G/TBT/N/EU/341  
 
27 January 2016  
(16-0538)  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 telephon e 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 applic able, otherwise national tariff heading. 
ICS numbers may be provided in  addition, where applicable): Isoproturon (pesticide 
active 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 
isoproturon, 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 Implementing Regulation (EU) No 540/2011 (4 pages, in English)  
6. Description of content: This draft Commission Implementing Regulation provides that 
the approval of the active substance isoproturon is not renewed in accordance with Regulation (EC) No 1107/2009. Existing authorised plant protection products containing 
isoproturon will be withdrawn from the market.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 decision 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 will be taken to lower MRLs to the limit of 
quantification (LOQ). 
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 pl ant protection products on the market), it 
must be demonstrated that the substance is not harmful to human health, animal health or the environment. Criteria are listed in Articl e 4 of the Regulation (and also detailed in G/TBT/N/EU/341 
 
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  Annex II) which must be met to enable approval. 
During the evaluation and peer-review of th e substance, a number of concerns and areas 
that could not be finalised were identified. These are detailed in the conclusion of the 
European Food Safety Authority (EFSA); importantly, the EFSA concluded that there is a 
high potential for the representative uses assessed to result in groundwater exposure above the drinking water limit of 0.1 µg/L by the relevant metabolites of isoproturon in 
situations represented by all pertinent groundwater scenarios. In addition, a high long 
term risk to birds, wild mammals and aquatic organisms was also identified.  
These concerns mean that isoproturon does not meet the approval criteria as outlined in 
Regulation (EC) No 1107/2009 and cannot be approved currently. 
Existing authorisations will need to be withdrawn; Member States must withdraw existing 
plant protection products containing isoproturon 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 on 30 November 2016 (allowing for a final season of use).
 
8. Relevant documents:  
 Regulation (EC) No 1107/2009 of the Europe an 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  
9. Proposed date of adoption: 2nd quarter 2016 
Proposed date of entry into force: 1 July 2016 
10. Final date for comments: 60 days from notification 
11. Texts available from: National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, 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_0316_00_e.pdf