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Commission 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

Modified by

Commission Implementing Regulation (EU) 2018/1039of 23 July 2018concerning the authorisation of Copper(II) diacetate monohydrate, Copper(II) carbonate dihydroxy monohydrate, Copper(II) chloride dihydrate, Copper(II) oxide, Copper(II) sulphate pentahydrate, Copper(II) chelate of amino acids hydrate, Copper(II) chelate of protein hydrolysates, Copper(II) chelate of glycine hydrate (solid) and Copper(II) chelate of glycine hydrate (liquid) as feed additives for all animal species and amending Regulations (EC) No 1334/2003, (EC) No 479/2006 and (EU) No 349/2010 and Implementing Regulations (EU) No 269/2012, (EU) No 1230/2014 and (EU) 2016/2261(Text with EEA relevance), 32018R1039, July 24, 2018

Corrected by

Corrigendum to Commission Implementing Regulation (EU) No 1230/2014 of 17 November 2014 concerning the authorisation of copper bilysinate as a feed additive for all animal species, 32014R1230R(02), May 30, 2015

Commission Implementing Regulation (EU) No 1230/2014of 17 November 2014concerning the authorisation of copper bilysinate as a feed additive for all animal species(Text with EEA relevance)

Article 1The 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 2This 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

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-reportsCategory of nutritional additives. Functional group: compounds of trace elements

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
Identification number of the additive	Name of the holder of authorisation	Additive		Species or category of animal	Maximum age	Content of element (Cu) in mg/kg of complete feedingstuff with a moisture content of 12 %		Other provisions	End of period of authorisation
3b411	—	Copper bilysinate	Characterisation of the additivePowder or granulate with a content of copper ≥ 14,5 % and lysine-HCl ≥ 84,0 %.Characterisation of the active substanceCopper chelate of L-lysinate-HClChemical formula: Cu(C6H13N2O2)2 × 2HClCAS number: 53383-24-7Analytical methods: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,orInductively 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, orInductively coupled plasma atomic emission spectrometry (ICP-AES) — EN 15510, orInductively 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.

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