Commission Implementing Regulation (EU) No 788/2011 of 5 August 2011 approving the active substance fluazifop-P, 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 and Commission Decision 2008/934/EC Text with EEA relevance

• CELEX: Implementing Regulation (EU) No 788/2011
• Articles: 7

Article 1 Approval of active substance

The active substance fluazifop-P, 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 fluazifop-P 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 fluazifop-P 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 fluazifop-P 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 fluazifop-P 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 Amendments to Decision 2008/934/EC

The line concerning fluazifop-P in the Annex to Decision 2008/934/EC is deleted.

Article 5 Entry into force and date of 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

Fluazifop-P

CAS No 83066-88-0 (fluazifop-P)

CIPAC No 467 (fluazifop-P)

(R)-2-{4-[5-(trifluoromethyl)-2-pyridyloxy]phenoxy}propionic acid (fluazifop-P)

≥ 900 g/kg in fluazifop-P-butyl

The following impurity 2-chloro-5-(trifluoromethyl) pyridine must not exceed 1,5 g/kg in the material as manufactured.

1 January 2012

31 December 2021

PART A

Only uses as herbicide for orchards (basal application) with one application every year 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 fluazifop-P-butyl, 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 the operator safety and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate,

—

shall pay particular attention to the protection of surface water and groundwater in vulnerable zones,

—

shall pay particular attention to the risk for non-target plants.

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

The applicant shall submit confirmatory information as regards:

(1)

the specification of the technical material, as commercially manufactured, including information on the relevance of the impurity R154719;

(2)

the equivalence between the specifications of the technical material, as commercially manufactured, and the specifications of the test material used in the toxicity studies;

(3)

the potential long-term risk to herbivorous mammals;

(4)

the fate and behaviour in the environment of the metabolite compounds X  ( 2 ) and IV  ( 3 ) ;

(5)

the potential risk to fish and aquatic invertebrates for the metabolite compound IV.

The applicant shall submit to the Commission, the Member States and the Authority the information set out in points (1) and (2) by 30 June 2012 and the information set out in points (3), (4) and (5) by 31 December 2013.

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

( 2 )   5-(trifluoromethyl)-2(1H)-pyridinone.

( 3 )   4-{[5-(trifluoromethyl)-2-pyridinyl]oxy}phenol.

ANNEX II

ANNEX II

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

‘15

Fluazifop P

CAS No 83066-88-0 (fluazifop-P)

CIPAC No 467 (fluazifop-P)

( R )-2-{4-[5-(trifluoromethyl)-2-pyridyloxy]phenoxy}propionic acid (fluazifop-P)

≥ 900 g/kg in fluazifop P-butyl

The following impurity 2-chloro-5-(trifluoromethyl)pyridine must not exceed 1,5 g/kg in the material as manufactured.

1 January 2012

31 December 2021

PART A

Only uses as herbicide for orchards (basal application) with one application every year 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 fluazifop-P-butyl, 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 the operator safety and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate,

—

shall pay particular attention to the protection of surface water and groundwater in vulnerable zones,

—

shall pay particular attention to the risk for non-target plants.

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

The applicant shall submit confirmatory information as regards:

(1)

the specification of the technical material, as commercially manufactured, including information on the relevance of the impurity R154719;

(2)

the equivalence between the specifications of the technical material, as commercially manufactured, and the specifications of the test material used in the toxicity studies;

(3)

the potential long-term risk to herbivorous mammals;

(4)

the fate and behaviour in the environment of the metabolite compounds X  ( *1 ) and IV  ( *2 ) ;

(5)

the potential risk to fish and aquatic invertebrates for the metabolite compound IV.

The applicant shall submit to the Commission, the Member States and the Authority the information set out in points (1) and (2) by 30 June 2012 and the information set out in points (3), (4) and (5) by 31 December 2013.

( *1 )   5-(trifluoromethyl)-2(1H)-pyridinone.

( *2 )   4-{[5-(trifluoromethyl)-2-pyridinyl]oxy}phenol.’