China health food with new functions - Technical evaluation rules announced for trial implementation

China health food with new functions has new technical evaluation rules announced by the State Administration for Market Regulation (SAMR) on August 28, 2023, for trial implementation, effective immediately.

These regulations align with China's Food Safety Law, Management Measures for the Catalog of Health Food Raw Materials and Functions, and Health Food Registration and Filing Management Measures. This blog post provides a detailed overview of the key highlights and implications of these new regulations.

General provisions

The regulations are designed to regulate the evaluation of new functions and products in the health food sector, with a focus on meeting consumer health needs while adhering to principles of promoting health, scientific rationality, authenticity, and objectivity. Any entity or individual, referred to as "proponents," can submit proposals for new functions based on their research to the National Food Evaluation Center of SAMR. The proposals, if approved, will be included in the Health Function Catalog and undergo post-market evaluations.

Research on New Functions

New functions are categorized into three groups: supplementing dietary nutrients, maintaining or improving health conditions, and reducing the risk factors for diseases. Research samples should be newly developed health foods or existing registered health foods with newly discovered functions, complying with safety, quality, and health function requirements.

Material Submission

Proponents must provide comprehensive technical evaluation materials and electronic documents when submitting proposals, marking commercial secrets and intellectual property rights for clarity. SAMR will either accept or reject the proposal based on the provided materials.

Technical Assessment

SAMR's National Food Evaluation Center will conduct technical assessments based on specific criteria, including health function names, explanations, mechanisms, research reports, evaluation methods, comparative studies, and scientific literature. Proposals are either recommended for inclusion in the Health Function Catalog or deemed unsuitable.

Post-Market Evaluation

Health food products approved for market entry must conduct post-market evaluations, including data collection, health impact analysis, and consumer feedback. If adjustments to the Health Function Catalog or health claims are required, SAMR will facilitate the process.