Md. Code Regs. 10.15.04.16 - Unit Processing Operations - Food Labeling

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

(1) Except as provided in §B of this regulation, or as otherwise stipulated in COMAR 10.15.01, 10.15.02, 10.15.04, 10.15.07, or 10.15.10 food labeling is accomplished by:

(a) Placing the information required in §A(2) of this regulation on the food container by:

(i) Imprinting;

(ii) Embossing;

(iii) Lithography; or

(iv) Ink jetting; or

(b) Another method:

(i) Set forth in 21 CFR Parts 100 and 101; or

(ii) In conformance with §A(3) of this regulation;

(2) Except as provided in §B 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 name of the ingredients in descending order of prominence;

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

(i) The full street address including the zip code if the manufacturer or distributor 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 English or avoirdupois units and equivalent metric units;

(ii) Measure;

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

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

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

(j) When a health or nutrition claim is made, the nutritional labeling required in 21 CFR § 101.9;

(k) A "sell by" date if the package contains a potentially hazardous food that is:

(i) In a vending machine; or

(ii) A bakery product manufactured, packaged, and labeled as set forth in Regulation .14P of this chapter;

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

(m) 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";

(n) A code date with the date of manufacture and the batch number if the food is:

(i) Pasteurized crab meat;

(ii) Canned food; or

(iii) Bottled water;

(o) 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;

(p) For shell eggs, the information set forth in COMAR 15.04.01.08E; and

(q) For a poultry product produced under the exemption provided in 9 CFR § 381.10(a)(5) or (6), the statement "Exempted- P.L. 90-492 ";

(3) A food label and the labeling information in §A(2) of this regulation are:

(a) Durable;

(b) Conspicuous;

(c) Legible; and

(d) Able to remain on a container in conformance with §A(3)(a)-(c) of this regulation for the shelf life of the food;

(4) The information required in §A(2)(a)-(f) 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".

B. 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.

C. The person-in-charge may forego:

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

(i) Are at insignificant levels;

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

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

(b) Complying with the requirements in §A(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:

(i) 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

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

Notes

Md. Code Regs. 10.15.04.16

Regulations .16 adopted effective November 22, 2004 (31:23 Md. R. 1652)
Regulation .16A amended effective March 5, 2012 (39:4 Md. R. 337); amended effective 43:03 Md. R. 272, eff.2/15/2016