Commission Implementing Regulation (EU) No 375/2013 of 23 April 2013 approving the active substance spiromesifen, 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 375/2013
• Articles: 6

Article 1 Approval of active substance

The active substance spiromesifen, 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 spiromesifen as an active substance by 31 March 2014.

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 spiromesifen 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 30 September 2013 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 spiromesifen as the only active substance, where necessary, amend or withdraw the authorisation by 31 March 2015 at the latest; or

(b)

in the case of a product containing spiromesifen as one of several active substances, where necessary, amend or withdraw the authorisation by 31 March 2015 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 October 2013.

Schedules & Appendices

ANNEX I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

Spiromesifen

CAS No 283594-90-1

CIPAC No 747

3-mesityl-2-oxo-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutyrate

≥ 965 g/kg (racemic)

The impurity N,N-dimethylacetamide is of toxicological relevance and must not exceed 4 g/kg in the technical material.

1 October 2013

30 September 2023

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 spiromesifen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013, shall be taken into account.

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

—

the long-term risk to aquatic invertebrates,

—

the risk to pollinating hymenoptera and non-target arthropods if exposure is not negligible,

—

the protection of workers and operators.

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

The applicant shall submit confirmatory information as regards the recalculation of the predicted concentration in groundwater (PECGW) with a FOCUS GW scenario adapted to the supported uses using a Q10 value of 2,58.

The applicant shall submit to the Commission, the Member States and the Authority that information by 30 September 2015.

( 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

‘41

Spiromesifen

CAS No 283594-90-1

CIPAC No 747

3-mesityl-2-oxo-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutyrate

≥ 965 g/kg (racemic)

The impurity N,N-dimethylacetamide is of toxicological relevance and must not exceed 4 g/kg in the technical material.

1 October 2013

30 September 2023

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 spiromesifen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013, shall be taken into account.

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

—

the long-term risk to aquatic invertebrates,

—

the risk to pollinating hymenoptera and non-target arthropods if exposure is not negligible,

—

the protection of workers and operators.

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

The applicant shall submit confirmatory information as regards the recalculation of the predicted concentration in groundwater (PECGW) with a FOCUS GW scenario adapted to the supported uses using a Q10 value of 2,58.

The applicant shall submit to the Commission, the Member States and the Authority that information by 30 September 2015.’

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