§ 59.411 - Requirement of formulas and approval of labels for use in official egg products plants.

(a) No label, container, or packaging material which bears official identification may bear any statement that is false or misleading. Any label, container, or packaging material which bears any official identification shall be used only in such manner as the Administrator may prescribe. No label, container, or packaging material bearing official identification may be used unless it is approved by the Administrator in accordance with paragraph (b) of this section. The use of finished labels must be approved as prescribed by the Administrator. If the label is printed on or otherwise applied directly to the container or packaging material, the principal display panel thereof shall be considered as the label.

(b) No label, container, or packaging material bearing official identification may be printed or prepared for use until the printers’ or other final proof has been approved by the Administrator in accordance with the regulations in this part, the Egg Products Inspection Act, the Federal Food, Drug, and Cosmetic Act, the Fair Packaging and Labeling Act, and the regulations promulgated under these acts. Copies of each label submitted for approval shall be accompanied by:

(1) A statement showing by their common or usual names the kinds and percentages of the ingredients comprising the egg product. A range may be given in cases where the percentages may vary from time to time. Formulas are to be expressed in terms of a liquid product except for products which are dry blended. Also, for products to be dried, the label may show the ingredients in the order of descending proportions by weight in the dried form. However, the formula submitted must include the percentage of ingredients in both liquid and dried form.

(2) When required, scientific data demonstrating that the substance or mixture is safe and effective for its intended use and does not promote deception or cause the product to be otherwise adulterated or misbranded.

(c) Containers of product bearing official identification shall display the following information:

(1) The common or usual name, if any, and if the product is comprised of two or more ingredients, such ingredients shall be listed in the order of descending proportions by weight in the form in which the product is to be marketed (sold), except that ingredients in dried products (other than dry blended) may be listed in either liquid or dried form. When water (excluding that used to reconstitute dehydrated ingredients back to their normal composition) is added to a liquid or frozen egg product or to an ingredient of such products (in excess of the normal water content of that ingredient), the total amount of water added, including the water content of any cellulose or vegetable gums used, shall be expressed as a percentage of the total product weight in the ingredient statement on the label.

(2) The name, address, and ZIP code of the packer or distributor. When the distributor is shown, it shall be qualified by such terms as “packed for,” “distributed by,” or “distributors”;

(3) The lot number or approved alternative code number indicating date of production;

(4) The net contents;

(5) Official identification and plant number;

(6) Egg products which are produced in an official plant from edible shell eggs of other than current production or from other egg products produced from shell eggs of other than current production, shall be clearly and distinctly labeled in close proximity to the common or usual name of the product, e.g., “Manufactured from eggs of other than current production”;

(7) Egg products produced from edible shell eggs or the egg product produced from such shell eggs of the turkey, duck, goose, or guinea shall be clearly and distinctly labeled as to the common or usual name of the product indicating the type of eggs or egg products used in the product, e.g., “Frozen whole turkey eggs,” “Frozen whole chicken and turkey eggs.” Egg products labeled without qualifying words as to the type of shell egg used in the product shall be produced only from the edible shell egg of the domesticated chicken or the egg product produced from such shell eggs.

(d) Liquid or frozen egg products identified as whole eggs and prepared other than in natural proportions, as broken from the shell, shall have a total egg solids content of 24.20 percent or greater.

(e) Nutrition information may be included on labels used to identify egg products, providing such labeling complies with the provisions of 21 CFR part 101, promulgated under the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. Since these regulations have different requirements for consumer packaged products than for bulk packaged egg products not for sale or distribution to household consumers, label submission shall be accompanied with information indicating whether the label covers consumer packaged or bulk packaged product. Nutrition labeling is required when nutrients, such as proteins, vitamins, and minerals are added to the product, or when a nutritional claim or information is presented on the labeling, except for the following which are exempt from nutrition labeling requirements:

(1) Egg products shipped in bulk form for use solely in the manufacture of other food and not for distribution to household consumers in such bulk form or containers.

(2) Products containing an added vitamin, mineral, or protein, or for which a nutritional claim is made on the label, or in advertising, which is supplied for institutional food use only: Provided, That the manufacturer or distributor provides the required nutrition information directly to those institutions.

(3) Any nutrient(s) included in product solely for technological purpose may be declared solely in the ingredients statement, without complying with nutrition labeling, if the nutrient(s) is otherwise not referred to in labeling or in advertising. All labels showing nutrition information or claims are subject to review by the Food and Drug Administration prior to approval by the Department.

(f) If the Administrator has reason to believe that the statement on formulation shows the product to be adulterated or misbranded or that any labeling, or the size or form of any container in use or proposed for use in respect to egg products at any official plant is false or misleading in any way, he may direct that such use be withheld unless the labeling or container is modified in such a manner as he may prescribe so that it will not be false or misleading, and/or the formulation of the product is altered in such a manner that he may prescribe so that it is not adulterated, or would not cause misbranding. Any person so denied the approval of any label shall be notified promptly of the reasons for the denial on a form approved by the Administrator. If the person using or proposing to use the label does not accept the determination of the Administrator, he may request a hearing by filing with the Administrator within 10 days after receiving the notice of denial, a written application for a hearing setting forth specifically, the errors alleged to have been made by the Administrator in denying approval of the label. The use of the label shall be withheld pending hearing and final determination by the Administrator if the Administrator so directs. Hearings held pursuant to this subsection shall be presided at by the Administrator. The applicant shall be given the opportunity to present evidence both oral and written in support of his allegation that the Administrator erred in denying approval of the label. The notice of denial together with all other available data and information used as a basis for such denial shall be considered part of the record. The Administrator may take official notice of such matters as are judicially noticed by the Courts of the United States and of any other matter of technical, scientific, or commercial fact of established character. The Administrator shall make his final determination with respect to the matter upon the basis of evidence before him. Such determination shall be conclusive unless, within 30 days after the receipt of notice of such final determination, the person adversely affected thereby appeals to the U.S. Court of Appeals for the circuit in which he has his principal place of business, or to the U.S. Court of Appeals for the District of Columbia Circuit. The provisions of section 204 of the Packers and Stockyards Act of 1921, as amended, shall be applicable to appeals taken under this section.