EN   EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10185/2018 rev. 1 […](2018) XXX  draft 
 
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
concerning the non-renewal of the approval of the active substance chlorothalonil, 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) 
  
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
concerning the non-renewal of the approval of  the active substance chlorothalonil, in 
accordance with Re gulation (EC) No 1107/2009 of the Eu ropean Parliament and of the 
Council concerning the placing of plant protection products on the market, and 
amending Commission Implementi ng 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 Par liament and of the 
Council of 21 October 2009 concerning the placing  of plant protection products on the market 
and repealing Council Dir ectives 79/117/EEC and 91/414/EEC
1, and in particular 
Article 20(1) and Artic le 78(2) thereof, 
Whereas: (1) Commission Directive 2005/53/EC
2 included chlorothalonil 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 chlorothal onil, as set out in Part A of the Annex 
to Implementing Regulation (EU) No 540/2011, expires on 31 October 2019. 
(4) An application for the renewal of the approval of chlorothalonil was submitted in 
accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012
5 within the time period provided for in that Article. 
(5) The applicants submitted the supplementary  dossiers required in accordance with 
Article 6 of Implementing Regulation (EU)  No 844/2012. The application was found 
to be complete by the rapporteur Member State. 
                                                 
1 OJ L 309, 24.11.2009, p. 1. 
2 Commission Directive 2005/53/EC of 16 September 2005 amending Council Directive 91/414/EEC to 
include chlorothalonil, chlorotoluron, cypermethr in, daminozide and thiophanate-methyl as active 
substances (OJ L 241, 17.9.2005, p. 51). 
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 market (OJ L 252, 19.9.2012, p. 26).  
EN 2  EN (6) The rapporteur Member State prepared a renewal assessment re port in consultation 
with the co-rapporteur Member State and submitted it to the European Food Safety 
Authority (‘the Authority’) and the Commission on 2 September 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 s upplementary summary dossier available 
to the public. 
(8) On 6 december 2017 the Authority communicated to the Commission its conclusion
6 
on whether chlorothalonil can be expected to meet the approval criteria provided for in 
Article 4 of Regula tion (EC) No 1107/2009.  
(9) A critical concern was identified by the Authority in relation to the contamination of 
groundwater by metabolites of chlorothalon il. In particular, metabolites R417888, 
R419492, R471811, SYN507900, M3, M11, M2, M7 and M10 are predicted to occur above the parametric value of 0.1 μg/L in all pertinent scenarios for all proposed uses of 
chlorothalonil. Therefore, it cannot currently  be established that the presence of  
metabolites of chlorothalonil in groundwater  will not result in unacceptable effects on 
groundwater and in harmful effects on human h ealth as required by Article 4(3)(b) of 
Regulation (EC) No 1107/2009. Furthermore, the Authority could not exclude a genotoxicity concern for residues to which consumers will be exposed and identified a high risk to amphibians and fish for all the uses evaluated. 
(10) Furthermore, several areas of the risk a ssessment could not be finalised due to 
insufficient data in the dossier. In partic ular, the assessment of consumer risk from 
dietary exposure could not be completed be cause of lack of data to confirm the 
definition of the residue in plants and the livestock exposure assessment, including the 
toxicological assessment of a metabolite.  
(11) Additionally, chlorothalonil is classified as carcinogen category 2 in accordance with 
Regulation (EC) No 1272/2008 of the European  Parliament and of  the Council while 
in the conclusion of the Authority it is indicated that chlorothalonil should be 
classified as carcinogen category 1B. For th e representative uses considered, residue 
levels as referred to in point (b) of Article 18(1) of Regu lation (EC) No 396/2005 
could not be confirmed for plant and anima l products due to lack of data on the 
magnitude and toxicity of metabolites that are included in the residue definition for risk assessment. Consequently , the requirement set out in Point 3.6.3 of Annex II to 
Regulation (EC) No 1107/2009 is not fulfilled.  
(12) The Commission invited the applicants to submit their comments on the conclusion of 
the Authority and, in accordance with the third subparagraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, to submit comments on the draft renewal report. The applicants submitted comments, which have been carefully examined. 
(13) However, despite the arguments put forward by  the applicants, the concerns related to 
the substance could not be eliminated.  
(14) 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 
                                                 
6 EFSA (European Food Safety Authority), 2016. Conclusion on the peer review of the pesticide risk 
assessment of the active substance chlorothalonil. EFSA Journal2018;16(1):5126, 40 pp.; https://doi.org/10.2903/j.efsa.2018.5126.  
EN 3  EN Article 4 of Regulation (EC) No 1107/2009 are sa tisfied. It is therefore appropriate not 
to renew the approval of the active substance chlorothalonil in accordance with Article 20(1)(b) of that Regulation. 
(15) Implementing Regulation (EU) No 540/2011 should therefore be amended 
accordingly. 
(16) Member States should be allo wed sufficient time to withdr aw authorisations for plant 
protection products containing chlorothalonil.  
(17) For plant protection products containing ch lorothalonil, 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 [publications office insert date 12 months from the 
date of entry into force] .  
(18) Commission Implementing Regulation (EU) 2018/1262
7 extended the approval period 
of chlorothalonil to 31 October 2019 in orde r to allow the renewal process to be 
completed before the expiry of the approval of that substance. However, given that a 
decision on the non-renewal of the approval is taken ahead of that extended expiry 
date, this Regulation should apply as soon as possible. 
(19) This Regulation does not prevent the sub mission of a further application for the 
approval of chlorothalonil in accordance with Article 7 of Regulation (EC) No 1107/2009. 
(20) 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 substan ce chlorothalonil is not renewed.  
Article 2 
Amendments to Implementin g Regulation (EU) No 540/2011  
In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 101, on 
chlorothalonil, is deleted. 
Article 3 
Transitional measures 
Member States shall withdraw  authorisations for plant pr otection products containing 
chlorothalonil as active substance by [ Office of Publications please insert date 6 months  from 
the date of entry into force ] at the latest.  
                                                 
7 Commission Implementing Regulation (EU) 2018/1262 of 20 September 2018 amending 
Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the 
active substances 1-methylcyclopropene, beta-cyfluthrin, chlorothalonil, chlorotoluron, clomazone, 
cypermethrin, daminozide, deltamethrin, dimethenamid-p, diuron, fludioxonil, flufenacet, 
flurtamone, fosthiazate, indoxacarb, MCPA, MCPB, prosulfocarb, thiophanate-methyl and tribenuron (OJ L 238, 21.9.2018, p. 62 ).  
  
EN 4  EN 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 [insert date 12 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