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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec 587.100 Label Declaration of Certification-Exempt Color Additives November 2005

Final
Issued by:
Guidance Issuing Office
Human Foods Program
Office of Inspections and Investigations

BACKGROUND:

On 8/1/85 this CPG issued without the term "color added" as a permissible label declaration under Section 403(k) when a color is added to a food. This is in accord with the literal requirement of Section 403(k). However, it has come to our attention that food manufacturers have, in good faith, been complying with the previous long standing declaration of policy in permitting the term "color added" to declare the presence of an artificial color. Since it would not serve any useful purpose to change policy at this time, we are reissuing the 8/1/85 edition of this CPG, with appropriate revisions.

Section 403(k) of the FD&C Act states that if a food contains an artificial color it should bear labeling "stating that fact."

Section 403(i)(2) of the FD&C Act permits a color to be listed on a food label as such without naming specifically the color used.

21 CFR 74.705(d)(2) states that all foods, including butter, cheese, and ice cream that contain FD&C Yellow No. 5 shall specifically declare the presence of this color additive in the list of ingredients.

Questions have arisen concerning the use of the terms "Food Color Added," "color added," "artificial color," and "natural color" on a label to indicate the presence of artificial color.

POLICY:

For the purpose of the label declaration in accordance with Section 403(k) of the Act, the terms "Artificially Colored," "Artificial Color Added," *"color added,"* or an equally informative statement should be used which clearly indicates the addition of a color to a food, except where regulations require specific declaration of the color by common or usual name. FDA *also* will not insist upon the use of the word "artificial" with the declaration of color as an ingredient *when* the declaration identifies the color by specific common or usual name and by function. Thus, terms such as "colored with _____" or "_____ (color)" (the blank being filled with the specific color name such as annatto, beet powder, beta carotene, etc.) is considered satisfactory.

The use of the words *"food color added," "natural color," or similar words containing the term "food" or* "natural" may be erroneously interpreted to mean the color is a naturally occurring constituent in the food. Since all added colors result in an artificially colored food, we would object to the declaration of any added color as *"food" or* "natural."

*Material between asterisks is new or revised.*

Issued: 9/23/76
Revised: 8/16/78, 10/1/80, 8/1/85, 7/1/86, 5/2005
Updated: 11/29/05

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

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