COMMI SSION IMPLEMENTING REGUL ATION (EU) 2019/1101 
of 27 June 2019 
renewing the appro val of the activ e subst ance tolclof os-meth yl in accordance with Regulation (EC) 
No 1107/2009 of the European Parliament and of the Council concer ning 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) 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regar d to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 
concer ning the placing of plant prote ction products on the mark et and repealing Council Directives 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-meth yl as an active substance in Annex I to Council 
Directive 91/414/EEC (3). 
(2)  Active substances included in Annex I to Directive 91/414/EEC are deemed to have been appro ved under 
Regulation (EC) No 1107/2009 and are liste d in Part A of the Annex to Commission Implementing Regulation 
(EU) No 540/2011 (4). 
(3)  The approval of the active substance tolclof os-meth yl, as set out in Part A of the Annex to Implementing 
Regulation (EU) No 540/2011, expires on 30 Apr il 2020. 
(4)  An application for the renewal of the approval of tolclofos-methyl was submitted in accordance with Article 1 of 
Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provi ded for in that Article. 
The applicant submitted the supplementar y dossiers required in accordance with Article 6 of Imple menting 
Regulation (EU) No 844/2012. The application was found to be complet e by the rappor teur Member State. 
(5)  The rappor teur Member State prepared a renewal assessment repor t in consultation with the co-rappor teur 
Member State and submitt ed it to the European Food Safet y Author ity (‘the Author ity’) and the Commission on 
11 November 2016. 
(6)  The Author ity communicate d the renewal assessment repor t to the applicant and to the Member States for 
comments and forwarded the comments received to the Commission. The Authority also made the supple ­
mentar y summar y dossier available to the public. 
(7)  On 8 December 2017, the Authority communicat ed to the Commission its conclusion (6) on whether tolclof os- 
meth yl can be expect ed to meet the approval criteria provid ed for in Article 4 of Regulation (EC) No 1107/2009. 
An amended version of this conclusion was adopt ed by the Author ity 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 scenar io out of the 3 is considered as acceptable ) from the representative uses in ornamental crops for 
prot ected structures. The initial version of the conclusions was remo ved from EFSA Jour nal. The Commission 
present ed the draf t renewal repor t for tolclofos-methyl to the Standing Committee on Plants, Animals, Food and 
Feed on 24 October 2018. 28.6.2019 L 175/20 Official Jour nal of the European Union EN     
(1)OJ L 309, 24.11.2009, p. 1. 
(2)Commission Directive 2006/39/EC of 12 Apr il 2006 amending Council Directive 91/414/EEC to include clodinaf op, pirimicarb, 
rimsulfuron, tolclof os-meth yl 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 concer ning 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 regar ds the list of approved active substances (OJ L 153, 11.6.2011, p. 1). 
(5)Commission Implementing Regulation (EU) No 844/2012 of 18 Sept ember 2012 setting out the provisions necessar y for the implemen ­
tation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and 
of the Council concer ning the placing of plant prot ection products on the market (OJ L 252, 19.9.2012, p. 26). 
(6)EFSA (European Food Safet y Authority), 2018. Conclusion on the peer review of the pesticide risk assessment of the active substance 
tolclof os-methyl. EFSA Journal 2018;16(1):5130 [25 pp.]. doi: 10.2903/j.efsa.2018.5130. (8)  As regar ds the criteria to identify endocr ine-disr upti ng proper ties introduced by Commission Regulation (EU) 
2018/605 (7), the conclusion of the Author ity, based on the fact that there was no evidence of endocr ine- 
mediat ed effects in vivo, indicate s that it is highly unlikely that tolclofos-meth yl is an endocr ine disrupter. Thus, 
the Commission concludes that tolclofos-methyl is not to be considered as having endocr ine-disr upting 
proper ties. 
(9)  The Commission invited the applicant to submit its comments on the amended version of the conclusion of the 
Author ity and, in accordance with the third paragraph of Article 14(1) of Imp lementing Regulation (EU) 
No 844/2012, on the draf t renewal repor t. 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 prote ction product 
containing tolclofos-methyl that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 
are satisfied. 
(11)  It is theref ore appropr iate to renew the appro val of tolclofos-meth yl. 
(12)  In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 of that 
Regulation and in the light of current scientifi c and technical kno wledge, it is, however , necessar y to provide for 
certain conditions and restr ictions. It is, in particular , appropr iate to restr ict the use of plant protection products 
containing tolclof os-meth yl in order to minimise the exposure for consumers to certain metabolites and to 
reduce the exposure of aquatic organisms and wild mammals to this substance by appro ving its use in 
ornamentals and potat oes only . 
(13) The risk assessment for the renewal of the approval of tolclofos-methyl is based on a limited number of represen ­
tative uses, whic h, however , do not restr ict the uses for which plant protection products containing tolclof os- 
meth yl may be author ised. It is theref ore appropr iate to remove the restr iction for use only as a fungicide. 
(14)  The Annex to Implemen ting Regulation (EU) No 540/2011 should theref ore be amended according ly. 
(15)  Commission Implemen ting Regulation (EU) 2019/168 (8) extended the approval period of tolclofos-methyl to 
30 Apr il 2020 in order to allow the renewal process to be complet ed before the expir y of the approval of that 
substance. However , given that a decision on renewal has been taken ahead of that extended expir y date, this 
Regulation should apply from 1 Septembe r 2019. 
(16)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
Renewal of appro val of activ e subs tance 
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. 28.6.2019 L 175/21 Official Jour nal of the European Union EN     
(7)Commission Regulation (EU) 2018/605 of 19 Apr il 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific 
criteria for the determination of endocr ine disrupting proper ties (OJ L 101, 20.4.2018, p. 33). 
(8)Commission Implementing Regulation (EU) 2019/168 of 31 Januar y 2019 amending Implementing Regulation (EU) No 540/2011 as 
regar ds the exten sion of the approval periods of the active substances abamectin, Bacillus subtilis (Cohn 1872) Strain QST 713, Bacillus 
thur ingiensis subsp. Aizaw ai, Bacillus thur ingiensis subsp. israeliensis, Bacillus thur ingiensis subsp. kurstaki, Beauveria bassiana, benf luralin, 
clodinaf op, clop yralid, Cydia pomonella Granulovir us (CpGV), cyprodinil, dichlor prop-P , epoxiconazole, fenpyroximate, fluazinam, 
flutolanil, fosetyl, Lecanicillium muscar ium, mepanip yrim, mepiquat, Metarhizium anisopliae var. Anisopliae, metconazole, metraf enone, 
Phlebiopsis gigantea, pirimicarb, Pseudomonas chloror aphis strain: MA 342, pyrimethanil, Pythium oligandr um, rimsulfuron, spinosad, 
Streptomyces K61, thiaclopr id, tolclof os-methyl, Trichoder ma asperellum, Trichoder ma atroviride, Trichoder ma gamsii, Trichoder ma harzianum, 
triclop yr, trinexapac, triticonazole, Verticillium albo-atr um and ziram (OJ L 33, 5.2.2019, p. 1). Article 3 
Entr y into force and date of application 
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union. 
It shall apply from 1 Sept ember 2019. 
This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 27 June 2019. 
For the Commission 
The President 
Jean-Claude JUNCK ER  28.6.2019 L 175/22 Official Jour nal of the European Union EN     ANNEX I 
Common Name,  
Identification Numbers IUPAC Name Purity(1) Date of approval Expiration of 
approval Specific provisions 
Tolclof os-methyl 
CAS No 57018-04-9 
CIPAC No 479 O-2,6-dichlor o-p-to ­
lylO, O-dimethyl 
phosphorothioat e 
O-2,6-dichlor o-4- 
meth ylphenyl O, O- 
dimeth yl phosphor ­
othioat e ≥ 960 g/kg 
The followi ng impurity is 
of toxicological concer n 
and must not exceed the 
following level in the 
technical mater ial: 
Methanol max. 1 g/kg 1 September 
2019 31 August 
2034 Only for use on ornamentals and on potat oes. 
For the implementation of the unif orm principles, as referred to in 
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the 
renewal repor t on tolclofos-meth yl, and in particular Appendices I and II 
thereof, shall be taken into account. 
In this overall assessment Member States shall pay particular attention 
to: 
—  the risk to aquatic organisms and mammals, 
—the risk to consumers, in particular the poten tial risk from metab ­
olite DM- TM-CH2OH in potatoes, 
—  the risk to operat ors, work ers and bystanders. 
Conditions of use shall include risk mitig ation measures, where appro ­
priate. 
(1)  Further details on identity and specification of active substance are provided in the renewal repor t.   28.6.2019 L 175/23 Official Jour nal of the European Union EN     ANNEX II 
The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:  
(1) in Part A, entr y 126 on tolclofos-methyl is deleted;  
(2) in Part B, the followi ng entr y is added: 
No Common Name,  
Identification Numbers IUPAC Name Purity(1) Date of approval Expiration of 
approval Specific provisions 
‘138 Tolclof os-methyl 
CAS No 57018-04-9 
CIPAC No 479 O-2,6-dichloro-p- 
tolylO, O-dimeth yl 
phosphorothioate 
O-2,6-dichloro-4- 
methylphen yl O, 
O-dimethyl phos ­
phorothioate ≥ 960 g/kg 
The follo wing impur ity 
is of toxicological 
concer n and must not 
exceed the followi ng 
level in the technical 
mater ial: 
Methanol max. 1 g/kg 1 Septembe r 
2019 31 August 
2034 Only for use on ornamentals and on potatoes. 
For the imple mentation of the unif orm principles, as refer red 
to in Article 29(6) of Regulation (EC) No 1107/2009, the 
conclusions of the renewal repor t on tolclofos-methyl, and in 
particular Appendices I and II thereof, shall be take n into ac­
count. 
In this overall assessment Member States shall pay particular 
attenti on to: 
—  the risk to aquatic organisms and mammals, 
—  the risk to consumers, in particular the poten tial risk 
from metabolite DM- TM-C H2OH in potat oes, 
—  the risk to operat ors, workers and bystanders; 
Conditions of use shall include risk mitig ation measures, 
where appropr iate.’ 
(1)  Further details on identity and specificatio n of active substance are provided in the renewal repor t.   28.6.2019 L 175/24 Official Jour nal of the European Union EN