FCC and USP Designations

The Food Chemical Codex (FCC) and United States Pharmacopeia (USP) are quality standards often cited in the context of food additives, pharmaceuticals, and other substances that come into contact with the human body. These standards were created when the industry was completely unregulated (1800s), and the quality of ingredients was suspect.

What You Need to Know

If you buy a compound with an FCC or USP designation, it means that it meets an accepted level of purity for food consumption set by industry, not the government. But not every food or flavour product has an FCC/USP designation. The FCC only has 1,287 monographs for the roughly 4,000 compounds approved for food use. The USP has over 5000 standards, but many of those are for drugs, medicine and compounds used to make pharmaceuticals, not necessarily food as the USP is an organization that guides the pharmaceutical and medical organizations.

This means that you will probably not find a “food grade” designation for many of the compounds used in flavours, which is okay. What you need to look for is a relatively pure compound, typically 95% and above, and every reputable supplier will provide this information in the form of a Certificate of Analysis, commonly called a C of A.

FCC (Food Chemicals Codex)

The Food Chemicals Codex (FCC) is a compendium of internationally recognized standards for the purity and identity of food ingredients, including food additives. It’s published by the United States Pharmacopeial Convention (also responsible for the USP) and is used as a reference standard by regulatory agencies, manufacturers, and trade associations worldwide.

The FCC provides specifications for things like solubility, melting point, and purity, as well as approved analytical methods for testing these parameters. The aim is to ensure that the food additives meet a minimum standard of quality and are safe for human consumption.

USP (United States Pharmacopeia)

The United States Pharmacopeia (USP) is a nonprofit organization that sets federally recognized standards for the quality, purity, strength, and consistency of drugs, food ingredients, and dietary supplements. While the USP covers a broader range of substances than the FCC, it also includes food additives and other food ingredients.

Like the FCC, the USP provides specifications and analytical methods, but it also includes additional information relevant to pharmaceuticals, such as bioavailability, stability, and packaging requirements.

Why These Designations Were Created

Both the FCC and USP standards were created to provide a reliable, scientific basis for the quality and safety of substances consumed or used by humans. Before such standards existed, there was significant variability in the quality and purity of food additives, drugs, and other substances, which could lead to adverse health effects or ineffective products.

  1. Quality Control: These compendia provide manufacturers with standardized methods for testing the quality of ingredients, ensuring consistency across batches and between different suppliers.
  2. Consumer Safety: By setting minimum purity and quality standards, these designations help protect consumers from adulterated or substandard products.
  3. Regulatory Compliance: Regulatory agencies often refer to FCC and USP standards when setting legal requirements for food additives and other substances, making it easier for manufacturers to comply with laws and regulations.
  4. Global Trade: Because these standards are internationally recognized, they facilitate global trade in food ingredients and pharmaceuticals by providing a common set of criteria that both exporters and importers can agree upon.

In summary, FCC and USP provide a scientific basis for quality control for a limited set of compounds that are widely used in the food and pharmaceutical industry.

Updated on October 29, 2023