EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12120/2015 Rev. 1  
[…](2015) XXX  draft  
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of approval of the active substance isoproturon, 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 Implem enting 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 isoproturon, 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 Reg ulation (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 
Article  20(1) and Article 78(2) thereof,  
Whereas:  
(1) Commission Directive 2002/18/EC2 included isoproturon  as an 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 isoproturon , 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 isoproturon  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 2002/18/EC  of 22 February 2002 amending Annex I to Council Directive 
91/414/EEC concerning the placing of plant -protection products on the market to include isoproturon as 
an active substance  (OJ L 55, 26.2.2002, p. 29) . 
3 Council  Directive 91/414/EEC  of 15 July 1991 concerning the placing of pl ant 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 European Food Safety 
Authority (hereinafter ‘the Authority’) and the Commission on 28 February  2014.  
(7) The Authority communicated the renewal assessment report to the applicant and to the 
Member States for comments and forwarde d the comments received to the 
Commission. The Authority also made  the supplementary summary dossier available 
to the public.  
(8) On 5 August 2015 the Authority communicated to the Commission its conclusion6 on 
whether isoproturon 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 the relevant metabolites of 
isoproturon in situations represented by all  pertinent groundwater scenarios . In 
addition , a high long -term risk to birds and wild mammals and a high risk to aquatic 
organisms from isoproturon were 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 ren ew the 
approval of isoproturon  in accordance with Article 20(1)(b) of Regulation (EC) No 
1107/2009.  
(10) Additionally, isoproturon is classified as carcinogenic category 2 and in the conclusion 
of the Authority it is indicated that during the peer review it was  proposed that 
isoproturon should be classified as toxic for reproduction category 2 . Therefore, 
isoproturon should be considered to have endocrine disrupting properties pursuant to 
the interim provisions of the third paragraph of point 3.6.5 of Annex II t o Regulation 
(EU) No  1107/2009. However, given that the identified risks referred to in recital 8 
preclude approval of isoproturon, it was not appropriate to consider whether exposure 
to isoproturon under realistic proposed conditions of use is negligible.  Therefore, it 
could not be concluded whether isoproturon 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.  
(11) Given th e 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 Re gulation (E U) No 1141 /2010, on 
the draft review report. The applicant submitted its comments, 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 
protection products containing isoproturon . 
(15) For plant protection products containing isoproturon , where Member States grant any 
grace period in accordance with Article 46 of Re gulation (EC) No 1107/2009, that 
period should, at the latest , expire  on 31 March  2017. 
                                                 
6  EFSA (European Food Safety Authority), 2015. Conclusion on the peer review of the pesticide risk assessment of 
the active substance isoproturon. EFSA Journal 2015;13( 8):4206, 99 pp. doi:10.2903/j.efsa.2015.4206  EN 4   EN (16) This Regulation does not prejudice the submission of a further application for 
isoproturon  in accordance with  Article 7 of Regulation (EC) No 1107/2009.  
(17) The measures p rovided 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 isoproturon  is not renewed .  
Article 2  
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
isoproturon as active substance by 30th September 2016 . 
Article 3 
Grace periods  
Any grace period granted by M ember States in accordance with Article 46 of Regulation (EC) 
No 1107/ 2009 shall be as short as 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 28 on 
isoproturon 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