G/TBT/N /EU/431  
 
15 December 2016   
(16-6853) 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  
EU-TBT E nquiry Point  
Fax: +(32) 2 299 80 43  
E-mail: grow-eu-tbt@ec.europa.eu   
Website: http://ec.europa.eu/growth/tools -databases/tbt/   
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 :   
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):  Fluroxypyr (pesticide 
active substance)  
5. Title, number of pages  and language(s)  of the notified document:  Draft Commission 
Implementing Regulation amending Implementing Regulation (EU) No 540/2011 as regards 
the conditions of approval of the active substance fluroxypyr (4 pages plus Annex 2 pages, in 
English)     
6. Desc ription of content:  This draft Commission Implementing Regulation provides that 
the conditions of approval of the active substance fluroxypyr are amended. Existing 
authorisations for plant protection products containing fluroxypyr will be amended or 
withdr awn from the market. The amendment is based on evaluation of confirmatory 
information submitted following the approval of the substance for use as a pesticide active 
substance in the EU under Regulation (EC) No 1107/2009.  
This decision concerns the placin g on the market of this substance and does not affect the 
Maximum Residue Levels (MRLs) for residues of the concerned pesticide.   
7. Objective and rationale , including the nature of urgent problems where applicable: 
Protection of human health or safety; protection of animal or plant life or health; 
protection of the environment.  
During the evaluation and peer -review of the confirmatory data provided on fluroxypyr 
following its renewed approval (Commission Implementing Regulation 736/2011), it was 
identifi ed that a toxicologically relevant impurity (NMP) is present in the technical material 
at a level that would trigger classification of the substance. It was considered necessary to 
set a limit for this impurity at < 3 g/kg to ensure that there would be no impact on 
consumers. This is indicated in the Technical Report of the European Food Safety Authority 
(EFSA) published in July 2015.  
In order to ensure the protection of consumers it is necessary to amend the approval to 
include a limit for impurity NMP.  G/TBT/N/EU/431  
 
- 2 - 
 
  Existing authorisations will need to be amended or withdrawn; Member States must amend 
or withdraw existing plant protection products containing fluroxypyr at the latest by 3 
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 15 mo nths from the entry 
into force.  
8. Relevant documents:   
 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 
October 2009 concerning the placing of p lant protection products on the market and 
repealing Council Directives 79/117/EEC and 91/414/EEC: http://eur -
lex.europa.eu/legal -
content/EN/TX T/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 substan ces (OJ L 153, 11.6.2011, 
p. 1-186): http://eur -lex.europa.eu/legal -
content/EN/TXT/?qid=1442928512004&uri=CELEX:32011R0540  
 Commission Implementing Regulat ion (EU) No 736/2011 of 26 July 2011 approving 
the active substance fluroxypyr, 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 th e Annex to Commission 
Implementing Regulation (EU) No 540/2011: http://eur -lex.europa.eu/legal -
content/EN/ALL/?uri=CELEX:32011R0736  
 EFSA (European Food Safety Authority), 2 015. Technical Report on the outcome of 
the consultation with Member States, the applicant and EFSA on the pesticide risk 
assessment for fluroxypyr in light of confirmatory data. EFSA supporting publication 
2015:EN -857. 43 pp.: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2015.EN -
857/abstract  
9. Proposed date of adoption:  2nd quarter 2017  
Proposed date of entry into force:  20 days following publication in the OJ ( amendment 
or withdrawal of existing authorisations at the latest by 3 months after entry into force).   
10. Final date for comments:  60 days from notification  
11. Texts available from : National enquiry point  [  ] or address, telephone and fax 
number s and email and website address es, 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 Website: http://ec.europa.eu/growth/tools -databases/tbt/   
https://members.wto.org/crnattachments/2016/TBT/EEC/16_5129_00_e.pdf   
https://members.wto.org/crnattachments/2016/TBT/EEC/16_5129_01_e.pdf