G/TBT/N/EU/783  
11 March 2021  
(21-2035) 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 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 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  
Famoxadone (pesticide active substance); Pesticides and other agrochemicals (ICS 
65.100)  
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 sub stance famoxadone, 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 Commission Implementing Regulation (EU) No 
540/2011 (4 page(s),  in English)  
6. Description of content:  This draft Commission Implementing Regulation provides that 
the approval of the active substance famoxadone is not renewed in accordance with 
Regulation (EC)  No 1107/2009. EU Member States shall withdraw authorisati ons for plant 
protection products containing famoxadone 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 substanc e 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 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/783  
 
- 2 - 
 
  animal health o r 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 famoxadone, a number of concerns and areas that could 
not be finali sed were identified. These are detailed in the conclusion of the European Food 
Safety Authority (EFSA) and reported hereafter:  
• the estimated worker exposure levels during crop hand -harvesting exceed the 
AOEL (112 % of the AOEL) even when the use of PPE (t rousers, long -sleeved 
shirt and gloves) is considered;  
• the high long -term risk for mammals;  
• the high risk for aquatic organisms.  
Furthermore, the available information is insufficient to satisfy the requirements set out 
in Article 4(1) to (3) of Regulation  (EC) No 1107/2009 concerning the long -term risk 
assessments for birds. These concerns and areas that could not be finalised mean that 
famoxadone does not meet the approval criteria as outlined in Regulation (EC) No 
1107/2009 and cannot be approved current ly. Existing authorisations will need to be 
withdrawn; EU Member States must withdraw existing plant protection products 
containing famoxadone at the latest by 6 months from the date of entry into force. A 
period of grace in line with Article 46 of Regulat ion 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  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 
famoxadone.  
EFSA Journal 2015;13(7):41 94 [116 pp.]. Conclusion on the peer review of the pesticide 
risk assessment of the active substance famoxadone. doi:10.2903/j.efsa.2015.4194.  
9. Proposed date of adoption:  2nd quarter 2021  
Proposed date of entry into force:  3 days following publication i n 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.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_1858_00_e.pdf