Commission Implementing Regulation (EU) 2018/692 of 7 May 2018 renewing the approval of the active substance zoxamide 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. )

• CELEX: Implementing Regulation (EU) 2018/692
• Articles: 5

Article 1 Renewal of the approval of active substance

The approval of the active substance zoxamide 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 July 2018.

Schedules & Appendices

ANNEX I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

Zoxamide

CAS No 156052-68-5

CIPAC 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.

( 1 )   Further details on identity and specification of active substance are provided in the review report.

ANNEX II

ANNEX II

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

(1)

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

(2)

in Part B, the following entry is added:

Number

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

‘123

Zoxamide

CAS No 156052-68-5

CIPAC 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.’

( 1 )   Further details on identity and specification of active substance are provided in the review report.