Commission Implementing Regulation (EU) 2023/1163 of 14 June 2023 concerning the authorisation of L-Lysine monohydrochloride and L-Lysine sulphate produced by Corynebacterium glutamicum CGMCC 17927 as feed additives for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2023/1163
• Articles: 3

Article 1 Authorisation

The substances specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’, 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

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 additive/kg of complete feed with a moisture content of 12 %

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

3c322IV

L-lysine monohydrochloride

Additive composition

L-lysine monohydrochloride with a minimum content of 78,8 % of L-Lysine on a dry matter basis and maximum moisture content of 1 %

Solid form

All species

-

1.

The lysine content shall be indicated on the labelling of the additive

2.

The additive may be used via water for drinking.

3.

The directions for use of the additive and premixture shall indicate the storage conditions, the stability to heat treatment and the stability in water for drinking.

4.

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

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the 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 eye and skin protective equipment.

6 July 2033

Characterisation of the active substance

L-lysine monohydrochloride produced by Corynebacterium glutamicum CGMCC 17927]

Chemical formula: C 6 H 14 N 2 O 2

CAS number: 657-27-2

Analytical method

( 1 )

For the identification of L-lysine monohydrochloride in the feed additive: Food Chemical Codex ‘L-lysine monohydrochloride monograph’

For the quantification of lysine in the feed additives and premixtures (containing more than 10 % lysine): – ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) – EN ISO 17180

For the quantification of lysine in premixtures and compound feed: – ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS), Commission Regulation (EC) No 152/2009 (Annex III, F)

For the quantification of lysine in water: – ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD); or – ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS)

Identification number of the 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 additive/kg of complete feed with a moisture content of 12 %

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

3c329

L-lysine sulphate

Additive composition

L-lysine sulphate with a minimum L-lysine content of 55 % on dry matter basis and a maximum content of:

—

4 % moisture;

—

26,5 % sulphate;

—

0,8 % free amino acids other than lysine

Solid form

All species

-

-

10 000

1.

The lysine content shall be indicated on the labelling of the additive.

2.

The additive may be used via water for drinking.

3.

The directions for use of the additive and premixture shall indicate the storage conditions, the stability to heat treatment and the stability in water for drinking.

4.

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

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the 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 eye and skin protective equipment.

6 July 2033

Characterisation of the active substance

L-lysine sulphate produced by Corynebacterium glutamicum CGMCC

17927

Chemical formula: C 12 H 28 N 4 O 4 -O 4 S

CAS number: 60343-69-3

Analytical method

( 2 )

For the identification of sulphate in the feed additive (L-lysine sulphate): European Pharmacopoeia monograph 20301

For the quantification of lysine in the feed additives and premixtures (containing more than 10 % lysine): – ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) – EN ISO 17180

For the quantification of lysine in premixtures and compound feed: – ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS), Commission Regulation (EC) No 152/2009 (Annex III, F)

For the quantification of lysine in water: – ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD); or – ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS)

( 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 )   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