Chinas State Administration for Market Regulation has issued a draft Catalogue of Raw Materials for Health Foods: Lycopene on April 2, 2026, seeking public consultation as part of efforts to streamline and advance the registration and filing framework for health food products under the Food Safety Law of the People's Republic of China. Stakeholders have been invited to submit comments through official channels, with a deadline of May 10, 2026.
The draft introduces lycopene as a standardized raw material eligible for health food use and establishes detailed technical, compositional, and regulatory requirements for its application. It also signals a regulatory shift toward filing-based management for certain previously registered products.
A key regulatory provision mandates that health food products already approved with functions such as enhancing immunity or antioxidant support must transition from registration to the filing system, reflecting Chinas ongoing reform to simplify approvals for well-established ingredients.
The draft specifies three categories of lycopene raw materials:
1.Lycopene derived from tomato extract or oleoresin
2.Purified lycopene from tomato extract with ?85% lycopene content
3.Synthetic lycopene produced via Wittig condensation reaction
All forms must comply with defined technical specifications, including:
Molecular formula: C??H??
Relative molecular mass: 536.89 (based on 2022 standards)
Mandatory compliance with sensory, physicochemical, and key constituent indicators (as per specified tables)
The regulation outlines strict source and processing requirements. Natural lycopene must be extracted from tomato (Lycopersicon) using approved methods such as supercritical CO? or organic solvents (e.g., n-hexane, ethyl acetate), followed by purification processes where applicable.
Specific usage and compliance conditions for commercial raw materials are also introduced: Only excipients permitted under GB 2760 (National Food Safety Standard for Food Additives) or the official health food excipient list may be used
Antioxidants such as vitamin C or vitamin E may be added for processing purposes, but their levels must be analytically verified and included in product specifications
Labels must declare their presence-No health claims may be made for these added excipients
Additional labelling precautions are required where intake thresholds are exceeded, including statements such as:
Do not exceed recommended intake
Do not consume simultaneously with similar nutrients
The regulation also emphasizes safety and efficacy validation requirements. For products combining lycopene with other nutrients, manufacturers must submit supporting research data demonstrating product safety and functional effectiveness.
Storage conditions for all lycopene raw materials are standardized, requiring protection from light, airtight sealing, and controlled temperature conditions to maintain stability and quality.
Overall, the draft represents a significant step in Chinas health food regulatory modernization, introducing clear standards for lycopene while reinforcing a shift toward a risk-based, filing-oriented regulatory system. The move is expected to facilitate innovation while maintaining strict safety, quality, and labelling controls.
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