Q: What are the key considerations and review requirements for health food ingredients prepared using organic solvents, purification, enzymatic hydrolysis, fermentation, synthesis, cell wall breaking, and other specific pre-treatment processes?
A: Health food ingredients prepared using complex pre-treatment processes such as organic solvent extraction, purification, enzymatic hydrolysis, fermentation, synthesis, and cell wall breaking require high-quality control standards due to their complicated processing methods. The following considerations and review requirements must be observed when submitting such ingredients for health food registration:
In addition to providing the detailed preparation process, process explanation, basis for process rationality, quality requirements, and certification of quality inspection in accordance with the current regulations (such as the “Health Food Registration Review and Approval Guidelines” and the “Health Food Registration Application Service Guide”), applicants must also clearly state the raw material sources and provide manufacturer information. For raw materials that meet applicable national, local, or industry standards, the submission of the production process may be waived.
During technical review, special attention will be given to these raw materials. Raw materials using enzymatic hydrolysis, fermentation, and synthesis will be reviewed in the same manner as extracts. The review will also focus on risk-based compliance and safety checks to ensure that the raw materials are safe and their quality is controlled. (Source: Food Evaluation Center, General Administration of Market Supervision)
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