Commission Implementing Regulation (EU) 2023/1710 of 7 September 2023 concerning the renewal of the authorisation of a preparation of ammonium chloride as a feed additive for all ruminants and cats and dogs, an authorisation of a preparation of ammonium chloride as a feed additive for sows (holder of the authorisation: Latochema Co. Ltd) and repealing Implementing Regulations (EU) No 832/2012 and (EU) 2016/1007 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2023/1710
• Articles: 5

Article 1 Renewal of the authorisation

The authorisation of the preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, is renewed for ruminants, cats and dogs, subject to the conditions laid down in that Annex.

Article 2 Authorisation

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

Article 3 Repeal

Implementing Regulations (EU) No 832/2012 and (EU) 2016/1007 are repealed.

Article 4 Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Schedules & Appendices

ANNEX

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

Preparation of ammonium chloride ≥ 99,5 %

Solid form

Characterisation of the active substance

Ammonium chloride ≥ 99,5 %

Chemical formula: NH 4 Cl

CAS No: 12125-02-9

Sodium chloride ≤ 0,5 % Produced by chemical synthesis

Analytical method

( 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.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

2.

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

3.

For lambs for fattening, the additive shall be used for a feeding period which does not exceed three months.

4.

For ruminants other than lambs for fattening the additive shall be used under the following conditions:

—

maximum content of 5 000 mg additive/kg complete feed for a feeding period exceeding three months or

—

maximum content of 10 000 mg additive/kg complete feed for a feeding period not exceeding three months.

5.

For sows the additive shall only be used from 9th to 11th week of gestation and from 15th week of gestation to 1st week of lactation.

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal eye and breathing protective equipment.

7.

The mixture of different sources of ammonium chloride shall not exceed the permitted maximum levels in complete feedingstuffs for ruminants, including lambs for fattening, for cats, dogs and sows.

28 September 2033

Ruminants other than lambs for fattening

—

—

5 000 / 10 000

Cats and dogs

—

—

5 000

Sows

—

—

5 000

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en.