Regulatory Status of Resveratrol Application in the Food Industry in Major Countries Worldwide

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Resveratrol, a natural polyphenol compound widely found in plants such as grapes, giant knotweed, and peanuts, is subject to strict regulation for food applications across the globe. Below is the regulatory status in major countries and regions.

I. European Union (EU)

1. Regulatory Category & Authorization Status

Synthetic trans-resveratrol: Classified as a Novel Food, requiring evaluation by the European Food Safety Authority (EFSA) and authorization by the European Commission.
Natural resveratrol: If derived from traditional edible plants (e.g., grape skin extract), it can generally be used as a food ingredient, subject to relevant purity and safety standards.
Key authorization: Regulation (EU) 2017/2470 approved trans-resveratrol from Saccharomyces cerevisiae fermentation as a Novel Food.

2. Safety Assessment & Dosage Limits

EFSA published a scientific opinion in 2015, concluding that synthetic trans-resveratrol is safe for adults at a daily dose of 150 mg.
Prohibited in foods for infants and young children (under 3 years old) and pregnant/lactating women.
Permitted uses: food supplements, functional beverages, chocolate, bakery products, etc.

3. Rules on Health Claims

Only health claims supported by scientific evidence (e.g., “contributes to antioxidant activity”) are allowed.
Disease-prevention or therapeutic claims (e.g., anti-cancer, cardiovascular disease treatment) are prohibited.
All claims require approval by the EU Nutrition and Health Claims Committee (NHC).

II. United States (USA)

1. Regulatory Category

Dietary supplements: The most common form, regulated by the Dietary Supplement Health and Education Act (DSHEA) without prior FDA approval.
Conventional food ingredients: May gain market access via the GRAS (Generally Recognized as Safe) notification process.
New Dietary Ingredient (NDI): For synthetic or non-traditional sources, an NDI notification must be submitted.

2. GRAS Status & Application Scope

Key GRAS notice: GRN No. 224 approved trans-resveratrol in bottled water at a maximum concentration of 10 mg/L.
Other GRAS petitions for functional beverages, energy bars, etc., are under evaluation.
The FDA maintains a cautious approach to high-purity resveratrol (≥98%).

3. Health Claim Restrictions

Disease claims (e.g., prevents heart disease, anti-cancer) are prohibited.
Structure/function claims (e.g., supports cardiovascular health, antioxidant activity) are allowed, with the mandatory label:
“This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”
In 2010, the FDA rejected a health claim linking resveratrol to reduced heart disease risk due to insufficient scientific evidence.

III. China

1. Regulatory Status

Ordinary food: Not listed in the Catalogue of Substances Used as Both Food and Traditional Chinese Medicinal Materials; prohibited as a regular food ingredient.
Health food: Under review for inclusion in the Health Food Ingredient Catalogue. In November 2023, it was published for public comment as a “proposed health food ingredient” by the State Administration for Market Regulation (SAMR).
Cross-border e-commerce: Requires proof of authorized use in the country of origin; listed as one of eight sensitive ingredients in 2024.

2. Progress for Health Food

Proposed allowed claims:
– “Contributes to antioxidant activity”
– “Helps maintain cardiovascular health”
Proposed daily recommended intake limit: 150 mg.
As of September 2025, some resveratrol-containing health foods have obtained the “Blue Hat” certification.

3. Import Requirements

Imported resveratrol products (food supplements) must comply with Chinese health food registration/filing requirements.
Cross-border e-commerce imports must follow the Positive List for Cross-Border E-Commerce Retail Imports and relevant inspection and quarantine rules.

IV. Japan

1. Regulatory Framework

Mainly regulated under the Food with Function Claims (FFC) system and Food for Specified Health Uses (FOSHU) system.
Resveratrol can be used as a functional food ingredient, complying with safety standards set by the Ministry of Health, Labour and Welfare (MHLW).

2. Notification & Evaluation

FFC: Prior notification system – manufacturers submit scientific evidence for function claims, reviewed by MHLW.
FOSHU: Requires MHLW approval, with higher standards of scientific evidence.
Permitted claims: “antioxidant effect”, “supports healthy lifestyle”, etc. Medical claims are prohibited.

3. Safety Standards

Daily intake recommended not to exceed 150 mg (aligned with EU standards).
Prohibited in infant foods and foods for special medical purposes.

V. Australia & New Zealand

1. Regulatory Authorities & Categories

Australia: Therapeutic Goods Administration (TGA), classifies resveratrol as a Complementary Medicine.
New Zealand: Ministry for Primary Industries (MPI), regulates as a food supplement.
Food Standards Australia New Zealand (FSANZ) evaluates safety for food additives and novel foods.

2. Registration & Notification

Australia: Complementary medicines must be registered in the Australian Register of Therapeutic Goods (ARTG) with safety and quality data.
New Zealand: Food supplements must comply with the Food Act and relevant standards, with labels conforming to the Australia New Zealand Food Standards Code.

3. Dosage & Claim Limits

Recommended daily intake ≤ 150 mg.
Therapeutic claims are prohibited; evidence-based nutrition claims are allowed.

VI. Canada

1. Regulatory Authorities & Category

Regulated by Health Canada; resveratrol is mainly managed as a Natural Health Product (NHP).
Use as a food additive or novel food requires the Canadian Novel Food Ingredient notification process.

2. Natural Health Product Regulation

Requires a Natural Product Number (NPN) or Drug Identification Number for Homeopathic Medicines (DIN-HP).
Applications must include: source, dosage, instructions, safety data, and supporting evidence for function claims.

3. Safety & Claims

Recommended maximum daily dose: 150 mg.
Permitted claims: “antioxidant”, “supports cardiovascular health”, etc. Medical claims are prohibited.

VII. Other Countries/Regions

Country/Region	Regulatory Features	Key Restrictions
South Korea	Regulated by MFDS as a health functional food ingredient	Daily limit 150 mg; no medical claims
India	Regulated by FSSAI; allowed in food supplements	Must comply with plant extract standards
Brazil	Regulated by ANVISA; must be registered as a dietary supplement	High-dose products (>200 mg/day) prohibited

VIII. Global Regulatory Comparison

Dimension	EU	USA	China	Japan	Australia
Main category	Novel Food / Food supplement	Dietary supplement / GRAS	Health food (pending)	FFC	Complementary medicine
Daily max dose	150 mg	No official cap (≤150 mg recommended)	Proposed 150 mg	150 mg recommended	150 mg
Health claims	EU-approved	Structure/function claims (self-substantiated)	2 proposed claims	Prior notification	TGA-approved
Infant foods	Prohibited	Not recommended	Prohibited	Prohibited	Prohibited

IX. Compliance Recommendations

Clarify product positioning: Choose the appropriate category (food supplement, functional food, etc.) based on the target market.
Source & purity: Prioritize natural or authorized (GRAS/Novel Food) resveratrol, ensuring ≥98% trans-isomer purity.
Dosage control: Strictly follow local daily intake limits (generally ≤150 mg).
Label compliance: Clearly list ingredients, dosage, directions; avoid medical claims; meet local labeling rules.
Regulatory filing: Complete pre-market approval in the EU, China, and other markets requiring authorization.