Colorant testing regulations

The disputes that followed these events centered around interpretation of the 1938 act, which states that "The Secretary shall promulgate regulations providing for the listing of coal-tar colors which are harmless and suitable for use in food..." The FDA felt that harmless meant that a colorant must be safe regardless of the amount used, that is, harmless per se and on this basis deHsted the colorants in question. The food-color manufacturers argued that the FDA interpretation of the law was too strict, that a color additive need only be harmless when properly used, and that the FDA should estabHsh safe limits. They also contended that the conditions used for the new animal feeding tests were too severe. 

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. 

Test article (FDA) Any food additive, color additive, drug, biological product, electronic product, medical device for human use, or any other article subject to regulation under the FFDCA or PHSA. 

The types of scientific tests needed to estabhsh safety are dependent on the nature of the regulated product and its proposed use. A product such as a food or color additive will require tests to elucidate the potential of the product to induce adverse acute, subchronic, and chronic effects. The safety tests are generally performed in animals and other biological systems. Both the t5rpes of tests and the methodology of particular tests have changed over the years with scientific advances in the field of toxicology. 

The FDA regulations or guidelines prescribe the types of safety tests for a particular product. Sponsors may conduct the studies in their own laboratories or have them performed by a contract laboratory, a university, or some other type of laboratory. The sponsor submits the study reports to the FDA in food and color additive petitions, investigational new drug applications, new drug applications, new animal drug applications, biological product license applications, and other requests for permission to market a product. 

Other publications, which include "Interstate Commerce Commission Rules and Regulations for the Transportation of Explosives and Other Dangerous Articles , and ASTM (American Society for Testing and Materials) Dl209-69 publication, entitled "Standard Method of Test for Color of Clear Liquids (Platinum-Cobalt Scale) are listed in the same Spec... 

Regulation also limits the levels of permitted impurities in color additives. Detailed standards of quality and purity have been incorporated into regulatory requirements, establishing maximum amounts of organic impurities such as subsidiary dyes and residues of starting materials, intermediates, or other contaminants. Each batch of color made must be tested for compliance with chemical specifications in order to be certified (130,142,151). Therefore, there is a need for rapid and reliable techniques to separate the dyes from impurities and to monitor the quality of commercial dyes (154). 

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