Commission Implementing Regulation (EU) 2020/1175 of 7 August 2020 concerning the authorisation of L-cysteine hydrochloride monohydrate produced by fermentation with Escherichia coli KCCM 80180 and Escherichia coli KCCM 80181 as a feed additive for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/1175
• Articles: 3

Article 1

The substances specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, are authorised as feed additives 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 .

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

2b920i

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L-cysteine hydrochloride monohydrate

Additive composition :

L-cysteine hydrochloride monohydrate

Characterisation of the active substance :

L-cysteine hydrochloride monohydrate

Produced by fermentation with Escherichia coli KCCM 80180 and Escherichia coli KCCM 80181

Purity: min. 98,5 %

Chemical formula: C 3 H 7 NO 2 S •HClH 2 O.

CAS number 7048-04-6

FLAVIS 17.032

Method of analysis

( 1 ) :

For the identification of L-cysteine hydrochloride monohydrate in the feed additive:

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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:

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ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FD)

For the quantification of L-cysteine hydrochloride monohydrate in premixtures:

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ion-exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS), Commission Regulation (EC) No 152/2009

(Annex III, F)

All animal species

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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. 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.

30.9.2030

( 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