Commission Implementing Regulation (EU) 2018/692

law://eu/reg/2018/692@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 2003/119/EC^note included zoxamide 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 zoxamide, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 January 2019.

(4)An application for the renewal of the approval of zoxamide 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.

(5)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.

(6)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 5 August 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 supplementary summary dossier available to the public.

(8)On 21 August 2017 the Authority communicated to the Commission its conclusion^note on whether zoxamide can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft renewal report for zoxamide to the Standing Committee on Plants, Animals, Food and Feed on 26 January 2018.

(9)The applicant was given the opportunity to submit comments on the draft renewal report.It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

(10)It is therefore appropriate to renew the approval of zoxamide.

(11)The risk assessment for the renewal of the approval of zoxamide is based on a limited number of representative uses, which, however, do not restrict the uses for which plant protection products containing zoxamide may be authorised. It is therefore appropriate to remove the restriction for use only as a fungicide.

(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 and technical knowledge, it is, however, necessary to include certain conditions and restrictions. It is, in particular, appropriate to require further confirmatory information.

(13)Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

(14)Commission Implementing Regulation (EU) 2018/84^note extended the expiry date of zoxamide to 31 January 2019 in order to allow the renewal process to be completed before the expiry of the approval of that active substance. However, given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation should apply from 1 July 2018.

(15)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 the approval of active substance#

The approval of the active substance zoxamide 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 July 2018.

Annex I

Common Name, Identification Numbers	IUPAC Name	Purity^note	Date of approval	Expiration of approval	Specific provisions
ZoxamideCAS No 156052-68-5CIPAC No 640	(RS)-3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-p-toluamide	≥ 953 g/kg	1 July 2018	30 June 2033	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 zoxamide, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of groundwater from metabolite RH-141455,the protection of bees, aquatic organisms and earthworms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in drinking water within two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater is made public by the Commission.

Annex II

(1)in Part A, the entry 77 on zoxamide is deleted;

(2)in Part B, the following entry is added:^noteNumberCommon Name, Identification NumbersIUPAC NamePurity^noteDate of approvalExpiration of approvalSpecific provisions‘123ZoxamideCAS No 156052-68-5CIPAC No 640(RS)-3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-p-toluamide≥ 953 g/kg1 July 201830 June 2033For 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 zoxamide, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:

—the protection of groundwater from metabolite RH-141455,

—the protection of bees, aquatic organisms and earthworms.

Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in drinking water within two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater is made public by the Commission.’

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

Commission Implementing Regulation (EU) 2018/692

Commission Implementing Regulation (EU) 2018/692

Article 1Renewal of the 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

Connections

Key facts

History · 2 versions

Article 1Renewal of the 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