GRAS Services: Frequently Asked Questions

“GRAS” is an acronym for the phrase Generally Recognized As Safe, a regulatory classification where a food ingredient is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use. [FDA]

Some ingredients are food additives. A food additive is any substance where the intended use is expected to result – directly or indirectly – in it becoming a component of any food. Exceptions include:

• Ingredients determined to be GRAS
• Prior Sanctioned Ingredients, those substances authorized for use by the FDA or the USDA prior to the 1958 Food Additives Amendment.
• Color additives and pesticides, where other legal pre-market approval requirements apply.
• Dietary supplement ingredients.

A food additive must be authorized by the FDA before it can be used in food on the market. This authorization review is initiated when a Food Additive Petition submitted to FDA.

All food ingredients must be considered GRAS, a food additive, or prior-sanctioned. For ingredients not considered a food additive or prior-sanctioned, a GRAS determination is mandatory. However, submitting a GRAS notification to FDA is currently voluntary. This policy is currently under review.

No. Available safety data will determine that the food ingredient is GRAS for only specific uses, as defined in the GRAS document. Limitations may be on the type of food the ingredient can be added to, the amount of ingredient permissible for each type of food, as well as target population group(s).

There are two pathways to achieve GRAS for a food ingredient. Self-Affirmed and FDA-Notification.

For Self-Affirmed, also referred to as Self-Determined, the GRAS dossier is reviewed internally, typically by an independent panel of experts. FDA has provided a Guidance for Industry, entitled “Best Practices for Convening a GRAS Panel”.

For FDA-Notified, the GRAS dossier is submitted to FDA to review and comment. As FDA does not approve food ingredients, an ingredient deemed permissible by FDA will be listed accordingly in the FDA GRAS registration database.

It is important to note there is no distinction between Self-Affirmed GRAS and FDA-Notified GRAS. The safety and use data must meet the same threshold for both options.

The key steps in GRAS determination include:

1. Define the substance and its intended use.
2. Conduct an extensive literature review and data gathering (scientific procedures or history of common use)
3. Identify any data gaps and studies, if necessary.
4. Conduct toxicological assessments and exposure estimates.
5. Prepare a comprehensive GRAS dossier, to include an allergenicity review and Estimated Daily Intake assessment.
6. Convene an independent expert panel (strongly recommended for self-affirmations).
7. (Optional) Submit a GRAS Notice to FDA.

EAS Consulting Group has a team of consultants who are highly experienced with FDA submissions, to include GRAS for both human and animal foods. EAS Consulting Group can assist with:

1. Defining the substance and properly identifying its intended use.
2. Conducting a Feasibility Assessment, which includes an extensive literature review and data gathering. Once the Feasibility Assessment is completed, EAS Consulting Group will provide the best regulatory path forward.
3. Conducting toxicological assessments and exposure estimates.
4. Preparing a comprehensive GRAS dossier, to include an allergenicity review and Estimated Daily Intake assessment.
5. Coordinating an independent expert panel to review the GRAS dossier.
6. Submitting the GRAS Notice to FDA and then tracking it throughout the review process.

An expert GRAS panel typically consists of three qualified experts who independently evaluate whether the available scientific data, information, and methods establish that a substance is safe under the conditions of its intended use in human food or animal food. The GRAS panel’s analysis will support the conclusion that the safety of the intended use is “generally recognized” by qualified experts.

EAS Consulting Group has access to numerous independent experts for both human food and animal food. These experts have qualifications in nutrition, toxicology, chemistry, microbiology, as well as other related fields.

For both self-affirmed and FDA-submitted GRAS, it is incumbent on the GRAS “owner” to facilitate these periodic assessments.  In some cases, FDA will rescind GRAS registrations and prohibit the use of an ingredient or material, based on current scientific data.

Since other agencies such as USDA and TTB do not have a new ingredient review process, they will rely on FDA to do so. It is important to note that if an ingredient’s intended use is in a product regulated by another agency such as USDA or TTB, an FDA submission is required. There is not an option for self-affirmed GRAS.

Depending on the country, there can be differences between GRAS determination requirements for the US and those requirements for other countries.

Given that the US and Canada have mutual recognition of many food regulatory requirements, the data needed for a GRAS submission in the US may meet the requirements for a Novel Food in Canada. For other countries and regions, such as the EU, there may be significant differences. In all cases, the submission process will be completely different for each country / region.

EAS Consulting Group traces its history back to 1960. With a team of expert consultants, EAS Consulting Group has extensive experience in GRAS submissions for both human and animal foods. In support of our GRAS and FDA submissions team is a cadre of Subject Matter Experts in nutrition, microbiology, chemistry, toxicology, as well as many other science fields. All our consultants have more than 30 years of experience in their chosen fields, in either FDA or industry.