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Toxicology Requirements

What substances must be tested for an FCN?

Mar 2001

Question: What substances must be tested for an FCN?

Answer: Generally, the test substance should be identical to the substance expected to migrate to food. The toxicity testing requirements apply to the food-contact substance and to any constituents (e.g., raw materials, byproducts, or decomposition products) expected to migrate to food.

For a polymer, toxicity testing should be conducted on the low-molecular weight (oligomer) fraction, where feasible. However, if the monomers are not genotoxic, oligomer testing may not be needed. Also, for most polymer adjuvants, testing is conducted on the food-contact substance itself. However, if the food-contact substance decomposes in food-contact articles or food (hydrolysis products, or oxidation products for antioxidants, for example), the decomposition products should be tested.

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