Commission Implementing Regulation (EU) 2019/1101

law://eu/reg/2019/1101@2026-11-12

Contents

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 products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC^note, and in particular Article 20(1) thereof,Whereas:

(1)Commission Directive 2006/39/EC^note included tolclofos-methyl as an active substance in Annex I to Council Directive 91/414/EEC^note.

(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 540/2011^note.

(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 approval of tolclofos-methyl was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012^note within the time period provided for in that Article. 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 complete by the rapporteur Member State.

(5)The rapporteur Member State prepared a renewal assessment report 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 supplementary summary dossier available to the public.

(7)On 8 December 2017, the Authority communicated to the Commission its conclusion^note 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 concerning the partially acceptable risk for aquatic organisms (one FOCUS scenario out of the 3 is considered as acceptable) from the representative uses in ornamental 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 criteria to identify endocrine-disrupting properties introduced by Commission Regulation (EU) 2018/605^note, the conclusion of the Authority, based on the fact that there was no evidence of endocrine-mediated effects in vivo, indicates that it is highly unlikely that tolclofos-methyl is an endocrine disrupter. Thus, the Commission concludes 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 Implementing Regulation (EU) 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 containing tolclofos-methyl that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

(11)It is therefore appropriate to renew the approval of tolclofos-methyl.

(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 scientific and technical knowledge, it is, however, necessary to provide for certain conditions and restrictions. It is, in particular, appropriate to restrict the use of plant protection products containing tolclofos-methyl 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 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 which plant protection products containing tolclofos-methyl may be authorised. It is therefore appropriate to remove the restriction for use only as a fungicide.

(14)The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

(15)Commission Implementing Regulation (EU) 2019/168^note extended the approval period of tolclofos-methyl to 30 April 2020 in order to allow the renewal process to be completed before the expiry of the approval of that substance. However, given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation should apply from 1 September 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 1Renewal of approval of active substance#

The approval of the active substance tolclofos-methyl is renewed as set out in Annex I.

Article 2Amendments 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 3Entry 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 September 2019.

Annex I

Common Name, Identification Numbers	IUPAC Name	Purity^note	Date of approval	Expiration of approval	Specific provisions
Tolclofos-methylCAS No 57018-04-9CIPAC No 479	O-2,6-dichloro-p-tolylO, O-dimethyl phosphorothioateO-2,6-dichloro-4-methylphenyl O, O-dimethyl phosphorothioate	≥ 960 g/kgThe following impurity is of toxicological concern and must not exceed the following level in the technical material:Methanol max. 1 g/kg	1 September 2019	31 August 2034	Only for use on ornamentals and on potatoes.For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on tolclofos-methyl, 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 potential risk from metabolite DM-TM-CH2OH in potatoes,the risk to operators, workers and bystanders.Conditions of use shall include risk mitigation measures, where appropriate.

Annex II

(1)in Part A, entry 126 on tolclofos-methyl is deleted;

(2)in Part B, the following entry is added:^noteNoCommon Name, Identification NumbersIUPAC NamePurity^noteDate of approvalExpiration of approvalSpecific provisions‘138Tolclofos-methylCAS No 57018-04-9CIPAC No 479O-2,6-dichloro-p-tolylO, O-dimethyl phosphorothioateO-2,6-dichloro-4-methylphenyl O, O-dimethyl phosphorothioate≥ 960 g/kgThe following impurity is of toxicological concern and must not exceed the following level in the technical material:Methanol max. 1 g/kg1 September 201931 August 2034Only for use on ornamentals and on potatoes.For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on tolclofos-methyl, 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 potential risk from metabolite DM-TM-CH₂OH in potatoes,

—the risk to operators, workers and bystanders;

Conditions of use shall include risk mitigation measures, where appropriate.’

The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

Commission Implementing Regulation (EU) 2019/1101

Commission Implementing Regulation (EU) 2019/1101

Article 1Renewal of approval of active substance#

Article 2Amendments to Implementing Regulation (EU) No 540/2011#

Article 3Entry into force and date of application#

Annex I

Annex II

History · 2 versions

Connections

Article 1Renewal of approval of active substance#

Article 2Amendments to Implementing Regulation (EU) No 540/2011#

Article 3Entry into force and date of application#

Annex I

Annex II

Key facts