Commission Implementing Regulation (EU) 2023/1455 of 13 July 2023 concerning the urgent provisional authorisation of cobalt(II) acetate tetrahydrate, cobalt(II) carbonate, cobalt(II) carbonate hydroxide (2:3) monohydrate and cobalt(II) sulphate, heptahydrate as feed additives for ruminants with a functional rumen, equidae and lagomorphs (Text with EEA relevance)

Provisional 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 provisionally authorised as additives in animal nutrition, subject to the conditions laid down in that Annex.

Entry into force

Article 2

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

ANNEXSupplementary provisions

ANNEX Identification number of the additive 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 x 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 the 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 the determination of particle size distribution: — ISO 13320 - Particle size analysis - Laser diffraction methods. Ruminants with a functional rumen, equidae, lagomorphs - - 1 (total) 1. The additive shall be incorporated into compound feed in the form of a premixture. 2. 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.’ 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. 4. Declaration to be made in the instructions of use of the compound feed: ‘Protective measures to avoid exposure with Cobalt by inhalation or by dermal route should be taken.’ As soon as a decision on the authorisation of the additive has been taken under Article 9 of Regulation (EC) No 1831/2003 and at the latest on 14 July 2028. 3b302 Cobalt(II) carbonate Additive composition Cobalt(II) carbonate, as powder, with a content of 45% - 48% cobalt Cobalt carbonate: minimum 75% Cobalt hydroxide: 3% - 15% Water: maximum 6% Particles < 11 μm: below 90 % Characterisation of the active substance Chemical formula: CoCO 3 CAS number: 513-79-1 Analytical methods  ( 1 ) For the identification of carbonate in the additive: — European Pharmacopoeia monograph 01/2008:20301. For the crystallographic characterisation of the 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 the determination of particle size distribution: — ISO 13320 - Particle size analysis - Laser diffraction methods. Ruminants with a functional rumen, equidae, lagomorphs - - 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. 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.’ 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. 4. Declaration to be made in the instructions of use of the compound feed: ‘Protective measures to avoid exposure with Cobalt by inhalation or by dermal route should be taken.’ As soon as a decision on the authorisation of the additive has been taken under Article 9 of Regulation (EC) No 1831/2003 and at the latest on 14 July 2028. 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 x 3Co(OH) 2 x 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 the 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 the determination of particle size distribution: — ISO 13320 - Particle size analysis - Laser diffraction methods. Ruminants with a functional rumen, equidae, lagomorphs - - 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. 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.’ 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. 4. Declaration to be made in the instructions of use of the compound feed: ‘Protective measures to avoid exposure with Cobalt by inhalation or by dermal route should be taken.’ As soon as a decision on the authorisation of the additive has been taken under Article 9 of Regulation (EC) No 1831/2003 and at the latest on 14 July 2028. 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 x 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 the 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 the determination of particle size distribution: — ISO 13320 - Particle size analysis - Laser diffraction methods. Ruminants with a functional rumen, equidae, lagomorphs - - 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. 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.’ 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. 4. Declaration to be made in the instructions of use of the compound feed: ‘Protective measures to avoid exposure with Cobalt by inhalation or by dermal route should be taken.’ As soon as a decision on the authorisation of the additive has been taken under Article 9 of Regulation (EC) No 1831/2003 and at the latest on 14 July 2028. ( 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