GRAS – What are GRAS ingredients?

In this post, we'll discuss one legislative element that works to safeguard our foods: Generally Recognized as Safe (GRAS) ingredients.

As we've discussed in previous blogs, food scientists and regulatory agencies work together to ensure our foods are safe from ingredients that can cause harm. But, how do we know an ingredient is safe? In this post, we'll discuss one legislative element that works to safeguard our foods: Generally Recognized as Safe (GRAS) ingredients.

What is GRAS?

Generally Recognized as Safe (GRAS) rules refer to sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act and state that any ingredient added to food must undergo evaluation for approval by the U.S. FDA unless it's a GRAS ingredient.

What is a GRAS ingredient?

A GRAS ingredient is an ingredient that has undergone safety evaluations by experts and has been proven not to cause harm when used as intended. Once experts agree that it does not cause harm when used as intended, it’s added to the GRAS ingredient list which means manufacturers can now use the GRAS ingredient in their products going forward.
Or, it's an ingredient that has been used commonly before 1958, and in significant quantities, across a large population, and over a sustained period without known harm. Ingredients falling into that category are considered safe and do not require additional safety evaluations.

How does an ingredient become a GRAS ingredient?

There are two avenues to become a GRAS ingredient:

  1. an industry wanting to use a new ingredient must perform rigorous scientific safety assessments, gain safety consensus from a non-biased panel of food safety experts, and prepare and submit a final report tonotify the U.S. FDA that an ingredient meets GRAS criteria. The U.S. FDA then reviews the report and informs the manufacturer if there are issues that suggest the ingredient should not be considered safe. If there are no apparent issues, the ingredient is added to the GRAS list.
  2. it has been in safe use before 1958 and is by default a GRAS ingredient.

Why do we need GRAS ingredients?

In practice, GRAS ingredients allow food manufacturers to produce foods and food products that are safe and to do so promptly. If the U.S. FDA was required to reevaluate an ingredient for every new product containing the ingredient, it would overburden the regulatory agency, and it could stifle innovation.

By creating an approved list of GRAS ingredients, food manufacturers can continue to innovate and respond to the market by incorporating these approved GRAS ingredients in their new formulations without additional FDA approvals.

Are there concerns over GRAS ingredients?

Yes, there are concerns from various organizations and advocacy groups about the GRAS approval process. The current process was enacted in 1997 and gives the food industry the ability to designate ingredients as GRAS via the report and notification process or if they have evidence that an ingredient has been used since before 1958.

It is the report and notification process that has garnered the most significant attention. While the FDA can review the notification reports, ingredients have been added to the GRAS list which some argue have not undergone adequate peer-review. There are organizations working to reform this process, to require greater U.S. FDA oversight over ingredients.

Can the status of a GRAS ingredient change?

Yes, if scientists discover that a GRAS ingredient raises safety concerns, the U.S. FDA will revoke the ingredient's GRAS status, and it will no longer be allowed in foods. This has occurred several times over the years and includes ingredients such as Partially Hydrogenated Oils (also known as trans fats), specific synthetic flavorings, and more.

Where can I learn more about GRAS ingredients and the history of this legislation?

You can learn more about the approach and the history of GRAS ingredients on the U.S. FDA's website.

In our next posts, we'll explore some of the GRAS ingredients in our summer staples!

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