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Regulatory and labeling challenges of natural colors and flavors in the U.S.

colors in test tube
Finding new, natural colors and flavors to replace synthetic agents is only half the battle.

Synthetic coloring and flavoring agents used in foods have periodically come under fire for having potentially adverse effects, especially for children consuming these ingredients. As a result, industry has re-doubled its efforts to develop research into colors and flavors from natural sources.

In the past, industry has been disappointed with naturally derived colors and flavors because they not only lacked vibrance and stability but were very expensive compared to synthetics. Nonetheless, consumers’ purchasing habits still reflect a demand for bold colors and tastes. Just in the past couple of years, a number of large food companies, including Mars, Nestle, and Hershey, have publicly committed to transitioning from artificial to natural colors in their products, adding fuel to the fire in the race for a “clean label” with no artificial ingredients. Industry’s redoubling of research includes the re-examination of old sources, using more modern techniques, and looking at new and unique sources of color, or employing new technologies such as nanotechnology.  

Finding new, natural colors and flavors to replace the synthetic agents is only half the battle. The other half of the battle is proving safety, which was the focus of the early federal oversight of the use of colors in foods, due to the use of blatantly poisonous materials (e.g., lead, arsenic, mercury) being used to prepare coloring ingredients in the late 1800s, and the use of carcinogenic “coal tar” colors of the 1920s. As a result, the modern Food and Drug Administration requirements for a demonstration of safety and eventual approval of any new color ingredients are rigorous. In part to address the issue of poisonous colors being used in food (many times to conceal poor quality food), Congress passed the Food and Drugs Act in 1906, which paved the way for passage of the Federal Food, Drug, and Cosmetic Act of 1938. The FD&C Act provided the current mandatory process for certification of synthetic colors through the FDA, while the later Color Additive Amendments Act of 1960 prescribed the overall stringent process for approval of a food color additive and strict product labeling of added colors.

Today, the process for approval of new color additives requires very specific and comprehensive documentation of identity of the substance, method of manufacture, specifications and use limitations. All additives, including colors, must be fit for consumption, stable, and properly analyzed and labeled. Color additives for food in the U.S. fall into two categories: those that must go through FDA’s batch certification process (generally synthetic organic dyes, lakes or pigments), and those color additives that are exempt from the certification process (generally those additives derived from plant, animal or mineral sources).

In addition to the challenges of a new color or flavor additive approval, the recent focus on “clean label” and the switch by industry to natural substitutes for synthetics increases the likelihood that consumers will “over consume” (consume more than a safe level, or acceptable daily intake) certain natural substances that may have also been approved for other uses (e.g., as a preservative). For example, rosemary extract is increasingly being utilized as an alternative to synthetic antioxidants, particularly for foods and meats. Because no use limitations or acceptable daily intake are stated in its listing in 21 CFR §182.20 as a substance generally recognized as safe, rosemary extract could easily be added for all kinds of reasons to numerous and various foods, resulting in overly high (above the acceptable daily intake) levels of consumption of the extract. When rosemary extract was approved for use, limited only by Good Manufacturing Practice, the use was as a flavor, which are generally added at very low levels. Therefore, food manufacturers and formulators must keep consumption levels of ingredients top of mind when considering reformulating food products, and substituting substances with natural alternatives.

At the Engredea 2016 session entitled “Natural Colors and Flavors: Supply Solutions for Growing Demand," I will discuss these challenges, provide the regulatory definitions of different colors and flavors, discuss the regulatory process to obtain approval for the U.S. market for naturally sourced substances, and give examples of some recently approved food colors. Join us to learn more about how manufacturers and suppliers can work together to overcome regulatory challenges and hurdles, and meet the growing demand for natural colors and flavors.

Ray A. Matulka, Ph.D., is the director of toxicology at Burdock Group, a leading food safety consulting firm, headquartered in Orlando. Dr. Matulka has more than a decade of experience in the analysis of toxicity data and conducting safety and risk assessments.

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