Or. Admin. Code § 603-029-2000

Current through Register Vol. 63, No. 10, October 1, 2024

Section 603-029-2000 - Label Approval

(1) No final label may be used on any product unless the label has been submitted for approval to the Department, accompanied by an application for Approval of Labels, Marking, and Devices, and approved by the Department, except for generically approved labels authorized for use in OAR 603-029-2010. Such records must be made available to any duly authorized representative of the Department upon request.

(2) All labels required to be submitted for approval as set forth in section (1) of this rule shall be submitted to the Department. A parent company for a corporation may submit only one label application for a product produced in state-inspected establishments that are owned by the corporation.

(3) The Department requires the submission of labeling applications for the following:

(a) Sketch labels as defined in section (4) of this rule for products which are produced under a religious exemption;

(b) Special statements and claims as defined in section (5) of this rule and presented in the context of a final label.

(c) Requests for the temporary use of final labels as prescribed in section (6) of this rule.

(4) A "sketch" label is the concept of a label. It may be a printer's proof or equivalent that is sufficiently legible to clearly show all labeling features, size, and location. The Department will accept sketches that are hand drawn or computer generated, or other reasonable facsimiles that clearly reflect and project the final version of the label.

(5) "Special statements and claims" are claims, logos, trademarks, and other symbols on labels that are not defined in Division 29 regulations or the USDA FSIS Food Standards and Labeling Policy Book, published in August of 2005 (except for "natural" and negative claims (e.g., "gluten free")), health claims, ingredient and processing method claims (e.g., high-pressure processing), structure-function claims, claims regarding the raising of animals, organic claims, and instructional or disclaimer statements concerning pathogens (e.g., "for cooking only" or "not tested for E. coli O157:H7"). Examples of logos and symbols include graphic representations of hearts and geographic landmarks. Special statements and claims do not include allergen statements (e.g., "contains soy") applied in accordance with the Food Allergen Labeling and Consumer Protection Act.

(6)

(a) Temporary approval for the use of a final label that may be deemed deficient in some particular may be granted by the Department. Temporary approvals may be granted for a period not to exceed 180 calendar days, under the following conditions:

(b) The proposed label would not misrepresent the product;

(c) The use of the label would not present any potential health, safety, or dietary problems to the consumer;

(d) Denial of the request would create undue economic hardship; and

(e) An unfair competitive advantage would not result from the granting of the temporary approval.

(7) Extensions of temporary approvals may also be granted by the Department, provided that the applicant demonstrates that new circumstances, meeting the above criteria, have developed since the original temporary approval was granted.

Or. Admin. Code § 603-029-2000

DOA 19-2022, adopt filed 07/27/2022, effective 7/28/2022

Statutory/Other Authority: ORS 603.085, ORS 619.042 & ORS 619.046

Statutes/Other Implemented: ORS 619.042 & ORS 619.046