EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/11965/2017  
[…](2018) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of approval of the active substance chlorpropham, 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 Commi ssion Implementing Regulation (EU) No 540/2011  
(Text with EEA relevance)    
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of approval of the active substance chlorpropham, 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 COMMI SSION,  
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  79/11 7/EEC and 91/414/EEC1, and in particular 
Article  20(1)  and Article 78(2) thereof,  
Whereas:  
(1) Commission Directive 2004/20 /EC2 included chlorpropham  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 (EU) No  540/20114. 
(3) The approval of the active subs tance chlorpropham , as set out in Part A of the Annex 
to Implementing Regulation (EU) No 540/2011 , expires on 31  July 2018 . 
(4) An application for the renewal of the approval of chlorpropham  was submitted in 
accordance with Article 1 of Commission Implementing  Regulation (EU) 
No 844/20125 within the time period provided for in that Article.  
(5) The applicant submitted the supplementary dossiers required in accordance with 
Article  6 of Implementing  Regulation (EU) No  844/2012. The application was found 
to be complet e by the rapporteur Member State.  
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Directive 2004/20/EC of 2 March  2004 amending Council Directive 91/414/EEC to 
include chlorpropham as an active substance  (OJ L 70, 9.3 .2004, p. 32). 
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 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 Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the 
provisions necessary for the implementation of the renewal procedure for active substances, as provided 
for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the 
placing of plant protection products on the mar ket (OJ L 252, 19.9.2012, p. 26 ).  
EN 2  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 Foo d Safety 
Authority ( ‘the Aut hority’) and the Commission on 29 April  2016. 
(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 
Commission. The Authority also made the supplementary summary dossier  available 
to the public.  
(8) On 18 June 2017  the Authority communicated to the Commission its conclusion6 on 
whether chlorpropham  can be expected to meet the approval criteria provided for in 
Article  4 of Regulation (EC) No  1107/2009. The Authority concluded that  a final 
consumer risk  assessment cannot be performed due to several data gaps identified for the 
food crop uses. It also concluded that the consumer risk assessment through dietary 
intake could not be finalised due to several data gaps. In addition, a  critical area of 
concern for chlorpropham was identified regarding the results of an indicative 
consumer risk assessment where acute and chronic dietary risks for consumers have 
been identified both for chlorpropham and  for its major metabolite  3-chloroaniline . 
Moreover, the Authority also concluded that further scientific assessment of the 
potential endocrine disrupting properties of chlorpropham is needed and the risk 
assessment to non-target arthropods for field uses  could not be finalised . 
(9) The Commission invited the ap plicant to submit its comments on the conclusion of the 
Authority  and, in accordance with Article  14(1) of Implementing Regulation (EU) 
No 844/2012, on the draft renewal report. The applicant submitted its comments, 
which have been carefully examined.  
(10) Howe ver, despite the arguments put forward by the applicant, the concerns regarding  
the active  substance  could  not be eliminated.  
(11) Consequently,  it has not been  established with respect to one or more representative 
uses of at least one plant protection produc t that the approval criteria provided for in 
Article  4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not 
to renew the approval of the active substance chlorpropham  in accordance with 
Article  20(1)(b) of that Regulation . 
(12) Impleme nting Regulation (EU) No 540/2011 should therefore be amended 
accordingly.  
(13) Member States should be allowed sufficient  time to withdraw authorisations for plant 
protection products containing chlorpropham .  
(14) For plant protection products containing chlorprop ham, 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  [Office of Publications please insert date 
15 months from the date of entry into force] .  
(15) Commission  Implementing Regulation (EU) 2017 /8417 extended the expiry date of 
chlorpropham  to 31  July 2018  in order to allow the renewal process to be completed 
                                                 
6 EFSA (Europ ean Food Safety Authority), 2017 . Conclusion on the peer review of the pesticide risk 
assessment of the active substance chlorpropham. EFSA Journal 2017;15 (7):4903 , 29 pp. 
doi:10.2903/j.efsa.2017.4903 . 
7 Commission Implementing Regulation (EU) 2017/841 of 17 May 2017 amending Implementing 
Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 
alpha -cypermethrin, Ampelomyces quisqualis strain: aq 10, benalaxyl,  bentazone, bifenazate, 
bromoxynil, carfentrazone ethyl, chlorpropham, cyazofamid, desmedipham, diquat, DPX KE 459  
EN 3  EN before the expiry of the approval of that substance. However, given that a decision has 
been taken ahead of that extended expiry date, this Regulation should apply as soon as 
possible.  
(16) This Regulation does not prevent  the submission of a further application for the 
approval of chlorpropham  pursuant to Article 7 of Regulation (EC) No  1107/2009.  
(17) The measures pr ovided 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 chlorproph am is not renewed.   
Article 2  
Amendments to Implementing Regulation (EU) No 540/2011  
In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 78, on 
chlorpropham , is deleted.  
Article 3  
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
chlorpropham  as active substance by [ Office of Publications please insert date 6 months from 
the date of entry into force ] at the latest.   
Article 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.  
                                                                                                                                                         
(flupyrsulfuron -methyl), etoxazole, famoxadone, fenamidone, flumioxazine, foramsulfuron, 
Gliocladium catenulatum strain: j1446, imazamox, ima zosulfuron, isoxaflutole, laminarin, metalaxyl -m, 
methoxyfenozide, milbemectin, oxasulfuron, pendimethalin, phenmedipham, pymetrozine, s -
metolachlor, and trifloxystrobin (OJ L 1 25, 18.5.2017 , p. 12).   
EN 4  EN Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER