Recent industry reports in China suggest that China Customs is increasing regulatory checks on 12 commonly used ingredients in health and wellness products:
Artemisia argyi, Ergothioneine, Polypodium leucotomos extract, NMN, Quercetin, Saw Palmetto, Ashwagandha, Epilobium parviflorum, Erythrina mulungu, Damiana, Berberis aristata, and NAD+.
Importers are now required to demonstrate that these ingredients comply with regulations in their country of origin and to provide supporting documentation to Chinese authorities.
This isn't entirely new. In 2024, similar compliance requirements were applied to ingredients such as Coenzyme Q10, Chamomile, N-Acetylcysteine (NAC), Glutathione, Resveratrol, and others.
Although not yet formalized through an official government notice, this trend highlights China's growing focus on ingredient-level compliance in the cross-border e-commerce (CBEC) space. For global brands, ensuring that not just final products—but also core ingredients—are fully compliant is becoming critical.
It's a common misconception that products sold via cross-border e-commerce (CBEC) to China are exempt from compliance requirements. In reality, compliance remains essential. The core principle is ensuring that the product is legally and compliantly marketed in its country of origin, and a critical part of that lies in the regulatory status of its ingredients.
Given the variation in food regulations across regions (e.g. botanical ingredient rules differ greatly between the EU, U.S., and Southeast Asia), China Customs has adopted a dual-standard approach:
✅ Ingredient compliance in the country of origin,
✅ Plus valid documentation to prove it.
This approach aligns with international norms while ensuring imported products meet basic safety requirements for Chinese consumers.
Let's take Ergothioneine, a trending antioxidant ingredient, as an example:
Ergothioneine is not considered a traditional food or dietary ingredient in the U.S., and its use requires regulatory clearance as either GRAS (Generally Recognized as Safe) status, or NDI (New Dietary Ingredient) notification to the FDA. For U.S.-origin products containing Ergothioneine, GRAS or NDI documentation can serve as key compliance references when imported via CBEC to China.
So far, two companies have successfully received GRAS FDA status:
GRN 734 - Blue California
Ergothioneine produced by E. coli K12 MG1655 via fermentation. Approved for use in cakes, cookies, pastries, tea, coffee, soft drinks, and chocolate (max 5 mg/serving).
GRN 1191 - Shanghai EGT Synbio Group Co., LTD
Produced by Escherichia coli BL-21 (DE3) expressing ergothioneine synthases from Schizosaccharomyces pombe (ergothioneine). Same approved uses and dosage.
Additionally, several companies have obtained self-affirmed GRAS (not publicly disclosed).
Ergothioneine is not considered a conventional food or food supplement ingredient in the EU. It is classified as a novel food, and its use requires prior approval from the European Commission. For EU-origin products containing Ergothioneine, Novel Food authorization can serve as key compliance documentation when imported via CBEC to China.
According to EU Regulation 2017/2470, Ergothioneine has been approved for use in non-alcoholic beverages, dairy-based drinks, dairy products, cereal bars, chocolate confectionery, and food supplements.
While the official approval does not disclose the precise production method, EFSA's assessment suggests that the approved Ergothioneine, submitted by Tetrahedron (France), is produced via chemical synthesis.
In Japan, Ergothioneine (L-エルゴチオネイン) is listed among Ingredients that are not considered pharmaceuticals unless claims regarding medicinal efficacy or therapeutic effects are made (「医薬品的効能効果を標ぼうしない限り医薬品と判断しない成分本質（原材料）」).
As of now, 12 functional food products featuring Ergothioneine have been registered in Japan's FOSHU system, with permitted claims related to antioxidant activity and cognitive support.
CBEC continues to play a vital role in international trade. In a July 2025 press conference, China Customs reported that China's CBEC trade volume reached RMB 1.32 trillion (USD 182 billion) in the first half of the year—a 5.7% increase YoY.
Compared to general trade, CBEC offers lower entry barriers (especially for special-use items like dietary supplements), favorable tax policies, and simplified logistics. Acting as a "digital bridge" between global brands and Chinese consumers, CBEC is a major driver of international trade and daily life in China.
However, rapid growth comes with tighter regulations. In March 2025, China issued guidelines to strengthen food safety supervision, including establishing a negative list for high-risk imports, improving data sharing between Customs and regulators, and clarifying recall responsibilities.
As CBEC continues to grow and regulations evolve in China, ingredient-level compliance for food products—particularly health foods and dietary supplements—has become increasingly important.
Whether it's the 12 newly flagged ingredients or other trending substances, the core principle remains the same: products must comply with regulations in their country of origin and be supported by credible documentation.
Given the wide variation in ingredient regulations across markets, it is recommended that CBEC businesses develop a clear understanding of country-specific requirements. By planning ahead and staying attuned to regulatory developments, companies can better seize opportunities in China's CBEC market while minimizing compliance risks and supporting long-term growth.
For a longer-term solution, businesses may also consider pursuing full compliance under China's general trade channels—such as obtaining notification/registration for health foods (blue hat) or ensuring ingredient and labeling compliance for pre-packaged food imports.
If you're facing challenges in navigating China's regulatory landscape—whether related to CBEC product compliance and marketing claims, health food registration, or new food ingredient approval—our team is here to help. Feel free to reach out at info@zmuni.com for tailored guidance and professional support.
