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Is Elemental Copper Considered GRAS?

March 24, 2015
Question 

Is elemental copper a GRAS item for single use packaging where it may come into contact with food? I can find no direct reference to this on the FDA website. It is curious that other similar items such as glass, stainless steel, and aluminum have been used for centuries in packaging food and there is no mention of them. Are these "prior sanctioned items" that were "grandfathered" into the FDA GRAS items? If they are GRAS, how do you prove it or cite a document?

Answer 

There are several lists of generally recognized as safe (GRAS) substances; however, not all GRAS substances are on these lists since manufacturers are entitled to make their own determination as to whether a substance is GRAS for its intended use in food or in contact with food. Some GRAS substances are listed in the regulations (see Title 21 Code of Federal Regulations (C.F.R.) C.F.R. Part 182, 184, and 186).

FDA also publishes a GRAS Notice Inventory, which provides information about notices filed under FDA's proposed GRAS notification program. Under this program, a company or person may notify FDA that a particular use of a substance has been determined to be GRAS, along with supporting data. After evaluating the notice and supporting data, FDA responds to the notifier by letter.

Cupric gluconate, cupric sulfate, and cuprous iodode are listed or the subject of a GRAS Notice on FDA's website for specified purposes: cupric gluconate as a nutrient and/or dietary supplement; cupric sulfate in paper and paperboard products used in food packaging; and cuprous iodide as a source of dietary iodine in table salt. Whether elemental copper may be used to package food under the Federal Food, Drug and Cosmetic Act and FDA regulations will require investigation based on the intended use and related matters. You should consult legal counsel.