If you have ever eaten any processed food, it is likely that you have ingested a food additive. Although there are many concerns with the safety of food additives, they offer several benefits in foods. These may include:

  1. Maintaining product consistency
  2. Maintaining nutritional value
  3. Maintaining palatability and wholesomeness
  4. Improving functionality
  5. Enhancing flavor

The FDA is responsible for the regulation of food additives under the Food Additives Amendment Act (1958), including foods under the USDA jurisdiction. Manufacturers of meat or meat products seeking a petition for use of an additive, must go through two layers of approval i.e. they must seek approval through both the USDA and the FDA.While the USDA must abide by any food additive regulation established by the FDA, it reserves the authority to require higher standards.

What is a Food Additive?

Food additives include all substances, the intended use for which results or may reasonably be expected to result directly or indirectly in becoming a component or otherwise affecting the characteristics of food. Indirect additives include radiation, packaging and transportation. Food additives do not include the following:

  1. Pesticide chemical or residue
  2. Color additive
  3. A new animal drug
  4. Ingredients intended for use in dietary supplements
  5. A substance that is GRAS under conditions of intended use
  6. “Prior sanctioned” food ingredients, i.e. foods having FDA or USDA approval prior to 1958

So What’s a GRAS Substance?

GRAS, or “generally recognized as safe” means that the substance has been shown to be safe prior to 1958, based on credible scientific evidence; not limited to government research, that is widely agreed on by experts, and well documented, or by historical use, demonstrating safety. GRAS foods are not limited to foods originating in the US. Congress has determined that the GRAS list will not be cast in stone but will be reviewed and updated as new technology informs us more about the safety of the substances on the list. Previous to 1997, the FDA required a petition process to evaluate new potential GRAS substances. This process was resource and time intensive. Therefore, the FDA amended its regulations to allow voluntary notification of use. If the food manufacturer submits a notification, the FDA will review the notification and respond by:

  1. Indicating that it does not question the basis of the notifier’s GRAS determination
  2. Determining that it does not meet the criteria based on insufficient information
  3. Indicating that the data raises questions about its safety

The voluntary nature of this notification means that food manufacturers can actually put the food into commerce, without seeking permission from the FDA. However, the agency still expects companies to have on file the appropriate information needed to prove safety if called upon to do so.

The fact that food manufacturers are allowed to self-affirm GRAS status begs the question as to whether or not the FDA is doing enough to protect consumer safety against companies who may put harmful substances in food that they claim to be GRAS. After all, will they not likely seek to gain profits at the expense of consumer health?

Food Additives Approval Process

Substances that are not considered GRAS must go through pre-market approval seeking permission for the substance to be used as a food additive for one or more intended use. The petition must include:

  1. Name
  2. Chemical identity and composition
  3. How it should be used
  4. Purpose/functionality of the additive
  5. How much will be included in the food
  6. Description of analytical methods to determine quantity in food
  7. Description of any new substances formed in food due to the presence of the additive
  8. Safety evaluation reports on the additive

The following are steps in the petition process. The FDA issues a ruling within 90 days, but the process may be extended up to 180 days.

  1. Food manufacturer submits petition
  2. Within 15 days, the FDA provides notice that petition is accepted or incomplete
  3. Within 30 days of approving a petition the FDA publishes a notice of food additive filing in the Federal Register
  4. The FDA invites comments on ruling for 30 days
  5. The FDA issues a final rule on the use of the food additive

Pre-Market Approval Exemptions

Exempt from pre-market approval are “food contact substances” (formerly called indirect food additives) that do not have a technical effect on the food (based on the FDA Modernization Act of 1997). Furthermore, substances with a de minimis migration level (generally 0.5 ppb), are not required to submit a formal food additive petition. In other words if a toxic chemical migrates from the packaging into the food at a level of 0.5 ppb or less, this is considered too minimal to be concerned with, and therefore the substance will not need pre-approval.

Reference: Sanchez, M. C. (2015). Food law and regulation for non-lawyers – A US perspective. New York, NY: Springer International.

Courtney Simons
Courtney Simons is a food science professor. He holds a BS degree in food science and a Ph.D. in cereal science from North Dakota State University.
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