Commission Implementing Regulation (EU) 2015/2306 of 10 December 2015 concerning the authorisation of L-cysteine hydrochloride monohydrate as a feed additive for cats and dogs (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2015/2306
• Articles: 4

Article 1 Authorisation

The substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, is authorised as a feed additive in animal nutrition subject to the conditions laid down in that Annex.

Article 2 Transitional Measures

1.   The substance specified in the Annex and premixtures containing this substance, which are produced and labelled before 30 June 2016 in accordance with the rules applicable before 31 December 2015 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Compound feed and feed materials containing the substance specified in the Annex which are produced and labelled before 31 December 2017 in accordance with the rules applicable before 31 December 2015 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 3 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 active substance/kg of complete feedingstuff with a moisture content of 12 %.

Category: Sensory additives. Functional group: Flavouring compounds.

2b920

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L-cysteine hydrochloride monohydrate

Additive composition

L-cysteine hydrochloride monohydrate.

Characterisation of the active substance

L-cysteine hydrochloride monohydrate

C 3 H 7 NO 2 S·HClH 2 O

CAS No: 7048-04-6

L-cysteine hydrochloride monohydrate solid form, produced by hydrolysis of keratin from avian feathers.

Purity: min. 98,5 % assay.

Method of analysis

( 1 )

For the quantification of L-cysteine hydrochloride monohydrate in feed additive: titrimetry, European Pharmacopoeia (Ph. Eur. 6,0, method 01/2008:0895).

For the quantification of Cyst(e)ine (including L-cysteine hydrochloride monohydrate) in premixtures and feedingstuffs: ion exchange chromatography method with post-column derivatisation and photometric detection: Commission Regulation (EC) No 152/2009  ( 2 ) (Annex III, F).

Cats and dogs

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1.

Indicate in the directions for use of the additive and premixture:

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the storage conditions;

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supplementation with L-cysteine hydrochloride monohydrate shall depend on the requirements of cats and dogs for sulphur-containing amino acids and the level of other sulphur-containing amino acids in the ration.

2.

For safety: breathing protection, safety glasses and gloves shall be worn during handling.

31 December 2025

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

( 2 )   Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed ( OJ L 54, 26.2.2009, p. 1 ).