G/TBT/N/GBR/63  
4 July 2023  
(23-4534) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  UNITED KINGDOM  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Health and Safety Executive  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
UK TBT Enqui ry Point  
Trade Policy Group Department for Business and Trade  
Old Admiralty Building  
London  
SW1A 2DY  
TBTEnquiriesUK@trade.gov.uk  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  The 
technical changes to the data requirements will apply across the full range of b iocidal 
Product Types, active substances and products. The updated data requirements will only 
apply to applications submitted after the implementation date.  
5. Title, number of pages and language(s) of the notified document:  REVISION OF 
GB BIOCIDAL PROD UCTS REGULATION ANNEXES II AND III; (32 page(s), in English)  
6. Description of content:  HSE is seeking to make technical amendments to Annexes II 
and III of the Great Britain Biocidal Products Regulation (EU) No 528/2012 (GB BPR), 
which sets out the information that applicants must submit when they apply for biocidal 
active substances, and bi ocidal products to be authorised in Great Britain, respectively. 
These changes reflect current guidance, Organisation for Economic Co -operation and 
Development (OECD) validated tests and other scientific and technical advances.  
The changes affect Great Br itain (England, Scotland and Wales).  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  These changes will ensure the safety and efficacy of biocidal active 
substances and products can be evaluated in accordance with the  most recent scientific 
and technical advances including validated OECD test methods, thus ensuring the 
protection of human and animal health and the environment and will also reduce the 
degree to which animal tests are required for compliance with GB BPR.  
The changes will:  G/TBT/N/GBR/63  
 
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  1. Introduce and place emphasis on in vitro studies rather than in vivo studies.  
2. Make new tests for endocrine disruptors part of the legal data requirements in 
GB BPR, rather than only being done on an ad hoc basis.  
3. Change mutageni city requirements to reflect new information.  
4. Change requirements in relation to reproductive toxicity and generational 
studies.  
5. Change the requirements to include developmental neurotoxicity studies if 
certain triggers are met.  
6. Change the requirements to include efficacy data to support the innate activity 
of the active substance for the intended use.  
 
A public consultation was undertaken in Great Britain on the proposed changes and is 
linked to this notification. The consultation documents  contain more detailed information 
about the upcoming changes.; Protection of human health or safety  
8. Relevant documents:   
Regulation (EU) No 528/2012 of the European Parliament and of the Council  of 22 May 
2012 concerning the making available on the market and use of biocidal products (Text 
with EEA relevance) (legislation.gov.uk)  as amended.  
(Note: this Regulation was modified in 2019 to make it applicable to Great Britain upon 
Exiting the EU, and further amended in 2020 and 2022)  
The Consultation Document for the national consultation, the proposed changes to the 
legislation and the draft Impact Assessment are attached as PDF files.  
9. Proposed date of adoption:  1 April 2024  
Proposed date of entry into force:  1 April 2024  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
UK TBT Enquiry Point Trade Policy Group Department for International Trade Old 
Admiralty Building London SW1A 2DY TBTEnquiriesUK@trade.gov.uk  
https://members.wto.org/crnattachments/2023/TBT/GBR/23_10775_00_e.pdf  
https://members.wto.org/crnattachments/2023/TBT/GBR/23_10775_01_e.pdf  
https://members.wto.org/crnattachments/2023/TBT/GBR/23_10775_02_e.pdf