Compliance of Colorants in Cosmetics for Export to the United States: Guide to FDA and MOCRA Regulations

In the United States, the use of colorants in cosmetic products is allowed with FDA authorization, except for coal-tar-based hair dyes which have a different regulatory framework

The essential requirements for entering the U.S. market in light of the Food, Drug, and Cosmetic Act and the Modernization of Cosmetics Regulation Act (MOCRA)

The use of colorants in cosmetic products intended for the U.S. market is subject to strict regulations set by the Food and Drug Administration (FDA) and, starting December 29, 2023, further strengthened by the Modernization of Cosmetics Regulation Act (MOCRA). Compliance with these regulations is imperative to avoid import rejection and ensure market access. This guide provides an overview of the fundamental requirements for exporters.
 

Modernization of Cosmetics Regulation Act (MOCRA): A New Regulatory Framework

MOCRA represents a significant update in cosmetic regulation in the United States. It introduces new provisions that exporters need to be aware of, including:

• Facility Registration: Companies that produce or process cosmetics must register their facilities with the FDA.
• Ingredient Listing: Requirement to provide a list of ingredients used in cosmetic products.
• Adverse Event Reporting: Obligation to report serious adverse events related to cosmetic use to the FDA.
• Good Manufacturing Practices (cGMP): The FDA is authorized to issue cGMP regulations for cosmetics.

Specific Requirements for Colorants under the FD&C Act and MOCRA

The use of colorants in cosmetics is regulated by Section 721 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). MOCRA does not directly modify this section but introduces new obligations that indirectly affect the use of colorants, such as traceability and overall product safety.

To ensure colorant compliance, exporters must adhere to the following principles:

1. FDA Approval: All colorants used must be approved by the FDA for specific use in cosmetics. The list of approved colorants, along with usage restrictions and concentration limits, is available in the Code of Federal Regulations (CFR), particularly in Title 21, Parts 70 and 73. It is essential to consult these regulations to ensure the colorant is approved for the intended application (e.g., lips, eyes, general use).
    
2. Certification (when required): Some colorants, especially synthetic ones (FD&C, D&C), require FDA certification before being marketed. This certification ensures the purity and compliance of the colorant with safety standards. Generally, certified colorant suppliers provide the necessary documentation. However, it is the exporter's responsibility to verify the validity of the certification.
    
3. Compliance with Specifications: Colorants must meet the identity and purity requirements specified in 21 CFR. This includes standards related to chemical composition, impurities, and other physical and chemical characteristics.
    
4. Usage Restrictions: The use of colorants is subject to specific restrictions based on the type of cosmetic product and the area of application. For example, some colorants may be approved for general use, while others may be limited to lip products or nail polishes. It is crucial to adhere to these limitations to avoid compliance issues.
    

Implications for Export and Customs Controls

Non-compliance with colorant regulations, as well as the new provisions of MOCRA, can lead to the blocking and rejection of goods at U.S. customs. Customs authorities conduct random checks on imported products to verify compliance with FDA and MOCRA regulations. Therefore, it is essential for exporters to ensure their products meet all requirements before shipment.

Recommendations:

• Consult 21 CFR: The primary source of information on approved colorants and related restrictions is the Code of Federal Regulations, Title 21, Parts 70 and 73.
• Collaborate with Reliable Suppliers: Work with colorant suppliers who provide complete documentation of compliance with FDA regulations and are aware of MOCRA implications.
• Obtain Specialist Advice: In case of doubts or uncertainties, it is advisable to consult a U.S. cosmetic regulatory expert to ensure full product compliance.