G/SPS/N/EU/385  
 
13 May 2020  
(20-3573) 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):  Benfluralin (pesticide active substance)  
4. Regions or countries likely to be affected, to the extent relevant or practicab le: 
[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 benfluralin, in accordance with 
Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning 
the placing of plant protection p roducts 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_3169_00_e.pdf  
6. Description of content:  This draft Commission Implementing 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 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 placi ng 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 w ill be made in accordance with SPS procedures.  
This draft Commission Implementing Regulation was also notified under the TBT 
Agreement in notice G/TBT/N/EU/718 . 
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 ma rket), 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.  G/SPS/N/EU/385  
 
- 2 - 
 
  During the evaluation and peer -review of benfluralin, 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). In particular a long -term risk to birds and 
mammals in cluding 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 tox icological assessment.  
These concerns mean that benfluralin does not meet the approval criteria as outlined in 
Regulation (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). 
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 An imal 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 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=14429285 12004&uri=CELEX:32011R0540   
− EFSA (European Food Safety Authority). 2019. Conclusion on the peer review 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   
10. Proposed date of adoption (dd/mm/yy) : 3rd quarter 2020.  
Proposed date of publication (dd/mm/yy) : 3rd quarter 2020.  
11. Proposed date of entry into force: [  ] Six months from date of publication , 
and/or  (dd/mm/yy) : 20 days following publication in the Official Journal of the EU.  
[ ] Trade facilitating measure   G/SPS/N/EU/385  
 
- 3 - 
 
  12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notifi cation and/or (dd/mm/yy) : 5 July 2020 - Comments are to be addressed to the 
TBT Enquiry Point on notice G/TBT/N/EU/718.  
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