ANNEXSupplementary provisions
ANNEX Identification number of the additive Name of the 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 the element (Cu) in mg/kg of complete feed with a moisture content of 12 % Category: nutritional additives. Functional group: compounds of trace elements 3b416 Copper (II)– betaine complex Additive composition Copper betaine complex with a minimum content of 19 % of copper and a minimum content of 36 % of betaine; Nickel: maximum 77 mg/kg; Solid form ---------------------------------------------------- Characterisation of the active substances Name: catena-[diaqua-sulphato-μ2-(trimethylammonio)acetato-copper(II)]; Chemical formula: [Cu(H 2 O) 2 ((CH 3 ) 3 NCH 2 COO)(SO 4 )]n Specifications: Copper: minimum of 19 %; Betaine: minimum 36 %; Sulphur: 9 %–12 %; Moisture: maximum 5 % Analytical methods ( 1 ) For the quantification of total copper in the feed additive: — Inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15621 or EN 15510) or — Atomic absorption spectrometry, AAS (ISO 6869). For the quantification of total copper in the premixtures : — Inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15621 or EN 15510) or — Atomic absorption spectrometry, AAS (ISO 6869) or — Inductively coupled plasma-mass spectrometry, ICP-MS (EN 17053). For the quantification of total copper in the compound feed : — Inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15621 or EN 15510) or — Atomic absorption spectrometry, AAS (Commission Regulation (EC) No 152/2009 (Annex IV-C) or ISO 6869) or — Inductively coupled plasma-mass spectrometry, ICP-MS (EN 17053). For the quantification of betaine in the feed additive : — High performance liquid chromatography with refraction index detection (HPLC-RI). For the quantification of sulphur and sulphate in the feed additive : — Inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15621). For proving the formation of copper (II) betaine complex: — Powder X-ray diffraction (XRD). Bovines Before start of rumination 15 1. The additive shall be incorporated into feed in the form of a premixture. 2. The following information 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.’ 3. Users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address the potential risks of exposure by inhalation, dermal contact or eyes contact, in particular due to the content of nickel. Where such risks cannot be eliminated by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment, including eyes, skin and breathing protection. 1 January 2036 Other bovines 30 Ovines 15 Caprines 35 Piglets suckling and weaned Up to 4 weeks after weaning 150 Piglets From 5-th week after weaning up to 8 weeks after weaning 100 Crustaceans 50 Other animal species and categories 25 ( 1 ) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en .