G/TBT/N/EU/422  
 
14 November 2016  
(16-6245) 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 Enq uiry 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 (i ncluding 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) : Oxyfluorfen (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 oxyfluorfen (4 pages, + Annex 2 pages, in 
English)  
6. Description of content : This draft Commission Implementing Regulation provides that 
the conditions of approval of the active substance oxyfluorfen are amended. Existing 
authorisations for plant protection products containing oxyfluorfen will be amended or 
withdrawn from the mar ket. 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 unde r Regulation (EC) No 1107/2009.  
This decision only concerns the placing on the mar ket 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 ur gent 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 oxyfluorfen 
following its approval (Commission Implementing Regulation (EU) No 798/2011), it was 
identified that there  is a high risk to aquatic organisms from exposure to parent substance 
and its metabolites. This is indicated as a critical area of concern in the conclusion of the 
European Food Safety Authority (EFSA) conclusion published in August 2015.  
In order to ens ure the protection of aquatic organisms it is necessary to amend the 
approval to include a rate restriction (maximum rate of 150 g active substance per ha per 
year). Use at this rate enables acceptable scenarios for aquatic organisms to be G/TBT/N/EU/422  
 
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  demonstrated. Fu rthermore, further reference to mitigation measures must be included in 
the approval.  
Existing authorisations will need to be amended or withdrawn; Member States must amend 
or withdraw existing plant protection products containing oxyfluorfen 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 12 months from the date of 
withdrawal of the authorisation.  
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  
 Commission Implementing Regulation (EU) No 798/2011 of 9 August 2011 
approving the active substance oxyfluorfen, in accordance with Regulation  
(EC) No 1107/2009 of the Europe an 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 and  
Commission Decision 2008/934/EC (OJ L 205, 10.8.2011, p. 9 -14):  
http://eur -lex.europa.eu/legal -content/EN/ALL/?uri=CELEX:32011R0798   
 EFSA (European Food Safety Authority), 2015. Conclusion on the peer review  
of the pesticide risk assessment f or the active substance oxyfluorfen  
in light of confirmatory data. EFSA Journal 2015;13(8):4205, 45 pp. 
doi:10.2903/j.efsa.2015.4205 : 
https://www.efsa.europa.eu/en/efsajournal/pub/4205  
9. Proposed date of adoption : 1st quarter 2017  
Proposed date of entry into force : 20 days following publication in the Official Journal of 
the EU (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 e mail 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_4704_01_e.pdf   
https://members.wto.org/crnatt achments/2016/TBT/EEC/16_4704_00_e.pdf