G/TBT/N/EU/645  
 
1 March 2019  
(19-1186) Page: 1/3 
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 Commission  
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 [  ], other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable): 
Thiophanate -methyl (pesticide active substance)  
5. Title, number of pages and language(s) of the notified documen t: Draft 
Commission Implementing Regulation concerning the non -renewal of approval of the 
active substance thiophanate -methyl, in accordance with Regulation (EC) No 1107/2009 
of the European Parliament and of the Council concerning the placing of plant pro tection 
products on the market, and amending the Annex to Commission Implementing 
Regulation (EU) No 540/2011. (5 page(s), in English)   
6. Description of content: This draft Commission Implementing Regulation provides that 
the approval of the active substance thiophanate -methyl  is not renewed in accordance 
with Regulation (EC)  No 1107/2009. Existing authorised plant protection products 
containing thiophanate -methyl  will be withdrawn from the market. The non -approval is 
based on the first evaluation of the substance for use as a pesticide active substance in 
the EU under Regulation (EC) No 1107/2009. The substance was formerly approved under 
Directive  91/414/ EEC.  
This decision only concerns the placing on the market of this substance. Following non -
approval and the expiry of all grace periods for stocks of products containing this substance, 
separate action will likely be taken on MRLs and a separate notification will  be made in 
accordance with SPS procedures.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of human health or safety; protection of animal or plant life or 
health; protection of the environment.  
In order f or an active substance to be approved in accordance with Regulation 
(EC) No 1107/2009 (concerning the placing of plant protection products on the market), 
it must be demonstrated that the substance is not harmful to human health, animal health G/TBT/N/EU/645  
 
- 2 - 
 
  or the envir onment. Criteria are listed in Article 4 of the Regulation (and also detailed in 
Annex  II) which must be met to enable approval.  
During the evaluation and peer -review of thiophanate -methyl, a number of concerns and 
areas that could not be finalised were i dentified. These are detailed in the conclusion of 
the European Food Safety Authority (EFSA).  
In particular, it was not possible to exclude risk to consumers, operators, workers, 
bystanders and residents due to their exposure to residues of thiophanate -methyl (for which 
the genotoxic potential could not be excluded) and its main metabolite carbendazim (for 
which harmonised classification is mutagen category 1B and toxic for reproduction 
category  1B).  
The Authority also concluded that a high long -term risk was identified to birds and mammals 
for all representative uses. Finally, the Authority highlighted lack of toxicological data for the 
metabolites 2 -AB, FH -432, DX -105 to which consumers might be expo sed and for metabolite 
CM-0237 which might occur in surface and groundwater.  
Furthermore, the Authority concluded that there is enough evidence to conclude that the 
substance is an endocrine disruptor and that the mechanism is relevant to humans.  
These co ncerns mean that thiophanate -methyl does not meet the approval criteria as 
outlined in Regulation (EC) No 1107/2009 and cannot be approved currently.  
Existing authorisations will need to be withdrawn; EU Member States must withdraw 
existing plant protectio n products containing thiophanate -methylat the latest by 6 months 
from the date of entry into force. A period of grace in line with Article 46 of Regulation 
1107/2009 is allowed for and shall expire at the latest 12 months from the entry into force 
(allowi ng for a final season of use).  
8. Relevant documents:   
• Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 
21 October 2009 concerning the placing of plant protection products on the 
market and repealing Council Directives 79/117/EEC and 91/414/EEC: http://eur -
lex.europa.eu/legal -
content/EN/TXT/PDF/?uri=CELEX:32009R1107&qid=1437730988988&from=EN  
• Commission Implementing Regulation (EU) No  540/2011 of 25  May 
2011implementing R egulation (EC) No  1107/2009 of the European Parliament 
and of the Council as regards the list of approved active substances ( OJ L 153, 
11.6.2011, p. 1 -186). http://eur -lex.europa.eu/legal -
content/EN/TXT/?qid=1442928512004&uri=CELEX:32011R0540  
• Conclusion on the peer review of the pesticide risk assessment of the active 
substance thiophanate -methyl. EFSA (European Food Safety Authority), 2018. l 
EFSA Journal 2018;16(1):5133. 
https://www.efsa.europa.eu/en/efsajournal/pub/5133   
9. Proposed date of adoption:  2nd quarter 2019  
Proposed date of entry into force:  3 days following publication in the Official Journal 
of the EU.  
10. Final date for comments: 60 days from notification  G/TBT/N/EU/645  
 
- 3 - 
 
  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/2019/TBT/EEC/19_1140_00_e.pdf