There are a number of factors that can impact whether or not a substance is eligible for GRAS.
If the ingredient is manufactured with the intent of being added to conventional foods, then it falls under the definition of food additive. But certain “whole foods,” which are minimally processed prior to addition to convention foods, wouldn’t be eligible for GRAS. Take carrots for example:
Scenario 1:
Carrots are harvested, washed, peeled, and sliced. The sliced carrots are then intended for use as an ingredient in conventional foods. The chemical composition of the carrot has not been altered, as minimal processing has occurred. The sliced carrots are essentially “whole foods,” and would not be considered a food additive.
Scenario 2:
Carrots are harvested, ground and crushed, then mixed with a solvent to extract carotenoids. The resulting extract is purified and evaporated to obtain beta-carotene (98% purity). Here, the chemical composition of the carrot has been significantly altered during the manufacturing process. The beta-carotene would be considered a food additive, and the appropriate regulatory requirements would need to be satisfied prior to use in conventional foods.
In instances when a GRAS conclusion has already been reached for a particular ingredient, it’s not always necessary for other manufacturers to undertake a new GRAS assessment, especially if the intended use and manufacturing process are substantially similar. Sometimes, pursing a GRAS conclusion is strictly a business decision. It’s not uncommon for a customer to require a manufacturer’s GRAS dossier prior to purchasing an ingredient, whether or not it’s a regulatory requirement.
To see if an ingredient has already been subject to FDA regulation or review, the following sources should be searched:
• The Substances Added to Food inventory (formerly EAFUS)
• FDA’s GRAS Notice Inventory
• FDA’s Indirect Food Additives list
• FDA’s Food Contact Substance (FCS) notification list
If the ingredient isn’t listed in any of these databases, the composition, proposed uses, and/or use levels vary from those which have already been reviewed for that substance, or the manufacturing process differs considerably, it’s likely that a GRAS assessment is warranted. Other factors, such as the discovery of newly published safety data on the substance and the use of fermentation or biotransformation processes should also be considered.
Establishing the safety of an ingredient under the intended use is an integral part of the GRAS assessment. If pivotal safety studies have been published in peer-reviewed literature, then it’s likely that a GRAS assessment could be undertaken. However, if the ingredient has not been studied extensively or there is a lack of publicly available information, the requirement for “general recognition of safety” will not likely be met, so pursuing a GRAS assessment would not be advisable until pivotal safety studies are published.
Before pursing a GRAS conclusion, it’s important for manufacturers to understand the composition of the food additive and ensure that the ingredient is manufactured under Current Good Manufacturing Practices (CGMP). An upcoming blog post will discuss establishing specifications and quality control of ingredients prior to initiating a GRAS assessment.
Of course, there instances in which a GRAS Notice is almost always recommended (i.e., steviol glycosides). There are also ingredients which FDA has stated cannot be considered GRAS due to previous evaluation and/or use as a drug (i.e., CBD).
It can be difficult to determine if and when an ingredient is eligible for a GRAS assessment. If you aren’t sure where to start or if you’re looking for some help with navigating the GRAS process, please feel free to reach out directly.
The next blog post in this series will compare and contrast Independent GRAS Conclusions and GRAS Notices.
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📷 1: Sandie Clarke on Unsplash