G/TBT/N/EU/434  
 
22 December 2016   
(16-7031) 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):  Tall oil crude (pesticide 
active substance)  
5. Title, number of pages  and language(s)  of the notified document:  Draft Commission 
Implementing Regulation concerning the non -approval of the active substance 
orthosulfamuron, in accordance with Regulation (EC) No 1107/2009 of the European 
Parliament and of th e Council concerning the placing of plant protection products on the 
market  (4 pages, in English).     
6. Description of content:  This draft Commission Implementing Regulation provides that 
the active substance orthosulfamuron is non -approved. The non -approval is based on the 
evaluation of the new active substance orthosulfamuron, made in the context of the work 
provided for in Articles 5 and 6 of Directive 91/414/EEC concerning the placing of plant 
protection products on the market, to be read in conjunc tion with Regulation (EU) No 
188/2011, laying down detailed rules for the assessment of new active substances and the 
transitional provisions foreseen in Article 80(1)(a) of Regulation (EC) No 1107/2009, 
repealing Directive 91/414/EEC.  
This decision only c oncerns the placing on the market of this substance and does not affect 
the Maximum Residue Levels (MRLs) for residues of the concerned pesticide substances.  
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 or 
the environment. For orthosulfamuron, the effects on human and animal health and the 
environment have been assessed, in accordance with the provisions  of Article 6(2) and (4) 
of Directive 91/414/EEC, for the uses proposed by the applicant.  G/TBT/N/EU/434  
 
- 2 - 
 
  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 conclusi on of the 
European Food Safety Authority (EFSA); the Authority concluded that with the available 
information, the risk assessment to consumers, soil dwelling organisms except 
microorganisms and aquatic organisms could not be finalised. In addition, the Aut hority 
identified concerns that the exposure assessment to groundwater could not be finalised.  
These concerns mean that orthosulfamuron does not meet the approval criteria as outlined 
in Regulation (EC) No 1107/2009 and cannot be approved currently.  
The su bstance was allowed to be authorised provisionally for a period not longer than 
three years in EU member States. As all such authorisations have expired, it is not 
necessary to provide an additional period to withdraw authorisations for plant protection 
products containing orthosulfamuron.  
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 Implement ing 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  
Commission Implementing Regulation (EU) No  637/2012 of 13  July 2012 amending 
Implementing Regulation (EU) N o 540/2011 as regards the conditions of approval of the 
active substances iron sulphate, repellents by smell of animal or plant origin/tall oil crude 
and repellents by smell of animal or plant origin/tall oil crude. OJ L 186, 14.7.2012, p. 
20?24   
http://eur -lex.europa.eu/legal -content/EN/TXT/PDF/?uri=CELEX:32012R0637&from=EN    
9. Proposed date of adoption:   2nd 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 availa ble, 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_5246_00_e.pdf