Commission Implementing Regulation (EU) 2025/1395 of 15 July 2025 correcting and amending Implementing Regulation (EU) 2020/997 as regards the terms of the authorisation of L-lysine base, liquid, as a feed additive for all animal species

Correction and amendment to Implementing Regulation (EU) 2020/997

Article 1

The Annex to Implementing Regulation (EU) 2020/997 is replaced by the Annex to this Regulation.

Transitional measures

Article 2

1.   The feed additive L-lysine base, liquid, with identification number 3c320, produced with Corynebacterium glutamicum NRRL B-67439 or with Corynebacterium glutamicum NRRL B-67535, as authorised by Implementing Regulation (EU) 2020/997, and premixtures containing this additive, which is produced and labelled before 5 February 2026 in accordance with the rules applicable before 5 August 2025 may continue to be placed on the market and used until the stocks concerned are exhausted. 2.   Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are produced and labelled before 5 August 2026 in accordance with the rules applicable before 5 August 2025 may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for food-producing animals. 3.   Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are produced and labelled before 5 August 2027 in accordance with the rules applicable before 5 August 2025 may continue to be placed on the market and used until the stocks concerned 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 feed 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/kg of complete feed with 12 % moisture content Category: nutritional additives. Functional group: amino acids, their salts and analogues 3c320 L-Lysine base, liquid Additive composition: Preparation of L-lysine with a minimum content of 50 % L-lysine – Aqueous solution ————————— 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 ————————— 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 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. 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. 3. The additive may 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 conditional essential amino acids in order to avoid imbalances.’ 30.7.2030 3c320ii L-Lysine base, liquid Additive composition: Preparation of L-lysine with a minimum content of 50 % L-lysine – Aqueous solution ————————— Characterisation of the active substance : L-lysine produced by fermentation with Corynebacterium glutamicum NRRL B-68248 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 All species - - - 1. The lysine content shall be indicated on the labelling of the additive. 2. 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.’ 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 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 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 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://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en .