The Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Amendment of Commission Regulation (EU) 2020/354) (Wales) Regulations 2024

Regulation 3(1)

SCHEDULE 12 Authorisation of a preparation of L-lysine base (liquid) produced by fermentation with Corynebacterium glutamicum (KCCM 80183) (identification number 3c320) as a feed additive for all animal species

The preparation of L-lysine base (liquid) produced by fermentation with Corynebacterium glutamicum (KCCM 80183) specified in the table, 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 subject to the conditions set out in the table.

(1) CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry.
(2) Details of the analytical methods are set out in the document referenced “Ares(2019)7003671 - 12/11/2019” and “JRC F.5/CvH/SB/AS/Ares”, and last updated on 27 January 2020. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2019-00160028_en.
(3) Under reference 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 30 April 2013 (ISBN 978 0 580 76077 8). Available at: https://knowledge.bsigroup.com.
(4) Content of L-lysine (mg/kg of complete feed with a moisture content of 12%).
Additive	L-lysine base (liquid)
Identification number	3c320
Authorisation holder	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) (NH2(CH2)CH(NH2)COOH) produced by fermentation with Corynebacterium glutamicum (KCCM 80183). CAS number(1): 56-87-1
Analytical methods(2)	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)(2) (BS EN ISO 17180:2013)
	For quantification of lysine in premixtures, feed materials and compound feed: Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) (Commission Regulation (EC) No 152/2009 laying down the methods of sampling and analysis for the official control of feed - Annex 3, F)
	For the quantification of lysine in water: Ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) (BS EN ISO 17180:2013(3)), or Ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) (Commission Regulation (EC) No 152/2009 - Annex 3, F)
Species or category of animal	All animal species
Maximum age	None
Minimum content(4)	None
Maximum content(4)	None
Other provisions	1. The L-lysine content must be stated on the labelling of the additive.
	2. The additive may be used via water for drinking.
	3. The following must be stated, in English or in English and Welsh, on the labelling of the additive and premixture: In English: “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”. In Welsh: “Dylai’r atchwanegiad ag L-lysin, yn arbennig drwy ddŵr i’w yfed, ystyried yr holl asidau amino hanfodol ac amodol hanfodol er mwyn osgoi anghydbwysedd”.