G/TBT/N/EU/790  
25 March 2021  
(21-2443) 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/e n/  
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):  Phosmet 
(pesticide active substance); Pesticides and other agrochemicals in general 
(ICS 65.100.01)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Implementing Regulation concerning the non -renewal of approval of the  
active substance phosmet, in accordance with Regulation (EC) No 1107/2009 of the 
European Parliament and of the Council concerning the placing of plant protection 
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 phosmet is not renewed in accordance with 
Regulation (EC)  No 1107/2009. EU Member States shall wi thdraw authorisations for plant 
protection products containing phosmet 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 1107/200 9. The substance was formerly 
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 be taken on 
MRLs and a separate notification will be made in accordance with SPS procedures.  G/TBT/N/EU/790  
 
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  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, 
animal health or the environment. 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 phosmet, 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). The Authority identified an unacceptable risk to operators, 
workers, bystanders and residents, even with the use of personal protective equipmen t 
or application of available mitigation measures, a high acute and chronic risk to 
consumers and a high risk to birds, mammals, non -target arthropods (including bees) 
and aquatic organisms. Furthermore, the Authority could not carry out a complete 
consume r risk assessment because neither all commodities nor all potentially relevant 
metabolites could be assessed based on the information provided by the applicant. Finally, 
the Authority concluded that the assessment of developmental neurotoxicity could not 
finalised since no appropriate study was submitted by the applicant. These concerns mean 
that phosmet does not meet the approval criteria as outlined in Regulation (EC) 
No 1107/2009. Existing authorisations will need to be withdrawn; Member States must 
withdraw existing plant protection products containing phosmet at the latest by 3 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 6 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 C ouncil 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 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 phosmet (EFSA Journal 2021;19(3):6237)  
https://www.efsa.europa.eu/en/efsajournal/pub/6237  
9. Proposed date of adoption:  2nd quarter 2021  
Proposed date of entry into force:  7 days following publication in the Official Journal 
of the EU  
10. Final date for comments:  60 days from notification  G/TBT/N/EU/790  
 
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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 text is available on the EU -TBT Website: http://ec.europa.eu/growth/tools -
databases/tbt/en/  
https://members.wto.org/crnattachments/2021/TBT/EEC/21_2189_00_e.pdf