G/SPS/N/EU/387  
 
20 May 2020  
(20-3717) 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):  Benalaxyl (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 approval of the active substance benalaxyl, in accordance with 
Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning 
the placing of plant protection pro ducts on the market, and amending the Annex to 
Commission Implementing Regulation (EU) No 540/2011 . Language(s):  English . 
Number of pages:  4 
https://members.wto.org/crnattachments/2020/SPS/EEC/20_3275_00_e.pdf  
6. Description of content:  This draft Commission Implementing Regulation provides that 
the approval of the active substance benalaxyl is not renewed in accordance with 
Regulation (EC) No 1107/2009. EU Member States shall withdraw authorisations for plant 
protection products containing benalaxyl 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 formerly 
assessed and approved under Directive 91/414/ EEC.  
This decision only concerns the placing o n 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 notificatio n will be made in accordance with SPS 
procedures.  
7. Objective and rationale: [ X] food safety, [ X] animal health, [ X] plant protection, 
[X] protect humans from animal/plant pest or disease, [ X] protect territory 
from other damage from pests.  
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 environm ent. 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 benalaxyl, a number of concerns and areas that could not be finalised were G/SPS/N/EU/387  
 
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  identi fied. These are detailed in the conclusion of the European Food Safety 
Authority  (EFSA).  
In Particular, the Authority could not exclude the potential groundwater contamination by 
relevant metabolites and identified as a critical area of concern a long-term risk to birds 
and earthworm -eating birds from secondary poisoning from benalaxyl. Additionally, the 
Authority identified concerns in relation to the risk to in -field and off -field non -target 
arthropods for all representative uses.  
Finally, follow ing the request by the Authority for additional information, the applicant 
confirmed that no additional studies would be performed or submitted. Consequently, the 
assessment of the endocrine disrupting potential of benalaxyl could not be finalised and 
it could not be concluded that the substance has no endocrine disrupting properties. These 
concerns mean that benalaxyl does not meet the approval criteria as outlined in 
Regulation (EC) No 1107/2009 and cannot be approved currently.  
Existing authorisations wi ll need to be withdrawn; EU Member States must withdraw 
existing plant protection products containing benalaxyl 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 an d 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. 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 standard?  
[ ] 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 mar ket 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 benalaxyl.  
− EFSA (European Food Safety Authorit y). 2019. Conclusion on the peer review of the 
pesticide risk assessment of the active substance benalaxyl. EFSA Journal 
2020;18(1):5985, 41 pp. doi: 10.2903/j.efsa .2020.5985  
− https://www.efsa.europa.eu/en/efsajournal/pub/5985  
− This draft Commission Implementing Regulation was also notified under the TBT 
Agreement in notice G/TBT/N/EU/721.  
10. Proposed date of adoption (dd/mm/yy) : 3rd quarter 2020.  
Proposed date of publication (dd/mm/yy) : 3rd quarter 2020.  G/SPS/N/EU/387  
 
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  11. Proposed date of entry into force: [  ] Six months from date of publication , 
and/or  (dd/mm/yy) : 20 days following publication in the Offi cial Journal of the EU.  
[ ] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 14 July 2020  - Comments are only to be addressed 
to the TBT Enquiry Point on notice G/T BT/N/EU/721.  
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: + (322) 299 8043  
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: + (322) 299 8043  
E-mail: grow-eu-tbt@ec.europa.eu