
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 
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, 5 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 219 on the active substance aluminium ammonium sulphate is replaced by the following:

Number Common name, identification numbers IUPAC name Purity Date of approval Expiration of approval Specific provisions
‘219 Aluminium ammonium sulphateCAS No 7784-26-1 (dodecahydrate), 7784-25-0 (anhydrous)CIPAC No 840 Aluminium ammonium sulphate ≥ 960 g/kg (expressed as dodecahydrate)≥ 502 g/kg (anhydrous) 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 review report on aluminium ammonium sulphate (SANCO/2985/2008) 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.
Conditions of use shall include, where appropriate, risk mitigation measures.
The notifier shall submit confirmatory information as regards:

((a)) the impact on the environment of the transformation/dissociation products of aluminium ammonium sulphate;
((b)) the risk to non-target terrestrial organisms other than vertebrates and aquatic organisms.
This information shall be submitted to the Member States, the Commission and the Authority by 1 January 2016.’


((2)) Row 229 on the active substance fat distillation residues is replaced by the following:

Number Common name, identification numbers IUPAC name Purity Date of approval Expiration of approval Specific provisions
‘229 Fat distillation residuesCAS No: not allocatedCIPAC No 915 Not available ≥ 40 % of cleaved fatty acidsRelevant impurity: Ni maximum 200 mg/kg 1 September 2009 31 August 2019 
PART A Only uses as repellent may be authorised. Fat distillation residues of animal origin must be in compliance with Regulation (EC) No 1069/2009 of the European Parliament and of the Council and Commission Regulation (EU) No 142/2011 (OJ L 54, 26.2.2011, p. 1).

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 fat distillation residues (SANCO/2610/2008) 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.
Conditions of use shall include, where appropriate, risk mitigation measures.
The notifier shall submit confirmatory information as regards the specification of the technical material and the analysis of the maximum levels of impurities and contaminants of toxicological concern. This information shall be submitted to the Member States, the Commission and the Authority by 1 May 2013.’


((3)) Row 248 on the active substance repellents by smell of animal or plant origin/fish oil is replaced by the following:

Number Common name, identification numbers IUPAC name Purity Date of approval Expiration of approval Specific provisions
‘248 Fish oilCAS No 100085-40-3CIPAC No 918 Fish oil ≥ 99 %Relevant impurity:
 Dioxine max. 6 pg/kg for animal feed
 Hg max. 0,5 mg/kg feed derived from fish and other sea food processing
 Cd max. 2 mg/kg feed of animal origin except in feed for domestic pets
 Pb max. 10 mg/kg
 PCBs max. 5 mg/kg 1 September 2009 31 August 2019 
PART A Only uses as repellent may be authorised. Fish oil must be in compliance with Regulation (EC) No 1069/2009 and Regulation (EU) No 142/2011.

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 fish oil (SANCO/2629/2008) 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.
Conditions of use shall include, where appropriate, risk mitigation measures.
The notifier shall submit confirmatory information as regards the specification of the technical material and the analysis of the maximum levels of impurities and contaminants of toxicological concern. This information shall be submitted to the Member States, the Commission and the Authority by 1 May 2013.’


((4)) Row 257 on the active substance urea is replaced by the following:

Number Common name, identification numbers IUPAC name Purity Date of approval Expiration of approval Specific provisions
‘257 UreaCAS No 57-13-6CIPAC No 913 Urea ≥ 98 % w/w 1 September 2009 31 August 2019 
PART A Only uses as attractant and 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 urea (SANCO/2637/2008) 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.
Conditions of use shall include, where appropriate, risk mitigation measures.
The notifier shall submit confirmatory information as regards:

((a)) the analysis method for urea and for the impurity biuret;
((b)) the risk for operators, workers and bystanders.
The information set out in point (a) and in point (b) shall be submitted to the Member States, the Commission and the Authority respectively by 1 May 2013 and 1 January 2016.’


