EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11940/2019 Rev 1  
[…](2019) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of the approval of the active substance chlorpyrifos -methyl, 
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 the Annex to Commission Implementing Regulation (EU) No 540/2011  
(Text with EEA relevance)   EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of the approval of the active substance chlorpyrifos -methyl, 
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 the Annex to Commission Implementing Regulation (EU) No 540/2011  
(Text with EEA relev ance)  
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 p roducts 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 2 005/72 /EC2 included  chlorpyrifos -methyl  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 substance chlorpyrifos -methyl , as set out in Part A of the 
Annex to Implementing Regulation (EU) No 540/2011 , expires on 31 January  2020.  
(4) Application s for the renewal of the approval of the active substance chlorpyrifos -
methyl  were submitted in accordance with Article 1 of Commission Implementing 
Regulation (E U) No 844/20125 within the time period provided for in that Article.  
(5) The applicant s submitted the supplementary dossiers requ ired in accordance with 
Article  6 of Implementing Regulation (EU) No 844/2012 . The applications were found 
to be complete by the rapporteur Member State.  
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Directive 2005/72/EC of 21 October 2005 amending Council Directive 91/414/EEC to 
include chlorpyrifos , chlorpyrifos -methyl , mancozeb, maneb, and metiram as active substances. (OJ L 
279, 22.10.2005, p.  63). 
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 Commissio n 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 Regul ation (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 market  (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 th e European Foo d Safety 
Authority ( ‘the Aut hority’) and the Commission on 3 July 2017.  
(7) The Authority made the supplementary summary dossier available to the public. The 
Authority also circulated the renewal assessment report to the applicant s and to the 
Mem ber States for comments and launched a public consultation on it. The Authority 
forwarded the comments received to the Commission.  
(8) On 4 July 2018,  the Authority requested that the applicant supply additional 
information to the Member States, the Commission  and the Authority. The assessment 
of the additional information by the rapporteur Member State was submitted to the 
Authority in the form of an updated renewal assessment report.  
(9) The Authority organised an expert discussion in April 2019 , to discuss certain 
elements related to the human health risk assessment . Due to concerns about 
genotoxicity and developmental neurotoxicity raised during that discussion, o n 
1 July 2019 the Commission sent a mandate to the Authority requesting a statement  on 
the available outcomes of the human health assessment and an indication whether the 
active substance can be expected to meet the approval criteria which are applicable to 
human health as laid down in Article  4 of Regulation (EC) No  1107/2009.  
(10) On 31 Ju ly 2019 , the Authority sent its statement6 to the Commission . In its statement, 
the Authority confirmed that its conclusions on the human health assesment indicate that 
critical areas of concerns exist . A genotoxic potential of chlorpyrifos -methyl cannot be 
ruled out , when taking into account the concerns raised for chlorpyrifos. During the 
peer review, experts considered read across between the two substances justified as 
they are structurally similar and have similar toxicokinetic behaviour . Consequently , it 
is not possible to establish health -based reference values for chlorpyrifos -methyl  and to 
conduct the relevant consumer and non -dietary risk assessment s. That conclusion was 
confirmed in a second expert discussion held in September 2019.  Furthermore, 
concerns were identified concerning  developmental neurotoxic ity (DNT) for which  
epidemiological evidence exists , showing a n association between exposure to 
chlorpyrifos -methyl during development and adverse neurodevelopmental outcomes in 
children. Moreover, it is indicated that the peer review experts considered it 
appropriate to classify chlorpyrifos -methyl as toxic for reproduction, category 1B, in  
accordance with the criteria established under Regulation (EC) No  1272/2008 of the 
European Parliame nt and of the Council7. 
(11) The Commission invited the applicant s to submit their comments on the statement  of 
the Authority. Furthermore, in accordance with the third subparagraph of  Article  14(1) 
of Implementing Regulation (EU) No  844/2012, the Commission in vited the 
applicant s to submit comments on the draft renewal report. The applicant s submitted 
their comments, which have been carefully examined.  
                                                 
6 EFSA (European Food Safety Authority), 2019. Statement on the available outcomes of the human 
health assessment in the context of the pesticides peer review of th e active substance 
chlorpyrifos -methyl. EFSA Journal 2019;17(5):5810 .  
7 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, amending and repeal ing 
Directives  67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 
31.12.2008, p.  1). EN 3  EN (12) However, despite the arguments put forward by the applicant s, the concerns regarding 
the active substance  could not be eliminated . 
(13) Consequently, 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 of Regulation (EC) No  1107/2009 are satisfied.  The environmental risk 
assessment, although not finalised, cannot alter this conclusion since the approval 
criteria related to the effects on human health are not satisfied and should therefore not 
delay further the decision -making on the renewal of the ac tive substance. It is 
therefore appropriate not to renew the approval of the active substance 
chlorpyrifos -methyl  in accordance with Article  20(1)(b) of that Regulation . 
(14) Implementing Regulation (EU) No 540/2011 should therefore be amended 
accordingly.  
(15) Memb er States should be given  sufficient  time to withdraw authorisations for plant 
protection products containing chlorpyrifos -methyl . 
(16) For plant protection products containing chlorpyrifos -methyl , where Member States 
grant any grace period in accordance with A rticle  46 of Regulation (EC) 
No 1107/2009, t hat period should  not exceed 3 months  from the date of entry into 
force of this Regulation . 
(17) Commission Implementing Regulation (EU) 2018 /17968 extended the approval period  
of chlorpyrifos -methyl  to 31 January  2020 , in order to allow the renewal process to be 
completed before the expiry of th e approval period  of that substance . However, g iven 
that a decision on the non -renewal of the approval is  being taken ahead of the expiry 
of that extended approval period , this Regulation should apply as soon as possible.  
(18) This Regulation does not prevent  the submission of a further application for the 
approval of chlorpyrifos -methyl  pursuant to  Article 7 of Regulation (EC) 
No 1107/2009.  
(19) The measures provided for in this Regul ation are in accordance with the opinion of the  
Standing Committee on Plant s, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Non-renewal of the approval of the active substance  
The approval of the active substance chlorpyrifos -methyl  is not renewed.   
Article 2 
Amendment  to Implementing Regulation (EU) No 540/2011  
In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 112, on 
chlorpyrifos -methyl , is deleted.  
                                                 
8 Commission Implementing Regulation (EU) 2018/1796 of 20 November 2018 amending Implementing 
Regulation (EU) No 540/2011 as regards the exten sion of the approval periods of the active substances 
amidosulfuron, bifenox, chlorpyrifos, chlorpyrifos -methyl, clofentezine, dicamba, difenoconazole, 
diflubenzuron, diflufenican, dimoxystrobin, fenoxaprop -p, fenpropidin, lenacil, mancozeb, mecoprop -p, 
metiram, nicosulfuron, oxamyl, picloram, pyraclostrobin, pyriproxyfen and tritosulfuron ( OJ L 294, 
21.11.2018, p.  15). EN 4  EN Article 3  
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
chlorpyrifos -methyl  as an active substance by  … [Office of Publications please insert date 
1 month from the date of entry into force ]. 
Article 4  
Grace period  
Any grace per iod granted by Member States in accordance with Article 46 of Regulation (EC) 
No 1107/2009 shall expire by … [Office of Publications please insert date 3 months from the 
date of entry into force] . 
Article 5  
Entry into force  
This Regulation shall enter into force on the third 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  
 (Name to be inserted )