EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANCO/12764/2014 Rev. 0  
[…](2015) XXX  draft  
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of approval of the active substance amitrole, 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 
Implement ing Regulation (EU) No 540/2011  
(Text with EEA relevance)    
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning  the non -renewal of approval of the active substance amitrole, 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 Regula tion (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 co ncerning the placing of plant protection products on the market 
and repealing Council Directives 79/117/EEC and 91/414/EEC1, and in particular 
Article  20(1) and Article 78(2) thereof,  
Whereas:  
(1) Commission Directive 2001/21/EC2 included amitrole  as active substance in Annex I 
to Council  Directive 91/414/EEC3. 
(2) Active substances included in Annex I to Directive 91/414/EEC are deemed to have 
been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the 
Annex to Commission Implementing  Regulation (E U) No 540/20114. 
(3) The approval of the active substance amitrole , as set out in Part A of the Annex to 
Implementing Regulation (EU) No 540/2011, expires on 30  June 2016.  
(4) An application for the renewal of the inclusion  of amitrole  in Annex I to  Council 
Directive 91/414/EEC was submitted in accordance with Article 4 of Commission 
Regulation (E U) No 1141/20105 within the time period provided for in that Article.  
(5) The applicant submitted the supplementary dossiers  required in accordance with 
Article  9 of Regulation (E U) No 1141/2010.  The application  was found to be complete 
by the rapporteur Member State . 
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Directive 2008/127/EC  of 18 December 2008 amending Council Directive 91/414/EEC to 
include several active substances (OJ L 344, 20.12.2008, p. 89) . 
3 Council  Directive 91/414/EEC  of 15 July 1991 concerning the placing of plant protection products on 
the market  (OJ L 230, 19.8. 1991, p. 1).  
4 Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 amending 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) . 
5 Commission Regulation (EU) No 1141/2010  of 7 December 2010  laying down the procedure for the 
renewal of the inclusion of a second group of active substances in Annex I to Council 
Direc tive 91/414/EEC and establishing the list of those substances  (OJ L 322, 8.12.2010, p. 10) .  
EN 3   EN (6) The rapporteur Member State prepared a renewal assessment report in consultation 
with the co -rapporteur Member State and submitted it to the Europe an Food Safety 
Authority (hereinafter ‘the Authority’) and the Commission on 2 April 2014.  
(7) The Authority communicated the renewal assessment report to the applicant and to the 
Member States for comments and forwarded the comments received to the 
Commissio n. The Authority also made the supplementary summary dossier available 
to the public.  
(8) On 19 June 2014  the Authority communicated to the Commission its conclusion6 on 
whether amitrole  can be expected to meet the approval criteria provided for in 
Article  4 of Regulation (EC) No 1107/2009. The Authority concluded that there is a 
high potential for the representative uses assessed to result in groundwater exposure 
above the parametric drinking water limit of 0.1μg/L by a relevant metabolite of 
amitrole in situations represented by all pertinent groundwater scenarios . In addition , a 
high risk to operators, workers and bystanders  from the use of amitrole was identified .  
(9) Based on these identified risks, it has not been established with respect to one or more 
representative uses of at least one plant protection product that the approval criteria 
provided for in Article 4 are satisfied. It is therefore appropriate not to renew the 
approval of amitrole  in accordance with Article 20(1)(b) of Regulation (EC) No 
1107/2009.  
(10) Additionally, amitrole  is classified as toxic for reproduction category 2  and it has toxic 
effects on endocrine organs. Therefore, amitrole  should be  considered to have 
endocrine disrupting properties pursuant to the interim provisions of the fourt h 
paragraph of point 3.6.5 of Annex II to Regulation (EU) No  1107/2009 . Furthermore,  
in the conclusion of the Authority , it is indicated that during the peer review it was 
proposed that amitrole  should be classified as  toxic for reproduction category 1B . 
However, given that the identified risks referred to in recital 8 preclude approval of 
amitrole, it was not appropriate to consider  whether exposure to amitrole  under 
realistic  proposed conditions of use is negligible. Therefore, it could not be concluded 
whether amitrole  meets the approval criteria related to endocrine disrupting properties 
as outlined in the first paragraph of point 3.6.5 of Annex II to Regulation (EU) 
No 1107 /2009 , nor the approval criteria related to reproductive toxicity as outlined in 
point 3.6. 4 of Annex II to Regulation (EU) No  1107/2009.  
(11) Given the concerns detailed in recital 8, there is no room for applying the derogation 
provided for in Article 4(7) of  Regulation (EU) No 1107/2009.  
(12) The Commission invited the applicant to submit its comments on the conclusion of the 
Authority and, in accordance with Article 1 7(1) of Regulation (E U) No 1141 /2010, on 
the draft review report. The applicant submitted its com ments, which have been 
carefully examined.  
(13) However, despite the arguments put forward by the applicant, the concerns related to 
the substance  could  not be eliminated.  
(14) Member States should be provided with time to withdraw authorisations for plant 
protecti on products containing amitrole . 
                                                 
6 EFSA (European Food Safety Authority), 2014. Conclusion on the peer review of the pesticide risk  
assessment of the active substance amitrole. EFSA Journal 2014;12(7):3742, 84 pp. 
doi:10.2903/j.efsa.2014.3742 .  
EN 4   EN (15) For plant protection products containing amitrole, where Member States grant any grace 
period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period 
should, at the latest, expire on 31 March  2017.  
(16) This Regulation does not prejudice the submission of a further application for amitrole  
in accordance with  Article 7 of Regulation (EC) No 1107/2009.  
(17) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee  on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Non-renewal of approval of active substance  
The approval of the active substance amitrole  is not renewed .  
Article 2  
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing amitrole  
as active substance by 30th September 2016.  
Article 3  
Grace periods  
Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) 
No 1107/2009 shall be as short a s possible and shall expire on 31 March 2017 at the latest.  
Article 4 
Amendments to Implementing Regulation (EU) No 540/2011  
In Part A of the Annex to Implementing Regulation (EU) No 540/2011 , row 14 on amitrole is 
deleted.  
Article 5 
Entry into force  
This Regulation shall enter into force on 1 July 2016 .  
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