Commission Implementing Regulation (EU) 2022/1525 of 13 September 2022 concerning the authorisation of L-lysine monohydrochloride and L-lysine sulphate produced by fermentation with Corynebacterium glutamicum CGMCC 14498 as feed additives for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2022/1525
• Articles: 3

Article 1

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 feed additives in animal nutrition subject to the conditions laid down in that Annex.

Article 2

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 holder of authorisation

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.

3c322iii

-

L-lysine monohydrochloride

Additive composition

Preparation of L-lysine monohydrochloride with a minimum of 78,8 % L-lysine and with a moisture ≤ 1 %

Powder form

All species

-

-

-

1.

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

2.

The additive can be used via water for drinking.

3.

Declarations to be made on the labelling of the additive and premixtures: ‘The supplementation with L-lysine, in particular via water for drinking, should take into account all essential and conditionally essential amino acids in order to avoid imbalances.’

4.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, eye or dermal contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including eyes, skin and breathing protection.

4.10.2032

Characterisation of the active substance

L-lysine monohydrochloride produced by fermentation with

Corynebacterium glutamicum CGMCC 14498

Chemical formula: C 6 H 15 ClN 2 O 2

CAS Number: 657-27-2

Analytical methods

( 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 additive 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, compound feed and feed materials:

—

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 or IEC-VIS/FLD).

3c328

L-lysine sulphate

Additive composition

Preparation of L-lysine sulphate with a minimum content of 73,0 % (L-lysine ≥ 55,0 % and other amino acids ≥ 10 %)

Powder form

All species

-

-

10 000

1.

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

2.

The additive can be used via water for drinking.

3.

Declarations to be made on the labelling of the additive and premixtures: ‘The supplementation with L-lysine, in particular via water for drinking, should take into account all essential and conditionally essential amino acids in order to avoid imbalances.’

4.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, eye or dermal contact. Where those risks cannot be eliminated or reduced to a minimum level by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including eyes, skin and breathing protection.

4.10.2032

Characterisation of the active substance

L-lysine sulphate produced by fermentation with Corynebacterium glutamicum CGMCC 14498

Chemical formula: [C 6 H 14 N 2 O 2 ] 2 SO 4

CAS number: 60343-69-3

Analytical methods

( 1 )

For the quantification of lysine in the feed additive and premixtures containing more than 10 % lysine:

—

ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS/FLD) – EN ISO 17180

For the identification of sulphate in the feed additive:

—

European Pharmacopoeia Monograph 20301

For the quantification of lysine in premixtures, compound feed and feed materials:

—

ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) – Commission Regulation (EC) No 152/2009 (Annex III, F).

( 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