Commission Implementing Regulation (EU) No 797/2011 of 9 August 2011 approving the active substance spiroxamine, 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 797/2011
• Articles: 6

Article 1 Approval of active substance

The active substance spiroxamine, 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 spiroxamine as an active substance by 30 June 2012.

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 Part B of 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 spiroxamine 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 December 2011 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 Part B of 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 spiroxamine as the only active substance, where necessary, amend or withdraw the authorisation by 31 December 2015 at the latest; or

(b)

in the case of a product containing spiroxamine as one of several active substances, where necessary, amend or withdraw the authorisation by 31 December 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 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 application

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union .

It shall apply from 1 January 2012.

Schedules & Appendices

ANNEX I

ANNEX I

Common name, identification numbers

IUPAC name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

Spiroxamine

CAS No 1181134-30-8

CIPAC No 572

8- tert -butyl-1,4-dioxaspiro[4.5]decan-2-

ylmethyl(ethyl)(propyl)amine (ISO)

≥ 940 g/kg

(diastereomers A and B combined)

1 January 2012

31 December 2021

PART A

Only uses as fungicide may be authorised.

PART B

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 spiroxamine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.

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

(1)

the risk to operators and workers and ensure that conditions of use include the application of adequate personal protective equipment;

(2)

the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;

(3)

the risk to aquatic organisms.

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

The notifier shall submit confirmatory information as regards:

(a)

the possible impact on the worker, the consumer and the environmental risk assessment of the potential stereo-selective degradation of each isomer in plant, animals and the environment;

(b)

the toxicity of the plant metabolites formed in fruit crops and the potential hydrolysis of fruit crop residues in processed commodities;

(c)

the groundwater exposure assessment for metabolite M03  ( 2 ) ;

(d)

the risk to aquatic organisms.

The notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) by two years after the adoption of specific guidance and the information set out in points (b), (c) and (d) by 31 December 2013.

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

( 2 )   M03: [(8-tert-butyl-1,4-dioxaspiro[4.5]dec-2-yl)methyl]ethyl(propyl)amine oxide.

ANNEX II

ANNEX II

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

(1)

in Part A, the entry relating to spiroxamine is deleted;

(2)

in Part B, the following entry is added:

‘7

Spiroxamine

CAS No 1181134-30-8

CIPAC No 572

8- tert -butyl-1,4-dioxaspiro[4.5]decan-2-ylmethyl(ethyl)(propyl)amine (ISO)

≥ 940 g/kg

(diastereomers A and B combined)

1 January 2012

31 December 2021

PART A

Only uses as fungicide may be authorised.

PART B

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 spiroxamine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.

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

(1)

the risk to operators and workers and ensure that conditions of use include the application of adequate personal protective equipment;

(2)

the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;

(3)

the risk to aquatic organisms.

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

The notifier shall submit confirmatory information as regards:

(a)

the possible impact on the worker, the consumer and the environmental risk assessment of the potential stereo-selective degradation of each isomer in plant, animals and the environment;

(b)

the toxicity of the plant metabolites formed in fruit crops and the potential hydrolysis of fruit crop residues in processed commodities;

(c)

the groundwater exposure assessment for metabolite M03  ( *1 ) ;

(d)

the risk to aquatic organisms.

The notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) by two years after the adoption of specific guidance and the information set out in points (b), (c) and (d) by 31 December 2013.

( *1 )   M03: [(8-tert-butyl-1,4-dioxaspiro[4.5]dec-2-yl)methyl]ethyl(propyl)amine oxide.’