(a) No final labeling shall be used on any product unless the sketch labeling of such final labeling has been submitted for approval to the Food Labeling Division, Regulatory Programs, Food Safety and Inspection Service, and approved by such division, accompanied by FSIS Form, Application for Approval of Labels, Marking, and Devices, except for generically approved labeling authorized for use in § 381.133(b) (2)-(9). The management of the official establishment or establishment certified under a foreign inspection system, in accordance with subpart T of this part, must maintain a copy of all labeling used, along with the product formulation and processing procedure, in accordance with subpart Q of this part. Such records shall be made available to any duly authorized representative of the Secretary upon request.
(b) The Food Labeling Division shall permit submission for approval of only sketch labeling, as defined in § 381.132(d), for all products, except as provided in § 381.133(b) (2)-(9) and except for temporary use of final labeling as prescribed in paragraph (f) of this section.
(c) All labeling required to be submitted for approval as set forth in § 381.132(b) shall be submitted in duplicate to the Food Labeling Division, Regulatory Programs, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250. A parent company for a corporation may submit only one labeling application (in duplicate) for a product produced in other establishments that are owned by the corporation.
(d) “Sketch” labeling is a printer's proof or equivalent which clearly shows all labeling features, size, location, and indication of final color, as specified in subpart N of this part. FSIS will accept sketches that are hand drawn, computer generated or other reasonable facsimiles that clearly reflect and project the final version of the labeling. Indication of final color may be met by: submission of a color sketch, submission of a sketch which indicates by descriptive language the final colors, or submission with the sketch of previously approved final labeling that indicates the final colors.
(e) Inserts, tags, liners, pasters, and like devices containing printed or graphic matter and for use on, or to be placed within, containers and coverings of product shall be submitted for approval in the same manner as provided for labeling in § 381.132(a), except that such devices which contain no reference to product and bear no misleading feature shall be used without submission for approval as prescribed in § 381.133(b)(9).
(1) Consistent with the requirements of this section, temporary approval for the use of a final label or other final labeling that may otherwise be deemed deficient in some particular may be granted by the Food Labeling Division. Temporary approvals may be granted for a period not to exceed 180 calendar days under the following conditions:
(i) The proposed labeling would not misrepresent the product;
(ii) The use of the labeling would not present any potential health, safety, or dietary problems to the consumer;
(iii) Denial of the request would create undue economic hardship; and
(iv) An unfair competitive advantage would not result from the granting of the temporary approval.
(2) Extensions of temporary approvals may also be granted by the Food Labeling Division, provided that the applicant demonstrates that new circumstances, meeting the above criteria, have developed since the original temporary approval was granted.
[60 FR 67456, Dec. 29, 1995]
Title 9 published on 2014-01-01
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