Commission Implementing Regulation (EU) 2019/1964 of 26 November 2019 concerning the authorisation of L-lysine base, liquid, L-lysine monohydrochloride, liquid, L-lysine monohydrochloride, technically pure, and L-lysine sulphate as feed additives for all animal species (Text with EEA relevance)

Authorisation

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 an additive in animal nutrition subject to the conditions laid down in that Annex.

Transitional measures

Article 2

1.   Concentrated liquid L-lysine (base), concentrated liquid L-lysine monohydrochloride, L-lysine monohydrochloride, technically pure, and L-lysine sulphate produced by fermentation with Corynebacterium glutamicum authorised by Commission Directive 88/485/EEC and premixtures containing them may be placed on the market until 18 June 2020 in accordance with the rules applicable before 18 December 2019 and used until the existing stocks are exhausted. 2.   Feed materials and compound feed containing the substances referred to in paragraph 1 which are produced and labelled before 18 December 2020 in accordance with the rules applicable before 18 December 2019 may be placed on the market and used until the existing stocks are exhausted if they are intended for food producing animals. 3.   Feed materials and compound feed containing the substances referred to in paragraph 1 which are produced and labelled before 18 December 2021 in accordance with the rules applicable before 18 December 2019 may be placed on the market and used until the existing stocks are exhausted if they are intended for non-food producing animals.

Entry into force

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

ANNEXSupplementary provisions

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 Escherichia coli FERM BP-10941 or Escherichia coli FERM BP-11355 or Corynebacterium glutamicum KCCM 11117P or Corynebacterium glutamicum NRRL B-50547 or Corynebacterium glutamicum NRRL B-50775 or Corynebacterium glutamicum KCCM 10227. 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 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 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 can 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.’ 18.12.2029 3c321 - L-lysine monohydrochloride, liquid Additive composition: Aqueous solution of L-lysine monohydrochloride with a minimum of 22 % L-lysine and a maximum moisture content of 66 % (minimum of 58 % L-lysine in the dry matter). Characterisation of the active substance: L-lysine monohydrochloride produced by fermentation with Escherichia coli FERM BP-10941 or Escherichia coli FERM BP-11355. 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). All species - - - 1. The lysine content shall be indicated on the labelling of the additive. 2. L-lysine monohydrochloride, 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 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 and eye protection. 4. Declarations to be made on the labelling of the additive and premixtures: ‘The supplementation with L-lysine should take into account all essential and conditional essential amino acids in order to avoid imbalances.’ 18.12.2029 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 Escherichia coli FERM BP-10941 or Escherichia coli FERM BP-11355 or Escherichia coli CGMCC 3705 or Escherichia coli CGMCC 7.57 or Corynebacterium glutamicum NRRL B-50547 or Corynebacterium glutamicum NRRL B-50775 or Corynebacterium glutamicum KCCM 11117P or Corynebacterium glutamicum KCCM 10227. 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. 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 ) . 4. 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. 5. The additive can be also used via water for drinking. 6. 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.’ 18.12.2029 3c324   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 KCCM 10227 or Corynebacterium glutamicum DSM 24990. 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-UV) – Commission Regulation (EC) No 152/2009. 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. Declarations to be made on the labelling of the additive and premixtures: ‘The supplementation with L-lysine should take into account all essential and conditional essential amino acids in order to avoid imbalances.’ 18.12.2029 ( 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 2018;16(10):5458); analytical method: European Pharmacopoeia 2.6.14. (bacterial endotoxins).