G/TBT/N/EU/471  
 
4 April 2017  
(17-1819) 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 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):  Flupyrsulfuron -methyl 
(DPX KE 459) (pesticide act ive substance)  
5. Title, number of pages  and language(s)  of the notified document:  Draft Commission 
Implementing Regulation concerning the non -renewal of approval of the active substance 
DPX KE 459 (flupyrsulfuron -methyl), in accordance with Regulation (E C) No 1107/2009 of 
the European Parliament and of the Council concerning the placing of plant protection 
products on the market, and amending Commission Implementing Regulation 
(EU) No 540/2011 (5  pages, in English)  
6. Description of content:  This draft C ommission Implementing Regulation provides that 
the approval of the active substance flupyrsulfuron -methyl is not renewed in accordance 
with Regulation (EC)  No 1107/2009. Existing authorised plant protection products 
containing flupyrsulfuron -methyl will b e withdrawn from the market. The non -approval 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 approved under 
Directive  91/414/ EEC.  
This deci sion only concerns the placing on the market of this substance and does not affect 
the Maximum Residue Levels (MRLs) for residues of the concerned pesticide. However, 
following non -approval, separate action may be taken on MRLs and if so a separate 
notific ation will be made in accordance with SPS procedures.  G/TBT/N/EU/471  
 
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  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.  
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 the market), it 
must be demonstrated that the substance is not harmful to human health, animal health o r 
the environment. Criteria are listed in Article 4 of the Regulation (and also detailed in 
Annex  II) which must be met to  enable approval.  
During the evaluation and peer -review of the substance, a number of concerns and areas 
that could not be finalised w ere identified. These are detailed in the conclusion of the 
Europea n Food Safety Authority (EFSA).  
Based on the studies assessed, the Authority concluded that the parent substance has 
certain intrinsic toxicological properties, in particular as regards to carcinogenicity and 
reproductive toxicity. In the view of the Authority this information even justifies the 
classification as carcinogen category 2 and as toxic for reproduction category 2 in 
accordance with Regulation (EC) No 1272/2008 of the European Par liament and of the 
Council. The Authority concluded that considering the representative uses assessed, there 
is a high potential to result in groundwater exposure above the parametric drinking water 
limit of 0.1μg/L by several metabolites of DPX KE 459 (fl upyrsulfuron -methyl) in situations 
represented by all p ertinent groundwater scenarios.  
Regardless of the classification proposed by the Authority, given the intrinsic toxicological 
properties of the parent substance shown in the studies, in particular in r elation to 
carcinogenicity and reproductive toxicity, the presence of the metabolites in groundwater 
is of particular concern since it has not been demonstrated that these metabolites do not 
share the same intrinsic properties. Therefore it cannot currentl y be established that the 
presence of the metabolites in groundwater will not result in unacceptable effects on 
groundwater and in h armful effects on human health.  
Furthermore, the Authority concluded that the groundwater exposure assessment could 
not be f inalised based on the availabl e information for metabolite IN -JE127, the genotoxic 
potential of which cannot be exclud ed. 
Given the uncertainty about the presence of that metabolite in groundwater, unacceptable 
effects on groundwater and harmful effects on  human healt h cannot currently be excluded.  
Moreover, the Authority concluded that there is a high risk to aquatic organisms, in 
particular for algae and aquatic plants, from exposure to DPX KE 459 (flupyrsulfuron -
methyl).  
These concerns mean that flupyrsu lfuron -methyl does not meet the approval criteria as 
outlined in Regulation (EC) No 1107/2009 and cannot be approve d currently.  
Existing authorisations will need to be withdrawn; Member States must withdraw existing 
plant protection products containing pic oxystrobin 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 months from the entry into force (allowing for 
a final season of use) . 
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:  
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 -G/TBT/N/EU/471  
 
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  content/EN/TXT/?qid=1442928512004&uri=CELEX:32011R0540   
 Conclusion on the peer review of the pesticide risk assessment of the active 
substance flupyrsulfuron (variant evaluated flupyrsulfuron -methyl -sodium). EFSA 
Journal 2014;12(11):3881, 86 pp. doi:10.2903/j.efsa.2014.3881: 
http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2014.3881/epdf  
 Regulation (EC) No 1272/2 008 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, 3 1.12.2008, p.  1):  
http://eur -lex.europa.eu/legal -
content/en/TXT/?uri=CELEX:32015R1221&qid=1484416483641   
9. Proposed date of adoption: 3rd quarter 2017  
Proposed date of entry into force: 20 days following publication in the Official Journal of 
the EU  
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 _1637_00_e.pdf