AAFCO identified gaps in the FDA's proposed GRAS notification rule, particularly that it only exempts ingredients from the 2024 Official Publication but excludes those reviewed through AAFCO's SRIS pathway, and is urging the FDA to make the exemption permanent and explicitly recognize the SRIS process.
- The FDA published its GRAS notification proposal on August 11, with a public comment deadline of December 9.
- The rule would require manufacturers to notify the FDA when introducing new GRAS substances to human or animal food.
- AAFCO flagged a critical gap: the exemption applies only to the 2024 Official Publication and does not extend to ingredients reviewed through the SRIS pathway, potentially requiring duplicate FDA notifications.
- AAFCO is requesting the FDA make the exemption permanent and ongoing rather than frozen to a single edition.
- AAFCO emphasized that its SRIS process meets the same rigor as FDA-recognized standards, including expert review, conflict-of-interest controls, public comment, and membership votes.
The Association of American Feed Control Officials said it is reviewing the U.S. Food and Drug Administration's proposed rule on generally recognized as safe (GRAS) notifications and outlined its early concerns and priorities ahead of submitting formal comments.
The FDA published the proposed rule Aug. 11, requiring manufacturers to notify the agency when they determine a substance added to human or animal food is GRAS. The rule is open for public comment through Dec. 9, 120 days after publication.
Under the proposal, companies would be required to notify the FDA when introducing new GRAS substances. Ingredients already on the market would be exempt from that notification requirement but would need to submit certain information to the agency within a year of the rule's finalization.
According to AAFCO, the FDA proposed recognizing the 2024 AAFCO Official Publication by reference in federal regulation, under 21 CFR 570.205(b)(6), exempting ingredients listed there from mandatory GRAS notification.
AAFCO called the provision a significant federal recognition of its ingredient-definition process. But the organization noted the exemption as written applies only to the 2024 Official Publication and does not extend to ingredient definitions developed afterward, including those reviewed through AAFCO's Scientific Review of Ingredient Submissions (SRIS) pathway. That gap means an ingredient favorably reviewed by SRIS and adopted by AAFCO's membership could still require a separate FDA GRAS notification if the rule is finalized as written.
Where AAFCO is focused
AAFCO said it is focusing on collaboration with the FDA as it develops its comments. The organization said the SRIS pathway was built to meet the same rigor the FDA already recognizes in the 2024 Official Publication and Association of American Feed Ingredient Companies (AFIC) exceptions, including expert review, conflict-of-interest controls, public comment and a full membership vote.
AAFCO said its comments will encourage the FDA to:
- Make the 2024 Official Publication exception permanent and ongoing rather than frozen to a single edition.
- Explicitly recognize the AAFCO SRIS process as qualifying for the exception.
- Preserve the FDA's authority to flag safety concerns and require a GRAS notice when warranted.
For more information, visit AAFCO's website or email [email protected].
