BETALAIN COMPOSITIONS

Description

1 / 68 “BETALAIN COMPOSITIONS” TECHNICAL FIELD

[001] The present invention relates to new dye formulations comprising one or more dyes comprising a betalain with improved stability under heat conditions. BACKGROUND

[002] Synthetic red dyes, and particularly azo dyes like Allura Red AC (Red 40), are commonly used in the US market for food coloring, thanks to their attractive cost, vibrant red color, and excellent stability to light, heat, oxygen, pH, and low microbiological contamination. However, these pigments have several side effects on health due to their toxicity.

[003] This significant health threat has created increasing pressure to find alternatives to these pigments; currently, the most widespread red food colorings are carmine (E120), anthocyanin (E163), and beetroot red (E162). However, these pigments suffer from a number of limitations.

[004] Carmine is a bright red-pink pigment obtained from the aluminum complex derived from carminic acid; this pigment is quite stable against light and heat, which makes it an attractive product in the food industry. However, this pigment is extracted from an animal source (cochineal insect), which makes it unsuitable for vegans, and it is not entirely natural, as it is chemically modified (complexed with aluminum).

[005] Anthocyanins are unstable at pH > 3 and do not provide the desired vibrant red hue, which limits their use in dairy, baking and meat applications, where the pH ranges from 5.5 to 6.5.

[006] Color is one of the most important organoleptic qualities. Petition 870250091620, dated 07 / 10 / 2025, page 7 / 95 2 / 68 of food products. Betanin, a water-soluble natural pigment that provides a red color, is a safe and healthy food coloring. Betanin, which is the main constituent of betacyanin (75% - 90%), is found mainly in beetroot, amaranth, and cactus plants such as dragon fruit, and is the source of the mauve-red color of these plants. However, environmental factors such as high temperature cause betanin to degrade and discolor easily, limiting its wide application in the food industry. Currently, there are many studies on improving the stability of betanin, but most effective methods are through encapsulation systems such as microcapsules, liposomes, and hydrogels. For example, Chinese patent application number: CN202110616032.4, which discloses a method for preparing betanin microcapsules with composite wall materials, taking betanin solution as a core material and a mixed solution of maltodextrin-rice protein-Jerusalem artichoke polysaccharide as the wall materials, pouring the core material into the mixed solution, forming the microcapsules by a pH adjustment method, and lyophilizing the microcapsules into microcapsule powder.

[007] Given these constraints, manufacturers have been under pressure to find robust solutions to satisfy consumers of natural, vegan, halal, and kosher products; thus, the search for new ways to stabilize natural compounds, more specifically beetroot extract, is very active at present.

[008] Several scientific articles and patents have reported that ascorbic acid can improve the stability of beetroot extract.US patent 4132793 introduced the use of ascorbic acid or isoascorbic acid to improve the stability of betanin. WO 2014 / 102304 also reported the use of acerola extract as a natural source of ascorbic acid. Petition 870250091620, dated 07 / 10 / 2025, p. 8 / 95 3 / 68

[009] Another stabilizing effect using EDTA was reported in Herbach, KM, Stintzing, FC and Carle, R. (2006), Stability and Degradation of Betalain — Structural and Chromatic Aspects. Journal of Food Science, 71: R41-R50) and in Castro-Enríquez, DD, Montano-Leyva, B., Del Toro-Sánchez, CL et al. Stabilization of betalains by encapsulation—a review. J Food Sci Technol 57, 1587-1600 (2020). https: / / doi.org / 10.1007 / s13197-019-04120.

[010] Despite all these attempts, there is still a need to effectively improve the stability of betanin.

[011] In order to overcome this limited performance, a new red beet formulation was introduced that minimizes the main degradation reactions that cause strong color shift, such as the betalain hydrolysis reaction, leading to betalamic acid (yellow) and cyclo-Dopa 5-Ob-glucoside, and oxidative dehydrogenation, leading to Neobetanin (yellow). FIGURES Figure 1. Color evaluation after heat treatment of samples 1A and 1B. Figure 2. Photograph of cakes after baking with the inventive formulation (2F) compared with the control formulations (2A-2E). Figure 3. Color evaluation after heat treatment of samples 3A to 3F. Figure 4. Evaluation of the color regeneration of the inventive formulation after heat treatment compared to control samples. Figure 5. Formulation 2 incorporated into a snack recipe. Figure 6. The new stable beet (6A) is redder (greater values ​​of a) than 6B (standard beet) after extrusion at different temperatures. Figure 7. Color measurements of cooked ham immediately after opening. L* Figure 8. Color measurements of cooked ham immediately after opening. a*, Petition 870250091620, dated 07 / 10 / 2025, page 9 / 95 4 / 68 Figure 9. Color measurements of cooked ham immediately after opening. b*. SUMMARY

[012] A new dye formulation has been developed that minimizes color drift of the dye comprising a Betalain, especially a betanin, when subjected to heat treatment.

[013] As demonstrated in examples 1, 2 and 3, the formulations of the invention surprisingly provide color protection of dyes comprising a Betalain, especially a red color of betanin, in consumer products, even after heat treatment (cooking).

[014] Surprisingly, it was also observed that, in consumer products containing the formulations of the invention, even if a deviation from the red color was observed after heat treatment, a reversal of this color loss to the original red color was achieved (see example 5).

[015] In a first illustrative aspect, a dye composition is provided comprising components A) and B), wherein A) is one or more dyes comprising a Betalain, especially a betanin, and B) comprises one or more of citric acid, ascorbic acid, malic acid and ethylenediaminetetraacetic acid, and at least one salt. In certain embodiments, the at least one salt is a salt of one or more acids (citric acid, ascorbic acid, malic acid and ethylenediaminetetraacetic acid).

[016] In a second illustrative aspect, a dye composition comprising components A) and B) is provided, wherein A) is one or more dyes comprising a betalain, especially a betanin, and B) comprises citric acid and ascorbic acid, and at least one salt. In certain embodiments, the at least one salt is selected from salts of citric acid and / or salts of ascorbic acid. Petition 870250091620, dated 07 / 10 / 2025, page 10 / 95 5 / 68

[017] These compositions will be referred to in the present invention as the “composition” or “compositions” of the invention.

[018] According to a third illustrative aspect, a method is provided for thermally stabilizing a dye comprising betalains, especially betanin, comprising the steps of: i. provide one or more colorants comprising a betalain, especially a betanin; ii. provide one or more of citric acid, ascorbic acid, malic acid and / or ethylenediaminetetraacetic acid, and at least one salt, especially a salt of one or more acids; iii. mix the ingredients.

[019] According to a further illustrative aspect, a method is provided for thermally stabilizing a dye comprising Betalains, especially betanin, comprising the steps of: i. provide one or more colorants comprising a betalain, especially a betanin ii. provide citric acid and ascorbic acid, and at least one salt, especially a salt of citric acid and / or ascorbic acid iii. mix the ingredients.

[020] According to another illustrative aspect, a kit is provided comprising one or more of: a colorant comprising Betalains, citric acid, ascorbic acid, and at least one salt, and optionally instructions on how to mix, prepare and / or use said ingredients.

[021] According to another illustrative aspect, a kit is provided comprising one or more of: a dye comprising Betalains, one or more of citric acid, ascorbic acid, malic acid and / or ethylenediaminetetraacetic acid, and at least one salt, specifically Petition 870250091620, dated 07 / 10 / 2025, page 11 / 95 6 / 68 actually a salt of one or more acids

[022] According to another illustrative aspect, a consumable, pharmaceutical, cosmeceutical, nutraceutical or cosmetic product is provided comprising a dye composition according to the invention or the kit components according to the invention. DETAILED DESCRIPTION

[023] The following text provides a broad description of numerous different embodiments of the present invention. The description should be interpreted as exemplary only and does not describe all possible embodiments, since describing all possible embodiments would be impractical, if not impossible. It will be understood that any aspect, feature, component, composition, ingredient, product, step or methodology described in the present invention may be deleted, combined or replaced by, in whole or in part, any other aspect, feature, component, composition, ingredient, product, step or methodology described in the present invention. Numerous alternative embodiments could be implemented, using both current technology and technology developed after the filing date of this patent, which would still fall within the scope of the claims.

[024] The terms “comprises,” “comprising,” “has,” “having,” “includes,” “including,” “contains,” “containing,” or any other variation are open-ended and intended to encompass a non-exclusive inclusion of elements, so that an article, apparatus, compound, composition, combination, method, or process that “comprises,” “has,” or “includes,” or “contains” a cited list of elements does not include only those elements, but may include other elements not expressly listed, mentioned, or written in the specification or claims. An element or aspect preceded by the language “comprises . . . a,” “contains . . . a,” “has . . . a,” or “includes . . Petition 870250091620, dated 07 / 10 / 2025, page 12 / 95 7 / 68 .um” does not exclude, without further restrictions, the existence or inclusion of additional elements or aspects in the article, apparatus, compound, composition, combination, method or process that comprises, contains, has, or includes the element or aspect.

[025] The terms a and an are defined as one or more, unless expressly stated otherwise or restricted by other language in this document. An element or aspect preceded by a or an may be interpreted as one of the element or aspect mentioned, or more than one of the element or aspect.

[026] The terms approximately, roughly, essentially, substantially, any other version thereof, or any other similar relative term, or similar approximating term, are defined as being close, as understood by one skilled in the art. By way of illustrative and non-limiting embodiments, such terms are defined as being within 20% of a mentioned value, or defined as being within 10% of a mentioned value, or defined as being within 5% of a mentioned value, or defined as being within 4% of a mentioned value, or defined as being within 3% of a mentioned value, or defined as being within 2% of a mentioned value, or defined as being within 1% of a mentioned value, or defined as being within 0.5% of a mentioned value, or defined as being within 0.25% of a mentioned value, or defined as being within 0.1% of a mentioned value.

[027] It should be understood that when a quantity expressed as a percentage by weight is described in the present invention, it is intended that any and all quantities within the range, including endpoints, are to be considered as having been expressly disclosed. For example, the description of a range from about 1 to about Petition 870250091620, dated 07 / 10 / 2025, p. 13 / 95 8 / 68 should be read as indicating each and every possible number along the continuum between about 1 and about 10. It should be understood that the invention acknowledges and understands that any and all data points within the range should be considered as having been specified, and that the invention owns the entire range and all points within the range.

[028] The term color refers to the properties of color, such as hue, chroma, purity, saturation, intensity, vividness, value, lightness, brightness and darkness, and to the parameters of the color model system used to describe these properties, such as the L*a*b* values ​​of the CIELAB color space of the Commission Internationale de l'Éciairage CIE 1976.

[029] The term “hue” refers to the property of color that gives a color its name, for example, red, blue and brown.

[030] When a concentration is expressed as ppm, the concentration is in parts per million by weight, based on the total weight of the consumable. It should be understood that when a range of values ​​is described in the present invention, it is intended that any and all values ​​within the range, including endpoints, are considered to have been disclosed. For example, a range of 1 ppm to 1000 ppm of a component of the composition should be read as indicating each and every possible number along the continuum between 1 and 1000. It should be understood that the invention acknowledges and understands that any and all values ​​within the range are to be considered to have been specified, and that the invention owns the entire range and all values ​​within the range.

[031] The following text provides a broad description of numerous different embodiments of the present invention. The description should be interpreted as exemplary only and does not describe all possible embodiments, since describing all embodiments Petition 870250091620, dated 07 / 10 / 2025, page 14 / 95 9 / 68 possible would be impractical, if not impossible. It will be understood that any aspect, feature, component, composition, ingredient, product, step or methodology described in the present invention may be deleted, combined or replaced by, in whole or in part, any other aspect, feature, component, composition, ingredient, product, step or methodology described in the present invention. Numerous alternative embodiments could be implemented, using both current technology and technology developed after the filing date of this patent, which would still fall within the scope of the claims.

[032] The details, examples and preferences provided in relation to any or more of the stated aspects or embodiments of the present invention are further described in the present invention and apply equally to all aspects and embodiments of the present invention. Any combination of embodiments, examples and preferences described below in the present invention in all possible variations is encompassed by the present invention, unless otherwise indicated in the present invention, or otherwise clearly contradicted by the context.

[033] The present invention relates to a dye composition comprising components A) and B), wherein A) is one or more dyes comprising a betalain, especially a betanin, and B) comprises one or more of citric acid, ascorbic acid, malic acid, and ethylenediaminetetraacetic acid, and at least one salt. In certain embodiments, the at least one salt is a salt of one or more acids (citric acid, ascorbic acid, malic acid, and ethylenediaminetetraacetic acid). In certain embodiments, the dye composition of the invention is heat stable.

[034] Component B comprises one or more of the acids selected from citric acid, ascorbic acid, malic acid, and Petition 870250091620, dated 07 / 10 / 2025, p. 15 / 95 10 / 68 ethylenediaminetetraacetic acid and at least one salt. Thus, component B may comprise, for example, one, two, three, or four acids, and any combinations of said acids: - citric acid and ascorbic acid, - citric acid and malic acid, - citric acid and ethylenediaminetetraacetic acid - ascorbic acid and malic acid - ascorbic acid and ethylenediaminetetraacetic acid - ascorbic acid, malic acid, and ethylenediaminetetraacetic acid, - ascorbic acid and malic acid and citric acid, etc

[035] Component B also comprises at least one salt. The minimum salt can be any food-grade salt. In certain preferred embodiments, the minimum salt used is a salt of one or more acids present in component B. That is, the minimum salt is a salt of an acid selected from citric acid, ascorbic acid, malic acid, and / or ethylenediaminetetraacetic acid. In certain more preferred embodiments, the minimum salt used in component B is a salt of the acid or acids used in component B. For example, if citric acid and ascorbic acid are used, the minimum salt can be a salt of citric acid and / or a salt of ascorbic acid.

[036] In certain preferred embodiments, the acids used are citric acid and ascorbic acid.

[037] In certain preferred embodiments, the acids used are citric acid and ascorbic acid and the salt is one or more salts of citric acid and / or ascorbic acid.

[038] Thus, in one embodiment, the present invention relates to a dye composition comprising components A) and B), wherein A) is one or more dyes comprising a betalain, especially a betanin, and B) comprises citric acid. Petition 870250091620, dated 07 / 10 / 2025, p. 16 / 95 11 / 68 and ascorbic acid, and at least one salt. In certain embodiments, the at least one salt is a salt of citric acid and / or ascorbic acid. In certain embodiments, the dye composition of the invention is heat stable.

[039] In one embodiment, the present invention relates to a heat-stable dye composition comprising components A) and B), wherein A) is one or more dyes comprising a Betalain, especially a betanin, and B) comprises one or more of citric acid, ascorbic acid, malic acid, and ethylenediaminetetraacetic acid, and at least one salt of one or more of said acids.

[040] In one embodiment, the present invention relates to a heat-stable dye composition comprising components A) and B), wherein A) is one or more dyes comprising a betalain, especially a betanin, and B) comprises citric acid and ascorbic acid, and at least one salt. In certain embodiments, the at least one salt is a salt of said acids (citric acid and / or ascorbic acid).

[041] These compositions will be referred to interchangeably in the present invention as the “composition”, “dye composition”, “compositions” or “dye compositions” of the invention. Betalains

[042] Betalains are a class of red and yellow pigments derived from tyrosine, found in plants of the order Caryophyllales, where they replace anthocyanin pigments. There are two categories of betalains: a) Betacyanins, which appear reddish to violet. Examples of betacyanins found in plants include betanin, isobetanin, probetanin, and neobetanin; and b) Betaxanthins, which appear yellow or orange. Petition 870250091620, dated 07 / 10 / 2025, page 17 / 95 12 / 68 betaxanthins present in plants include vulgaxanthin, miraxanthin, portulaxanthin, and indicaxanthin.

[043] Therefore, the betalains used in the present invention may be betacyanins (such as betanin, isobetanin, probetanin, and neobetanin), betaxanthins (such as vulgaxanthin, miraxanthin, portulaxanthin, and indicaxanthin) or mixtures thereof.

[044] Betalains are glycosides of a betanidine aglycone, whose core structure is betalamic acid (i.e., 4-(2-oxoethylidene)-1,2,3,4-tetrahydropyridine-2,6-dicarboxylic acid).

[045] Betanin is usually obtained from the juice extract of Beta vulgaris (red beets, beetroot). Basic structure of Betanin

[046] In certain embodiments of the dye composition of the invention, component A) comprises a dye comprising a betanin.

[047] In certain embodiments, component A) comprises a dye comprising a betanin and one or more of isobetanin, probetanin, neobetanin, vulgaxanthin, miraxanthin, portulaxanthin, and indicaxanthin. In certain embodiments, component A has a red color.

[048] Betacyanins (such as betanin, isobetanin, probetanin, and neobetanin) and betaxanthins (such as vulgaxanthin, miraxanthin, portulaxanthin, and indicaxanthin) can be obtained from different parts of plants, such as leaves, fruits, roots, tubers. Petition 870250091620, dated 07 / 10 / 2025, page 18 / 95 13 / 68 culo or the stems.

[049] In certain embodiments, pigments comprising some Betacyanins (such as betanin, isobetanin, probetanin, and neobetanin) and / or some betaxanthins (such as vulgaxanthin, miraxanthin, portulaxanthin, and indicaxanthin) can be produced by fermentation using microorganisms such as bacteria, fungi, or yeasts.

[050] In certain embodiments of the dye composition of the invention, the pigments comprising some Betacyanins (such as betanin, isobetanin, probetanin, and neobetanin) and / or some betaxanthins (such as vulgaxanthin, miraxanthin, portulaxanthin, and indicaxanthin) can be obtained from beetroot roots (Beta vulgaris L.), amaranth (Amarathus sp.), pitaya, Opuntia sp., Eulychnia sp. and Hylocereus sp., red-fleshed pitaya Hylocereus polyrhizus, colored chard (B. vulgaris L. ssp. cicla), Celosia argentea L., Bougainvillea sp. ulluco (Ullucus tuberosus Caldas) or blood berries (Rivina humilis L. berries) or mixtures thereof.

[051] In certain embodiments, component A) comprises one or more plant extracts and / or plant concentrates obtained or obtainable from one or more of: beetroot roots (Beta vulgaris L.), amaranth (Amarathus sp.), pitaya, Opuntia sp., Eulychnia sp. and Hylocereus sp., red-fleshed pitaya Hylocereus polyrhizus, colored chard (B. vulgaris L. ssp. cicla), Celosia argentea L., Bougainvillea sp. ulluco (Ullucus tuberosus Caldas) or blood berries (Rivina humilis L. berries) and / or pigments comprising a betanin produced by microorganisms such as bacteria, fungi or yeasts.

[052] In certain embodiments, the pigment component A) comprises a betanin and may be obtained, for example, from red beet and / or prickly pear. Preferably it is used as a Petition 870250091620, dated 07 / 10 / 2025, p. 19 / 95 14 / 68 plant concentrate, which is obtained by pressing red beet and / or prickly pear and subsequent drying.

[053] The color intensity of the constituents of component (A) is defined as follows. The color intensity of the plant extracts and plant concentrates of component (A) is the absorbance determined by an absorbance measurement E1 % at a pH of 5 and a wavelength of 535 nm. Plant extracts and plant concentrates containing betanin having an extinction value E1 % in a range of 3 to 50 are preferred here.

[054] Natural dyes and components used which have these color intensities generally have, in addition to adequate color intensity, other particularly favorable coloring properties, for example, with respect to hue, color brightness, etc., and in particular with respect to color intensity and covering power.

[055] In certain embodiments of the dye composition of the invention, component A) will provide an initial color hue of h (340-350). In certain embodiments of the dye composition of the invention, component A will provide a red or reddish color, and thus the final color of the composition of the invention is red or reddish.

[056] In certain embodiments of the dye composition of the invention, one or more dyes comprising a Betalain comprise at least 1% w / w of a Betalain, such as at least 2% w / w, at least 3% w / w, at least 4% w / w, at least 5% w / w, at least 6% w / w, at least 7% w / w, at least 8% w / w, at least 9% w / w, at least 10% w / w, at least 11% w / w, at least 12% w / w, at least 13% w / w, at least 14% w / w, at least 15% w / w, at least 16% w / w, at least 17% w / w, at least 18% w / w, at least 19% w / w, at least 20% w / w, at least 25% w / w, at least 30% p / p, no mí Petition 870250091620, dated 07 / 10 / 2025, page 20 / 95 15 / 68 minimum 35% w / w, minimum 4% w / w, minimum 45% w / w, minimum 50% w / w of Betalain in relation to the total weight of the dye.

[057] In certain preferred embodiments, the dye comprises a betanin, such as one or more betanins obtained from beetroot root.

[058] In certain embodiments, one or more colorants comprising a betanin comprise at least 1% w / w of a betanin, such as at least 2% w / w, at least 3% w / w, at least 4% w / w, at least 5% w / w, at least 6% w / w, at least 7% w / w, at least 8% w / w, at least 9% w / w, at least 10% w / w, at least 11% w / w, at least 12% w / w, at least 13% w / w, at least 14% w / w, at least 15% w / w, at least 16% w / w, at least 17% w / w, at least 18% w / w, at least 19% w / w, at least 20% w / w, at least 25% w / w, at least 30% w / w, at least 35% w / w, at least 4% w / w, at least 45% w / w, at least 50% w / w of a betanin relative to the total weight of the dye. In certain embodiments, the dye comprising a betanin is a beetroot root plant concentrate.

[059] Component B) of the compositions of the invention comprises one or more of the acids selected from citric acid, ascorbic acid, malic acid, and ethylenediaminetetraacetic acid and at least one salt. Thus, component B may comprise, for example, one, two, three or four acids, and any combinations of said acids, such as: - citric acid and ascorbic acid, - citric acid and malic acid, - citric acid and ethylenediaminetetraacetic acid - ascorbic acid and malic acid - ascorbic acid and ethylenediaminetetraacetic acid - ascorbic acid, malic acid, and ethylenediaminetetraacetic acid, - ascorbic acid and malic acid and citric acid, etc Petition 870250091620, dated 07 / 10 / 2025, page 21 / 95 16 / 68

[060] Component B also comprises at least one salt. The minimum salt used can be any food-grade salt. In certain preferred embodiments, the minimum salt used is a salt of one or more acids present in component B. That is, the minimum salt is a salt of an acid selected from (citric acid, ascorbic acid, malic acid, and / or ethylenediaminetetraacetic acid). In certain more preferred embodiments, the minimum salt used in component B is a salt of the acid or acids used in component B. For example, if citric acid and ascorbic acid are used, the minimum salt can be a salt of citric acid and / or a salt of ascorbic acid.

[061] In certain preferred embodiments of the dye composition of the invention, component B) comprises citric acid and ascorbic acid, and at least one salt. In a preferred embodiment, the at least one salt is a salt of citric acid and / or ascorbic acid.

[062] Citric acid, ascorbic acid, malic acid and ethylenediaminetetraacetic acid and at least one salt, especially at least one salt of any of the aforementioned acids, may be of natural or synthetic origin or any mixture thereof.

[063] In certain embodiments, the citric acid used in the present invention has a purity of at least 5%, such as at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95% or 99% by weight. In certain embodiments, the citric acid can be obtained or be obtainable from a citrus fruit (such as lemons, limes, etc.).

[064] In certain embodiments, the ascorbic acid used in the present invention has a purity of at least 5%, such as at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95% or 99% by weight.

[065] In certain embodiments, ascorbic acid can be obtained or be obtainable from acerola (Malpighia emarginata DC) fruit Petition 870250091620, dated 07 / 10 / 2025, p. 22 / 95 17 / 68 Citrus fruits, any other natural source rich in ascorbic acid, and any mixtures thereof.

[066] In certain embodiments the malic acid used in the present invention has a purity of at least 5%, such as at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95% or 99% by weight.

[067] In certain embodiments the ethylenediaminetetraacetic acid used in the present invention has a purity of at least 5%, such as at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95% or 99% by weight.

[068] In certain embodiments, at least one salt (such as a citric acid salt, an ascorbic acid salt, a malic acid salt and / or an ethylenediaminetetraacetic acid salt) used in the present invention has a purity of at least 5%, such as at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95% or 99% by weight.

[069] In certain embodiments, at least one salt is selected from any citrate salts known in the art (such as potassium citrate, potassium-sodium citrate and potassium-magnesium citrate), any ascorbate salts known in the art (such as sodium ascorbate, calcium ascorbate, potassium ascorbate, magnesium ascorbate), any malic acid salts known in the art (such as sodium malate, calcium malate, potassium malate, magnesium malate) or any ethylenediaminetetraacetic acid salts known in the art (such as sodium ethylenediaminetetraacetate, calcium ethylenediaminetetraacetate, potassium ethylenediaminetetraacetate, magnesium ethylenediaminetetraacetate), and any mixtures thereof.

[070] In certain embodiments, at least one salt is selected from citrate salts (such as potassium citrate, potassium citrate) Petition 870250091620, dated 07 / 10 / 2025, page 23 / 95 18 / 68 sodium ascorbate and potassium-magnesium citrate), ascorbate salts (such as sodium ascorbate, calcium ascorbate, potassium ascorbate, magnesium ascorbate) and any mixtures thereof.

[071] In certain embodiments the weight ratio of at least one betalain (such as a betanin) to component B is from about 0.1:50 to about 50:0.1, such as from about 0.5, 1, 5, 10, 15, 20, 25, 30, 35, 40, 45 to (:) about 50, 45, 40, 35, 30, 25, 20, 15, 10, 5, 1, 0.5, 0.1; such as from about 1:30 to 30:1, such as from about 0.5:30 to about 2:35, such as about 1:30.

[072] In certain embodiments, 2 acids are used and the weight ratio of the first acid to the second acid (e.g., citric acid to ascorbic acid) is from about 0.5:30 to about 30:0.5, such as from 0.5, 1, 5, 10, 15, 20, 25, 30 to (:) 25, 20, 15, 10, 5, 1, 0.5, such as from about 1:25 to about 25:1, such as from about 0.5:25 to about 2:25, such as about 1:20.

[073] In certain embodiments, the weight ratio of citric acid to ascorbic acid is from about 0.5:30 to about 30:0.5, such as from 0.5, 1, 5, 10, 15, 20, 25, 30 to (:) 25, 20, 15, 10, 5, 1, 0.5, such as from about 1:25 to about 25:1, as well as from about 0.5:25 to about 2:25, as well as about 1:20.

[074] In certain embodiments, the weight ratio of one or more acids to at least one salt is from about 0.5:10 to about 10:0.5, such as from 0.5, 1.2, 3, 4, 5, 6, 7, 8, 9 to (:) 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.5, such as from about 1:5 to about 5:1, such as from about 0.5:2 to about 2:1, such as about 1:2.

[075] In certain embodiments, citric acid is used, and the weight ratio of citric acid to at least one salt (for example, one or more citric acid salts) is from about 0.5:10 to about 10:0.5, such as from 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9 to (:) 10, 9, Petition 870250091620, dated 07 / 10 / 2025, p. 24 / 95 19 / 68 8, 7, 6, 5, 4, 3, 2, 1, 0.5, such as from about 1:5 to about 5:1, such as from about 0.5:2 to about 2:1, such as from about 1:2.

[076] In certain embodiments, ascorbic acid is used, and the weight ratio of ascorbic acid to at least one salt (for example, one or more among ascorbic acid salts) is from about 0.5:10 to about 10:0.5, such as from 0.5, 1.2, 3, 4, 5, 6, 7, 8, 9 to (:) 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.5, such as from about 1:5 to about 5:1, such as from about 0.5:2 to about 2:1, such as about 1:2.

[077] In certain embodiments, malic acid is used, and the weight ratio of ascorbic acid to at least one salt (for example, one or more among malic acid salts) is from about 0.5:10 to about 10:0.5, such as from 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9 to (:) 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.5, such as from about 1:5 to about 5:1, such as from about 0.5:2 to about 2:1, such as about 1:2.

[078] In certain embodiments, ethylenediaminetetraacetic acid is used, and the weight ratio of ascorbic acid to at least one salt (for example, one or more among ethylenediaminetetraacetic acid salts) is from about 0.5:10 to about 10:0.5, such as from 0.5, 1.2, 3, 4, 5, 6, 7, 8, 9 to (:) 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.5, such as from about 1:5 to about 5:1, such as from about 0.5:2 to about 2:1, such as about 1:2.

[079] In certain embodiments, combinations of 2 acids are used, and the weight ratio of the 2 acids referred to for at least one salt (for example, one or more salts of one or more of the 2 acids) is from about 0.5:10 to about 10:0.5, such as from 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9 to (:) 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.5, such as from about 1:5 to about 5:1, such as from about Petition 870250091620, dated 07 / 10 / 2025, p. 25 / 95 20 / 68 from 0.5:2 to approximately 2:1, as well as approximately 1:2.

[080] For example, in certain embodiments, citric acid and ascorbic acid are used, and the weight ratio of the acids to at least one salt (for example, one or more among salts of citric acid and / or salts of ascorbic acid) is from about 0.5:10 to about 10:0.5, such as from 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9 to (:) 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.5, such as from about 1:5 to about 5:1, such as from about 0.5:2 to about 2:1, such as about 1:2.

[081] In other embodiments, ascorbic acid and malic acid are used, and the weight ratio of the acids to the minimum one salt (for example, one or more of ascorbic acid salts and / or malic acid salts) is from about 0.5:10 to about 10:0.5, such as from 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9 to (:) 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.5, such as from about 1:5 to about 5:1, such as from about 0.5:2 to about 2:1, such as about 1:2.

[082] In certain embodiments, combinations of 3 acids are used, and the weight ratio of the 3 acids referred to for the minimum one salt (for example, one or more salts of one or more of the 3 acids) is from about 0.5:10 to about 10:0.5, such as from 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9 to (:) 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.5, such as from about 1:5 to about 5:1, such as from about 0.5:2 to about 2:1, such as about 1:2.

[083] In certain embodiments, combinations of 4 acids are used, and the weight ratio of the 3 acids referred to for the minimum one salt (for example, one or more salts of one or more of the 4 acids) is from about 0.5:10 to about 10:0.5, such as from 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9 to (:) 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.5, such as from about 1:5 to about 5:1, such as from about 0.5:2 to about 2:1, such as about 1:2.

[084] In certain forms, B is citric acid, ascorbic acid and Petition 870250091620, dated 07 / 10 / 2025, p. 26 / 95 21 / 68 sodium citrate.

[085] In certain embodiments, the weight ratio between citric acid, ascorbic acid and sodium citrate is about 1:2:10, such as about 0.5:2:10, such as about 2:2:10, such as about 1:1:10, such as about 1:3:10, such as about 1:2:9, such as about 1:2:11.

[086] In certain embodiments, (A) is present in an amount from about 1 to about 99% by weight, such as in an amount from about 2 to about 10% by weight, preferably from about 2 to about 5% by weight and (B) is present in an amount from about 1 to about 99% by weight, such as in an amount from about 10 to about 40% by weight, preferably in an amount from about 25 to about 35%, such as about 32% by weight of the final composition.

[087] In certain modalities, A) comprises a quantity of Betalains, especially betanin, from about 0.5 to about 99% w / w by weight, preferably an amount from about 1 to about 30% w / w by weight.

[088] In certain embodiments, the composition of the invention comprises an amount of betanin of 1 w / w 30% w / w by weight, preferably 5 w / w 10% w / w by weight of the final composition.

[089] In certain embodiments the dye composition of the invention comprises from about 1% to 30% w / w beetroot (comprising from 10% w / w betanin to about 30% w / w betanin, such as 15% w / w betanin), from about 10% to about 65% w / w ascorbic acid, from about 1% to about 15% citric acid and from 3% to about 15% w / w sodium citrate, optionally the remainder being a carrier.

[090] In certain embodiments the dye composition of the invention Petition 870250091620, dated 07 / 10 / 2025, p. 27 / 95 22 / 68 composition comprises from about 10% to 25% w / w, such as about 16% w / w of beetroot (from 10% w / w of betanin to about 30% w / w of betanin, such as 15% w / w of betanin), from about 55% to about 65% w / w such as about 60% w / w of ascorbic acid, from about 4% to about 7%, such as 6% w / w of citric acid and from 10% to about 15% w / w, such as 12% w / w of sodium citrate.

[091] The dye composition according to the invention may be presented as a solid or as a liquid.

[092] The dye composition according to the invention may be formulated as a composition which additionally contains a component (C) or carrier selected from the group consisting of gum arabic, dextrose, salt, mono- and diglycerides of fatty acids, MPG, Polysorbate 80, dextrose, vegetable oil, glucose syrup, glycerin, decaglycerol monooleate, fatty acid esters, benzyl alcohol, ethyl alcohol, propylene glycol, polysorbates, sorbitans, sorbitan trioleate, caprylic / capric triglycerides, dextrose, maltodextrin, guar gum, trehalose, alginate, starches and modified starch, sucrose, dextran, inulin, whey protein isolate, potato protein isolate, xanthan gum, pectin, soy protein, chitosan, gelatin, soluble fiber as beta-d-glucan, pullulan, and combinations thereof. In a preferred embodiment, the carrier is polysorbate 80.

[093] In certain embodiments, the ratio between the composition of the invention and the carrier may be from 1:99 to 99:1, as well as from 10:90 to 90:10, as well as from 10:90 to 30:70. As a person skilled in the art would know, the concentration of the carrier can be adapted to the end use of the dye. Thus, if a highly concentrated dye is required, less carrier would be used, whereas, when a less concentrated dye is required, more carrier can be used. Petition 870250091620, dated 07 / 10 / 2025, page 28 / 95 23 / 68 lo.

[094] In a preferred embodiment, the composition is in dry form. In another embodiment, the composition may be in liquid form.

[095] In certain embodiments, the composition of the invention is suitable for human consumption. Methods

[096] The invention also relates to a dye composition according to the invention, prepared by a process comprising the steps of: i. Provide component (A), ii. Provide component (B), iii. Optionally provide component (C), iv. Mix the ingredients.

[097] The ingredients (A), (B) as previously described in the present invention and optionally (C) can be mixed in any order and using any method generally known in the art. The different components (A), (B) and optionally (C) can be mixed in a solid form or in a liquid form.

[098] In another aspect, the invention relates to a method for obtaining a thermally stable dye comprising Betalains, especially betanin, comprising the steps of: i. provide one or more colorants comprising a betalain, especially a betanin; ii. provide one or more of citric acid, ascorbic acid, malic acid and / or ethylenediaminetetraacetic acid, and at least one salt, especially a salt of one or more acids; iii. mix the ingredients.

[099] In certain preferred embodiments, component (B) is citric acid and ascorbic acid, and at least one salt, especially in Petition 870250091620, dated 07 / 10 / 2025, page 29 / 95 24 / 68 minimum a salt of citric acid and / or ascorbic acid.

[0100] Thus, in another aspect, the invention relates to a method for obtaining a thermally stable dye comprising a Betalain, especially a betanin, comprising the steps of: i. provide (A) one or more colorants comprising a betalain, especially a betanin ii. provide (B) citric acid and ascorbic acid, and at least one salt, iii. mix the ingredients.

[0101] In certain embodiments, the methods of the invention for obtaining a thermally stable dye comprising a Betalain of the invention may further comprise mixing in a compound C). In a particular embodiment, component C is selected from gum arabic, maltodextrin, guar gum, trehalose, alginate, starches and modified starch, sucrose, dextran, inulin, whey protein isolate, potato protein isolate, xanthan gum, pectin, soy protein, chitosan, gelatin, soluble fiber, such as beta-dglucan, pullulan or mixtures thereof.

[0102] Ingredients (A), (B) and optionally (C) may be mixed in any order and using any method generally known in the art. The different components (A), (B) and optionally (C) may be mixed in a solid form or in a liquid form.

[0103] The dye comprising a heat-stable Betalain obtained by this method may be in a solid or liquid form.

[0104] The dye composition according to the invention may be presented as a solid or as a liquid.

[0105] The dye composition according to the invention can be formulated as a composition which additionally contains Petition 870250091620, dated 07 / 10 / 2025, page 30 / 95 25 / 68 a vehicle as described above. For example, the vehicle referred to may be selected from the group consisting of gum arabic, dextrose, salt, mono- and diglycerides of fatty acids, MPG, Polysorbate 80, dextrose, vegetable oil, glucose syrup, glycerin, decaglycerol monooleate, fatty acid esters, benzyl alcohol, ethyl alcohol, propylene glycol, polysorbates, sorbitans, sorbitan trioleate, caprylic / capric triglycerides, dextrose and combinations thereof.

[0106] In a preferred embodiment, the composition is in dry form. In another embodiment, the composition may be in liquid form.

[0107] In the present invention, the term heat-stable means that the color hue provided by the dye composition of the invention comprising components A) and B) is not altered or has an alteration of less than 30% in relation to the color hue measured before heat treatment, such as less than 20%, such as less than 10%, such as less than 5% alteration of the color hue. In the present invention, heat-stable also means that, even if the color hue may change after heat treatment, there is a reversion to the original color hue. Thus, the final color can be considered as unaltered.

[0108] Thus, in certain embodiments, the color provided by the dye composition of the invention (such as a red color) is stable after a heat treatment of more than 40°C, such as a treatment of more than 50°C, 60°C, 70°C, 80°C, such as more than 90°C, more than 100°C, more than 110°C, more than 120°C, 130°C, 140°C, 150°C, 160°C, 170°C, 180°C, 190°C or more than 200°C for a period of at least 30 seconds, at least 1 minute, at least 5 minutes, at least 10 minutes, at least 30 minutes, at least 1 hour, at least 2 hours, such as at least 5 hours. Petition 870250091620, dated 07 / 10 / 2025, p. 31 / 95 26 / 68

[0109] In certain embodiments of the dye composition of the invention, betalanine (especially betanin) is stable after heat treatment of more than 40°C, such as treatment of more than 50°C, 60°C, 70°C, 80°C, such as more than 90°C, more than 100°C, more than 110°C, more than 120°C, 130°C, 140°C, 150°C, 160°C, 170°C, 180°C, 190°C or more than 200°C for a period of at least 30 seconds, at least 1 minute, at least 5 minutes, at least 10 minutes, at least 30 minutes, at least 1 hour, at least 2 hours, as well as at least 5 hours.

[0110] In certain embodiments, the dye composition of the invention is stable after a heating process, such as any heating method available in the art and used to produce, for example, food products and beverages.

[0111] In certain embodiments, the dye composition of the invention is stable after one or more of an extrusion process, after a cooking process, a baking process, a pressurization process, a frying process, and any other heating method available in the art and used to produce food and beverage products.

[0112] In certain embodiments, the color provided by the dye composition of the invention (such as a red color) is stable after one or more of an extrusion process, after a cooking process, a baking process, a pressurization process, a frying process, and any other heating method available in the art and used to produce food and beverage products.

[0113] In certain embodiments, the dye composition of the invention is stable after one or more of an extrusion process, after a cooking process, a baking process, a pressurization process, a frying process, and any other method of Petition 870250091620, dated 07 / 10 / 2025, page 32 / 95 27 / 68 heating available in the technique and used to produce food and beverage products.

[0114] In certain embodiments, the color provided by the dye composition of the invention (such as a red color) is stable after one or more of an extrusion process, after a cooking process, a baking process, a pressurization process, a frying process, and any other heating method available in the art and used to produce food and beverage products. KIT

[0115] The present invention also relates to a kit comprising the different elements of the dye composition of the invention separately, i.e., component A, component B and optionally component C as previously described in the present invention, and optionally instructions on how to mix, prepare and / or use said ingredients. In certain embodiments, the kit comprises the elements already mixed and ready for use (e.g., as a mixture) and optionally instructions on how to use said ingredients. In certain embodiments, the kit comprises other colors, such as yellow or red colors. Uses and products

[0116] The present invention also relates to a consumable, cosmetic, pharmaceutical or nutraceutical preparation comprising a stabilized dye composition of the invention or a kit of the invention.

[0117] In one aspect, the use of a stabilized colorant composition of the invention as described above is provided for in coloring a food product. The colorant composition of the present invention can be added to a food product in an amount effective to increase, enhance and / or modify the colors. Petition 870250091620, dated 07 / 10 / 2025, page 33 / 95 28 / 68 color characteristics of a food product or portion thereof. The components of the kit of the present invention can be added to a food product in an amount effective in increasing, enhancing and / or modifying the color characteristics of a food product or portion thereof.

[0118] A method for obtaining a stabilized color of a consumable, pharmaceutical, cosmeceutical, nutraceutical or cosmetic product comprising adding, to a consumable, pharmaceutical, cosmeceutical, nutraceutical or cosmetic product base, a composition according to the invention or the components of the invention kit.

[0119] Food encompasses the following general food categories, as defined by the U.S. FDA (Food and Drug Administration): bakery products and baking mixes, including all ready-to-eat and ready-to-bake products, pre-baked products such as pastries and cakes, flours and mixes that require preparation before serving; alcoholic beverages, including malt beverages, wines, distilled liquors and cocktail mixes; non-alcoholic beverages and beverage bases, including only specialty or spiced teas, soft drinks, coffee substitutes and fruit and vegetable flavored gelatin drinks; breakfast cereals, including ready-to-eat and instant and regular hot cereals; cheeses, including curd and whey cheeses, creamy, natural, grating, processed, spreadable, dipping and miscellaneous cheeses; chewing gum, including all forms;Coffee and tea, including regular, decaffeinated and instant types; condiments and relishes, including simple sauces and seasoning pastes, olives, pickles and relish, but not spices or herbs; confectionery and toppings, including flavored candies and toppings, marshmallows, cooking chocolate and brown sugars, in lumps, rock, maple, powder and raw form; dairy product analogues, including non-dairy milks; Petition 870250091620, dated 07 / 10 / 2025, p. 34 / 95 29 / 68 liquid or frozen creams, coffee clarifiers, toppings and other non-dairy products; egg products, including liquid, frozen or dehydrated eggs, and dishes made from them, i.e. spring rolls, egg fu young, egg salad and frozen multi-course meals with eggs, but not fresh eggs; fats and oils, including margarine, salad dressings, butter, salad oils, cooking fats and oils; fish products, including all prepared main dishes, salads, appetizers, frozen multi-course meals and pastas containing fish, seafood and other aquatic animals, but not fresh fish; fresh eggs, including boiled eggs and egg dishes made only with fresh eggs in the shell; fresh fish, including only fresh and frozen fish, seafood and other aquatic animals; fresh fruits and fruit juices, including only raw fruits, citrus fruits, melons and berries, and homemade ades and punches made from them;Fresh meats, including only fresh or home-frozen beef or veal, pork, lamb or mutton, and dishes, salads, appetizers or sandwich spreads containing fresh meat prepared at home from them; fresh poultry, including only fresh or home-frozen poultry and game birds, and dishes, salads, appetizers or sandwich spreads containing fresh poultry prepared at home from them; fresh vegetables, tomatoes and potatoes, including only fresh and home-prepared vegetables; frozen dairy desserts and mixes, including ice cream, frozen milks, sorbets and other frozen dairy desserts and specialties; fruit and water sorbets, including all frozen fruit and water sorbets; gelatins, puddings and fillings, including flavored gelatin desserts, puddings, creams, parfaits, pie fillings and gelatin-based salads;Grain and pasta products, including noodle and vermicelli products, rice dishes and frozen multi-course meals, without meat or vegetables; broths and mo; Petition 870250091620, dated 07 / 10 / 2025, p. 35 / 95 30 / 68 Sauces, including all meat sauces and broths, and tomato, milk, butter, and special sauces; hard candies and cough drops, including all types of hard candies; herbs, seeds, spices, seasonings, blends, extracts, and flavorings, including all natural and artificial spices, blends, and flavors; homemade jams and jellies, including only homemade jams, jellies, fruit butters, preserves, and sweet pastes; commercial jams and jellies, including only commercially processed jams, jellies, fruit butters, preserves, and sweet pastes; meat products, including all meats and meat-containing dishes, salads, appetizers, frozen multi-course meat meals, and sandwich ingredients prepared by commercial processing or using commercially processed meats with home preparation; whole and skim milk, including only whole, low-fat, and skim fluid milks;Dairy products, including flavored milk and milk drinks, powdered milk, toppings, snack sauces, spreads, weight-control milk drinks, and other dairy products; tree nuts and tree nut products, including whole or shelled nuts, peanuts, coconut, and nut and peanut butters; plant-based protein products, including the National Academy of Sciences / National Research Council category of reconstituted plant protein, and meat, poultry, and fish substitutes, analogues, and extender products made from plant proteins; poultry products, including all poultry and poultry-containing dishes, salads, appetizers, frozen poultry multicourse meals, and sandwich ingredients prepared by commercial processing or using commercially processed poultry with home preparation; processed fruits and fruit juices, including all commercially processed fruits, citrus, berries, and blends;salads, juices and juice punches, concen; Petition 870250091620, dated 07 / 10 / 2025, page 36 / 95 31 / 68 blends, dilutions, and beverage substitutes made from them; processed vegetables and vegetable juices, including all vegetables, vegetable dishes, frozen multi-course meals of vegetables and juices, and commercially processed vegetable mixes; snacks, including potato chips, pretzels, and other innovative snacks; soft candies, including chocolate bars, chocolates, fudge, mints, and other chewy or nougat candies; soups, prepared at home, including meat, fish, poultry, vegetable soups and homemade combinations; soups and soup mixes, including commercially prepared meat, fish, poultry, vegetable soups and combinations; sugar, white, granulated, including only granulated white sugar; sugar substitutes, including granulated, liquid, and tablet sugar substitutes;and sweet sauces, toppings and syrups, including sweet sauces and toppings of chocolate, red berries, fruit, corn syrup and maple syrup.

[0120] For example, the food coloring composition as described above in the present invention can be used to impart a stable red color similar to the color obtained by using Allura Red AC (red dye 40) or carmine E120 (artificial color) to food products such as dairy products, candies, beverages, sauces / broths, etc.

[0121] A dairy product can refer to yogurt, cream, milk smoothie, milkshake, milk ice cream.

[0122] A confectionery product may refer to a sweet or candy-like food product, such as chewing gum or hard and soft confectionery products. Non-limiting examples of confectionery products include cakes, biscuits, pies, chocolates, chewing gum, jellies, ice cream, puddings, jams, jellies, gums, hard candies, chewy candies, cereals and other breakfast foods, fruits in syrup and fruit sauces. Petition 870250091620, dated 07 / 10 / 2025, p. 37 / 95 32 / 68

[0123] A beverage product may refer to beverages, beverage mixes and concentrates, including, but not limited to, ready-to-drink alcoholic and non-alcoholic beverages and dry powder. Non-limiting examples of beverages may include carbonated and non-carbonated beverages, for example, soft drinks, fruit or vegetable juices.

[0124] A sauce product may refer to a sweet or savory semi-solid composition used to add flavor, moisture, and / or visual appeal to a dish. Non-limiting examples of sauces include broth and barbecue sauce.

[0125] A meat analogue product may refer to foods made from vegetarian ingredients which approximate certain aesthetic qualities (such as texture, flavor, appearance) or chemical characteristics of specific types of meat. Non-limiting examples of meat analogues include veggie burgers.

[0126] In yet another aspect, a food product comprising the stabilized colorant composition of the invention as described above is provided in the present invention. For example, the food product may be as described above.

[0127] One skilled in the art will recognize that the optimum amount of food color composition present in a given food product is determined by factors such as desired overall color, solubility, regulatory approval, etc. One skilled in the art can readily determine the optimum amount of color for a given product based on these factors.

[0128] It was surprisingly found that the dye composition of the invention has very high thermal stability even in high moisture content environments.

[0129] In certain forms, the product (a consumable such as Petition 870250091620, dated 07 / 10 / 2025, page 38 / 95 33 / 68 a food or beverage product, a pharmaceutical, cosmeceutical, nutraceutical or cosmetic product) comprising the dye composition of the invention has a low moisture content. Low moisture content in the present invention means less than 10% w / w of water in the final product.

[0130] In certain embodiments, the product (a consumable such as a food or beverage product, a pharmaceutical, cosmeceutical, nutraceutical or cosmetic product) comprising the dye composition of the invention has an average moisture content. Average moisture content in the present invention means between 10% w / w and 50% w / w of water in the final product.

[0131] In certain embodiments, the product (a consumable such as a food or beverage product, a pharmaceutical, cosmeceutical, nutraceutical or cosmetic product) comprising the dye composition of the invention has a high moisture content. High moisture content in the present invention means more than 50% w / w of water in the final product.

[0132] The present invention relates to a consumable, pharmaceutical, cosmeceutical, nutraceutical or cosmetic product comprising the dye of the invention, wherein the product is treated with a heating process and the color provided by the dye composition of the invention is stable after said heating process. The heating process or heat treatment are interchangeable in the present invention.

[0133] In certain embodiments, the color provided by the dye composition of the invention (such as a red color) is stable in the product (a consumable such as a food or beverage product, a pharmaceutical, cosmeceutical, nutraceutical or cosmetic product) after heat treatment of more than 40°C, such as treatment of more than 50°C, 60°C, 70°C, 80°C, such as more than 90°C, more than Petition 870250091620, dated 07 / 10 / 2025, page 39 / 95 34 / 68 100°C, more than 110°C, more than 120°C, 130°C, 140°C, 150°C, 160°C, 170°C, 180°C, 190°C or more than 200°C for a period of at least 30 seconds, at least 1 minute, at least 5 minutes, at least 10 minutes, at least 30 minutes, at least 1 hour, at least 2 hours, as well as at least 5 hours.

[0134] In certain embodiments, the color of the product (a consumable such as a food or beverage product, a pharmaceutical, cosmeceutical, nutraceutical or cosmetic product) comprising the colorant composition of the invention is stable after heat treatment of more than 40°C, such as treatment of more than 50°C, 60°C, 70°C, 80°C, such as more than 90°C, more than 100°C, more than 110°C, more than 120°C, 130°C, 140°C, 150°C, 160°C, 170°C, 180°C, 190°C or more than 200°C for a period of at least 30 seconds, at least 1 minute, at least 5 minutes, at least 10 minutes, at least 30 minutes, at least 1 hour, at least 2 hours, as well as at least 5 hours.

[0135] In certain embodiments, the color of the product (a consumable such as a food or beverage product, a pharmaceutical, cosmeceutical, nutraceutical or cosmetic product) comprising the colorant composition of the invention, is stable after a heat treatment selected from one or more of an extrusion process, after a cooking process, a baking process, a pressurization process, a frying process, and any other heating method available in the art and used to produce, for example, food and beverage products.

[0136] In certain embodiments, the product is a food product, such as a sweet, a cake, a biscuit, etc., that has been baked at a minimum of 100°C.

[0137] In certain forms, the product is a food product that is a snack that has first been cooked, baked and / or pressurized to a Petition 870250091620, dated 07 / 10 / 2025, page 40 / 95 35 / 68 temperature of at least 100°C and then fried, for example, at a high temperature, such as more than 190°C, such as 200°C. In one aspect, the use of a stabilized dye composition of the invention as described above is provided for in coloring a pharmaceutical, cosmeceutical, nutraceutical or cosmetic product. The stabilized dye composition of the invention can be added to the product (pharmaceutical, nutraceutical or cosmetic product) in an amount effective to increase, enhance and / or modify the color characteristics of the product or a portion thereof, for example, to provide a bright and stable red color.

[0138] In another aspect, the invention relates to a pharmaceutical, cosmeceutical, nutraceutical or cosmetic composition comprising a stabilized dye composition of the invention as defined herein and, optionally, a suitable vehicle for formulating said stabilized dye composition of the invention in said pharmaceutical, cosmeceutical or cosmetic composition. The stabilized dye composition of the invention would provide a desired color (such as a stable red color) to said pharmaceutical, cosmeceutical, cosmetic or nutraceutical formulation.

[0139] Pharmaceutical composition, as used in the present invention, refers to compositions and molecular entities that are physiologically tolerable. Preferably, the term pharmaceutically acceptable means that it is approved by a state or federal government regulatory agency or is included in the U.S. Pharmacopoeia or other generally recognized pharmacopoeia for use in animals, and more particularly in humans.

[0140] Cosmetic composition, as used in the present invention, refers to a composition suitable for use in the personal hygiene of humans or animals, or to enhance natural beauty. Petition 870250091620, dated 07 / 10 / 2025, page 41 / 95 36 / 68 ral or alter the appearance of the body without affecting the structure or functions of the human or animal body, comprising one or more products that provide such effects. If desired, the cosmetic composition provided by the invention may contain, in addition to the composition of the invention, one or more cosmetics or cosmetic products, that is, substances or mixtures intended to be placed in contact with the external parts of the human or animal body (e.g., epidermis, hair system, nails, lips, etc.) or with the teeth and oral mucosa, for the sole or main purpose of cleaning them, perfuming them, altering their appearance, protecting them, maintaining them in good condition, or correcting body odors. Illustrative examples of cosmetically acceptable vehicles include the products contained in the INCI (International Nomenclature of Cosmetic Ingredients) list.The composition of the present invention can be added to a wide variety of cosmetic products, including makeup, cleansing creams, skin protection, treatment or care products, particularly for the face, hands and feet (for example, day and night creams, makeup removers, foundations and sunscreens), liquid foundations, makeup remover lotions, protective or skin care body lotions, sunscreen lotions, lotions, gels or foams for skin care, such as cleansing, sunscreen and tanning lotions, bath preparations, deodorant compositions, aftershave gels or lotions, depilatory creams and compositions used for insect bites and pain relief. The composition of the invention can take a wide variety of forms, and include, for example, dressings, lotions, solutions, sprays, creams, gels, ointments or the like.

[0141] In certain embodiments, the composition of the invention or the kit of the invention may be used to prepare color cosmetics or makeup. Color cosmetics or makeup encompass different Petition 870250091620, dated 07 / 10 / 2025, page 42 / 95 37 / 68 categories of products for the skin, eyes, cheeks and lips, such as face makeup, such as foundation, blushes, highlighters, lotions, face creams and bronzing powders, loose and compact powders, and mineral powders; eye makeup, such as eyeshadows, eyeliners, eyebrow pencils, kohl and mascara, and mineral powders; lip makeup, such as lipstick, gloss, lip pencils, lip volumizers, pots and palettes; and nail makeup, such as varnishes and enamels, hardeners and strengtheners, base and top coat.

[0142] In certain embodiments, the composition of the invention or the kit of the invention may be used encapsulated with a clay such as montmorillonite. WO2021191243A1, incorporated herein by reference, described the use of micronized montmorillonite to prepare an encapsulated natural dye for color cosmetics.

[0143] In certain embodiments, the composition of the invention or the kit of the invention can be used directly as a colorant (such as a red dye) for cosmetic application to color cosmetic formulas such as shower gel, shampoo, lotion, cream, etc.

[0144] As used in the present invention, the term cosmeceutical product refers to a product suitable for use on the human or animal body comprising one or more cosmeceutical products (functional cosmetics, dermaceuticals or active cosmetics), i.e., topical hybrid products with cosmetic-pharmaceutical characteristics containing active ingredients that have an effect on the skin, hair and / or nails of the user, in higher and more effective concentrations, therefore, they are located at an intermediate level between cosmetic and medicine. Illustrative examples of cosmeceutical products include essential oils, ceramides, enzymes, minerals, peptides, vitamins, etc.

[0145] As used in the present invention, the term nutraceutical product refers to a product suitable for use in beings Petition 870250091620, dated 07 / 10 / 2025, page 43 / 95 38 / 68 humans or animals, comprising one or more natural products with therapeutic action, which provide a health benefit or have been associated with the prevention or reduction of diseases, and includes dietary supplements presented in a non-food matrix (e.g., capsules, powder, etc.) of a concentrated natural bioactive product, generally present (or not) in foods and which, when taken in a dose higher than that existing in these foods, exerts a favorable effect on health that is greater than the effect that normal food can have. Therefore, the term nutraceutical product includes isolated or purified food products, as well as food additives or supplements that are generally presented in dosage forms normally used orally, for example, capsules, tablets, sachets, drinkable ampoules, etc.; the products referred to provide a physiological benefit or protection against diseases, generally against chronic diseases.If desired, the nutraceutical product provided by the invention may contain, in addition to the composition of the invention, one or more nutraceuticals (products or substances associated with the prevention or reduction of diseases), for example, flavonoids, omega-3 fatty acids, etc., and / or one or more prebiotics (non-digestible food ingredients which stimulate the activity and / or growth of probiotics), for example, oligofructose, pectin, inulin, galacto-oligosaccharides, lactulose, human milk oligosaccharides, dietary fiber, etc.

[0146] In certain forms, the product (consumable or food product, pharmaceutical, cosmeceutical, nutraceutical or cosmetic) has a pH ranging from 2.8 to 7

[0147] In certain embodiments, the product (consumable or food, pharmaceutical, cosmeceutical, nutraceutical or cosmetic product) has been treated with a heat treatment and / or exposed to light.

[0148] It was surprisingly found that the addition of a Petition 870250091620, dated 07 / 10 / 2025, page 44 / 95 39 / 68 The dye composition according to the invention, applied to a product (consumable or food, pharmaceutical, cosmeceutical, nutraceutical or cosmetic product), stabilizes the color of the dye present in the composition of the invention, even if said product is heated. Furthermore, surprisingly, even if some color loss occurs after heating, the presence of the components of the composition of the invention provides a recovery of the color hue of the dye present in the composition of the invention to the color hues that the product had before the heat treatment (see example 4).

[0149] In certain embodiments, the consumable, pharmaceutical, cosmeceutical, nutraceutical or cosmetic product according to the invention has been subjected to heat treatment and then packaged in the presence of water.

[0150] It has been surprisingly found that the present dye composition of the invention provides a similar pink or red color in meat products to that of meat products treated with nitrites and / or nitrates. The use of natural dyes in cooked meats is not easy, because most natural dyes are not stable to heat or certain pH conditions.

[0151] The present invention also relates to the use of a stabilized dye composition of the invention as described in the present invention in coloring a meat food product, wherein the meat products exhibit a cured color without the use of nitrites. In certain embodiments, the color is a pink color or a red color. In certain embodiments, the red or pink color is similar to the color obtained in the same product when nitrites are used.

[0152] In certain embodiments, the color obtained using the dye composition of the invention (i.e., red or pink color) is heat stable and / or stable at low pH.

[0153] In certain embodiments the dye composition of the invention Petition 870250091620, dated 07 / 10 / 2025, p. 45 / 95 40 / 68 composition comprises from about 15% to 25% w / w, such as about 20% beetroot (5% betanin), from about 55% to about 65% w / w, such as about 60% w / w ascorbic acid, from about 4% to about 7%, such as 6% w / w citric acid and from 10% to about 15% w / w, such as 12% w / w sodium citrate.

[0154] In certain embodiments, the food product (such as a meat product) during production has been subjected to heating or cooking and / or has a pH lower than 6.

[0155] In certain embodiments, the product is a cooked meat product, such as cooked ham or a sausage. The present invention also relates to a curing aid composition of the invention. Composition of the Healing Aid of the Invention

[0156] The present invention relates to a curing aid composition comprising (I) a dye composition comprising components A) and B), wherein A) is one or more dyes comprising a Betalain, especially a betanin and B) comprises one or more of citric acid, ascorbic acid, malic acid and ethylenediaminetetraacetic acid, and at least one salt and (II) one or more of antioxidants and / or one or more antimicrobials.

[0157] In certain embodiments, the antioxidant and / or antimicrobial is selected from one or more of the following extracts: Lamiaceae (such as rosemary extract, sage extract), ascorbic acid (such as acerola ascorbic acid), acetic acid (such as vinegar), green tea, organic acids, yeast extracts, pomegranate extract, artichoke extract, olive extract, green coffee extract, Camu camu juice or extract, rosehip extract, etc.

[0158] The present invention also relates to the use of a healing aid as described in the present invention comprising Petition 870250091620, dated 07 / 10 / 2025, page 46 / 95 41 / 68 stabilized dye composition of the invention as described in the present invention for coloring a meat food product wherein the meat products exhibit a cured color without the use of nitrites. In certain embodiments, the color is a pink or red color. In certain embodiments, the red or pink color is similar to that obtained in the same product when nitrites are used.

[0159] In certain embodiments, the color obtained using the dye composition of the invention (i.e., red or pink color) is heat stable and / or stable at low pH.

[0160] In certain embodiments, the food product (such as a meat product) has been subjected to heating or cooking during production and / or has a pH lower than 6.

[0161] In certain forms, the product is a cooked meat product, such as cooked ham or a sausage.

[0162] The stabilized dye composition of the invention can be used together with smaller amounts of Nitrites along with other antioxidant and / or antimicrobial products to impart the properties of a curing agent (red or pink color and antioxidant and antimicrobial protection) while using smaller amounts of Nitrites.

[0163] For example, if normally to cure a specific meat product a certain amount of Nitrite is used, now, with the stabilized color composition of the invention, the concentration of Nitrite can be reduced to more than 50%, more than 60%, more than 70% or more than 80% without losing the characteristic pink or red color of Nitrite. Additionally, to obtain the antimicrobial effect of Nitrites on meat, additional antioxidants and / or antimicrobials can be used together with the stabilized color composition of the invention.

[0164] Therefore, the present invention also relates to a mé Petition 870250091620, dated 07 / 10 / 2025, p. 47 / 95 42 / 68 all for manufacturing a meat product with reduced nitrite, having the properties of a meat product that has been cured with nitrites, comprising the step of adding (I) a colorant composition of the invention comprising components A) and B), wherein A) is one or more colorants comprising a betalain, especially a betanin, and B) comprises one or more of citric acid, ascorbic acid, malic acid and ethylenediaminetetraacetic acid, and at least one salt, and (II) one or more of food-grade antioxidants and / or antimicrobials and optionally nitrites. In certain embodiments, the nitrite concentration may be reduced to more than 50%, more than 60%, more than 70% or more than 80% of the normal amount used to cure said food product without losing the characteristic pink or red color of nitrite and the antimicrobial properties.

[0165] The stabilized dye composition of the invention can be used together with antioxidant and / or antimicrobial products, to impart the properties of a curing agent without using nitrites.

[0166] Therefore, the present invention also relates to a method for manufacturing a nitrite-free meat product having the properties of a meat product that has been cured with nitrites, comprising the step of adding the curing aid of the invention comprising (I) a colorant composition of the invention comprising components A) and B), wherein A) is one or more colorants comprising a betalain, especially a betanin, and B) comprises one or more of citric acid, ascorbic acid, malic acid and ethylenediaminetetraacetic acid, and at least one salt, and (II) one or more of food-grade antioxidants and / or antimicrobials, optionally without the addition of nitrite and / or nitrate.

[0167] Food-grade antioxidants and / or antimicrobials are known in the art and may be of natural or artificial origin.

[0168] In a preferred embodiment, antioxidants and / or an Petition 870250091620, dated 07 / 10 / 2025, page 48 / 95 43 / 68 of these microorganisms are of natural origin.

[0169] In certain embodiments, the food-grade antioxidant and / or antimicrobial may be selected from one or more of those cited by the FSA, such as: Lamiaceae extract (such as rosemary extract, sage extract), ascorbic acid (such as acerola ascorbic acid), acetic acid (such as vinegar), green tea, organic acids, yeast extracts, pomegranate extract, artichoke extract, olive extract, green coffee extract, etc.

[0170] As used in the present invention, the term extract of Lamiaceae may refer to an extract from a plant in the Lamiaceae family, including, but not limited to, rosemary, sage, oregano, thyme, mints and the following genera: Salvia (such as Salvia Apiana and Salvia officinalis), Rosmarinus (such as Rosmarinus officinalis), Lepechinia, Oreganum, Thymus, Hyssopus and any mixtures thereof.

[0171] The Lamiaceae material used to extract the extract of Lamiaceae can refer to any part of the plant, such as leaves, roots, flowers, stems, etc. In a preferred embodiment, the plant part is the leaves and / or stems.

[0172] Lamiaceae material can be processed before extraction, for example, it can be washed, dried, ground or crushed, etc.

[0173] Lamiaceae extract (such as rosemary and / or sage extract) can be obtained or obtainable by extracting the aerial parts of a Lamiaceae extract (such as rosemary and / or sage extract) with acetone or ethanol (e.g., aqueous ethanol), followed by optional purification, depending on the concentration of phenolic diterpene(s) required in the final extract.

[0174] Particular solvents and extraction methods for obtaining extracts rich in phenolic diterpenes are known in the art. For example, a detailed procedure for preparing an extract of Petition 870250091620, dated 07 / 10 / 2025, page 49 / 95 44 / 68 Rosemary was described in U.S. Patent No. 5,859,293 (PCT W096 / 34534), which is incorporated herein by reference in its entirety.

[0175] As used in the present invention, the term Phenolic Diterpenes may refer to carnosic acid, carnosol, methylcarnosate and other phenolic diterpene derivatives (rosmanol, isorosmanol, 11,12-di-O-methylisorosmanol, 12-O-methylcarnosic acid, rosmanol-9-ethyl ether, circi-maritin, methylated mono-oxidized product of carnosic acid, genkwanin, epirosmanol, epiisorosmanol, carnosic acid derivative, epirosmanol ethyl ether, cryptotanshinone) and mixtures thereof.

[0176] In some embodiments, the Lamiaceae extract (such as rosemary and / or sage extract) comprises at least about 1%, at least about 2%, at least about 3%, at least about 4%, at least about 5%, at least about 6%, at least about 7%, at least about 8%, at least about 9%, at least about 10%, at least about 15%, at least about 20%, at least about 30%, at least about 40%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 95%, or at least about 99% by weight of one or more phenolic diterpenes such as those described above. In a preferred embodiment, one or more Lamiaceae extracts that may be used in the present invention comprise carnosic acid and / or carnosol.

[0177] In certain embodiments, the Lamiaceae extract (such as rosemary and / or sage extract) may comprise (or consist essentially of) the following phenolic diterpenes: carnosic acid and / or carnosol. In certain embodiments, the ratio between carnosic acid and carnosol is 40:1 to 1:40, such as 30:1, 20:1, 10:1, 5:1 or 1:1. Petition 870250091620, dated 07 / 10 / 2025, page 50 / 95 45 / 68

[0178] In a particular embodiment, the Lamiacea extract is an extract in which most of the volatile oil components have been removed. As used in the present invention, the term “volatile oil components” may refer to compounds such as essential oils, such as: (-)-borneol, (-)-bornyl acetate, (-)-camphor, 1,8-cineole (eucalyptol) and verbenone.

[0179] In one embodiment the ratio between the total % of phenolic diterpene(s) (such as carnosic acid and carnosol) / total % of volatile oil components (such as (-)-borneol, (-)-bornyl acetate, (-)-camphor, 1,8-cineole (eucalyptol) and verbenone) is not less than 15.

[0180] In the present application, "ascorbic acid" means ascorbic acid and / or its salt, including, but not limited to, sodium ascorbate, erythorbic acid, and sodium erythorbate. The ascorbic acid and its salts that may be used in the present invention may be of natural or synthetic origin. In a preferred embodiment, the ascorbic acid and / or its salt is obtained from some natural source rich in ascorbic acid, including, but not limited to, acerola (Malpighia glabra L.), the citrus family (genus Citrus), including, but not limited to, orange, lemon, calamansi, lime, kumquat, tangerine, and grapefruit, etc. Also included in the present invention are ascorbic acid and / or its salt obtained using fermentation methods. The ascorbic acid and / or its salt may be further purified to obtain highly concentrated ascorbic acid and / or its salt.

[0181] Thus, in certain embodiments, the curing aid composition of the invention comprises ascorbic acid from acerola (such as acerola juice, dehydrated juice, etc.) and may be present in element (II) of the composition in an amount from about 1% to about 90% w / w, such as from about 2% w / w to about 50% w / w, such as from about 5% to about 30% w / w or about 9% or about 25% w / w. In certain embodiments, the Petition 870250091620, dated 07 / 10 / 2025, p. 51 / 95 46 / 68 Acerola juice or dehydrated juice contains 5% to 10% ascorbic acid and has an ascorbic acid content of at least 30% w / w.

[0182] In certain embodiments, the compositions of the invention may comprise ascorbic acid in element (II) of the composition in an amount from about 0.1% to about 99.9%, such as from about 1% w / w to 30% w / w, such as from 1% w / w to about 25% w / w, such as from about 1% w / w to 10%, such as from 2% w / w to about 10% w / w, such as 3%, 4% w / w, 5% w / w or about 9% w / w.

[0183] In certain embodiments, acerola juice or dehydrated juice may have an ascorbic acid concentration of at least 10% w / w, such as at least 20%, at least 30%, such as at least 40% w / w.

[0184] Acerola juice can be dehydrated using techniques known in the art to provide a powder rich in ascorbic acid.

[0185] The acetic acid in the present invention includes acetic acids and any of their salts. The acetic acid may be present in element (II) of the composition in an amount from about 2% to about 99%, such as from about 2% w / w to about 90% w / w, such as from about 2% w / w to about 50% w / w, such as from about 3% w / w to about 30% w / w, such as from about 3% w / w to about 20% w / w, such as from about 5% w / w to 20% w / w, such as from about 10% w / w to about 30% w / w, such as about 10% w / w or about 20% w / w, or about 5% w / w to 17% w / w.

[0186] In certain embodiments, the acetic acid is from buffered vinegar and the concentration of acetic acid in element (II) of the composition is 3% w / w, approximately 30% w / w, such as 10 to 20% w / w, such as 17% w / w.

[0187] In certain forms, acetic acid is not vinegar Petition 870250091620, dated 07 / 10 / 2025, p. 52 / 95 47 / 68 buffered and the concentration of acetic acid in element (II) of the composition of the invention is 2% w / w approximately 20% w / w, such as 2% to 10% w / w, such as 5% w / w.

[0188] Any source of acetic acid may be used in the present invention, including, but not limited to, vinegar, unbuffered vinegar, buffered vinegar, concentrated vinegar, unconcentrated vinegar, or any mixtures thereof. Vinegar includes, but is not limited to, white wine vinegar, champagne vinegar, rice vinegar, apple cider vinegar, raisin vinegar, apricot vinegar, sherry vinegar, malt vinegar, beer vinegar, red wine vinegar, balsamic vinegar, or black vinegar. Vinegar may be concentrated or not. Vinegar may be buffered or not. Vinegar may be used in solid form (as a dry powder) or as a liquid. Acetic acid obtained using fermentation methods known in the art is also included in the present invention.

[0189] Acetic acid can be used as a liquid or as a powder. Acetic acid can be dried using techniques known in the art mentioned to provide a powder rich in acetic acid.

[0190] For example, vinegar (such as buffered vinegar or unbuffered vinegar) can be a source of acetic acid. Vinegar (such as buffered vinegar or unbuffered vinegar) may be present in element (II) of the composition in an amount from about 10% w / w to about 99% w / w, such as from about 20% w / w to about 90% w / w, such as from about 30% w / w to about 80% w / w, such as from about 20% w / w to about 60% w / w, such as about 28% w / w, or about 52% w / w, or about 70% w / w.

[0191] Vinegar (such as buffered vinegar or non-buffered vinegar) Petition 870250091620, dated 07 / 10 / 2025, p. 53 / 95 48 / 68 buffered) can be dried by any method known in the art in order to obtain a powder rich in acetic acid containing at least 5% w / w, such as at least 10%, at least 15%, 20%, 25%, 30%, 40%, 50%, 60%, as well as at least 80% of acetic acid.

[0192] In certain embodiments of the products, methods or processes of the invention, the concentration of carnosic acid in the final product (such as a meat product like cooked ham, fish or an analogous meat product) is from about 5 ppm, 10 ppm, 12 ppm, 15 ppm, 20 ppm, 30 ppm, 40 ppm, 50 ppm, 60 ppm, 70 ppm, 80 ppm, 90 ppm, 100 ppm, to about 6%, 5%, 4%, 4%, 3%, 2%, 1% (10000 ppm), 9000 ppm, 8000 ppm, 7000 ppm, 6000 ppm, 5000 ppm, 4000 ppm, 3000 ppm, 2000 ppm, 1000 ppm, 800 ppm, 600 ppm, 500 ppm, 400 ppm, 300 ppm to 200 ppm w / w, such as 50 ppm to 1000 ppm; and / or the carnosol concentration in the final product is from about 2 ppm, 5 ppm, 10 ppm, 15 ppm, 20 ppm, 30 ppm, 40 ppm, 50 ppm, 60 ppm, 70 ppm, 80 ppm, 90 ppm, 100 ppm, to about 3%, 2%, 1% (10000 ppm), 3000 ppm, 2000 ppm, 1000 ppm, 800 ppm, 600 ppm, 500 ppm, 400 ppm, 300 ppm to 200 ppm w / w, such as 5 ppm to 100 ppm.In one embodiment, the ratio between carnosic acid and carnosol is 40:1 to 5:1, such as 30:1, 20:1, 10:1, or 5:1.

[0193] In certain embodiments of the methods or processes of the invention, the concentration of ascorbic acid in the final product (such as meat, fish or a meat analogue product) is from about 12 ppm, 15 ppm, 20 ppm, 30 ppm, 40 ppm, 50 ppm, 60 ppm, 70 ppm, 80 ppm, 90 ppm, 100 ppm, 150 ppm to about 6%, 5%, 4%, 4%, 3%, 2%, 1% (10000 ppm), 9000 ppm, 8000 ppm, 7000 ppm, 6000 ppm, 5000 ppm, 4000 ppm, 3000 ppm, 2000 ppm, 1000 ppm, 800 ppm, 600 ppm, 500 ppm, 400 ppm, 300 ppm to 200 ppm w / w, as well as 50 ppm to 1000 ppm, in relation to the final weight of the product.

[0194] In certain modalities of the methods or processes of in Petition 870250091620, dated 07 / 10 / 2025, page 54 / 95 49 / 68 Convention, the concentration of acetic acid in the final product (such as meat, fish or a meat analogue product) is from about 12 ppm, 15 ppm, 20 ppm, 30 ppm, 40 ppm, 50 ppm, 60 ppm, 70 ppm, 80 ppm, 90 ppm, 100 ppm, to about 6%, 5%, 4%, 4%, 3%, 2%, 1% (10000 ppm), 9000 ppm, 8000 ppm, 7000 ppm, 6000 ppm, 5000 ppm, 4000 ppm, 3000 ppm, 2000 ppm, 1000 ppm, 800 ppm, 600 ppm, 500 ppm, 400 ppm, 300 ppm to 200 ppm, as well as 50 ppm to 1000 ppm, as well as 500 ppm in relation to the final weight of the product.

[0195] In certain embodiments, the concentration of carnosic acid in the final product (such as meat, fish or a meat analogue product) is from about 5 ppm, 10 ppm, 15 ppm, 20 ppm, 30 ppm, 40 ppm, 50 ppm, 60 ppm, 70 ppm, 80 ppm, 90 ppm, 100 ppm, to about 6%, 5%, 4%, 4%, 3%, 2%, 1% (10000 ppm), 9000 ppm, 8000 ppm, 7000 ppm, 6000 ppm, 5000 ppm, 4000 ppm, 3000 ppm, 2000 ppm, 1000 ppm, 800 ppm, 600 ppm, 500 ppm, 400 ppm, 300 ppm to 200 ppm w / w, such as 50 ppm to 1000 ppm;and / or the concentration of carnosol in the final product is from approximately 5 ppm, 10 ppm, 15 ppm, 20 ppm, 30 ppm, 40 ppm, 50 ppm, 60 ppm, 70 ppm, 80 ppm, 90 ppm, 100 ppm, to approximately 6%, 5%, 4%, 4%, 3%, 2%, 1% (10000 ppm), 9000 ppm, 8000 ppm, 7000 ppm, 6000 ppm, 5000 ppm, 4000 ppm, 3000 ppm, 2000 ppm, 1000 ppm, 800 ppm, 600 ppm, 500 ppm, 400 ppm, 300 ppm to 200 ppm w / w, such as 5 ppm to 100 ppm, the concentration of ascorbic acid in the final product is from approximately 12 ppm, 15 ppm, 20 ppm, 30 ppm, 40 ppm, 50 ppm, 60 ppm, 70 ppm, 80 ppm, 90 ppm, 100 ppm, to approximately 6%, 5%, 4%, 4%, 3%, 2%, 1% (10000 ppm), 9000 ppm, 8000 ppm, 7000 ppm, 6000 ppm, 5000 ppm, 4000 ppm, 3000 ppm, 2000 ppm, 1000 ppm, 800 ppm, 600 ppm, 500 ppm, 400 ppm, 300 ppm to 200 ppm w / w, as well as 50 ppm to 1000 ppm; and / or the carnosol concentration in the final product is from approximately 5 ppm, 10 ppm, 15 ppm, 20 ppm, 30 ppm, 40 ppm, 50 ppm; Petition 870250091620, dated 07 / 10 / 2025, page 55 / 95 50 / 68 ppm, 70 ppm, 80 ppm, 90 ppm, 100 ppm, at approximately 6%, 5%, 4%, 4%, 3%, 2%, 1% (10000 ppm), 9000 ppm, 8000 ppm, 7000 ppm, 6000 ppm, 5000 ppm, 4000 ppm, 3000 ppm, 2000 ppm, 1000 ppm, 800 ppm, 600 ppm, 500 ppm, 400 ppm, 300 ppm to 200 ppm w / w, as well as 5 ppm to 100 ppm, in relation to the final weight of the product.

[0196] For example, the anti-botulinum compositions of the invention may be present in the product in an amount from about 0.1 g / kg to about 20 g / kg, such as from about 0.5 g / kg to about 15 g / kg, such as from about 0.5 g / kg to about 5 g / kg, such as 1 g / kg to about 15 g / kg, such as from about 0.5 to about 15 g / kg, such as 3 g / kg, 5 g / kg and 10 g / kg.

[0197] The ratio between acetic acid and ascorbic acid can be 95:3 to 20:60, such as 90, 80, 70, 60, 50, 40, 30, 20:3, 5, 10, 20, 30, 40, 50 or 60, such as 80:10 to 80:20, such as 71:24 to approximately 35:56, such as 80:15 or 30:60 or such as 77:17.

[0198] The ratio between ascorbic acid and at least one phenolic diterpene (such as carnosic acid and carnosol) can be from 3:2 to 60:20, as well as 3, 5, 10, 20, 30, 40, 50, or 60:2, 5, 10 or 20, as well as 15:5 or 60:10, as well as 24:5 to about 56:8, as well as 17:6.

[0199] The ratio between acetic acid, ascorbic acid and at least one phenolic diterpene (such as carnosic acid and carnosol) can be from 95:3:2 to 20:60:20, such as 80:15:5 or 30:60:10, such as 71:24:5 to about 35:56:8, such as 77:17:6.

[0200] In certain embodiments, Lamiaceae extract (such as rosemary and / or sage extract) is added to the product to provide from 5 ppm to 1%, such as from 5 ppm to 200 ppm, such as from 10 ppm to 100 ppm, such as about 40 ppm of at least one phenolic diterpene relative to the final weight of the product; ascorbic acid is added to the product to provide a final concentration in the product of from 10 ppm to 1%, such as from 50 ppm to Petition 870250091620, dated 07 / 10 / 2025, page 56 / 95 51 / 68 500 ppm, such as 100 ppm to 200 ppm, such as 110 ppm in relation to the final weight of the product, and acetic acid is added to the product in order to provide a final concentration in the product of from 10 ppm to 1%, such as 100 ppm to 1000 ppm, such as 500 ppm in relation to the final weight of the product.

[0201] In certain embodiments, at least one phenolic diterpene is added to the product in order to obtain a concentration in the final product of from 5 ppm to 1%, such as from 5 ppm to 200 ppm, such as from 10 ppm to 100 ppm, such as about 40 ppm of at least one phenolic diterpene relative to the final weight of the product; ascorbic acid is added to the product in order to provide a final concentration in the product of from 10 ppm to 1%, such as from 50 ppm to 500 ppm, such as from 100 to 200 ppm, such as 110 ppm relative to the final weight of the product; and acetic acid is added to the product in order to provide a final concentration in the product of from 10 ppm to 1%, such as from 100 ppm to 1000 ppm, such as 500 ppm in relation to the final weight of the product.

[0202] In certain forms, the meat product is essentially free of nitrite and nitrate.

[0203] In certain forms, the meat product has less than 250 ppm of nitrite and / or nitrate.

[0204] Essentially free of nitrite and nitrate means in the present invention that no external source of nitrite and / or nitrate is added to the final product. For example, the final product preferably has less than 100 ppm, such as less than 50 ppm, such as less than 10 ppm, such as less than 5 ppm of nitrite and / or nitrate, such as 0 ppm, capable of controlling microbial growth and providing a red or pink color to a meat product that is stable to heat and / or low pH.

[0205] In certain modalities, the ratio between component (I) and Petition 870250091620, dated 07 / 10 / 2025, p. 57 / 95 52 / 68 (II) is within the range of 1:4 to 2:5.

[0206] In certain embodiments, the curing aid is added to the product (such as a meat product) in an amount ranging from 0.2% to 1% by weight, such as 0.5% by weight.

[0207] In certain embodiments, microbial growth control includes preventing and / or inhibiting Clostridium growth, preventing and / or inhibiting Clostridium sporulation, preventing and / or inhibiting Clostridium spore germination, and / or preventing and / or inhibiting Clostridium toxin production in a product, and preventing and / or inhibiting Listeria monocytogenes growth. KIT II

[0208] The present invention also relates to a kit comprising the different elements of the healing aid composition of the invention separately, that is, component (I) and component (II) as previously described in the present invention, and optionally instructions on how to mix, prepare and / or use said ingredients. In certain embodiments, the kit comprises the elements already mixed and ready for use (e.g., as a mixture) and optionally instructions on how to use said ingredients. In certain embodiments, the kit comprises other colors, such as yellow or red colors. Method for manufacturing a meat product

[0209] The present invention also relates to a method for manufacturing a consumable product (such as a meat product) comprising the steps of adding a stabilized colorant composition of the invention to a consumable (such as a meat product) in an amount capable of imparting a red or pink color to the meat product that is stable to heat and / or low pH.

[0210] The present invention also relates to a method for manufacturing a consumable product (such as a meat product) with Petition 870250091620, dated 07 / 10 / 2025, page 58 / 95 53 / 68 comprising the steps of adding a curing aid composition according to the invention to a consumable (such as a meat product) in an amount capable of controlling microbial growth and imparting a red or pink color to the meat product that is stable to heat and / or low pH.

[0211] The curing aid composition of the invention can be added as a ready-to-use mixture or as separate elements of the curing aid composition of the invention (such as the elements of the invention kit)

[0212] The consumable product or food product (such as a food or beverage), packaged or not, of the present invention may be essentially free of nitrite and nitrate. In certain embodiments, the concentration of nitrite and nitrate salts in the product (such as a food or beverage), packaged or not, of the present invention is preferably less than 250 ppm, more preferably less than 200 ppm, even more preferably less than 150 ppm, and most preferably 0 ppm.

[0213] In certain forms, the meat product is essentially free of nitrite and nitrate.

[0214] In certain forms, the meat product has less than 250 ppm of nitrite and / or nitrate

[0215] In the present invention, the food can be cooked.

[0216] In certain forms, the meat product is a cooked meat product, such as cooked ham or sausages (hot dogs).

[0217] It is evident to a person skilled in the art that any other food-grade products used for the preparation of said meat products may be used. For example, in the case of cooked ham, other products such as salts and polyphosphates may be used.

[0218] In certain forms, the food product may have been Petition 870250091620, dated 07 / 10 / 2025, page 59 / 95 54 / 68 subjected to a temperature of 40°C or higher for at least 10 minutes. The food product may have been subjected to a constant temperature for at least 10 minutes, or at least 1 hour, at least 10 hours, at least 20 hours; or it may be subjected to increasing temperatures for varying periods of time. For example, the food product may be subjected to a temperature of 50°C for 20 min, then to 55°C for about 10 min, then to 74°C for about 23 min and finally cooled to 10°C for 5 min. The relative humidity during the heating process may range from about 10% relative humidity to about 99% relative humidity.In a preferred embodiment, the food product (such as emulsified sausages like Frankfurter or hot dogs, cervelas, etc.) can be subjected to a temperature of about 50°C for about 20 minutes (at a relative humidity of 99%), then 55°C for about 10 minutes, 74°C for about 23 minutes, and finally cooled to 10°C for 5 minutes (at a relative humidity of 10%). In another embodiment, the temperature can be 80°C and the heating time can be up to 15 to 16 hours (such as for cooked ham).

[0219] Typically, the food product may have a fat content from about 1% to about 60%, or from 5% to about 50% by weight of the product, such as from about 10% to about 40% by weight or from about 20% to about 30%.

[0220] Typically, food products can have a pH ranging from about 4 to about 10, or from about 5 to about 8, or from about 6 to about 7, such as about 6.5. pH is measured by routine techniques, such as a pH meter.

[0221] The product (such as a food or beverage), packaged or not, may have a pH in a range of about 4.6 to about 8.5, such as 5.8 to about 6.2. The product (such as a food or beverage), Petition 870250091620, dated 07 / 10 / 2025, p. 60 / 95 55 / 68, whether packaged or not, may have a salt content of less than approximately 5.0% by weight.

[0222] The product (such as food or drink), packaged or not, may have a pH in a range of about 3 to about 6, such as 4.5 to about 5.5. Color evaluation

[0223] The color compositions and food products of the present invention can be analyzed with a spectrophotometer, and the CIELAB L*a*b* values ​​can be calculated from the spectral data, as described in more detail below. The L*a*b* values ​​provide a means of representing the color characteristics and evaluating the magnitude of the difference between two colors. The L*a*b* values ​​also provide a means of representing the color characteristics and evaluating the magnitude of the difference between two colors not only of solutions, but also of products. Measurements of color compositions and products in solid form are performed using measurements of the product surface reflectance.

[0224] For example, the L*a*b* values ​​consist of a set of coordinate values ​​defined in a three-dimensional Cartesian coordinate system. L* is the lightness coordinate and provides a lightness scale from black (0 L* units) to white (100 L* units) on a vertical axis. a* and b* are coordinates related to both hue and chroma. a* provides a scale for green (-a* units) to red (+a* units), with neutral at the midpoint (0 a* units), on a horizontal axis; b* provides a scale for blue (-b* units) to yellow (+b* units), with neutral at the midpoint (0 b* units), on a second horizontal axis perpendicular to the first horizontal axis. The three axes intersect where L* has a value of 50 and a* and b* are both zero.

[0225] Δε is a measure of the magnitude of the total color difference Petition 870250091620, dated 07 / 10 / 2025, p. 61 / 95 56 / 68 between two colors represented in the CIELAB L*a*b* color space. It has been reported that an experienced color observer cannot distinguish any difference between two colors when ΔE is about 2.3 or less. The ΔE of two different colors with the values ​​L*a*b*, L*ia*ib*ie Ubabbb, is calculated using Equation 1: ΔEα / = Equation 1

[0226] The present invention is further illustrated by the following non-limiting examples. EXAMPLES Example 1 Materials and methods: • High-concentration Beetroot Extract (water-soluble powder, WSP): The extract was prepared by aqueous extraction, then purified by adsorption-desorption column, sterilized and spray-dried; the final betanin content is greater than 15%. • Market-grade beetroot: standard market-grade beetroot was used to compare the performance of the new formulation; this market reference has (4.8-5.2% betanin) and ascorbic acid. • Citric acid (water-soluble powder, WSP): Citric acid monohydrate was used in the current formulation (citric acid content >99.5%) • Ascorbic acid (water-soluble powder, WSP): Ascorbic acid was used in the current formulation (ascorbic acid content >99%) • Sodium citrate (water-soluble powder, WSP): Sodium citrate dihydrate was used in our formulation (purity >99%) Formulation 1: Stable liquid formulation of red beet: The ingredients in Table 1 were mixed for 20 min under stirring. Ingredients Petition 870250091620, dated 07 / 10 / 2025, page 62 / 95 57 / 68 (Beetroot, 15% betanin) 5% Ascorbic acid 20% Citric acid 2% Water 68.88% Potassium sorbate 0.12% Sodium citrate 4% Total 100% Table 1. Formulation 2: Stable red beet powder formulation The formulation was prepared by simply mixing powders; the composition is detailed in Table 2: Ingredients: % Beetroot, 15% Betanin, 16% Maltodextrin, 5% Ascorbic acid, 61% Citric acid, 6% Sodium citrate, 12% Table 2. Ingredients % Flour 31.2 Sugar 22 Oil 10 Milk 20.8 Powdered fiber 1 Eggs 16.67 Table 3. Application in baking: Cupcake recipe Example 1: Improvement of betanin retention after heat treatment in a pH 6 model buffer system. Sample 1A: 0.1 g of formulation 1 was dissolved in 100 ml of buffer. Petition 870250091620, dated 07 / 10 / 2025, page 63 / 95 58 / 68 phosphate pH 6, Sample 1B (control): 0.16 g of commercial red beet formulation (stabilized with ascorbic acid) was dissolved in 100 ml of phosphate buffer pH 6.

[0227] Samples 1A and 1B (control) were heated to 70°C for min. The initial color of the samples was recorded before and after heating.

[0228] As shown in Figure 1, formulation 1A showed a lower dE2000 (color deviation), suggesting that formulation 1A allowed for better betanin retention. Example 2: Improving thermal stability in baking applications - Synergistic effect of ascorbic acid, citric acid, and sodium citrate:

[0229] In order to investigate the impact of different stabilizers, heat stability was evaluated using the different ingredients separately, according to Table 4: Example 2A 2B 2C 2D 2E 2F Control Composition: 0.1028 g red beet extract (15% betanin) 0.1028 g red beet (15%) + 0.4 g ascorbic acid 0.1028 g red beet (15%) + 0.04 g citric acid 0.1028 g red beet (15%) + 0.08 g sodium citrate 0.32 g commercial red beet stabilized with ascorbic acid Formulation 1 Dosage in baking (%) 0.1028 0.4 0.04 0.08 0.32 2 E(1%) 182.63 182.63 182.63 182.63 58.26 9.39 Table 4. Petition 870250091620, dated 07 / 10 / 2025, page 64 / 95 59 / 68

[0230] Different formulations were used to color baking dough, then the cakes were baked at 170°C for 20 min.

[0231] Both the initial Lab values ​​of the cake masses and L, a, b after baking were recorded. Table 5 shows the color evolution before and after baking. Petition 870250091620, dated 07 / 10 / 2025, pp. 65 / 95 samples L*(D65) a*(D65) b*(D65) C*(D65) h(D65) dL*(D65) dC*(D65) dH*(D65) dE00(D65) 2A-NH 35.44 35.23 4.76 35.55 7.69 — — — 2A-170 °C-20 min 57.45 26.12 48.8 55.35 61.84 22.01 19.8 40.38 34.74 2B - NH 35.68 37.09 5.34 37.47 8.2 — — — 2B-170 °C-20 min 45.77 40.3 28.76 49.51 35.51 10.1 12.04 20.34 16.05 2C - NH 35.47 35.77 5.21 36.15 8.29 — — — 2C-170 °C-20 min 52.09 33.78 38.15 50.96 48.48 16.62 14.81 29.49 25.09 2D - NH 35.18 35.05 4.71 35.36 7.65 — — — 2D-170 °C-20 min 56.74 26.91 44.51 52.01 58.84 21.56 16.65 37.06 32.66 2E - NH 34.72 34.48 5.14 34.87 8.47 — — — 2E-170 °C-20 min 53.21 29.38 41.38 50.75 54.63 18.49 15.89 32.98 28.37 2F - NH 35.73 37.44 6.75 38.04 10.22 — — — 2F-170 °C-20 min 41.68 42.58 23.18 48.49 28.57 5.95 10.44 13.7 10.46 60 / 68 Table 5: NH: Samples without heating. Petition 870250091620, dated 07 / 10 / 2025, page 66 / 95 61 / 68

[0232] As shown in Table 5, 2F (Inventive Formulation) 1) showed a more intense red color expression after cooking compared to the other control samples. This proves that formulation 1 (2F) allows for good retention of the color provided by betanin. This result is also emphasized by the dE2000 values, since sample 2F has the smallest color deviation in relation to the unbaked doughs (see figure 2). Example 3: Synergistic effect of ascorbic acid, citric acid, and sodium citrate on the stability of betanin in a model pH 6 buffer system.

[0233] In order to investigate the impact of different stabilizers, thermal stability was evaluated using the different ingredients separately according to the table below: Example 3A 3B 3C 3D 3E 3F Composition - 0.1 g of Formulation 1 - 99.9 g of phosphate buffer PH6 - 0.005 g of red beet (15% betanin) - 99.9 g of phosphate buffer PH6 - 0.005 g of red beet (15%) - 0.02 g of ascorbic acid - 99.97 g of phosphate buffer PH6 - 0.005 g of red beet (15%) - 0.002 g of citric acid - 99.93 g of phosphate buffer PH6 - 0.005 g of red beet (15%) - 0.004 g of sodium citrate - 99.91 g of phosphate buffer PH6 - 0.02 g of commercial red beet (5% betanin) - 0.004 g of sodium citrate - 99.91 g of phosphate buffer pH 6 Table 6.

[0234] As shown in Table 6, 2F (Inventive Formulation) 1) exhibited a more intense red color expression after cooking, suggesting that Inventive Formulation 1 allows for good Petition 870250091620, dated 07 / 10 / 2025, page 67 / 95 62 / 68 betanin retention. This result is also emphasized by the dE2000 values: sample 2F has the smallest color deviation compared to the unbaked doughs.

[0235] Different samples were subjected to thermal stress at 70°C for 30 min

[0236] The initial absorbance was recorded at the wavelength of maximum absorption and the absorbance was measured after heating; the color retention is given by this equation: R = A (after heating) * 100 Before heating (t0)

[0237] As can be seen in figure 3, the inventive formulation (3A) exhibited the highest percentage of betanin retention due to the greater stability of this formulation, this finding suggests that there is an unexpected synergistic effect between ascorbic acid, citric acid and sodium citrate, making the stabilization of betanin more effective. Example 4: Improved betanin regeneration after heat treatment in a pH 6 buffer model system.

[0238] In order to study the improvement of betanin regeneration after heat treatment, the impact of different stabilizers used in the previous example was selected (table 6). Example 4A 4B 4C 4D 4E 4F Composition - 0.1 g of Formulation 1 - 99.9 g of phosphate buffer Ph6 - 0.005 g of beetroot (15% betanin) - 99.9 g of phosphate buffer Ph6 - 0.005 g of beetroot (15%) - 0.02 g of ascorbic acid - 99.97 g of buffer - 0.005 g of beetroot (15%) - 0.002 g of ascorbic acid - 99.93 g of buffer - 0.005 g of beetroot (15%) - 0.004 g of sodium citrate - 99.91 g of buffer - 0.02 g of commercial beetroot (5% betanin) - 0.004 g of sodium citrate Petition 870250091620, dated 07 / 10 / 2025, page 68 / 95 63 / 68 PH6 phosphate bread PH6 phosphate bread PH6 - 99.91 g of tam- PH6 phosphate bread Table 7. Different heated samples from examples 3 stored at 4°C for 12 hours. Betanin regeneration was calculated using this equation: R = A (after 12h at 40C) * 100 After heating (example 3)

[0239] Figure 4 shows the color regeneration in the sample with the inventive formulation compared to other formulations using ascorbic acid, citric acid, and sodium citrate separately. Surprisingly, sample 4A showed the greatest pigment regeneration, suggesting, without relying on any theory, that the new formulation accelerated the condensation kinetics of betalamic acid and cyclodopa-So-glucoside. Example 5: Enhanced performance of stabilized beetroot in cooked and fried (snack) matrix. Table 8. Formulation 2. Stable red beet powder formulation Ingredients: Beetroot, 15% betanin, 16% maltodextrin, 5% ascorbic acid, 61% citric acid, 6% sodium citrate. Table 8. Formulation 2. Stable red beet powder formulation Petition 870250091620, dated 07 / 10 / 2025, page 69 / 95 64 / 68 - Recipe for use in a snack:

[0240] The base was prepared using 50% corn semolina + 50% water (adjusted to pH 7 with sodium bicarbonate), the dye (red beet) is first diluted in a small amount of water and then added to the base.

[0241] The base was baked at 120°C for 40 min, extrusion and pressurization could also be used instead (parameter: T: 125°C 30 min)

[0242] The extruded or cooked base is then fried at 200 °C for min.

[0243] Formulation 2 was incorporated into the snack recipe (described above in the materials section) at a dose level of 1%. The mixture was cooked at 120 °C for 40 min and then fried at 200 °C for 1 min.

[0244] Surprisingly, the red color hue of formulation 2 was maintained after this strong thermal processing, which shows the improved heat resistance of our new formulation (figure 5). Example 6: Enhanced performance of beetroot stabilized on an extruded protein base. Recipe and high-moisture extrusion process • Recipe: Protein base: ADM Arcon SM Soy Protein Powder • Base formulation: 37% Soy Protein + 63% Water • Colorants added to the base formulation • Extrusion device: Bühler 30 mm pilot-scale extruder (BCTM) • Thermal processing: 3 tests were performed at 140°C, 150°C and 160°C Ingredients: Beetroot, 15% betanin 16 Petition 870250091620, dated 07 / 10 / 2025, pp. 70 / 95 65 / 68 Maltodextrin 5%, Ascorbic acid 61%, Citric acid 6%, Sodium citrate 12% Table 9: Formulation 2 (stabilized beetroot) Sample 6A: Formulation 2 was incorporated at 1% into the protein base, as described below, and extruded at 3 different temperatures: 140°C, 150°C, and 160°C. The L,a,b values ​​were recorded after extrusion to evaluate color retention. Sample 6B: Market beetroot was incorporated at 0.5% (betanin content equivalent to 1% of formulation 2) into the protein base, as described below, and extruded at 3 different temperatures: 140°C, 150°C, and 160°C.

[0245] As shown in Table 10 below, the values ​​of a after extrusion for all temperatures show that the new stable beet (6A) is redder (higher a values) than 6B (standard beet). This demonstrates better stability, even when extruded at high temperatures. This result is also highlighted in Figure 6 (photos of extruded samples 6A formulation of the invention and 6B - standard beet). L samples 6A-160°C 38.55 26.18 16.19 6B-160°C 41.85 18.81 20.81 Table 10. Example 7. Cooked ham a. Brine preparation. Petition 870250091620, dated 07 / 10 / 2025, page 71 / 95 66 / 68

[0246] The brine is prepared with tap water at room temperature, following the composition (see table 10). Ingredients % of brine composition Amount in final meat product Salt NaCl 19.8% 18 g / kg Sugar (Dextrose) 5.5% 5 g / kg Erythorbate, sodium or potassium ascorbate 0.55% 0.5 g / kg Polyphosphates S98 2.8% 3.6 g / kg Water 74.15% Table 11. Brine composition

[0247] When extracts are added to brine, they are first incorporated into the water before the other ingredients are added. The composition of the tested mixture is shown in Table 12. Name Specifications Target active ingredient in the mixture (%) Active ingredients in meat when dosed at 0.5% (%) Amount required in the mixture (%) Buffered vinegar Acetic acid 10.0-12.0% HPLC 10 0.0500 35.21 Sage extract Carnosic acid + Carnosol 0.80-1.50% - HPLC 0.9 0.0045 2.82 Acerola powder Ascorbic acid 2.0-3.0% - HPLC 2.5 0.0125 7.54 Gum arabic 54.43 Table 12. Composition of the preservation block Ingredients: Beetroot, 5% betanin, 20g Maltodextrin Petition 870250091620, dated 07 / 10 / 2025, page 72 / 95 67 / 68 Ascorbic acid 60 Citric acid 6 Sodium citrate 12 Table 13. Formulation 3: Stable red beet powder formulation for application in meat.

[0248] The preservation block will be used between 0.3-1.0% in meat products, especially at 0.5 or 0.75%.

[0249] The color block (Formulation 3 as defined in the table) 13) will be used between 0.1-0.5% in meat products, especially at 0.17%. b. Process of cooked ham.

[0250] The standard process for preparing cooked ham was followed. After a massaging step, the meat samples are injected with brine between 10% and 20% (15%). Turning was carried out following the sequence below: - 15-25 min at 5-9 rpm under vacuum or without vacuum (17.5 min at 7 rpm without vacuum) - 16 hours alternating = 5 min of rotation at 7 rpm / 15 min of rest - 14 hours alternating = 5 min of rotation at 8 rpm / 15 min of rest

[0251] The muscles were placed together in a net and molded under vacuum before the cooking and cooling steps. Temperature limit of 2 h 50°C, then 1 h 30 min at 60°C and finally 66°C to 64.5°C at the core. After the cooling steps, the cooked hams were sliced ​​and stored in modified atmosphere packaging N2 / CO2 80 / 20 or 70 / 30 v / v at 4°C to 8°C. c. Color measurements.

[0252] After 10 days, each package of cooked ham was opened. Color measurements were performed in triplicate immediately after opening and after 4 h of exposure to room temperature.

[0253] The letters L*, a* and b* represent each of the three values Petition 870250091620, dated 07 / 10 / 2025, page 73 / 95 The 68 / 68 color space that CIELAB uses to measure objective color and calculate color differences. L* represents the lightness from black to white on a scale of zero to 100, while a* and b* represent chromaticity without specific numerical limits. Negative a* corresponds to green, positive a* corresponds to red, negative b* corresponds to blue, and positive b* corresponds to yellow. d. Results of Example 7.

[0254] Color measurements of cooked ham immediately after opening. L* is shown in figure 7, a* is shown in figure 8, b* is shown in figure 9. Petition 870250091620, dated 07 / 10 / 2025, p. 74 / 95

Claims

1 / 4 CLAIMS 1. Dye composition comprising components A) and B), characterized in that A) is one or more dyes comprising a Betalain, especially a betanin, and B) comprises one or more of citric acid, ascorbic acid, malic acid and ethylenediaminetetraacetic acid, and at least one salt.

2. A composition according to any of the preceding claims, characterized in that the betalain is selected from a betacyanin, such as a betanin, an isobetanin, a probetanin, and a neobetanin; or a betaxanthin, such as a vulgaxanthin, a miraxanthin, portulaxanthin, and indicaxanthin, and combinations thereof.

3. Composition according to any of the preceding claims, characterized in that A) it comprises one or more plant extracts and / or plant concentrates obtained or obtainable from one or more of: beetroot roots (Beta vulgaris L.), amaranth (Amarathus sp.), pitaya, Opuntia sp., Eulychnia sp. and Hylocereus sp., red-fleshed pitaya Hylocereus polyrhizus, colored chard (B. vulgaris L. ssp. cicla), Celosia argentea L., Bougainvillea sp. ulluco (Ullucus tuberosus Caldas) or blood berries (Rivina humilis L. berries) and / or pigments produced by microorganisms, such as bacteria, fungi or yeast.

4. Composition according to any of the preceding claims, characterized in that at least one salt is selected from a salt of citric acid, ascorbic acid, malic acid and ethylenediaminetetraacetic acid or mixtures thereof.

5. Composition according to any of the preceding claims, characterized in that the acid is citric acid and ascorbic acid. Petition 870250091620, dated 07 / 10 / 2025, page 75 / 95 2 / 4 6. Composition according to any of the preceding claims, characterized in that at least one salt is selected from citrate salts (such as potassium citrate, potassium-sodium citrate and potassium-magnesium citrate), ascorbate salts (such as sodium ascorbate, calcium ascorbate, potassium ascorbate, magnesium ascorbate) or mixtures thereof.

7. Composition according to any of the preceding claims, characterized in that the weight ratio of betalains to component B is from about 0.05:50 to about 50:0.1, such as from about 1:30 to about 30:1, such as about 1:

30.

8. Composition according to any of the preceding claims, characterized in that if 2 acids are used (such as citric acid and ascorbic acid) the weight ratio of the first acid to the second acid is from about 1:30 to about 30:1, such as from about 1:25 to about 25:1, such as about 1:

20.

9. Composition according to any of the preceding claims, characterized in that the weight ratio of one or more acids (such as citric acid and ascorbic acid) to at least one salt is from about 1:10 to about 10:1, such as from about 1:5:5:1, such as from about 1:2 to about 2:1, such as about 1:

2.

10. Composition according to any of the preceding claims, characterized in that B is citric acid, ascorbic acid and sodium citrate.

11. Composition according to claim 10, characterized in that the weight ratio between citric acid, ascorbic acid and sodium citrate is 1:2:10 12. Composition according to any of the preceding claims, characterized by the fact that it is heat stable. Petition 870250091620, dated 07 / 10 / 2025, page 76 / 95 3 / 4 13. Composition according to any of the preceding claims, characterized in that it further comprises (II) one or more antioxidants and / or one or more antimicrobials.

14. Composition according to claim 13, characterized in that the antioxidant and / or antimicrobial is selected from one or more of the following: Lamiaceae extract (such as rosemary extract, sage extract), ascorbic acid (such as ascorbic acid from acerola, especially acerola juice or dehydrated acerola juice), acetic acid (such as vinegar), green tea, organic acids, yeast extracts, pomegranate extract, artichoke extract, olive extract, green coffee extract.

15. Composition according to claim 13 or 14, characterized in that the antioxidant and / or antimicrobial is selected from a Lamiaceae extract (such as rosemary extract and / or sage extract), acerola juice or dehydrated juice comprising ascorbic acid and vinegar.

16. Method for obtaining a thermally stable dye comprising betalains, especially betanin, characterized in that it comprises the steps of: i. providing one or more dyes comprising a betalain, especially a betanin; ii. providing one or more of citric acid, ascorbic acid, malic acid and / or ethylenediaminetetraacetic acid, and at least one salt, especially a salt of one or more of said acids; iii. mixing the ingredients.

17. Stabilized dye, characterized in that it comprises betalains, especially betanin, obtained by the method defined in claim 16.

18. Dye composition according to any one of claims 1 to 15 or dye according to claim 17, characterized in that it is stable after a heating process.

19. A consumable, pharmaceutical, cosmeceutical, nutraceutical, or cosmetic product, characterized in that it comprises a composition as defined in any one of claims 1 to 15, 17, and 18.

20. A consumable, pharmaceutical, cosmeceutical, nutraceutical, or cosmetic product according to claim 19, characterized in that the product is treated with a heating process and the color provided by the dye composition is stable after said heating process.

21. A consumable, pharmaceutical, cosmeceutical, nutraceutical, or cosmetic product according to claim 20, characterized in that the heating process is selected from one or more of an extrusion process, a cooking process, a baking process, a pressurization process, a frying process, etc.

22. Consumable according to any one of claims 19 to 21, characterized in that it is selected from cooked meat products, such as cooked ham or sausages (hot dogs), sweets, cakes, biscuits.

23. Method for manufacturing a nitrite-free meat product having the properties of a meat product that has been cured with nitrites, characterized in that it comprises the step of adding a colorant composition, as defined in any one of claims 1 to 15, optionally without the addition of nitrite and / or nitrate. Petition 870250091620, dated 10 / 07 / 2025, pp. 78 / 95

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