This guidance represents the FDA's current thinking regarding considerations for assessing the impact of a significant manufacturing process change on the safety and regulatory status of a food substance. In addition, the guidance provides relevant recommendations for assessing the effect of a significant manufacturing process change on the safety and regulatory status of food substances, including those that are the subject of a food additive or color additive regulation, a food contact substance notification, or a generally recognized as safe (GRAS) determination.
According to the report, the guidance describes the factors to consider when determining whether a significant change in manufacturing process for a food substance already in the market including…
· Affects the identity of the food substance;
· Affects the safety of the use of the food substance;
· Affects the regulatory status of the use of the food substance; and
· Warrants a regulatory submission to FDA.
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