The Feed Additives (Authorisations) (Wales) Regulations 2023

Regulation 3(1)

SCHEDULE 12 Authorisation of L‐lysine monohydrochloride (technically pure) produced from Corynebacterium glutamicum (KCCM 80216 or KCTC 12307BP) (identification number 3c327) as a feed additive for all animal species

The substance L‐lysine monohydrochloride (technically pure) 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) European Inventory of Existing Commercial Substances, as published in OJ No C 146A, 15.6.90, p.1.
(3) Details of the analytical methods are set out in the document referenced “Ares(2020)4503369-31/08/2020” and “JRC F.5/CvH/MGH/AS/Ares”, and last updated on 16 October 2020. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2020-0008_en.
(4) Food Chemicals Codex, United States Pharmacopeial Convention, 13th edition (online). Published by US Pharmacopeia (USP) on 1 March 2022 (ISSN 2153-1455). Available at https://www.foodchemicalscodex.org.
(5) 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.
(6) Content of L-lysine monohydrochloride (mg/kg of complete feed with a moisture content of 12%).
Additive	L‐lysine monohydrochloride (technically pure)
Identification number	3c327
Authorisation holder	None
Additive category	Nutritional additives
Functional group	Amino acids, their salts and analogues
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(s)	L-lysine monohydrochloride (technically pure) produced by fermentation with Corynebacterium glutamicum (KCCM 80216 or KCTC 12307BP) L-lysine monohydrochloride (C6H15ClN2O2) CAS number: 657-27-2(1) EINECS number: 211-519-9(2)
Analytical methods(3)	For the identification of L-lysine monohydrochloride in the feed additive: Food Chemicals Codex L-lysine monohydrochloride monograph(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) (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 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); 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	None
Minimum content(6)	None
Maximum content(6)	None
Other provisions	1. The lysine content must be stated 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