United Kingdom Biocidal Services
Which services do we offer:
Biocides scoping assessments
GB Representative appointment
Article 89 Transition period requirements
CLP compliance, label reviews, PCN notifications
Active substance approval preparation and submission
Product authorisation preparation and submission
Article 95 submissions
Claim Substantiation
Efficacy & Endpoint testing
Product portfolio audits
Stakeholder communication, BPR consultancy and regulatory monitoring
Hot topics:
If you require assistance with Biocide services, get in touch with our team today
In the spotlight:
GB BPR changes proposed
Following the end of the EU exit transition period on December 31 2020, businesses needed to resubmit product applications to HSE by various deadlines. Due to the large number of resubmissions received, a new law is being introduced in GB to temporarily extend the statutory deadlines for processing product applications under the GB Biocidal Products Regulation, for a period of up to 5 years.
The new law will allow biocidal products on the market in GB awaiting a decision on their application to remain there legally until they are processed by HSE. After 5 years the statutory deadline will revert to the existing length. The new law is planned to come into force imminently, subject to parliamentary procedures.For any applications affected by these changes, the HSE will contact you directly to explain the impact.
In addition to this, there are also changes proposed to the GB BPR regulation annexes II and III which should be carefully monitored as they will have an impact on future GB BPR applications. However, most of the proposed new requirements are identical to those made to EU BPR in March 2021. The consultation documents describe the changes in more detail but for example:
For Skin irritation/corrosion and eye damage/irritation – it is proposed to remove references to Regulation (EC) No 440/2008. Instead, the GB BPR will now specify the full details of the risk assessment process and the tiered evaluation required for these endpoints. This process specifies that in vitro testing is preferred to new in vivo tests in both cases. This is the same as the changes made to the EU BPR.
Whereas it is proposed that for active substance identity, the definition is to be updated to address in-situ precursors including descriptions of the reaction mechanism added. This includes the first GB BPR specific deviation under section 2.11.1 whereby a 5-batch analysis is required for in-situ generated active substances and must provide information on any constituent present above 0.1% w/w including precursor residues and impurities. Under EU BPR, there is no reference to impurities in this endpoint. This change will mean that, for GB BPR, additional information is required than will be needed for EU BPR for this endpoint.
These regulation changes came into force on 6th April. The new data requirements will apply to applications received 18 months after the legislation came into force, on 6th October 2025 and will not be applied to existing applications. Further guidance on these changes will be provided by the HSE.
Ensure your Active substance is still being supported in GB
Since Brexit companies have been making business decisions on whether to continue to proceed with supporting their active substances in GB as well as the EU. In some instances, companies have decided to withdraw support for certain actives on the GB Market. In December 2022 the HSE said ‘ approximately 72% of EU AS/ product type combinations are supported in GB’. For those actives that dossiers were not resubmitted open invites were issued and notifications should have already been submitted by 12/11/22.
If you require any assistance with any aspect of GB BPR and would like to get in touch you can do so via the following contact form.
GB active substance expiry dates postponed
A decision has been taken to postpone the active substance expiry dates for all biocidal active substance/product type combinations which expire between 1 January 2024 and 31 December 2026, until 31 January 2027.
This decision has been taken because, for reasons beyond the control of the applicant, the approvals are likely to expire before a decision can be taken on their renewal under GB BPR. The postponements will also give time for potential reforms to GB BPR to be considered. HSE plans to publish further information on this area of work in the near future.
The decision will impact up to 110 active substance/product type combinations. The expiry date postponements are subject to a timely renewal application being submitted and accepted.
To date, 46 active substance/product type combinations detailed on the HSE webpage have met these requirements and the expiry dates are postponed until 31 January 2027.
If you want to supply new biocidal products containing these active substances, you can still apply for GB BPR product authorisation. New products (including new trade names) must not be supplied in GB until product authorisation is granted.