(1)

In accordance with Council Directive 70/524/EEC (2) monensin sodium and narasin, were authorised as feed additives by, respectively, Commission Regulations (EC) No 1356/2004 (3) and (EC) No 1464/2004 (4).

(2)

In accordance with Regulation (EC) No 1831/2003, endo-1,4-beta-mannanase and diclazuril were authorised as feed additives by, respectively, Commission Regulations (EC) No 786/2007 (5), (EC) No 971/2008 (6), (EU) No 1118/2010 (7), (EU) No 169/2011 (8) and Commission Implementing Regulations (EU) No 888/2011 (9) and (EU) No 667/2013 (10).

(3)

The holder of authorisation, Eli Lilly and Company Ltd, has submitted an application in accordance with Article 13(3) of Regulation (EC) No 1831/2003 proposing to change the name of the holder of the authorisation for the feed additives concerned.

(4)

The holder of authorisation claims that, with effect from 30 March 2018, Elanco GmbH, a division of Eli Lilly and Company Ltd owns the marketing rights for the additives concerned. The holder of authorisation has submitted relevant data supporting its request.

(5)

The proposed change of the terms of the authorisation is purely administrative in nature and does not entail a fresh assessment of the additives concerned. The European Food Safety Authority was informed of the application.

(6)

To allow Elanco GmbH to exploit its marketing rights it is necessary to change the terms of the authorisations concerned.

(7)

Regulations (EC) No 1356/2004, (EC) No 1464/2004, (EC) No 786/2007, (EC) No 971/2008, (EU) No 1118/2010, (EU) No 169/2011 and Implementing Regulations (EU) No 888/2011 and (EU) No 667/2013, should, therefore, be amended accordingly.

(8)

Since safety reasons do not require the immediate application of the amendments made by this Regulation, it is appropriate to allow a transitional period during which existing stocks may be used up.

(9)

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

(1)

In accordance with Article 7(1) of Regulation (EC) No 1107/2009 the Netherlands received on 28 October 2014 an application from Exosect Limited for the approval of the active substance Beauveria bassiana strain IMI389521.

(2)

In accordance with Article 9(3) of Regulation (EC) No 1107/2009, the Netherlands, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (‘the Authority’) on 2 June 2015 of the admissibility of the application.

(3)

On 22 February 2016 the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

(4)

The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, it requested that the applicant supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report on 2 February 2017.

(5)

On 26 April 2017 the Authority communicated to the applicant, the Member States and the Commission its conclusion (2) on whether the active substance Beauveria bassiana strain IMI389521 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority made its conclusion available to the public.

(6)

On 24 October 2018 the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the draft review report for Beauveria bassiana strain IMI389521 and a draft Regulation providing that Beauveria bassiana strain IMI389521 is approved.

(7)

It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

(8)

It is therefore appropriate to approve Beauveria bassiana strain IMI389521.

(9)

In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions. In particular, it is appropriate to include risk mitigation measures where appropriate.

(10)

In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (3) should be amended accordingly.

(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)

On 18 September 2015 and 1 October 2015, the Council adopted Decisions (EU, Euratom) 2015/1600 (1) and (EU, Euratom) 2015/1790 (2) appointing the members of the European Economic and Social Committee for the period from 21 September 2015 to 20 September 2020.

(2)

A member's seat on the European Economic and Social Committee has become vacant following the end of the term of office of Ms Annie VAN WEZEL,

(1)

On 26 January 2015, 5 February 2015 and 23 June 2015, the Council adopted Decisions (EU) 2015/116 (1), (EU) 2015/190 (2) and (EU) 2015/994 (3) appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2015 to 25 January 2020.

(2)

An alternate member's seat on the Committee of the Regions has become vacant following the passing away of Mr Ralf GEISTHARDT,

(1)

Articles 7b and 7c of, and Annex IV to, Directive 98/70/EC and Articles 17 and 18 of, and Annex V to, Directive 2009/28/EC lay down similar sustainability criteria for biofuels and bioliquids, and similar procedures for verifying that biofuels and bioliquids comply with those criteria.

(2)

Where biofuels and bioliquids are to be taken into account for the purposes referred to in Article 17(1)(a), (b) and (c) of Directive 2009/28/EC, Member States must require economic operators to show that biofuels and bioliquids fulfil the sustainability criteria set out in Article 17(2) to (5) of that Directive.

(3)

The request for recognition that the ‘U.S. Soybean Sustainability Assurance Protocol’ demonstrates that consignments of biofuel comply with the sustainability criteria set out in Directives 98/70/EC and 2009/28/EC was submitted to the Commission on 15 November 2018. The scheme is based in 16305 Swingley Ridge Road, Suite 200 Chesterfield, MO 63017, United States. It covers soybeans produced in the United States and the chain of custody from the farms producing the soybeans to the place where they are exported.

(4)

In assessing the ‘U.S. Soybean Sustainability Assurance Protocol’ the Commission found that the scheme covers adequately the sustainability criteria set out in Directives 98/70/EC and 2009/28/EC, and uses a mass balance system in accordance with Article 7c(1) of Directive 98/70/EC and Article 18(1) of Directive 2009/28/EC.

(5)

The assessment of the ‘U.S. Soybean Sustainability Assurance Protocol’ found that it meets adequate standards of reliability, transparency and independent auditing and complies with the methodological requirements set out in Annex IV to Directive 98/70/EC and in Annex V to Directive 2009/28/EC.

(6)

The measures provided for in this Decision are in accordance with the opinion of the Committee on the Sustainability of Biofuels and Bioliquids,