Commission Implementing Regulation (EU) 2025/272 of 12 February 2025 concerning the renewal of the authorisation of L-cystine as a feed additive for all animal species and repealing Implementing Regulation (EU) No 1006/2013

• CELEX: Implementing Regulation (EU) 2025/272
• Articles: 5

Article 1 Renewal of the authorisation

The authorisation of the substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’, is renewed subject to the conditions laid down in that Annex.

Article 2 Repeal of Implementing Regulation (EU) No 1006/2013

Implementing Regulation (EU) No 1006/2013 is repealed.

Article 3 Transitional measures

1.   The feed additive L-cystine, as authorised by Implementing Regulation (EU) No 1006/2013 and premixtures containing that additive, which are produced and labelled before 5 September 2025 in accordance with the rules applicable before 5 March 2025, may continue to be placed on the market and used until the stocks concerned are exhausted.

2.   Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are produced and labelled before 5 March 2026 in accordance with the rules applicable before 5 March 2025, may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for food-producing animals.

3.   Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are produced and labelled before 5 March 2027 in accordance with the rules applicable before 5 March 2025, may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for non-food producing animals.

Article 4 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 feed additive

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 12 % moisture content

Category: nutritional additives. Functional group: amino acids, their salts and analogues

3c391

L-cystine

Additive composition

L-cystine with a minimum content of 98,5 %

Solid form.

Characterisation of the active substance

L-cystine produced by hydrolysis of keratin from poultry feathers

IUPAC name: (2R)-2-amino-3- [(2R)-2-amino-3-hydroxy-3-oxopropyl] disulfanyl-propanoic acid

CAS number: 56-89-3

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

Analytical method

( 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)

For the determination of cystine in compound feed:

—

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

All animal species

—

—

—

1.

In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.

2.

The label of the additive and premixtures shall indicate the following:

—

‘Supplementation with L-cystine shall depend on the requirements of the target animals for sulphur-containing amino acids and the level of other sulphur-containing amino acids in the ration.’

3.

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 breathing protective equipment.

5 March 2035

( 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 ).