G/TBT/N/EU/647  
20 March 2019  
(19-1740) 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 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):  
Dimethoate (pesticide active substance)  
5. Title, number of pages and language(s) of the notifie d document:  Draft 
Commission Implementing Regulation concerning the non -renewal of approval of the 
active substance dimethoate, in accordance with Regulation (EC) No 1107/2009 of the 
European Parliament and of the Council concerning the placing of plant pr otection 
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 substa nce dimethoate is not renewed in accordance with 
Regulation (EC)  No 1107/2009. Existing authorised plant protection products containing 
dimethoate will be withdrawn from the market.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 o f 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 for an active substance to be approved in accordance with Regulation 
(EC) No 1107/2009 (concerning the pla cing 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/647  
 
- 2 - 
 
  or the environment. 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 dimethoate, a number of concerns and areas 
that could not be finalised were identified. These are detailed in the conclusion of the 
European Food Safety Authority (EFSA).  
In particular, it was not possible to exclude exposure risk to consumers, operators, 
workers, bystanders and residents due to their exposure to residues of dimethoate (for 
which the genotoxic potential could not be excluded) and its main metabolite omethoate 
(which was conc luded to be an in vivo mutagenic agent by the majority of experts in the 
peer review). Furthermore, the Authority concluded that a high risk to mammals and to 
non-target arthropods (for dimethoate) and to honeybees (for both dimethoate and 
omethoate) was c oncluded for all the assessed representative uses. In addition, the 
Authority concluded that the technical specification (either the current or the revised one) 
is not supported by the (eco) toxicological assessment.  
These concerns mean that dimethoate doe s 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 protection products containing dimethoate at 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 (allowing for a final season of use).  
8. Relevant do cuments:   
• 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 Regulation (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 dimethoate. EFSA (European Food Safety A uthority), 2018. l EFSA 
Journal 2018;16(10):5454. 
https://www.efsa.europa.eu/en/efsajournal/pub/5454  
9. Proposed date of adoption:  2nd quarter 2019  
Proposed date of entry into force:  3 day s following publication in the Official Journal 
of the EU.  
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.e u  
The text is available on the EU -TBT Website: http://ec.europa.eu/growth/tools -
databases/tbt/en/  
https://members.wto.org/crnattachments/2019/TBT/EEC/19_1611_00_e.pdf