
Article 1 
Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.
Article 2 
Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing repellents by smell of animal or plant origin/tall oil crude as active substances in order to comply with the Annex to this Regulation by 1 May 2013.
Article 3 
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 November 2012.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 13 July 2012.
For the Commission
The President
José Manuel BARROSO
ANNEX

Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

((1)) Row 235 on the active substance iron sulphate is replaced by the following:

Number Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions
'235 Iron sulphate:
 Iron(II)sulfate anhydrous: CAS No 7720-78-7
 Iron(II)sulfate monohydrate: CAS No 17375-41-6
 Iron(II)sulfate heptahydrate: CAS No 7782-63-0CIPAC No 837 Iron(II)sulphateoriron(2+) sulfate Iron(II)sulfate anhydrous: ≥ 350 g/kg total iron.Relevant impurities:
 arsenic, 18 mg/kg
 cadmium, 1,8 mg/kg
 chromium, 90 mg/kg
 lead, 36 mg/kg
 mercury, 1,8 mg/kgexpressed on the basis of the anhydrous variant 1 September 2009 31 August 2019 
PART A Only uses as herbicide 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 amended review report on iron sulphate (SANCO/2616/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.
In this overall assessment Member States shall pay particular attention to:

— the risk for operator;
— the risk to children/residents playing on treated turf;
— the risk to surface waters and to aquatic organisms.
Conditions of use shall include, where appropriate, risk mitigation measures and the application of adequate personal protective equipment. The notifier shall submit to the Member States, the Commission and the Authority, confirmatory information as regards the equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the toxicity dossiers.
The Member States concerned shall ensure that the notifier submits to the Commission such information by 1 May 2013.'


((2)) Row 250 on the active substance Repellents by smell of animal or plant origin/tall oil crude is replaced by the following:

Number Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions
'250 Repellents by smell of animal or plant origin/tall oil crude:CAS No 8002-26-4CIPAC No 911 Not available The qualitative parameters below comprise the specification of repellents by smell of animal or plant origin/tall oil crude:
 acid number: min. 125 mgKOH/g
 water content: max. 2 %
 rosin acid content: min. 35 % (proposed)
 ash content: max. 0,2 %
 pH: approx. min. 5,5
 unsaponifiables: max. 12 %
 free mineral acids: max. 0,02 % 1 September 2009 31 August 2019 
PART A Only uses as repellent applied by glove or brush 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 amended review report on repellents by smell of animal or plant origin/tall oil crude (SANCO/2631/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.
In assessing applications to authorise plant protection products containing Repellents by smell of animal or plant origin/tall oil crude for uses other than as a repellent in forestry, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary information is provided before such an authorisation is granted.
In this overall assessment Member States shall pay particular attention to:

— the protection of operator, worker and bystander;
— the risk to non target species.
Conditions of use shall include, where appropriate, risk mitigation measures.
The Member States concerned shall request the submission of confirmatory information as regards:

((a)) the equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the toxicity dossiers;
((b)) the toxicological profile of repellents by smell of animal or plant origin/tall oil crude.
The Member States concerned shall ensure that the notifier submits to the Commission the information set out in point (a) by 1 May 2013 and the information set out in point (b) by 31 May 2014.'


((3)) Row 251 on the active substance Repellents by smell of animal or plant origin/tall oil pitch is replaced by the following:

Number Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions
'251 Repellents by smell of animal or plant origin/tall oil pitch:CAS No 8016-81-7CIPAC No 912 Not available Complex mixture of esters of fatty acids, rosin and small amounts of dimers and trimers of resin acids and fatty acids. 1 September 2009 31 August 2019 
PART A Only uses as repellent 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 amended review report on repellents by smell of animal or plant origin/tall oil pitch (SANCO/2632/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.
In assessing applications to authorise plant protection products containing repellents by smell of animal or plant origin/tall oil pitch for uses other than as a repellent in forestry applied by glove or brush, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary information is provided before such an authorization is granted.
In this overall assessment Member States shall pay particular attention to:

— the protection of operator, worker and bystander;
— the risk to non target species.
Conditions of use shall include risk mitigation measures, where appropriate.
The Member States concerned shall request the submission of confirmatory information as regards:

((a)) the equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the toxicity dossiers;
((b)) the toxicological profile of repellents by smell of animal or plant origin/tall oil pitch.
The Member States concerned shall ensure that the notifier submits to the Commission the information set out in point (a) by 1 May 2013 and the information set out in point (b) by 31 May 2014.'


