Respondents to the information collection are manufacturers of foods that are fermented, hydrolyzed, or contain fermented or hydrolyzed ingredients and bear the claim “gluten-free,” “no gluten,” “free of gluten,” or “without gluten.” It imposes recordkeeping that FDA believes will provide a reasonable assurance that food so labeled is gluten-free before fermentation or hydrolysis; that the manufacturer has evaluated the potential for cross-contact with gluten during the manufacturing process; and that measures have been taken to prevent the introduction of gluten into the food during the manufacturing process.
The latest form for Gluten-Free Labeling of Fermented or Hydrolyzed Foods expires 2023-08-31 and can be found here.
Supporting Statement A
Approved without change
|New collection (Request for a new OMB Control Number)||2020-08-13|
Comment filed on proposed rule
|New collection (Request for a new OMB Control Number)||2016-05-16|
Federal Enterprise Architecture: Health - Consumer Health and Safety