Color Additives Amendments

Through the efforts of the Certified Color Industry and the FDA, a new law was formulated, the Color Additives Amendments of 1960 (PubHc Law 86-618) (21). The amendments provided a breathing speU by allowing the continued use of existing color additives pending the completion of... 

The 1938 law required colorants on the permitted list to be harmless and suitable for food but the FDA interpreted harmless to mean harmless at any level and this proved to be unworkable. The Color Additive Amendment of 1960 eliminated the harmless per se interpretation and resulted in a list of nine permitted colorants. The list was reduced to eight with the delisting of FD C... 

Red No. 3 in 1998 (Fig. 8.1). Colorants in the three categories above were termed certified colorants but the Color Additive Amendment also set up a category of exempt colorants which were not subject to the rigorous requirements of the certified colorants. There are 26 colorants in this category (Table 8.1) and they comprise most of the preparations which would be called natural in other countries. The US does not officially recognize the term natural but it is often used in the popular press. 

Over the years that followed, an overwhelming majority of the primary dyes used in food came from certified lots. Both the number of batches and the total pounds certified grew steadily over the life of the Wiley Act. Thus the voluntary certification plan worked reasonably well. With the enactment of the Food, Drug, and Cosmetic Act of 1938, food color certification became mandatory. Although somewhat modified, in response to changed scientific standards, by the Color Additive Amendment of 1960, Hesse s procedures remain today the basis of American regulatory policy. 

In the United States two classes of color additives are recognized colorants exempt from certification and colorants subject to certification. The former are obtained from vegetable, animal, or mineral sources or are synthetic forms of naturally occurring compounds. The latter group of synthetic dyes and pigments is covered by the Color Additives Amendment of the U.S. Food, Drug and Cosmetic Act. In the United States these color compounds are not known by their common names but as FD C colors (Food, Drug and Cosmetic colors) with a color and a number (Noonan 1968). As an example,... 

Color Additive Amendment of 1960 Federal Food, Drug and Cosmetic Act. Section 706 (b) (5) (B) A color additive that will result in ingestion shall be deemed unsafe, and shall not be listed,. .. if, after tests which are appropriate for the evaluation of the safety of additives for such use or after other relevant exposure of man or animal to such additive it is found by the Secretary to induce cancer in man or animal. ... 

The 1960 Color Additives Amendment also listed those color additives that need to be certified and those that are exempt from certification. The law establishes that color additives can be used under provisional listings imtil scientific investigations determine that they are suitable for permanent listing. See Tables 1 and 2 for a listing of permanently and provisionally listed colorants.f ... 

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. 

This interpretation was upheld by the Supreme Court in 1958 ( ) and ultimately led to enactment of the Color Additives Amendment of 1960, which required that color additives only be shown to be "safe" under their conditions of use.(22)... 

Copper Chlorophyll. Current efforts to improve the green color of processed foods include the use of copper complexes of chlorophyll derivatives. Copper complexes of pheophytin and pheophorbide are available commercially under the names copper chlorophyll and copper chlorophyllin, respectively. Their use in canned foods, soups, candy, and dairy products is permitted in most European countries under regulatory control of the European Economic Community (47). The Food and Agriculture Organization (FAO) of the United Nations (48) has certified their safe use in foods provided that no more than 200 ppm of free ionizable copper is present. Use of copper-containing chlorophyll derivatives in foods is not allowed in the United States under the Color Additive Amendment to the Food, Drug, and Cosmetic Act of 1938. 

The Food Additive Amendment of 1958, the Color Additives Amendment of 1960, and the Animal Drugs... 

The Color Additive Amendment of 1960 regulates the listing and certification of color additives. About 1,700 samples are examined annually by FDA scientists. 

Colorants can be divided into two groups those listed for use and those provisionally listed. Listed additives are colors that have been sufficiently evaluated to convince FDA of their safety for the applications intended. These colorants are also known popularly as permanently listed colorants however, they in fact can be delisted for sufficient cause. Provisionally listed colorants, on the other hand, are dyes and pigments that are not considered unsafe but that have not undergone aU the tests required by the Color Additives Amendments of 1960 to establish their eligibility for permanent listing. Currently, these colors can still be used in those applications in which they were used prior to enactment of the 1960 amendments, unless newer temporary regulations restrict their use further. The... 

There are two classes of color additives, those that must be certified and those that are exempt from certification. Both are strictly controlled in the United States by regulatory statutes (Food Color Additives Amendments), but an official certificate is required for each commercial batch of color of the first group, while no such certificate is necessary for the second group. For certification the manufacturer must submit a sample of the batch to the Food Drug Administration for chemical analysis. The results of the analysis are compared with the specifications for certified colors published in the Code of Federal Regulations. If the compliance is complete, a certificate is issued for that particular batch of color. 

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