(1)

Pursuant to the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined Germany's application for the approval of amendments to the specification for the protected geographical indications ‘Rheinisches Zuckerrübenkraut’/‘Rheinischer Zuckerrübensirup’/‘Rheinisches Rübenkraut’, registered under Commission Implementing Regulation (EU) No 628/2012 (2).

(2)

Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the Official Journal of the European Union (3) as required by Article 50(2)(a) of that Regulation.

(3)

As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification should be approved,

(1)

In accordance with Article 7(1) of Regulation (EC) No 1107/2009 Austria received on 19 December 2013 an application from ISK Biosciences Europe N.V. for the approval of the active substance cyclaniliprole.

(2)

In accordance with Article 9(3) of that Regulation, the rapporteur Member State notified the applicant, the other Member States, the Commission and the European Food Safety Authority (hereinafter ‘the Authority’) of the admissibility of the application on 17 January 2014.

(3)

For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 11(2) and (3) of that Regulation, for the uses proposed by the applicant. The rapporteur Member State submitted a draft assessment report on 1 April 2015.

(4)

The draft assessment report was reviewed by the Member States and the Authority. The Authority presented to the Commission its conclusion on the pesticide risk assessment of the active substance cyclaniliprole (2) on 6 April 2016.

(5)

By letter of 28 September 2016 ISK Biosciences Europe N.V. withdrew its application for the approval of cyclaniliprole. Due to the withdrawal of the application, cyclaniliprole should not be approved pursuant to Article 13(2) of Regulation (EC) No 1107/2009.

(6)

This Regulation does not prejudice the submission of a further application for cyclaniliprole pursuant to Article 7 of Regulation (EC) No 1107/2009.

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

The active substance acrinathrin was approved in accordance with Regulation (EC) No 1107/2009 by Commission Implementing Regulation (EU) No 974/2011 (2) and is listed in Part B of the Annex to Commission Implementing Regulation (EU) No 540/2011 (3). In accordance with row 19 of Part B of the Annex to Implementing Regulation (EU) No 540/2011, ‘only uses as insecticide and acaricide may be authorised at rates not exceeding 22,5 g/ha per application’.

(2)

On 8 May 2012, Cheminova A/S, at whose request acrinathrin had been approved, submitted an application for an amendment to the conditions of approval of the active substance acrinathrin in order to allow uses as insecticide and acaricide to be authorised without rate restriction. That application was accompanied by information relating to the requested extension of uses. It was submitted to France, which had been designated rapporteur Member State by Commission Regulation (EC) No 1490/2002 (4).

(3)

France assessed the information submitted by the applicant and prepared an addendum to the draft assessment report. It submitted that addendum to the Commission, with a copy to the European Food Safety Authority, hereinafter ‘the Authority’, on 5 November 2012.

(4)

The Authority circulated the addendum to the applicant and the Member States and made it available to the public, granting a period of 60 days for the submission of written comments.

(5)

Taking into account the addendum to the draft assessment report, the Authority adopted its conclusion on acrinathrin on 21 November 2013 (5), as regards its unrestricted use as an insecticide and an acaricide.

(6)

The Authority communicated its conclusion to the applicant, the Member States and the Commission and made it available to the public. Taking into account the addendum to the draft assessment report by the rapporteur Member State and the conclusion of the Authority, the Commission presented a review report and a draft Regulation to the Standing Committee on Plants, Animals, Food and Feed.

(7)

The applicant was given the possibility to submit comments on the review report for acrinathrin including the addendum. The applicant submitted its comments, which have been carefully examined. However, despite the arguments put forward by the applicant, the concerns referred to in recital 8 could not be eliminated.

(8)

On the basis of the review report and other factors legitimate to the matter under consideration, it is to be considered that the additional information submitted by the applicant does not permit elimination of the specific concerns that led to the restriction of the use of acrinathrin at rates not exceeding 22,5 g/ha per application. In particular, acrinathrin is very toxic to fish and aquatic invertebrates and its acceptability on the basis of the current rates already require extensive risk mitigation. The new data provided by the applicant failed to demonstrate that the envisaged significant increase of rates, and consequently, of exposure, would still result in an acceptable risk for the concerned aquatic organisms. Finally, on the basis of confirmatory information submitted by the notifier, EFSA concludes that the higher rates would induce a high risk to non-target arthropods which further confirms that these rates cannot be increased.

(9)

Consequently, it has not been demonstrated that it may be expected that plant protection products containing acrinathrin satisfy in general the requirements laid down in Article 4(3) of Regulation (EC) No 1107/2009 when used as an insecticide or an acaricide without rate restrictions.

(10)

The conditions of approval of the active substance acrinathrin, as set out in row 19 of Part B of the Annex to Implementing Regulation (EU) No 540/2011, should, therefore, be confirmed.

(11)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

Commission Implementing Regulation (EU) No 798/2011 (2) approved oxyfluorfen as an active substance in accordance with Regulation (EC) No 1107/2009, under the condition that the Member States concerned ensure that the applicant at whose request oxyfluorfen was approved provides further confirmatory information on five specific aspects, one of which concerned the potential risk to aquatic organisms for the active substance and for the metabolites RH-45469, MW 306, MW 347, MW 274 and the unidentified metabolite Deg 27.

(2)

On 29 June and 15 December 2012 the applicant submitted additional information to address the confirmatory data requirements to the rapporteur Member State Spain within the time period provided for its submission.

(3)

Spain assessed the additional information submitted by the applicant. It submitted its assessment, in the form of an addendum to the draft assessment report, to the other Member States, the Commission and the European Food Safety Authority, hereinafter ‘the Authority’, on 14 July 2014.

(4)

The Member States, the applicant and the Authority were consulted and asked to provide comments on the assessment of the rapporteur Member State. The Authority published a Technical Report summarising the outcome of this consultation for oxyfluorfen on 6 November 2014 (3).

(5)

The Commission consulted the Authority in relation to certain areas of the assessment. The Authority presented its conclusion on the risk assessment of oxyfluorfen on 28 July 2015 (4). The draft assessment report, the addendum and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on Plants, Animals, Food and Feed and finalised on 24 January 2017 in the format of the Commission review report for oxyfluorfen.

(6)

The Commission invited the applicant to submit its comments on the review report for oxyfluorfen.

(7)

The Commission has considered that the additional information provided showed that parent substance and metabolites MW 347 and Deg 27 represent a high risk for aquatic organisms.

(8)

The Commission has concluded that the further confirmatory information required has not been fully provided and that a high risk for aquatic organisms resulting from exposure to oxyfluorfen and metabolites MW 347 and Deg 27 cannot be excluded except by imposing further restrictions.

(9)

In order to minimise the exposure of aquatic organisms, it is, therefore, appropriate to further restrict the conditions of use of this active substance and to provide for specific risk mitigation measures for the protection of those species.

(10)

The Annex to Commission Implementing Regulation (EU) No 540/2011 (5) should therefore be amended accordingly.

(11)

Member States should be provided with time to amend or withdraw authorisations for plant protection products containing oxyfluorfen.

(12)

For plant protection products containing oxyfluorfen, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest, expire on 21 June 2018.

(13)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

Commission Directive 2011/6/EU (2) included buprofezin as active substance in Annex I to Council Directive 91/414/EEC (3), under the condition that the Member States concerned ensure that the notifier, at whose request buprofezin was included in that Annex, provides further confirmatory information as regards the processing and conversion factors for consumer risk assessment.

(2)

Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

(3)

On 30 January 2013, the applicant submitted additional information concerning the processing and conversion factors to the rapporteur Member State United Kingdom within the time period provided for its submission.

(4)

The United Kingdom assessed the additional information submitted by the applicant. It submitted its assessment, in the form of an addendum to the draft assessment report, to the other Member States, the Commission and the European Food Safety Authority, hereinafter ‘the Authority’, on 9 September 2014.

(5)

The Commission consulted the Authority which presented its conclusion on the risk assessment of buprofezin on 28 July 2015 (5). The draft assessment report, the addendum and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on Plants, Animals, Food and Feed and finalised on 24 January 2017 in the format of the Commission review report for buprofezin.

(6)

The Commission invited the applicant to submit its comments on the review report for buprofezin.

(7)

The Commission has considered that the additional information provided showed that under high-temperature processing conditions buprofezin is degraded into several metabolites, including aniline. Aniline is a carcinogen for which a genotoxic mechanism cannot be excluded and therefore no threshold for acceptable exposure can be assumed.

(8)

The Commission has concluded that the further confirmatory information required has not been fully provided and that exposure of consumers to aniline via consumption of processed crops cannot be excluded except by imposing further restrictions. In particular, the use of buprofezin should be limited to non-edible crops only.

(9)

It is confirmed that the active substance buprofezin is to be deemed to have been approved under Regulation (EC) No 1107/2009. In order to minimise the exposure of consumers to aniline, it is, however, appropriate to amend the conditions of use of this active substance.

(10)

The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

(11)

Member States should be provided with time to amend or withdraw authorisations for plant protection products containing buprofezin.

(12)

For plant protection products containing buprofezin, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest, expire on 21 June 2018.

(13)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

(2)

The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

(1)

Tables I and II of Protocol No 2 to the Agreement list the products to which that Protocol applies. All products of heading HS 2202 fall within the scope of Protocol No 2, except fruit juice or vegetable juice diluted with water or aerated. Diverging interpretations on the definition of fruit juice or vegetable juice diluted with water or aerated have resulted in an inconsistent classification practice.

(2)

The description of the products of heading HS 2202 excluded from the scope of the protocol should therefore be clarified in Table II.

(3)

For the implementation of Protocol No 2 to the Agreement, domestic reference prices have been fixed for the Contracting Parties.

(4)

Actual prices have changed on the domestic markets of the Contracting Parties as regards raw materials for which price compensation measures are applied.

(5)

It is therefore necessary to update the reference prices and amounts listed in Tables III and IV, point (b) of Protocol No 2 accordingly,

(a)

Table II is amended as set out in Annex I to this Decision;

(b)

Table III is replaced by the text set out in Annex II to this Decision;

(c)

in Table IV, point (b) is replaced by the text set out in Annex III to this Decision.