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What Good Manufacturing Practice (GMP) Requirements Apply to Food-Contact Substances?

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What Good Manufacturing Practice (GMP) Requirements Apply to Food-Contact Substances?


For compliance with the FDA's indirect Food Additives, 21 CFR 174.5, do additives/raw materials that will be used to manufacture color concentrates in thermoplastics for use in food contact applications need to be manufactured using cGMP, or is the cGMP really for the manufacture of the packaging itself? For instance, a stearic acid is an ingredient in a color concentrate that will be used in the manufacture of a (177.1210) closures with sealing gaskets for food containers. The stearic acid is of a suitable purity but it has not been manufactured following the cGMP guidelines, can it still be used? It appears in 21 CFR 174.5 that the reference to good manufacturing practice is for the use of the additive, not for it's manufacture.


Any food packaging material intended to come in contact with food must comply with the Food and Drug Administration's (FDA) good manufacturing practices (GMP) regulation, found in Title 21 of the Code of Federal Regulations (C.F.R.) Section 174.5 ("General provisions applicable to indirect food additives"). Section 174.5 implements Section 402(a) of the Federal Food, Drug, and Cosmetic Act, which prohibits the adulteration of food. GMP requirements apply to both the use level of an additive, as well as its suitable purity. This means that additives may only be used in an amount necessary to achieve its function or purpose, and must also not contain impurities at levels sufficient to adulterate the food.

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