LegalizeCommission Implementing Regulation (EU) No 1230/2014 of 17 November 2014 concerning the authorisation of copper bilysinate as a feed additive for all animal species Text with EEA relevance
Article 1
The substance specified in the Annex, 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 laid down in that Annex.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX
| Identification number of the additive | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|---|
| Content of element (Cu) in mg/kg of complete feedingstuff with a moisture content of 12 % | |||||||||
| Category of nutritional additives. Functional group: compounds of trace elements | |||||||||
| 3b411 | — | Copper bilysinate | Characterisation of the additive Powder or granulate with a content of copper ≥ 14,5 % and lysine-HCl ≥ 84,0 %. Characterisation of the active substance Copper chelate of L-lysinate-HCl Chemical formula: Cu(C6H13N2O2)2 × 2HCl CAS number: 53383-24-7 Analytical methods (1): For the quantification of Lysine content in the feed additive: — Ion-exchange chromatography combined with post-column derivatisation and colorimetric or fluorescence detection — EN ISO 17180. For the quantification of total copper content in the feed additive and premixtures: — Inductively coupled plasma atomic emission spectrometry (ICP-AES) — EN 15510, — or — Inductively coupled plasma atomic emission spectrometry after pressure digestion, (ICP-AES) — EN 15621. For the quantification of total copper in the feed materials and compound feed: — Atomic absorption spectrometry (AAS) — Commission Regulation (EC) No 152/2009, or — Inductively coupled plasma atomic emission spectrometry (ICP-AES) — EN 15510, or — Inductively coupled plasma atomic emission spectrometry after pressure digestion (ICP-AES) — EN 15621. | All animal species | — | — | Bovines: — Bovines before the start of rumination: 15 (total); — Other bovines: 30 (total). Ovines: 15 (total). Caprines: 35 (total) Piglets: — suckling and weaned up to 4 weeks after weaning: 150 (total); — from 5-th week after weaning up to 8 weeks after weaning: 100 (total). Crustaceans: 50 (total). Other animals: 25 (total). | 1. The additive shall be incorporated into feed in the form of a premixture. 2. For user safety: breathing protection, safety glasses and gloves should be worn during handling. 3. The following words shall be included in the labelling: — For feed for sheep if the level of copper in the feed exceeds 10 mg/kg: — ‘The level of copper in this feed may cause poisoning in certain breeds of sheep.’ — For feed for bovines after the start of rumination if the level of copper in the feed is less than 20 mg/kg: — ‘The level of copper in this feed may cause copper deficiencies in cattle grazing pastures with high contents of molybdenum or sulphur.’ — ‘The lysine content of the additive should be considered when formulating feed.’ | 8 December 2024. |
| (1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports |
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