In response to inquiries about the use of color additives as colorants in paper and paperboard intended for use in contact with food, FDA provides the following advice: (Note this advice is a clarification of advice issued as an advisory opinion by the Associate Commissioner for Regulatory Affairs on September 18, 1979, (Docket Number 79A-0165/AP).
We have no objection to the use of colorants in paper and paperboard intended for food contact if the colorants are color additives regulated for direct addition to food generally and do not have specific restrictions on the levels or kinds of use. These color additives, which are restricted only by good manufacturing practice, would be among the color additives exempt from certification, which are listed in 21 CFR Part 73, Subpart A; those subject to certification, which are listed in 21 CFR Part 74, Subpart A; and those provisionally listed in 21 CFR 81.1(a) for food use.
These colorants, however, when used in paper and paperboard should not impart a color to the food by migration.
The use of any other color additive as a colorant in paper and paperboard is not authorized by the above policy. Inquiries or requests for such uses should be submitted to CFSAN/Office of *Food Additive Safety (HFS-275)*. Additionally, 21 CFR 176.170(b) lists specific colorants regulated for use in food contact paper and paperboard. Office of *Food Additive Safety* evaluates the use of additional colorants in paper and paperboard on a case-by-case basis. Actions in this area should be based solely on headquarters initiated assignments. Any questions that might arise concerning the need for sample collections, inspections, or special investigations should be referred to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) for review and recommendation.
*Material between asterisks is new or revised*
Reissued: 10/1/80, 2/26/88
Revised: 3/95, 5/05
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)
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