I. Definition and Legal Background of GRAS

II. Operation of the GRAS Notification Procedure

GRAS is a unique food safety evaluation mechanism in the United States, with its full name being Generally Recognized As Safe. This concept was first introduced in the 1958 Food Additives Amendment in the U.S. Unlike ordinary food additives, GRAS substances do not require pre-market approval from the U.S. Food and Drug Administration (FDA). They only need to be recognized as safe by scientifically trained and qualified experts based on sufficient scientific evidence or long-term usage experience. This special legal status makes GRAS substances play a significant role in food safety management.

IV. Essential Information Required for GRAS Notification

The GRAS notification procedure allows individuals, institutions, or businesses to voluntarily submit to the FDA a conclusion that a substance is GRAS under its intended conditions of use. The legal basis for this procedure is the Federal Food, Drug, andCosmetics & Personal CareCosmetic Act and its relevant sections. In this process, applicants must provide the FDA with detailed information about the substance, including its characteristics, production methods, uses, exposure levels, etc. Upon receiving the notification, the FDA conducts a thorough evaluation and determines whether to recognize the substance as GRAS.

III. Scope of GRAS notification application

GRAS notifications apply not only to human food and animal feed but also to food contact substances. It is important to note that GRAS does not apply to food color additives, which are subject to a separate set of regulatory requirements. Additionally, the Flavor and Extract Manufacturers Association (FEMA) has established a specialized procedure for determining the GRAS status of flavoring ingredients within its jurisdiction.

V. Operations and Review Cycle After GRAS Notification

According to 21 CFR Part 170 Subpart E of the Code of Federal Regulations, a GRAS notification must include seven main sections: a signed statement, substance characteristics, dietary exposure, self-limiting use levels, history of use, summary description, and a list of supporting data. Together, these elements form the basis for a comprehensive assessment of the substances GRAS status.

VII. Publicity and Query Methods of GRAS Notification

After submitting a GRAS notification, businesses may begin sales without waiting for FDA approval, but voluntary notification benefits market promotion and sales. The FDA typically evaluates and responds to GRAS notifications within 180 days, though actual processing times may be longer.

VI. Status changes of GRAS substances

If safety concerns arise regarding a GRAS substance, the FDA will revoke its GRAS status. Historically, substances such as partially hydrogenated oils and brominated vegetable oil have had their GRAS designations revoked.

GRAS is a unique food safety assessment mechanism in the United States, with its full name being Generally Recognized As Safe. This concept was first introduced in the 1958 Food Additives Amendment in the United States. Unlike ordinary food additives, GRAS substances do not require pre-market approval from the U.S. Food and Drug Administration (FDA), as long as they are recognized as safe by scientifically trained and qualified experts based on sufficient scientific evidence or long-term usage experience. This special legal status makes GRAS substances occupy an important position in food safety management.

Since 1997, the FDAs GRAS notification procedure has enhanced transparency. All GRAS notifications submitted to the FDA are publicly available on its website, including the substance name, notification file number, and FDA response. Additionally, the FDA maintains some GRAS lists in the Code of Federal Regulations, though these are not exhaustive positive lists.

The U.S. GRAS system provides a flexible and efficient pathway for assessing and confirming the safety of food ingredients. By understanding the basic concepts, notification procedures, and requirements of GRAS, businesses can more effectively manage product safety and compliance, ensuring success in global markets.