This is the original version (as it was originally made).
1. The preparation 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.
| Additive | L-lysine sulphate | |
| Identification number | 3c324i | |
| Authorisation holder(1) | None | |
| Additive category | Nutritional additives | |
| Functional group | Amino acids, their salts and analogues | |
| Additive composition | Granulated preparation of L-lysine sulphate with a minimum of 52% L-lysine, a maximum of 24% sulphate and a maximum moisture content of 4% | |
| Characterisation of the active substance(s) | L-lysine sulphate produced by fermentation with Corynebacterium glutamicum (KCCM 80227) (C12H28N4O4·H2SO4):
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| Analytical methods(3) | For quantification of lysine in the feed additive and premixtures containing more than 10% lysine:
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| For identification of sulphate in the feed additive:
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| For quantification of lysine in premixtures, feed materials and compound feed:
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| For quantification of lysine in water:
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| Species or category of animal | All animal species | |
| Maximum age | No maximum | |
| Content of L-lysine sulphate (mg/kg of complete feed with a moisture content of 12%) | Minimum content | No minimum |
| Maximum content | 10,000 mg/kg | |
| Other provisions | 1. The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture | |
| 2. The L-lysine content must be stated on the labelling of the additive | ||
| 3. The following must be stated on the labelling of the additive and premixture: “The supplementation with L-lysine should take into account all essential and conditionally essential amino acids in order to avoid imbalances.” | ||
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.
This is a reference to the CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry.
Details of the analytical methods are set out in the document referenced “Ares(2021)2533252 – 14/04/2021” and “JRC F.5/CvH/ZE/AS/Ares”, and last updated on 2 July 2021. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2020-00820085_en.
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.
European Pharmacopoeia Monograph – Ph. Eur. 6.0, 01/2008: 20301: “Identification reactions of ions and functional groups – sulphates”. Published online by the European Directorate for the Quality of Medicines and Healthcare. Available at https://pheur.edqm.eu/home.
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