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A Food Additive Petition (FAP) is a formal request submitted to the U.S. Food and Drug Administration (FDA) seeking approval to use a new food additive that is not Generally Recognized As Safe (GRAS). This Regulatory pathway ensures that any substance added to food is scientifically evaluated for safety before it reaches consumers. FAPs are mandatory under the Federal Food, Drug, and Cosmetic Act (FD&C Act), Section 409.

What does a food additive petition include?

A typical Food Additive Petition submitted to the FDA must provide:

  1. Chemical Identity and Composition – Detailed description of the additive’s molecular structure and composition.
  2. Manufacturing Process – Full disclosure of how the additive is manufactured, ensuring consistency and purity.
  3. Proposed Uses and Levels of Use in Food—The specific foods where the additive will be used and the maximum quantity allowed.
  4. Toxicological and Safety Data – Comprehensive safety assessments, including toxicology reports and exposure analysis.
  5. Environmental Assessment – Analysis of environmental impacts or a claim for categorical exclusion.
  6. Labeling Information – Where applicable, proposed labeling requirements for the additive.

FDA Review Process

Upon submission, the FDA evaluates the complete scientific data package to assess whether the additive is safe for its intended use. If approved:

  • The FDA issues a regulation in the Code of Federal Regulations (CFR), officially authorizing the use of the additive.
  • Specific usage limits, specifications, or labeling requirements may also be established.

When does the FDA require a food additive petition?

FAP submission requirements by law for additives such as:

  • Sweeteners
  • Preservatives
  • Emulsifiers
  • Other non-GRAS substances used in conventional foods

Unlike GRAS substances, these additives cannot be marketed until they receive formal FDA approval through the FAP process.

Why is an FAP Important?

Filing a Food Additive Petition ensures that food additives undergo rigorous safety evaluations, protecting public health while allowing manufacturers to innovate with new ingredients. Once approved, the additive’s usage is codified within the FDA CFR regulations, offering clear guidelines for industry compliance.

For expert assistance in compiling and submitting FDA Food Additive Petitions, consult Regulatory specialists like Freyr Solutions to streamline your approval process and facilitate faster market access