Imported Lycopene May Be Eligible for Health Food Filing in China

On April 2, 2026, the State Administration for Market Regulation released the Catalog of Health Food Ingredients: Lycopene (Draft for Public Comment). The deadline for submitting comments and suggestions is May 10, 2026.

The ingredients directory released this time includes two claimed functions:

Function 1: Lycopene – Nutritional supplement

This falls under the category of nutritional supplementation. For this function, it is expected that both domestically produced and imported products will be eligible to apply for filing.

Permitted ingredients: Lycopene (tomato extract) (lycopene content ≥5%), lycopene (lycopene oil resin) (lycopene content ≥5%), lycopene (purified tomato extract) (lycopene content ≥85%)
Permitted dosage forms: Must comply with Technical Requirements for Dosage Forms of Filed Health Food Products
Permitted excipients: Must comply with Permitted Excipients and Usage Regulations for Filed Health Food Products
Is the combination with other nutrients permitted?: Yes. However, for filed products combining lycopene with other nutrients, R&D data must be provided to demonstrate the safety and efficacy of the filed product.

“Catalog of Health Food Ingredients: Lycopene” – Nutritional Supplement (Expected to be eligible for filing for both domestic and imported products)

Ingredient	Use Level per Day				Function
Name	Use Level	Suitable for	Not suitable for	Notice	Function
Lycopene (tomato extract) (lycopene content ≥5%); Lycopene (lycopene oil resin) (lycopene content ≥5%)	15-30mg	Adults	adolescents, children, pregnant women, and nursing mothers	Fruits and vegetables such as tomatoes and grapefruit contain lycopene, and some products are fortified with lycopene. When consuming these products together, adjust the dosage within the recommended range based on your daily intake. This product is recommended for individuals with acute or chronic impairments in their ability to cope with oxidative stress (such as athletes).	Nutritional supplement
Lycopene (purified tomato extract) (lycopene content ≥85%)	15-30mg	Adults	adolescents, children, pregnant women, and nursing mothers		Nutritional supplement

Health Function	Definition
Nutritional Supplement	Lycopene is a carotenoid that helps boost immunity and provides antioxidant benefits.

Function 2: Lycopene – Helps boost immunity:

This does not fall under the category of nutritional supplements. Similar to coenzyme Q10 and other ingredients previously included in the raw material catalog, this applies only to the filing of domestically produced products.

Permitted raw material: Lycopene (synthetic)
Permitted dosage forms: Must comply with the Dosage Forms and Technical Requirements for Filed Health Food Products
Permitted excipients: Must comply with the Permitted Excipients and Usage Regulations for Filed Health Food Products
Permitted combination with other ingredients: Synthetic lycopene can only be used as a single ingredient for product filing

“Catalog of Health Food Ingredients: Lycopene” – Helps boost immunity (Domestic products only)

Ingredient	Use Level per Day				Function
Name	Use Level	Suitable for	Not suitable for	Notice	Function
Lycopene (synthetic)	15-30mg	Individuals with a weakened immune system	adolescents, children, pregnant women, and nursing mothers	Recommended for individuals whose immunity has been compromised by oxidative stress	Helps boost immunity

About CIRS Food Division

Established in 2012, the Food Business Division of CIRS Group has helped over 1,000 food companies globally in achieving one-stop compliance solutions. CIRS offers a full range of regulatory services, including but not limited to China novel food applications, synthetic biology-derived foods, U.S. GRAS notices, EU novel food application, health food registration, and food for special medical purposes (FSMP).

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

We have launched a LinkedIn newsletter to keep you up to date on the latest developments across the chemical industry including food and FCMs and personal and home care.