The Green Processing of a Novel FDA Exempt ("Natural") Food Color Additive.

Consumers are demanding replacement of synthetic food colors with compounds from naturalsources. We have prepared a stable water-soluble yellow-red extract from avocado seeds.AvoColor® has favorable colorant properties in a variety of food systems. Structural analysisidentified the major pigment as a novel glycosylated benzotropone. The overall goal of theproposed studies is to commercialize a "green" process for the safe and efficient preparation of anexempt food color additive derived from avocado seeds and bring AvoColor® to market in PhaseIII.To accomplish this we have the following Technical Objectives:1. Identify major impurities as required by 21CFR 71.1(c) A.2. Conduct a techno-economicanalysis of the process to investigate process alternatives and optimize process parameters.3. Obtain stability data needed to insure the identity strength quality or purity of the coloradditive the expiration period that will be employed and packaging and labeling precautionsneeded to preserve stability (21CFR71.1(c)A.).4. Establish the intended use and restrictions ifany to estimate intake/exposure and labeling requirements.5. Identify the chemical changesoccurring during the NaOH "stabilization" process.6. Write Standard Operating Procedures(SOPs) including production controls necessary to maintain conformance with specifications.7. Develop methodologies to determine the identity and quantity of AvoColor® in any article offood and any substance formed in or on such article because of the use of AvoColor®.8.Write specification for AvoColor® per 21CFR71.1(c)A.In Phase I we demonstrated that AvoColor® is non-toxic to mice at doses that greatly exceed thoseexpected in food applications and that we can efficiently manufacture AvoColor®. The global foodcolors market is now dominated by natural colors with yellow orange and red the largest classesin 2016 and which is predicted to grow at 8.4% a year to 2022. With consumers continuing todemand natural ingredients it is anticipated that the "natural" share of the total food color market of$2.3 billion will exceed 70% by 2022.