G/SPS/N/EU/613  
 
31 January 2023  
(23-0702) Page: 1/3 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION  
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved:   
2. Agency responsible:  European Commission, Health and Food Safety Directorate -General  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  Oxamyl (pesticide active substance)  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Draft Commission Implementing Regulation 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 (Text with EEA 
relevance) . Language(s):  English . Number of pages:  5 
https://members.wto.org/crnattachments/2023/SPS/EEC/23_0781_00_e.pdf  
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 
European  Union under Regulation (EC) No 1107/2009. The substance was formerly 
assessed and approved under Directive 91/414/ EEC.  
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, animal health or the 
environment. Criteria are li sted 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 finali zed were 
identified. 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 di etary risk assessment did indicate a large exceedance of the acute 
reference dose (ARfD) for all the representative uses : 1,538% (potatoes , children), 
1,223% (watermelons, children), 656% (cucumbers, children) and 581% (tomatoes, 
children) 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 
renewed. Existing authorisat ions will need to be withdrawn. EU member States must 
withdraw existing plant protection products containing oxamyl at the latest by six months 
from the date of entry into force. A period of grace in line with Article 46 of Regulation 
No 1107/2009 is allow ed for and shall expire at the latest 12 months from the entry into 
force (allowing for a final season of use).  G/SPS/N/EU/613  
 
- 2 - 
 
  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 Maximum Residue Limits and a separate notification will be made in accordance 
with SPS procedures.  
This draft Commission Implementing Regulation was also notified under the 
TBT Agreement in notice G/TBT/N/EU/945.  
7. Objective and rationale: [X]  food safety, [X]  animal health, [X]  plant protection, 
[ ] protect humans from animal/plant pest or disease, [X]  protect territory from 
other damage from pests.   
8. Is there a relevant international standard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) :  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[X] None  
Does this proposed regulation conform to the relevant international st andard?  
[ ] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language(s) in which these are available:   
− 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  
https://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 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  June 2011, 
p. 1–186) 
https://eur -lex.europa.eu/leg al-
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 on the peer review of the 
pesticide risk assessment of  the active substance oxamyl 
https://doi.org/10.2903/j.efsa.2022.7296  
(available in English)  
10. Proposed date of adoption (dd/mm/yy) : 2nd quarter 2023  
Proposed date of publication (dd/mm/yy) : 2nd quarter 2023  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : 20 days following publication in the Official Journal of the European Union . 
[ ] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Not applicable. Comments are only welcomed on TBT 
related issues and to be addressed to the TBT Enquiry Point on notice G /TBT/N/EU/945.  G/SPS/N/EU/613  
 
- 3 - 
 
  Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address (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  
13. Text(s) available from: [X]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (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