Protein Regulations Presentation

Originally Published: September 8, 2014
Last Updated: March 12, 2021

“Protein Regulations”  was presented at the 2014 Protein Trends & Technologies Seminar by Kathy Musa-Veloso, Ph.D., Director, Health Claims and Clinical Trials, Food and Nutrition Group, Intertek Scientific & Regulatory Consultancy.

Abstract: Regulations are central to product formulation efforts. They determine the ingredients (e.g., conventional or innovative) that can be used, the levels at which the ingredients may be used, and the claims that can be conveyed on product labels. This presentation provided a review of the U.S. regulations on nutrition and health claims related to protein and the approval process for the use of novel protein sources. The discussion was then expanded to look at the regulatory requirements related to protein claims in other regions, with a primary focus on Canada and Mexico. By gaining insights into the current environment for protein claims in the U.S. and its largest trading partners, formulators can better evaluate ingredient options for product success.

Excerpt from the written summary of this presentation: Determination of GRAS status in the U.S. is unique in the global world of food regulations, as evaluations are completed by the manufacturer (self-GRAS), who consults experts qualified by scientific training and experience to evaluate the safety of substances directly or indirectly added to food. Views are based on scientific procedures or experience based on common use in food (prior to 1958).

Musa-Veloso stated, “Pivotal data must be generally available to the scientific community. If the food was in common use prior to 1958, less scientific evidence is required. There must be evidence of substantial history of consumption by a significant number of consumers. If common use of the food was outside the U.S., then two independent sources must confirm history and circumstances of use.”

Click here to view the written summary “Regulations on Protein Claims & Ingredients” of this presentation.

Click on the button below to download a PDF of Musa-Veloso’s PowerPoint presentation “Protein Regulations.”

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