🥛 Health Food Peptide Regulation
Peptide-based ingredients are widely used in China's health food sector, with collagen peptides, soybean peptides, and corn peptides being the main categories. This chapter outlines the health food peptide registration and filing system, GB standard framework, health claim management requirements, and international comparisons, providing comprehensive regulatory navigation for peptide health food companies.
1. Health Food Management Pathways
| Product Type |
Management Method |
Regulatory Basis |
Applicable Peptides |
| Health Food Registration |
Registration approval |
"Health Food Registration and Filing Management Measures" |
Peptide products using new ingredients / non-traditional processes |
| Health Food Filing |
Filing system |
Same as above + Filing guidelines |
Products using peptides from the approved health food ingredient catalog |
| General Food (Nutrition Fortification) |
General food |
GB 2760 / GB 14880 |
Collagen peptide can be used as general food ingredient |
| Food for Special Medical Purposes (FSMP) |
Registration approval |
"FSMP Registration Management Measures" |
Short-chain peptides (deeply hydrolyzed protein) |
2. Approved Peptide Ingredients for Health Foods
The following peptides are included in China's permitted health food ingredient scope:
| Ingredient Name |
Source |
Food Standard |
Dosage Range |
Permitted Functional Claims |
| Collagen Peptide |
Bovine bone / fish scale / fish skin |
GB 31645 "Food Safety Standard – Collagen Peptide" |
2.5–10 g/day |
Improves skin moisture; increases bone density |
| Soybean Peptide Powder |
Soy protein |
QB/T 5732 "Soybean Peptide Powder" |
5–20 g/day |
Enhances immunity; relieves physical fatigue |
| Corn Oligopeptide Powder |
Corn protein |
QB/T 5298 "Corn Oligopeptide Powder" |
3–10 g/day |
Aids liver protection |
| Wheat Oligopeptide |
Wheat gluten protein |
QB/T 5743 "Wheat Oligopeptide" |
5–15 g/day |
Enhances immunity (per approval certificate) |
| Pea Peptide |
Pea protein |
Company standard |
5–20 g/day |
Enhances immunity (filing category) |
| Marine Fish Skin Collagen Oligopeptide |
Deep-sea fish skin |
SC/T 1029 |
2–8 g/day |
Improves skin moisture |
| Walnut Peptide |
Walnut meal |
Company standard |
3–10 g/day |
Enhances memory (research stage) |
| Oyster Peptide |
Oyster meat |
Company standard |
3–10 g/day |
Relieves physical fatigue |
| Ginseng Peptide |
Ginseng |
Company standard |
1–5 g/day |
Enhances immunity |
| Ejiao (Donkey-hide Gelatin) Peptide |
Donkey-hide gelatin |
Company standard |
3–10 g/day |
Improves nutritional anemia |
Important Note
Collagen peptide is currently the only peptide that can be sold as a general food ingredient (not limited to health foods), giving it the broadest application scope. Other peptides used as health foods must obtain a "Blue Hat" health food approval certificate or complete filing. Since 2024, some small-molecule peptides (such as oyster peptide and ginseng peptide) have gradually entered the market through company-standard filing.
3. GB / Industry Standard System Reference Table
| Standard No. |
Standard Name |
Scope |
Key Indicators |
| GB 31645 |
Collagen Peptide |
Collagen peptide from animal bone/skin/fish scale |
Hydroxyproline ≥3.0% (bovine) or ≥4.0% (fish) |
| QB/T 5732 |
Soybean Peptide Powder |
Soybean protein enzymatic hydrolysate |
Peptide content ≥80%; MW <5,000 Da fraction ≥80% |
| QB/T 5298 |
Corn Oligopeptide Powder |
Corn protein enzymatic hydrolysate |
Peptide content ≥80%; MW <1,000 Da fraction ≥80% |
| QB/T 5743 |
Wheat Oligopeptide |
Wheat gluten enzymatic hydrolysate |
Peptide content ≥80%; MW <5,000 Da fraction ≥85% |
| GB 16740 |
General Standard for Health Foods |
All health foods |
Physicochemical indices, microbial limits, contaminant limits |
| GB 2762 |
National Food Safety Standard – Contaminants |
Food contaminant limits |
Lead ≤1.0 mg/kg, Arsenic ≤1.0 mg/kg |
| GB 2760 |
Food Additive Usage Standard |
Food additives |
Usage limits for additives in peptide products |
| GB 7718 |
General Standard for Prepackaged Food Labeling |
Food labels |
Labeling standards for peptide products |
| GB 28050 |
General Standard for Nutrition Labeling of Prepackaged Foods |
Nutrition labels |
Peptide content / protein claim standards |
| GB 19295 |
Good Manufacturing Practice for Health Foods |
Health food production |
GMP production management requirements |
Peptide Physicochemical Indicator Comparison Table
| Indicator |
Collagen Peptide (GB 31645) |
Soybean Peptide (QB/T 5732) |
Corn Oligopeptide (QB/T 5298) |
Wheat Oligopeptide (QB/T 5743) |
| Total Nitrogen (%, w/w, dry basis) |
≥15.0 |
≥14.0 |
≥14.0 |
≥14.5 |
| Peptide Content (%, w/w, dry basis) |
≥90 |
≥80 |
≥80 |
≥80 |
| Hydroxyproline (%, w/w, dry basis) |
≥3.0 (bovine) / ≥4.0 (fish) |
— |
— |
— |
| Molecular Weight Distribution |
— |
<5,000 Da ≥80% |
<1,000 Da ≥80% |
<5,000 Da ≥85% |
| Moisture (%, w/w) |
≤7.0 |
≤7.0 |
≤7.0 |
≤7.0 |
| Ash (%, w/w) |
≤7.0 |
≤8.0 |
≤8.0 |
≤8.0 |
| Lead (mg/kg) |
≤1.0 |
≤1.0 |
≤1.0 |
≤1.0 |
| Arsenic (mg/kg) |
≤1.0 |
≤1.0 |
≤1.0 |
≤1.0 |
Per the "Health Food Function Claims Catalog and Interpretation" (2023 Edition), peptide products may claim the following functions:
| Function Name |
Applicable Peptides |
Function Description |
Evaluation Method |
| Enhances Immunity |
Soybean peptide, wheat peptide, collagen peptide |
Helps enhance immune function |
Immune cell activity / immunoglobulin indicators |
| Aids Liver Protection |
Corn peptide |
Helps reduce chemical liver injury |
Transaminase / liver histopathology |
| Improves Skin Moisture |
Collagen peptide |
Helps improve skin moisture content |
Stratum corneum hydration measurement |
| Increases Bone Density |
Collagen peptide (+ calcium combination) |
Helps increase bone density |
Bone density DEXA scan |
| Relieves Physical Fatigue |
Soybean peptide, oyster peptide |
Helps relieve physical fatigue |
Exercise endurance / blood lactate / urea nitrogen |
| Aids Blood Lipid Reduction |
Soybean peptide (functional) |
Helps reduce blood lipids |
Four blood lipid indicators |
| Aids Nutritional Anemia Improvement |
Ejiao (donkey-hide) peptide |
Helps improve nutritional anemia |
Hemoglobin / red blood cell indicators |
| Aids Gastric Mucosa Protection |
Wheat oligopeptide |
Helps protect gastric mucosa |
Stomach discomfort symptoms / gastroscopy (to be confirmed) |
Functional Claim Evaluation Requirements
| Functional Claim |
Human Trial Requirement |
Sample Size |
Trial Period |
Est. Trial Cost (¥10K) |
| Enhances Immunity |
Required |
≥100 |
30–60 days |
30–50 |
| Aids Liver Protection |
Required |
≥100 |
30–90 days |
35–60 |
| Improves Skin Moisture |
Required |
≥60 |
30–60 days |
25–40 |
| Increases Bone Density |
Required |
≥200 |
6–12 months |
60–100 |
| Relieves Physical Fatigue |
Required |
≥60 |
30 days |
20–35 |
| Aids Blood Lipid Reduction |
Required |
≥100 |
60–90 days |
40–70 |
5. Selected Approved Health Food Peptide Products
The following are representative peptide products that have obtained the "Blue Hat" health food approval certificate in recent years:
| Product Name |
Company |
Approval No. |
Peptide Ingredient |
Functional Claim |
Approval Year |
| Brand X Collagen Peptide Oral Liquid |
China Resources Sanjiu |
G2023xxxx |
Collagen peptide |
Improves skin moisture |
2023 |
| Brand Y Soybean Peptide Protein Powder |
Amway (China) |
G2022xxxx |
Soybean peptide powder |
Enhances immunity |
2022 |
| Corn Peptide Liver Protection Tablets |
By-Health |
G2021xxxx |
Corn oligopeptide |
Aids liver protection |
2021 |
| Collagen Peptide Calcium Tablets |
Infinitus |
G2022xxxx |
Collagen peptide + calcium |
Increases bone density |
2022 |
| Small-Molecule Soybean Peptide Powder |
Perfect (China) |
G2023xxxx |
Soybean peptide powder |
Relieves physical fatigue |
2023 |
| Wheat Oligopeptide Capsules |
Herbalife |
G2020xxxx |
Wheat oligopeptide |
Enhances immunity |
2020 |
| Collagen Peptide Fruit Drink |
Sirio Pharma |
G2023xxxx |
Collagen peptide |
Improves skin moisture |
2023 |
| Oyster Peptide Compound Tablets |
Dong-E-E-Jiao |
G2022xxxx |
Oyster peptide |
Relieves physical fatigue |
2022 |
| Ginseng Peptide Oral Liquid |
Tongrentang |
G2023xxxx |
Ginseng peptide |
Enhances immunity |
2023 |
| Marine Fish Skin Collagen Peptide Capsules |
Sinopharm |
G2021xxxx |
Marine fish skin collagen oligopeptide |
Improves skin moisture |
2021 |
| Walnut Peptide Compound Powder |
Health and Happiness Group |
G2024xxxx |
Walnut peptide |
Aids memory improvement |
2024 |
| Ejiao Peptide Oral Liquid |
Fupai Ejiao |
G2024xxxx |
Ejiao peptide |
Improves nutritional anemia |
2024 |
| Whey Protein Peptide Powder |
Abbott |
G2022xxxx |
Whey protein peptide |
Enhances immunity |
2022 |
| Pea Peptide Plant Protein Powder |
Nestlé Health Science |
G2023xxxx |
Pea peptide |
Enhances immunity |
2023 |
| Corn Oligopeptide Blueberry Tablets |
Jiuzhitang |
G2023xxxx |
Corn oligopeptide + blueberry extract |
Aids liver protection |
2023 |
6. Registration vs. Filing Process Comparison
| Process Step |
Registration (Application-Based) |
Filing System |
| Applicable Products |
New function / new ingredient products |
Products in the approved ingredient catalog |
| Review Method |
Technical review + administrative approval |
Formal review |
| Safety Requirements |
Full toxicology + human trial |
Safety assessment report |
| Efficacy Verification |
Human trial |
Third-party efficacy evaluation |
| Certificate Validity |
5 years |
Long-term |
| Approval Cycle |
12–24 months |
3–6 months |
| Application Cost (excl. R&D) |
¥500K–1M |
¥50K–150K |
| Total R&D Investment (incl. efficacy verification) |
¥2M–5M |
¥500K–1.5M |
Submission Materials Comparison
| Material Item |
Registration System |
Filing System |
| Formulation and Ingredient Sources |
✅ Detailed formulation + ingredient standards |
✅ Formulation list + ingredient compliance proof |
| Manufacturing Process |
✅ Detailed process flow + validation data |
✅ Brief process description |
| Safety Evaluation Report |
✅ Full toxicology (acute/subchronic/mutagenic/reproductive) |
✅ Safety assessment (literature citable) |
| Efficacy Evaluation Report |
✅ Human trial report |
✅ Third-party efficacy evaluation report |
| Product Quality Standard |
✅ Company standard + full-panel testing |
✅ Company standard + partial testing |
| Label and Instructions |
✅ Reviewed |
✅ Self-check |
| GMP Certificate |
✅ Site inspection |
✅ Self-declaration |
Filing-First Strategy
For products using ingredients from the approved health food ingredient catalog (such as collagen peptide, soybean peptide) with functional claims within the catalog scope, the filing system is the more efficient choice. New functional claims or new peptide ingredients require the registration pathway, with significantly longer timelines and higher costs.
7. International Health Food Peptide Regulation Comparison
| Comparison Dimension |
China |
European Union |
United States |
Japan |
| Regulatory Framework |
Health food registration/filing system |
Food Supplements Directive (2002/46/EC) |
DSHEA (Dietary Supplements) |
Foods with Health Claims (FOSHU) system |
| Peptide Management Approach |
Ingredient catalog + certificate system |
Novel Food Regulation (new resource approval) |
GRAS + NDI notification |
Functional food / nutrient function foods |
| Functional Claim Management |
Function catalog system (28 types) |
Function claim registration (EFSA approval) |
Structure-function claims (FDA no pre-approval) |
Functional representation licensing |
| Peptide Market Acceptance |
Collagen peptide most mature |
Collagen peptide + whey peptide dominant |
Wide range of peptides commonly used |
Highest collagen peptide penetration |
| New Peptide Approval Cycle |
12–24 months (registration) |
6–18 months (Novel Food) |
No approval required (company self-assurance) |
6–12 months (functional representation) |
| Efficacy Evidence Requirements |
Human trial (highest tier) |
EFSA scientific opinion |
Company's own responsibility |
Human trial or authoritative literature |
| Labeling Standards |
Blue Hat logo + function claim number |
Health-related claims require EFSA approval |
Supplement Facts panel |
FOSHU-specific label |
8. 2025 Regulatory Trends
| Regulatory Development |
Impact |
Expected Implementation |
| Health food function catalog expansion (new: helps maintain gut health / helps antioxidant) |
Beneficial for functional peptide products (e.g., soybean peptide, wheat peptide) |
2025–2026 |
| Peptide ingredient standard upgrade (Collagen Peptide standard revision) |
Raises industry quality threshold; eliminates low-end capacity |
2025–2026 |
| General food peptide reference dosage guideline release |
Provides reference for non-health food peptide products |
H2 2025 |
| Health food registration/filing separation reform |
Expands filing scope; shortens approval cycle |
2025–2026 |
| GLP-1-related health food regulatory guidance |
Standardizes peptide-based weight management health food claims |
2025–2026 |
Regulatory Basis: "Food Safety Law" (2021 Revision), "Health Food Registration and Filing Management Measures," "Health Food Function Claims Catalog and Interpretation" (2023 Edition), GB 16740 "National Food Safety Standard – Health Foods." For health food peptide product registration/filing consulting, formulation compliance confirmation, or functional evaluation plan design — contact the health food regulatory services for professional regulatory services and global peptide health food market access strategy support.