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U.S. Department of Health and Human Services

Animal & Veterinary

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Ask CVM - January/February 2005

FDA Veterinarian Newsletter January/February 2005 Volume XX, No I

Q: What are the rules concerning the use of color additives in animal feeds and pet foods?

The 1960 Color Additives Amendment brought all colors, natural and synthetic, under the Federal Food, Drug, and Cosmetic Act. Regulatory responsibility was given to the FDA’s Center for Food Safety & Applied Nutrition (CFSAN). Under this amendment and the color additives regulations, the term “foods” includes foods intended for animals.

Since the FDA’s Center for Veterinary Medicine (CVM) has responsibility for ensuring that animal feed products are safe and accurately labeled, CFSAN consults with CVM when a color additive is proposed for use in animal feed products.

In addition, when a color additive is proposed for use in a meat, poultry, or egg product, its safety, technical function, and conditions of use must also be evaluated by the Labeling and Compounds Review Division of the U.S. Department of Agriculture’s Food Safety and Inspection Service, as provided in the Federal Meat Inspection Act, the Poultry Products Inspection Act, the Egg Products Inspection Act, and related regulations.

CVM’s role in approving colors for use in animal feeds

CFSAN receives and processes color additive petitions (CAP) from firms seeking to use new color additives in animal feeds. A copy of the petition is sent to CVM for consulting review, usually within 90 days. After reviewing a combination of laboratory and field trials, CVM makes recommendations regarding safety of the product under the conditions of intended use. CVM comments on only the target animal safety section of the petition. CFSAN reviews the other sections including manufacturing chemistry, human food safety, efficacy, and environmental safety.

Prior to submitting the petition, upon CFSAN suggestion, the petitioner may contact CVM directly for advice on how to design, conduct, and report on target animal safety studies. CVM has not developed specific guidelines for evaluating the safety of color additives to the target species; thus, CVM follows the principles established in 21 CFR 570 and 571 for evaluating the safety of food additives intended for animals. For example, each target animal safety study must be accompanied by a statement that the study was conducted in compliance with the FDA’s Good Laboratory Practice (GLP) regulations to ensure that proper procedures were followed during the design, conduct, and reporting of the study.

If the target animal safety information is found acceptable, a memo is issued to CFSAN advising that CVM has no additional questions regarding the safety of the product to the target species under the conditions of intended use. If the information is found to be unsatisfactory, a memo is issued to CFSAN advising that the target animal safety section of the petition is incomplete. The CVM memo specifies what additional information is needed.

When the color additive is found to be safe under the conditions of intended use, CFSAN seeks CVM concurrence on the draft regulation and final product label.

Labeling feed products containing color additives

The labeling format recommended by the Association of American Feed Control Officials (AAFCO) in its Official Publication is used to ensure that adequate labeling is provided. In addition, the feed products containing color additives should conform to the labeling requirements specified in Part 70.25 of the 21 CFR, i.e., all color additives shall be labeled with sufficient information to assure their safe use and to allow a determination of compliance with any limitations imposed by the color additive regulations. Further, the presence of the color additive in finished feed should be declared in accordance with Part 501.22 of the 21 CFR, i.e., among other things, the feed label must contain a statement of artificial coloring. The presence of the color additive in the animal product (e.g., fish) that has been fed feeds containing the additive shall be declared in accordance with Sections 101.22(k)(2) and 101.100(a)(2) of the 21 CFR.

Certifiable colors

The Nutrition Labeling and Education Act of 1990 (NLEA) amended -section 403(i) of the Federal Food, Drug and Cosmetic Act to require that a certifiable color additive used in food must be listed in the ingredient statement by its common or usual name (e.g., Blue 2, Red 40), and not by generic terms such as “artificial colorings.” All labels printed after July 1, 1991, must comply with this requirement. However, color additives exempt from certification can still be declared generically.

While this provision of the Act applies both to human food and animal feed, there are no regulations pertaining to animal feeds. Therefore, the “old” regulations still apply to animal feed and pet foods at this time. Colors may be declared as “artificial color,” “artificial coloring” or by their common or usual names in the ingredient list. However, use of the common or usual name alone does not negate the requirement under 21 CFR 501.22 to declare the presence of an artificial color in the product, whether the color is certified or not. Thus, an ingredient statement listing titanium dioxide, caramel, beta-carotene or other substance whose intended use is to impart color to the food must be further identified as a color in the ingredient list, unless the presence of an artificial color is conspicuously declared elsewhere on the label. Examples would be “caramel color,” or “colored with titanium dioxide.”

Color additives used in animal feeds

CVM has used regulatory discretion and has permitted all color additives approved for use in human foods under Part 73-Subpart A (Foods), Part 74-Subpart A (Foods) and Part 82-Subpart B (foods, drugs, and cosmetics) of the 21 CFR to be used in animal feeds. That is, it is unlikely that CVM would take regulatory action against their use in animal feeds, provided that they are used as color additives in accordance with the regulations, and used at levels consistent with good manufacturing practice. In addition, there are color additives approved for specific uses in animal feeds.

The primary reasons for adding colors to feeds are to impart color to the feed itself and to impart color to animal products, such as meat, skin, and eggs. With regard to pet food, the reasons manufacturers add colors to these products are similar to the ones for human food, i.e., in most cases, colors are added to meet consumer expectations.

Imparting color to feed

Additives intended to impart color to feeds are added for feed identification purposes. For example, during the feed manufacturing process, a marker (color) is added to a selenium premix to identify that a manufactured feed contains selenium. A feed manufacturer may also use color to identify a feed that contains a certain animal drug.

Additives used to impart color to animal feeds are the same ones listed for use in human foods, i.e., the ones listed under sections 73, 74, 82 of the 21 CFR. For the purpose of imparting color to animal feeds, there are two color additives specifically approved: ultramarine blue, which colors salt intended for animal feed, and synthetic iron oxide, which is intended to color dog and cat foods.

Labeling claims

If the manufacturer of a color additive intends to claim that, in addition to impart color to animal products, it performs other technical functions such as increase rate of weight gain, increase the rate of egg production, and/or improve feed efficiency, such color additive is regarded by CVM as an animal drug. Thus, to be used in animal feed, such product needs to be approved both as a color additive by CFSAN and as an animal drug by CVM.

We note that there are animal drugs, e.g., Roxarsone (21 CFR 558.530), that were approved for uses such as increased rate of weight gain, improved feed efficiency, and improved pigmentation. Color additive approval was not required for the “improve pigmentation” claim, because these products contain no colorants and they are not intended to add color to the skin of the bird. By improving the animal health and skin appearance, they improve the pigmentation already present in the skin, which makes the product more appealing to the consumer.

Adverse reaction reports

Many customers and pet nutritionists believe that, among other ingredients, the presence of artificial colorings can cause problems such as allergic reactions. However, according with CVM’s Division of Surveillance, no adverse reactions have been reported that could be traced back to a color additive present in an animal feed product.