The Grocery Manufacturers Association (GMA) announced last week that it is implementing a five-part initiative designed to modernize and increase transparency in the procedures used to assess food ingredient safety. The focus of the initiative relates to Generally Recognized as Safe (GRAS) determinations in food ingredients.

Under the Federal Food, Drug, and Cosmetic Act (the Act) any substance that is intentionally added to food is a food additive, and subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.  According to the FDA “safe” is defined as a “reasonable certainty in the minds of competent scientists that the substance is not harmful under its intended conditions of use. The specific data and information that demonstrate safety depend on the characteristics of the substance, the estimated dietary intake, and the population that will consume the substance.”

The GMA’s five-part initiative includes:

  1. Creating a Publicly Available Standard (PAS) to provide guidance on how to conduct transparent, modernized, food ingredient GRAS safety assessments.  The PAS will be a science-based framework developed by independent experts in a public process available to all interested stakeholders.  The PAS procedures will be designed to ensure GRAS assessments meet the regulatory requirements of the Act.
  2. A GMA-sponsored database listing all GRAS assessments conducted by the food industry.  The information in the database will be made available to FDA.
  3. An expanded curriculum of GRAS education and training including the establishment of the Center for Research and Ingredient Safety at Michigan State University.  The Center was launched in early 2014 and will serve as an independent academic center on the safety of ingredients used in food.
  4. GMA members adopted at Code of Practice outlining member commitment to the PAS procedures, to maintaining the database, and to training employees on GRAS procedures.
  5. A communication outreach program to inform the public, consumers, and industry and governmental stakeholders of GMA and food industry commitment to increasing the integrity and transparency of the procedures used to assess food ingredient safety.

The five-step initiative “will improve the process and increase transparency for making GRAS determinations of ingredients added to food,” according to Dr. Leon Bruner, Chief Science Officer for GMA.

FDA’s GRAS page can be found here.

FDA’s Guidance for industry, frequently asked questions about GRAS can be found here.