Commission Implementing Regulation (EU) No 601/2013 of 24 June 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

Authorisation

Article 1

The substances specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex.

Transitional measures

Article 2

The substances specified in the Annex which were authorised by Directive 70/524/EEC and feed containing them, which are produced and labelled before 15 January 2014 in accordance with the rules applicable before 15 July 2013 may continue to be placed on the market and used until the existing stocks are exhausted.

Entry into force

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

ANNEXSupplementary provisions

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 (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(CH 3 COO) 2 × 4H 2 O CAS number: 6147-53-1   Analytical methods  ( 1 )   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/EEC  ( 2 ) , 89/656/EEC  ( 3 ) , 92/85/EEC  ( 4 ) and 98/24/EC  ( 5 ) . Appropriate protective gloves, respiratory and eye protection according to Council Directive 89/686/EEC  ( 6 ) 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: CoCO 3 CAS number: 513-79-1 Chemical formula Co(OH) 2 CAS number: 21041-93-0   Analytical methods  ( 1 )   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 Council  ( 7 ) . 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: 2CoCO 3 × 3Co(OH) 2 × H 2 O CAS number: 51839-24-8   Analytical methods  ( 1 )   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: 2CoCO 3 × 3Co(OH) 2 × H 2 O CAS number: 51839-24-8   Analytical methods  ( 1 )   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: CoSO 4 × 7H 2 O CAS number: 10026-24-1   Analytical methods  ( 1 )   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 ( 1 )   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 ( 2 )    OJ L 183, 29.6.1989, p. 1 . ( 3 )    OJ L 393, 30.12.1989, p. 18 . ( 4 )    OJ L 348, 28.11.1992, p. 1 . ( 5 )    OJ L 131, 5.5.1998, p. 11 . ( 6 )    OJ L 399, 30.12.1989, p. 18 . ( 7 )    OJ L 158, 30.4.2004, p. 50 .