The Feed Additives (Authorisations) (England) Regulations 2023

Regulation 3

SCHEDULE 11 Authorisation of L‐lysine base (liquid) produced from Corynebacterium glutamicum (KCCM 80216 or KCTC 12307BP) (identification number 3c326) as a feed additive for all for all animal species

The substance of L‐lysine base (liquid), belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’, is authorised as an additive in animal nutrition in accordance with the specifications in the following table.

(1) There is no requirement to include the name of the holder of this authorisation as this authorisation does not fall within the scope of Article 9(5) of Regulation (EC) 1831/2003.
(2) This is a reference to the CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://cas.org/cas-data/cas-registry.
(3) The EINECS number is given in the European Inventory of Existing Commercial Substances, as published in O.J. No. C146A, 15.6.90, p.1.
(4) Details of the analytical methods is set out in the document referenced “Ares(2020)4503369-31/08/2020” and last updated on 16th October 2020, available at: https://joint-research-centre.ec.europa.eu/publications/fad-2020-0008_en.
(5) BS EN ISO 17180:2013 “Animal feeding stuffs. Determination of lysine, methionine and threonine in commercial amino acid products and premixtures”. Published by the British Standards Institution on 30th April 2013 (ISBN 978 0 580 76077 8) and available at: https://knowledge.bsigroup.com.
Additive		L‐lysine base (liquid)
Identification number		3c326
Authorisation holder(1)		None
Additive category		Nutritional additives
Functional group		Amino acids, their salts and analogues
Additive composition		Aqueous solution with a minimum of 50% L-lysine.
Characterisation of the active substance(s)		L‐lysine base (liquid) (C6H14N2O2) produced by fermentation with Corynebacterium glutamicum (KCCM 80216 or KCTC 12307BP) CAS no: 56-87-1(2) EINECS no: 200-294-2(3)
Analytical methods(4)		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) in accordance with BS EN ISO 17180:2013(5)
		For the quantification of lysine in premixtures, feed materials and compound feed: Ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) in accordance with Commission Regulation (EC) 152/2009 (Annex 3-F)
		For the quantification of lysine in water: Ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) in accordance with BS EN ISO 17180:2013(5); or Ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) in accordance with Commission Regulation (EC) 152/2009 (Annex 3-F)
Species or category of animal		All animal species
Maximum age		Not applicable
Content of L-lysine (mg/kg of complete feed with a moisture content of 12%)	Minimum content	No minimum
	Maximum content	No maximum
Other provisions		1) The lysine content must be stated 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