Color Additive Requirements: FDA Guide to Safe Use and Labeling

Color Additive Requirements have a long and significant history in the FDA’s regulatory framework. This program ensures consumers receive safe products with accurate labeling. How does the FDA regulate color additives, and what must companies do when introducing a new color additive? The answers to these questions are provided in the following article from UCC.

1. Color Additive Requirements Overview

1.1. Reasons for Using Color Additives in Food

Manufacturers use color additives in food for various reasons, including:

• Compensating for color loss due to exposure to light, air, extreme temperatures, moisture, and storage conditions.
• Adjusting natural color variations.
• Enhancing the inherent colors of foods.
• Adding color to colorless foods to increase visual appeal.

1.2. FDA Regulations on Color Additives

The FDA’s Color Additive Requirements mandate evidence proving that a color additive is safe for its intended use before being added to food products. When the FDA approves a color additive for use in food, the agency specifies the following:

• The petition must specify the types of food in which the color additive can be used.
• The maximum allowable amount of the color additive.
• The method of labeling the color additive on food packaging.

1.3. FDA Color Additive Classification

The FDA classifies color additives into two groups: Certified Color Additives and Exempt Color Additives, each subject to specific Color Additive Requirements and safety standards.

1. Certified Color Additives are synthetic (artificial) substances commonly used for their strong, uniform colors, low cost, and easy blending. These include seven FDA-approved color additives, known as “FD&C” colors, which are also used in pharmaceuticals and cosmetics. An example is FD&C Yellow No. 6.
2. Exempt Color Additives come from natural sources like plants, minerals, or animals. For example, annatto extract (yellow), dehydrated beets (red to brown), caramel (light brown to yellow), beta-carotene (yellow to orange), and grape skin extract (red or purple). Although these additives are exempt from certification, they must, nonetheless, meet safety standards before use in food.

2. Color Additives Certification Process

2.1. Color Additive Certification

Color additive certification is the process by which the FDA ensures that new batches of color additives meet identity and specification requirements. The manufacturer must submit each batch with a “Certification Request” to the FDA’s Color Certification Branch, which includes details such as the color additive’s name, the manufacturer’s information, lot weight, storage conditions, and intended use.

FDA evaluates the sample based on criteria such as purity, moisture content, impurities, and heavy metals (e.g., lead, arsenic, mercury). If the sample meets the required standards, the FDA issues a certification, including details like the batch name, weight, intended use, and a unique certification number. Only after certification can the batch be used in food, pharmaceuticals, cosmetics, or medical devices.

This certification process typically takes up to five business days. Specifically, the FDA outlines Color Additive Requirements in 21 CFR Part 80 for certification, storage, fees, records, and inspections, and in 21 CFR Part 70.25 for labeling. Moreover, manufacturers can submit information and receive certification quickly through the FDA’s online system. In addition, the FDA may inspect certified batches at any time to ensure ongoing compliance.

2.2. Adding New Color Additives

The FDA is responsible for evaluating the safety of new color additives or new uses for listed color additives under the Color Additive Requirements. This process includes reviewing factors such as expected consumption levels, cumulative exposure, safety concerns, and analytical methods to determine purity and impurity levels. Once the FDA approves a petition, it may, therefore, issue new regulations or amend existing ones to incorporate the new color additive or its intended use. Additionally, the FDA ensures that all additives comply with these stringent Color Additive Requirements before being approved for use.

The petition must include comprehensive data and documentation demonstrating the safety and suitability of the new color additive or intended use, including specific information such as:

• The color additive’s identity.
• Physical, chemical, and biological properties of the new color additive
• Chemical specifications.
• Description of the production process of new color additive
• Stability data.
• Uses and limitations.
• Labeling instructions.
• Limits and tolerances.
• Testing methods to verify compliance of new color additive.
• Safety studies.
• Estimated exposure levels.
• Proposed regulations and, if applicable, exemption from batch certification.
• Environmental assessments or exemption requests.

FDA reviews this data, public comments, and relevant research to make a final decision.

3. FDA Enforcement Actions for Non-Compliance with Color Additive Requirements

When the FDA identifies violations related to color additives, the agency is empowered to enforce the FD&C Act to protect public health. These violations can include the use of unapproved additives, exceeding usage limits, or improper labeling. Additionally, the FDA may take further action to ensure compliance and safeguard consumers.

If a company fails to voluntarily correct a violation (e.g., by recalling products), the FDA can take several enforcement actions, including:

• Warning Letters: Typically, the FDA’s first step, warning companies of violations and requiring prompt action to correct the issue. The goal is to emphasize the seriousness of the violation and prevent further harm.
• Seizure: The FDA may seize violative products at manufacturing sites, warehouses, or in the market to prevent their distribution.
• Import Alerts: For violations involving imported products, the FDA can ban the importation of those products into the U.S., often targeting foreign companies or manufacturers not in compliance.
• Seizure/Forfeiture: The FDA may seek court orders to seize and destroy violative products, removing potentially harmful items from the market entirely.

 For more information: FSVP Representative: Key Role in Import Compliance

Through this article, we trust that you now have a more comprehensive understanding of the color additive regulations. Should you have any further inquiries regarding FDA standards, please do not hesitate to contact UCC for expert guidance and assistance.