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

[F1 ANNEX U.K.

Textual Amendments

F1 Substituted by Commission Implementing Regulation (EU) No 131/2014 of 11 February 2014 amending Implementing Regulation (EU) No 601/2013 concerning the authorisation of cobalt(II) acetate tetrahydrate, cobalt(II) carbonate, cobalt(II) carbonate hydroxide (2:3) monohydrate, cobalt(II) sulphate heptahydrate and coated granulated cobalt(II) carbonate hydroxide (2:3) monohydrate as feed additives (Text with EEA relevance).

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
						Element (Co) in mg/kg of complete feed with a moisture content of 12 %
Category of nutritional additives. Functional group: compounds of trace elements
3b301	—	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(CH 3 COO) 2  × 4H 2 O 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 compound 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/EEC b , 89/656/EEC c , 92/85/EEC d and 98/24/EC e . Appropriate protective gloves, respiratory and eye protection according to Council Directive 89/686/EEC f shall be worn during handling. 3. Declarations to be made on the labelling of the additive and premixture: Cobalt content ‘ 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. ’ 4. Declarations to be made on the instructions of use of the compound feed: ‘ Protective measures to avoid exposure with Cobalt by inhalation or by dermal route should be taken. ’	15 July 2023
3b302	—	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: CoCO 3 CAS number: 513-79-1 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 compound feed in the form of a premixture. This compound feed shall be placed on the market in a non-powder form. 2. Appropriate measures shall be taken to avoid the cobalt emission in the air and prevent the exposure by inhalation or by dermal route. If such measures are technically not feasible or not sufficient, 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 Council g . 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: Cobalt content ‘ 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. ’ 4. Declarations to be made on the instructions of use of the compound feed: ‘ Protective measures to avoid exposure with Cobalt by inhalation or by dermal route should be taken. ’	15 July 2023
3b303	—	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: 2CoCO 3  × 3Co(OH) 2  × H 2 O 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 compound feed in the form of a premixture. This compound feed shall be placed on the market in a non-powder form. 2. Appropriate measures shall be taken to avoid the cobalt emission in the air and prevent the exposure by inhalation or by dermal route. If such measures are technically not feasible or not sufficient, 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: Cobalt content ‘ 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. ’ 4. Declarations to be made on the instructions of use of the compound feed: ‘ Protective measures to avoid exposure with Cobalt by inhalation or by dermal route should be taken. ’	15 July 2023
3b304	—	Coated granulated cobalt(II) carbonate	Additive composition Coated granulated preparation of cobalt(II) carbonate 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: CoCO 3 CAS number: 513-79-1 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. 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 and 98/24/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, if applicable: Cobalt content ‘ 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
3b305	—	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: CoSO 4  × 7H 2 O 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 compound feed in the form of a premixture. This compound feed shall be placed on the market in a non-powder form. 2. Appropriate measures shall be taken to avoid the cobalt emission in the air and prevent the exposure by inhalation or by dermal route. If such measures are technically not feasible or not sufficient, 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: Cobalt content ‘ 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. ’ 4. Declarations to be made on the instructions of use of the compound feed: ‘ Protective measures to avoid exposure with Cobalt by inhalation or by dermal route should be taken. ’	15 July 2023