G/TBT/N/EU/536  
 
22 January 2018  
(18-0532) 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/en/  
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): Oxasulfuron 
(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 oxasulfuron, in accordance with Regulation (EC) No 1107/2009 of the European 
Parliament and of the Council concerning the placing of plant protection produc ts on the 
market, and amending Implementing Regulation (EU) No 540/2011 (5 page(s), in English)    
6. Description of content: This draft Commission Implementing Regulation provides that 
the approval of the active substance oxasulfuron is not renewed in accordance with 
Regulation (EC)  No 1107/2009. Existing authorised plant protection products containing 
oxasulfuron will be withdrawn from the market.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 th e concerned pesticide. However, 
following non -approval, separate action may be taken on MRLs and if so a separate 
notification will be made in accordance with SPS procedures.  
7. Objective and rationale, including the nature of urgent problems where 
applic able: 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 protec tion 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 Article 4 of the Regulation (and also detailed in G/TBT/N/EU/536  
 
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  Annex  II) which must be met to enable approv al.  
During the evaluation and peer -review of the 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).  
The Authority identified numerous d eficiencies in the dossier resulting in a large number of 
data gaps and areas in which the risk assessment could not be finalised. In particular, the 
available information on oxasulfuron and its metabolites did not allow finalising the 
assessment of the ov erall consumer exposure, the groundwater exposure, the risk to 
aquatic organisms, earthworms, soil macro - and microorganisms and non -target terrestrial 
plants. The situation where a large number of fundamental parts of risk assessment were 
not finalised cr eated insecurity which lead to the non -renewal.  
These concerns mean that oxasulfuron 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; EU Mem ber States must withdraw 
existing plant protection products containing oxasulfuron 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 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 re gards 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  
 Conclusion on the peer review of the pesticide risk assessment of  
the active substance oxasulfuron. EFSA Journal 2017;15(3):4722,25 pp. 
doi:10.2903/j.efsa.2017.4722  
http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2017.4722/epdf   
9. Proposed date of adoption: 1st quarter 2018  
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 
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 EU -TBT Website: http://ec.europa.eu/growth/tools -
databases/tbt/en/  
https://members.wto.org/crnattachments/2018/TBT/EEC/18_0472_00_e.pdf