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GUIDANCE DOCUMENT

CPG Sec 562.650 "Processing" - Use of Term in Section 405 of the FD&C Act February 1989

Final
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition
Office of Regulatory Affairs

BACKGROUND:

*Inquiries* are sometimes received as to whether foods intended for use as ingredients in other foods come within the exemption from labeling requirements provided in Section 405 of the Federal Food, Drug, and Cosmetic Act, for "food which is in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed..."

*Any exemption must be in accordance with regulations. Examples of existing regulations are 21 CFR 101.100(d)(1) and (2) which specify the form of agreement which must be signed by a shipper and processor, 21 CFR 101.100(d)(3), which specifies the conditions for shipping unpasteurized egg products for pasteurization or use in acidic dressings; 21 CFR 101.100(e), which specifies the conditions which affect expiration of the above agreements, and 21 CFR 101.100(f) which defines "processed" as it refers to holding cheese for the purpose of aging or curing.*

POLICY:

*Except as provided in 21 CFR 101.4(a), the term "processed" as used in Section 405 of the Federal Food, Drug, and Cosmetic Act does not apply to the additional processing of a finished food. For example, dried beans do not meet the Section 405 labeling exemption even though they may be further processed into canned beans by the addition of packing medium and subsequent cooking.*

The term "processing" in Section 405 of the Act applies to the completion of a process which produces a final finished food. For example, shipment of unpasteurized cheese to a suitable facility for aging may be considered appropriate for the Section 405 labeling exemptions, since it is not a finished food until the aging process is completed.

*Material between asterisks is new or revised.*

Issued: 10/26/76
Reissued: 10/1/80
Revised: 2/1/89


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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