EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11586/2016 rev 0  
[…](2016) XXX  draft  
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
withdrawing the approval of the active substance repellents by smell of animal or plant 
origin/tall oil crude, 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  
(Text with EEA relevance)   EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
withdrawing the approval of the active substance repellents by smell of animal or plant 
origin/tall oil crude, 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 Commission Implementing Regulation (EU) No 540/2011  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to 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/EEC1, and in particular the second 
alternative of Article 21(3) and Article 7 8(2) thereof,  
Whereas:  
(1) Commission Directive 2008/127/EC2 included repellents by smell of animal or plant 
origin/tall oil crude as active substance  in Annex I to Council Directive 91/414/EEC3. 
Commission Implementing Regulation 637/20124 required  that Member States 
concerned ensure that the notifier  at whose request repellents by smell of animal or 
plant origin/tall oil crude ha s been included provide further confirmatory information 
on the equivalence between the specifications of the technical m aterial as 
commercially manufactured and those of the test material used in the toxicity dossiers 
and on the toxicological profile of the substance by 1  May 2013 and 31  May 2014 
respectively.  
(2) Active substances included in Annex I to Directive 91/414/EEC ar e deemed to have 
been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the 
Annex to Commission Implementing Regulation (EU) No 540/20115. 
(3) In April 2013, the notifier submitted information, with a view to complying with the 
obligation  to submit further information as referred to in recital 1 , to the rapporteur 
Member State, Greece.  
                                                 
1 OJ L 309, 24.11.2009 , p. 1. 
2 Commission Directive 20 08/127 /EC of 18 December 2008  amending Council Directive 91/414/EEC to 
include several  active substance s (OJ L 344 , 20.12.2008, p. 89 ). 
3 Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection product s on 
the market (OJ L 230, 19.8.1991, p. 1).  
4 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 pitch (OJ L 186, 14.7.2012, p.20).  
5 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).  EN 3   EN (4) Greece assessed the information submitted by the notifier including some further 
information related to the initial submission that was submitted during the  evaluation 
process. It submitted its assessment, in the form of addenda to the draft assessment 
report, to the other Member States, the Commission and the European Food Safety 
Authority, herein after 'the Authority' in November 2014 and November 2015.   
(5) The Member States, the applicant and the Authority were consulted and asked to 
provide comments on the assessment of the rapporteur Member State. The Authority 
published a Technical Report summarising the outcome of this consultation for tall oil 
crude on 27  March  20156. 
(6) In the light of the information provided by the notifier , 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 conclude 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 
substance .  
(7) The Commission invited the notifier  to submit its comments on the considerations of 
the Commission.  
(8) However, despite the arguments put forward by the notifier , the Commission has come 
to the conclusion that the information submitted is incomplete and does not allow a 
conclusion on the equivalence between the specifications of the technical material as 
commercially manufactured and those of the test material used in t he toxicity dossiers 
nor on the toxicological profile of the substance to be made.   
(9) Consequently, it is appropriate to withdraw the approval of that active substance .  
(10) The Annex to  Implementing Regulation (EU) No 540/2011 should therefore be 
amended accord ingly.  
(11) Member States should be provided with time to withdraw authorisations for plant 
protection products containing  that active substance . 
(12) For plant protection products containing  that active substance , where Member States 
grant any grace period in accor dance with Article  46 of Regulation (EC) 
No 1107/2009, th at period should , at the latest,  expire  on [Office of Publications 
please  insert date 15  months from the date of entry into force ].   
(13) The measures provided for in this Regulation are in accordance wi th the opinion of the 
Standing Committee on Plants, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Withdrawal of approval  
The a pproval of the active substance  repellents by smell of animal or plant origin/tall oil crude  
is withdrawn.  
                                                 
6 EFSA (European Food Safety Authority), 2015. Technical report on the outcome of the consultation 
with Member States, the applicant and EFSA on the pesticide risk assessment of confirmatory data for 
tall oil crude. EFSA supporting publication 2015:EN -781. 14 pp.   EN 4   EN Article 2 
Amendment to Implementing Regulation (EU) No 540/2011  
In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 25 0, repellents 
by smell of animal or plant origin/tall oil crude is deleted.  
Article 3 
Transitional measures  
Member St ates shall withdraw authorisations for plant protection products containing 
repellents by smell of animal or plant origin/tall oil crude  as active substance  by [Office of 
Publications please insert date 3 months after entry into force]  at the latest . 
Artic le 4 
Grace period  
Any grace period granted by Member States  in accordance with Article 46 of Regulation (EC) 
No 1107/2009 shall be as short as possible and shall expire by [Office of Publications please  
insert date 15 months  from the date of entry into force]  at the latest.   
Article 5 
Entry into force  
This Regulation shall enter into force on the twentieth  day following that of its publication in 
the Official Journal of the European Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER