G/TBT/N/EU/718  
6 May 2020  
(20-3460) 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 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):  Benfluralin 
(pesticide active s ubstance)  
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 benfluralin, in accordance with Regulation (EC) No 1107/2009 of the 
Europ ean 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 Imp lementing Regulation provides that 
the approval of the active substance benfluralin is not renewed in accordance with 
Regulation (EC)  No 1107/2009. EU Member States shall withdraw authorisations for plant 
protection products containing benfluralin as an ac tive 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 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, 
animal health o r the environment. Criteria are listed in Article 4 of the Regulation (and G/TBT/N/EU/718  
 
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  also detailed in Annex  II thereto) which must be met to enable approval. During the 
evaluation and peer -review of benfluralin, a number of concerns and areas that could not 
be final ised were identified. These are detailed in the conclusion of the European Food 
Safety Authority (EFSA). In particular a long -term risk to birds and mammals including 
the risk from secondary poisoning of earthworm -eating birds and mammals was identified 
as a critical area of concern. Furthermore, a long -term risk to aquatic organisms from 
benfluralin even when applying mitigation measures and the long -term risk to aquatic 
organisms from metabolites 371R and 372R could not be excluded. Finally, a genotoxic 
potential of an impurity cannot be excluded since the technical specification, including the 
level of that impurity, was not supported by the toxicological assessment. These concerns 
mean that benfluralin does not meet the approval criteria as outlined in R egulation (EC) 
No 1107/2009 and cannot be approved currently. Existing authorisations will need to be 
withdrawn; EU Member States must withdraw existing plant protection products 
containing benfluralin 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 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 Counc il 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  
• EFSA (European Food Safety Authority). 2019. Conclusion on the peer re view of 
the pesticide risk assessment of the active substance benfluralin. EFSA Journal 
2019;17(10):5842, 34 pp. doi:10.2903/j.efsa.2019.5842. 
https://www.efsa.europa.eu/en/efsajournal/pub/5842  
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  
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_3094_00_e.pdf