Which services do we offer:

• Biocides Scoping Assessments

• GB and EU Representative appointment-

• Article 95 or 

• Authorisation Holder 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 including

• Expert opinion on available ecotoxicological data

• Literature search and Systematic Data Reviews

• Assessment of endocrine disrupting properties

• Data gap analysis and testing strategies

• Regulatory exemption evaluations and assessment

• Product portfolio audits

• Stakeholder communication, BPR consultancy and regulatory monitoring

Hot topics:

GB BPR changes

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.Any applications affected by these changes, the HSE will contact 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. 

This 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- Up and coming GB active substance renewal submission deadlines.

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.

This is why it's important to ensure your Active substance is supported to ensure market continuity. One of the steps to ensure this is to ensure Active substance renewals are submitted by the deadlines to keep products on the GB (and EU) market.Active substance approvals will expire unless a renewal application is submitted at least 550 days before their expiry date.

The 550-day deadlines are coming up for the following active substance/product type combinations under GB BPR:

30 July 2025

• Hydrogen peroxide (CAS 7722-84-1 EC 231-765-0) in product types 1, 2, 3, 4, 5 and 6

• N-((6-chloro-3-pyridinyl)methyl)-N′-cyano-N-methylethanimidamide (acetamiprid) (CAS 135410-20-7 EC N/A) in product type 18

28 October 2026

• Calcium dihydroxide / calcium hydroxide / caustic lime / hydrated lime / slaked lime (CAS 1305-62-0 EC 215-137-3) in product types 2 and 3

• Calcium magnesium oxide / dolomitic lime (CAS 37247-91-9 EC 253-425-0) in product types 2 and 3

• Calcium magnesium tetrahydroxide / calcium magnesium hydroxide / hydrated dolomitic lime (CAS 39445-23-3 EC 254-454-1) in product types 2 and 3

• Calcium oxide / lime / burnt lime / quicklime (CAS 1305-78-8 EC 215-138-9) in product types 2 and 3

• Chlorocresol (CAS 59-50-7 EC 200-431-6) in product types 1, 2, 3, 6, 9 and 13

• Coco alkyltrimethylammonium chloride (ATMAC/TMAC) (CAS 61789-18-2 EC 263-038-9) in product type 8

The 550-day deadlines are coming up for the following active substance/product type combinations under EU BPR. This affects NI:

29 June 2025

• Copper, granulated (CAS 7440-50-8 EC 231-159-6) in product type 8

29 March 2026

• Peracetic acid (CAS 79-21-0 EC 201-186-8) in product types 1, 2, 3, 4, 5 and 6

28 September 2026

• Fludioxonil (CAS 131341-86-1 EC 603-476-3) in product types 7, 9 and 10

Do these active substance/product type combinations affect you, consider contacting your suppliers to ensure you are covered.

If a renewal application is not submitted for the above active substance/product type combinations under GB BPR or EU BPR respectively for NI, the approvals will expire. This means the active substances will no longer be able to be used in biocidal products of the relevant product types.

In addition, articles treated with such products will no longer be able to be placed on the market.

If you would like assistance with your renewal application, get in touch today. contact form.

GB active substance expiry dates postponed- additional Active substances affected

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 – 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 could 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.

Recently further active substances have been added to the list of active substance approvals being postponed including  

• 3-phenoxybenzyl(1RS,3RS;1RS,3SR)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate (permethrin) (CAS 52645-53-1 EC 258-067-9) in product types 8 and 18 From 30 April 2026 to 31 January 2027

• Creosote (CAS 8001-58-9 EC 232-287-5) in product type 8 

From 13 February 2025 to 31 March 2026

In the spotlight:

GB ARTICLE 95

GB Article 95 entries following Brexit failing to provide, Confirmation of being established in the UK (GB&NI) and Resubmission of the data dossier or Letter of Access to a relevant data dossier supporting the Article 95 active substance entry were scheduled for removal 3rd March 2025.

Therefore, companies should be sure to check your GB Article 95 active substance supply is compliant and if needed get in touch with your Active substance supplier or the HSE ASAP if you are affected. 

If you have any questions or require further information or biocide services assistance. Yordas are here to help. Please get in touch through our contact form.

Separately, theHealth and Safety Executive pledged to tackle instances where current approaches are limiting processes and looking to identify areas for improvement and opportunities to adapt under the new approaches to ensure regulators and regulation support growth. This includes the HSE and DEFRA consulting on how international approvals can be recognised to reduce the time and cost to bring chemical products, including biocides, to the GB market.

This interesting point may be the start of modifications to GB marketing requirements and should be monitored closely.