Generally Recognised as Secret (GRAS)

13 August 2026

By Dr Howard Dengate

The USA system has allowed many additives to be used without full safety assessment under what is called the “GRAS loophole”, meaning that the additives were not subject to a full scientific assessment, so it is pleasing that a review of GRAS (actually, Generally Recognised as Safe) is underway [1].

While we certainly do not agree with many actions by Health and Human Services Secretary Robert F. Kennedy Jr, who oversees the US Food and Drug Administration (USFDA), this review is long overdue [2].

Former FDA head David Kessler warns that human "biology was never intended to handle" ultraprocessed foods [3], and these thousands of unstudied chemicals which have slipped into their food supply potentially endanger public health.

Now let us see if anything actually changes or whether delays allow the food industry to escape again ...

And in Australia and New Zealand?

Our food regulator FSANZ does not use the GRAS system but requires explicit pre-market approval and positive listing for all new food additives and novel foods.

However real problems remain in all food additive evaluation, principally that they are not tested in the combinations actually used in foods, they are not tested for behavioural and learning effects for children, and they are now often disappearing as once-regulated additives and re-appearing as unregulated ingredients.

These latter “hidden additives” escape regulation – we do not know how much of them is being used as nobody is looking. The problem is that enforcement of regulations is up to individual States and is often not adequately funded to perform any useful level of testing. In Victoria, local Councils enforce food regulations!

Another loophole is that regulation allows many ingredients at GMP (Good Manufacturing Practice) levels, which means that the amount of these ingredients used is set by the manufacturer - see Schedule 15 of the Food Standards Code [5] to see which chemicals. For example, the bread preservatives 281 (Sodium propionate) and 282 (Calcium propionate), which many seek to avoid, are now not limited by statute but are allowed at GMP.

“Fermented wheatflour” is now found in nearly all breads – the active chemical in this ingredient was once regulated as additives 280-283. Now, who knows what levels are used?

References

[1] https://www.fda.gov/food/food-ingredients-packaging/generally-recognized-safe-gras