EP4262428A1

EP4262428A1 - Milk replacer comprising animal-free formulations of fat-soluble vitamins

Info

Publication number: EP4262428A1
Application number: EP21836572.4A
Authority: EP
Inventors: Thomas Lindemann; Christos TSEKOU; Kai Urban; Christian Schaefer
Original assignee: DSM IP Assets BV
Current assignee: DSM IP Assets BV
Priority date: 2020-12-18
Filing date: 2021-12-16
Publication date: 2023-10-25
Also published as: WO2022129435A1; CN116669565A

Abstract

The present invention is directed to a milk replacer comprising an animal-free formulation comprising a) Vitamin A or a C_1-20 alkyl ester thereof and optionally vitamin D; b) Gum Arabic in an amount of ≤ 25 weight-%; c) at least one ingredient selected from modified food starches, starch hydrolysates, mono- and disaccharides; d) at least an antioxidant; e) an anti-caking agent; f) optionally an oil; g) optionally residual moisture; whereby all amounts a) to f) sum up to 100 weight-% and are based on the sum of the weight of a) to f), whereby the compound a) is encapsulated in a matrix formed by compounds b) and c). The present invention is further directed to said animal-free formulation, as well as its use in a milk replacer, especially for young non-human mammals such as calves, foals, young goats, young sheep and camel foals. Further objects of the present invention are processes for the manufacture of such animal-free formulations and such milk replacer.

Description

Milk replacer comprising animal-free formulations of fat-soluble vitamins Summary of the invention The present invention is directed to a milk replacer comprising an animal-free formulation comprising a) Vitamin A or a C_1-20 alkyl ester thereof and optionally vitamin D; b) Gum Arabic in an amount of ≤ 25 weight-%; c) at least one ingredient selected from modified food starches, starch hydrolysates, mono- and disaccharides; d) at least an antioxidant; e) an anti-caking agent; f) optionally an oil; g) optionally residual moisture; whereby all amounts a) to f) sum up to 100 weight-% and are based on the sum of the weight of a) to f), whereby the compound a) is encapsulated in a matrix formed by compounds b) and c). “encapsulated” means that the compound a), i. e. Vitamin A or a C_1-20 alkyl ester thereof and optionally vitamin D, is embedded in the matrix of Gum Arabic b) and the compound c) and thereby protected against oxidation and degradation. The precursor of the formulation, i. e. the dispersion obtained after having performed step C) of the process for the manufacture of the formulation according to the present invention, forms an oil-in-water type dispersion whereby the compound a) is the oil being located in the internal phase and the Gum Arabic acts as emulsifier. The compound c) is the filler and additional emulsifier in the matrix contributing to its stability. After drying of the dispersion in the presence of the anti-caking agent e), i. e. preferably “spray drying” or “powder catching” of the dispersion, the matrix comprising the compound a) is coated by the anti-caking agent. “Coated” in the context of the present invention means that the anti-caking agent surrounds the matrix. The present invention is further directed to said animal-free formulation, as well as its use in a milk replacer, especially for young non-human mammals such as calves, foals, young goats, young sheep and camel foals. “Young” in this context means the time from birth of the mammal until the mammal would be lactated by its mother. A milk replacer is specially a powder, which is dissolved in water, and administered to young non-human mammals, such as preferably calves, foals, young goats, young camels and young sheep, instead of milk from the animals’ mother. The milk replacer preferably contains essential nutrients including proteins, amino acids, carbohydrates, fats, vitamins and minerals. Preferably the compound a) is first encapsulated, i. e. embedded in the matrix of Gum Arabic b) and the compound c), especially according to a process as disclosed below, to obtain the animal-free formulation and then mixed with other ingredients such as proteins, amino acids, carbohydrates, fats, water-soluble vitamins and minerals to obtain the milk replacer according to the present invention. Other fat-soluble vitamins may be encapsulated together with compound a) or separately and then mixed with the other ingredients to obtain the milk replacer according to the present invention. Other fat-soluble vitamins beside compound a) may also be encapsulated in other hydrocolloids. Further objects of the present invention are processes for the manufacture of such animal-free formulations and such milk replacer. Background of the invention Vitamin A is necessary for the development of young and growing animals. In the absence of vitamin A, animals will grow poorly and eventually die. Vitamin A deficiency causes four main different physiologically distinct lesions: - Loss of vision due to a failure of rhodopsin formation in the retina - Defects in bone growth and structure - Defects in reproduction - Defects in growth and differentiation of epithelial tissues. Therefore, milk replacers, especially for non-human mammals such as calves, foals, young goats, camel foals and young sheep, comprise formulations of vitamin A or derivatives thereof to assure that its/their required optimum levels are taken up by the young mammal. Such formulations are preferably animal-free, i.e. they do not contain gelatin or any other ingredient of an animal source. Since milk replacers have, when dissolved in water, a color similar to milk, i.e. a white or beige or yellow color, such formulation also has preferably such color. To ensure an even distribution of the formulation in the milk replacer it is advantageous if the formulation has the same or a similar bulk density as the milk replacer without such formulation. Milk replacers have typically a bulk density ranging from 0.4 g/cm³ to 0.9 g/cm³. Thus, there is a need to provide an animal-free formulation of vitamin A, vitamin A derivatives and any mixtures thereof which has the same or a similar bulk density as the milk replacer without such formulation, i.e. a bulk density ranging from 0.4 g/cm³ to 0.9 g/cm³, and may, therefore, ensure an even distribution within said milk replacer. Detailed description Thus, this need is fulfilled by the present invention, which is directed to a milk replacer comprising an animal-free formulation comprising a) Vitamin A or a C_1-20 alkyl ester thereof and optionally vitamin D; b) Gum Arabic in an amount of ≤ 25 weight; c) at least one ingredient selected from modified food starches, starch hydrolysates, mono- and disaccharides; d) at least an antioxidant; e) an anti-caking agent; f) optionally an oil; g) optionally residual moisture; whereby all amounts a) to f) sum up to 100 weight-% and are based on the sum of the weight of a) to f), whereby the compound a) is encapsulated in a matrix formed by compounds b) and c). Preferably the amount of Gum Arabic b) in relation to the sum of the amounts of the ingredient(s) b) and c) is at most 50 weight-%. More preferably the weight ratio of Gum Arabic to the ingredient(s) c) is <1. In a preferred embodiment of the present invention the animal-free formulation consists of the ingredients a) to g). The term “consisting of” means that the formulation does not comprise any further ingredients besides a) to g). The amount of residual moisture in the final formulation is preferably ranging from 0.1-8.0 weight-%, more preferably ranging from 0.5 to 7.0 weight-%, most preferably ranging from 1.0 to 6.0 weight-%, based on the total weight of the formulation, i.e. the sum of the weight of a), b), c), d), e), f) and g). By disclosing these ranges any combination of any lower value with any higher value to a range is also disclosed, i.e.1.0-8.0 weight-%, 0.5-6.0 weight-% etc. Animal-free formulation The formulation is described in more detail below. The essential ingredients and their amounts, as well as the ingredients being absent in the formulations are further disclosed. Hereby any combination of any preference with another preference is encompassed by the present invention even though its specific combination may not be explicitly disclosed. Not present ingredients The formulation is animal-free, i.e. that the formulation does not contain proteins or other compounds from animal origin such as e.g. gelatin. In contrast to the formulations disclosed in EP 494417 A2 the matrix of the formulations of the present invention does not comprise any of the following salts: water-soluble salts of carboxylic acids, sodium carbonate, potassium carbonate, calcium sulfate, and calcium phosphate. Examples of such water-soluble salts of carboxylic acids not being present in the matrix of the formulations of the present invention are: aluminum subacetate, sodium tartrate, sodium glutarate, sodium acetate, calcium acetate, sodium propionate, calcium propionate and sodium benzoate. Some of these salts may, however, be used as anti-caking agents. The process of the present invention has the advantage that no organic solvent except water is used, so that the formulation according to the present invention is substantially free of organic solvents. “substantially free” means that the amount thereof is ≤ 5 weight-%, preferably ≤ 3 weight-%, more preferably ≤ 1 weight-%, even more preferably ≤ 0.5 weight-%, most preferably ≤ 0.1 weight-%, based on the total weight of the formulation. Further ingredients that are not present in the formulations according to the present invention are polyhydric alcohols. Examples of absent polyhydric alcohols are glycerol, monoesters of glycerol with C_1-5 monocarboxylic acids, monoethers of glycerol, diglycerol, triglycerol, polyglycerol, propylene glycol, dipropylene glycol, 1,3-butylene glycol, ethylene glycol, polyethylene glycol, sorbitol, xylitol, maltitol, erythritol, mannitol, etc. Furthermore, no cross-linking agent such as e.g. acetaldehyde, glutaraldehyde or glyoxal are present in the formulations of the present invention. Since the formulation of the present invention has to be water-soluble, cross-linking is not desired. Phenols with bulky alkyl groups such as e.g. butylated hydroxyanisoles (“BHA”) and butylated hydroxytoluenes (“BHT”) are also not present in the formulations of the present invention. The BHA is preferably a mixture of 2-tert-butyl-4-hydroxy-anisole and 3-tert-butyl- 4-hydroxy-anisole. The BHT is preferably 2,6-di-tert-butyl-p-cresol (IUPAC name = 2,6-di-tert-butyl-4-methylphenol). Ethoxyquin, also known as “EMQ” (IUPAC name: 6-Ethoxy-2,2,4-trimethyl-1,2- dihydroquinoline), is also not present in the formulations of the present invention. Essential ingredients Fat-soluble vitamin The term "fat-soluble vitamins" comprises for the purpose of the present invention vitamins A and/or D, and the corresponding derivatives such as esters, especially C₁-C₂₀ alkyl esters, as well as any mixture thereof. “Vitamin D” means either Vitamin D₃ (cholecalciferol) or Vitamin D2 (ergocalciferol) or both. “Vitamin D derivative” means any derivative of Vitamin D as for example 25- hydroxy vitamin D₃ (so-called “HyD”), 1,25-dihydroxy vitamin D₃ or 24,25-dihydroxy vitamin D₃. Vitamin K may also be present. “Vitamin K” means either Vitamin K1 or Vitamin K2 or Vitamin K₃ or any mixture thereof. Vitamin K₁ is also called phylloquinone and has the systematic name all-E-2-methyl-3-(3,7,11,15-tetramethylhexadec-2- enyl)naphthalene-1,4-dione. Vitamin K₂ is a mixture of homologue molecules based on a naphthoquinone structure and varying lengths of the isoprenoid chain. These compounds are called menaquinones. Menaquinones have side chains composed of all-E polyprenyl residues; generally they are designated as MK-n, where n specifies the number of isoprenyl repeating units. The minimum value of n is 2 (n typically has a value of 2 - 11). The most preferred menaquinone is MK-7 (with 7 isoprenyl groups). Vitamin K₃ is also called menadione. Vitamin K₃ is the most preferred vitamin K in the formulation and milk replacer of the present invention. Especially preferred examples of fat-soluble vitamins are vitamin A, vitamin A acetate, vitamin A propionate, vitamin A butanoate, vitamin A palmitate, vitamin D₃ and 25-hydroxy-vitamin D, as well as any mixture thereof. More preferred are vitamin A acetate, vitamin D₃ and any mixture thereof. Even more preferred the fat- soluble vitamin is vitamin A acetate or a mixture of vitamin A acetate and vitamin D₃, preferably in a weight ratio of vitamin A acetate to vitamin D₃ ranging from 1:1 to 100:1, more preferably ranging from 10:1 to 85:1. Most preferred the fat-soluble vitamin is vitamin A acetate. The amount of the vitamin A or its derivative thereof is chosen in such a way so that its final amount in the formulation is preferably in the range of from 10 to 29 weight-%, more preferably its final amount is in the range of from 12 to 24 weight- %, even more preferably its final amount is in the range of from 15 to 23 weight-% most preferably its final amount is in the range of from 17 to 22 weight-%, based on the sum of the weight of a) to f). By disclosing these ranges any combination of any lower value with any other value to a range is also disclosed, i.e.10-22 weight-%, 12-29 weight-%, 15-24 weight-% etc. If a mixture of Vitamin A acetate and vitamin D₃ is used, the amount of vitamin A acetate is as given above for the vitamin A derivative and the amount of vitamin D3 is chosen in such a way so that its final amount in the formulation is preferably in the range of from 0.01 to 10 weight-%, more preferably its final amount is in the range of from 0.05 to 5 weight-%, even more preferably its final amount is in the range of from 0.1 to 3.5 weight-%, most preferably its final amount is in the range of from 0.3 to 2.5 weight-%, based on the total weight of a) to f). By disclosing these ranges any combination of any lower value with any higher value to a range is also disclosed, i.e.0.01-5 weight-%, 0.05-10 weight-%, 0.1-5 weight-% etc. When vitamin D, preferably vitamin D₃, is present in the formulation of the present invention advantageously also an oil is present. Oil The oils can be natural, modified or synthetic. If the oils are natural they are preferably plant oils. Thus, the term “oil” encompasses any vegetable oil like corn oil, sunflower oil, soybean oil, safflower oil, rapeseed oil, peanut oil, palm oil, palm kernel oil, cotton seed oil, olive oil, coconut oil, canola oil, sesame oil, hazelnut oil, almond oil, cashew oil, macadamia oil, mongongo nut oil, pracaxi oil, pecan oil, pine nut oil, pistachio oil, sacha Inchi (Plukenetia volubilis) oil, walnut oil, as well as middle chain triglycerides (“MCT”) and any mixture thereof. Preferably corn oil, peanut oil, safflower oil or sunflower oil are used. Preferably the oil or fat is not from animal origin. The weight ratio of vitamin D to the oil is preferably ranging from 1:1 to 1:10, more preferably from 1:2 to 1:5. Gum Arabic Gum Arabic, also called “Gum Acacia”, is obtained as sticky exudates from the stems and branches of acacia trees when they are subjected to stress. The gum is collected from Acacia senegal trees and, to a lesser extent, from Acacia seyal trees in several countries in the Sahara region of Africa. It is preferably used in the form of a spray-dried powder. Preferably Gum Arabic is used whose aqueous 25 weight-% solution has a viscosity ranging from 60 to 150 mPa s when measured with a Brookfield viscosimeter according to the Method PM GA 02. The term “Gum Arabic” encompasses “native Gum Arabic”, as well as “modified Gum Arabic”. Native Gum Arabic means that it is chemically unmodified. Gum Arabic from Acacia seyal with a tannin content > 700 ppm (w/w) as disclosed in more detail in WO 2017/017248 may also be used. “Modified Gum Arabic” refers to Gum Arabic which has been submitted to hydrolysis to degrade the polysaccharide and, where appropriate, the protein portion as e. g. described in WO 2006/053761. Preferably the modified Gum Arabic is a Gum Arabic whose protein part is hydrolyzed up to a degree of 30%, preferably to a degree of from 1 to 30%, more preferably to a degree of from 1 to 10%, most preferably to a degree of from 1 to 5%. In certain embodiments of the present invention modified Gum Arabic is used whose protein part is hydrolyzed between 0.05 and 1%. Preferably the term “Gum Arabic” does not comprise “heat-treated Gum Arabic” meaning especially Gum Arabic that has been treated according to the method as disclosed in WO 2008/110225, i.e. either at a temperature ranging from 100°C to 115°C, preferably ranging from 105°C to 115°C, more preferably ranging from 108°C to 113°C and most preferably at 110°C, for 13 to 38 hours, preferably for more than 15 and less than 24 hours and more preferably for 16 to 18 hours, or at a temperature ranging from 55°C to 85°C, preferably ranging from 65°C to 85°C, more preferably ranging from 70°C to 85°C, most preferably ranging from 70°C to 80°C, for 17 to 65 hours, preferably for 38 to 65 hours, more preferably for 42 to 65 hours, most preferably for 42 to 50 hours. The amount of Gum Arabic b) in the formulations of the present invention is chosen in such a way so that its final amount in the formulation is preferably ranging from 10 to 25 weight-%, more preferably from 15 to 25 weight-%, most preferably from 19 to 24.5 weight-%, based on the sum of the weight of the ingredients a) to f). Ingredient(s) c) The ingredients c) are selected from modified food starches, starch hydrolysates and mono- and disaccharides, as well as any mixture thereof. At least one ingredient c) is used. The amount of the ingredient(s) c) in the formulations of the present invention is chosen in such a way so that its/their final total amount(s) in the formulation is/are preferably ranging from 35 to 58 weight-%, more preferably from 38 to 55 weight-%, most preferably from 40 to 52 weight-%, based on the sum of the weight of the ingredients a) to f). In a preferred embodiment of the present invention the weight ratio of Gum Arabic to the ingredient(s) c) is ranging from 1:1.3 to 1:3, preferably it is ranging from 1:1.5 to 1:2.6. Preferably the ingredient c) is either a starch hydrolysate with the preferences as defined below or a mixture of a modified food starch and a disaccharide such as e.g. sucrose. If a mixture of modified food starch and a disaccharide such as e.g. sucrose is used as ingredient c), preferably their mixture with a weight ratio of modified food starch to the disaccharide ranging from 1:2 to 2:1, more preferably with a weight ratio ranging from 1:1.5 to 1.5:1, most preferably with a weight ranging from 1:1.3 to 1.3:1, is used. Here one or more modified food starches and/or one or more disaccharides may be used. Starch hydrolysates Starch hydrolysates are classified according to their DE value. The term “dextrose equivalent” (DE) denotes the degree of hydrolysis and is a measure of the amount of reducing sugar calculated as D-glucose based on dry weight; the scale is based on native starch having a DE close to 0 and glucose (= dextrose) having a DE of 100. Dextrins have a DE = 1-13; maltodextrins have a DE = 3-20 and glucose syrups have a DE > 20. Preferably a starch hydrolysate with a DE ≤ 40, more preferably with a DE ≤ 30, even more preferably with a DE ≤ 25, is used. In a preferred embodiment of the present invention a dried glucose syrup with a DE of 20-23, commercially available under the name “Maltodextrin 2023” has been used. Modified food starches A modified food starch is a food starch that has been chemically modified by known methods to have a chemical structure which provides it with a hydrophilic and a lipophilic portion. Preferably the modified food starch has a long hydrocarbon chain as part of its structure (preferably C₅-C₁₈). At least one modified food starch is preferably used as ingredient c), but it is possible to use a mixture of two or more different modified food starches for the formulation and thus, also for the milk replacer of the present invention. Starches are hydrophilic and therefore do not have emulsifying capacities. However, modified food starches are made from starches substituted by known chemical methods with hydrophobic moieties. For example, starch may be treated with cyclic dicarboxylic acid anhydrides such as succinic anhydrides, substituted with a hydrocarbon chain. A particularly preferred modified food starch has the following formula (I) wherein St is a starch, R is an alkylene radical and R´ is a hydrophobic group. Preferably R is a lower alkylene radical such as dimethylene or trimethylene. R´ may be an alkyl or alkenyl group, preferably having 5 to 18 carbon atoms. A preferred compound of formula (I) is an “OSA-starch” (starch sodium octenyl succinate). The degree of substitution, i.e. the number of esterified hydroxyl groups to the number of free non-esterified hydroxyl groups usually varies in a range of from 0.1% to 10%, preferably in a range of from 0.5% to 4%, more preferably in a range of from 2% to 3%. The term “OSA-starch“ denotes any starch from any natural source that was treated with octenyl succinic anhydride (OSA). The degree of substitution, i.e. the number of hydroxyl groups esterified with OSA to the number of free non- esterified hydroxyl groups usually varies in a range of from 0.1% to 10%, preferably in a range of from 0.5% to 4%, more preferably in a range of from 2% to 3%. “Modified food starch” is a synonym often used for OSA-starches. The natural source of the starch may be corn, waxy corn, wheat, tapioca, pea and potato or synthesized. The term “OSA-starches” encompasses also such starches that are commercially available e.g. under the tradenames HiCap 100, Capsul (octenylbutanedioate amylodextrin), Capsul HS, Purity Gum 2000, Cleargum COA1, Cleargum CO03, UNI- PURE, HYLON VII; from Ingredion and Roquette, respectively; from Cargill under the tradename C*EmCap or from Tate & Lyle. The terms “modified starches” and “OSA-starches” encompass further also modified starches/OSA-starches that were partly hydrolysed enzymatically, e.g. by glycosylases (EC 3.2; see http://www.chem.qmul.ac.uk/iubmb/enzyme/EC3.2/), as well as to modified starches/OSA-starches that were partly hydrolysed chemically by known methods (so-called acid degradation). The enzymatic hydrolysis is conventionally carried out at a temperature of from about 5°C to about < 100°C, preferably at a temperature of from about 5°C to about 70°C, more preferably at a temperature of from about 20°C to about 55°C. The glycosylases can be from fruit, animal origin, bacteria or fungi. The glycolase may have endo-activity and/or exo-activity. Therefore, enzyme preparations of endo- and exo-glycosylases or any of their mixtures may be used. Preferably the glycosylases have pectolytic and/or hemicelluloytic activity. Usually the glycosylases show also unknown side activities, but which are not critical for the manufacture of the desired product. Examples of glycosylases are the commercially available enzyme preparations from the suppliers Novozymes, Genencor, AB-Enzymes, DSM Food Specialities, Amano, etc. The glycosylase is added to provide a concentration of from about 0.01 to about 10 weight-%, preferably of from about 0.1 to about 1 weight-%, based on the dry weight of the modified starch/OSA-starch. In a preferred embodiment of the process of the invention, the enzyme is added at once. The enzymatic hydrolysis may also be carried out stepwise. For instance, the glycosylase or a mixture of glycosylases is added to the incubation batch in an amount of e.g.1 % whereupon, e.g. after 5 to 10 minutes (at a temperature of 35 °C) further glycosylase or a mixture of glycosylases which may by the same or different from the first added glycosylase or mixture of glycosylases is added, e.g. in an amount of 2 % whereupon the incubation batch is hydrolysed at 35 °C for 10 minutes. Using this procedure, starting modified starches/OSA-starches having a degree of hydrolysis of approximately zero can be used. The duration of hydrolysis may vary between about a few seconds and about 300 minutes. The exact duration of the enzymatic treatment may be determined in an empirical way with respect to the desired properties of the modified starch/OSA- starch, such as emulsifying stability, emulsifying capacity, droplet size of the emulsion, depending strongly on parameters like enzyme activities, or composition of the substrate. Alternatively, it may be determined by measuring the osmolality (W. Dzwokak and S. Ziajka, Journal of food science, 1999, 64 (3) 393-395). The inactivation of the glycosylase is suitably achieved by heat denaturation, e.g. by heating of the incubation batch to about 80 to 85 °C for 5 to 30 minutes, especially for 5 to 10 minutes. The OSA-starches modified according to the processes as disclosed in WO 2020/093962, WO 2020/093919, WO 2020/093960 and CN-A 109517080 may also be used as ingredient c) for the formulation and for the milk replacer of the present invention. Mono- and Disaccharides Examples of monosaccharides are fructose, glucose (= dextrose), mannose, galactose, sorbose, as well as any mixtures thereof. The term “glucose” in the context of the present invention does not only mean the pure substance, but also a glucose syrup with a DE ≥ 90 (DE is defined above). This also applies for the other monosaccharides. Examples of disaccharides are saccharose (= sucrose), isomaltose, lactose, maltose and nigerose, as well as any mixture thereof. Preferably sucrose is used. Antioxidant(s) d) The antioxidant may be a water-soluble antioxidant or a fat-soluble antioxidant or any mixture thereof. Thus, mixtures of water-soluble antioxidants, mixtures of fat- soluble antioxidants and mixtures of one or more water-soluble antioxidants and one or more fat-soluble antioxidants are also included in the term “antioxidant”. Preferred are fat-soluble antioxidants as well as mixtures thereof and mixtures of water- and fat-soluble antioxidants. Especially preferred is the use of a single fat- soluble antioxidant. Inorganic antioxidants may also be present. Examples of inorganic antioxidants are NaBH₄, Na₂SO₃ and/or Na₂S₂O₃. Examples of fat-soluble antioxidants are ascorbyl palmitate, polyphenols, flavones being substituted with one or more hydroxy groups, isoflavones being substituted with one or more hydroxy groups, tocotrienols and analogues thereof, tocopherols and analogues thereof, or any mixture thereof. Preferred examples of fat-soluble antioxidants are ascorbyl palmitate, tocotrienols and analogues thereof, tocopherols and analogues thereof, or any mixture thereof. Analogues of tocopherols and tocotrienols are especially compounds with a shorter side chain in position 2 compared to tocopherols and tocotrienols. Examples of flavones substituted with one or more hydroxy groups are: 6- hydroxyflavone, 5,7-dihydroxyflavone (= chrysin), 4',5,7-trihydroxyflavone (= apigenin), 3',4',5,7-tetrahydroxyflavone (luteolin) and 4',5,6,7,8-pentamethoxy- flavone (tangeritin). Examples of isoflavones substituted with one or more hydroxy groups and optionally methoxy groups are daidzein (= 4’,7-dihydroxyisoflavone), genistein (= 4’,5,7-trihydroxyisoflavone), prunetin (= 4’,5-dihydroxy-7-methoxyisoflavone), biochanin A (= 5,7-dihydroxy-4’-methoxy-soflavone), orobol (= 3’,4’,5,7- tetrahydroxyisoflavone), santal (= 3’,4’,5-trihydroxy-7-methoxy-isoflavone) and pratensein (= 3’,5,7-trihydroxy-4’-methoxyisoflavone). Examples of water-soluble antioxidants are ascorbic acid and its salts such as e.g. sodium ascorbate, citric acid and its salts such as e.g. sodium citrate, as well as any mixture thereof. Examples of mixtures of water- and fat-soluble antioxidants are tocopherol and sodium ascorbate, tocopherol and ascorbic acid, whereby the tocopherol may be alpha-, beta-, gamma- or delta-tocopherol, preferably whereby the tocopherol is alpha- or delta-tocopherol, more preferably whereby the tocopherol is alpha- tocopherol, most preferably whereby the tocopherol is DL-alpha-tocopherol. Tocopherols, tocotrienols and analogues thereof Examples of suitable tocopherols and analogues thereof are e.g. compounds of formula (II)

wherein R^1a and R^2a are independently from each other H or C_1-11-alkyl or (CH₂)_n─OH with n being an integer from 1 to 4, or R^1a and R^2a represent together a keto group, A is CHR^3a or C(=O), and wherein R^3a, R^4a and R^6a are independently from each other H or C_1-4-alkyl, and wherein R^5a is H or OH or C_1-4-alkyl or C_1-4-alkoxy, as disclosed in WO 2019/185894. Further suitable tocopherols are compounds of formula (II), wherein one of the two substituents R^1a and R^2a is C_12-21-alkyl and the other of the two substituents R^1a and R^2a is either hydrogen or C1-5-alkyl or (CH₂)n-OH with n being an integer from 1 to 5, and wherein A is CH(R^3a), and wherein R^3a, R^4a and R^6a are independently from each other H or C_1-4-alkyl, and wherein R^5a is H or OH or C_1-4-alkyl or C_1-4-alkoxy, as disclosed in WO 2019/185938. Compounds of formula (II), wherein A is CH₂, R^1a is C_1-5-alkyl, R^2a is either H or C_1-2- alkyl, R^5a is either H or C_1-4-alkoxy or C_1-4-alkyl, and R^4a and R^6a are independently from each other either H or C_1-4-alkyl, with the preferences as disclosed in WO 2019/185900 are also suitable antioxidants in the formulations of the present invention. Preferred examples of the antioxidants of formula (II) as disclosed in WO 2019/185894 are the following compounds of formula (1)-(11) with “Me” being methyl: Further examples of suitable antioxidants that can be used in the formulations of the present invention are compounds of formula (III) and (IV), wherein R^1b and R^2b are independently from each other H or C_1-11-alkyl or (CH₂)_n─OH with n being an integer from 1 to 6 or R^1b and R^2b together represent a keto group, and wherein R^3b, R^4b, R^5b, and R^6b are independently from each other H or C_1-6-alkyl or C_1-6-alkoxy, and R^7b is H or C_1-6-alkyl, as disclosed in WO 2019/185898. “alkyl” and “alkoxy” hereby encompass linear alkyl and branched alkyl, and linear alkoxy and branched alkoxy, respectively. Preferred examples of compounds of formula (III) and (IV) are the following compounds (12)-(19):

Further suitable antioxidants are compounds of formula (V), whereby R¹, R² and R³ are independently from each other H or linear C_1-6-alkyl or branched C_3-8-alkyl, whereby preferably R¹ is H or methyl or ethyl or n-propyl or iso-propyl or tert-butyl and R² and R³ are independently from each other H or methyl or ethyl, with the further preferences as disclosed in WO 2019/185940. Also, the compounds of formula (VI) with n being 1 or 2, R^1b and R^3b being independently from each other H or C_1-5-alkyl, and R^2b being either H or C_1-5-alkyl or C1-5-alkyloxy, preferably with the proviso at least one of R^1b, R^2b and R^3b being H, as disclosed in WO 2019/185904 can be used as antioxidants in the formulations of the present invention. Hereby the following compounds of formulae (VI-1) and (VI-2) are especially preferred: The asterisks * mark each a chiral/stereogenic center, i.e. all possible isomers having any configuration at said centers are encompassed by the term “compound of formula (VI-1)” and “compound of formula (VI-2)”, respectively. Also, suitable antioxidants are compounds of the following formulae (VII) and (VIII) with R^1c, R^2c and R^3c being independently from each other H or C_1-4-alkyl as published in WO 2019/185942 and WO 2019/185888, respectively. Preferred examples thereof are tocotrienols and tocopherols of the formulae (20) to (27) as shown below.

The asterisks * mark each a chiral/stereogenic center. The term “compound of formula (VII)/(VIII)” encompasses all possible isomers having any configuration at said centers. Especially preferred examples of the compound of formula (VII) are the following compounds of formulae (20) (= alpha-tocotrienol), (21) (= beta-tocotrienol), (22) (= gamma-tocotrienol) and (23) (= delta-tocotrienol), whereby all possible diastereomers and enantiomers are included.

Especially preferred examples of the compound of formula (VIII) are the following compounds of formulae (20) (= alpha-tocopherol), (21) (= beta-tocopherol), (22) (= gamma-tocopherol) and (23) (= delta-tocopherol), whereby all possible diastereomers and enantiomers are included. The asterisks * mark each a chiral/stereogenic center. The term “compound of formula (20)/(21)/(22)/(23)/(24)/(25)/(26)/(27)” encompasses all possible isomers having any configuration at said centers. Polyphenols Examples of suitable polyphenols are 2,4,5-trihydroxybutyrophenone, epigallo- catechin gallate (“EGCG”), epigallo-catechin, gallo-catechin, hydroxytyrosol, resveratrol, carnosol, 2-(3,4-dihydroxyphenyl)acetic acid and C_1-6 alkyl esters thereof, and any mixture thereof. Further suitable polyphenols are derivatives, preferably esters and (earth) alkali metal salts, of hydroxybenzoic acids such as e.g. gallic acid (= 3,4,5-trihydroxybenzoic acid) and syringic acid (= 4-hydroxy-3,5-dimethoxy-benzoic acid). Examples of preferred esters are C1-20 alkyl esters of gallic acid such as e.g. propyl gallate, octyl gallate or dodecyl gallate, and C_1-20 alkyl esters of syringic acid. Also, derivatives, preferably esters and (earth) alkali metal salts, of cinnamic acid and hydroxycinnamic acids such as e.g. ferulic acid (= 3-(4-hydroxy-3- methoxyphenol)prop-2-enoic acid), caffeic acid (= 3,4-Dihydroxycinnamic acid), dihydrocaffeic acid (= 3-(3,4-dihydroxyphenyl) propanoic acid), chlorogenic acid (= the ester of caffeic acid and (−)-quinic acid), o-, m-, p-coumaric acid (= 2-/3-/4- hydroxycinnamic acid), rosmarinic acid (= a caffeic acid ester of 3-(3,4- dihydroxyphenyl)lactic acid), or sinap(in)ic acid (= 3,5-dimethoxy-4-hydroxycinnamic acid) may be used as antioxidants in the present invention. Examples of derivatives of cinnamic acid are Z-ethoxyethyl p-methoxycinnamate, ethylhexyl p-methoxycinnamate, 2-ethylhexyl 4-methoxycinnamate, methyl diiso- propylcinnamate, isoamyl 4—methoxycinnamate, and diethanolamin 4-methoxy- cinnamate. The most preferred antioxidants used in the formulation of the present invention are DL-alpha-tocopherol, as well as a mixture of DL-alpha-tocopherol and sodium ascorbate, a mixture of DL-alpha-tocopherol and ascorbic acid and a mixture of DL-alpha-tocopherol and ascorbyl palmitate. The weight ratio of DL-alpha-tocopherol to sodium ascorbate and of DL-alpha- tocopherol to ascorbic acid is preferably ranging from 5:1 to 1:5, more preferably from 2:1 to 1:4.5, most preferably from 1.5:1 to 1:4.1. Preferably the total amount of the antioxidant(s) is chosen in such a way so that its/their final amount in the formulation is preferably ≤ 7.5 weight-%, more preferably its/their final amount is ranging from 0.5 to 7.5 weight-%, based on the total weight of a) to f) in the formulation. If DL-alpha-tocopherol is used as sole antioxidant, it is preferably used in an amount of at least 1 weight-%, more preferably in an amount ranging from 1.0 to 5.0 weight-%, based on the sum of the weight of the ingredients a) to f). It is assumed that the amount of other tocopherols or analogues thereof, as well as of tocotrienols and analogues thereof is in a similar range as for DL-alpha- tocopherol. Anti-caking agent e) Suitable organic anti-caking agents are talc, cellulose, microcrystalline cellulose, cellulose derivatives or fibres, ferric ammonium citrate, sodium salts of fatty acids such as e.g. sodium stearate, potassium salts of fatty acids such as e.g. potassium stearate, calcium salts of fatty acids such as e.g. calcium stearate, magnesium salts of fatty acids such as e.g. magnesium stearate, aluminum salts of fatty acids such as e.g. aluminum stearate, ammonium salts of fatty acids such as e.g. ammonium stearate, and any mixture of any of them. Other suitable anti-caking agents are inorganic anti-caking agents such as e.g. silicic acid H_2n+₂Si_nO_3n+1 and alkaline/earth alkali metal salts thereof, precipitated silicic acid, silica (= silicon dioxide), modified silica, hydrophobically modified silica, precipitated silica, magnesium oxide, dicalcium diphosphate, tricalcium phosphate, magnesium phosphate, sodium carbonate, potassium carbonate, calcium carbonate, magnesium carbonate, calcium oxide, magnesium oxide, potassium silicate, calcium silicate, magnesium silicate, magnesium trisilicate, aluminum silicate, sodium aluminum silicate, potassium aluminum silicate, calcium aluminum silicate, zeolithe (aluminosilicates), disodium sulfate or mixtures thereof. Also, mixtures of organic and inorganic anti-caking agents may be used. The preferred anti-caking agents used in the formulations of the present invention are anti-caking agents with a particle size D(v,50%) from 100 nm to 10 μm, preferably from 100 nm to 9 μm, more preferably from 150 nm to 5 μm, measured as dry dispersion with a Malvern MasterSizer 3000 (laser diffraction). The particle size of the anti-caking agent can be determined with a laser diffraction system e.g. Malvern MasterSizer 3000, either as dry dispersion or as wet dispersion in oil or Volasil (a mixture of volatile and cyclic silicones such as octamethylcyclo- tetrasiloxane and decamethylcyclopentasiloxane). The particle size can also be determined with electron microscopy. The more preferred anti-caking agents are silicic acid H_2n+₂Si_nO_3n+1, silica, microcrystalline cellulose, as well as any mixture thereof. The most preferred anti-caking agents are hydrophilic precipitated silicic acid H_2n+₂Si_nO_3n+1, hydrophilic precipitated silica and any mixture thereof. Thus, the term “anti-caking agent” does preferably not comprise titanium dioxide. Thus, the animal-free formulation of the present invention as well as the milk replacer according to the present invention does not comprise titanium dioxide. The amount of the anti-caking agent e) is preferably ranging from 0.01 to 10 weight-%, based on the sum of the weight of the ingredients a) to f). The more preferred amount of the anti-caking agent is dependent on the drying technique and disclosed below. Characteristics of the formulations of the present invention The formulations of the present invention show preferably a bulk density ranging from 0.4 to 0.9 g/cm³, more preferably a bulk density ranging from 0.6 to 0.7 g/cm³. Furthermore, the formulations of the present invention show preferably a tap density ranging from 0.7 to 0.85 g/cm³. The bulk density and the tap density are measured as follows: A 250 ml glass cylinder is filled with the sample. The volume and the weight are measured. Bulk density is the weight divided by the volume. For measuring the tap density, the sample is tapped with a 2000 Taps with a Stampfvolumeter JEL STAV II (J. Engelsmann AG). The tapped volume is measured. Tap density is the weight divided by the tapped volume. Particle size and measurement To determine the particle size of the animal-free formulation of the present invention a sieve test can be performed with filters of 850 μm pores (mesh 20), 425 μm pores (mesh 40) and 150 μm pores (mesh 100). Furthermore, the particle size of the animal-free formulation may also be determined by laser diffraction analytic whereby the dry dispersion of the sample is measured with a Malvern Mastersizer 2000 or 3000 and Fraunhofer calculation. The particle sizes of the formulation, when determined with laser diffraction with a Malvern Mastersizer 3000 and Fraunhofer calculation, are as follows: D(v,10%) = 1-60 μm; D(v, 50%) = 80-140 μm; D(v, 90%) = 180-240 μm. Synonyms of “D(v,10%)” are “d(v,10%)”, “d(v,10)”, “d(v,0.1)”, “D(v,10)” and “D(v,0.1)”. This applies in an analogous manner for “D(v,50%)” and “D(v,90%)”. Preferred embodiments of the formulations of the present invention Table I and Table II show preferred formulations of the present invention and their composition. Instead of Vitamin A acetate another Vitamin A C1-20 alkyl ester, preferably another Vitamin A C_2-16 alkyl ester, may also be used. The formulations preferably only contain the ingredients cited in the corresponding tables and no further ingredients. Thus, the formulations preferably consist only of the ingredients as cited in the corresponding tables. All amounts in Table I and II except residual moisture are given in weight-%, sum up to 100 weight-% and are based on the total weight of all ingredients except residual moisture. The amount of moisture in Table I and II is given in weight-% and based on the total weight of the formulation. The formulations according to Table I comprise vitamin A acetate and optionally vitamin D3, Gum Arabic; a starch hydrolysate with a DE ≤ 40, preferably with a DE ≤ 30, more preferably with a DE ≤ 25; one or more antioxidants, an anti-caking agent and optionally residual moisture. When vitamin D₃ is present, an oil in the amounts as given above is preferably also present. Preferably the weight ratio of Gum Arabic to the starch hydrolysate with a DE ≤ 40 is ranging from 1:1.3 to 1:3, more preferably it is ranging from 1:1.5 to 1:2.6. The formulations according to Table II comprise vitamin A acetate and optionally vitamin D3, Gum Arabic, modified food starch, a disaccharide, one or more antioxidants, an anti-caking agent and optionally residual moisture. When vitamin D₃ is present, an oil in the amounts as given above is preferably also present. Preferably the weight ratio of modified food starch to the disaccharide is ranging from 1:2 to 2:1, more preferably from 1:1.5 to 1.5:1, most preferably from 1:1.3 to 1.3:1. Table I: Table II

Process for the manufacture of the formulation The formulation of the present invention is preferably manufactured according to a process comprising the following steps: A) Dissolving Gum Arabic b), the ingredient(s) c) and, if present, a water- soluble antioxidant(s) d) in water to obtain a matrix; B) Heating the fat-soluble vitamin(s) a), the fat-soluble antioxidant(s) d) and, if present, the oil f), to obtain an active phase; C) Emulsifying the active phase obtained in step B) into the matrix obtained in step A) to obtain a dispersion; D) Drying the dispersion obtained in step C), optionally in presence of an anti-caking agent, to obtain the formulation. The single steps are disclosed in more detail below. Further details, that may also be generalized, are given in the examples. Step A) The amounts of the Gum Arabic b), the ingredient(s) c) and if present, the water- soluble antioxidant(s) c) are chosen so that the final amounts of these compounds in the animal-free formulation after having performed steps A) to D) is as described above. Step A) is preferably performed at a temperature ranging from 45 to 80°C, more preferably ranging from 50 to 78°C, most preferably ranging from 55 to 75°C. Step B) The amounts of the fat-soluble vitamin(s) a), the fat-soluble antioxidant(s) d) and, if present, the oil f) are chosen so that the final amounts of these compounds in the animal-free formulation after having performed steps A) to D) is as described above. Step B) is preferably performed at a temperature to bring the components a) and d) into a liquid state. When vitamin D, preferably vitamin D₃, is present in the formulation of the present invention, the vitamin D is preferably added to the other fat-soluble vitamin and the fat-soluble antioxidant as oily suspension, whereby the weight ratio of vitamin D to the oil is preferably ranging from 1:1 to 1:10, more preferably from 1:2 to 1:5. Step C) Preferably this step is performed at a mixing temperature in the range of from 40 to 78°C, more preferably at a mixing temperature in the range of 50 to 75°C, even more preferably at a mixing temperature in the range of 55°C to 70°C to obtain a dispersion. The homogenization can be achieved by using a rotor-stator device or a high- pressure homogenizer or both. Other devices known to the person skilled in the art may also be used. Step D) The dividing and drying of the mixture of the oil-in-water preparation to produce the animal-free formulation according to the present invention can be done in any conventional way, such as spray cooling, modified spray cooling, spray drying, spray-drying in combination with fluidized bed granulation, modified spray drying or sheet drying and crushing, see e.g. WO 91/06292 A1. Furthermore, the conversion to the animal-free formulation can be achieved by a powder-catch technique, whereby the sprayed dispersion droplets are caught by the anti-caking agent (so-called “catch media”), and dried. If spray drying is carried out as drying step, preferably an anti-caking agent is added in an amount so that the amount in the final formulation is at most 1.5 weight-%, preferably the amount is ranging from 0.01 to 1.0 weight-%, based on the sum of the weight of the ingredients a) to f) together. If a powder catch process is carried out as drying step, preferably an anti-caking agent is added in an amount so that the amount in the final formulation is at least 5.0 weight-%, preferably the amount is ranging from 5.0 to 10.0 weight-%, more preferably the amount is ranging from 5.0 to 7.0 weight-%, based on the sum of the weight of the ingredients a) to f) together. Further embodiments of the present invention Use The present invention is also directed to the use of the formulation according to the present invention with the preferences as given above as additive to milk replacers, especially for young non-human mammals such as calves, foals, young goats, young camels and young sheep. Milk replacer according to the present invention The present invention is also directed to a milk replacer comprising the formulation according to the present invention with the preferences as given above. “Milk replacer” means any substance or product, including additives, whether processed, partially processed or unprocessed, intended to be used to replace the milk of non-human mammals such as calves, foals, young sheep, camel foals and young goats. Such milk replacer preferably further contains essential nutrients including proteins, amino acids, carbohydrates, fats, vitamins and minerals The amount of the animal-free formulation and the fat-soluble vitamin respectively in such milk replacers follows the regulatory guidelines in the regions depending on the specific animal species and its age. In the Supplementation Guidelines the amount of the vitamins A and D₃ is given in International Units (“I.U.”). To ensure that the active content in the feed is communicated in a systematic way, “I.U.” is used as a universal unit for fat soluble vitamins because there are different forms of the vitamins with varying amounts of fat-soluble vitamins. The formulation according to the present invention is usually added to milk replacers in form of a premix, i.e. a mixture with other micro-nutrients such as other vitamins or their formulations and minerals. The premix inclusion in feed is < 1 weight-% for many species. It can, however, also be added as such. The amount of the formulation according to the present invention needed to be included into the milk replacer is calculated based on the active content of the milk replacer and the targeted dosage of the fat-soluble vitamin considering said inclusion level. The conversion factors of the fat-soluble vitamins are as follows: 1 I.U. Vitamin A corresponds to 0.344 μg of Vitamin A acetate; 1 I.U. Vitamin D₃ corresponds to 0.025 μg of Vitamin D₃; 1 g of Vitamin K₃ (menadione) corresponds to 2.0 g of menadione sodium bisulfite (MSB) or to 2.3 g of menadione nicotin-amide bisulfite (MNB). The following Table III shows the amounts of the added fat-soluble vitamins. The exact amount is depending on several factors such as phase/age of the animal, animal species and legal local limits. Table III 1) Amount added per kg of calf milk replacer powder. 2) Supplementary amount per animal per day. The invention is now further illustrated in the following non-limiting examples. Examples The following examples 1 and 2 illustrate the manufacture of the formulation of the present invention. Examples 1 and 2 (Table 1) The matrix components, i.e. Gum Arabic, the ingredient(s) c) and the water-soluble antioxidant are dissolved in water at approximately 70°C to obtain the “matrix”. Vitamin A acetate, the fat-soluble antioxidant and, if present, the oil are heated at approximately 65°C under stirring until complete melting of vitamin A acetate (“active phase”). They are then emulsified into the matrix. Hereby, the amounts of the ingredients are chosen in such a way that their concentrations in the final formulation are as disclosed in Table 1 (n.d. = not determined). After thorough mixing the resulting dispersion is sprayed into a spray tower optional in the presence of an anti-caking agent to form droplets of the desired size. The solidified droplets are then dried by a drying air of various temperatures (5-75°C). Example 1: If spray-drying is carried out: The dried powder is sieved through a 1 mm sieve to discard agglomerates. Example 2: If powder-catch is carried out: The dried powder is separated from the majority of the anti-caking agent and sieved through 150 μm and 600 μm filters. The particle size of the dried powder is determined with laser diffraction analytic with a Malvern Mastersizer 3000. The sample is hereby dry dispersed. By applying the Fraunhofer theory the particle size distribution of the sample is calculated. Furthermore, the bulk and the tap density are measured according to the procedures as described above. Table 1

Claims

Claims 1. A milk replacer comprising an animal-free formulation comprising a) Vitamin A or a C_1-20 alkyl ester thereof and optionally vitamin D; b) Gum Arabic in an amount of ≤ 25 weight; c) at least one ingredient selected from modified food starches, starch hydrolysates, mono- and disaccharides; d) at least an antioxidant; e) an anti-caking agent; f) optionally an oil; g) optionally residual moisture; whereby all amounts a) to f) sum up to 100 weight-% and are based on the sum of the weight of a) to f), whereby the compound a) is encapsulated in a matrix formed by compounds b) and c).

2. The milk replacer according to claim 1, wherein the milk replacer is used for young non-human mammals, preferably for young non-human mammals selected from calves, foals, young goats, young sheep and camel foals.

3. An animal-free formulation comprising a) Vitamin A or a C_1-20 alkyl ester thereof and optionally vitamin D; b) Gum Arabic in an amount of ≤ 25 weight; c) at least one ingredient selected from modified food starches, starch hydrolysates, mono- and disaccharides; d) at least an antioxidant; e) an anti-caking agent; f) optionally an oil; g) optionally residual moisture; whereby all amounts a) to f) sum up to 100 weight-% and are based on the sum of the weight of the ingredients a) to f), whereby the compound a) is encapsulated in a matrix formed by compounds b) and c).

4. The animal-free formulation according to claim 3, whereby said formulation has a bulk density ranging from 0.4 to 0.9 g/cm³.

5. The animal-free formulation according to claim 3 and/or 4, whereby the amount of the ingredient(s) c) is ranging from 35 to 58 weight-%, preferably it is ranging from 38 to 55 weight-%, more preferably it is ranging from 40 to 52 weight-%, based on the sum of the weight of the ingredients a) to f).

6. The animal-free formulation according to any one or more of claims 3 to 5, wherein the ingredient c) is either a starch hydrolysate with a DE ≤ 40 or a mixture of a modified food starch and a disaccharide, whereby the weight ratio of the modified food starch to the disaccharide is preferably ranging from 1:2 to 2:1.

7. The animal-free formulation according to any one or more of claims 3 to 6, wherein said anti-caking agent e) has a particle size D(v,50%) ranging from 100 nm to 10 μm, measured as dry dispersion with a Malvern MasterSizer 3000 (laser diffraction).

8. The animal-free formulation according to any one or more of claims 3 to 7, wherein the amount of Vitamin A or a C_1-20 alkyl ester thereof is ranging from 10 to 29 weight-%, preferably it is ranging from 12 to 24 weight-%, more preferably it is ranging from 15 to 23 weight-%, most preferably it is ranging from 17 to 22 weight-%, based on the sum of the weight of the ingredients a) to f).

9. The animal-free formulation according to any one or more of claims 3 to 8, wherein the amount of the Gum Arabic b) is ranging from 10 to 25 weight-%, preferably it is ranging from 15 to 25 weight-%, most preferably it is ranging from 19 to 24.5 weight-%, based on the sum of the weight of the ingredients a) to f).

10. The animal-free formulation according to any one or more of claims 3 to 9, wherein the amount of the antioxidant d) is ≤ 7.5 weight-%, preferably it is ranging from 0.5 to 7.5 weight-%, based on the sum of the weight of the ingredients a) to f).

11. The animal-free formulation according to any one or more of claims 3 to 10, wherein the amount of the anti-caking agent e) is ranging from 0.01 to 10 weight-%, based on the sum of the weight of the ingredients a) to f).

12. Use of the formulation according to any one or more of claims 3 to 11 in a milk replacer.

13. The use according to claim 12, wherein the milk replacer is used for calves, foals, young sheep, young goats and young camels.

14. A process for the manufacture of a formulation according to any one or more of claims 3 to 11 comprising the following steps: A) Dissolving Gum Arabic b), the ingredient(s) c) and, if present, a water- soluble antioxidant(s) d) in water to obtain a matrix; B) Heating the fat-soluble vitamin(s) a), the fat-soluble antioxidant(s) d) and, if present, the oil f) to obtain an active phase; C) Emulsifying the active phase obtained in step B) into the matrix obtained in step A) to obtain a dispersion; D) Drying the dispersion obtained in step C), optionally in presence of an anti-caking agent, to obtain the formulation.

15. A process for the manufacture of a milk replacer according to claim 1 and/or claim 2 by mixing an animal-free formulation according to any one or more of claims 3 to 11 with essential nutrients including proteins, amino acids, carbohydrates, fats, vitamins and minerals.