EN   EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/11271/2018 
[…](2018) XXX  draft 
 
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
renewing the approval of the active substance tolclofos-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  
renewing the approval of  the active substance tolclofo s-methyl in a ccordance with 
Regulation (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 the 
Annex to 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) thereof, 
Whereas: (1) Commission Directive 2006/39/EC
2 included tolclofos-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 tolclofos-methyl, as set out in Part A of the 
Annex to Implementing Regulation (EU) No 540/2011, expires on 30 April 2020.  
(4) An application for the renewal of the appr oval of tolclofos-methyl 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. The applicant 
submitted the supplementary dossiers requi red 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 2006/39/EC of 12 April 2006 amending Council Directive 91/414/EEC to 
include clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl and triticonazole as active substances as 
active substance  (OJ L 104, 13.4.2006, p. 30). 
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 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 (5) 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 11 November 2016. 
(6) 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. 
(7) On 8 December 2017, the Authority communi cated to the Commission its conclusion
6 
on whether tolclofos-methyl can be expected  to meet the approval criteria provided for 
in Article 4 of Regulation (EC) No 1107/2009. An amended version of this conclusion 
was adopted by the Authority on 5 October 2018 and re-published on 
15 November 2018 with an explanation concer ning the partially acceptable risk for 
aquatic organisms (one FOCUS scenario out of the 3 is considered as acceptable) from 
the representative uses in ornemental crops for protected structures. The initial version of the conclusions was removed from EFSA  Journal. The Commission presented the 
draft renewal report for tolclofos-methyl to the Standing Committee on Plants, Animals, Food and Feed on 24 October 2018. 
(8) As regards the new criteria to identify e ndocrine disrupting prope rties introduced by 
Commission Regulation (EU) 2018/605
7, which became applicable on 
10 November 2018, the conclusion of the Authority, based on the fact that there was 
no evidence of endocrine-mediated effects in vivo , infers that it is unlikely that 
tolclofos-methyl is an endocrine disr upter. Thus, the Commission considers that 
tolclofos-methyl is not to be considered as having endocrine disrupting properties. 
(9) The Commission invited the applicant to submit its comments on the amended version 
of the conclusion of the Authority and, in  accordance with the third paragraph of 
Article 14(1) of Implemen ting Regulation (EC) No 844/2012, on the draft renewal 
report. The applicant submitted its comments, which have been carefully examined. 
(10) It has been established with respect to one or more representative uses of at least one 
plant protection product containi ng tolclofos-methyl that th e approval criteria provided 
for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.  
(11) It is therefore appropriate to rene w the approval of tolclofos-methyl.  
(12) In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction 
with Article 6 thereof and in the light of current scientific a nd technical knowledge, it 
is, however, necessary to include certain conditions and restrictions. It is, in particular, appropriate to restrict the use of plant pr otection products containi ng tolclofos-methyl 
in order to minimise the exposure for consumers to certain metabolites and to reduce the exposure of aquatic organi sms and wild mammals to this substance by approving 
its use in ornamentals and potatoes only. 
(13) The risk assessment for the renewal of the approval of tolclofos-methyl is based on a 
limited number of representative uses, which, however, do not restrict the uses for 
                                                 
6 EFSA (European Food Safety Authority), 2018. Conclusion on the peer review of the pesticide risk 
assessment of the active substance tolclofos-methyl. EFSA Journal 2018;16(1):5130 [25 pp.]. 
doi: 10.2903/j.efsa.2018.5130.  
7 Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) 
No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (OJ L 101, 20.04.2018, p. 33).  
EN 3  EN which plant protection products containing to lclofos-methyl may be  authorised. It is 
therefore appropriate to remove the re striction for use only as a fungicide. 
(14) Implementing Regulation (EU) No 540/ 2011 should therefore be amended 
accordingly. 
(15) Implementing Regulation (EU) 2019/1688 extended the expiry date of tolclofos-
methyl to 30 April 2020 in order to allow th e renewal process to be completed before 
the expiry of the approval of that subs tance. However, given that a decision on 
renewal has been taken ahead of that ex tended expiry date, this Regulation should 
apply from 1 August 2019.   
(16) 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 
Renewal of approval of active substance  
The approval of the active substance tolclofos- methyl is renewed as set out in Annex I.  
Article 2 
Amendments to Implementing Regulation (EU) No 540/2011 
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with 
Annex II to this Regulation.  
Article 3 
Entry into force and date of application 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
It shall apply from 1 August 2019. 
This Regulation shall be binding in its entirety and directly applicable in all Member States. 
                                                 
8 Commission Implementing Regulation (EU) 2019/168 of 31 January 2019 amending Implementing 
Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 
abamectin, Bacillus subtilis (Cohn 1872) Strain QST 713, Bacillus thuringiensis subsp. Aizawai, Bacillus thuringiensis subsp. israeliensis, Bacillus thuringiensis subsp. kurstaki, Beauveria bassiana, benfluralin, clodinafop, clopyralid, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, epoxiconazole, fenpyroximate, fluazinam, flutolanil, fosetyl, Lecanicillium muscarium, mepanipyrim, mepiquat, Metarhizium anisopliae var. Anisopliae, metconazole, metrafenone, Phlebiopsis gigantea, 
pirimicarb, Pseudomonas chlororaphis strain: MA 342, pyrimethanil, Pythium oligandrum, rimsulfuron, 
spinosad, Streptomyces K61, thiacloprid, tolclofos-methyl, Trichoderma asperellum, Trichoderma atroviride, Trichoderma gamsii, Trichoderma harzianum, triclopyr, trinexapac, triticonazole, Verticillium albo-atrum and ziram
 (OJ L 33, 5.2.2019, p.  1).  
EN 4  EN Done at Brussels, 
 For the Commission 
 The President  Jean-Claude JUNCKER