Contents
Article 1Authorisation#
The substance specified in Annex I, belonging to the additive category ‘technological additives’ and to the functional groups ‘binders’ and ‘anticaking agents’ is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2Amendment to Implementing Regulation (EU) 2023/263#
The Annex to Implementing Regulation (EU) 2023/263 is replaced by Annex II to this Regulation.
Article 3Transitional measures#
1.The substance sepiolitic clay, as authorised by Implementing Regulation (EU) 2023/263, and premixtures containing this substance, which are intended for salmonids and chickens for fattening, and which are produced and labelled before 15 August 2026 in accordance with the rules applicable before 15 February 2026 may continue to be placed on the market and used until the stocks concerned are exhausted.
2.Compound feed and feed materials containing the substance referred to in paragraph 1, which are intended for salmonids and chickens for fattening, and which are produced and labelled before 15 February 2027 in accordance with the rules applicable before 15 February 2026 may continue to be placed on the market and used until the stocks concerned are exhausted.
Article 3aTransitional measures#
1.The substance sepiolitic clay and premixtures containing that substance, which are intended for all animal species other than ruminants for milk production or reproduction, weaned piglets of porcine species, porcine species for fattening, salmonids and chickens for fattening, and which are produced and labelled before 22 January 2027 in accordance with the rules applicable before 22 July 2026 may continue to be placed on the market and used until the stocks concerned are exhausted.
2.Compound feed and feed materials containing the substance referred to in paragraph 1, which are intended for all animal species other than ruminants for milk production or reproduction, weaned piglets of porcine species, porcine species for fattening, salmonids and chickens for fattening and which are produced and labelled before 22 July 2027 in accordance with the rules applicable before 22 July 2026 may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for food-producing animals.
3.Compound feed and feed materials containing the substance referred to in paragraph 1, which are intended for all animal species other than ruminants for milk production or reproduction, weaned piglets of porcine species, porcine species for fattening, salmonids and chickens for fattening and which are produced and labelled before 22 July 2028 in accordance with the rules applicable before 22 July 2026 may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for non-food-producing animals.
Article 4Entry into force#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Annex II
| Identification number of the feed 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 |
|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feed with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: binders | ||||||||
| 1g563 | Sepiolitic clay | Additive compositionHydrated magnesium silicate of sedimentary origin, containing ≥ 40 % sepiolite and ≥ 25 % illite.Powder form.Characterisation of the active substanceSepiolite (hydrous magnesium silicate): ≥ 40 %CAS number: 63800-37-3Einecs number: 264-465-3Chemical formula: Mg4Si6O15(OH)2·6H2O.Illite (potassium and iron aluminium silicate): ≥ 25 %CAS number: 12173-60-3Einecs number: 601-803-4Chemical formula: (K,H3O)(Al,Mg,Fe)2(Si,Al)4O10[(OH)2·(H2O)]Carbonates (dolomite, calcium and magnesium carbonate): ≤ 35 %Free of asbestosnoteImpurities:Nickel ≤ 20,3 mg/kgAnalytical methodnoteFor the characterisation of the feed additive:X-ray diffraction (XRD) andX-ray fluorescence (XRF) or atomic absorption spectrometry (AAS). | Ruminants for milk production or reproductionWeaned piglets of porcine speciesPorcine species for fatteningSalmonidsChickens for fattening | - | 20000 | 1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. 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 protective equipment, including skin and breathing protection. Particular attention shall be given to compliance with Union legislation on the protection of workers from the inhalation risks related to exposure to crystalline silica and nickel. | 28 February 2033 |
| Identification number of the feed 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 |
|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feed with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: anticaking agents | ||||||||
| 1g563 | Sepiolitic clay | Additive compositionHydrated magnesium silicate of sedimentary origin, containing ≥ 40 % sepiolite and ≥ 25 % illite.Powder form.Characterisation of the active substanceSepiolite (hydrous magnesium silicate): ≥ 40 %CAS number: 63800-37-3Einecs number: 264-465-3Chemical formula: Mg4Si6O15(OH)2·6H2O.Illite (potassium and iron aluminium silicate): ≥ 25 %CAS number: 12173-60-3Einecs number: 601-803-4Chemical formula: (K,H3O)(Al,Mg,Fe)2(Si,Al)4O10[(OH)2·(H2O)]Carbonates (dolomite, calcium and magnesium carbonate): ≤ 35 %Free of asbestosnoteImpurities:Nickel ≤ 20,3 mg/kgAnalytical methodnoteFor the characterisation of the feed additive:X-ray diffraction (XRD) andX-ray fluorescence (XRF) or atomic absorption spectrometry (AAS). | Ruminants for milk production or reproductionWeaned piglets of porcine speciesPorcine species for fatteningSalmonidsChickens for fattening | - | 20000 | 1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. 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 protective equipment, including skin and breathing protection. Particular attention shall be given to compliance with Union legislation on the protection of workers from the inhalation risks related to exposure to crystalline silica and nickel. | 28 February 2033 |
| Identification number of the feed 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 |
|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feed with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: binders | ||||||||
| 1g563 | Sepiolitic clay | Additive compositionHydrated magnesium silicate of sedimentary origin, containing ≥ 40 % sepiolite and ≥ 25 % illite.Powder form.Characterisation of the active substanceSepiolite (hydrous magnesium silicate): ≥ 40 %CAS number: 63800-37-3Einecs number: 264-465-3Chemical formula: Mg4Si6O15(OH)2·6H2O.Illite (potassium and iron aluminium silicate): ≥ 25 %CAS number: 12173-60-3Einecs number: 601-803-4Chemical formula: (K,H3O)(Al,Mg,Fe)2(Si,Al)4O10[(OH)2·(H2O)]Carbonates (dolomite, calcium and magnesium carbonate): ≤ 35 %Free of asbestosnoteImpurities:Nickel ≤ 20,3 mg/kgAnalytical methodnoteFor the characterisation of the feed additive:X-ray diffraction (XRD) andX-ray fluorescence (XRF) or atomic absorption spectrometry (AAS). | All animal species other than ruminants for milk production or reproduction, weaned piglets of porcine species, porcine species for fattening, salmonids and chickens for fattening | - | 20000 | 1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. 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 protective equipment, including skin and breathing protection. Particular attention shall be given to compliance with Union legislation on the protection of workers from the inhalation risks related to exposure to crystalline silica and nickel. | 15 February 2036 |
| Identification number of the feed 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 |
|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feed with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: anticaking agents | ||||||||
| 1g563 | Sepiolitic clay | Additive compositionHydrated magnesium silicate of sedimentary origin, containing ≥ 40 % sepiolite and ≥ 25 % illite.Powder form.Characterisation of the active substanceSepiolite (hydrous magnesium silicate): ≥ 40 %CAS number: 63800-37-3Einecs number: 264-465-3Chemical formula: Mg4Si6O15(OH)2·6H2O.Illite (potassium and iron aluminium silicate): ≥ 25 %CAS number: 12173-60-3Einecs number: 601-803-4Chemical formula: (K,H3O)(Al,Mg,Fe)2(Si,Al)4O10[(OH)2·(H2O)]Carbonates (dolomite, calcium and magnesium carbonate): ≤ 35 %Free of asbestosnoteImpurities:Nickel ≤ 20,3 mg/kgAnalytical methodnoteFor the characterisation of the feed additive:X-ray diffraction (XRD) andX-ray fluorescence (XRF) or atomic absorption spectrometry (AAS). | All animal species other than ruminants for milk production or reproduction, weaned piglets of porcine species, porcine species for fattening, salmonids and chickens for fattening | - | 20000 | 1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. 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 protective equipment, including skin and breathing protection. Particular attention shall be given to compliance with Union legislation on the protection of workers from the inhalation risks related to exposure to crystalline silica and nickel. | 15 February 2036 |
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