Commission Implementing Regulation (EU) 2026/402 of 24 February 2026 concerning the authorisation of L-cystine produced with Escherichia coli DSM 34232 as a feed additive for all animal species

• CELEX: Implementing Regulation (EU) 2026/402
• Articles: 3

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 an additive 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

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L-cystine

Additive composition

L-cystine

Solid form

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Characterisation of the active substance

L-cystine produced with Escherichia coli DSM 34232

IUPAC name: (2R)-2-Amino-3-[[(2R)-2-amino-2-carboxyethyl]disulfanyl]propanoic acid

Chemical formula:C 6 H 12 N 2 O 4 S 2

CAS number: 56-89-3

FLAVIS number: 17.006

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

Analytical methods

( 1 )

For the identification of L-cystine in the feed additive:

—

Food Chemical Codex “L-cystine monograph”

For the determination of cystine in the feed additive:

—

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

For the determination of cystine in premixtures:

—

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

—

Commission Regulation (EC) No 152/2009  ( 2 ) , or

—

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

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 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 recommended maximum content referred to in point 3.

17 March 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 ).