (GB BPR).
A person, company, task force or consortium can support renewal of an active substance/product type combination. The renewal supporter does not have to be the organisation that supported the original approval.
A renewal application must normally be submitted to HSE at least 550 days before the approval expiry date.
For a GB renewal, the applicant should provide:
- relevant data required under GB BPR generated since the initial approval or previous renewal; and
- an assessment of whether the conclusions of the previous assessment remain valid, together with supporting information.
HSE determines whether a full evaluation is required and, following its assessment, makes a recommendation to the Secretary of State and Devolved Authorities on renewal and any changes to the conditions of approval.
Expiry dates may also be postponed in some circumstances while a renewal decision is pending. Organisations should therefore check the current regulatory status and expiry date rather than relying solely on an earlier approval date.
Further information is available from HSE – Active substance renewals: biocides.
For Northern Ireland, EU decisions relating to renewal of active substance approvals continue to apply, and applications to support renewal for the EU/Northern Ireland market are submitted to ECHA.
Exclusion criteria and candidates for substitution
Renewal can become more complex where an active substance has properties that engage the BPR’s exclusion criteria or candidate for substitution provisions.
Active substances meeting the exclusion criteria should, in principle, not be approved unless the relevant conditions for derogation are satisfied.
The BPR also establishes criteria for identifying active substances as candidates for substitution. This status has implications both for active substance approval and for biocidal products containing the substance.
These circumstances can make evidence concerning uses, alternatives and the consequences of different regulatory outcomes particularly important.
Relevant questions may include:
- which uses depend on the active substance;
- what function the substance performs;
- whether technically suitable alternatives exist;
- whether alternatives are sufficiently effective;
- what risks or disadvantages alternatives may introduce;
- the consequences of substitution or loss of particular uses; and
- impacts on manufacturers, downstream users, supply chains and wider society.
The evidence needed will depend on the regulatory provision and decision being considered.
Analysis of alternatives and active substance renewal
Where alternatives are relevant to the regulatory assessment, an analysis of alternatives (AoA) can provide a structured basis for identifying and assessing possible substitutes.
A robust analysis may need to consider more than whether another chemical or technology exists. Depending on the context, it can include:
- the function and performance required;
- efficacy;
- technical feasibility;
- availability;
- human health and environmental considerations;
- practical constraints;
- economic implications; and
- the consequences associated with substitution.
ECHA has published a recommended framework specifically for analysis of alternatives to biocidal active substances:
Related RPA page: Analysis of Alternatives for Biocidal Active Substances
Socio-economic evidence
Some active substance decisions raise questions about the consequences of different regulatory outcomes that cannot be answered through hazard and risk assessment alone.
Socio-economic analysis (SEA) can help develop evidence on those consequences where it is relevant to the regulatory decision.
Depending on the issue being considered, the analysis may examine:
- the benefits associated with continued availability of particular uses;
- the costs and consequences associated with their loss;
- impacts on manufacturers and downstream users;
- supply-chain effects;
- the availability, feasibility and costs of alternatives;
- impacts on users and wider society; and
- how costs and benefits are distributed between affected groups.
The purpose is not simply to quantify economic impacts. The analysis needs to be designed around the regulatory question and the evidence required to inform it.
Related RPA page: Socio-economic Analysis for Biocides
What happens if approval is not renewed?
A decision not to renew an active substance can have consequences beyond the substance approval itself.
Products that rely on that active substance for the relevant product type may subsequently be affected. Product authorisations may need to be cancelled or amended, while applicable regulatory provisions determine the arrangements for making products available on the market and their existing stocks.
Changes to the conditions of active substance approval can also affect the uses or conditions permitted for biocidal products containing the substance.
For organisations supplying or using affected products, it can therefore be important to consider the potential implications for product authorisations, uses, customers, supply chains and continued market access.
Renewal strategy should consequently consider both the evidence needed to support the active substance assessment and the potential implications of different regulatory outcomes.
How RPA can contribute to active substance approval and renewal
Active substance approval and renewal can involve interconnected regulatory, scientific and economic questions.
RPA’s work can include:
- developing regulatory strategy for approval and renewal;
- reviewing existing scientific and regulatory evidence;
- identifying evidence gaps and issues requiring further assessment;
- assessing the implications of regulatory developments or new evidence;
- undertaking analysis of alternatives;
- undertaking socio-economic analysis;
- gathering evidence from affected industries and stakeholders;
- examining the consequences of different regulatory outcomes; and
- considering implications for uses, products and market access.
The appropriate approach depends on the active substance, product type, uses and regulatory questions involved. The objective is to develop evidence that addresses the decision being considered and provides a clear basis for regulatory and commercial decision-making.
Official guidance and legislation
European Chemicals Agency (ECHA) – Approval of active substances
European Chemicals Agency (ECHA) – Renewal of active substances
Health and Safety Executive (HSE) – Active substance renewals
Health and Safety Executive (HSE) – BPR active substance lists for GB and Northern Ireland
Health and Safety Executive (HSE) – Active substance approval