
Article 1 
The active substance bitertanol, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
Article 2 

1. Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing bitertanol 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 bitertanol as either the only active substance or as one of several active substances, 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, where necessary, amend or withdraw the authorisation by 30 June 2014.
Article 3 
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
Article 4 
The line concerning bitertanol in the Annex to Decision 2008/934/EC is deleted.
Article 5 
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 8 December 2011.
For the Commission
The President
José Manuel BARROSO
ANNEX I

Common name, identification numbers IUPAC name Purity Date of approval Expiration of approval Specific provisions
BitertanolCAS No: 55179-31-2CIPAC No: 386 (1RS,2RS;1RS,2SR)-1-(biphenyl-4-yloxy)-3,3-dimethyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol (20:80 ratio of (1RS,2RS)- and (1RS,2SR)-isomers) ≥ 970 g/kg (A≥ 80, B≤ 20)RS + SR 80 – 90 %RR + SS 10 – 20 % 1 January 2012 30 June 2015 
PART A Only uses as fungicide for seed treatment may be authorised.
Member States shall ensure that authorisations provide that seed coating be performed exclusively in professional seed treatment facilities and that these facilities apply the best available techniques to exclude the release of dust clouds during storage, transport and application.

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 bitertanol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 October 2011 shall be taken into account.
In this overall assessment Member States:

((a)) shall pay particular attention to the risk to operators and workers and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;
((b)) shall pay particular attention to the dietary exposure of consumers to the residues of triazole derivative metabolites (TDMs);
((c)) shall pay particular attention to the risk to birds and mammals.
Conditions of use shall include risk mitigation measures, where appropriate.
The applicant shall submit confirmatory information as regards:

((1)) the toxicological relevance of the impurities BUE 1662, thus referred to for confidentiality reasons, and 3-chlorophenoxy compound;
((2)) the acute and short-term risk to granivorous birds;
((3)) the long-term risk to granivorous mammals;
((4)) residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin;
((5)) the possible impact of the variable isomer-ratio in the technical material and of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and the environmental risk assessment.
The applicant shall submit to the Commission, the Member States and the Authority the information set out in point (1) by 30 June 2012, the information set out in points (2), (3) and (4) by 31 December 2013 and the information set out in point (5) two years after the adoption of specific guidance.


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 Date of approval Expiration of approval Specific provisions
‘21 BitertanolCAS No: 55179-31-2CIPAC No: 386 (1RS,2RS;1RS,2SR)-1-(biphenyl-4-yloxy)-3,3-dimethyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol (20:80 ratio of (1RS,2RS)- and (1RS,2SR)-isomers) ≥ 970 g/kg (A ≥ 80, B ≤ 20)RS + SR 80 – 90 %RR + SS 10 – 20 % 1 January 2012 30 June 2015 
PART A Only uses as fungicide for seed treatment may be authorised.
Member States shall ensure that authorisations provide that seed coating be performed exclusively in professional seed treatment facilities and that these facilities apply the best available techniques to exclude the release of dust clouds during storage, transport and application.

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 bitertanol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 October 2011 shall be taken into account.
In this overall assessment Member States:

((a)) shall pay particular attention to the risk to operators and workers and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;
((b)) shall pay particular attention to the dietary exposure of consumers to the residues of triazole derivative metabolites (TDMs);
((c)) shall pay particular attention to the risk to birds and mammals.
Conditions of use shall include risk mitigation measures, where appropriate.
The applicant shall submit confirmatory information as regards:

((1)) the toxicological relevance of the impurities BUE 1662, thus referred to for confidentiality reasons, and 3-chlorophenoxy compound;
((2)) the acute and short-term risk to granivorous birds;
((3)) the long-term risk to granivorous mammals;
((4)) residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin;
((5)) the possible impact of the variable isomer-ratio in the technical material and of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and the environmental risk assessment.
The applicant shall submit to the Commission, the Member States and the Authority the information set out in point (1) by 30 June 2012, the information set out in points (2), (3) and (4) by 31 December 2013 and the information set out in point (5) two years after the adoption of specific guidance.’


