
Article 1 
The active substance orange oil, 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 orange oil as an active substance by 31 October 2014.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 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 orange oil 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 30 April 2014 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 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 orange oil as the only active substance, where necessary, amend or withdraw the authorisation by 31 October 2015 at the latest; or
(b) in the case of a product containing orange oil as one of several active substances, where necessary, amend or withdraw the authorisation by 31 October 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 those substances, whichever is the latest.
Article 3 
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
Article 4 
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 May 2014.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 18 November 2013.
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
Orange oilCAS No 8028-48-6 (Orange extract)5989-27-5 (D-limonene)CIPAC No 902 (R)-4-isopropenyl-1-methylcyclohexene or p-mentha-1,8-diene ≥ 945 g/kg (of D-limonene)The active substance shall comply with the specifications of Ph. Eur. (Pharmacopoeia Europea) 5.0 (Aurantii dulcis aetheroleum) and ISO 3140:2011(E) 1 May 2014 30 April 2024 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 orange oil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to:
((a)) the protection of operators and workers;
((b)) 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 metabolite fate of orange oil and the route and rate of degradation in soil;
((2)) the validation of endpoints used in the ecotoxicological risk assessment.The applicant shall submit that information to the Commission, Member States and the Authority by 30 April 2016.

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
‘56 Orange oilCAS No 8028-48-6 (Orange extract)5989-27-5 (D-limonene)CIPAC No 902 (R)-4-isopropenyl-1-methylcyclohexene or p-mentha-1,8-diene ≥ 945 g/kg (of D-limonene)The active substance shall comply with the specifications of Ph. Eur. (Pharmacopoeia Europea) 5.0 (Aurantii dulcis aetheroleum) and ISO 3140:2011(E) 1 May 2014 30 April 2024 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 orange oil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to:
((a)) the protection of operators and workers;
((b)) the risk to birds and mammals.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards the metabolite fate of orange oil and the route and rate of degradation in soil and on the validation of endpoints used in the ecotoxicological risk assessment.The applicant shall submit that information to the Commission, Member States and the Authority by 30 April 2016.’

