Guidance for Industry: Cochineal Extract and Carmine: Declaration by Name on the Label of All Foods and Cosmetic Products That Contain These Color Additives; Small Entity Compliance Guide

April 2009

You may submit written or electronic comments regarding this guidance at any time. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

Additional copies are available from:
Office of Food Additive Safety
Division of Petition Review HFS-265
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
(Tel) 301-436-1200
http://www.cfsan.fda.gov/guidance.html

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
April 2009

Contains Nonbinding Recommendations

Table of Contents

Guidance for Industry⁽¹⁾
Cochineal Extract and Carmine: Declaration by Name on the Label of All Foods and Cosmetic Products That Contain These Color Additives

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate telephone number listed on the title page of this guidance.

I. INTRODUCTION

On January 5, 2009, the Food and Drug Administration (FDA) published a final rule in the Federal Register that amended its regulations to require the declaration by name of the color additives cochineal extract and carmine on the label of all food and cosmetic products in the United States (74 FR 207). The final rule is effective on January 5, 2011, although FDA encourages manufacturers to have new labels printed that are in compliance with the new requirements so they may be used as soon as current inventories are exhausted to ensure a smooth and timely changeover. FDA has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). This guidance document restates in plain language the legal requirements of the January 5, 2009 final rule set forth in 21 CFR parts 73 and 101 concerning the requirement for the declaration by name of the color additives cochineal extract and carmine on the label of all food and cosmetic products in the United States. These regulations are binding and have the full force and effect of law.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

II. QUESTIONS AND ANSWERS

1. Is the presence of cochineal extract or carmine in food products intended for human use required to be declared on the label?

   Yes. Cochineal extract or carmine must be declared on the label of all food products intended for human use, including butter, cheese, and ice cream, when present in the food (21 CFR 73.100 (d)(2)).

2. How must the presence of cochineal extract or carmine be listed on the label?

   Cochineal extract or carmine must be listed on the label by its respective common or usual name, "cochineal extract" or "carmine." (21 CFR 73.100 (d)(2))

3. Where must "cochineal extract" or carmine be declared on the label?

   Cochineal extract or carmine must be declared in the statement of ingredients in accordance with 21 CFR 101.4 (21 CFR 73.100 (d)(2)).

4. Are cosmetics containing carmine that are not subject to the requirements of 21 CFR 701.3 required to declare the presence of carmine on the label?

   Yes. (21 CFR 73.2087 (c)(2)).

5. How must carmine be declared on the label of a cosmetic that is not subject to the requirements of 21 CFR 701.3?

   Carmine must be declared prominently and conspicuously at least once in the labeling (21 CFR 73.2087 (c)(2)).

6. Can you provide an example of a label statement for a cosmetic that contains carmine?

   The presence of carmine may be declared on the label in the following manner: "Contains carmine as a color additive." (21 CFR 73.2087 (c)(2)).

7. Can color additives for which individual declarations are required by applicable regulations in 21 CFR part 73 still be declared on the label as "Artificial Color," "Artificial Color Added," or "Color Added?"

   No. These color additives must be declared by their respective common or usual names. (21 CFR 101.22(k)(2)).

⁽¹⁾This guidance has been prepared by the Division of Petition Review in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.