ARTICLE
22 March 2017

FDA Reopens Comment Period For Notice On Food Color Additive Regulations

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The draft guidance, when finalized, will assist manufacturers in determining whether a color additive derived from a plant material meets the specifications under certain FDA color additive regulations.
Worldwide Food, Drugs, Healthcare, Life Sciences

In the March 1, 2017, Federal Register, FDA reopened the comment period for the draft guidance titled "Fruit Juice and Vegetable Juice as Color Additives in Food," which appeared in the Federal Register on December 14, 2016. Color additives must be approved for use by FDA and must be used only in compliance with the approved uses, specifications, and restrictions set out in FDA regulations. The authorization for the use of fruits and vegetables (21 CFR 73.250 and 21 CFR 73.260, respectively) as color additives in food are limited to the juice from certain fruits and vegetables and under certain conditions. The basis for these color additive regulations is that the fruit or vegetable from which the juice is made has been safely consumed as food. The fact that a plant material can be eaten does not necessarily mean that juice from such plant material meets the specifications of these regulations. Manufacturers have approached FDA about a variety of color additives made from plant materials, and FDA has provided responses on a case-by-case basis. For example, FDA has advised that juice made from purple corn and black carrots can meet the specifications of the vegetable juice color additive regulation, but juice made from safflower petals and hibiscus flowers do not meet the specifications. The draft guidance, when finalized, will assist manufacturers in determining whether a color additive derived from a plant material meets the specifications under certain FDA color additive regulations. Comments are now due May 1, 2017.

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