FDA Postpones the Release of Proposed Rule on GRAS Reform Until December

Last September, the U.S. Department of Health and Human Services (HHS) and the FDA first proposed the GRAS reform plan in their proposed rulemaking agenda , aiming to eliminate the Self-GRAS mechanism and replace it with a mandatory requirement to submit GRAS notice to the FDA. The plan was originally scheduled to issue relevant regulations in October 2025 but was subsequently delayed due to factors such as the government shutdown.

Recently, HHS/FDA updated the GRAS reform rule entry in the Federal Register’s “Uniform Agenda”, adjusting the proposed rule’s publication date to December of this year. More importantly, this update not only reflects a change in the timeline but also reveals the design philosophy behind the rule.

CIRS Group has noted the following details in this update:

1. The core principle remains unchanged, continuing to emphasize the shift from “voluntary” to “mandatory”

Currently, companies are not required to submit their Self-GRAS conclusions to the FDA, which often results in the FDA lacking timely awareness of companies’ self-determinations. The new rule will require mandatory submission of GRAS notices to the FDA regarding the use of certain food substances.

2. The rule repeatedly refers to “certain food substances” for specific uses, rather than explicitly stating that all GRAS uses will be subject to regulation

The biggest unknown at present lies in the scope of the new rule. Early proposed notices had hinted at the possibility of broad mandatory reporting while retaining some exemptions, but the wording in the latest version of the Regulatory Agenda is less explicit. The FDA now repeatedly uses the phrasing “the proposed rule would require the submission of GRAS notices to the FDA for certain uses of food substances”, suggesting that the new rule may apply selectively rather than comprehensively. The final scope of application will require further clarification in the text of the proposed rule.

3. Establishing a Simplified Transition Filing Mechanism for Certain Substances Already on the Market

The FDA may provide a simplified filing pathway for certain substances with existing uses that were already on the market prior to the final rule’s effective date. Eligible companies may submit simplified documentation within a limited timeframe to meet the new mandatory FDA GRAS notices requirements.

Strategies for Companies

For food companies, this postponement of the timeline does not mean they can adopt a wait-and-see approach. A more pragmatic approach is to review existing ingredients and uses as early as possible to ensure that safety data, exposure levels, identity information, manufacturing processes, and technical documentation are complete and up to date. Companies should consider actively submitting FDA GRAS notices while implementing Self-GRAS.

What CIRS Can Do for You

Established in 2007, the CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services from regulatory compliance, laboratory testing, R&D to data services across multiple industries. This includes chemicals, cosmetics, food and food beverages, medical devices, agrochemical products, disinfectants, and consumer goods. It helps clients gain a competitive advantage by reducing business risks associated with regulatory affairs.

The vast majority of members in CIRS Food Business Division have over 10 years of professional experience in food compliance, with more than 80% holding Master’s or Doctoral degrees in food-related disciplines. The CIRS toxicology expert team consists 24 Chinese Certified Toxicologists (DCST), 2 American Board Certified Toxicologists (DABT), and 2 European Registered Toxicologists (ERT). CIRS has provided one-stop food compliance services to over 1,000 domestic and international food and related enterprises. Leveraging its technical expertise, diverse resources, and global network, the CIRS Food Business Division offers global food compliance services, including but not limited to:

• Health food registration and filing in China;
• Application for “Three New Foods (new food additives, new food raw materials and new food-related products” in China;
• U.S. GRAS, NDI, and CAP notifications;
• EU Novel Food, food additives, and food enzymes applications; and
• Application for new feed ingredients and feed additives in China, the U.S., and the EU.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.