By Jeanne Yacoubou, MS
VRG Research Director

In October 2011, The VRG received an email with this question: "I was…wondering if the color added to butter is vegetarian, because I have heard that beta-carotene is added to it and that gelatin is often used as a stabilizer in beta-carotene.”

Beta-carotene is a highly pigmented (red, orange, or yellow) substance known as a carotenoid which is commonly found in vegetables and fruits. It is known as a "provitamin" because beta-carotene is cleaved into vitamin A in the body. Gelatin is derived from collagen found in animals' skins and bones. Pig and cattle are the most common sources; fish gelatin is also commercially available.

While looking into this issue, The VRG discovered that beta-carotene is used only rarely to color butter these days. It is, however, common in margarine today. The beta-carotene gives a yellowish color to the margarine which would otherwise be white.

In November 2011, we called Land O'Lakes® and Smart Balance®, manufacturers of several margarine products. Company representatives for both companies told us that they used beta-carotene in their products, but it is not stabilized (or "carried") by gelatin. Wegman's® also told us that their brand margarine, although it contains beta-carotene, does not contain gelatin. Wegman's® stated that they use a vegetable oil-stabilized beta-carotene.

Further research revealed that gelatin stabilization of beta-carotene may also occur in fruit juices/drinks and soft drinks. In fact, as a food technologist at a major company which manufactures many beta-carotene products explained to The VRG, gelatin (or some other suitable carrier), is more likely to be used in water-based products to carry the beta-carotene rather than in oil-based products such as margarine. (Beta-carotene in margarine is easily stabilized by vegetable oils similar or identical to the vegetable oil(s) that compose the margarine itself because beta-carotene is fat-soluble.)

The food technologist explained to us that because beta-carotene is insoluble in water, it needs a carrier in the form of an encapsulation to keep it dissolved in a water-based juice/drink. Without a carrier, beta-carotene would likely form an oily ring at the surface of a fruit juice or soft drink. She referred to a major soft drink in which unencapsulated beta-carotene formed such an oily ring until it was reformulated with something suitable to carry it.

We also learned that beta-carotene is a sensitive substance that decomposes quickly and loses its color-fastness easily. A carrier helps prevent beta-carotene's breakdown. (Other antioxidants added to a juice/drink perform this function for beta-carotene once it is dissolved in solution.) Without a carrier, beta-carotene would not provide the desired beverage color in a dissolved form.

The VRG learned from the Vegan Society of the UK that Coca-Cola® UK is an example of one of a few companies that uses gelatin-stabilized beta-carotene in several of its beverages. To quote from the Coca-Cola® UK website http://www.coca-cola.co.uk/faq/ingredients/coca-cola-drinks-suitable-for-vegans-vegetarians.html:

None of the Coca Cola and Schweppes brands contains milk, eggs or any products derived from mammals. However, vegans and vegetarians should note that a few of our drinks contain small traces of fish gelatine, which is used as a stabiliser for the beta-carotene colour. These products are Lilt, Lilt Zero, Kia-Ora Orange Squash, Kia-Ora Orange Squash No Added Sugar and Schweppes Orange Squash.

To the best of our understanding, Coca-Cola® does not need to label the gelatin as an ingredient in these beverages. According to page 14 of the UK Food Labelling Regulations 1996, clause 17, titled "Ingredients which need not be named":

(d) any substance other than water which is used as a solvent or carrier for an additive and is used in an amount that is no more than that which is strictly necessary for that purpose.

A Commission Directive published in the Official Journal of the European Union (27 November 2007) and accessed at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:310:0011:0014:EN:PDF
states that a permanent exemption from labeling is given to "4(a) fish gelatine used as a carrier for vitamin or carotenoid preparations…"

In the UK, gelatin would fall into the category of "solvent or carrier" for beta-carotene. As explained above, beta-carotene, insoluble in water, forms an oily film at the surface of water-based drinks unless it is formulated with something else (such as gelatin) that prevents this.

The VRG wondered if gelatin-carried beta-carotene were used as a color additive in any beverages sold in the United States. The short answer to this question, to the best of our present knowledge, is "no."

We canvassed a large number of juice companies including Sunny Delight®, Very Fine®, Minute Maid®, Dole®, Nestle®, Cascadian Farms®, Muir Glen®, Apple & Eve®, Fuze®, and Wegman's® in November and December 2011. Among those that add beta-carotene to their beverages, (and not all listed here do), The VRG was told in all cases that gelatin is not the stabilizer for the beta-carotene.

The VRG also contacted Coca-Cola® USA in December 2011 to ask if any of their beverages contained gelatin-stabilized beta-carotene. A media representative at Coca-Cola® US responded promptly to our inquiry by phone and told us that "Coca-Cola® US does distribute products with beta-carotene. The beta-carotene is used as a colorant in some products and in others it may be used as a source of vitamin A." In a later email response she said:

The final word is that we do use beta-carotene but it does not have the fish gelatin. All the products having beta-carotene are kosher. I include a complete list of products below.

Vitaminwater XXX, Vitaminwater Zero XXX, Vitaminwater Zero Glow, Vitaminwater Zero Rise, Vitaminwater Essential, Vitaminwater Zero Drive; Vitaminwater Energy

Minute Maid Orange Juice 100 Kids Plus, Minute Maid Light Orange Beverage

Odwalla Super Protein Mango, Odwalla Mango Tango, Odwalla Superfood Mo Beta, Odwalla Super Protein Pumpkin, Odwalla Strawberry Banana, Odwalla Superfood Red Rhapsody, Odwalla Super Protein Mango

Fuze Banana Colada, Fuze Mixed Berry, Fuze Slenderize Tropical Punch, Fuze Peach Mango, Fuze Orange Mango, Fuze Slenderize Cranberry Raspberry, Fuze Slenderize Strawberry Melon, Fuze Strawberry Guava, Fuze Slenderize Pomegranate Acai Berry, Fuze Slenderize Blueberry Raspberry.

A look at the Food and Drug Administration (FDA) regulations shows that unlike the European regulations which have a specific exemption from labeling ("d" above) for solvents or carriers, US regulations do not have anything comparable. They are otherwise very similar in wording to the European regulations. They read as follows in Title 21, Part 101, Subpart G:
§ 101.100 Food; exemptions from labeling.

(3) Incidental additives that are present in a food at insignificant levels and do not have any technical or functional effect in that food. For the purposes of this paragraph (a)(3), incidental additives are: (i) Substances that have no technical or functional effect but are present in a food by reason of having been incorporated into the food as an ingredient of another food, in which the substance did have a functional or technical effect.(ii) Processing aids, which are as follows: (a) Substances that are added to a food during the processing of such food but are removed in some manner from the food before it is packaged in its finished form. (b) Substances that are added to a food during processing, are converted into constituents normally present in the food, and do not significantly increase the amount of the constituents naturally found in the food. (c) Substances that are added to a food for their technical or functional effect in the processing but are present in the finished food at insignificant levels and do not have any technical or functional effect in that food.

However, even without an exemptive clause specifically for solvents or carriers, The VRG wondered if the US regulations given above could somehow be interpreted such that a food or beverage company could legally exclude gelatin used as an incidental additive or as a processing aid (which is a type of incidental additive according to the regulation stated above), from an ingredients label. We asked the FDA and two food technologists this question.

When we first called the general information line at the FDA in December 2011 and spoke to Ann, she told us that in order to rule on exemption from labeling decisions made by companies, a company must demonstrate to the FDA that the incidental additive or processing aid does not "…make a significant difference to the end product. [When it does] it must be labeled."

We asked two food technologists if the gelatin carrying beta-carotene was making a significant difference to the final beverage and got somewhat different answers. One stated that gelatin stabilized the beta-carotene color blend before addition to the final product (but not against chemical breakdown), while a second thought the gelatin stabilized the beta-carotene against chemical breakdown (and subsequent color breakdown) before addition to the beverage. The second food technologist also thought that the gelatin encapsulation made the beta-carotene water soluble.

If the former reason were true and gelatin functioned only before addition to a final product, it appears to the writer that FDA regulations would not require gelatin to be labeled on an ingredients statement. However, if the gelatin were functioning to keep the beta-carotene dissolved in water and/or keeping its color stable in the final product, (in which case the gelatin would have a functional role in the final product), it would need to be labeled. If gelatin were operative in both ways, one of which is functional in the finished product, then it appears labeling would be required.

An email response received from the FDA in January 2012 on this question was in agreement with this prediction:

We do not generally make determinations as to whether an ingredient in a particular product is an incidental additive or not.

However, the key as to whether an ingredient is an incidental additive and thus must be included in the ingredient statement is whether the ingredient functions in the finished product. In this case you suggest that the gelatin helps the beta-carotene stay dissolved in the product. It would seem then, that the gelatin is functioning in the finished product to keep the beta-carotene dissolved.

Because The VRG hasn't located a company in the United States that uses gelatin to stabilize beta-carotene in its foods or beverages doesn't imply that no one does. Readers should remember that labeling decisions about whether an incidental additive or processing aid is functional in a final product are made by individual companies which submit their proposals to the FDA. When a dispute arises, or if a petition is made by an individual or another company to the FDA for further investigation, a company may be ordered to change its labeling or what it uses to make its final product.

In most cases, consumers are left to hope that companies are doing all they can to meet "truthful and not misleading" FDA requirements for their labels based on the regulations. However, since there is no legal definition of "vegetarian" or "vegan" in the US, and, therefore, no regulations about it, companies, (and the average consumer), are often left with questions on vegetarian/vegan labeling issues in terms of incidental additives and processing aids. Companies use the regulations that are available (see above) in making their labeling decisions about all substances added to foods and beverages whether they are added directly or indirectly.

It may be asked if, since fish is a major food allergen according to the Food Allergen Labeling and Consumer Protection Act of 2004, (FALCPA), gelatin derived from fish would be required to be labeled even if present as a processing aid, unlike the analogous European law as described above exempts fish gelatin. There is no specific mention of fish gelatin as exempt from labeling according to FALCPA. The only specific exemption from labeling in the case of an ingredient derived from a major food allergen is highly refined oils and ingredients derived from those oils. http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplianceRegulatoryInformation/ucm106187.htm

What makes the situation unusually problematic for "natural" (i.e., not synthesized in a lab) beta-carotene is that it is exempt from being explicitly labeled; "coloring" is sufficient. (See the third column of "color additives" entry in the table at the end of http://www.fda.gov/food/foodingredientspackaging/ucm094211.htm.) In the case of "natural" beta-carotene labeled only as "coloring," it is unclear if gelatin, when present, would need to be labeled especially if there are more than one coloring agent in the beverage.

Further research revealed that there are several formulations of beta-carotene that are all-vegetable and do work well in beverage applications. These are known as "cold water dispersants" or "non-ringing emulsions." We were told that these formulations are more expensive than gelatin-stabilized beta-carotene. A sales representative at a major company that produces beta-carotene ingredients told The VRG that the all-vegetable varieties are "one-third more expensive" than gelatin-containing formulations at the same beta-carotene concentration level. She emphasized that "it's not really the gelatin that determines the price but the beta-carotene concentration and the stability of its matrix."

A sales representative from another other company partially concurred stating: "Regarding cost, the primary driver is the concentration of beta-carotene, not the cost of gelatin versus starch or other ingredients." For example, according to two companies which sell beta-carotene, an all-vegetable, 10% cold water dispersible beta-carotene formulation, encapsulated in dextrin, vegetable oil, sucrose esters, and/or gum arabic, with DL-alpha-tocopherol and ascorbyl palmitate as antioxidants, and silicon dioxide as a processing aid, may cost $140-$195/kilogram.

Companies certainly want their ingredients to be as inexpensive as possible, but, even more importantly, we were told that they want to ensure that the beta-carotene is stable and will remain stable during production and while on the store shelf. A sales representative told us that the process of making an all-vegetable beadlet to carry the beta-carotene is less stable (and, therefore, more costly) that that needed to make a gelatin-carried formulation. The encapsulation itself may break down. Companies are always working to develop encapsulations that won't decompose easily but are inexpensive.

Currently, there are several companies manufacturing all-vegetable beta-carotene products suitable for coloring water-based beverages. Specific formulations suitable for certain applications depend on many factors including juice acidity and desired color intensity. Some companies market their products as animal-free such as this BASF® advertisement describes: "Lucarotin® 10 CWD/O is based on a dispersion of stabilized beta-carotene in vegetable oil. Very fine droplets of this dispersion are embedded in a matrix of modified food starch and glucose syrup. The free-flowing powder product is protein-free and manufactured without ingredients of animal origin."

The VRG would like to remind concerned readers to inquire about ingredients if they have doubts. For example, we located a kosher-certified beta-carotene formulation that was made with porcine gelatin. The colored gelatin is often used to make supplement and pill caplets.

The contents of this article, our website, and our other publications, including the Vegetarian Journal, are not intended to provide personal medical advice. Medical advice should be obtained from a qualified health professional. We often depend on product and ingredient information from company employees or company statements without any guarantee of absolute truth in any case. Information does change and mistakes are always possible. Please use your own best judgment about whether a product is suitable for you. Further research or confirmation may be warranted.

For more information on sources of food ingredients and to purchase our Guide to Food Ingredients, visit the VRG at http://www.vrg.org/ingredients/index.php

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