Md. Code Regs. 10.15.04.13

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.15.04.13 - Labeling

A. In accordance with Health-General Article, §21-212, Annotated Code of Maryland, a federal rule that exempts a food from label requirements is effective automatically in the State.

B. The person-in-charge shall ensure that:

(1) Except as provided in §A of this regulation, food labeling meets the requirements in 21 CFR Part 101 ;

(2) Except as provided in §A of this regulation, the following information is provided on a label of food in packaged form:

(a) Common or usual name of the food;

(b) Statement of ingredients that gives the common or usual names of the ingredients in descending order of prominence with subingredients listed;

(c) Name and address of the manufacturer or distributor with:

(i) The full street address including the zip code of the manufacturer or distributor if the address is not listed on a website, current city directory, or telephone directory; or

(ii) A minimum of the town and zip code if the manufacturer or distributor is listed on a website, current city directory, or telephone directory;

(d) Net quantity in terms of:

(i) Weight in U.S. Customary units and equivalent metric units;

(ii) Fluid measure in U.S. Customary units and equivalent metric units;

(iii) Numerical count; or

(iv) Combination of numerical count and weight;

(e) If a food coloring has been added, the food coloring in the statement of ingredients;

(f) If a chemical preservative has been added, a label declaration stating:

(i) The common or usual name of the ingredient; and

(ii) A separate description of its function such as "preservative" or "mold inhibitor";

(g) Major food allergens in accordance with 21 U.S.C. § 343(w);

(h) For a food that requires refrigeration for safety, the words "keep refrigerated" or equivalent;

(i) For a food that requires refrigeration for safety after the food's packaging is opened, the words "refrigerate after opening" or equivalent;

(j) For a food that is frozen for safety or quality, the words "keep frozen" or equivalent;

(k) A "use by date" if the package contains a food whose safety is assured only until the date specified on the label;

(l) For a food that is frozen during processing or after processing and then thawed before being offered for human consumption, the words "previously frozen, should not refreeze"; and

(m) The exact words "WARNING: This product has not been pasteurized and, therefore, may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems." for a juice product that has not been processed in accordance with COMAR 10.15.12;

(3) A food label and the labeling information in §B(1) of this regulation are:

(a) Durable;

(b) Conspicuous;

(c) Legible;

(d) Able to remain on a container for the shelf life of the food; and

(e) Placed on the food container by:

(i) Imprinting;

(ii) Embossing;

(iii) Lithography;

(iv) Ink jetting; or

(v) Another method set forth in 21 CFR Parts 100 and 101 or in conformance with §B(2) of this regulation;

(4) The information required in §B(2) of this regulation is located on the principal display panel;

(5) If the food is not manufactured by the business whose name appears on the label, the business name is qualified by a phrase that reveals the connection the business has with the food, such as "Manufactured for" or "Distributed by";

(6) If the address given on the label is not the place where the food was actually manufactured, packaged, or distributed, it is the address of the principal place of business of the manufacturer or distributor given on the label;

(7) A food's labeling or packaging is not false or misleading in any way; and

(8) A food that has been frozen or thermally processed is not labeled "fresh".

C. The person-in-charge may forego:

(1) Declaring on the label the common or usual name of each ingredient for incidental additives that:

(a) Have no technical or functional effect in the food; and

(b) Are not required by a federal rule to be declared; and

(2) Complying with the requirements in §B(2)(a)-(f) and (j) of this regulation for a shipment of food that, in accordance with the practice of trade, is processed, labeled, or repacked in substantial quantity at an establishment other than where originally processed or packed if:

(a) The person who introduced the shipment of food into interstate commerce is the operator of the establishment where the food is to be processed, labeled, or repacked; or

(b) The shipment or delivery to the establishment is made under a written agreement as set forth in 21 CFR § 101.100(d).

Md. Code Regs. 10.15.04.13

Regulations .13 adopted effective November 22, 2004 (31:23 Md. R. 1652); amended effective 43:03 Md. R. 272, eff.2/15/2016; adopted effective 51:15 Md. R. 708, eff. 8/5/2024.