Safety of colorants

This chapter is devoted to a description of the chemistry, applications, and safety of the wide variety of natural and synthetic colorants available today. But another aspect has entered into consideration. Food safety of colorants has usually been considered to be a negative if we ignore the many benefits of making food more attractive in appearance. The recent meteoric rise of the nutraceutical industries has made it possible to claim health benefits for many categories of food including the colorants. Where appropriate, the health claims will be included in this chapter. 

Henkel, J. From Shampoo to Cereal—Seeing to the Safety of Color Additives, U.S. Food and Drug Administration, FDA Website http //vm.cfsan.fda.gov/ dms/cos-221.html, FDA Consumer, December 1993.. 

In general, concerns over the safety of coloring agents in pharmaceuticals and foods are associated with reports of hypersensitivity " and hyperkinetic activity, especially among children. ... 

Color Additive Amendment required manufacturers to establish safety of color additives in foods, drugs, and cosmetics and prohibited the use of any color additive shown to induce cancer as per the Delaney Amendment noted above. 

In 1899, the National Confectioners Association published a list of unfit colorants for foods. This was the first time that any group addressed the issue of safety of colorants. Unfortunately, this was not very effective. In August, 1904, the... 

The most popular natural antioxidants on the market are rosemary extracts and tocopherols. Natural antioxidants have several drawbacks which limit use. Tocopherols are not as effective ia vegetable fats and oils as they are ia animal fats. Herb extracts often impart undesirable colors or flavors ia the products where used. In addition, natural antioxidants cost considerably more than synthetic ones. Despite this, the pubHc s uncertainty of the safety of synthetic antioxidants continues to fuel the demand for natural ones (21). 

Orga.nic Colora.nts. The importance of coal-tar colorants cannot be overemphasized. The cosmetic industry, in cooperation with the FDA, has spent a great deal of time and money in efforts to estabUsh the safety of these dyes (see Colorants for food, drugs, cosmetics, and medical devices). Contamination, especially by heavy metals, and other impurities arising from the synthesis of permitted dyes are stricdy controlled. Despite this effort, the number of usable organic dyes and of pigments derived from them has been drastically curtailed by regulatory action. 

Recently there have been a variety of suppliers with chemical peel kits claiming ease of use and increased efficacy. These proprietary kits vary from the vehicle used in delivering the TCA to having color indicators to inform the physician of a peel s completion. Caution should be used when using such kits as many times the physician loses the ability to easily assess the degree of frosting and in turn the depth and safety of the chemical peel. 

Lobbying by other P-carotene producers — In addition to approvals of mixed carotenes from palm oil, P-carotene from Dunaliella microalgae, and other natural products, the EU Health and Consumer Protection Directorate General was asked for an opinion on the safety of P-carotene from a dried biomass source, obtained from a fermentation process with Blakeslea trispora for use as a coloring matter for foodstuffs. 

The current trend in analytical chemistry applied to evaluate food quality and safety leans toward user-friendly miniaturized instruments and laboratory-on-a-chip applications. The techniques applied to direct screening of colorants in a food matrix include chemical microscopy, a spatial representation of chemical information from complex aggregates inside tissue matrices, biosensor-based screening, and molec-ularly imprinted polymer-based methods that serve as chemical alternatives to the use of immunosensors. 

The official permission to use a synthetic colorant in food is determined by its quality and safety. Detailed and accurate analysis became compulsory in order to verify purity and quantify the labeled concentrations of colorants in food. For the analysis of synthetic colorants added to food products, (1) simple and rapid methods are used to determine their presence, (2) accurate and precise methods evaluate then-concentrations, or (3) certain methods evaluate their degradations to unstable and unsafe forms. This chapter is dedicated to these three methods used to identify and quantify synthetic colorants as pure or mixed pigments in foodstuffs. 

Part 70 Color additives — This part includes a definition of a color additive, restrictions on use of color additives, packaging and labeling requirements, and safety evaluation of color additives. 

In order to control food color, underlying mechanisms cansing variation in color must be understood. Three types of colorants can be distinguished from the perspective of quality and safety control natural colorants, formed colorants, and color additives. Depending on the type of colorant, specific strategies are required to control dynamics of colorants and achieve constant qnality in terms of safety, desired color, appearance, and health (Section 7.1.3). The extent to which underlying food color-affecting mechanisms are understood determines how well the quality of food color can be predicted. 

The approved color additives appear on positive lists issued by the Food and Drug Administration in the US, the EU, and Japan, but the colorants permitted in each market vary considerably. US and EU regulatory organizations provide provisional and permanent lists of approved color additives. The permanently listed additives are considered safe for use in cosmetic and toiletry products by the regulatory bodies. Provisionally listed color additives are those on which some safety studies are still to be undertaken or their test results are under review. The Japanese regulations include only a permanent list of color additives. 

According to the 21 CFR 73, the FDA coordinates the color additive regnlations and imposes the safe nse of each food colorant. In 1993, the FDA pnblished the Redbook of Colorants, which sets forth the toxicological principles for safety assessments of direct food and color additives used in foods, and a review of the statns of food additives in the US was pnblished. ... 

Prancis, P.J., Safety of natural food colorants, in Natural Food Colorants, Hendry, G.A.P. and Houghton, J.D., Eds, Blackie, Glasgow, 1996. 

Surfactants are useful in formulating a wide variety of disperse systems. They are required not only during manufacture but also for maintaining an acceptable physical stability of these thermodynamically unstable systems. Besides the stabilizing efficiency, the criteria influencing the selection of surfactants for pharmaceutical or cosmetic products include safety, odor, color, and purity. 

Whenever ambient noise levels are above emergency alarm signals or tones, flashing lights or beacons should be considered that are visible in all portions of the affected area. The color of flashing lights should be consistent with the safety warning colors adopted at the facility. 

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