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U.S. Regulation of Food Colors

U.S. Regulation of Food Colors2018.10.18

In the United States, the act states that a material otherwise meeting the definition of color additive to be exempt from section 721 of the act, on the basis that it is used (or intended to be used) solely for a pur-pose or purposes other than color-ing, the material must be used in a way that any color imparted is clearly unimportant insofar as the appear-ance, value, marketability, or con-sumer acceptability is concerned. (It is not enough to warrant exemption if conditions are such that the pri-mary purpose of the material is other than to impart color.)


Plainly stated, if the purpose of an addi-tive is to change the color of a food, then the additive is a color. As a color, it has to be approved as a color for use in food by the Food and Drug Administration.


Two main categories make up the FDA’s list of permitted color additives. They are the certified color additives and the exempt-from-certification color additives. The certified color additives are primarily man-made synthetic organic colors. The manufacturer submits a sample of the batch for certification, and the FDA tests the sample to determine whether it meets the color’s requirement for composition and purity. When the batch is approved, the FDA issues a certified lot number to the batch, and the manufacturer can then sell the product. The name is changed to its unique FD&C nomenclature. Only then can that lot be used to make FDA-regu-lated colors. Following is the list of color additives subject to certification:

•FD&C Red #3
•FD&C Red #40
•FD&C Yellow #5
•FD&C Yellow #6
•FD&C Green #3
•FD&C Blue #1
•FD&C Blue #2
The exempt color additives are largely from plant, animal or mineral sources, or are synthetic variations of naturally occur-ring colorants. While not subject to batch certification, they are still artificial color additives and must meet the requirements for composition and purity as listed in the Code of Federal Regulations. Some of the colors exempt from certification are limited to certain classifications of food products or certain usage levels. It is important to check 21 CFR Section 73 for these limita-tions. The common color additives exempt from certification are shown in Figure 1.


In the United States, color additives are required to be labeled. Certified colors must always be declared by name in the ingredient statement. It is not necessary to include the FD&C prefix or the term No.in the declaration, although the term lake must be included where applicable (e.g., Yellow 5, Blue 1 Lake).


Exempt-from-certification colors are described in 21 CFR Part 73. Labeling options for most exempt-from-certification colors are varied, and include the following:
•artificial color
•artificial color added
•color added


FDA also allows for alternative equally informative terms, as long as it is clearly indicated that a color has been used. Exceptions to the above options are indi-cated by a statement in the exempt color description in Part 73 to the effect that dec-laration must be by name. Currently, the only exempt-from-certification colors to require declaration by name are cochineal extract and carmine.


Although industry often refers to exempt-from-certification colors as natural colors, use of this term is prohibited on an ingredient statement. Regardless of the source of the color, FDA regulations do not consider any added color to be natural unless the color is “natural to” the food product itself, such as coloring strawberry ice cream with strawberry juice.


source: Global Regulations of Food Colors

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