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Regulatory Guidance
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Evaluation of the Joint FAO/WHO Expert Committee on Food
Additives (JECFA), 2004
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The FDA has confirmed the Joint Expert Committee on Food
Additives’ (JECFA) ruling (Sept 8, 2004) that free lutein and
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f f h
i
zeaxant n are sa e or uman consumpt on.
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Vitamin status in some countries
General Method Requirements
1 Q i i
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f
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.
uant tat ve extract on rom matr ces
a. Raw materials from which dosage forms are formulated
b. Finished products (e.g., softgels, beadlets) including proteolytic or
other matrix release methods
2. Ensure against losses (e.g., oxidation, photolysis) during
extraction, workup and analysis
3. Separation from matrix interferent for accurate and
reproducible quantitation
4. The analytical range of the chosen method must encompass
below 1 mg