The Feed Additives (Authorisations) (Scotland) Regulations 2022

Regulation 3(2)

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

Authorisation

1.  The preparation specified in the table in this schedule, 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 in this schedule.

Table

Column 1		Column 2
Additive		Manganese chelate of lysine and glutamic acid
Identification number of the additive		3b509
Authorisation holder (1)
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 method(2)		1. For quantification of total manganese in the feed additive and premixtures:
		Atomic Absorption Spectrometry (AAS) in accordance with international standard BS EN ISO 6869:2000 entitled “Animal feeding stuffs. Determination of the contents of calcium, copper, iron, magnesium, manganese, potassium, sodium and zinc. Method using atomic absorption spectrometry”(3); Inductively Coupled Plasma-Atomic Emission Spectrometry, (ICP-AES) in accordance with European standard EN 15510:2017 entitled “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”(4) (for premixtures and feed only); or Inductively Coupled Plasma-Atomic Emission Spectrometry after pressure digestion (ICP-AES) in accordance with European standard EN 15621:2017 entitled “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”(5).
		2. 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)(6); Atomic Absorption Spectrometry, AAS in accordance with international standard BS EN ISO 6869:2001; Inductively Coupled Plasma-Atomic Emission Spectrometry, (ICP-AES) in accordance with European standard EN 15510:2017 entitled “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” (for premixtures and feed only); or Inductively Coupled Plasma – Atomic Emission Spectrometry after pressure digestion, ICP-AES (EN 15621).
		3. For quantification of lysine and glutamic acid in the feed additive:
		Ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS).
		4. For proving the chelated structure 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		Not applicable
Content of Manganese chelate of lysine and glutamic acid in mg/kg of complete feed with a moisture content of 12%	Minimum content	No minimum
	Maximum content	Fish 100 (total) All other animal species 150 (total)
Other provisions		The additive must be incorporated into the feed in the form of a premixture.

(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)

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.

(3)

ISO standards are published in Geneva by the International Organisation for Standardisation, and are available on their website (www.iso.org) or at ISO Central Secretariat, International Organization for Standardization (ISO), 1 rue de Varembé, Case postale 56, CH-1211, Geneva 20, Switzerland. Under reference BS EN ISO 6869:2001, it was published as a UK standard by the British Standards Institution on 15 March 2001 (ISBN 0 580 36933 1).

(4)

This standard was approved by the European Committee for Standardization (CEN) on 6 February 2017. Under reference BS EN 15510:2017, it was published as a UK standard by the British Standards Institution on 30 August 2017 (ISBN 978 0 580 94541 0).

(5)

This standard was approved by the European Committee for Standardization (CEN) on 6 February 2017. Under reference BS EN 15621:2017, it was published as a UK standard by the British Standards Institution on 31 August 2017 (ISBN 978 0 580 94543 4).

(6)

EUR 152/2009. There are amendments to EUR 152/2009 not relevant to these Regulations.