G/TBT/N/EU/453  
 
13 February 2017   
(17-0868) 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 ad dress (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 withdrawing the approval of the active substance repellents by 
smell of animal or plant origin/tall oil crude, in acc ordance with Regulation 
(EC) No 1107/2009 of the E uropean 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the approval of the active substance tall oil crude is withdrawn. Existing authorisations for 
plant protection products containing this substance must be withdrawn from the market. 
The withdrawal is based on evaluation of confirmatory informa tion submitted following the 
approval of the substances for use as pesticide active substances in the EU unde r 
Regulation (EC) No 1107/2009.  
This decision only concerns the placing on the market of this substance and does not affect 
the Maximum Residue Lev els (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 envi ronment.  
Commission Directive 2008/127/EC included repellents by smell of animal or plant 
origin/tall oil crude as active substance in Annex I to Council Directive 91/414/EEC. The 
conditions of approval were amended by Commission Implementing Regulation 63 7/2012 
with the condition that Member States concerned ensure that the applicants at whose 
request repellents by smell of animal or plant origin/tall oil crude has been included 
provide further confirmatory information on the equivalence between the specif ications of 
the technical material as commercially manufactured, and those of the test material used G/TBT/N/EU/453  
 
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  in the toxicity dossiers and the toxicological profile of the substance by 1  May 2013 and 
31 May 2014 respectively.  
In the light of the additional informat ion provided by the applicant, the evaluation of this 
information by the rapporteur Member State and the comments submitted on the 
evaluation by Member States and EFSA, the Commission considers that the confirmatory 
information is not sufficient to conclud e on the equivalence between the specifications of 
the technical material as commercially manufactured, and those of the test material used 
in the toxicity dossiers nor on the toxicological profile of the substances.  
Existing authorisations will need to b e amended or withdrawn; Member States must amend 
or withdraw existing plant protection products containing ta ll oil crude 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 allo wed for and shall expire at the latest 12 months from the date of 
withdrawal of the aut horisation.  
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 protect ion 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=C ELEX: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 15 3, 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) No  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 adopt ion: 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 an d 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 Webs ite: http://ec.europa.eu/growth/tools -databases/tbt/   
https://members.wto.org/crnattachments/2017/TBT/EEC/17 _0818_00_e.pdf