Listed colorants

Food coloring is restricted by law to prevent misuse that may lead to deception of consumers related to reduced value or usability. For this purpose, the European Union implemented food colorant guidelines in 1994 based on the understanding that food coloration presents a technological need. While European Parliament and Council Directive 94/36/EC lists colors and their uses in food, the European Commission Directive 95/45/EC contains specific purity criteria for colors in foodstuffs, e.g., a maximal lead content of 20 ppm. " ... 

Part 71 Color additive petitions — These regulations describe the pre-market approval process for new color additives or new uses for listed color additives. ... 

Part 73 Listing of color additives exempt from certification — This part identifies listed color additives exempt from certification, provides chemical specifications for these color additives, and identifies uses, restrictions, labeling requirements, and requirements for certification. 

Part 82 Listing of certified provisionally listed colors and specifications —... 

This part identifies listed color additives, provides chemical specifications for the color additives, and identifies uses and restrictions. 

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. 

Prepare a table as follows. Along the left side of a sheet of paper in a vertical column, list Glaze 1, Glaze 2, Glaze 3, Glaze 4 across the top, list color, opaque or transparent, texture. Record your observed properties for each glaze. 

From the original 1960 catalog of about 200 provisionally listed colors, which included straight colors and lakes, only lakes of some colors remain on the provisional list. Industry withdrew or the FDA banned... 

Government regulations concerning the use of color additives change frequently, thereby making it difficult to be complete and accurate in listing colorants for use in international pharmaceutical development. 

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 ... 

Table 1 List of permanently listed color additives subject to U.S. certification in 2000 ...

Table II Permanently listed color additives subject to US certification in 2002, excluding those approved exclusively for use in medical devices.

Provisionally listed color additives subject to US certification in 2002. 

The Federal Food and Drug Administration (FDA) regulates the use of food colors and food contact colors in the United States. Food colors must be approved in an extensive petition process with the FDA. There are two methods by which food contact colors can be used. First there is the traditional food additive petition for use of a food contact substance. If successful, this process leads to listing in the Code of Federal Regulations (CFR) as a new color available for various substrates. Restrictions may be applied to the use of listed colors. The CFR should be consulted and... 

Art. 22 refers to the Ordinance on Cosmetic Ingredients as last amended 31 January 2000, which lists colorants with certain specifications under which these are permitted and also lists certain dyes and organic pigments which are excluded from cosmetic products. 

REGULATIONS GOVERNING USE 14.7.1. Listed and Provisionally Listed Colorants... 

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... 

Most colorants in use today have specifications that must be met before they can be sold. In the case of the provisionally listed colors, these specifications may be revised if and... 

Listed color(ant)s Color additives that have been sufficiently evaluated to convince the Food and Drug Administration of their safety for the application intended. 

TABLE V Permanently Listed Colors Exempt from Certification... 

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