On August 12, 2016 the U.S Food and Drug Administration (FDA) published a final rule “detailing the criteria for concluding that the use of a substance in human or animal food is ‘generally recognized as safe’ (GRAS).” The GRAS rule may also be applied to certain substances present in food contact materials (FCMs) that may become indirect additives to food. GRAS substances do not require pre-market approval by the FDA, the agency explains. The final rule specifies “the types of scientific evidence that can be used to demonstrate safety” and details the voluntary GRAS notification procedure. FDA encourages companies to follow the notification procedure and inform the agency of GRAS conclusions to aid FDA’s food safety monitoring efforts. FDA notes that the GRAS final rule is a step taken “to strengthen the FDA’s oversight of substances added to human and animal food.” Additional guidance related to GRAS shall be issued in a next step. The final rule will be published in the Federal Register on August 17, 2016 – a pre-publication version is already available.

Tom Neltner of the non-profit organization Environmental Defense Fund (EDF) commented on FDA’s final rule regarding GRAS in a blog post published on August 12, 2016. Neltner considers FDA’s decision “a lost opportunity to close a widely-abused loophole that allows chemicals to be approved for use in food with no notification to or review by FDA.” He points out that ‘general recognition’ can be based on “unpublished exposure or toxicology data” and that FDA rejected making the notification procedure mandatory. Neltner concludes that “the rule allows the industry to continue making secret decisions about what we eat without the agency’s – or the public’s – knowledge.”

Read more

FDA (August 12, 2016). “FDA issues final rule on food ingredients that may be ‘generally recognized as safe.’

Tom Neltner (August 12, 2016). “Lost opportunity for safer food additives.EDF


FDA (August 12, 2016). “Substances generally recognized as safe.(pdf; pre-publication)