G/TBT/N/EU/418  
 
28 Oc tober 2016  
(16-5938) 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  
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/   
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) : Buprofezin (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 buprofezin (4 pages, in English)  
6. Description of con tent: This draft Commission Implementing Regulation provides that 
the conditions of approval of the active substance buprofezin are amended. Existing 
authorisations for plant protection products containing buprofezin will be amended or 
withdrawn from the m arket. 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 specific decision concerns the placing on t he 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; protecti on of animal or plant life or 
health; protection of the environment.  
During the evaluation and peer -review of the confirmatory data provided on buprofezin 
following its approval (Commission Directive 2011/6/EU), it was identified that during high 
temperatu re processing the metabolite aniline may form. Aniline is a carcinogen for which 
a genotoxic mechanism cannot be excluded and no reference values for exposure can be 
derived since no threshold for such a substance can be assumed. This is indicated as an 
issue that should be considered a priori  as a concern in the conclusion of the European 
Food Safety Authority (EFSA) published in July 2015.  
In order to ensure the protection of consumers from exposure to aniline, it is necessary to 
amend the approval to in clude a restriction of use. Buprofezin will be restricted to use on 
non-edible crops only.  G/TBT/N/EU/418  
 
- 2 - 
 
  Existing authorisations will need to be amended or withdrawn; Member States must amend 
or withdraw existing plant protection products containing buprofezin at the la test 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 months 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 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/leg al-
content/EN/TXT/?qid=1442928512004&uri=CELEX:32011R0540  
 Commission Directive 2011/6/EU of 20  January 2011 amending Council Directive 
91/414/EEC to include buprofezin as active substance (OJ L 18, 21.1.2011, 
p. 38-40): http://eur -lex.europa.eu/legal -
content/EN/TXT/PDF/?uri=CELEX:32011L0006&from=EN  
 EFSA (European Food Safety Authority), 2015. Conclusion on the peer review of the 
pesticide risk assessment for the active substance buprofezin in light of confirmatory 
data. EFSA Journal 2015;13(8):4207, 24 pp. doi:10.2903/j.efsa.2015.4207: 
http://onlinelibrary.wiley.com/doi/10.2903/j.efsa. 2015.4207/epdf  
9. Proposed date of adoption : 1st 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 da te 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_4537_00_e.pdf