Commission Implementing Regulation (EU) 2026/1012 of 7 May 2026 concerning the authorisation of L-cysteine, L-cysteine hydrochloride monohydrate and L-cysteine hydrochloride as feed additives for all animal species

• CELEX: Implementing Regulation (EU) 2026/1012
• Articles: 3

Article 1 Authorisation

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

Article 2 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 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/kg of complete feed with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b92457

L-cysteine

Additive composition

L-cysteine

Solid form

Characterisation of the active substance

L-cysteine

Purity: minimum 98 % on a dry matter basis

Produced by electrochemical reduction of L-cystine (produced with Escherichia coli DSM 34232)

IUPAC name: (2R)-2-amino-3-sulfanylpropanoic acid

Chemical formula:C 3 H 7 NO 2 S

CAS number: 52-90-4

FLAVIS number: 17.033

Analytical methods

( 1 )

For the identification of L-cysteine monohydrochloride in the feed additive:

—

Food Chemical Codex ‘L-cysteine monohydrochloride monograph’

For the determination of cysteine in the feed additive:

—

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

For the determination of cysteine in premixtures:

—

Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) – Commission Regulation (EC) No 152/2009  ( 2 )

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 premixtures, 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 per kg of complete feedingstuff with a moisture content of 12 %: 25mg.’

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 premixture where the use level on the label of the premixture would result in exceeding the content referred to in point 3.

28 May 2036

( 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

( 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 , ELI: http://data.europa.eu/eli/reg/2009/152/oj ).

Identification number of the additive

Name of the 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/kg of complete feed with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b17032

L-cysteine hydrochloride

Additive composition

L-cysteine hydrochloride

Solid form

Characterisation of the active substance

L-cysteine hydrochloride

Purity: minimum 98,5 % on a dry matter basis

Produced by electrochemical reduction of L-cystine (produced with Escherichia coli DSM 34232)

IUPAC name: (2R)-2-amino-3- sulfanylpropanoic acid; hydrochloride

Chemical formula:C 3 H 8 ClNO 2 S

CAS number: 52-89-1

FLAVIS number: 17.032

Analytical methods

( 3 )

For the identification of L-cysteine monohydrochloride in the feed additive:

—

Food Chemical Codex ‘L-cysteine monohydrochloride monograph’

For the determination of cysteine in the feed additive:

—

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

For the determination of cysteine in premixtures:

—

Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) – Commission Regulation (EC) No 152/2009

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 premixtures, 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 per kg of complete feedingstuff with a moisture content of 12 %: 25 mg.’

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 premixture where the use level on the label of the premixture would result in exceeding the content referred to in point 3.

5.

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 skin, eye and breathing protective equipment.

28 May 2036

( 3 )   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 .

Identification number of the additive

Name of the 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/kg of complete feed with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b920i

L-cysteine hydrochloride monohydrate

Additive composition

L-cysteine hydrochloride monohydrate Solid form

Characterisation of the active substance

L-cysteine hydrochloride monohydrate

Purity: minimum 98,5 % on a dry matter basis

Produced by electrochemical reduction of L-cystine (produced with Escherichia coli DSM 34232).

IUPAC name: (2R)-2-amino-3- sulfanylpropanoic acid; hydrate; hydrochloride;

Chemical formula:C 3 H 8 ClNO 2 S·H 2 O

CAS number: 7048-04-6

FLAVIS number: 17.032

Analytical methods

( 4 )

For the identification of L-cysteine monohydrochloride in the feed additive:

—

Food Chemical Codex ‘L-cysteine monohydrochloride monograph’

For the determination of cysteine in the feed additive:

—

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

For the determination of cysteine in premixtures:

—

Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) – Commission Regulation (EC) No 152/2009

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 premixtures, 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 per kg of complete feedingstuff with a moisture content of 12 %: 25 mg.’

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 premixture where the use level on the label of the premixture would result in exceeding the content referred to in point 3.

5.

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 skin, eye and breathing protective equipment.

28 May 2036

( 4 )   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 .