COMMISSION IMPLEMENTING REGULATION (EU) No 832/2012

of 17 September 2012

concerning the authorisation of a preparation of ammonium chloride as a feed additive for lambs for fattening (holder of authorisation Latochema Co. Ltd)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition(1), and in particular Article 9(2) thereof,

Whereas:

(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) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of ammonium chloride. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3) The application concerns the authorisation of the preparation of ammonium chloride, as specified in the Annex, as a feed additive for lambs for fattening, to be classified in the additive category ‘zootechnical additives’.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 31 January 2012(2) that, under the proposed conditions of use and for a limited period of feeding, the preparation of ammonium chloride, as specified in the Annex, does not have an adverse effect on animal health, human health or the environment, and that its use can reduce the pH value in the urine in lambs for fattening. 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) The assessment of the preparation of ammonium chloride, as specified in the Annex, shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this preparation should be authorised as specified in the Annex to this Regulation.

(6) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the

Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 17 September 2012.

For the Commission

The President

José Manuel BARROSO

(1)

OJ L 268, 18.10.2003, p. 29

(2)

EFSA Journal 2012

; 10(2):2569.

ANNEX

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of the additive/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: other zootechnical additives (reduction of urinary pH)

4d7

Latochema

Co. Ltd

Ammonium chloride

Additive composition

Ammonium chloride ≥ 99,5 %

(Solid form)

Characterisation of the active substance

Ammonium chloride ≥ 99,5 %

NH4Cl CAS No: 12125-02-9

Sodium chloride ≤ 0,5 %

Produced by chemical synthesis

Method of Analysis (1)

Quantification of ammonium chloride in feed additive: titration with sodium hydroxide (European Pharmacopoeia, monograph 0007) or titration with silver nitrate (JECFA monograph ‘ammonium chloride).

Lambs for fattening

—

10 000

1.	The additive shall be incorporated into feed in the form of a premixture.

2.	For safety: breathing protection, eye protection, gloves and protective clothing shall be used during handling.

3.	Feed containing the additive shall not be feed for a period exceeded three months.

8 October 2022

(1) Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx