Synthetic colorants regulation

Hair Coloring Regulation Issues. In the United States the classification of color additives is complex. Under the Federal Food, Dmg and Cosmetic Act, all cosmetic colors must be the subject of an approved color additive petition to the Food and Dmg Administration there is an exception for coal-tar colorants used to color hair. Based on the composition of these colorants, FDA can require a certification on each manufactured batch of colorant to assure conformance with the approved specifications. In the early 1990s FDA has required certification only for synthetically derived coal-tar type colors. Many of the approved color additives, both certified and noncertified, are restricted ia their potential use. These restrictions can be found ia the color additive regulations ia the Code of Federal Regulations at 21 CFR 73 and 74. 

Considering the concerns of consumers for synthetic colorants and interest in natural formulas, many food manufacturers seek alternative healthy solutions to replace colorants, even the regulated ones from positive lists (like p-carotene), with colored fruit and vegetable extracts to be used as functional food ingredients or nutraceuticals (food supplements). ... 

LIST OF SYNTHETIC COLORANTS USED (EU AND FDA REGULATIONS) AS FOOD ADDITIVES... 

The Establishment of Synthetic Food Color Regulation in the United States, 1906-1912... 

The colors of foods are the result of natural pigments or of added colorants. The natural pigments are a group of substances present in animal and vegetable products. The added colorants are regulated as food additives, but some of the synthetic colors, especially carotenoids, are considered nature identical ... 

Early uses of synthetic colors were at times a threat to health because they were used without discrimination between those that were toxic and those that were safe. Increasing public concern around the world led to early studies and regulations that produced various lists of colors found suitable for addition to foods and drugs. 

Recent discussions within the EU have indicated that the colorant list from 94/36/EC will be rationalized into a new pharmaceutical color directive in the future so that the colorant lists will be aligned. It is now considered acceptable to use these colors in new drug applications even though the formal directives have not yet been finalized. However, each country may have some specific regulations for the use of these colorants in pharmaceuticals that must also be considered. Some non-member European countries, such as some Scandinavian countries, severely restrict the use of synthetic colors and in some cases oppose their use entirely. 

The synthetic organic dyes are superior to the natural colorants in consistency of strength, range and brilliance of shade, stability, ease of application, and cost-effectiveness. However, the manner in which synthetic colorants are employed, from a safety viewpoint, has much to be desired. Therefore, regulations were introduced to control the use of these added food colorants. 

Of all the food additives, perhaps the addition of colors is the hardest to justify. Many people feel that foods have a natural color, so why tamper with it. Indeed, color additives have met strong opposition and regulations have been passed banning some and restricting the use of others. Most of the opposition and regulation involves the synthetic colors, while the natural colors receive less attention. However, 90% of the colors used in food come from a small group of synthetic colors, while the diverse group of natural color sources is used in about 1 0% of foods only. 

C. Cal2olari, L. Coassini, and L. ToUat, QuademiMerceol 1, 89—131 (1962). Synthetic Food Colors. Reviews the regulation of food colors in various countries, the toxicity of the intermediates used to prepare them, and the toxicity of the degradation products of colorants. 

S. H. Hochheiser, Synthetic Foods Colors in the United States A. History Under Regulation, University Microfilms International, 83-04269, Ann Arbor, Mich., 1986. An excellent history of the development of legislation to control colorants used in foods, dmgs, and cosmetics. 

Color Additives. The FDA has created a unique classification and strict limitations on color additives (see also CoLORANTS FOR FOOD, DRUGS, COSMETICS, AND MEDICAL DEVICES). Certified color additives are synthetic organic dyes that ate described in an approved color additive petition. Each manufactured lot of a certified dye must be analyzed and certified by the EDA prior to usage. Color lakes are pigments (qv) that consist of an insoluble metallic salt of a certified color additive deposited on an inert substrate. Lakes are subject to the color additive regulations of the EDA and must be certified by EDA prior to use. Noncertifted color additives requite an approved color additive petition, but individual batches need not be EDA certified prior to use. 

Colorants were the first food additives subjected to governmental regulation in the United States (US). After successive toxicological evaluations, the Food and Drug Administration established a list of permitted colorants and lakes. Only 7 synthetic pigments (and 2 others with restrictions) and 6 of their lakes are now permitted as food colorants in the US while 17 are permitted in the European Union (EU) see Table 7.3.L - ... 

In the food industry, synthetic dyes can be used also in the form of lakes obtained by precipitation of a soluble colorant onto an insoluble base. There are several insoluble bases, but only alumina is permitted for food application by FDA and EU regulation. All the synthetic food dyes can be obtained and used in food in the form of aluminium lakes, except erythrosine due to concerns about inorganic iodine content. 

The structures of four of the synthetic carotenoids (beta-carotene, canthaxanthin, beta-apo-8 -carotenol, beta-apo-8 -carotenoic acid) are shown in Fig. 8.2. By virtue of their conjugated double bond structure, they are susceptible to oxidation but formulations with antioxidants were developed to minimize oxidation. Carotenoids are classified as oil soluble but most foods require water soluble colorants thus three approaches were used to provide water dispersible preparations. These included formulation of colloidal suspensions, emulsification of oily solutions, and dispersion in suitable colloids. The Hoffman-LaRoche firm pioneered the development of synthetic carotenoid colorants and they obviously chose candidates with better technological properties. For example, the red canthaxanthin is similar in color to lycopene but much more stable. Carotenoid colorants are appropriate for a wide variety of foods.10 Regulations differ in other countries but the only synthetic carotenoids allowed in foods in the US are beta-carotene, canthaxanthin, and beta-8-carotenol. 

This paper is adapted from Chapter II of my Ph.D. dissertation at the University of Wisconsin-Madison, "Synthetic Food Colors in the United States A History Under Regulation" (1982). I wish to thank my major professor, Aaron Ihde, and the other official readers of the dissertation, John Parascandola and Stanley Schultz, for their helpful suggestions for improving the original draft. 

Iron oxide pigments produced from pure starting materials may be used as colorants for food and pharmaceutical products [3.42], Synthetic iron oxides do not contain crystalline silica and therefore are not considered to be toxic, even under strict Californian regulations. 

Legislation covers all chemicals, including dyes. Only the use of chemicals and colorants in foodstuffs, food-packaging materials, or pharmaceuticals is mentioned here. The exposure level of dyes is generally very low, but people are inadvertently exposed to dyes and other synthetic chemicals for these applications through dermal contact. Therefore, the use of colorants is especially regulated in many countries. General requirements on dyes for the incorporation into packa-... 

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