Commission Implementing Regulation (EU) No 601/2013Dangos y teitl llawn

ANNEX

a Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx
b OJ L 183, 29.6.1989, p. 1.
c OJ L 393, 30.12.1989, p. 18.
d OJ L 348, 28.11.1992, p. 1.
e OJ L 131, 5.5.1998, p. 11.
f OJ L 399, 30.12.1989, p. 18.
g OJ L 158, 30.4.2004, p. 50.
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 (Co) in mg/kg of complete feedingstuff with a moisture content of 12 %
Category of nutritional additives. Functional group: compounds of trace elements
3b801	—	Cobalt(II) acetate tetrahydrate	Additive composition Cobalt(II) acetate tetrahydrate, as crystals/granules, with a minimum content of 23 % cobalt Particles < 50 μm: below 1 % Characterisation of the active substance Chemical formula: Co(CH3COO)2 × 4H2O CAS number: 6147-53-1 Analytical methods a For the identification of acetate in the additive: European Pharmacopoeia monograph 01/2008:20301. For the crystallographic characterisation of additive: X-Ray diffraction. For the determination of total cobalt in the additive, premixtures, compound feed and feed materials: EN 15510 — inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) or CEN/TS 15621 — inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) after pressure digestion. For determination of particle size distribution: ISO 13320:2009 — Particle size analysis — Laser diffraction methods	ruminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals	—	—	1 (total)	1. The additive shall be incorporated into feed in the form of a premixture. 2. Protective measures shall be taken according to national regulations implementing EU legislation on health and safety at work including Council Directives 89/391/EECb, 89/656/EECc, 92/85/EECd and 98/24/ECe. Appropriate protective gloves, respiratory and eye protection according to Council Directive 89/686/EECf shall be worn during handling. 3. Declarations to be made on the labelling of the additive and premixture: ‘It is recommended to limit the supplementation with Cobalt to 0,3 mg/kg in complete feed. In this context, the risk for Cobalt deficiency due to local conditions and the specific composition of the diet should be taken into account.’	15 July 2023
3b802	—	Cobalt(II) carbonate	Additive composition Cobalt(II) carbonate, as powder, with a minimum content of 46 % cobalt Cobalt carbonate: minimum 75 % Cobalt hydroxide: 3 % - 15 % Water: maximum 6 % Particles < 11 μm: below 90 % Characterisation of the active substances Chemical formula: CoCO3 CAS number: 513-79-1 Chemical formula Co(OH)2 CAS number: 21041-93-0 Analytical methods a For the identification of carbonate in the additive: European Pharmacopoeia monograph 01/2008:20301. For the crystallographic characterisation of additive: X-Ray diffraction. For the determination of total cobalt in the additive, premixtures, compound feed and feed materials: EN 15510 — inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) or CEN/TS 15621 — inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) after pressure digestion. For determination of particle size distribution: ISO 13320:2009 — Particle size analysis — Laser diffraction methods	ruminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals	—	—	1 (total)	1. The additive shall be incorporated into feed in the form of a premixture. This feed shall be placed on the market in a pelleted form. 2. Protective measures shall be taken according to national regulations implementing EU legislation on health and safety at work including Directives 89/391/EEC, 89/656/EEC, 92/85/EEC, 98/24/EC and 2004/37/EC of the European Parliament and of the Councilg. Appropriate protective gloves, respiratory and eye protection according to Directive 89/686/EEC shall be worn during handling. 3. Declarations to be made on the labelling of the additive and premixture: ‘It is recommended to limit the supplementation with Cobalt to 0,3 mg/kg in complete feed. In this context, the risk for Cobalt deficiency due to local conditions and the specific composition of the diet should be taken into account.’	15 July 2023
3b803	—	Cobalt(II) carbonate hydroxide (2:3) monohydrate	Additive composition Cobalt(II) carbonate hydroxide (2:3) monohydrate, as powder, with a minimum content of 50 % cobalt Particles < 50 μm: below 98 % Characterisation of the active substance Chemical formula: 2CoCO3 × 3Co(OH)2 × H2O CAS number: 51839-24-8 Analytical methods a For the identification of carbonate in the additive: European Pharmacopoeia monograph 01/2008:20301. For the crystallographic characterisation of additive: X-Ray diffraction. For the determination of total cobalt in the additive, premixtures, compound feed and feed materials: EN 15510 — inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) or CEN/TS 15621 — inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) after pressure digestion. For determination of particle size distribution: ISO 13320:2009 — Particle size analysis — Laser diffraction methods	ruminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals	—	—	1 (total)	1. The additive shall be incorporated into feed in the form of a premixture. This feed shall be placed on the market in a pelleted form. 2. Protective measures shall be taken according to national regulations implementing EU legislation on health and safety at work including Directives 89/391/EEC, 89/656/EEC, 92/85/EEC, 98/24/EC and 2004/37/EC. Appropriate protective gloves, respiratory and eye protection according to Directive 89/686/EEC shall be worn during handling. 3. Declarations to be made on the labelling of the additive and premixture: ‘It is recommended to limit the supplementation with Cobalt to 0,3 mg/kg in complete feed. In this context, the risk for Cobalt deficiency due to local conditions and the specific composition of the diet should be taken into account.’	15 July 2023
3b804	—	Coated granulated cobalt(II) carbonate hydroxide (2:3) monohydrate	Additive composition Coated granulated cobalt(II) carbonate hydroxide (2:3) monohydrate with a cobalt content of 1 % - 5 % Coating agents (2,3 % - 3,0 %) and dispersants (choice of poly-oxy-ethylene, sorbitan monolaurate, glycerol polyethyleneglycol ricinoleate, polyethyleneglycol 300, sorbitol, and maltodextrin) Particles < 50 μm: below 1 % Characterisation of the active substance Chemical formula: 2CoCO3 × 3Co(OH)2 × H2O CAS number: 51839-24-8 Analytical methods a For the identification of carbonate in the additive: European Pharmacopoeia monograph 01/2008:20301. For the crystallographic characterisation of additive: X-Ray diffraction. For the determination of total cobalt in the additive, premixtures, compound feed and feed materials: EN 15510 — inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) or CEN/TS 15621 — inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) after pressure digestion. For determination of particle size distribution: ISO 13320:2009 — Particle size analysis — Laser diffraction methods	ruminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals	—	—	1 (total)	1. Protective measures shall be taken according to national regulations implementing EU legislation on health and safety at work including Directives 89/391/EEC, 89/656/EEC, 92/85/EEC and 98/24/EC. Appropriate protective gloves, respiratory and eye protection according to Directive 89/686/EEC shall be worn during handling. 2. Declarations to be made on the labelling of the additive and premixture, if applicable: ‘It is recommended to limit the supplementation with Cobalt to 0,3 mg/kg in complete feed. In this context, the risk for Cobalt deficiency due to local conditions and the specific composition of the diet should be taken into account.’	15 July 2023
3b805	—	Cobalt(II) sulphate, heptahydrate	Additive composition Cobalt(II) sulphate, heptahydrate, as powder, with a minimum content of 20 % cobalt Particles < 50 μm: below 95 % Characterisation of the active substance Chemical formula: CoSO4 × 7H2O CAS number: 10026-24-1 Analytical methods a For the identification of sulphate in the additive: European Pharmacopoeia monograph 01/2008:20301. For the crystallographic characterisation of additive: X-Ray diffraction. For the determination of total cobalt in the additive, premixtures, compound feed and feed materials: EN 15510 — inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) or CEN/TS 15621 — inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) after pressure digestion. For determination of particle size distribution: ISO 13320:2009 — Particle size analysis — Laser diffraction methods	ruminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals	—	—	1 (total)	1. The additive shall be incorporated into feed in the form of a premixture. This feed shall be placed on the market in a pelleted form. 2. Protective measures shall be taken according to national regulations implementing EU legislation on health and safety at work including Directives 89/391/EEC, 89/656/EEC, 92/85/EEC, 98/24/EC and 2004/37/EC. Appropriate protective gloves, respiratory and eye protection according to Directive 89/686/EEC shall be worn during handling. 3. Declarations to be made on the labelling of the additive and premixture: ‘It is recommended to limit the supplementation with Cobalt to 0,3 mg/kg in complete feed. In this context, the risk for Cobalt deficiency due to local conditions and the specific composition of the diet should be taken into account.’	15 July 2023