G/TBT/N/EU/447  
 
20 January 2017  
(17-0398) 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 a ddress (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) : Diflubenzuron (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 diflubenzuron (5 pages, in English)   
6. Description o f content : This draft Commission Implementing Regulation provides that 
the conditions of approval of the active substance diflubenzuron  are amended. Existing 
authorisations for plant protection products containing diflubenzuron  will be amended or 
withdrawn  from the market. The amendment is based on evaluation of information 
submitted following a review of the approval of the substance for use as a pesticide active 
substance in the EU unde r Regulation (EC) No. 1107/2009.  
This specific decision concerns the p lacing 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 safet y; protection of animal or plant life or 
health; protection of the environment.  
During the evaluation and peer -review of the confirmatory data provided on diflubenzuron 
following the amendment of its approval (Commission Directive 2010/39/EU), it was found  
that the metabolite and impurity 4 -chloroaniline (PCA) is an in vivo  genotoxic and 
carcinogenic agent, but that a genotoxic and carcinogenic potential were not observed in 
studies with an appropriate animal model for human exposure to diflubenzuron, and h ence 
to PCA as a metabolite and impurity.  
However, a new concern was identified on potential exposure to PCA as a residue, given 
the genotoxic and carcinogenic properties of PCA.  G/TBT/N/EU/447  
 
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   During the subsequent evaluation and peer -review of data submitted for the review of the 
approval of diflubenzuron, it was found that the additional information provided did not 
demonstrate that the risk from the potential exposure of consumers to PCA as a residue is 
acceptable. In particular, the presence of PCA in the metabolic  pathway has been 
demonstrated in some plants and livestock and could not be excluded in others. Moreover, 
studies indicated a significant transformation of diflubenzuron residues into PCA under 
conditions similar or equal to food sterilisation processes, and such transformation could 
not be excluded for household processing practices.  
Given the genotoxic and carcinogenic properties of PCA and the absence of a threshold for 
acceptable exposure, the review failed to establish that the exposure of consumers t o PCA 
as a residue, consequent on application consistent with good plant protection practice, has 
no harmful effects.  
In order to ensure the protection of consumers from exposure to PCA, it is necessary to 
amend the approval to include a restriction of use . Diflubenzuron will be restricted to use 
on non -edible crops only, and crops treated with diflubenzuron must not enter the food 
and feed chain.  
Existing authorisations will need to be amended or withdrawn; Member States must amend 
or withdraw existing pla nt protection products containing diflubenzuron at the latest by 
3 months from the date of entry into force. A period of grace in line with Article 46 of 
Regulation (EC) No 1107/2009 is allowed for and shall expire at the latest 15 months from 
the entry in to force.  
8. Relevant documents : 
 Regulation (EC) No 1107/2009 of the European Parl iament 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 (OJ  L 309, 
24.11.2009, p. 1 -50): http://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=CELEX:32009R1107  
 Commission Implementing Regulation (EU) No  540/2011 of 25  May 2011 
impleme nting 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://eu r-lex.europa.eu/legal -content/EN/TXT/?uri=CELEX:32011R0540  
 Commission Directive 2008/69/EC of 1 July 2008 amending Council Directive 
91/414/EEC to include clofentezine, dicamba, difenoconazole, diflubenzuron, 
imazaquin, lenacil, oxadiazon, picloram and py riprox yfen as active substances 
(OJ L 172, 2.7.2008, p. 9 -14): http://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=CELEX:32008L0069  
 Commission Directive 2010/39/EU of 22 Jun e 2010 amending Annex I to Council 
Directive 91/414/EEC as regards the specific provisions relating to the active 
substances clofentezine, diflubenzuron, lenacil, oxadiazon, picloram and 
pyriproxyfen (OJ L 156, 23.6.2010, p. 7 -11): http://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=CELEX:32010L0039  
 European Food Safety Authority; Conclusion on the peer review of the pesticide risk 
assessment of confirmatory data submitted fo r the active substance diflubenzuron. 
EFSA Journal 2012;10(9):2870. [26 pp.] doi:10.2903/j.efsa.2012.2870 : 
https://www.efsa.europa.eu/en/efsajournal/pub/2870  
 European Food Safety Authority;  Conclusion on the peer review on the review of the 
approval of the active substance diflubenzuron regarding the metabolite PCA. EFSA 
Journal 2015;13(8):4222. [30 pp.] doi:10.2903/j.efsa.2015.4222 : 
https://www.efsa.europa.eu/en/efsajournal/pub/4222  G/TBT/N/EU/447  
 
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  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 mo nths after entry into force). 
Possibility for Member States to grant grace periods for sale and distribution, and for 
disposal, storage and use of existing stocks (maximum total of 15 months)   
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/2017/TBT/EEC/17_0406_00_e.pdf