Document Type
Oral Presentation
Location
Oxford Convention Center, 102 Ed Perry Boulevard Oxford, MS 38655
Event Website
https://oxfordicsb.org/
Start Date
16-4-2024 10:00 AM
End Date
16-4-2024 10:30 AM
Description
Premarket regulation of ingredients added to food is a key pillar ensuring the safety of food as it allows the opportunity to address potential safety concerns prior to consumer exposure. In the United States, food and color additives are substances that are intentionally added to food and are subject to pre-market approval by the Food and Drug Administration (FDA) and require a listing in the Code of Federal Regulations, unless the intended use of the substance is generally recognized as safe (GRAS), among qualified experts. GRAS is not an inherent property of a substance, as is often misunderstood; rather, it relies on the substance’s proposed use and use level, the manufacturing process, dietary exposure, and other relevant safety data and information. Currently, the U.S. FDA manages a notification program, in which a manufacturer may inform FDA of its conclusion and basis that the use of a substance is GRAS. Notably, the safety standard is the same for food and color additives and GRAS substances—reasonable certainty of no harm. FDA’s general approach to the safety assessment of food ingredients with consideration for novel plant-derived ingredients will be discussed. FDA routinely engages in outreach to help food safety professionals and manufacturers understand U.S. food ingredient regulations, the GRAS provision, and welcomes consultations with the Agency throughout the process to support the safe and legal marketing of ingredients added to human foods.
Recommended Citation
Hubbard, Troy, "Introduction to the Premarket Review of Human Food Ingredients in the United States and Concepts in the Safety Assessment of Novel Plant-Derived Ingredients" (2024). Oxford ICSB. 12.
https://egrove.olemiss.edu/icsb/2024_ICSB/Schedule/12
Publication Date
April 2024
Accessibility Status
Searchable text
Included in
Introduction to the Premarket Review of Human Food Ingredients in the United States and Concepts in the Safety Assessment of Novel Plant-Derived Ingredients
Oxford Convention Center, 102 Ed Perry Boulevard Oxford, MS 38655
Premarket regulation of ingredients added to food is a key pillar ensuring the safety of food as it allows the opportunity to address potential safety concerns prior to consumer exposure. In the United States, food and color additives are substances that are intentionally added to food and are subject to pre-market approval by the Food and Drug Administration (FDA) and require a listing in the Code of Federal Regulations, unless the intended use of the substance is generally recognized as safe (GRAS), among qualified experts. GRAS is not an inherent property of a substance, as is often misunderstood; rather, it relies on the substance’s proposed use and use level, the manufacturing process, dietary exposure, and other relevant safety data and information. Currently, the U.S. FDA manages a notification program, in which a manufacturer may inform FDA of its conclusion and basis that the use of a substance is GRAS. Notably, the safety standard is the same for food and color additives and GRAS substances—reasonable certainty of no harm. FDA’s general approach to the safety assessment of food ingredients with consideration for novel plant-derived ingredients will be discussed. FDA routinely engages in outreach to help food safety professionals and manufacturers understand U.S. food ingredient regulations, the GRAS provision, and welcomes consultations with the Agency throughout the process to support the safe and legal marketing of ingredients added to human foods.
https://egrove.olemiss.edu/icsb/2024_ICSB/Schedule/12