G/TBT/N/EU/933  
27 October 2022  
(22-8087) 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:  EUROPEAN UNION  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  European Commission  
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:   
European Comm ission,  
EU-TBT Enquiry Point,  
Fax: +(32) 2 299 80 43,  
E-mail: grow-eu-tbt@ec.europa.eu  
Website: http://ec.europa.eu/growth/tools -databases/tbt/en/  
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):  Biocidal 
products and treated articles treated with or incorporating biocidal products  
5. Title, number of pages and language(s) of the n otified document:  Draft 
Commission Implementing Decision not approving d -Allethrin as an existing active 
substance for use in biocidal products of product -type 18 in accordance with Regulation 
(EU) No 528/2012 of the European Parliament and of the Council;  (3 page(s), in English)  
6. Description of content:  This draft Commission Implementing Decision does not approve 
d-Allethrin as an active substance for use in biocidal products of product -type 18.  
According to the opinion of the Agency, biocidal products of product -type 18 containing 
d-Allethrin cannot be expected to meet the criteria laid down in Article 19(1), points 
(b)(iii), and (iv), of Regulation (EU) No 528/2012.  
In its opinion, the Agency noted that the proposed reference specifications, establishe d 
on the basis of data provided by one of the applicants, are not in line with the composition 
of the material that was used for testing to generate the toxicological data provided by 
the applicants. As a result, on the basis of the data provided in the ap plications, it could 
not be established whether the representative biocidal products could fulfil the criteria 
referred to in Article 19(1), point (b) of Regulation (EU) No 528/2012.  
According to the opinion of the Agency, based on the available toxicologi cal data, an 
unacceptable risk has been identified for the general public due to secondary exposure to 
genotoxic photometabolites formed after the application of the representative products.  
In addition, according to the opinion of the Agency, an unacceptable risk to the 
environment has been identified for the aquatic compartment (surface water and 
sediment) and for soil.  G/TBT/N/EU/933  
 
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  In conclusion, no safe use could be identified when considering the risks to human health 
and the environment for each of the re presentative biocidal products submitted in the 
applications.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Harmonisation of the EU market on biocidal products; Protection of human 
health or safety; Protection of th e environment; Harmonization  
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 (OJ L 
167, 27.6.2012, p. 1.). Available in all EU languages  
EUR-Lex - 32012R0528 - EN - EUR-Lex (europa.eu)  
The opinion of the European Chemicals Agency can be found on its website 
(http://echa.europa.eu/regulations/biocidal -products -regulation/approval -of-active -
substances/bpc -opinions -on-active -substance -approval ). 
9. Proposed date of adoption:  January 2023  
Proposed date of entry into force:  20 days from publication in the Official Journal of 
the EU (Application 12 months after adoption)  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
European Commission,  
EU-TBT Enquiry Point,  
Fax: + (32) 2 299 80 43,  
E-mail: grow-eu-tbt@ec.europa.eu  
The text is available on the EU -TBT Website : http://ec.europa.eu/growth/tools -
databases/tbt/en/  
https://members.wto.org/crnattachments/2022/TBT/EEC/22_7293_00_e.pdf