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Color Additives in Animal Feed and Pet Food: A Regulatory Guide for Manufacturers
Last Updated: November 4, 2026
Quick Summary
Any substance that imparts color to the feed itself, or intended to color the flesh of the animal is classified as a color additive. Color additives used in animal feed and pet food are strictly regulated under the Federal Food, Drug, and Cosmetic Act (FFDCA). They require premarket FDA approval and listing in the color additive regulations (21 CFR Parts 70–82) before they may be used.
The listing process is managed by CFSAN with CVM collaboration for animal uses. Certified colors require batch certification; exempt colors must still meet specific identity, purity, and use limitations. Proper labeling under 21 CFR 501.22(k) is mandatory. Noncompliance can render products adulterated or misbranded. The FFDCA section 201(s)(3) explicitly excludes color additives from the definition of “food additive,” therefore, they cannot qualify as Generally Recognized as Safe (GRAS).
Table of Contents
- What Color Additives Are Under 21 CFR Part 70 Color Additives Rules
- Defining a Color Additive
- Color Additives Cannot Be GRAS — The Explicit Statutory Exclusion
- Regulatory Authority: CFSAN with CVM Collaboration
- The Color Additive Listing and Petition Process
- Certified Colors versus Colors Exempt from Certification
- FDA Actions to Reduce or Eliminate Petroleum-Based Artificial Colors
- Labeling Requirements for Animal Food
- Compliance Risks and Enforcement
- Practical Considerations for Animal Feed and Pet Food Manufacturers
- How Seven Hills Regulatory Services, LLC Can Support Your Compliance Strategy
- Conclusion
- Frequently Asked Questions
What Color Additives Are Under 21 CFR Part 70 Color Additives Rules
Color additives play a critical role in animal feed, pet food, and other animal food products. They help correct natural color variations, enhance visual appeal for pet owners, support product consistency, and in some cases, impart desired pigmentation to animal products such as egg yolks, poultry skin, or fish flesh through biological processes. For manufacturers of livestock feed, pet food, and specialty animal foods, understanding the strict regulatory framework governing these substances is essential to ensure compliance, avoid adulteration findings, and maintain market access.
Under the Federal Food, Drug, and Cosmetic Act (FFDCA), color additives are subject to premarket approval by the U.S. Food and Drug Administration (FDA). Unlike many other food ingredients, color additives cannot qualify as Generally Recognized as Safe (GRAS). This distinction shapes every aspect of their use in animal food and creates unique obligations for manufacturers.
The FDA's color additive petitions page outlines the submission route. The agency's color additives overview explains the premarket approval framework the petition feeds into. This article provides a comprehensive overview of color additive regulation as it applies to animal feed, pet food, and animal food manufacturers. It covers definitions, the approval process, the respective roles of FDA centers, listing requirements, labeling rules, and practical compliance considerations.
Defining a Color Additive
FDA regulations in 21 CFR Part 70 define a color additive as any material (not otherwise exempted under section 201(t) of the FFDCA) that is a dye, pigment, or other substance made by synthesis or extracted, isolated, or otherwise derived from a vegetable, animal, mineral, or other source, and that, when added or applied to a food, drug, cosmetic, or the human body, is capable (alone or through reaction with another substance) of imparting color. The regulations are published in 21 CFR Part 70 on the eCFR, and the agency's own color additives overview explains the premarket approval framework.
Critically, any article that imparts color to animal feed itself is classified as a color additive. In addition, an ingredient of an animal feed whose intended function is to impart—through the biological processes of the animal—a color to the meat, milk, or eggs of the animal is itself a color additive. This definition applies whether or not the ingredient has nutritive or other functions in addition to the property of imparting color. “Color” includes black, white, and intermediate grays. A substance that meets this definition is regulated as a color additive unless it is used solely for a purpose other than coloring and any color imparted is clearly unimportant to the appearance, value, marketability, or consumer acceptability of the product.
These definitions apply equally to human food and animal food. The FFDCA defines “food” broadly to include articles used for food or drink for man or other animals, so animal feed and pet food fall squarely within the regulatory scheme. Even for animal food, CFSAN leads the color additive program with CVM collaboration when the use is intended for animals.
Color Additives Cannot Be GRAS — The Explicit Statutory Exclusion
A foundational principle of U.S. color additive law is that color additives are ineligible for GRAS status. Section 201(s) of the FFDCA defines the term “food additive.” Within that definition, section 201(s)(3) explicitly excludes color additives from the scope of the food additive definition (and therefore from the GRAS exemption that applies to food additives). Because color additives are carved out of the food additive definition, the GRAS pathway is unavailable to them.
Section 721 of the FFDCA independently requires that color additives (with limited exceptions such as certain coal-tar hair dyes) be listed by regulation before they may be used. There is no parallel GRAS pathway. Manufacturers sometimes assume that a long history of safe use or expert consensus can support a self-affirmed GRAS conclusion for a colorant. That approach is unavailable. Any substance intended to impart color in food—including animal food—must either be listed in the color additive regulations for that use or be the subject of an approved color additive petition that results in listing. Use of an unlisted color additive renders the product adulterated under the FFDCA.
Regulatory Authority: CFSAN with CVM Collaboration
The primary responsibility for evaluating and listing color additives rests with FDA’s Center for Food Safety and Applied Nutrition (CFSAN), specifically the Office of Food Additive Safety. Color additive petitions are submitted to CFSAN, and the resulting regulations appear in 21 CFR Parts 70–82.
When a color additive is intended for use in animal food, CFSAN collaborates with the Center for Veterinary Medicine (CVM). CVM provides expertise on animal safety, target animal species considerations, residue issues (particularly for food-producing animals), and labeling requirements specific to animal food. This collaboration ensures that both human food safety (where relevant) and animal food safety are addressed. For color additives used only in animal feed to pigment animal products destined for human consumption, additional scrutiny applies regarding potential residues.
Manufacturers should therefore expect input from both Centers when pursuing new listings or expanded uses for animal food applications.
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The Color Additive Listing and Petition Process
Color additives must be shown to be safe and suitable for their intended use and then listed in the Code of Federal Regulations before marketing. An interested person may file a color additive petition (CAP) under 21 CFR Part 71.
A complete petition typically includes:
- Identity and composition of the color additive, including manufacturing methods and specifications.
- Proposed uses, including specific animal species or classes of animal food, maximum use levels, and any limitations.
- Safety data, including toxicological studies (often guided by FDA’s Redbook principles), exposure estimates, and, where relevant, target animal safety and residue data.
- Analytical methods for determining purity and detecting the additive in the finished product.
- Environmental assessment or claim of categorical exclusion.
- Labeling proposals.
FDA reviews the petition for completeness, files it (or requests additional information), evaluates the data, and may publish a notice in the Federal Register. If the data support safety, FDA issues a regulation listing the color additive in either 21 CFR Part 73 (exempt from certification) or Part 74 (subject to certification). The listing specifies identity, specifications, uses and restrictions, and labeling requirements.
Pre-petition consultations with FDA are available and strongly recommended, particularly for novel colorants or uses intended for multiple animal species. The process can be resource-intensive, but it is the only lawful route for new color additives or new uses of existing ones in animal food.
A Step-by-Step Verification Workflow
Use this sequence on every new formula. It takes less time than a reformulation.
Step | Action | What You Need |
|---|---|---|
1 | Identify the color by regulatory name | Regulatory name, not trade name |
2 | Confirm the approved use | Listing entry for your product category |
3 | Check species and conditions of use | Any species limits or use restrictions |
4 | Confirm certification status | Certified or certification-exempt |
5 | Verify supplier documentation | Certification records for each lot |
6 | Draft the label declaration | 21 CFR 501 and AAFCO labeling guidelines |
7 | File the record | Dated copy of the listing you relied on |
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Certified Colors versus Colors Exempt from Certification
FDA classifies listed color additives into two categories:
Subject to certification (primarily synthetic “FD&C” colors):
These must undergo batch certification by FDA. Each batch is chemically analyzed to confirm identity and compliance with specifications before it may be used. Common examples approved for food use (and therefore available for many animal food applications when the regulation permits) include FD&C Blue No. 1, Blue No. 2, Green No. 3, Red No. 3, Red No. 40, Yellow No. 5, and Yellow No. 6. Lakes of these colors are also regulated.
Exempt from certification:
These are typically derived from natural sources (vegetables, minerals, animals, or algae) or certain synthesized substances that do not require batch testing. Examples frequently relevant to animal food include annatto extract, caramel, titanium dioxide, synthetic iron oxide, canthaxanthin, astaxanthin and related carotenoids, haematococcus algae meal, tagetes (Aztec marigold) meal and extract, ultramarine blue (for animal feed), spirulina extract, and various algae- or yeast-derived pigments approved for specific animal feed uses such as salmonid or poultry feed.
Even exempt colors must meet the identity and purity specifications in their listing regulations and may only be used under the conditions stated (species, maximum levels, etc.). Exceeding those limits or using a color outside its authorized uses is not permitted.
Several color additives have specific authorizations limited to animal food. Examples include certain carotenoids and algal meals for salmonid feed to produce desired flesh pigmentation, tagetes meal for chicken feed, and ultramarine blue for animal feed. Manufacturers must consult the precise regulation for each color additive rather than assuming general food listing covers animal applications.
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FDA Actions to Reduce or Eliminate Petroleum-Based Artificial Colors
In recent years, the FDA has taken coordinated steps to reduce reliance on petroleum-based synthetic (certified) color additives in the U.S. food supply. These include the revocation of authorization for FD&C Red No. 3 (with a compliance deadline of January 15, 2027 for food), final revocation of Orange B, a proposed revocation of Citrus Red No. 2, and a broader initiative announced to work with industry on the voluntary phase-out of the six remaining widely used certified colors (FD&C Blue No. 1, Blue No. 2, Green No. 3, Red No. 40, Yellow No. 5, and Yellow No. 6) by the end of 2027. At the same time, the agency has accelerated the review and approval of naturally derived alternatives (such as beetroot red and expanded uses of spirulina extract) and, in February 2026, announced enforcement discretion allowing certain “no artificial colors” labeling claims on human foods that contain no certified colors listed in 21 CFR Part 74. While these actions are primarily directed at human food, they have practical implications for animal feed and pet food manufacturers: many of the same certified colors are authorized for animal food uses, consumer and retailer pressure for “cleaner” labels is rising across the broader food sector, and any reformulation must still comply with the existing color additive listing, certification, and labeling requirements that apply equally to animal food. Manufacturers should monitor both binding revocations and voluntary industry commitments closely when evaluating current formulations or planning transitions to exempt-from-certification alternatives.
Labeling Requirements for Animal Food
Labeling of color additives in animal food, including pet food and livestock feed, is governed by 21 CFR 501.22(k). Certified color additives must be declared by their common or usual name as listed in the applicable regulation (the “FD&C” prefix and “No.” are optional). Color additives exempt from certification may be declared individually by name or collectively as “artificial color,” “artificial color added,” “color added,” or similar terms, provided the declaration is not misleading.
FDA issued CVM Guidance for Industry #223 (Small Entity Compliance Guide – Declaring Color Additives in Animal Foods) to assist manufacturers, particularly smaller firms, with these requirements. Proper declaration is critical; failure to declare certified colors by name or improper collective declarations can result in misbranding.
In addition to ingredient statement requirements, the color additive itself and any mixtures sold for coloring purposes must be labeled in accordance with 21 CFR 70.25.
Compliance Risks and Enforcement
Use of an unapproved color additive, use outside the conditions of the listing regulation, failure to obtain required batch certification, or incorrect labeling can render an animal food adulterated or misbranded. Color additive violations are a frequent basis for FDA warning letters and import detentions. For animal food manufacturers, this risk extends to both domestic production and imported ingredients or finished products.
Manufacturers should maintain robust supplier qualification programs that verify the regulatory status of every color additive, confirm batch certification where required, and ensure specifications match the applicable CFR listing. Internal change-control processes should flag any formulation or sourcing changes that could affect color additive compliance.
Troubleshooting Common Compliance and Labeling Errors
Problem | Fix | Why It Matters |
|---|---|---|
Color approved for another species | Recheck the listing for your species | Approval does not transfer |
Trade name used on the label | Search by regulatory name | Trade names hide the listing entry |
No lot-level certification record | Request certification per lot | Certified colors need batch proof |
Ingredient framework used for a color | Separate the 21 CFR 570 check | Different legal pathway |
Claims language left unreviewed | Review claims as drug claims | Claims are regulated as drugs |
Undated listing record | Date every check | Listings change over time |
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Practical Considerations for Animal Feed and Pet Food Manufacturers
When evaluating a color additive for a new product or reformulation:
- Confirm the exact listing regulation and authorized uses (species, maximum levels, any restrictions).
- Verify whether certification is required and establish procedures to obtain certified batches.
- Ensure labeling statements comply with 21 CFR 501.22(k).
- For food-producing animals, consider residue implications and any related CVM guidance.
- If no suitable listed color additive exists, evaluate the feasibility of a color additive petition early in product development.
- Document the regulatory basis for each color additive used; this documentation is essential during inspections or in response to regulatory inquiries.
Trends toward “natural” or “no artificial colors” claims create additional considerations. While FDA has indicated enforcement discretion approaches for certain voluntary claims on human foods (and has signaled alignment for animal foods in some contexts), any such claim must be truthful and not misleading, and the underlying color additives must still be properly listed and declared.
How Seven Hills Regulatory Services, LLC Can Support Your Compliance Strategy
Navigating color additive regulations requires specialized knowledge of CFSAN and CVM processes, petition requirements, labeling nuances, and the interplay between human-food and animal-food rules. Seven Hills Regulatory Services, LLC assists animal feed and pet food manufacturers with regulatory strategy, petition preparation and management, labeling reviews, and responses to FDA inquiries related to color additives and other ingredients.
Whether you are evaluating existing formulations, planning new product development, or considering a color additive petition for a novel pigment or expanded use, early engagement with experienced regulatory counsel can reduce risk, accelerate timelines, and protect market position.
For further reference material, see our resources page.
Conclusion
Color additives are powerful tools for product differentiation and consistency in the animal food industry, but they operate under a uniquely stringent regulatory regime. Because FFDCA section 201(s)(3) excludes them from the food additive definition (and thus from the GRAS pathway), and because any substance that imparts color to feed or to the flesh, milk, or eggs of an animal is classified as a color additive, manufacturers must treat them with particular care. Understanding the definitions in 21 CFR Part 70, the petition process under Part 71, the listing regulations in Part 73 and Part 74, the collaboration between CFSAN and CVM, and the labeling rules in 21 CFR 501.22 is essential for ongoing compliance.
By staying current with the regulations, verifying the status of every colorant used, and seeking expert guidance when needed, animal feed and pet food manufacturers can confidently incorporate color additives while meeting FDA expectations and safeguarding their products and brands.
For personalized assistance with color additive compliance, petitions, or related regulatory matters, contact Seven Hills Regulatory Services, LLC. For a pre-filing consultation follow the provided link.
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Frequently Asked Questions
What are color additives in animal food?
A color additive is any dye, pigment, or substance that imparts color to animal food, including livestock feed and pet food. Under 21 CFR Part 70, the definition covers substances added to feed to color it, plus substances that color the animal's body or products like eggs or milk. Colors must be authorized for the specific use, and certification may be required depending on the color.
Does a color additive need FDA approval before use in pet food or livestock feed?
Yes, in most cases. A color additive must be listed for the intended use under 21 CFR Part 70, and certified colors need batch certification before shipment. To confirm status, check the FDA color additives list and the conditions of use for animal food. If no listing covers your use, you may need a color additive petition before the ingredient can legally appear in the product.
What should a color additive petition include?
A color additive petition typically needs identity and manufacturing process details, proposed conditions of use, labeling, and safety data including toxicology and exposure estimates. The petition is submitted to FDA, with CFSAN leading the process and CVM collaborating when the use is intended for animals. Pre-filing consultation with FDA can clarify data gaps before submission.
Can a color additive ever be considered GRAS for use in animal feed or pet food?
No. FFDCA section 201(s)(3) explicitly excludes color additives from the definition of “food additive.” Because the GRAS pathway applies only to substances that fall within the food additive definition (or meet the statutory GRAS criteria for such substances), color additives are ineligible for GRAS status. They must be listed by FDA regulation under section 721 of the FFDCA before they may lawfully be used.
Does an ingredient that colors an animal’s flesh, eggs, or milk count as a color additive even if it also has nutritional value?
Yes. Under 21 CFR 70.3(f), an ingredient of an animal feed whose intended function is to impart color—through the biological processes of the animal—to the meat, milk, or eggs of the animal is a color additive. This classification applies whether or not the ingredient has additional nutritive or other functions. Any article that simply imparts color to the feed itself is likewise classified as a color additive.
Who reviews color additive petitions intended for animal food—CFSAN or CVM?
CFSAN has primary responsibility for evaluating and listing color additives and manages the color additive petition process. When the proposed use is in animal food, CFSAN collaborates with CVM, which provides expertise on target-animal safety, species-specific considerations, residues in food-producing animals, and animal-food labeling requirements.
What is the difference between certified and certification-exempt color additives for animal food?
Certified colors (primarily the synthetic FD&C colors) must have each batch chemically analyzed and certified by FDA before use. Certification-exempt colors (often derived from natural sources) do not require batch certification but must still meet the exact identity, purity specifications, and use limitations (including any species or maximum-level restrictions) set forth in their listing regulations in 21 CFR Part 73. Both categories require prior FDA listing for the intended use.
How must color additives be declared on animal food labels?
Under 21 CFR 501.22(k), certified color additives must be declared by their common or usual name as listed in the applicable regulation (the “FD&C” prefix and “No.” are optional). Color additives exempt from certification may be declared individually by name or collectively using terms such as “artificial color,” “artificial color added,” or “color added,” provided the declaration is not misleading.
Color additive compliance rewards the team that checks the listing before the formula, not after. Seven Hills Regulatory Services, LLC supports pre-filing consultation, labeling and claims review, and regulatory submissions drafting, with animal scientists, toxicologists, and former FDA scientists on the team. Get started with Seven Hills Regulatory Services, LLC and bring your next animal food product to review with the documentation already in order.
