Commission Implementing Regulation (EU) No 1330/2014 of 15 December 2014 approving the active substance meptyldinocap, 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) No 1330/2014
• Articles: 6

Article 1 Approval of active substance

The active substance meptyldinocap, as specified in Annex I, is approved subject to the conditions laid down in that Annex.

Article 2 Re-evaluation of plant protection products

1.   Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing meptyldinocap as an active substance by 30 September 2015.

By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.

2.   By way of derogation from paragraph 1, for each authorised plant protection product containing meptyldinocap as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 31 March 2015 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009.

Following that determination Member States shall:

(a)

in the case of a product containing meptyldinocap as the only active substance, where necessary, amend or withdraw the authorisation by 30 September 2016 at the latest; or

(b)

in the case of a product containing meptyldinocap as one of several active substances, where necessary, amend or withdraw the authorisation by 30 September 2016 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest.

Article 3 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 4 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 April 2015.

Schedules & Appendices

ANNEX I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

Meptyldinocap

CAS No 6119-92-2

CIPAC No 811

Mixture of 75-100 % ( RS )-2-(1-methylheptyl)-4,6-dinitrophenyl crotonate and 25-0 % ( RS )-2-(1-methylheptyl)-4,6-dinitrophenyl isocrotonate

≥ 900 g/kg (mixture of trans- and cis- isomers with a defined ratio range of 25:1 to 20:1)

Relevant impurity:

2,6-dinitro-4-[(4 RS )-octan-4-yl]phenyl (2 E/Z )-but-2-enoate

max content 0,4 g/kg

1 April 2015

31 March 2025

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on meptyldinocap, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 May 2014 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

(a)

the risk to operators;

(b)

the risk to aquatic invertebrates.

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

The applicant shall submit confirmatory information as regards:

(a)

the groundwater exposure assessment for metabolites (3 RS )-3-(2-hydroxy-3,5-dinitro-phenyl)-butanoic acid (X103317) and (2 RS )-2-(2-hydroxy-3,5-dinitro-phenyl)-propionic acid (X12335709);

(b)

the possible impact of any preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and the environment.

The applicant shall submit to the Commission, the Member States and the Authority the information set out in point (a) by 31 March 2017 and the information set out in point (b) two years after the adoption of specific guidance by the Commission.

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

ANNEX II

ANNEX II

In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

Number

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

‘80

Meptyldinocap

CAS No 6119-92-2

CIPAC No 811

Mixture of 75-100 % ( RS )-2-(1-methylheptyl)-4,6-dinitrophenyl crotonate and 25-– 0 % ( RS )-2-(1-methylheptyl)-4,6-dinitrophenyl isocrotonate

≥ 900 g/kg (mixture of trans- and cis- isomers with a defined ratio range of 25:1 to 20:1)

Relevant impurity:

2,6-dinitro-4-[(4 RS )-octan-4-yl]phenyl (2 E/Z )-but-2-enoate

max content 0,4 g/kg

1 April 2015

31 March 2015

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on meptyldinocap, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 May 2014 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

(a)

the risk to operators;

(b)

the risk to aquatic invertebrates.

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

The applicant shall submit confirmatory information as regards:

(a)

the groundwater exposure assessment for metabolites (3 RS )-3-(2-hydroxy-3,5-dinitro-phenyl)-butanoic acid (X103317) and (2 RS )-2-(2-hydroxy-3,5-dinitro-phenyl)-propionic acid (X12335709);

(b)

the possible impact of any preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and the environment.

The applicant shall submit to the Commission, the Member States and the Authority the information set out in point (a) by 31 March 2017 and the information set out in point (b) two years after the adoption of specific guidance by the Commission.’

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