Commission Implementing Regulation (EU) 2021/669 of 23 April 2021 concerning the authorisation of technically pure L-lysine monohydrochloride and liquid L-lysine base produced by Corynebacterium casei KCCM 80190 or Corynebacterium glutamicum KCCM 80216 or Corynebacterium glutamicum KCTC 12307BP as feed additives for all animal species (Text with EEA relevance)

Article 1

The substances specified in the Annex, belonging to the category ‘nutritional additives’ and 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 .

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.
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.
The additive can be also used via water for drinking.
4.
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.’
5.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the 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 appropriate personal protective equipment, including breathing protection, safety glasses and gloves.
16 May 2031
Characterisation of the active substance:
L-lysine produced by fermentation with Corynebacterium casei KCCM 80190
Chemical formula: NH 2 -(CH 2 ) 4 -CH(NH 2 )-COOH
CAS Number: 56-87-1
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 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/FLD); or
—
ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS).
3c326
-
L-lysine base, liquid
Additive composition:
Aqueous solution of L-lysine with a minimum of 50 % L-lysine.
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 the 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 appropriate personal protective equipment, including breathing protection.
16 May 2031
Characterisation of the active substance:
L-lysine produced by fermentation with Corynebacterium glutamicum KCCM 80216 or Corynebacterium glutamicum KCTC 12307BP
Chemical formula: NH 2 -(CH 2 ) 4 -CH(NH 2 )-COOH
CAS Number: 56-87-1
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 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/FLD); or
—
ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS).
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 %.
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.
The additive can be also used via water for drinking.
4.
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.’
5.
The endotoxin content of the additive and its dusting potential shall ensure a maximal endotoxin exposure of 1 600 IU endotoxins/m 3 air  ( 2 ) .
6.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the 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 appropriate personal protective equipment, including breathing protection, safety glasses and gloves.
16 May 2031
Characterisation of the active substance:
L-lysine monohydrochloride produced by fermentation with
Corynebacterium casei KCCM 80190
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 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/FLD); or
—
ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS).
3c327
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 %.
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 the potential risks by inhalation and eye 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 appropriate personal protective equipment, including breathing protection and safety glasses.
16 May 2031
Characterisation of the active substance:
L-lysine monohydrochloride produced by fermentation with
Corynebacterium glutamicum KCCM 80216 or Corynebacterium glutamicum KCTC 12307BP
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 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).
( 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
( 2 )   Exposure calculated based on the endotoxin level and the dusting potential of the additive according to the method used by EFSA ( EFSA Journal 2017;15(3):4705); analytical method: European Pharmacopoeia 2.6.14 (bacterial endotoxins).

Schedules & Appendices

Cite this act