REGULATORY STATUS

BenfoPure® has been reviewed by an independent panel of experts with unanimous conclusion that it is generally recognized as safe (GRAS).
Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), and FDA’s implementing regulations in 21 CFR 170.3 and 21 CFR 170.30, the use of a food substance may be GRAS either through scientific procedures or, for a substance used in food before 1958, through experience based on common use in food.

  • Under 21 CFR 170.30(b), general recognition of safety through scientific procedures requires the same quantity and quality of scientific evidence as is required to obtain approval of the substance as a food additive and ordinarily is based upon published studies, which may be corroborated by unpublished studies and other data and information.
  • Under 21 CFR 170.30(c) and 170.3(f), general recognition of safety through experience based on common use in foods requires a substantial history of consumption for food use by a significant number of consumers.

http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/default.htm

The Expert Panel has independently and collectively critically evaluated this safety assessment of Hamari Chemical’s BenfoPure®, and unanimously conclude that the intended use of BenfoPure® as a food ingredient, produced in accordance with Good Manufacturing Practice, and meeting the specifications presented in the document that is the basis for the GRAS determination, is generally recognized as safe.  The Expert Panel further concludes that the intended use is GRAS based on scientific procedures and corroborated by a history of safe use (exposure). The Expert Panel believes that other experts qualified by training and experience to evaluate the safety of food ingredients would concur with this GRAS conclusion.