G/TBT/N/EU/945  
16 January 2023  
(23-0362) 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 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 CC CN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  oxamyl 
(pesticide active substance)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Implementing Regul ation concerning the non -renewal of the approval of the 
active substance oxamyl, in accordance with Regulation (EC) No 1107/2009 of the 
European Parliament and of the Council, and amending 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 oxamyl is not renewed in accordance with Regulation 
(EC) No 1107/2009. EU Member States shall withdraw authorisations for  plant protection 
products containing oxamyl as an active substance. The non -renewal of 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 forme rly assessed and 
approved under Directive 91/414/ EEC.  
This decision only concerns the placing on the market of this substance and plant 
protection products containing it. 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:  In order for  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, G/TBT/N/EU/945  
 
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  animal health or the environ ment. Criteria are listed in Article 4 of the Regulation (and 
also detailed in Annex II thereto) which must be met to enable approval.  
During the evaluation and peer -review of oxamyl, a number of concerns and areas that 
could not be finalised were identifi ed. These are detailed in the conclusion of the European 
Food Safety Authority (EFSA) and reported here after:  
· The operators' exposure is unacceptable (min 112% of the AEOL and min 389% of the 
AAOEL) even when the use of PPE is considered;  
· The preliminary consumer dietary risk assessment did indicate a large exceedance of 
the acute reference dose (ARfD) for all the representative uses - 1538% (potatoes; 
children), 1223% (watermelons, children), 656% (cucumbers, children) and 581% 
(tomatoes, chil dren) even when oxamyl residues at the LOQ of 0.01mg/kg were 
considered.  
These concerns and areas that could not be finalised mean that oxamyl does not meet 
the approval criteria as outlined in Regulation (EC) No 1107/2009 and its approval cannot 
be renewe d. 
Existing authorisations will need to be withdrawn. EU Member States must withdraw 
existing plant protection products containing oxamyl at the latest by 6 months from the 
date of entry into force. A period of grace in line with Article 46 of Regulation N o 
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); Protection of human health or safety; Protection 
of animal or plant life or health; Protection of the environment  
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 M ay 2011 implementing 
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 
oxamyl.  
EFSA Journal 2022;20(5):7296 [36 pp.]. Conclusion o n the peer review of the pesticide 
risk assessment of the active substance oxamyl 
https://doi.org/10.2903/j.efsa.2022.7296  
9. Proposed date of adoption:  2nd quarter 2023  
Proposed date of entry into force:  20 days following publication in the Official Journal 
of the EU  
10. Final date for comments:  60 days from notification  G/TBT/N/EU/945  
 
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  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 te xt is available on the EU -TBT Website : http://ec.europa.eu/growth/tools -
databases/tbt/en/  
https://members.wto.org/crnattachments/2023/TBT/EEC/23_0438_00_e.pdf