Commission Implementing Regulation (EU) 2015/51 of 14 January 2015 approving the active substance chromafenozide, 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 allowing Member States to extend provisional authorisations granted for that active substance Text with EEA relevance

Approval of active substance

Article 1

The active substance chromafenozide, as specified in Annex I, is approved subject to the conditions laid down in that Annex.

Re-evaluation of plant protection products

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 chromafenozide as an active substance by 30 September 2015. 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 chromafenozide 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 March 2015 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 chromafenozide as the only active substance, where necessary, amend or withdraw the authorisation by 30 September 2016 at the latest; or (b) in the case of a product containing chromafenozide as one of several active substances, where necessary, amend or withdraw the authorisation by 30 September 2016 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.

Amendments to Implementing Regulation (EU) No 540/2011

Article 3

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Extension of existing provisional authorisations

Article 4

Member States may extend existing provisional authorisations for plant protection products containing chromafenozide for a period ending on 30 September 2016 at the latest.

Entry into force and date of application

Article 5

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 April 2015. However, Article 4 shall apply from the date of the entry into force of this Regulation.

ANNEX ISupplementary provisions

ANNEX I Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) Date of approval Expiration of approval Specific provisions Chromafenozide CAS No 143807-66-3 CIPAC No 775 N′-tert -butyl-5-methyl-N′-(3,5-xyloyl)chromane-6-carbohydrazide ≥ 935 g/kg The following relevant impurity must not exceed a certain threshold in the technical material: Butyl acetate (n-buthyl acetate, CAS No 123-86-4): ≤ 8 g/kg 1 April 2015 31 March 2025 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 chromafenozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 10 October 2014, shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the risk to groundwater, if the substance is applied under vulnerable soil or climatic conditions; (b) the risk to non-target Lepidoptera in off-crop areas; (c) the risk to sediment-dwelling organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the non-significance of the difference between the material used for ecotoxicological testing and the agreed specification of the technical material for the risk assessment; (2) the assessment of the risk to sediment dwelling organisms from metabolite M-010; (3) the leaching potential of metabolites M-006 and M-023 to groundwater. The applicant shall submit to the Commission, the Member States and the Authority the relevant information requested under (1) by 30 September 2015 and under (2) and (3) by 31 March 2017. ( 1 )   Further details on identity and specification of active substance are provided in the review report.

ANNEX IISupplementary provisions

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  ( *1 ) Date of approval Expiration of approval Specific provisions ‘81 Chromafenozide CAS No 143807-66-3 CIPAC No 775 N′-tert -butyl-5-methyl-N′-(3,5-xyloyl)chromane-6-carbohydrazide ≥ 935 g/kg The following relevant impurity must not exceed a certain threshold in the technical material: Butyl acetate (n-buthyl acetate, CAS No 123-86-4): ≤ 8 g/kg 1 April 2015 31 March 2025 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 chromafenozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 10 October 2014, shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the risk to groundwater, if the substance is applied under vulnerable soil or climatic conditions; (b) the risk to non-target Lepidoptera in off-crop areas; (c) the risk to sediment-dwelling organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the non-significance of the difference between the material used for ecotoxicological testing and the agreed specification of the technical material for the risk assessment; (2) the assessment of the risk to sediment dwelling organisms from metabolite M-010; (3) the leaching potential of metabolites M-006 and M-023 to groundwater. The applicant shall submit to the Commission, the Member States and the Authority the relevant information requested under (1) by 30 September 2015 and under (2) and (3) by 31 March 2017.’ ( *1 )   Further details on identity and specification of active substance are provided in the review report.