G/TBT/N/EU/710  
17 April 2020  
(20-3051) 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):  Bromoxynil 
(pesticide active su bstance)  
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 bromoxynil, in accordance with Regulation (EC) No 1107/2009 of the Europea n 
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. (5 page(s), in English)  
6. Description of content:  This draft Commission Impl ementing Regulation provides that 
the approval of the active substance bromoxynil is not renewed in accordance with 
Regulation (EC)  No 1107/2009. EU Member States shall withdraw authorisations for plant 
protection products containing bromoxynil as an activ e 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 may 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 also detailed in 
Annex  II thereto) which must be met to enable approval.  G/TBT/N/EU/710  
 
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  During the evaluation and peer -review of bromoxynil, 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).  
The conclusion of the Authority indicates that, during the peer review, experts from 
Member States and the Authority suggested that bromoxynil, curren tly subject to 
harmonised classification and labelling in accordance with Regulation (EC) No  1272/2008 
as toxic for reproduction category  2, should be classified as toxic for reproduction category 
1B in accordance with the criteria laid down in that Regula tion. The Commission therefore 
requested the Authority to consider whether negligible exposure in accordance with 
Point 3.6.4 of Annex II to Regulation (EC) No  1107/2009 could be demonstrated. On 
8 November 2018, the Authority communicated to the Commissio n its conclusion (EFSA 
Journal 2018;16 (12):5490, 15 pp.) that, for the representative uses considered, non -
dietary exposure to bromoxynil cannot be considered negligible. In that conclusion, the 
Authority identified a risk to child residents from the repr esentative uses of bromoxynil 
even when taking into account available mitigation measures.    
In its conclusion from 2017, the Authority also identified a high risk to wild mammals from 
dietary exposure to bromoxynil. Furthermore, the Authority concluded th at the consumer 
risk assessment for products of animal origin and the risk assessment for aquatic 
organisms could not be finalised.  
Derogation in accordance with Article  4(7) of Regulation (EC) No  1107/2009 does not 
apply for the reasons set out in the dr aft Regulation.  
These concerns mean that bromoxynil 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 existin g plant protection 
products containing bromoxynil 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 for ce (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  
• Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 
16 December 2008 on classification, labelling and pack aging of substances and 
mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and 
amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).  
https://eur -lex.europa.eu/legal -content/en/TXT/?uri=CELEX%3A32008R1272    
• EFSA (European Food Safety Authority), 2017. Conclusion on the peer review of the 
pesticide risk assessment of the active substance bromoxynil (variant evaluated 
bromoxynil octanoate).  EFSA Journal 2017;15(6):4790, 24 pp.  
https://doi.org/10.2903/j.efsa.2017.4790  
• EFSA (European Food Safety Authority), 2018. Conclusion on the peer review of the 
pesticide risk assessment for the act ive substance bromoxynil in light of negligible 
exposure data submitted. EFSA Journal 2018;16 (12):5490, 15 pp.  G/TBT/N/EU/710  
 
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  https://doi.org/10.2903/j.efsa.2018.5490  
• EFSA (European Food Safety Authority), 2018. Scientiﬁc report on evaluation of data 
concerning the necessity of bromoxynil as herbicide to control a serious danger to 
plant health which cannot be contained by other available means, including non -
chemical methods. EFSA Journal 2018;16(8):5391, 80 pp.  
https://doi.org/10.2903/j.efsa.2018.5391     
9. Proposed date of adoption:  4th quarter 2020  
Proposed date of entry into force:  3 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_2744_00_e.pdf