Commission Implementing Regulation (EU) 2020/997 of 9 July 2020 concerning the authorisation of L-lysine base, liquid, L-lysine sulphate and L-lysine monohydrochloride, technically pure, as feed additives for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/997
• Articles: 3

Article 1

The substances specified in the Annex are authorised as feed additives in animal nutrition in the additive category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’, 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.

3c320

-

L-lysine base, liquid

Additive composition:

Aqueous solution of L-lysine with a minimum of 50 % L-lysine

-----------------

Characterisation of the active substance:

L-lysine produced by fermentation with Corynebacterium glutamicum NRRL-B-67439 or

Corynebacterium glutamicum NRRL B-67535.

Chemical formula: NH 2 -(CH 2 ) 4 -CH(NH 2 )-COOH

CAS Number: 56-87-1

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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 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)

For the quantification of lysine in water:

—

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

All species

-

-

-

1.

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

2.

L-lysine base, liquid, may be placed on the market and used as an additive consisting of a preparation.

3.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation and for the skin and eyes. 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 breathing, skin and eye protection.

4.

The additive may be also used via water for drinking.

5.

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 conditional essential amino acids in order to avoid imbalances.’

30.7.2030

3c322

L-lysine monohydrochloride, technically pure

Additive composition:

Powder of L-lysine monohydrochloride with a minimum of 78 % L-lysine and a maximum moisture content of 1,5 %.

-----------------

Characterisation of the active substance:

L-lysine monohydrochloride produced by fermentation with

Corynebacterium glutamicum NRRL-B-67439 or

Corynebacterium glutamicum NRRL B-67535 or

Corynebacterium glutamicum CGMCC 7.266.

Chemical formula: NH 2 -(CH 2 ) 4 -CH(NH 2 )-COOH

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 photometric 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 photometric 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 photometric detection (IEC-VIS).

All species

-

-

-

1.

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

2.

L-lysine monohydrochloride, technically pure, may be placed on the market and used as an additive consisting of a preparation.

3.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation. 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 breathing protection.

4.

The additive may be also used via water for drinking.

5.

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 conditional essential amino acids in order to avoid imbalances.’

30.7.2030

3c325

L-lysine sulphate

Additive composition:

Granulate with a minimum L-lysine content of 52 % and a maximum content of 24 % sulphate.

-----------------

Characterisation of the active substance:

L-lysine sulphate produced by fermentation with Corynebacterium glutamicum CGMCC 7.266

Chemical formula: C 12 H 28 N 4 O 4 •H 2 SO 4 /[NH 2 -(CH 2 ) 4 -CH(NH 2 )-COOH] 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)

For the quantification of lysine in water:

—

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

All species

-

-

10 000

1.

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

2.

L-lysine sulphate may be placed on the market and used as an additive consisting of a preparation.

3.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation. 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 breathing protection.

4.

The additive may be also used via water for drinking.

5.

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 conditional essential amino acids in order to avoid imbalances.’

30.7.2030

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports