Commission Implementing Regulation (EU) 2026/353 of 18 February 2026 concerning the authorisation of L-histidine and L-histidine monohydrochloride monohydrate, produced with Corynebacterium glutamicum KCCM 80389, as feed additives for all animal species

• CELEX: Implementing Regulation (EU) 2026/353
• Articles: 3

Article 1 Authorisation

The substances specified in the Annex, belonging to the category ‘nutritional additives’ and functional group ‘amino acids, their salts and analogues’, and to the category ‘sensory additives’ and 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 12 % moisture content

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

3c353

L-histidine

Additive composition

L-histidine

Solid form

Characterisation of the active substance

L-histidine ≥ 90 % (on a dry matter basis) produced with Corynebacterium glutamicum KCCM 80389

Histamine ≤ 100 ppm

IUPAC name: (2 S )-2-amino-3-(1 H -imidazol-5-yl) propanoic acid

Chemical formula: C 6 H 9 N 3 O 2

CAS number: 71-00-1

Analytical method

( 1 )

For the determination of histidine in the feed additive:

—

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

—

High performance liquid chromatography coupled with spectrophotometric detection (HPLC-UV)

For the determination of histidine in premixtures and compound feed:

—

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

For the determination of histidine in water for drinking:

—

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

For the determination of histamine in the feed additive:

—

High performance liquid chromatography coupled with spectrophotometric detection (HPLC-UV)

All animal species

—

—

—

1.

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

2.

The additive may be used via water for drinking.

3.

Feed business operators shall ensure that L-histidine is rumen protected, when fed to ruminants.

4.

The moisture content shall be indicated on the label of the additive.

5.

The label of the additive and premixtures shall indicate the following: ‘The supplementation with L-histidine, in particular via water for drinking, shall take into account all essential and conditionally essential amino acids in order to avoid nutritional imbalances.’

11 March 2036

3c354

L-histidine monohydrochloride monohydrate

Additive composition

L-histidine monohydrochloride monohydrate

Solid form

Characterisation of the active substance

L-histidine monohydrochloride monohydrate ≥ 98 % with a minimum content of 72 % histidine (on a dry matter basis), produced with Corynebacterium glutamicum KCCM 80389

Histamine ≤ 100 ppm

IUPAC name: (2 S )-2-amino-3-(1 H -imidazol-5-yl) propanoic acid hydrate hydrochloride

Chemical formula: C 6 H 9 N 3 O 2 ·HCl·H 2 O

CAS number: 5934-29-2

Analytical method

( 1 )

For the determination of histidine in the feed additive:

—

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

—

High performance liquid chromatography coupled with spectrophotometric detection (HPLC-UV)

For the determination of histidine in premixtures and compound feed:

—

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

For the determination of histidine in water for drinking:

—

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

For the determination of histamine in the feed additive:

—

High performance liquid chromatography coupled with spectrophotometric detection (HPLC-UV)

All animal species

—

—

—

1.

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

2.

The additive may be used via water for drinking.

3.

Feed business operators shall ensure that L-histidine monohydrochloride monohydrate is rumen protected, when fed to ruminants.

4.

The moisture content shall be indicated on the label of the additive.

5.

The label of the additive and premixtures shall indicate the following: ‘The supplementation with L-histidine monohydrochloride monohydrate, in particular via water for drinking, shall take into account all essential and conditionally essential amino acids in order to avoid nutritional imbalances.’

11 March 2036

Category: Sensory additives. Functional group: Flavouring compounds

3c353

L-histidine

Additive composition

L-histidine

Solid form

Characterisation of the active substance

L-histidine ≥ 90 % (on a dry matter basis) produced with Corynebacterium glutamicum KCCM 80389

Histamine ≤ 100 ppm

IUPAC name: (2S)-2-amino-3-(1H-imidazol-5-yl) propanoic acid

Chemical formula: C 6 H 9 N 3 O 2

CAS number: 71-00-1

Analytical method

( 1 )

For the determination of histidine in the feed additive:

—

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

—

High performance liquid chromatography coupled with spectrophotometric detection (HPLC-UV)

For the determination of histidine in premixtures:

—

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

For the determination of histamine in the feed additive:

—

High performance liquid chromatography coupled with spectrophotometric detection (HPLC-UV)

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

5.

The moisture content shall be indicated on the label of the additive.

11 March 2036

3c354

L-histidine monohydrochloride monohydrate

Additive composition

L-histidine monohydrochloride monohydrate

Solid form

Characterisation of the active substance

L-histidine monohydrochloride monohydrate ≥ 98 % with a minimum content of 72 % histidine (on a dry matter basis), produced with Corynebacterium glutamicum KCCM 80389

Histamine ≤ 100 ppm

IUPAC name: (2 S )-2-amino-3-(1 H -imidazol-5-yl) propanoic acid hydrate hydrochloride

Chemical formula: C 6 H 9 N 3 O 2 ·HCl·H 2 O

CAS number: 5934-29-2

Analytical method

( 1 )

For the determination of histidine in the feed additive:

—

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

—

High performance liquid chromatography coupled with spectrophotometric detection (HPLC-UV)

For the determination of histidine in premixtures:

—

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

For the determination of histamine in the feed additive:

—

High performance liquid chromatography coupled with spectrophotometric detection (HPLC-UV)

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

5.

The moisture content shall be indicated on the label of the additive.

11 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 ).