G/TBT/N/EU/898  
15 June 2022  
(22-4669) 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  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Implementing Decision not approvin g methylene dithiocyanate as an existing 
active substance for use in biocidal products of product -type 12 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 
methylene dithiocyanate as an active substance for use in biocidal products of product -
type 12.  
According to the opinion of the Agency, biocidal products of product -type 12 containing 
methylene dithiocyanate cannot be expected to meet the criteria laid down in Article 5(1), 
points (b) (iii) and (iv), and (c), read in conjunction with Article 10(1) of  Directive 
98/8/EC. The applicant did not submit data of sufficient quality to meet the data 
requirements set out in point 2.7 (specification of purity of the active substance in g/kg 
or g/l, as appropriate), point 2.8 (identity of impurities and additives  together with the 
structural formula and the possible range expressed as g/kg or g/l, as appropriate), and 
point 4.1 (analytical methods for the determination of pure active substance and, where 
appropriate, for relevant degradation products, isomers and impurities of the active 
substance and additives) of Title II of Annex IIA to Directive 98/8/EC. As a result, it was 
impossible to confirm the minimum purity of the active substance and to set a reference 
specification for methylene dithiocyanate. Moreover , it was not possible to confirm that 
the material used to conduct (eco)toxicological studies cover the presented specifications 
and to conclude on the relevance of the impurities due to the lack of (eco)toxicological G/TBT/N/EU/898  
 
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  data. Lastly, the environmental risk a ssessment identified unacceptable risks, and no 
suitable risk mitigation measure could be identified. 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 ). 
7. Objective and rationale, including the natur e of urgent problems where 
applicable:  Harmonisation of the EU market on biocidal products; Protection of human 
health or safety; Protection of the environment; Harmonization  
8. Relevant documents:   
Regulation (EU) No 528/2012 of the European Parliament a nd 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)  
9. Proposed date of adoption:  September 2022  
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/crnatta chments/2022/TBT/EEC/22_4136_00_e.pdf