Commission Implementing Regulation (EU) 2020/1761 of 25 November 2020 concerning the authorisation of L-cysteine hydrochloride monohydrate produced by fermentation with Escherichia coli KCCM 80109 and KCCM 80197 as a feed additive for all animal species (Text with EEA relevance)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
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.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
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 authorisatio n mg of active substance/kg of complete feedingstuff with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b920i - L-cysteine hydrochloride monohydrate Additive composition L-cysteine hydrochloride monohydrate Characterisation of the active substance L-cysteine hydrochloride monohydrate Produced by fermentation with Escherichia c oli KCCM 80109 and KCCM 80197 Purity: ≥ 98,5 % assay Chemical formula: C 3 H 7 NO 2 S•HClH 2 O CAS number: 7048-04-6. FLAVIS number: 17.032 Method of analysis ( 1 ) For the identification of L-cysteine hydrochloride monohydrate in the feed additive: ion-exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS), Ph.Eur. 6.6-2.2.56-Method 1 For the quantification of L-cysteine hydrochloride monohydrate in the feed additive: ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FD) For the quantification of L-cysteine hydrochloride monohydrate in premixtures: ion-exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS), Commission Regulation (EC) No 152/2009 ( 2 ) Annex III, F) All animal species - - - 1. The additive shall be incorporated into the feed in the form of a premixture. 2. In the directions for use of the additive and premixture, the storage conditions and the stability to heat treatment shall be indicated. 3. On the label of the additive the following shall be indicated: ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg’ 4. The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 25 mg/kg. 5. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves 16.12.2030 ( 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 ).
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.