The Feed Additives (Authorisations) (Wales) Regulations 2022

Regulation 3(1)

SCHEDULE 1 Authorisation of a preparation of manganese chelate of lysine and glutamic acid (identification number 3b509) as a feed additive for all animal species

The preparation specified in the table, belonging to the additive category “nutritional additives” and to the functional group “compounds of trace elements”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.

(1) Details of the analytical methods are set out in the document referenced “Ares(2018)3918699 - 24/07/2018” and the document referenced “Ares(2019)7167892 - 20/11/2019” and last updated 28 January 2020. These documents are available at the following address: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2018-0009?search&form-return
(2) Under reference BS EN ISO 6869:2001 “Animal feeding stuffs. Determination of the contents of calcium, copper, iron, magnesium, manganese, potassium, sodium and zinc. Method using atomic absorption spectrometry”. Published by the British Standards Institution on 15 March 2001 (ISBN 0 580 36933 1). Available from the British Standards Institution https://knowledge.bsigroup.com.
(3) Under reference BS EN 15510:2017 “Animal feeding stuffs. Methods of sampling and analysis. Determination of calcium, sodium, phosphorus, magnesium, potassium, iron, zinc, copper, manganese, cobalt, molybdenum and lead by ICP-AES”. Published by the British Standards Institution on 30 August 2017 (ISBN 978 0 580 94541 0). Available from the British Standards Institution https://knowledge.bsigroup.com.
(4) Under reference BS EN 15621:2017 “Animal feeding stuffs: Methods of sampling and analysis. Determination of calcium, sodium, phosphorus, magnesium, potassium, sulphur, iron, zinc, copper, manganese and cobalt after pressure digestion by ICP-AES”. Published by the British Standards Institution on 31 August 2017 (ISBN 978 0 580 94543 4). Available from the British Standards Institution https://knowledge.bsigroup.com.
(5) Under reference BS EN 17053:2018 “Animal feeding stuffs: Methods of sampling and analysis. Determination of trace elements, heavy metals and other elements in feed by ICP-MS (multi-method)”. Published by the British Standards Institution on 28 February 2018 (978 0 580 94471 0). Available from the British Standards Institution https://knowledge.bsigroup.com.
(6) Under reference BS EN ISO 13903:2005 “Animal feeding stuffs. Determination of amino acids content”. Published by the British Standards Institution on 24 October 2005 (ISBN 0 580 46218 8). Available from the British Standards Institution https://knowledge.bsigroup.com.
(7) Content of element (Mn) in mg/kg of complete feed with a moisture content of 12%.
Additive	Manganese chelate of lysine and glutamic acid
Identification number of the additive	3b509
Authorisation holder	None specified
Additive category	Nutritional additives
Functional group	Compounds of trace elements
Additive composition	A preparation of chelates of manganese with lysine and chelates of manganese with glutamic acid in a ratio of 1:1 as a powder with the following components: Manganese 15-17% Lysine 20-21.5% Glutamic acid 22-24% Moisture 3.5% maximum Nickel 4 ppm maximum
Characterisation of the active substance(s)	Manganese-2,6-diaminohexanoic acid, chloride and hydrogen sulphate salt (C6H19ClN2O8SMn)Manganese-2-aminopentanedioic acid, sodium and hydrogen sulphate salt (C5H10NNaO9SMn)
Analytical methods (1)	For quantification of total manganese in the feed additive: Atomic Absorption Spectrometry (AAS) (BS EN ISO 6869:2001(2)), or Inductively Coupled Plasma-Atomic Emission Spectrometry after pressure digestion (ICP-AES) (BS EN 15621:2017(4)).
	For quantification of total manganese in premixtures: Atomic Absorption Spectrometry (AAS) (BS EN ISO 6869:2001(2)), Inductively Coupled Plasma-Atomic Emission Spectrometry (ICP-AES) (BS EN 15510:2017(3)), Inductively Coupled Plasma-Atomic Emission Spectrometry after pressure digestion (ICP-AES) (BS EN 15621:2017(4)), or Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) (BS EN 17053:2018(5)).
	For quantification of total manganese in feed materials and compound feed: Atomic Absorption Spectrometry (AAS) – Commission Regulation (EC) No 152/2009 laying down the methods of sampling and analysis for the official control of feed (Annex 4-C)(1), Atomic Absorption Spectrometry (AAS) (BS EN ISO 6869:2001(2)), Inductively Coupled Plasma-Atomic Emission Spectrometry (ICP-AES) (BS EN 15510:2017(3)), Inductively Coupled Plasma-Atomic Emission Spectrometry after pressure digestion (ICP-AES) (BS EN 15621:2017(4)), or Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) (BS EN 17053:2018(5)).
	For quantification of lysine and glutamic acid content in the feed additive: Ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) (BS EN ISO 13903:2005(6)).
	For determination of the chelated form of the feed additive: Mid-infrared (IR) spectrometry together with the determination of the content of trace element and lysine and glutamic acid in the feed additive.
Species or category of animal	All animal species
Maximum age	None
Minimum content (7)	None
Maximum content (7)	Fish: 100mg/kg (total)
	All other animal species: 150mg/kg (total)
Other provisions	The feed additive must be incorporated into the feed in the form of a premixture.

(1)

EUR 2009/152, to which there amendments not relevant to these Regulations.