United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2020_register executive 2020-08-13 article Rules and Regulations D09002ee1c7b7023a D09002ee1c7b7030b United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA or we) is issuing a final rule to establish requirements concerning "gluten-free" labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients. These requirements f are needed to help ensure that individuals with celiac disease are not misled and receive truthful and accurate information with respect to fermented or hydrolyzed foods labeled as "gluten- free." Currently, FDA knows of no scientifically valid analytical method effective in detecting and quantifying with precision the gluten protein content in fermented or hydrolyzed foods in terms of equivalent amounts of intact gluten proteins. Thus, we plan to evaluate compliance of such fermented or hydrolyzed foods that bear a "gluten-free" claim based on records that are made and kept by the manufacturer of the food bearing the "gluten-free" claim and made available to us for inspection and copying. The records need to provide adequate assurance that the food or ingredients used in the food are "gluten-free" before fermentation or hydrolysis. Once we identify that a scientifically valid method has been developed that can accurately detect and quantify gluten in fermented or hydrolyzed foods or ingredients, it would no longer be necessary for the manufacturer of foods bearing the "gluten-free" claim to make and keep these records. In addition, because currently there is no scientifically valid analytical method effective in detecting and quantifying the gluten protein content in fermented or hydrolyzed foods the final rule requires the manufacturer of these kinds of foods bearing the "gluten- free" claim to document that it has adequately evaluated the potential for gluten cross-contact and, if identified, that the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process. Likewise, the final rule requires manufacturers of foods that contain fermented or hydrolyzed ingredients and bear the "gluten-free" claim to make and keep records that demonstrate with adequate assurance that the fermented or hydrolyzed ingredients are "gluten-free" in compliance with the 2013 gluten-free food labeling final rule. Finally, this final rule states that we will evaluate compliance of distilled foods by verifying the absence of protein using scientifically valid analytical methods that can reliably detect the presence of protein or protein fragments in the distilled food. 85 FR 49240 https://www.govinfo.gov/app/details/FR-2020-08-13/2020-17088 2020-17088 fr13au20-5 RIN 0910-AH00 4164-01-P Docket No. FDA-2014-N-1021 https://www.govinfo.gov/app/details/FR-2020-08-13/2020-17088 https://www.govinfo.gov/content/pkg/FR-2020-08-13/html/2020-17088.htm https://www.govinfo.gov/content/pkg/FR-2020-08-13/pdf/2020-17088.pdf Food Labeling Nutrition Reporting and Recordkeeping Requirements 22 p. 49240 49261 85 FR 49240 Title 21 Part 101 21 CFR Part 101 RIN 0910-AH00 Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods; Federal Register Vol. 85, Issue RULE 2020-17088 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2020-10-13 Docket No. FDA-2014-N-1021 4164-01-P 2020-17088 Final rule.

The Food and Drug Administration (FDA or we) is issuing a final rule to establish requirements concerning "gluten-free" labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients. These requirements f are needed to help ensure that individuals with celiac disease are not misled and receive truthful and accurate information with respect to fermented or hydrolyzed foods labeled as "gluten- free." Currently, FDA knows of no scientifically valid analytical method effective in detecting and quantifying with precision the gluten protein content in fermented or hydrolyzed foods in terms of equivalent amounts of intact gluten proteins. Thus, we plan to evaluate compliance of such fermented or hydrolyzed foods that bear a "gluten-free" claim based on records that are made and kept by the manufacturer of the food bearing the "gluten-free" claim and made available to us for inspection and copying. The records need to provide adequate assurance that the food or ingredients used in the food are "gluten-free" before fermentation or hydrolysis. Once we identify that a scientifically valid method has been developed that can accurately detect and quantify gluten in fermented or hydrolyzed foods or ingredients, it would no longer be necessary for the manufacturer of foods bearing the "gluten-free" claim to make and keep these records. In addition, because currently there is no scientifically valid analytical method effective in detecting and quantifying the gluten protein content in fermented or hydrolyzed foods the final rule requires the manufacturer of these kinds of foods bearing the "gluten- free" claim to document that it has adequately evaluated the potential for gluten cross-contact and, if identified, that the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process. Likewise, the final rule requires manufacturers of foods that contain fermented or hydrolyzed ingredients and bear the "gluten-free" claim to make and keep records that demonstrate with adequate assurance that the fermented or hydrolyzed ingredients are "gluten-free" in compliance with the 2013 gluten-free food labeling final rule. Finally, this final rule states that we will evaluate compliance of distilled foods by verifying the absence of protein using scientifically valid analytical methods that can reliably detect the presence of protein or protein fragments in the distilled food.

Effective date: This rule is effective October 13, 2020. With regard to the final rule: Carol D'Lima, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5001 Campus Dr., Rm. 4D-022, College Park, MD 20740, 240-402-2371, Carol.Dlima@fda.hhs.gov. With regard to the information collection: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, PRAStaff@fda.hhs.gov. Food Labeling Nutrition Reporting and Recordkeeping Requirements Food Labeling: Gluten-Free Labeling of Fermented or Hydrolyzed Foods, Carol.Dlima@fda.hhs.gov PRAStaff@fda.hhs.gov http://siweb.dss.go.th/standard/Fulltext/codex/CXS_118E.pdf http://www.glutenfreedietitian.com/should-manufacturers-consumers-use-lateral-flow-devices-ez-gluten-to-test-food-for-gluten/ https://onlinelibrary.wiley.com/doi/epdf/10.1002/j.2050-0416.2003.tb00592.x https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm https://www.fda.gov/food/food-labeling-nutrition/gluten-free-labeling-foods https://www.ingentaconnect.com/content/aoac/jaoac/2015/00000098/00000005/art00023?crawler=true&mimetype=application/pdf https://www.labelinsight.com/about https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3349865/pdf/251_2012_Article_599.pdf https://www.ncbi.nlm.nih.gov/pubmed/6692666 https://www.regulations.gov https://www.researchgate.net/publication/251972244_AACCI_Approved_Methods_Technical_Committee_Report_Collaborative_Study_on_the_Immunochemical_Determination_of_Partially_Hydrolyzed_Gluten_Using_an_R5_Competitive_ELISA https://www.ttb.gov/images/pdfs/rulings/2014-2.pdf Vol. 85, no. 157 Office of the Federal Register, National Archives and Records Administration 2020-08-13 continuing daily deposited born digital 369 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2020-08-13 P0b002ee1a7fe522b 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr13au20 https://www.govinfo.gov/app/details/FR-2020-08-13 https://www.govinfo.gov/content/pkg/FR-2020-08-13/pdf/FR-2020-08-13.pdf https://www.govinfo.gov/content/pkg/FR-2020-08-13/xml/FR-2020-08-13.xml fdlp 49229 49588 DGPO 2020-08-13 2024-05-30 FR-2020-08-13 machine generated eng FR FR-2020-08-13 85 157