Colorant testing toxicity data

In the case of noncompendial materials, specifications and complete descriptions of the test methodologies to be used for quality control release purposes by the sponsor should be included. In addition, it may be necessary for the sponsor to obtain a letter authorizing reference to a DMF from the supplier concerning the manufacturing and controls procedures used to make these materials, such as mixtures of colorants or flavors. It may be necessary to obtain toxicity data if the mixture or component has little or no history of human use (e.g., new polymers). If it is anticipated that an untried component will be used, it is recommended that discussions be initiated with the FDA s reviewing chemist and pharmacologist. These sessions should be scheduled as soon as possible to minimize the possibility of delays in NDA approval caused by inadequate information to support use of the material. 

In the US, a request to authorize a new food additive is presented to the FDA. A petition for an additive or a colorant must include data pertaining to the toxicity of the additive accompanied by toxicological tests on animals and even on humans. To evaluate whether an additive should be approved, the agency first considers the composition and attributes of the substance, the probable amount that will be ingested, the possible long-term effects on consumers and various additional safety factors. If the additive is approved, the FDA publishes regulations that may include the types of foods in which it can be used, the maximum quantities that can be added, and how it should be identified in the food labels. 

In heavy-metal analysis of the same pigments, metals found were present in only trace amounts. The data Hsted place the products tested in the category of nontoxic materials. The Radiant Color Co. has conducted toxicity tests on its own products similar to the A-Series and has found them to be nontoxic. Heavy metals were found only in trace amounts in these tests. 

Of course, many of these toxicity and environmental questions can be answered by the colorant vendor who will supply MSDSs (material Safety Data Sheets) and other safety and test data. In those cases where sufficient information about a particular compound is not available, it may be necessary to search one or more of the toxicity databases for analogous structures which have been examined for their toxic effects and use this information as a basis for making a judgment about the suitability of the colorant in question. These databases which are easily computer searchable include Registry of the Toxic Effects... 

When a new color is to be introduced, the petitioner is expected to provide data proving that the new additive is safe and effective. The safety tests are elaborate and expensive. They include chronic toxicity feeding tests with two animal species over several generations. The effectiveness tests include long-term color stability experiments in the foods to which the color is to be added. 

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