ZMUni Compliance Centre

Our Services

• Feasibility analysis for GRAS certification in the United States
• Self-affirmed GRAS application in the United States
• FDA GRAS application in the United States
• Testing services
• Other customized compliance services

Definition of GRAS Certification

GRAS stands for "Generally Recognized as Safe." GRAS is a specific category recognized in the United States.

According to the Federal Food, Drug, and Cosmetic Act, Section 201(s) and Section 409, any substance intended to be added to food is considered a food additive and must undergo pre-market review and approval by the FDA. However, there are exemptions, and GRAS is one of them.

GRAS certification is internationally recognized and serves as an important passport for companies to access international markets for their food ingredients or food additives.

Classification of GRAS Certification:

Self-affirmed GRAS

Qualified experts conduct a comprehensive evaluation of the substance's safety and other aspects and produce a consensus report. The report is generally not publicly available.

Through this process, companies make a self-affirmed declaration of the substance's safety and legally enter the U.S. market.

FDA GRAS Notice

Applicants submit an application to the FDA, which conducts a comprehensive evaluation of the substance's safety and other aspects and provides a response to the application. If the FDA response is "FDA has no questions," it indicates that the substance is recognized as GRAS.

The relevant GRAS application materials and FDA responses are published on the FDA's official website.

Applicants for GRAS Certification

Any individual, company, or institution can submit an application to the FDA.

GRAS Certification Application Documents

• Signed statement and assurance
• Substance information (characteristics, production process, quality standards, etc.)
• Dietary exposure data
• Self-limiting levels in food
• History of use in food before 1958
• Safety description
• Supporting data