SGS Publishes SafeGuardS on Proposed US FDA Mandatory GRAS Notification Requirements

BAAR, Switzerland - Sept. 8, 2026 - PRLog -- SGS, the world's leading testing, inspection and certification company, has published SafeGuardS 117.26, examining the US Food and Drug Administration's (FDA) proposals to increase transparency around substances marketed under generally recognized as safe (GRAS) determinations.

Title 21 of the Code of Federal Regulations (21 CFR) Part 170 (Food Additives) outlines procedures for evaluating food additives, food contact substances (FCSs) and GRAS substances intended for direct or indirect food use, including food contact notifications (FCNs), exemptions for certain low-risk food contact uses and the current voluntary GRAS notification program. This framework helps support food safety and consumer protection in the US.

On August 11, 2026, the FDA opened a 120-day consultation on a proposed rule (91 FR 51834) that would amend 21 CFR Parts 170 and 570 (Food Additives) and require the submission of GRAS notices for human and animal food substances that are claimed to be GRAS under the Federal Food, Drug and Cosmetic Act (FD&C Act, 21 U.S.C. 321(s)).

Highlights of the proposed changes include:
- Replacing the current voluntary GRAS notification program with a mandatory system requiring companies introducing substances under a GRAS determination to notify the FDA and provide the basis for that conclusion
- Improving transparency around GRAS determinations
- Clarifying when notifications are not required
- Identifying ineligible uses
- Updating regulations for food, food contact and animal food substances to align with current scientific approaches
- Updating the threshold of regulation (TOR) exemption framework and expanding its scope to certain food and food contact substance uses

SGS experts publish SafeGuardS to keep stakeholders informed about regulatory changes that could impact their business. SafeGuardS 117.26 includes a table comparing the existing regulations with the proposed changes.

Stakeholders are encouraged to refer to the original SafeGuardS 117.26 for more details.

SGS food contact material services
SGS's technical experts have extensive experience of testing materials and articles in contact with food. In the end, it's only trusted because it's tested. Learn more about SGS's food contact materials services (https://www.sgs.com/en/service-groups/food-contact-materials).

SGS SafeGuardS keep you up to date with the latest news and developments in the consumer goods industry. Read the full US FDA Consults on Proposed Mandatory GRAS Notification Requirements (https://www.sgs.com/en/news/2026/08/safeguards-11726-us-f...) SafeGuardS.

Subscribe today (http://www.sgs.com/subscribesg) and receive SGS SafeGuardS direct to your inbox.

For further information, contact Media Inquiries (https://try.sgs.com/en/cp/media-inquiries/) or:

Dr. HingWo Tsang
Global Information and Innovation Manager
Tel: +852 2774 7420
Website: www.sgs.com/hardlines
LinkedIn: SGS Connectivity & Products (https://www.linkedin.com/showcase/sgs-connectivity-and-products/?viewAsMember=true)

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