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Simple Additions

Colored Test Tubes Colored Test Tubes

Clean and natural are now the rule for added food colorings and flavorings.

Non-GMO Project

In response to the growing health awareness and food safety concerns, consumers are now inclined to seek authenticity in their choices and therefore are seeking products with simple, natural, non-GMO (genetically modified organism) or recognizable ingredients. This has led to the “clean label” culture, which is gaining momentum and getting more prominent in Europe, North America and Asia over the past decade.

“This clear change in consumer behavior has prompted food manufacturers to switch to natural ingredients to meet market demand. It is inevitable,” said Bryan See, regional product manager with New Jersey-based ExcelVite Inc. “Large multi-national food and beverage manufacturers, such as Nestle, General Mills and Kraft to name a few, have started reformulating their products with natural colors and flavors. Additionally, major fast food chains such as Pizza Hut and Subway are jumping on the bandwagon by removing synthetic colors or flavors in food preparation in order to meet consumer’s growing demand for clean label and to know what’s inside the food they consume.”

Ingredients to Watch

In 2007, a study published in The Lancet by researchers at the University of Southampton linked increased levels of hyperactivity in young children consuming mixtures of some artificial food colors. The European Food Safety Authority (EFSA) subsequently recommended further safety tests on the six synthetic food dyes— the so-called “Southampton Six.” This has led to a E.U.-wide mandatory warning labeling for any food and drink (except drinks with more than 1.2 percent alcohol) that contains any of these six artificial colors. Foods containing tartrazine (E102), quinoline yellow (E104), sunset yellow (E110), carmoisine (E122), ponceau 4R (E124) and allura red (E129), will have to be labeled “may have an adverse effect on activity and attention in children.”

“With this new enforcement, manufacturers have begun working toward finding natural alternatives to these colors,” See noted. “Most manufacturers and retailers have taken action to remove them and replace them with natural coloring agents.”

In terms of replacing artificial colors in the range of yellow-orange—particularly Tartrazine (E102) and Sunset Yellow (E110), said See, ExcelVite’s EVTene natural palm mixed carotenoids extracted and concentrated from sustainable and non-GMO Malaysian palm oil is a natural switch and gaining popularity. “Malaysian virgin crude palm oil contains high levels of carotenes in terms of retinol equivalents. It has up to 300 times as many retinol equivalents as carrots, leafy green vegetables and tomatoes,” he added. EVTene contains natural beta-carotene, alpha-carotene, gamma-carotene, lycopene and other minor carotenoids. “This unique mixture of carotenoids is commonly found in fruits and vegetables, presenting not one single carotene but a wholesome array of carotenoids. Therefore, EVTene is a true mixed carotene complex with the highest level of alpha-carotene in the market. What makes EVTene unique is that its carotenoids composition mirrors that of carrots.”


At ExcelVite, the common request/certification from clients are GRAS (generally recognized as safe) and E-Number, See explained. Palm Carotenoids Complex is self-affirmed GRAS with no objection letter from the U.S. Food and Drug Administration (FDA) (GRAS No. 320), and it can be used as a natural ingredient in functional food and beverage products. Furthermore, it is a natural extract (carotene) derived from palm fruits that comply with E.U. Commission Regulation No.231/2012:E160a.

“Being the only GMP (good manufacturing practice)-certified manufacturer of palm phytonutrients, tocotrienol complex and carotenoid complex, ExcelVite has taken the initiative to submit our EVTene ingredient series for Non-GMO Project Verification and currently, our EVTene 10% (H), EVTene 15% and EVTene 20% are Non-GMO Project Verified,” See said, adding that these ingredients are also kosher- and halal-certified.

“These attributes and certification position EVTene natural mixed carotenoid complex as the natural choice of functional ingredient (pro-vitamin A and antioxidant properties) as well as colorant in various food and drink systems,” he added.

“We are definitely seeing a departure of the market from using artificial colors and moving toward ‘coloring foods with food’ driven by strong consumer demands,” See noted. “EVTene fits right into this trend as it is extracted from a food (i.e. palm oil) and used to color another food/drink.”

Regulatory Awareness

Laurie C. Dolan, PhD, a senior toxicologist at Burdock Group, a food-safety consulting firm headquartered in Florida, pointed out that with many potential uses of new “natural colorings” manufacturers need to remember that all color additives are considered “artificial,” even if derived from a natural source, and require pre-market approval by the color additive petition process. “If a substance is deliberately added for its color, it is a color additive—even if it is a natural substance like beet juice,” she said.

“If an ingredient is used for another purpose (such as a flavor) and it will impart color to food at the anticipated usage rate, a color additive petition should be filed; otherwise the FDA may consider your ingredient an unapproved color additive. Only color additives that are listed in the Code of Federal Regulations (CFR) and meet all requirements of the regulation may legally be used in food products in the United States,” she noted. “All other color additives are not permitted. So, if you would like to use a certain color, the first thing to do is to see if it is listed in the CFR. If it is not listed, you cannot use it until it obtains approval via the color additive petition process and is listed in the CFR. If it is listed and does not meet all requirements of the regulation, it also cannot be used legally in food until it is approved as a color additive. Regulations for some color additives require specific methods of manufacture, limits on impurities and restrictions in use. All color additives must also meet regulations governing adulteration and labeling.”

Dolan explained that FDA recognizes “natural” flavors if they meet the definition in 21 CFR 101.22 (a)(3). “The hurdles to overcome with natural flavors are similar to colors. But for flavors, limitations for method of manufacture, specifications and use are not necessarily stated in a CFR regulation,” she noted. “They may be present in a food additive petition, GRAS dossier or JECFA evaluation.”

So, users need to consult all potential sources of regulatory information on flavors before deciding to use a particular flavor, Dolan added. “Some substances present in natural flavors are on the proposition 65 list. Natural substances inherent in food, not added by human activity and present at their lowest feasible levels are exempt. It is unclear where natural flavors lie – no guidance has been issued. Whether or not they are exempt may be dependent on whether they are inherently part of a particular food or added to a food. Regarding labeling, if a food contains a characterizing ingredient and flavor comes from it, the word natural can be used before the flavor. The term natural can’t be used if the flavor is added to a food that does not contain the flavor. In Vermont, the term natural is prohibited if the food contains a genetically modified ingredient unless the ingredient makes up <0.9 percent of the food weight.”

The Trouble With Natural

Natural colorings commonly faced color stability issues, which translate to short shelf life when developed into a product. In addition, natural colorings are more expensive to produce when compared to synthetic colors, so ingredient producers have increased their research efforts to address these issues.

“At ExcelVite,” said See, “we developed different delivery forms of EVTene natural mixed carotenoids complex. These are oil concentrate, water dispersible powder and water soluble emulsion—to cater for applications in a wide range of functional food and beverage formulations.”

As an example, ExcelVite’s EVTeneSem, cold water soluble natural mixed carotenoids emulsion can be diluted to different concentrations to provide color shades ranging from dark orange to light yellow. From the company’s in-house study, EVTEneSem does not produce “ringing” or turn cloudy; it is suitable for a clear beverage formula.

Natural Benefits

EVTene is a natural food colorant with nutritional benefits, derived from plant. The benefits include natural claim (clean label), extracted from a food, GRAS-approved, non-GMO, stable and clear in formulation as well as kosher- and halal-certified.

By using EVTene in food and beverage formulations, manufacturers can declare using natural colorings from food—“Clean Label.” Furthermore, the provitamin A and antioxidant properties of alpha-carotene and beta-carotene provide health benefits in terms of prevention of vitamin A deficiency (improve eye health vis-à-vis night blindness), and reduction in risk of some chronic diseases, respectively.

Recently, the prestigious British Medical Journal’s Open Diabetes Research and Care (Sugiura M, et al., 2015) published a first longitudinal cohort study that demonstrates that long term high consumption of carotenoids especially pro-vitamin A carotenoids (alpha-carotene, beta-carotene and beta-cryptoxanthin) reduces the risk of type 2 diabetes in middle aged and older Japanese patients. The results show that high concentration of carotenoids especially alpha-carotene, beta-cryptoxanthin and total Provitamin A carotenoids (alpha-carotene, beta-carotene and beta-cryptoxanthin) significantly reduce the risk of type 2 diabetes development. The inverse association between serum carotenoid and risk of type 2 diabetes is not only observed in non-smokers and non-drinkers, but also in light drinkers. Interestingly, other carotenoids such as lutein, lycopene exhibited inverse association, but the association is not significant.

Another new study, published in the European Journal of Nutrition (Min KB & Min JY. 2016), shows that increased level of blood carotenoids (i.e.: high consumption of carotenoid-rich foods) increases telomere length. Telomere length is a biomarker for age-related diseases. Shorter telomere length is associated with aging, cancer and a higher risk of developing age-related disease and vice versa.

A new and largest nested case-control study to date (American Journal of Clinical Nutrition, (Bakker MF, et al., 2016)) demonstrates that high plasma concentration of carotenoids (alpha-carotene and beta-carotene) lowers the risk of developing estrogen receptor-negative (ER-) breast cancer (i.e.: growth of cancer cells that is independent of estrogen hormone). This largest epidemiological study provides an insight into the significant role that alpha-carotene and beta-carotene play in the etiology of breast cancer. Among the biomarkers analyzed, the breast cancer risk was significantly reduced by 39 to 59 percent when comparing the highest concentration of plasma alpha-carotene and beta-carotene with the lowest concentration among ER-negative breast cancer females. In addition, there was a significant inverse association between plasma beta-carotene and ER-/PR- (progesterone receptor-negative) patients. However, plasma vitamin C, zeaxanthin and retinol did not show significant protective effects against breast cancer. NIE


Bakker MF, et al. (2016). Plasma carotenoids, vitamin C, tocopherols and retinol and the risk of breast cancer in the European Prospective Investigation into Cancer and Nutrition cohort. Am J Clin Nutr., doi:10.3945/ajcn.114. 101659.

Min KB & Min JY. (2016). Association between leukocyte telomere length and serum carotenoid in U.S. adults. Eur J Nutr., doi:10.1007/s00394-016-1152-x.

Sugiura M, et al. (2015). High-serum carotenoids associated with lower risk for developing type 2 diabetes among Japanese subjects: Mikkabi cohort Study. BMJ Open Diabetes Research & Care:e00147, doi:10.1136/ bmjdrc-2015-000147.

For More Information:
Burdock Group, (407) 802-1400
ExcelVite Inc., (732) 906 1901