G/SPS/N/EU/383  
 
24 April 2020  
(20-3222) 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):  Bromoxynil (pesticide active substance)  
4. Regions or countries likely to be affected, to the extent relevant or practicabl e: 
[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 bromoxynil, 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:  5 
https://members.wto.org/crnattachments/2020/SPS/EEC/20_2900_00_e.pdf  
6. Description of content:  
This draft Commission Implementing 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 active substance. The non -renewal of appro val 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 may be taken on 
MRLs and a separate notification wi ll 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/710.  G/SPS/N/EU/383  
 
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  7. Objective and rationale: [X]  food safety, [X]  animal health, [X]  plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] 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 th e market), 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.  
During the evaluation and peer -review of bromoxynil, 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).  
The conclusion of the Authority indicates that, du ring the peer review, experts from 
Member States and the Authority suggested that bromoxynil, currently subject to 
harmonised classification and labelling in accordance with Regulation (EC) No 1272/2008 
as toxic for reproduction category 2, should be class ified as toxic for reproduction category 
1B in accordance with the criteria laid down in that Regulation. 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 Commission its conclusion (EFSA 
Journal 2018;16 (12):5490, 15 pp.) that, for the representative uses considered, non -
dietary exposure to bromoxynil cannot be conside red negligible. In that conclusion, the 
Authority identified a risk to child residents from the representative 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 that the 
consumer risk assessment for products of animal origin and the risk assessment for 
aquatic organisms could not be finalized.  
Derogation in accordance with Article 4(7) of Regulation (EC) No 1107/2009 does not 
apply for the reasons set out in the draft Regulation.  
These concerns mean that bromoxynil does not meet the approval criteria as outlined in 
Regulation (EC) No 1107/2009 and cannot be approved cu rrently. Existing authorizations 
will need to be withdrawn; EU Member States must withdraw existing 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 Re gulation 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. 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:   G/SPS/N/EU/383  
 
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  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=14 42928512004&uri=CELEX:32011R0540  
− Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 
16 December 2008 on classification, labelling and packaging 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 (Euro pean 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 active substance bromoxynil in light of negligible 
exposure data submitted . EFSA Journal 2018;16 (12):5490, 15 pp.  
 
− 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 meth ods. EFSA Journal 2018;16(8):5391, 80 pp.  
10. Proposed date of adoption (dd/mm/yy) : 4th quarter 2020.  
Proposed date of publication (dd/mm/yy) : 4th quarter 2020.  
11. Proposed date of entry into force: [  ] Six months from date of publication , 
and/or  (dd/mm/yy) : 3 days following publication in the Official 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) : 17 June 2020 Comments are to be add ressed to the 
TBT Enquiry Point.  
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 Po int 
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