Ingredient Standards Are Vital to Supply Chain Integrity

Ingredient standards describe substances as they are used in the real world, not as abstract chemical entities, and are intended to be for material that is legally used in food or food production. Because regulatory requirements differ around the world, however, the existence of a standard does not necessarily mean that the substance described is allowed in specific jurisdictions or for all potential uses. Safety and toxicologic evaluations can be used to inform some components of a standard, such as limits on byproducts or contaminants.

Writing Standards

Standards are developed by entities called standards development organizations (SDOs). There are several organizations that develop standards for foods and food ingredients (see Table 2). These organizations collaborate and exchange information with each other to maximize consistency. The range of foods and substances covered by each organization, however, the depth of information provided, the process used to develop standards, and the organizational mandates differ.

One example of how these standards are developed and structured is the approach used by the Food Chemicals Codex (FCC). The FDA and the Institute of Medicine created the FCC in 1966 to “define the quality of food-grade chemicals in terms of identity, strength, and purity.” FCC standards are developed by a committee of expert volunteers working with FCC scientific staff and are based on the best scientific information available. Each draft standard undergoes an open and transparent public review and comment process through publication in the FCC Forum before being finalized and published.

The FCC is an independent SDO and the only one where standards are developed by independent experts, not organizational representatives. The FCC currently contains over 1,250 standards in the form of monographs and identity standards. Each standard includes specifications, the methods needed to determine if a sample of the substance meets these specifications, and any reference materials that are required to implement these methods.

FCC monographs and identity standards have several sections (see Figure 1). The first section provides general information such as the name of the substance, synonyms, the chemical formula, the chemical structure (if relevant), CAS number(s), INS numbers, and a qualitative description of the substance. This description can include information on how the ingredient is produced and how it should be stored. An identification section includes tests that can be used to determine if a sample of the substance is what it claims to be.

These tests use many analytical techniques, including chromatography and spectrophotometry, and include in detail all the information needed to run each test. Each test is accompanied by acceptance criteria, which may, for example, include a spectrum or a table of high-performance liquid chromotagraphy (HPLC) peak retention times. An assay section includes analytical tests to determine purity.

In addition to determining overall purity, each standard provides information on tests and acceptance criteria for relevant impurities. In this context, impurities include both organic and inorganic substances, such as heavy metals or residual solvents. Finally, tests for marker compounds and for properties that can affect functional quality (such as moisture content) are found in the specific tests section.

Because the utility and applicability of the analytic methods are critical for ensuring that FCC standards are practicable, many of the methods in the FCC are developed or evaluated by USP laboratories. This evaluation is carried out using multiple samples of the substance obtained from different sources. The lab ensures that the methods work as intended for each specific substance and that they are adequately described. In some cases, validated methods from recognized authorities such as the Joint FAO/WHO Expert Committee on Food Additives, International Organization for Standardization, or AOAC International have been adapted for use in the FCC. In other cases, FCC methods have been adopted by these other organizations.