NZ615307B2 - Nutritional compositions and uses thereof - Google Patents

Abstract

Described is a composition comprising: (i) an unstable material, wherein the material is an edible oil or other material susceptible to oxidation; (ii) an octenylsuccinyl anhydride-modified starch present in an amount between about 0.5% and 10% of the total weight of the composition; (iii) at least two sources of reducing sugars wherein the first source of reducing sugars has a dextrose equivalent value between 20 and 60, and the second source of reducing sugars has a dextrose equivalent value between 0 and 20. st two sources of reducing sugars wherein the first source of reducing sugars has a dextrose equivalent value between 20 and 60, and the second source of reducing sugars has a dextrose equivalent value between 0 and 20.

Description

Nutritional compositions and uses thereof Technical Field The present invention broadly relates to nutritional itions comprising unstable materials and the use thereof in food products. More Specifically, the invention relates to compositions comprising edible oils, in particular fatty acid-containing oils, and 7 the 'use thereof in the preparation of food ts such as infant formula.

Background of the Invention . The stabilisation of sensitive ents within ts that are susceptible d'egradation'1n the product's storage environment is ofparticularimportancein a number of fields, and in particular the food industry. f ' 'It is well known that long-chain polyunsaturated fatty acids are an important component of the human diet and that many people fail to consume an adequate amount of these compounds, and in particular docosahexaenoic acid (DHA), eicosapentaenoic acid acid (DPA). Because DHA 'is a major lipid present in the . (EPA) and docosapentaenoic brain with specific structural and functional roles'in neurological developnient adequate consumption ofDHA'is critical for infants, andin particular pre-term infants.

Long-chain saturated fatty acids comprise multiple double bonds in the arbon chain rendering sceptible to ion and also compounds that react with carbon-carbon double bonds. Accordingly, long-chain polyunsaturated fatty acids comprised in ional products are often stabilised by encapsulation. Materials used for encapsulation have included proteins, such as caseinate$ and whey protein concentrates.

However, because of the ility of allergic reactions in a-large cross section of the population such materials are unacceptable.

Emulsifying starches such as octenylsuccinic anhydride-modified starch in combinationwith carbohydrates offer a useful alternative for stabilisation of hain polyunsauirated fatty acids. However, in the context of infant formula the maximum amount of octenylsucclnic anhydride-modified starch mandated by the relevant standards (CODEX STAN 074-1981; REV. 1-2006) is such that the stabilisation of_a beneficial amount of long-chain saturated. fatty acids is ible.

- Surprisingly, the present inventors have discovered that beneficial amounts of long- - chain saturated fatty acids may be stabilised'using amounts of. octenylsuccinic anhydride-modified starch that comply with "the relevant standards relating to infant y of the invention In a first aspect, the present invention provides a composition comprising: (i) an unstable material; (ii) an‘oetenylsuccirfic anhydride-modified starch; (iii) at least one source of reducing value sugars having a dextrose equivalent between about 0 and 100 i The composition may be in the form of a .

The composition may be a spray-dried powder.

The composition may be in the formofan emulsion.

The unstable materialmay be a material that is susceptible to oxidation.

The unstable al may be an edible oil.

The edible " oil may comprise one or" more long-chain polyunsaturated fatty acids (LCPUFAs).

’Ihe edible oil may comprise one or more 3 fatty acids and/or one or more omega-6 fatty acids.

The edible oil may comprise DHA and ara'chadonic acid (AA).

The DHA and AA may comprise between about 10% and 70% by weight ofthe total . edible oil present in the composition.

The at least one source of reducing sugars may have a dextrose equivalent value between about 0 and 30, or between about 0 and 20, or between about 0 and 10, or between about 5 and 15.

The composition may compriseat least two sources of reducing sugars, n a first source of reducing sugars has a dextrose equivalent. yalue beMeen'O and 80, and a . second source of reducing sugars has a dextrose equivalent value between 0 and 30.

The composition may comprise at least two sources of reducing sugars, wherein a ’ first scarce of reducing sugars has a dextrose equivalent value between 20 and 60, and a second source of reducing sugars has a dextrose equivalent value between 0 and 20. - The composition may se at least tWO sources of reducing sugars, wherein a first source of. ng sugars has a se equivalent value betWeen 20 and 40, and a W0 2012/106777 second source of reducing sugars has a dextrose equivalent value between 0 and 15.

The composition may comprise at least two sources of reducing sugars, wherein a first source of reducing sugars has a dextrose equivalent value between 25 and 35, and a second source of reducing sugars has a dextrose equivalent value between 5 and 15.

The composition may comprise at least two sources of ng sugars, wherein a first source of reducing sugars has a dextrose equivalent value of about 30, and a second source of reducing sugars has a dextrose equivalent value of about 10; The first source of reducing sugars and the second source of ng sugars may be present in a ratio between about 1:1 and 1:10, orbetween about 1:1 and 1.8 or between about [:1 and about 1:6, or between about 1: l and 1:,4 by weight.

The at least one source of reducing sugars may be corn syrup solids.

The composition may further comprise one or more antioxidants.

The composition may further comprise a low. molecular weight emulsifier.

The octenylsuccinic ide-modified starch may be present in an amount of less than 18% of the total weight of the composition, or in an amount-between about 1% and I %, or in an amount n about'l% and 6%, ofthe total weight ofthe composition.

The unstable material may be present in an amount between about 0.1% and 80% of . the total weight ofthe composition, or in an amount between about 0.5% and 35% of the total weight of the composition, or in an amount between about 5% and 35% of the total weight of the composition. _ _ The source(s) of reducing sugars may be present in an aniount between about 10% and 80% ofthe total weight ofthe composition.

The composition may be free ofmannitol.

In a second aspect, the present invention provides use of the composition'of the first aspect in the preparation ofa food t.

In a third aspect, the present invention es. a' food product . comprising the composition ofthe first aspect.

The food product may be an infant a or a pro-term infam a.

In a . aspect, the present invention pro'vides use of at least one source of reducing sugars having a dextrose lent value between about 0 and 100 in the preparation of a composition comprising one or more long-chain polyunsaturated fatty acids and wherein the amount" . octenylsuccinic anhydride-modified , of octcnylsuccinic anhydride-modified starch as a percentage of the total weight of the composition is less than 18%: i The amount of octenylsuocinic anhydride-modified starch as a percentage ofthe total weight of the composition may be less than 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2% or The long-chain polyunsaturated fatty acids may be DHA and/or AA.

The composition may be an infant formula or a pro-term infant formula.

The composition may be free of mannitol.

In a fifth aspect, the present invention provides a method for preparing an emulsion ition comprising the following steps: preparing an s mixture comprising octenylsuccinic anhydride-modified starch in an amount between about 0.05% and 10% with respect to the total weight of the composition, at least one source of reducing sugars having a dextrose lent value between about 0 and 100 in an amount between about % and 50% with respect to the total weight of the composition, and an oil phase in an amount between about 1% and 30% with respect to the total weight ofthe composition, the oil phase comprising one or more long-chain polyunsaturated fatty acids, and homogenising the mixture so as to provide an emulsion composition. ' The long-chain polyunsaturated fatty acidsmay be DHA and/or AA.~ The composition may comprise betWeen about 20% and 55% water.

The octenylsuccinic anhydride-modifiedstarch may be present in an amount between about 0.5% and 8%, or in an amount n about 1% and 6%, or in an amount between about 1% and 5%, with respect to the total weight‘ofthe composition; The following statements apply to the fourth and filth s.

The at least one source of reducing sugars may have a se lent value between about 0 and 30, or between about 0 and 20, or between about 0 and 10,10r between ' about 5 and 15. > The at least 'one source of reducing sugars may comprise a first source of reducing. sugars having a dextrose equivalent value between 0 and 80, and a second source of reducing 811ng having a dextrose equivalent value betweeno and 30.

The at least one source of ng sugars may comprise a first source of reducing sugars having a dextrose equivalent value between 20 and 60, and a second source of ng sugars having a dextrose equivalent value between 0 and 20.

The at least one source of reducing sugars may comprise a first source of reducing sugars having a dextrose equivalent value between 20 and 40, and a second source of reducing sugars having a dextrose equivalent value between 0 and 15.

The at least one source of reducing sugars may comprise a first source of reducing sugars having a dextrose equivalent value between 25 and 35, and a second source of reducing sugars having a dextrose lent value n 5 and 15.

The at least one source of reducing sugars may comprise a first source of reducing sugars having a dextrose equivalent value of about 30, and a second source of reducing sugars having a dextrose equivalent value of about 10.

The first source of reducing sugars and the second source of reducing sugars may be present in a ratio between about 1:1 and 1:10, or between about 1:1 and 1:8, or between about 1:1 and about 1:6, or between about 1:1 and 1:4, or between about 1:2 and 1:6, by weight.

A further aspect of the present invention provides a composition comprising: (i) an le al, wherein said material is an edible oil or other material tible to oxidation; (ii) an octenylsuccinyl anhydride-modified starch t in an amount between about 0.5% and 10% of the total weight of the composition; (iii) at least two sources of reducing sugars wherein the first source of reducing sugars has a dextrose equivalent value between 20 and 60, and the second source of reducing sugars has a dextrose lent value between 0 and 20.

Brief Description of the s A preferred embodiment of the present invention will now be described, by way of example only, with reference to the accompanying gs wherein: Figure 1 shows the cross section of tangents to the time-pressure Oxipres curve corresponding to the induction period.

Figures 2 and 3 show the induction periods of microcapsules comprising LCPUFAs in accordance with the invention at 80 °C and 70 °C respectively.

Definitions The following are some definitions that may be helpful in understanding the description of the present invention. These are intended as general definitions and should in no way limit the scope of the present invention to those terms alone, but are put forth for a better understanding of the following ption. hout this specification, unless the context requires otherwise, the word ise", or variations such as "comprises" or" comprising", will be understood to imply the inclusion of a stated step or element or integer or group of steps or elements or integers, but not the exclusion of any other step or element or integer or group of elements or 2012/000135 integers. Thus, in the context of this cation, the term "comprising" means "including principally,- but not arily.solely" In the context of this specification, the term "abou " is understood to refer to a range ofnumbers that a person of skill in the art would consider equivalent to the recited value. in the context of achieving the same function or result.

In the context-of this specification, the terms "a" and 'lan" refer to one or to more than one (i.e. to at least one) of the grammatical object 'of the article. Byway of example, ' I "an elemen means. one element or more than one element.

In the centext of this specification, the term ”substantially free ofprotein" means that the amount of protein present in the composition is less than about 0.1%, or less than about - 0.01%.

In the context of this specification, the term "unstable material" is tood to mean that the material to which it refersis susceptible to unwanted change, be it physical or chemical, under particular conditions, for example atmospheric conditions.

In the t of this specification, the term "hypoallergenic" is tood to mean that the composition to which it refershas a decreased likelihood of provoking an allergic- ion in a subject, and/or that the composition is flee, or substantially free, of allergens.

In the context of this specification, the term "edible oil" means a non-toxic oil which is ered safe -for‘ consumption by humans. The edible oils may be liquids at a temperature of25 °C and atmospheric pressure. I In the context of this specification, the term "free-flowing powder" means a' particulate material that'IS capable of being poured without agglomeration or adherence to contact surfaces.

In the context of this specification, the term "low molecular weight emulsifier" is understood to mean an fying agent having a molecular Weight of 1000 g/mol or less.

In the context of this specification, the term "infant formula" includes‘fonnulas that are intended as breast milk replacements or supplements, and also milk fortifiers, including ‘ ' emulsions. The term "infant a" also encompasses pre-term infant formula.

In the context of this specification, the term "long-chain" is understood to refer to an unsaturated hydrocarbon chain having more than 12 carbon atoms. I' W0 2012/106777 . Detailed Descriptionof the Invention The present invention broadly relates to a ition comprising an unstable al, an octenylsuccinic anhydride-modified starch and at least one source of reducing sugars having a dextrose equivalent value between about 0 and 100.

The compositions of the invention may be'm the form of a powder, and may be obtained by spray drying. In one embodiment, the composition is flowing powder.

The powder may have a mean particle size between about 10 um and 1000 pm, or between about 50 um and 800 pm, or between about 100 um and 300 pm. In ative, embodimentsthe ition may be1n the form of granules.

The unstable material may be part ofa matrix comprising the oetenylsuccinic anhydride-modified starch and the source(s) of one or more reducing sugars and may be ' microencapsulated.

Solid compositions ofthe invention may be water-dispersible.

The compositions of the invention may be in the form of an emulsion, for example a liquid emulsion. The emulsion may be an oil-in-water emulsion or a water-in-oil emulsion.

Preferably the emulsionIS an oil-in-water emulsion.

The compositions may be free or ntially free of protein. The compositions may be free or ntially free .of dairy products. in one embodiment, the compositions are hypoallergenic.

The compositions of the invention comprise one or more le materials. The - unstable al may be present in an amount between about 0.1% and 80% of the total weight of the composition, or in an amount between about 1% and 60%, or in an amount n about 1% and 50%, or in an amount between about 1% and 45%, or in an amount - between about 1% and 40%, or in an amount between about 1% and 35%, or in an amount between about 1% and’30%, or in an amount between about 5% and 50%, or.in an amount between about 5% and 45%, or in an amount between about 5% and 40%, or in an amount between about 5% and 35%, or in an amount between about 10% and 50%, or in an amount between about 10% and 45%, or in an amount between about 10% and 40%, or in an amount between about 10% and 35%, or in an amount between about 15% and 50%, or in an amount between abOut 15% and 45%, or in an amount between about 15% and 40%, - or in an amount between about 15% and 35%, or in an amount between about 20% and 40%, of the total weight of the composition. in one embodiment the le material is a material that is light, heat, air, oxygen 'or moisture sensitive. In an ative embodiment the unstable material is a al that is susceptible to oxidation. The unstable material may be an edible oil. The edible oil may comprise. one or more components that are susceptible to oxidation, for example unsaturated fatty acids such as LCPUFAs.

Edible oils used in. the compositions, uses and methods of the invention may be obtained from natural sources, for example plants, microbes and marine sources. The sources of the edible oils may be genetically modified or non—genetically modified. Edible oils may also be obtained "synthetically. Suitable plant sources include, but are not limited to, d, walnuts, sunflower seeds, canola oil, safflower oil, say, wheat-germ, leafy green plants such as kale, 'spinach- and parsley, and corn oil. Suitable marine sources ' include, but are not limited to, crustaceans such as krill, molluscs such as oysters and fish such as salmon, trout, sardines, tuna, mackerel, sea bass, menhaden, herring, pilchards, , eel or whitebait. Suitable microbe sources include‘algae and fungi. The edible oil may be present in a purified form and/or in the form of an extract from a suitable source. in one embodiment, the edible oil is a fish oil. The fish oil may be obtained from, for exarnple one or more of the ing fish! tuna, salmon, trout, sea bass, menhaden, rds, mackerel, sardines, herring, kipper, eel, whitebait or any other "'fatty fish“.

The edible oil may be~a mixture of oils from different sources, for‘example oil obtained from fish, oil obtained from plants and oil obtained from microbes, such as algae'_ and fimgi. Oil mixtures that rticular application in the compositions of the invention include those sold under the trade names DHASCO® and ARASCO® by Martek Biosciences ation, Maryland, USA, and HiDHA® by Nu-Mega Ingredients, Altona North, Victoria. ' ' The edible oil may comprise, one or more omega-3 fatty acids and/or one or more , 6 fatty acids. In one embodiment, the edible oil comprises DHA and AA. The edible oil may comprise one or more of the following fatty acids: DHA, AA, EP-A, DPA and donic acid (SDA). The edible oil may comprise evening primrose oil. ' Where the compositions of the invention comprise DHA and AA, the DHA and AA may be present in a ratio between l :10 and 10:1, or in a ratio between about 1:5 and :1, or in a ratio between about 2:1 and 1:2, or in a ratio between about 1:l and 1:5, or in a W0 2012/106777 ratio between about 1:1 and 1:4, or me ratio between about 1:1 and 1:3, or in a ratio between about 1:1 and 1:2, or in a ratio ofabout 1:1.

In one embodiment of the inyention, of the total amount of edible oil present in the composition, between about 10% and about §0%, or between about 25% and about 80%, or between about 40% and about 30%, or between about 40% and.about 70%, or n about 10% and about 70%, or between about 10% and about 60%, or between about 10% and about 50%, may be DHA and/or AA.

Whilstit is preferred that the unstable material ses LCPUFAs, those skilled in - the art will appreciate that a range of alternative unstable materials (such as those susceptible to oxidation) may be - included in the itions of "the invention, for example vitamins, minerals, fatty acids, conjugated polyene compounds, probiotics and prebiotics.

. ,. ’ -'Ihe compositions further" comprise an .octenylsuccinic anhydride-modified starch.

The starch may se primary and/or secondary modifications and may be an ester or half ester. Suitable octenylsuccinic anhydride-modified starches include, for example, ' those based on waxy maize and sold under the trade names CAPSUL® IMF and HI CAP® IMF by National Starch and Chemical Pty Ltd, Seven Hills, NSW, Australia. The octenylsuCcinic anhydride-modified starch may be present in an amount of less than about 18%, 17%, 16%, 15%, 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6.5%, 6%, 5.5%, 5%, 4.5%, 4%, 3.5%, 3%, 2.5%, 2% or lessthan 1%, of the total weight of the ”composition.

The octenylsuccinic anhydride-modified starch may be present. in an amount between about 0.005% and 18%, or in an amount between‘about 1% and 18%, or in an amount between about 2% and 18%, or in an amount between % ”and 18%, or inan amount between about 4% and 18%, or in an amount between about 5% and 18%, or in an amount between about 0.005% and 15%, or in an amount between about 0.5% and 10%, or, in” an amount en. about 1% and 10%, o'r'in an amount n about 1% and 9%, or in an amount _ between about 1% and 8%, or in an amount between about 1% and 7%, or in an amount between about 1% and 6%, or in an amount between about 1% and 5%, or in an amount between about 0.1% and 10%, or in an amount n about'0.l% and 8%, or in an amount between abOut 0.1% and 6%, ofthe total weight of the composition. 1 Additional fyingstarches may also be included in the compositions of the invention as desired, depending on the nature of the unstable material.

Thecompositions r comprise at least one source of reducing sugars having a dextrose equivalent value between about 0 and 100. The at least one source of reducing sugars may have a dextrose equivalent value between about 0 and 80, 0 and 70, 0 and 60, 0 and.50, 0 and 40, 0 and 30, 0 and 20, 0 and 10, land 20, 1 and 15, 1 and 10, 5 and 20 or 5’ and 15. In one embodiment ofthe invention, the compositiOns comprise at least one source of reducing sugars having a dextrose equivalent value between 0 and 25, 0 and 20,. 0 and ,0 and 10 or 0 and 5. In other embodiments of the invention, the itions comprise atledst two sources of reducing sugars, wherein a first source of reducing sugars has a ' se equivalent value between 0 and 100, or between 0 and 80, or between 0 and 60, or between 10 and 60, or between 20 and 100, or between 20 and 80, or between 20 and 60, or between 20 and so, or between 20 and .40, or between 25 and 40,43: between 25 and 35, and the sécond source of ng sugars has a dextrose equivalent value between 0 and , or between 0 and 20, or n 0 and 15, or between 5 and 15. In these embodiments,‘ the weight ratio of the first source of reducing sugars to the second source of reducing '-sugars_ may be between about 1:10 and 10:1, or between about 1:6 and 6:1, or. between about 1:5 and 5:1, or_'between abbut 1:1 and 11:10, or between about 1:1 and 1:8, or between about 1:1 and 1:6, or between. about 1:1 and 1:5, or between about 1:1 and 1:4, or between abdut 1:2 and 1:10, orbetween about 1:2 and 1:8, or between about 1:2 and 1:6, or between about 1:2 and 1:5, or between about 1:3 and 1:10, or n about 1:3 and 1: 8, or between about 1:3 and 1:6, or between about 1:4 and 1: 10, or between about 1:4 and l: 8, or between about 1:4 and 1'6, or about 1:.4 In an embodiment of the invention, a first source of ng sugars has a dextrose equivalent value between 20 and 80, and a second source of reduéing sugars has a dextrose equivalent value between 0 and 15, n the first source of reducing sugars and the second source of reducing Sugars are present in a ratio between about 1:1 and 1:10 by . . I In another embodiment of the ion, a first source of reducing sugars has .a dextrose equivalent value between 20_and 50, and a second source of reducing sugars has a , dextrose equivalent value between 0 end 15,-wherein the first source of reducing sugars and the second. source of reducing sugars are present in a ratio between about 1:1 and 1:10 W0 2012/106777 l l? by weight.

In a further ment of the invention, a first source of ng sugars has a- dextrose equivalent value between 25 and 40, and a second source ofreducing sugars has a dextrose equivalent value between 0 and .15, wherein the first source of reducing sugars f and the second source of reducing Sugars are t in a ratio between about 1:1 and '1:6 by weight.

In another embodiment of the invention, a first source of ng sugars has a se lent value between 20 and 40, and a second source ofreducing sugars has a deitttose equivalent value between 5 and 15, wherein the first source of reducing sugars. and the second source of reducing sugars are present in a ratio between about 1:1 and 1:6- by weight.

In still a further embodiment of the invention, a first source of reducing sugars has a dextrose lent value between 25 and 35, and a second source of reducing sugars hasa dextrose equivalent value between 5 and 15, wherein the first source of reducing sugars and the second source of reducing sugars are present in a ratio between about 1:2 and 1:6 by weight. . _ ‘In another embodiment of the invention, a first source of reducing sugars has a- dextrose equivalent value of about 30, and a second source of reducing sugarshas a dextrose equivalent value of about 10, wherein the first source of reducing sugars and the ' second source of reducing sugars are present in a ratio between about 1:2 and 1:6, or about 1:4. i Sources of. ng sugars are well known to those skilled in the art and include monosaccharides and 'disaccharides, for exarnple e, fructose, maltose, ose, . glyceraldeh'yde and lactose. Suitable sources of ' reducing sugars also include I oligosaccharides, I for example glucose polymers, such as dextrin and maltodextrin and glucose syrup solids. The reducing sugars may also be derived from glucose syrup which ' typically contains not less than 20% by weight ofreducing sugars.

The source(s) of reducing sugars may be t in an amount between about 10% and 80% of the total weight of the composition, or in an amount between about 10% and 75%, or. in an amount between about 10% and 70%, or in an amount between about 15% and 70%, or in an amount between about 20% and 70%, or in an amount between about % and 65%, or in an amount between about 25% and-60%, or .in an amount between about 30%.and 55%, or man amount between about 35% and 65%, or in an amount between about 40% and 65%, or in an amount between about 45%. and 65%, or in an amount between about 50% and 65%, or in an amount between about 50% and 60%, of the. total weight of the ition.

The source(s) of reducing sugars and the octenylsuccinic anhydride-modified starch may be t in the compositions in a ratio between about 3:1 and 15:1, or between about 4:1 and 14:1, or between about 4: l and 13:1, or between about 5:1 and 15:1, or between about 7:1 and 15:1, or n about 8:1 and 14:,1 or between about 8:1 and 12:1, or betweenabout 8:1 and 11:1, orbetween about 10:1 and 11:1, by weight. - ‘ In an embodiment of the invention the compositions further comprise one or . more antioxidants. Suitable antioxidants are well known to those d in the art and include, but are not limited to: green tea extract, tocopherols, tocotrienols and ic acid, including salts and derivatives thereof. The compositions may comprise a soluble antioxidant and/or a soluble antioxidant. In one embodiment the compositions comprise an ascorbate salt such as sodium ascorbate, and a ‘ lipid-soluble ascorbate for example a fatty acid ester of ascorbic acid such as ascorbyl palmitate‘. _ derivative, ' The compositions may r comprise’one or more anti-caking agents. Anti-caking agents that are compatible with the compositions of the invention will be well known amongst those skilled in the art and include calcium phosphates, such as tricalcitun phosphate and carbonates, such as calcium and magnesium carbonate and silicon dioxide The compositions of the invention may furthertcomprise one" or more low lar weight emulsifiers. Suitable low molecular weight emulsifiers include, for example, mono- and di- glycerides, lecithin and sorbitan esters. Other suitable low molecular weight emulsifiers will be well known to those skilled in the art. The lowmoleéular weight emulsifier may be present in arr-amount between about 0.1% and 3% of the total weight of the cemposition, or in an amount between about 0.1% and about 2%, or in an amount n about 0. l% and.0.5%, or in an amount n about 011% and 0.3%, of the total weight ofthe composition.

The compositions of the invention may further comprise additional components, for . example flavouring agents, preservatives, colouring agents, chelating agents and the like.

W0 2012/106777 Such additional components are well known t those skilled in the art.

The itionsofthemvention may be free itol.

In one embodiment, the itions oftheinvention comprise: 0 an oil comprising DHA and AA, the . oil being present in an amount between about 10% and 50% by weight of the total weight of the composition; ‘ 0 a first source of ng sugars having a dextrose equivalent value in the range of 20 and 60in an amount between about 5% and 25% by weight of the total weight ofthecomposition; 0 a second source of reducing sugars having a dextrose equivalent value in t the range of 0 and 15 in an amount between about 25% and 70% by weight ofthe total weight ofthe composition; 0 an octenylsuccinic anhydride-modified starch in an amount between about 1% and 18% by weight of the total weight ofthe composition.

The composition may be in the form of a powder, and the first source of reducing sugars and the second source of reducing sugars may bepresent in a ratio between about, 1:1 and 1:10, or between about 11 and 1:,6 or'between about 1:3 and 1.',6 by weight. The DHA and. AA may comprisebetween about 10% and 70% of the oil by weight. The composition may further comprise one or more antioxidants. 1n anbther embodiment, the compositions nvention comprise: - an 011 comprising DHA and AA, the oil being present in an amount between about 1% and 35% by weight of the weight of the I total composition; 0 a first source of reducing sugars having a dextrose equivalent value in the range of 20 and 60in an amount between about 1% and 15% by weight of the total weight ofthe composition; 0 a second source of reducing sugarshaving a dextrose equivalent value in the range of 0 and 15m an amount n about 5% and 25% by weight of the total Weight of the composition; ’ '0 . an octenylsuccinic anhydride-modified starch'in an amount betweenabout . 0.05% and 10% by weight ofthe total weight of the composition.

The composition may be in the form of an emulsion, and the first source ofreducing ' sugars and the second source of reducing sugars may be present in a ratio between about ' 1:1 and 1:10 by weight. The DHA and AA may comprise between about 10% and 70% of the oil by weight. The composition may further comprise one or more antioxidants.

In‘another embodiment, the compositions ofthe invention comprise: 0 an oil comprising DHA and AA, the oil being present in an amount between about 1% and 35%_ by weight of the total weight of the \ i composition; o a first source of reducing sugars having a se equivalent value in the range of 20 and 60 in an'amount between about 1% and 15% by weight of - the total weight of the composition; _o a second source of reducing sugars having a dextrose'equivalent value in the range of0 and 1.5 in an amount bemen about 30% and 45% byweight ofthe total weight ofthe composition; 0 an octenylsuecinic anhydride-modified starch in an amount between about 1% and 5% by weight ofthe total weight of the composition.

The composition may be in the form of an emulsion, and the first source of reducing sugars and the second source of reducing sugars may be present in a ratio n about 1:1 and 1:10 by. weight The DHA and AA may comprise between about 10% and 70% of the oil by weight. The composition mayfurther comprise one or more antioxidants.

In a r embodiment, the compositions ofthe invention comprise: 0 an oil comprising DHA and AA, the oil being present in an amount. between about 20% and 35% by' weight of the total weight of the composition; I 0‘ a first source of reducing sugars having a dextrose-equivalent value in the. - range of 25 and 35 in an amount n about 10% and 15% by weight .» of the total weight ofthe composition; o a second source of ng sugars having a deXtrose equivalent value in the range of 5 and 15 in an amount between about 45% and 55% by weight ofthe total weight ofthe composition; '0 an lsuccinic anhydride-modified starch in an amount between about 3% and 8% by weight of the total weight ofthe ition, wherein the composition is in the form Of a , the DHA and AA comprise , n about 10% and 70% by weight of the oil, and wherein the first source of reducing sugars and the second source of reducing sugars are present in a ratio between about 1:3 ‘ and 1:6 by weight. The composition may further comprise one or more antioxidants.

. In a further embodiment, the compositions ofthe invention comprise: an oil comprising DHA and AA, the oil being present in. an amount between about 1% and 25% by weight of the total 'weight of the ition; a first source of reducing sugars having a dextrose equivalent value in the range of 25 and 35 in an amount between about 5% and 15% by weight of the total weight ofthe composition; ’ a second source of reducing sugars having a dextrose equivalent value1n~ the range of 5 and 10in an amount between about 30% and 40% by weight. of the total weight ofthe composition; an lsuccinic anhydride-modified starch in an amount between about 2% and 8% by weight of the total weight of the composition, n the composition is in the form‘of an emulsion,‘the DHA and AA comprise between about:10% and 70% by weight of the 'oil, and wherein the first source of reducing sugars and the second source of reducing sugars are present in ”a ratio between about 1:3' and l :6 by weight. The composition may further‘comprise one or more antioxidants.

In a thither embodiment, the compositions ofthe invention comprise: an oil comprising DHA and AA, the oil being present in an amount ' between about 28% and 30% .by of the-total weight of the _ weight composition; a first source of reducing sugars having a dextrose equivalent value of about 30 in an amount between about 10% and 15% by weight ofthe total weight ofthe composition; a second source of reducing sugars having a dextrose equivalent value of about 10in an amount between about 45% and 50% by weight ofthe total weight ofthe composition, 0 an octenylsuccinic anhydride-modified starch in an amount between about 3% and 5% by weight ofthe total weight ofthe composition, . n the composition is in the form of a , the DHA'and AA comprise n about 10% and 70% by weight of the oil and wherein the first source of reducing sugars and the second source of reducing sugars are present in a ratio between about 1:3 I. and 1:6 by weight. The composition may fiirthercomprise one or more antioxidants.

The compositions of the invention may be prepared by forming an aqueous mixture comprising the le material (which is typically in the form of an oil), the source(s) of reducing sugars and hoctenylsuceinic anhydride-modified , and drying the mixture, ably by spray drying. More'specificaily, the compositions of the inventionimay be prepared by solubilising the source(s) of reducing sugars and the octenylsuccinic anhydride—modified starch in an aqueous phase using a high shear mixer. The mixture is then heated to a temperature of about 65 °C to 70 °C afier which time one or more antioxidants may be added if desired. The unstable material, such as an edible oil for example, is dosed in-line to the aqueous mixture which is passed through a high shear mixer to form a coarse emulsion. The coarse emulsion is then passed through homogenisation at 240/40 bar. If it is desired to prepare a powdered t the coarse emulsion is rised and spray-dried at an inlet temperature of about '180 °C and an outlet-temperauire of 80 °C. Anti-caking agents may be dosed into the resulting powder ' which is then packaged into barrier packaging under amodified atmosphere of 100% nitrogen; ' In another aspect, the present invention relates to a method for preparing an emulsion composition comprising the following steps: preparing an aqueous e sing octenylsuccinic anhydride—modified starch inan amount between about 0.05% and 10% with respect tothe total weight of the composition, at least one source of reducing sugars having a dextrose lent value between about 0 and 100 in an amount between about % and 50% with respect to the total weight of the composition, and an oil phase in an amount between aboutrl% and 30% with respect to the tbtal weight of the ition, the oil phase comprising one or more long-chain polyunsaturated fatty acids, and - homogenising the mixture so as to provide an emulsion composition.

In this aspect of the invention the source(s) and amounts of reducing sugars may be as defined herein in connection with the compositions of the first aspect. The amount of octenylsuccinic Ianhydride-modified starch. in the emulsion may be as defined. herein in connection with the compositions of the first aspect. 'i’he composition may be free of 'mannitol.

The long-chain polyunsaturated fatty acids may be DHA and/or AA. In one embodiment, the composition may comprise between about 20% and 55% water.

Whilst the compositions of the invention may themselves be consumed, typically the compositions are incorporated into food products. Accordingly, the present ion further relates to the use 'of the compositions of the first aspect in the preparation of a food product, and further to feed products comprising the compositions ofthe first aspect.

Suitable food products include, but are not d to, bakery products,lspreads, salad dressings, beverages, snack bars and the like. In one embodiment, the compositions of the ion are incorporated into infant formula during and/or after the manufacture thereof.

When compositions of the invention comprising DHA and AA are incorporated into infant formula the resulting formula is able to provide ial levels of DHA and AA whilst meeting all t CODEX standards g0verning maxinium s of octenylsuccinic anhydride-modified starch. A suitable infant formula may be prepared as fOIIOWS. Dose 1.33% of a powdered composition of the ion '(for example composition 1 in the Examples below) into an infant formula base. Blend to achieve homogeneity. Reconstitute at a rate of l4g/100mL. The resulting formulation allows delivery ofup to 7 mg DHA and up to 14 mg AA per 100 mL, with the OSA starch level being less than 100 ppm which es with the relevant CODEX rds.

Without wishing to be bound by theory the inventors believe that the ability of the compositions of the invention to e the above noted amounts of DHA and AA in the presence of low levels of octenylsuccinic anhydride-modified starch may be facilitatedby inclusion of at least one source of reducing sugars having a low DE value.

Accordingly,‘in another aspect the present invention also relates to the use of at least one source of reducing sugars having a se equivalent value between about 0 and 100 in the preparation of a composition comprising one or more long-chain polyunsaturated ' fatty acids and lsuccinic anhydride-modified starch, wherein the amount of octenylsuccinic ide-modified starch as a percentage of the total weight of the composition is less than about 18%. in this aspect of the invention the e(s) and amounts of reducing sugars may be as defined herein in Connection with the itions ofthe first aspect.

The octenylsuccinic anhydrideamodificd starch may be present in an arfiount ofless than about 17%, 16%, 15%,14%, 13%,{12%, 11%, 10%, 9%, 8%, 7%, 6.5%, 6%, 5.5%, %, 4.5%, 4%, 3.5%, 3%, 2.5%, 2% or less than. 1%, of the total weight of- the composition. The lsuccinic anhydride-modified starch may be present in an amount between about 0.005% and 18%, or in an amount between about_1% and 18%, or in an ' amount between about 2% and 18%, or in an amount between about 3% and 18%, or in an amount between about 4% and 18%, or in an amount n about 5% and 18%, or in an amount between about 0.005% and 15%, or in an amount between about 0.5% and 10%, or .' in an amount between about 1% and 10%, or in an, amount between about 1% and 9%, or in an amount between about 1% and 8%, or in an amount between about 1% and 7%,.or in an amount n about 1% and 6%, or in an amount between about 1%and 5%, or in an amount between about 0.1% and 10%, or in an amount between about 0.1% and 8%, or in an amount between about 0.1% and 6%, of the total weight of the composition. In alternative embodiments, the'amount of octenylsuccinic anhydride-modified starch as a tage of the total weight of the composition may be between about 0.05% and-about .5%, or between about 0.1%.and about 5.5%, or between about 0.5% and. about 5.5%, or between about 1% and about 5%,. or n about 1.5% and about 5%, or between about. 2% and about 5%.

Examples Example 1 - Qommsitions Compositions in accordance with the invention include the following: Composition 1. '— Spray dried hypoallergenic microencapsulated LCPUFA com - osition also referred to hereinafier as RD18-V7-1‘3 1210 ~ Wu Wei t . 29-4 Ronoxan® A (ascorbyl palmitate,'lecithin and 0.03 ’ dl a-Toco therol ' 47-69 11.71 W0 2012/106777 PCT/AUZO12/000135 ‘ CAPSUL® IMF " '~ * Comprises 14.7% ARASCO and 14.7% DHASCO A further composition after referred to 'as Composition 2 (and also RD18-V6- ‘ 131210) was also prepared having the same components as Composition 1, except the oil ‘ phase comprising DHA and AA comprised 19.6% ARASCO and 9.8% DHASCO. ition '3 - Spray driegi hypoallergenic ncapsulated LCPUFA composition (also referretl to hereinafier as RD18-V1-271010) HiDHA® tuna oil ' . Ronoxan® A (ascorbyl palmitate, lecithin and 0.03 d1 oc-Toco herol ' Monomuls 90-35 mono_l. oeride c* MD01960 maltodextrmlo _-EI- —-m- Composition 4 ,- Spray dried lergenic microencapsulat'ed LCPUFA' composition (also referred to hereinafier as RD18-V2-27101'0) HiDHA® tuna oil A . 23.05 Ronoxan® A (ascorbyl palmitate, lecithin and d1 ct-Toco herol .

Monomuls 90-35 mono! ceride ' 0* MDO'1960 maitodextnn 10 Dn'dex 30 maltodextnn 30 “ HI CAP® IMF _.Ei£- Composition 5 - Spray dried hypoallergenic nficroenchpsulated LCPUFA composition (also referred to after as 3-291010) HiDHA® tuna oil 23 08 Ronoxan® A (ascorbyl paImitate, lecithin and' » d1 a-Toco uherol W0 2012/106777 ' 2012/000135 __-_E- _-E_ Composition 6 ' — Spray dried hypoallergenic microencapSIflated LCPUFA composition (also referred to hereinafier as RD18-V4-291010)_'.

HiDI-IA® tuna oil - 20.71 Ronoxan® A (ascorbyl palmitate, lecithin and d1 a-Toco n hero! - Monomuls 90-35 mono] eride 0. ' 92 —__.

—-IE- Composition 7 — Hypoallergenic LCPUFA emulsion composition (also referred to hereinafter as RD18-Vl-011210) Ronoxan® A (ascorbyl palmitate, lecithin andw ' dl a-Toco hero] ' - ,Tricalcium “ho hate Composition 8 — Hypoallergenic LCl’UFA emulsion composition (also ed to hereinafter _as RD18-V2-0‘11210) ‘ Hi-DHA® tuna oil Ronoxan® A (ascorbyl ate, lecithin and - dla-Tocoherol ‘ --__-_ Dridex 30 maltodextrm 30 117.93 Composition 9"— Hypoallergenic LCPUFA emulsion composition (also referred to hereinafter as RD18-V3-011210) ' Ronoxan® A (ascorbyl palmitate, lecithin andu dl a-Toco-herol _-!_. —_—— Composition 10 — Hypoallergenic LCPUFA emulsion composition (also ed to hereinafter as RD18-V4-01 1210) ‘ .-t - HiDHA®tunaoil 296.12 Ronoxan® A (ascorbyl palmitate, lecithin and 0.291 d] a-Toco : heroI ' ls 90-35 mono- ceride 2.43 C*I MD 01960 maltodextrin 10 480.28 117.93 48.54 -— ' 11.34 1 48.54 Sodium ascorbate water W0 2012/106777 —-E- Composition 11 - Hypoallergenic LCPUFA emulsion composition Ronoxan® orbyl palmitate, lecithin and ' " d1 a-Toco herol ——1_ —-E— Composition 12 — Hypoallergenic LCPUFA emulsion composition Ronoxan® A (ascorbyl palmitate, lecithin and 9.0206 :11 a-Toco - herol ‘ Composition 13 — Spray dried hypoallergenic microencapsulated LCPUFA composition (also referred to hereinafter as RD18-Vl -01 1210) ' n® A (ascorbyl palmitate, lecithin and dla—Tdco-herol ‘ Monomuls 90-35 mono ceride C*D MDOl960 maltodextrinlO __m_ Sodium moms - HICAP®IMF Composition l4 — Spray dried hypoallergenic 'microencapsulated ' LCPUFA composition (also referred to hereinafter as RD] 8-V2-Ol 1210) .——-r- HiDHA®tunaoi1 .' —- Ronoxan® A (ascorbyl ate, lecithin and“ d1 on-Tooo -herol .

Dridex 30 maitodexlrin 30 11 71 Tricalcium h’os hate - —E_ _-E_.

- CAPSUL®IMF ”— _-m- ition 15 — Spray dried hypoallergenic microencapsulated' LCPUFA composition (also referred to hereinafier as RD18-V3-011210) ' ' HiDHA®tunaoii .

Ronoxan® A byl palmitate, lecithin and 0.03 ' d1 a-Toeo ~herol Monomuls 90-35 monol ceridc » __mfi_ Composition l6 —:' Spray. ilried hypoallergenic micro'encapsulated LCPUF ' composition (also referred to hereinafier as RD18-V4-011210) ' %b weit - HiDI-IA® tuna oil 29.48 Ronoxan® A (ascorbyl palmitate, lecithin and‘ 0.03 dl o herol - Monomuls 90-35 monol ceride. 0.24 WO 06777 C*D MD 01960 maltodextrin 10 —_-!E_ 4 s3 _.m- Exam la 2 - ination of oia'da iv stabili usin Induction Period and $10 a 'l‘he ML Oxipres is a modification ofthe Oxygen Bomb method. traditionally used for testing efficiency of autioxidants on heterogeneous products containing oils and fats. The ML Oxipres monitors the ortidation of oils and fats in a heterogeneous product and can also be used to monitor oxidative stability of'oils and fats. 'The instrument gives a graph of oxygen absorption over time and the end of the ion period is the point of. inflection (Figure l) which is quite clear and sharp. Induction period is the time (in hours) elapsed ' between placing the pressure vessel in the block heater and the break point at a given temperature/pressure ation. The longer the period of time until "breakpoint" the more stable the oil or heterogeneous product containing the oil (e.g. microencapsulated ‘ sample). _‘\l .i .. ’ Hypoallergenic micro-encapsulated powders were analysed ' by ML Oxipres (Mikrolab Aarhus A/s Denmark) to compare the oxidative stability. A suitable amount of sample containing 4g of oil (e.g. ng 8g of 50% oil loaded ) was weighed into- reactor re vessels and placed into ML Oxipres pressure vessels and sealed. Pressure vessels were filled with oxygen to a defined initial pressure of 5 bar (’70 pSi). Vessels were then placed in the thermostat block pre-heated and maintained at 80°C. Pressure changes were recorded and the induction period calculated as the tithe after which the pressure began to decrease rapidly as measured from 'the cross section point of ts from the .‘ 'first and second parts of the curve recording pressure changes (see Figure l). Slope after induction period is a measure of how rapidly the oxygen is penetrating through the ulation matrix to the volume of lipid core and is measured as absorbed oxygen after IP (see Figure l). Oxidative stability for selected itions of the invention are shown \ ' inFigures 2 and 3.

Example g - flagid Exggsure Testing - Exposure of raw material and in infant formgla application at elevated atures in the absence of a modified here and exposed to UV radiation ’ - ‘- Protein free microcapsules corresponding to compositions 3 to 6 above dosed into infant formula application were assessed. samples were stored in theabsence of an inert atmosphere in open 5 layer foil laminate bags at ambient(24 °C) and accelerated (40 °C) ‘ I I storage conditions; ' ' MRP and MRP-RS microcapsules and commercial competitor. powders were dosed - into ia Karicare Follow-onto achieve anIOmega-3/6 DHA/AA concentration of , I 1mg DHA and/or 11mg AA per lOOmL reconstituted ge.

Z I Table 1: Exposure Plan Test . Hypoallergenic mierocapsules In infant formula application Temperature Test Test ' Test - . Test Test frequency _ 1' metre Duration Method s at begin, middle and end.

The first two Room Samples at samples are NM begin, ature 4 weeks middle and sealed and then standard . (24°C) stored in r. end. Protocol Three samples tasted at same time. .

Samples at begin, middle and end.

The first two Samples at samples are NM Accfgirated ' .33?!” d ' sealed and then standard ( C) rm e an stored in r. Protocol ' end. I Three samples tasted at same ‘ time.

To'determine if the rapid exposure compromised the quality of the raw material and quality in infant formula application a ation of oxidatiye stability and subjective sensory analysis were assessed: Ihe tables below outline the finished product stability testing methods. conducted in this study. The analytical methods employed were AuStralian Standard Methods, American on Chemists Society (AOCS) or in—house protocols basedon ' the International Union of Pure and Applied Chemistry Standard Methods detailed below.

W0 2012/106777 Table 2: ity testing protocol ' Test parameter for microcapsules" ‘The oil was removed quickly and carefully from the product and stored under nitrogen in amber bottles.

During this extraction protocol the oil tested has been d to air and the actual oxidative integrity of the oils may have been compromised during this process. Thus, the analytical results represent the oil as a removed from the encapsulation matrix and theoretically the oil incorporated into the Driphorm® rnicrocapsules and incorporated into the infant fonnula will be less oxidised'than as shown.

'In addition, the following sensory attributes were evaluated by an untrained se. . sensory panel minim‘umof five: Table 3: Sensory testing protocol '- ' Test parameter for microcapsules ' Absent/Detected Absent/Detected - Rancid Flavour .

- Absent/Detected -.

Fresh marme r Absent/Detected Overall .uali ~. Acce ntable/Unaocc table *Pertains to raw material testing protocol only Stage 1: Rapid Exposure Testing - Exposure of raw al at elevated temperatures - in the absence of a modified atmosphere and exposed to UV radiation Table 4i Rancid odour of hypoallergenic powder samples stored in the absence of an inert atmosphere in open 5_layer'foil' te bags at ambient (24°C) and rated (40°C) storage conditions .

Rancid Odour .

. RD lB-Vln27l010 RD l8-V2—2710l0 A Tune (weeks) Ambient Exposure rated Exposure .

Ambient-Exposure_ Accelerated Exposuré Acc Bor Rej Ace Bor Ace Bor Ace Bur . Rej' Rej . Rej 0 S 0 0 ' ' - - - 5 o o . - . 2 5 0 0 S ' ' 0 ' 0 S 0 0 5 0 . 0 4 s o ' o s o o 5- o e s o 0 W0 2012/106777 RD 18 V3 291010 RD 18 V4 29lOl0 Time (weeks) t Exposure Accelerated Exposure Ambient Exposure Accelerated Exposure - Ace Bor Rej Ace Bor Rej Ace Bor Rej Ace Bor Rej .- 2 5 o' o 5 o o s ' o o s o o 4 s " . o o s o o s o 0 5 0 Acc=Accept; Bar = Borderline acceptable; Rej = Reject ' Table 5: Marine odour of hypoallergenic powder samples stored in the absence of an inert atmosphere'in open 5 layer foil te bags at ambient (24°C) and rated (40°C) stora e conditions.

Marine Odour RD 18- V] w 27l010 ~ RD l8 - V2- 271010 Time (weeks) ‘ Ambient Exposure Accelerated Exposure Ambient Exposure Accelerated Exposure Ace Bor Rej Acc. Bor Rej Ace Bor Rej Bor Rej 0 ' 0 l) - - - . 5 0 0 - - - 2 4 l 0 5 O 0 4 l 0 4 I 0 4 4 l 0 4 I 0 5 0 0 5 0 0 Them“) Rots-v3 291010 ' . Rota-v4—291010- -_ Ambient Exposure Accelerated Exposure AmbientExposure Accelerated Exposure Ace Bor Rej Ace Ber ch Ace Bor Rej Ace Bor Re] 0’ s o o ' - - - 4 l o - - - 2 4 . 1 o 4- -I o 4 l o 4 .1 o 4 5 o. o 5 o o 4 l o- s - o o cept; Bor = Borderline acceptable; Rej = Reject Table 6: Rancid flavour of hypoallergenicpowder samples stored in the-absence of an inert atmosphere in open 5 layer foil laminate bags at ambient (24°C) and accelerated (40°C) storage conditions. ‘ ‘ Rancid Flavour RD lS-Vl —271010 RD 271010 Time (weeks) Ambient re Accelerated Exposure Ambient Exposure. Accelerated Exposure 7 Ace . Bor Rej Ace Bor Rej Ace Bor Rej Ace Bor Rej ‘ 0 5 0 0 ' - -- - 5 0 0 - - - 2 5 0 0 5 0 . 0 5 0 0 5 0 0 4 _s- 0 o s o o 5 0.0 s o -o W0 2012/106777 RD l8-V3—2910l0 RD now-291010 Time (weeks) Ambient Exposure Accelerated Exposure Ambient Exposure Accelerated Exposure Ace Bor ch Ace Bor Re} Ace Bor Rej Ace Bor Rej 0 5 0 ' 0 - - - 5 l) 0 - - . 2 s " o o s o o 5 o o s o o 4 s o . o '5 'o o 5 o . o 5 o o cept; Bar '-_- Borderline acceptable; Rej é Reject Table 7: Marine flavour of hypoallergenic poWder samples stored in the absence of an inert here in open 5 layer foil laminate bags at ambient (24°C) and accelerated (40°C) sto ' e conditions.

Marine Flavour RDVl~271010 RD 18-V2—2710l0 Time (weeks) Ambient Exposure, Accelerated Exposure Ambient Exposure. Accelerated re Ace Bor - Rej Ace Bor Rej Ace Bor Rej Acc Bor Re] 0 4 l 0 - - - 5 0 0 - - - ' 2 4 l 0 4 I 0 5 0 0 5 0 O 4 4 l 0 4 0 l 5 0 0 S 0 0 Time (weeks) RD l8-V3 -2910l0 ' . RD [8-V4-291010_ Ambient Exposure rated Exposure Ambient Exposure rated Exposure Acc Bor Rej ' Ace Bor Rej Ace Bor Rej Ace Bor _ Rej 0 5 0 0 ' ' - - - 5 0 - - - _ 0 2 s o . . o s o o s o o s o o 4 s o o 5 o 5 o s o o 4 1 o Acc=Accept; Bar = Borderline acceptable; Rej = Reject Table 8: Overall quality of lergenic powder samples stored in the absence ofan inert atmosphere in open 5 layer foil laminate bags at t (24°C) and accelerated (40°C) storage conditions. ' Overall quality ' " . RDlll-Vl-27l0l0 RDl8-V2-271010 Tune (weeks) ' Ambient Exposure. Accelerated Exposure Ambient Exposure, Accelerated Exposure Ace Bor Rej Ace Bur Rej Ace Bor Rej Ace Bor Re] 0 5 0 0 ‘ - - . 5 o o - - - - i 2 S 0 ' 5 , 0 4 l 0 0 0 4 l 0 4 4 l 0 4 0 l S 0 0 4 . l 0 Timetweeksim Ambient Exposure rated Exposure Ambient Exposure Accelerated Exposure . Ace 301‘ Rej Ace Bor Rej Ace Ber Rej Ace Bor Rej . ° 5 0 0 - - - 4 1 o - - . ., .2 5 o o 4 ‘1 . o 4 1 o 4_ 1 o 4 s o o 4 1 o- 5 o o 4 1 o Ace=Accept; Bor = Borderline acceptable; Rej =' Reject ' Table 9: Total fat content (%) of hypoallei'genic powder samples stored in the absence of an inert atmosphere'1n open 5 layer foil laminate bags at ambient (24°C) and accelerated g40°Czstorage conditions.

Fat (%) content . .—________________ 1-271010 RDls-V2-271010 RD 18-V3-29101'0 Time RD18—V4-291010 —.-_-I—-———-——.—————uu—_-_—-__-——.I— (weeks) Ambrent Accelerated Ambient Accelerated Ambient Accelerated t Accelerated Eggnsure Exposure Exgosure ExEosure BxEsure Exgosure Exmsure Erasure 0 24.6. - 24.2 24 - 4 24.2 24 23.4 23.9 23.3 23.7 24.9 24 Table 10: Concentration of long chain polyunsaturated fatty acids of hypoallergenic- powder s stored'1n the absence of an inert aunOSpher-e'111 Open 5 layer foil laminate bags at ambient g24°C2 and accelerated {40°C} storage conditions.

. Concentration oflong chain mlflnsamrated (Luz acids RD 18-V1-27l010 RDIB-V2-2‘7IOIO RDl8-V3-29IOIO RD I8-V4-291010 Ambient Ambient Ambient Ambient Accelerated Time rated - Accelerated Accelerated.

, Exposur Exposur Exposur Exposur ) Exposure Exposure re 1: e _ re e e .

DHA DHA DHA DHA , DHA DHA DHA ‘DHA . 22:3 (1)3 22:3 0113 22:3 (03 22:3 (113 22:3 1113 22:3 m3 22:3 (03 22:3 «93 male ms/s - rue/s Ins/g male rug/g Ins/s ms/s Sm'fi‘mm“ , 58:7 58*? 5M7 . 58:7 53:7 58*? 58:” . 58H 0 58.32 - 56.93 - 56.71 - - . 57.37 4 57.89 58.38 56.89 58.64 56.66 57.41 59.! 5 55.41.

DHA =, Docosahexaenoic acid ' Table ll: FFA, p-Anisidinc, Acid value and Peroxide Value of hypoallergenic powder- s stored in the absence of an inert atmosphere in open 5 layer foil laminate bags at ambient 324°C! and accelerated “0°C! storage conditions.

Oxidative Status Rois-Vl—mmo t ' Time , Accelerated > I . (weeks) 0 . . o Peroxide Acid 9- Peroxide Acid p- Value Value ' :Fnee .Anisidine “‘91. vane Value Anisidine ' 12F”: all); - Acid. . Acrd . . 3mg Speclfieanon - Smeqlkg 20 0.50% .Smeq 3mg KOH/g . [kg 20 KOl-llg ‘ 0.509/11 0 1.1 1.] 12.2 ' 0.6 ‘ - - - ' '63 8.4 10-.7 4.2V 5.3 11.5 12.4 5.8 W0 06777 RD 18 - V2—271010 Time Ambient Accelerated (weeks) Peroxide Acid p- ./ Peroxide Acid 13- Value - Value Amstdlne age Value Value Amsrdmc 1:36 Acid” Acid” . . 3 mg Specification pSmeq lkg 20 .3 mg KOHIg . 0.50% Smeq/kg- 20 0.50% .. KOI-llg 0 ' - 1.3 0.4 12.3 0.2 - - - - - 4 6.1 5.9 12.5 2.9 7.5 7.2 ' . 12.7 3.6 RD'18 ~V3 —291010 Time Ambient ‘ rated . (week) ' Peroitide Acid ~ p- 91:13:: Peroxide Acid 'p- 9:53!" , Value Value Amsldme Value Value Amsrdme Aci(1,; Acid“ . . 7 3 mg . 3mg Smeq Specification Smeq [kg 20 0.50% 20 . 0.50% KOl-l/g "‘3 KOHIg _ o 1.1' <_ 0.5 12.I 0.3 . 4 7.6 10.2 11.4 5.1 7.2 6.8 12.9 3.4 [q ' - . RD 291010 Time Ambient rated (““551“) o .

Peroxide Acid Peroxide Acid , p~ 13- ‘ $121” Value Value ' Anlsidine nit); 2.11”" Value ,Value Anisidine “E"; Acid Acid ' ' ' 3 mg ' ' . -. 3 mg Speclficatlon Smeq [kg 20 ‘ 0.50% Smeq {kg 20 0.50% KOH/g ’ . Kng 0 1.7 f 0.9 10 0.4 - . . .. ._ 4‘ 7 20.2 11.5 10.1 6.8 11.7 10.5 5.9 # as oleic ' ‘ ' Stage 1 Rapid Exposure Testing - re fortified infant formula at elevated ' temperatures in the absence of a modified atmosphere and exposed to UV radiation Table 12: Rancid odour of infant formula fortified with hypoallergenic powder samples stored in the absence of an inert atmosphere in open 5 layer foil laminate bags at t - 24°C and accelerated 40°C stora e conditions; Rancid Odour .' RD l8-Vl—271010 aons-vz-moro Tune (weeks) .

Ambient Exposure_ Accelerated Exposure Anthem Exposure. Accelerated Exposure Ace Bor Rej .Acc Bor Rej Ace Bcr Rej Ace Bor Rej o‘ s o o - - - - . 5 o o - - - 2 4 - l 0 4 1 0 5 0 ~ 0 4 l 0 4 4 l 0 4 ~ . l 0 5 o 0 4 I 0 W0 2012/106777 PCT/AUZO12/000135 RD Is-v3-29'lom RD 18 -v4—291010 Time (weeks) —,-—-——-————'————'~— Ambrent Exposure Accelerated Exposure Ambient Exposure Accelerated Exposure Ase Ber Rej Ace Ber Rej Ace Bar Ace Bor 4 Rej Rej 0 s ' 0 0 - ~ - - » 5 0 0 - - - 2 5 0 0 5 0 0 5 0 0 5 0 0 4 ‘ 5 o o s o o 4 1 o 5 o o eept; Bar = Borderline acceptable; Rej =Reject Table 13} Marine. odour of infant formula fortified with hypoallergenic powder samples stored in the absence of an inert atmosphere in open 5 layer foil laminate bags at ambient 24°C and accelerated 40°C ' stora econditions." Marine Odour . RD 18—V1—2710l0 RD 18-V2—271010 Tune (weeks) t Exposure. Accelerated Exposure Ambient Exposure_ Accelerated re » Ace Ber Rej Ace Bor Rej Ace Bor Rej Ace Bor Rej 0 5 0 0 - -‘ - - - . 5 0 0 . 2 ' 5 O 0 5 0 0 5- 0 0 5 0 ~. 0 4 . 5 0 0 5 0 0 5 0 0 5 0 0 . 'RDls-v3-2eloro RBIs-W—zeimo Time (weeks) t Exposure Accelerawd re , Ambient Exposure_ Accelerated Exposure Ace Bor Rej Ace Bor ' Rej Ace Bor Rej Ace Bot ‘ _ Rej 0 5 0 0 - . - 5 0 o . '. - 2 5 0 0 ‘ 5 0 0 5 0 0 5 0 0 4 , s o o s o . -o '5 o 0 5 0 0 Acc=Aceept; Bor = Bordeflineaeceptable; Rej -= Reject ' Table 14: Rancid flavour of. infant fermula fortified with hypoallergenic powder samples stored in the absence of an inert atmosphere in open 5 layer foil laminate bags at ambient 24°C and accelerated 40°C stora e conditions.

. Rancid Flavour . RD!8-Vl-271010 Tune (weeks) . RD]8-V2~27101(}. t Exposure_ . rated Exposure Ambient Exposure_ Accelerated Exposure Ace Bor Rej Ace Bar Rej Ace Ber Rej Ace Ber _ Rej 0 4 l '0 3 2 0' - - .- 2 3- 2 0 4 l ' 0 4 i 1 0 4' l 0 4 4 l 0 4 l‘ ‘ 0 5 0 0 S 0 0 WO 06777 Time (weeks) RD 18-V3—291010 RD 18-V4-291010 Ambient Exposure Accelerated Exposure Ambient Exposure Accelerated re ' Ace Bar Rej Ace 301' Rej Ace Bor Rej ADC Bor ‘ Re] 0 S 0 0 ' - - - S 0 0 - - - 2 5 0 0 5 0 0 ' 5 0 0 5 _ 0 0 4 - ,. 5 0 0 5 0 0 4 ‘l- 0 5 0 0 Aee=Accept; Bor = Borderline acceptable; Rej ‘ Reject; TED = To be determined Table 15‘: Marine flailour of infant formula fortified with lergenic powder samples stored in the absence of an. inert atmosphere in open 5 layer foil te bags at ambient 24°C and accelerated 40°C sto 6 conditions Marine Flavour '_ ' . l—z'llOlO . RDls-VZ—Z‘IIOIO Time (weeks) Ambient Exposure_ Accelerated Exposure Ambient Exposure_ Accelerated Exposure Acc Bur . Rej Ace Bor - Rej Ace Bor Rej Ace Bor Rej o s o 0 . ~ .- r - . s o o . - . 2 5 ' - 0 0 5 0 0 S 0 0 5 0 0 4 5 0 0 ‘ 5 0 - 0 . 5 0 0 5 0 0 Marine Flavour . RD 18oV3 -.29l0l0 RD l8-V4—2910I0 Time (weeks) Ambient Exposure. Accelerated Exposure , Ambient Exposure. , Accelerated Exposure . - Ace Bor 'Rej Acc Bor Ace Bor Bor ' , Rej Rej Ace. Rej 0 ' - - - - . 5 0 0 5 0 0 .- - 2 s ‘ o o 5 o . o s "o .o s o , o 4 5 0 0 5 0 0 5 0 0 5 0 0 Acc=Accept; 801' = Borderline acceptable; Rej - Reject Table 16: Overall quality of infant a fortified with hypoallergenic powder samples 'storedm the absence of an inert atmosphere111 open 5 layer foil laminate bags atambient 124°C! and accelerated 140°C! storage cc’mditions. - Overall quality , -RD18-VI—271010 RD 2710l0 Time (weeks) .

Ambient Exposure_ Accelerated Exposure t Exposure_ - ‘ Accelerated Exposure Ace Bor Rej Ace Bor Rej Ace Bor Rej Acc Bot Rej 0 ‘ 5 ‘0 0 - - - S 0 0 - . - 2 .

A 5 0 0 4 l 0- 5 0 0 4 l 0 4 4 l 0 5 0 0 5 0 0 5 - l) O RD 18-V3—291010 RD 18 -V4-291010 Time (weeks) Ambient Exposure . rated Exposure Ambient re rated Exposure Ace Bor Rej Acc Bor Rej Ace Bar Rej Acc Bor Rej 0 ’ 0 0 ' - '- - 5 0 - - . _ Q 2 ' 4 . 1 o 5 o o s . o o s o o 4 4 ' 1 0. 4 ~ 1 0 5 . 0 0 S 0 0 Acc=Accept; Bot = Borderline acceptable; Rej = Reject ‘ ' '- Table 17: Total fat content (%) of infant formula fortified with hypoallergenic powder samples stored1n the absence of an inert atmosphereto open 5 layer foil laminate bags at ambient 24°C and accelerated 40°C stora e conditions.

Fat (%) content ' RD [8 VI 471010» RD Is—v2-271010 RD laws-291010 RD 18—v4-291010 Time -——-,-————————-—————_—_—___ (weeks) Ambient Accelerated Ambient Accelerated Ambient Accelerated Ambient Accelerated Ex osure B osure Ex sure E osure sure sure Ex sure osure 0 22.16 ' - 22.3 — - . 21.63 22.02 - 4 ~ 21.73 22.35 2|.82 22.36 . 22.34 22.47 21.94 22.47 Table 18: Concentration of long-chain polyunsaturated fatty acids of infant formula fortified with hypoallergenic powder samples stored in the absence of an inert atmosphere in open 5 layer foil laminate bags at ambient (24°C) and accelerated (40°C) storage conditions.

Concentration oflon -cha1n ol saturated aclds RDISrVI-211010 RDl8—V2-271010 RD 18-V3-291010 RDls—V4-291010 Time Ambient Ambient Ambient Ambient Accelerated Accelerated Accelerated Accelerated (“V951“) EXP?” Expensur Expeosur r EXposure , Exposure re _ Exposure DHA DHA 22:3 DHA DHA 22:3 DHA DHA 2223 DHA DHA 2223 22:3 (1)3 (03 22:31:13 1113 22:3 «13 m3 ' 13 (113 Target ' (mg/1001. 11 11 11 11 11 11 11 11 prepared _ feed) ' 0 11.17 - ‘9.18 . - 7.91 - 11.48 - 4 10.67 10.83 8.99 9.18 , 7.44. 11.3 11.38 11.95 DI-IA = Docosahexaenoic acid ‘ W0 06777 Table 19: p-Anisidine, Acid value and: Peroxide Value of infant forlnula fortified with hypoallergenic powder samples stored in the absence of an inert atmosphere in open 5 layer foil laminate ba at ambient 24°C and accelerated 40°C st econditions.

- . RDls-VI—zmlo T" Ambient Accelerated 1me W( eeks ) ' . peroxide Acid Peroxide Acid _ p: 9';an p- fif’“ . Value Value Anisldine A33" Value Value Anisidine . A33, 'Specified 3mg ' ‘ 3mg Maximum sineqlkg 20 0.5% smeq/kg 20 0.50% mm; KGB/g 0 7.2 0.5 1.6 0.3 - - - 4 . 6.6 1.5 <0.1 0.7 3.9 1.6 <0.1 0.8 'RD [8 -v2—271010 Time Ambient Accelerated (“9"“) . a Peioxide Acid [11- ff”: Peroxide Acid [3-- if“ Value Value Anisidine Mfg“ Value Value Anisidine A333,, Specified " - 3mg 3mg . .

Smeqlkg 20 . 0.5% 5111ch 20 0.50% um. KOI-llg KOH/g - 0 6.] 1.6 <0.1 0.8 - - - - ,- 4 ' ' 6.8 1.6 1 0.8 3. 1.5 0.4 0.7 RD 18 - V3 491010 Ambient . Accelerated T'Imc wee( ks) , - ghee. .

Peroxide Acid . p- Peroxide Acid “fig, . p- Value ' Value ille. Value Value ~ Anisidine Specified 3mg ' - 3mg Smog/kg 20 0.5% - . 0 Maximum -1<0H/g _ smeqncg KOH/g 0.50/e 0 6.4 1.6 0.7 0.8 - - - - ' ‘ 4 6.1 1.6 1 <0.1‘ 0.8 6.1 1.1 . <0.1 0.5 . ,RD18-v4-29101o . Time Ambient rated 0’gF’” ‘ (weeks) o Peroxide Acid 11- Peroxide Acid p- ”If” Value Value Anisidine Value . Mag“ , A33" Value Anisidine mg; Smeqlkg 136353 20 0.5% . 5mcq lkg 130$; 20 0.50% 0 6.4 1.1 '- - . <01 05‘ - - . _ '4 5.6 . 1.7 <0.1 0.9 _4.8 1.7 1.9 0.8 #as oleic Stage 2 Rapid Exposure Testing - re of ratv material at elevated temperatures inthe absence of a modified here and exposed to UV radiation Table 20: Rancid odour of hypoallergenic powder samples stored in the absence ofan inert atmosphere in open 5 layer foil laminate bags at ambient (24°C) and accelerated (40°C) storage conditions. .

Rancid Odour . . ——_—_____—.______.

. RDls-V7-I31210 (RawMaten'11] Time (weeks) ) t Exposure Accelerated Exposure Ace Bor Rej - Ace Bor Rej _ o s = o 0 NA NA NA 2 5 0 0 4 l 0 AecéAeeept; Bar = Borderline acceptable; Raj = Reject Table 21: Marine odour of lergenic powder samples stored in the absence of an inert here in Open 5 layer foil laminate bags at ambient (24°C) and accelerated (40°C) stogge conditions. .

Marine Odour - RD!8-V7-l3l210(RawMaterial) Time (weeks) Ambient Exposure, p - Accelerated Exposure Ace Bor ' Ace _ Rej Bor . Rej 0 ‘ . 2 3 0 NA . NA NA 2 ’1 ' 2 ' 2 . 3 2 o 4' 2 ' ‘ - « 3 0 3 l l Aec=Aecept; Ber = Borderline acceptable; Rej = Reject Table 22: Rancid flavour of hypoallergenic powder samples stored in the absence of an -. inert atmosphere in open 5 layer foil laminate bags at ambient (24°C) and accelerated (40°C) storage ions. ' Rancid Flavour Time (weeks) - RDI 8-V7-131210 (Raw Material) Ambient Exposure . Accelerated Exposure Ace Bor Rej Ace Bor ' Rej o - . 4 1 -o NA . NA NA 2 '3 '. l ' - l 4 o 1 4 4 ' . o 1' 4 o l Acc=Aeeept; Bor = line acceptable; Rej = Reject ’ Table 23: Marine flavour of hypoallergenic powder samples stored in the absence of[an inert atmosphere in open 5 layer foil laminate bags at ambient (24°C) and accelerated 140°C} stogge conditions. , . .

Marine Flavour RD18-V7- 131210 (Raw l) Time (weeks) Ambient Exposure. Accelerated Exposure.

. Ace Bot Rej Am Bor Rej Tfi—W—T 2 2 3 o 2 » . ‘ 3 0 4 ' - 3 2 o - 3 2 ' . o .—————..___._._.____.___._____,, Acc=Accept; Bar = Borderline acceptable; Rej - Reject- Table 24: Overall quality 'of hypoallergenic powder samples stored in the absence of an inert here in open 5 layer foil laminatebags at t (24°C) and accelerated 40°C stor econditions. ' Overall y RDl8-V7-l3 l210 (Raw Material) Time (weeks) _ Ambient Exposure ‘ Accelerated Exposure Ace - . Bor Rej Ace _ . Bor Rej. 0 2 ' 3 0 ' 2 ' - 2 2 l 2 2 l 4 ' . 4 1 o 4 1 o ACFAceept; Bor é Borderline acceptable; Rej = Reject .

Table 25:' Total fat content (%)'of hypoallergenic powder samples stored in the e of an inert atmosphere'1n open 5 layer foil laminate bags at ambient (24°C) and accelerated (40°C) e conditions.

. Fat 1%) content RD18-V7-131210 g5,aw Material! Time (weeks) Ambient Accelerated 0 ' 34.3 - 4 34.0 32.4 Table 26: Concentration of long-chain polyunsaturated fatty acids of hypoallergenic powder s stored”1n the absence of an inert atmosphere'in open 5 layer foil laminate . bags at ambient 94°C! and accelerated 540°C! storage conditions. - Concentration of long-chain polflnsaturated fag! acids ' Time (weeks) RD18-V7-l3 1210 gRaw Material! Ambient ' Accelerated . AA 20:4to6 m DHA22:6 (1)3 AA 20:4m6 m DHA 22:6 (1:3 in Sm'f'm“ (”8/3) 56.5 1 9 56.5 x 9 56.5 s 9 56.5 a 9 0 - 68.04 68.52 - - 4 ' 66.47 66.97 ' 62.84 64.4§ DHA= hexaenoic acid; AA = Amhidonic acid 2012/000135 Table 27: Acid value and Peroxide Value of hypoallergenic powder samples stored in the e of an inert atmosphere in open 5 layer foil laminate bags at ambient (24°C) and accelerated 40°C stora econditions. ' RD18-V7nl312101Raw al! Ambient Time . Accelerated (weeks) Peroxide ' p- - "11$ Acid d p- Acid Value Amsrdine‘ Acids“ Value eValue Amsrdmc Value ‘23:“ . Acids” .Maximilim 5meq/kg 20 0.50% .- 3mg 3mg .8 ecification _ Smeq/kg 20 KOI-II . KOHI 0,§0% O 2.3 5.9 0.8 1.6 - - - - 4 3.9 6.7 1.5 2.9 5.1 5.9 ' 1.4 - . 0.7 __‘———'_—.—_—_———*_——_— # as‘oleic Stage 1: Rapid Exposure Testing - Exposure of fortified in infant formula at elevated ' temperatures in. the absence of a modified atmosphere and exposed to UV radiation Table 28: Rancid odour of -formula fortified With hypoallergenic powder samples stored in the absence of an inert atmosphere in open 5 layer foil laminate bags at ambient . g24°Czand accelerated g40°C2storage conditions.

Rancid Odour RDls-V7-131210 (In infant formula application) Time (weeks) .

Ambient Exposure . Accelerated Exposure Ace . Bor Rej Ace Bur Rej . 0 5 0 0 NA NA NA . 2 5 0 o. 5 0 D Aec=Accept; Boi- '= Borderline acceptable; Rej = Reject Table 29: Marine odour of infant formula fortified {with hypoallergenic powder samples - ~ stored'in the absence of an inert atmosphere in open 5 layer foil laminate bags at. ambient 124°C! and accelerated §40°C2 storagve conditions.

Marine Odour 7-l31210 (In infant formula application) Time (weeks) Ambrent Exposure. - Accelerated Exposure Ace Bot Rej Acc Bor - Rej 0 5 ' 0 0 NA NA NA ' ' 2 ' ~ 5 '~ 0 ~ . 0 9 o a 4 - 5 0 O 5 0 cept; Bor = Borderline acceptable; Rej = Reject W0 2012/106777 2012/000135 Table 30: Rancid flavour of_ infant fonnula fortified with hypoallergenic powder samples stored'in the absence of an inert atmosphere'in open 5 layer foil laminate bags at ambient £24°Cz and accelerated 140°C! stogge conditions. 7 Rancid r . RDIB V- 7-13]210 (In infant fomiula application) Time (weeks) Ambient Exposure rated Exposure Acc Bcr , Ace Bar _ Rej Rej 0 5 0 ‘ ' 0 NA NA NA 2 s - 0 , 0 - 5 0 0 4 S 0 0 5 ' O 0 him——‘——— Bor = Borderline acceptable; Rej = Reject ‘ ‘ . Acc=Accept; .

Table 31: Marine flavour of infant formula ed with hypoallergenic powder samples stored'1n the absence of an inert atmosphere'1n open 5 layer foil laminate bags at ambient g24°C! and accelerated 140°C! storage conditions. - . Marine Flavour Time (weeks) RDIB-VT-ISIZIQ (In infant fan-null: ation) ~ Ambient Exposure Accelerated Exposure 1 Ace 1301' 'Rej Acc . Ber Rej 0 5 0 0 NA . NA NA 2 5 0 o _ 5 O. 0 4 5 0‘ o . 5 0 0 Acc=Accept; Bar = Borderline acceptable; Rej = Reject Table 32: Overall qnality of infant formula fortified with hypoallergenic powder samples stored'in the absence of an inert atmospherein open 5 layer foil laminate bags at ambient {24°C} and accelerated {40°C} e conditions. - . Overall Quality RDIS-V7-l3 121.0 (In infant formula application) Time (weeks) Ambient Exposure . Accelerated Exposure Ace Bor Rej Ace Bor Raj o ' s o .0‘ NA NA ~ NA. 2 s ' - o o 's 0 ~' 0 4 s ‘ o o s . o o Acc=Accept; 801' = Borderline acceptable; Rej = Reject ' W0 2012/106777 Table 33: Total fat content (%) of infant formula fortified with hypoallergenic powder samples stored1n the absence of an inert here1n open 5 layer foil laminate bags at ambient (24°C) and accelerated g40°cg storage conditions.

Fat 1%) content RD18-V7-131210 (In infant Time (weeks) formula application) Ambient Accelerated 0 22.3 4 22.8 22.4 Table 34: tration of hain polyunsaturated fatty acids. of infant formula fortified with lergenic powder s stored in the absence of an inert atmosphere in open 5 layer foil laminate bags at ambient (24°C) and accelerated (40°C) storage - conditions. .

Concentration of long-chain polyunsaturated fatty acids Time (weeks) ' RDis-V7-l3 [210 (In infant formula application) - Ambient Accelerated .AA 20.4016 m DHA 22:6 1113 DHA 22:6 «3 Specification (my . 1003 ofp'repargl rug/100g ofpreparcd Afigfimflw myioOg ofprepared 100g prepared feed) feed - ' feed . feed 1 I ll ‘ ' l 1 ll 0 12.17 1181 I - - 4 10.51 10.77 10.02 10.21 DHA= Docosahexaenoic acid; AA- Arachidonic acid Table 35: Acid value and Peroxide Value of infant formula fortified with hypoallergenic powder samples stored'1n the absence of an inert atmosphere'in open 5 layer foil laminate b at ambient 24°C and accelerated 40°C stor e conditions.

RD18-V7-l31210 Slit infant a application! Ambient Time Accelerated (Weeks) Peroxide [1- fig? . _ Acid Peroxide p- Acid Value Amsidme Value me Value fig Acids“ Value Acid3” Maximium - - . 3mg 3mg .

S ecification Smeq/kg 0.5%, KOH/ Smeq/kg 20 0.5% KOH/ 0 5.5 0.1 0.8 1.5 - - - - 4 3.4 <0.1 0.9 1.1 2.1 1.1 1.1 0.6 Those skilled in the art Will appreciate that. the invention described herein is 0‘ susceptible to variations and modifications other than those cally described. It is to be understood that the invention includes all such variations and modifications. ,

Claims (13)

The claims defining the invention are as follows:

1. A composition comprising: (i) an unstable al, wherein said material is an edible oil or other material susceptible to oxidation; (ii) an octenylsuccinyl anhydride-modified starch present in an amount between about 0.5% and 10% of the total weight of the composition; (iii) at least two sources of reducing sugars wherein the first source of reducing sugars has a se equivalent value between 20 and 60, and the second source of reducing sugars has a dextrose equivalent value between 0 and 20.

2. The composition of claim 1, which is in the form of a powder.

3. The composition of claim 2, which is a dried powder.

4. The ition of claim 1, which is in the form of an emulsion.

5. The composition of any one of claims 1 to 4, wherein the unstable material is present in an amount between about 0.1% and 80% of the total weight of the composition.

6. The composition of claim 5, wherein the unstable material is present in an amount between about 0.5% and 35% of the total weight of the composition.

7. The composition of any one of claims 1 to 6, n the unstable material is an edible oil.

8. The composition of claim 7, wherein the edible oil comprises one or more long-chain polyunsaturated fatty acids.

9. The composition of claim 8, wherein the polyunsaturated fatty acids are omega-3 fatty acids and omega-6 fatty acids.

10. The composition of claim 7, wherein the edible oil comprises docosahexaenoic acid and arachadonic acid.

11. The composition of claim 10, wherein the docosahexaenoic acid and arachadonic acid comprise between about 10% and 70% by weight of the total edible oil present in the composition.

12. The composition of any one of claims 1 to 11, n the first source of ng sugars has a dextrose equivalent value n 20 and 40, and the second source of reducing sugars has a se equivalent value between 0 and 15.

13. The composition of claim 12, wherein the first source of reducing sugars has H:\mdt\Interwoven\NRPortbl\DCC\MDT\8235415_1.doc-14/