G/TBT/N/EU/721  
14 May 2020  
(20-3591) 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 Commission  
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):  Benalaxyl 
(pesticide active sub stance)  
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 benalaxyl, 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 (4 page(s), in English)  
6. Description of content:  This draft Commission Impleme nting 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 sub stance. 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 d ecision 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.  G/TBT/N/EU/721  
 
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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 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 benalaxyl, a number of concerns and areas that could not be finalis ed were 
identified. 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 conce rn 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, f ollowing 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 authorisatio ns will 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 f or 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 benalaxyl.  
• EFSA (European Food Safety Authority). 2019. Conclusio n 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/efsa journal/pub/5985   
9. Proposed date of adoption:  3rd quarter 2020  
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/721  
 
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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/2020/TBT/EEC/20_3204_00_e.pdf