Letter to the editor regarding "GRAS from the ground up: Review of the Interim Pilot Program for GRAS notification" by

Abstract

Present letter is aimed at clarifying some critical points highlighted by Hanlon et al. regarding the common knowledge element of the safety of food enzymes in support of their GRAS designation. Particularly, we outline the development of peer-reviewed, generally recognized safety evaluation methodology for microbial enzymes and its adoption by the enzyme industry, which provides the US FDA with a review framework for enzyme GRAS Notices. This approach may serve as a model to other food ingredient categories for a scientifically sound, rigorous, and transparent application of the GRAS concept.

Keywords: Decision tree; Enzymes; GRAS; History of safe use; Safe strain lineage.