(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

(2)

The use of preparation of narasin and nicarbazin as a feed additive was authorised for 10 years for chickens for fattening by Commission Regulation (EU) No 885/2010 (2).

(3)

In accordance with Article 13(3) of Regulation (EC) No 1831/2003, the holder of the authorisation proposed changing the terms of authorisation of the preparation by submitting an application to modify the content of micro tracer red from 11 g/kg to a range of 4-11g/kg. The application was accompanied by the relevant supporting data.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 18 October 2016 (3) that the reduction of the content of micro tracer red from 11g/kg to a range of 4-11g/kg of additive has no effect on the physicochemical and biological properties of the additive. Therefore it came to the conclusion that the assessment of safety and efficacy made for the former formulation with 11g/kg micro tracer red is still valid for the new formulation. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5)

On 10 July 2018 Eli Lilly and Company Ltd has also submitted an application under Article 13(3) of Regulation (EC) No 1831/2003 proposing to change the name of the holder of the authorisation. The applicant claimed that, with effect from 3 April 2018, Elanco GmbH, a division of Eli Lilly and Company Ltd, is to be considered holder of the marketing rights for the above mentioned additive. The application was accompanied by the relevant supporting data.

(6)

The proposed change of the terms of the authorisation concerning the name of the holder of the authorisation is purely administrative in nature and does not entail a new assessment of the additive concerned. The Authority was informed of the application.

(7)

The assessment of the preparation of narasin and nicarbazin with the new content of micro-tracer red shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.

(8)

Regulation (EU) No 885/2010 should therefore be amended accordingly.

(9)

Since safety reasons do not require the immediate application of the amendments made by this Regulation, it is appropriate to provide for a transitional period during which the existing stocks of the feed additive narasin and nicarbazin, which are in conformity with the provisions applying before the date of entry into force of this Regulation may continue to be placed on the market and used until they are exhausted.

(10)

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

a)

in column 2, the words ‘Eli Lilly and Company Ltd’ are replaced by ‘Elanco GmbH’;

b)

in column 4 ‘Composition, chemical formula, description, analytical method’, ‘Additive composition’, in the content of Micro tracer red, the words ‘11 g/kg’ are replaced by ‘4-11 g/kg’.