Frequently Asked Questions about FDA Generally Recognized As Safe (GRAS) Certification, Vol. 1

With the development of the food industry, there has been a growing emergence of new technologies and substances in recent years. Meanwhile, there is an increasing demand from food companies to seek new food ingredient compliance, including the GRAS certification in the United States. This article aims to address common questions about the food substance classification under the FDA GRAS, covering topics such as whether the use of a certain substance in human or animal food shall be classified as GRAS, and GRAS application compliance, among others.

Q1: What does FDA GRAS mean?

A1: “GRAS” is an acronym for the phrase Generally Recognized As Safe, which stands as an important food substance category in the United States. If a substance is generally recognized to be safe under the conditions of its intended use among qualified experts through scientific procedures, then it can be recognized as GRAS.

Under the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a food additive. Therefore, due to its convenient process and high international recognition, GRAS certification has become one of the important application projects for food enterprises to access international markets.

Q2: How should a food enterprise choose between Self GRAS and FDA GRAS?

A2: The notifier’s decision to submit a GRAS notice to CFSAN or CVM is voluntary, and the FDA’s response is not approved. It can be categorized into the following two types:

Self GRAS (Self-affirmed GRAS)

It only requires recognition from qualified experts demonstrating the safety of the substance, without submitting a notice to the FDA and without undergoing FDA review, thus it will not be publicly disclosed. This streamlined process shortens the procedure for developing and applying new products, allowing for earlier market release and sales.

FDA GRAS (FDA GRAS Notification)

Formal submission to the FDA is required, followed by an official FDA review. Substances approved will be publicly listed on the official website, adding authoritative validation. This serves as a strong endorsement for Chinese food enterprises when applying for domestic new food materials, providing evidence of the international usage background of the product.

Q3: If an ingredient is GRAS for one use, is it GRAS for all uses?

A3: Not necessarily. It is the use of a substance, rather than the substance itself, that is eligible for classification as GRAS.

Some uses of a human food substance are intended for a narrowly defined population. For example, some human food substances are intended for consumption by newborn infants who consume infant formula as the sole item of the diet. Likewise, some substances intended for use in animal food are intended for specific animal species, or for a specific life stage of an animal species; a substance that is safe for use in one animal species may not be safe for use in another species or in the same species at a different stage of life.

Q4: Is a substance that is used to impart color eligible for classification as GRAS?

A4: The short answer is “No.” To put it simply, the use of a substance capable of imparting color may constitute use as both a color additive and as a food additive or GRAS substance.

(Under 21 CFR 70.3(g), a material that otherwise meets the definition of color additive can be exempt from that definition on the basis that it is used or intended to be used solely for a purpose or purposes other than coloring, as long as the material is used in a way that any color imparted is unimportant insofar as the appearance, value, marketability, or consumer acceptability is concerned. )

In other words, if a substance is intended to be used solely for a purpose or purposes other than coloring, it can be exempted from the definition of a color additive and can undergo GRAS certification. However, if the intended use includes “coloring” purposes (even if not the primary purpose), it falls under the definition of a color additive. Therefore, a color additive petition is required for its compliant use. For example, betacarotene is both approved for use as a color additive and affirmed as GRAS for use as a nutrient in human food by FDA; in some food products, beta-carotene may be safely and lawfully used for both purposes.

Q5: If I submit a GRAS notice about a substance intended for use in human or animal food, must I wait until I receive an official response of “No questions” before I market that substance in the United States?

A5: No. Your decision to submit a GRAS notice to CFSAN or CVM is voluntary. If you are correct in concluding that a substance is GRAS under the conditions of its intended use, you may market a substance that is GRAS under the conditions of its intended use without informing CFSAN or CVM or, if CFSAN or CVM is so informed, while the applicable Center is evaluating your GRAS notice.

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