Generally Recognized as Safe Statement

Conclusion of the GRAS Status in Accordance with Regulations

Based on a critical evaluation on publicly available data summarized in this document, the expert Panel members whose signatures appear within, have individually and collectively concluded that consumption of Momordica sp. leaf extract (McB-E60) intended to be used as a flavoring agent (flavor enhancer) and as a food ingredient in rice, pasta and grain mixtures, savory snacks and soups (without meat), breakfast type bars and ready-to-eat cereals, nonalcoholic beverages, and processed fruit juices at use levels up to 100 mg per serving (reference amounts customarily consumed, 21 CFR 101.12), when not otherwise precluded by a Standard of Identity as described in this dossier, and resulting in the 90th percentile all-user estimated intake of 601 mg/person is safe and Generally Recognized As Safe (GRAS).

It is also our opinion that other qualified and competent scientists reviewing the same publicly available toxicological and safety information would reach the same conclusion.

Therefore, we have also concluded that bitter melon leaf extract, when used as described, is GRAS.

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