China Compliance — FlaxseedsPro (PRC Market Access)¶
Scope: FlaxseedsPro products (whole flaxseed, milled/ground flaxseed, flaxseed oil) exported to and placed on the market of the People's Republic of China. Covers the Food Safety Law, GB standards, import procedures, nutrition labelling, health food classification, and GAC decrees.
1. China Food Safety Law (2015 Revision)¶
1.1 Framework and Key Principles¶
The Food Safety Law of the People's Republic of China (2015 revision, effective 1 October 2015) is the cornerstone of Chinese food regulation. Administered by: - SAMR (State Administration for Market Regulation) — domestic food safety - GAC (General Administration of Customs, formerly AQSIQ) — import/export controls - CNCA (Certification and Accreditation Administration) — overseas manufacturer registration - NHC (National Health Commission) — standards and risk assessment
Key principles applicable to imported flaxseed:
| Principle | Article | Implication for FlaxseedsPro |
|---|---|---|
| Risk-based supervision | Art. 3 | Higher scrutiny for foods with known safety risks |
| Full-chain traceability | Art. 4 | Import records must trace from overseas supplier to Chinese distributor |
| Accountability of producers | Art. 5 | Foreign exporters are jointly liable with Chinese importers |
| Social co-governance | Art. 10 | Consumer complaints, media supervision encouraged |
| Recall obligations | Art. 63 | Mandatory recall of non-compliant imported food; importer must implement |
1.2 Registration for Overseas Manufacturers — GAC Decree 248¶
GAC Decree 248 (effective 1 January 2022) requires all overseas manufacturers of imported food to register with the General Administration of Customs.
| Registration Category | Requirements | Applicable to Flaxseed? |
|---|---|---|
| Category A (low-risk processed foods) | Self-declaration via the "Single Window" online system | Whole & milled flaxseed — YES, Category A |
| Category B (high-risk foods: meat, dairy, aquatic, infant formula, etc.) | On-site audit or review by CNCA | Flaxseed oil typically does not fall under Category B unless classified as "fats and oils for infant formula" |
Registration process for Category A (flaxseed products): 1. Overseas manufacturer registers via the Chinese Customs "Single Window" system (https://swapp.singlewindow.cn/) 2. Submit: company name, address, legal representative, product categories, HACCP/GMP certification, contact details 3. Receive a unique registration number — must be shown on product labels 4. Registration is valid indefinitely unless revoked
Registration number format: CUSA + 3-digit country code + 9-digit serial number (e.g., CUSA000000001)
2. GB Standards Relevant to Flaxseed¶
2.1 GB 19641 — Oilseeds (食用植物油料)¶
GB 19641-2015 (National Food Safety Standard — Oilseeds) sets mandatory requirements for raw oilseeds including flaxseed (亚麻籽):
| Parameter | Requirement | Test Method |
|---|---|---|
| Moisture & volatiles | ≤ 10.0% | GB 5009.3 |
| Crude fat | ≥ 35% (for pressing grade) | GB 5009.6 |
| Acid value (of oil) | ≤ 4.0 mg KOH/g | GB 5009.229 |
| Peroxide value (of oil) | ≤ 0.25 g/100g | GB 5009.227 |
| Aflatoxin B₁ | ≤ 5 μg/kg | GB 5009.22 |
| Pesticide residues | Per GB 2763 | Various |
| Heavy metals: Lead (Pb) | ≤ 0.2 mg/kg | GB 5009.12 |
| Heavy metals: Cadmium (Cd) | ≤ 0.1 mg/kg | GB 5009.15 |
| Heavy metals: Arsenic (As) | ≤ 0.2 mg/kg | GB 5009.11 |
| Heavy metals: Mercury (Hg) | ≤ 0.02 mg/kg | GB 5009.17 |
Note: Imported flaxseed must meet GB 19641 limits at the point of import. Non-compliant lots will be rejected at CIQ inspection.
2.2 GB/T 8235 — Flaxseed Oil (亚麻籽油)¶
GB/T 8235-2019 (National Standard — Flaxseed Oil) is a recommended standard (GB/T, not mandatory GB). However, it is widely used as a reference for quality grading:
| Grade | Acid Value (mg KOH/g) | Peroxide Value (g/100g) | Moisture & Volatiles |
|---|---|---|---|
| First-grade cold-pressed | ≤ 0.20 | ≤ 0.05 | ≤ 0.10% |
| First-grade hot-pressed/refined | ≤ 0.30 | ≤ 0.08 | ≤ 0.10% |
| Second-grade | ≤ 1.0 | ≤ 0.15 | ≤ 0.15% |
| Third-grade | ≤ 3.0 | ≤ 0.25 | ≤ 0.20% |
Other requirements in GB/T 8235: - Colour (Lovibond): Specified per grade - Smell and taste: Characteristic of flaxseed oil, no off-odours - Alpha-linolenic acid (ALA) content: ≥ 50% of total fatty acids (typical range 50–60%) - Solvent residues: Not detectable (for cold-pressed); ≤ 50 mg/kg for extracted oil - Added antioxidants: Permitted per GB 2760 (e.g., TBHQ ≤ 0.2 g/kg, tocopherols)
2.3 GB 7718 — Food Labelling (食品安全国家标准 预包装食品标签通则)¶
GB 7718-2011 is the mandatory standard for all prepackaged food labels in China. Key requirements for flaxseed products:
| Label Element | Requirement (GB 7718) |
|---|---|
| Product name | Must reflect true nature; e.g., "冷压亚麻籽油" (cold-pressed flaxseed oil) |
| Ingredient list | Descending order by weight; composite ingredients must declare sub-ingredients |
| Allergen information | Voluntary (not mandatory under GB 7718 as of 2026, but recommended) |
| Net content | Metric units (g, kg, ml, L) |
| Manufacturer/distributor | Name and address of Chinese Importer/Distributor — must be in Chinese |
| Overseas manufacturer | Country of origin + GAC registration number (Decree 248) |
| Date of production | Format: YYYY-MM-DD or DD.MM.YYYY |
| Shelf life / Best before | Must be clearly stated |
| Storage conditions | In Chinese (e.g., "阴凉干燥处保存" — store in cool, dry place) |
| Standard code | GB/T 8235 (for flaxseed oil) or GB 19641 (for whole flaxseed) |
| Nutrition facts | Per GB 28050 (see Section 4 below) |
| Food production licence | Chinese importer's licence number (QS/SC) |
Note on language: All mandatory label information must be presented in Chinese characters. Foreign languages may appear alongside but Chinese must be the primary language (font size and prominence).
2.4 Other Relevant GB Standards¶
| Standard | Scope | Relevance |
|---|---|---|
| GB 2760 | Food Additive Use | Permitted antioxidants, emulsifiers in flaxseed products |
| GB 2761 | Mycotoxin Limits | Aflatoxin B₁ (5 μg/kg in oilseeds); total aflatoxins |
| GB 2762 | Contaminant Limits | Pb, Cd, As, Hg limits per food category |
| GB 2763 | Pesticide MRLs | Maximum residue limits for pesticides in oilseeds |
| GB 14880 | Food Nutrition Fortification | Permitted nutrient additions (e.g., vitamin E to flaxseed oil) |
| GB 29921 | Pathogen Limits | Salmonella (not detected in 25 g), Staphylococcus aureus, etc. |
| GB 4806 series | Food Contact Materials | Packaging materials for flaxseed oil (plastic, metal, glass) |
3. Import Procedures¶
3.1 CNCA Registration (Overseas Manufacturer)¶
As per GAC Decree 248 (Section 1.2 above): - All overseas flaxseed processing facilities must be registered - Registration is free of charge via the online system - Documents required: business licence (translated and notarised), HACCP/GMP certificate, plant layout, product description
3.2 CIQ Inspection (Customs Inspection and Quarantine)¶
Every imported consignment of flaxseed must pass CIQ inspection:
Documentation required: 1. Bill of lading / airway bill 2. Commercial invoice and packing list 3. Certificate of Origin (issued by Chamber of Commerce) 4. Health certificate (issued by competent authority in country of origin — e.g., CFIA for Canada, USDA for US) 5. Phytosanitary certificate (for whole flaxseed — to verify freedom from quarantine pests) 6. GAC manufacturer registration certificate (from Decree 248 registration) 7. Certificate of analysis (chemical composition, microbiological, heavy metals) 8. Labelling compliance certificate (self-declaration or third-party verification that labels meet GB 7718/GB 28050)
Inspection process: - Document review: 1–3 working days - Physical inspection (if selected): 5–15 working days for laboratory testing - Sampling rate: Varies by risk level; approximately 5–20% of consignments for routine testing - Testing parameters per GB 19641: Moisture, acid value, peroxide value, aflatoxin B₁, heavy metals, pesticide residues, Salmonella
3.3 Label Registration¶
Important change: As of 2022, pre-approval of food labels for imported products is no longer required. Instead: - Labels are reviewed at the point of import by CIQ - FlaxseedsPro must maintain a label compliance file demonstrating that labels meet GB 7718 and GB 28050 - A self-declaration of label compliance is required - CIQ may request a third-party label review report if issues are suspected
4. Chinese Nutrition Labelling — GB 28050¶
4.1 Compulsory Nutrients¶
GB 28050-2011 (National Food Safety Standard — Nutrition Labelling of Prepackaged Foods) requires the Nutrition Facts Panel (营养成分表) to list:
| Nutrient | Mandatory (✓) / Voluntary | Unit |
|---|---|---|
| Energy (能量) | ✓ | kJ (primary) + kcal (optional) |
| Protein (蛋白质) | ✓ | g |
| Fat (脂肪) | ✓ | g |
| Carbohydrate (碳水化合物) | ✓ | g |
| Sodium (钠) | ✓ | mg |
| Optional: Saturated fat, trans fat, cholesterol, dietary fibre, sugars, vitamins, minerals | Voluntary | Varies |
For flaxseed products where a nutrient content claim is made (e.g., "source of fibre"), the claimed nutrient becomes mandatory in the panel.
4.2 Format Requirements¶
The Nutrition Facts Panel must follow a fixed tabular format:
Note: Values must be expressed per 100 g (or per 100 ml for liquids). Per-serving format is optional and supplementary.
4.3 NRV% Calculation¶
NRV (Nutrient Reference Values) are China-specific (not WHO/FAO or US DV):
| Nutrient | Chinese NRV | Source |
|---|---|---|
| Energy | 8,400 kJ (2,000 kcal) | GB 28050 |
| Protein | 60 g | GB 28050 |
| Fat | ≤ 60 g | GB 28050 |
| Carbohydrate | 300 g | GB 28050 |
| Sodium | 2,000 mg | GB 28050 |
| Dietary fibre | 25 g | GB 28050 |
| Vitamin A | 800 μg RE | GB 28050 |
| Vitamin D | 5 μg | GB 28050 |
| Vitamin E | 14 mg α-TE | GB 28050 |
| Calcium | 800 mg | GB 28050 |
| Iron | 15 mg | GB 28050 |
| Zinc | 15 mg | GB 28050 |
NRV% = (Actual content per 100g ÷ NRV) × 100%
Flaxseed oil example (per 100 g): - Energy: 3,696 kJ → NRV% = 3,696/8,400 × 100 ≈ 44% - Fat: 100 g → NRV% = 100/60 × 100 ≈ 167% (must state accurately — this is not a rounding matter) - Protein: 0 g → NRV% = 0% - Carbohydrate: 0 g → NRV% = 0% - Sodium: 0 mg → NRV% = 0%
4.4 Nutrient Content Claims and Conditions¶
Under GB 28050, claims follow specific conditions:
| Claim (Chinese) | Condition per 100 g | Flaxseed Applicability |
|---|---|---|
| 富含纤维 / Rich in fibre | ≥ 6 g dietary fibre | ✓ (whole/milled flaxseed) |
| 富含Omega-3 / Rich in Omega-3 | ≥ 0.6 g ALA | ✓ |
| 低饱和脂肪 / Low saturated fat | ≤ 1.5 g saturates & ≤ 10% energy from saturates | ✓ (~3.7 g saturates per 100 g) |
| 不含胆固醇 / Cholesterol-free | ≤ 5 mg cholesterol & ≤ 1.5 g saturates | ✓ (plant-based) |
| 不含反式脂肪酸 / Trans fat-free | ≤ 0.3 g trans fat | ✓ (if processing does not generate trans fats) |
5. Health Food Registration vs. Regular Food Classification¶
5.1 Regulatory Classification¶
In China, flaxseed products can be classified as either Regular Food (普通食品) or Health Food (保健食品):
| Criterion | Regular Food (普通食品) | Health Food (保健食品) |
|---|---|---|
| Definition | Provides nutrition, for general consumption | Claims specific health functions (27 permitted functions) |
| Regulation | Food Safety Law, GB standards | Administrative Measures on Health Food Registration & Filing |
| Market access | CIQ inspection + GB compliance | Pre-market approval (蓝帽子 / Blue Hat registration) |
| Registration time | Days–weeks (per shipment) | 1–3 years (full registration); faster for filing (备案) |
| Claims allowed | Nutrient content (GB 28050) only | Specific health function claims (e.g., "Helps lower blood lipids") |
5.2 Flaxseed as Regular Food¶
Whole flaxseed, milled flaxseed, and cold-pressed flaxseed oil are generally classified as regular food in China, provided: - They are sold as conventional food ingredients (not in capsule/tablet form) - They do not make health function claims (drug-like or therapeutic) - They comply with relevant GB standards
Products in capsule/tablet/capsule form containing flaxseed oil or flaxseed extract may be classified as: - Health food (if a health function claim is made) - General food in special form (if sold as a food ingredient in capsule format for dosing convenience — subject to interpretation by CIQ)
5.3 Flaxseed as Health Food (保健食品)¶
To market flaxseed with health claims (e.g., "helps maintain normal blood lipid levels" or "helps with bowel regularity"):
Option A — Health Food Registration (注册): - For products containing ingredients not yet in the "Health Food Raw Material Directory" - Complete toxicology, function, stability testing - Submit to SAMR for review (1–3 years) - Obtain 蓝帽子 (Blue Hat) certification - Cost: ¥100,000–500,000 RMB depending on testing requirements
Option B — Health Food Filing (备案): - Only for products using ingredients listed in the Health Food Raw Material Directory (保健食品原料目录) - As of 2026, flaxseed or flaxseed oil is not included in the Directory - Therefore, full registration (Option A) is required for any health claim
5.4 Traditional Food Use Status¶
Flaxseed (亚麻籽) and flaxseed oil (亚麻籽油) are listed in the China Food Composition Database and have a well-established history of consumption. However, concentrated extracts (e.g., SDG lignans 20%+) may face scrutiny as a new food ingredient (新食品原料) under the Administrative Measures for New Food Raw Materials — requiring a separate safety assessment by NHC.
6. GAC Decree 249 (2022) — New Import Food Safety Requirements¶
6.1 Overview¶
GAC Decree 249 (Administrative Measures on the Safety of Imported and Exported Food, 海关进出口食品安全管理办法), effective 1 January 2022, introduces significant changes for food importers including FlaxseedsPro.
6.2 Key Requirements¶
| Requirement | Details |
|---|---|
| Importer record filing | Chinese importers must register with Customs (HACCP certificate, business licence, food production/sc distribution licence) |
| Overseas manufacturer registration | All overseas food producers must register (via GAC Decree 248 — see Section 1.2) |
| Health certificate | Each shipment must be accompanied by a health certificate from the competent authority of the exporting country |
| Pre-inspection (optional) | Exporting country may request pre-inspection by Chinese authorities before shipment |
| Risk-based inspection | GAC assigns risk levels to imported foods; higher-risk foods face stricter inspection and higher sampling rates |
| Recall requirements | Importers must establish a recall system; non-compliant food found in the market must be recalled within 48 hours |
| Record keeping | Purchase, sales, and inspection records must be kept for no less than 2 years |
| Responsible person | Chinese importers must designate a person responsible for food safety |
6.3 Risk Classification for Flaxseed¶
| Risk Level | Foods | Inspection Regime |
|---|---|---|
| High risk | Meat, dairy, aquatic, infant formula | 100% inspection (document + physical + lab testing) |
| Medium risk | Processed foods, edible oils, seeds | Random sampling (5–20%); document review for each shipment |
| Low risk | Packaged foods with stable history | Documentary inspection; occasional random sampling |
Flaxseed products typically fall under Medium risk, but this can be adjusted based on: - Prior compliance history (RASFF-type alerts from other countries) - Country of origin food safety performance - Results of previous CIQ inspections
6.4 Penalties for Non-Compliance¶
| Violation | Penalty |
|---|---|
| Failure to register overseas manufacturer | Goods detained, refused entry, and manufacturer blacklisted |
| Non-compliant label | Goods detained; re-labelling permitted under CIQ supervision or return to origin |
| Contaminated/dangerous food (e.g., Salmonella, aflatoxin exceedance) | Destruction or return; manufacturer status reviewed; possible suspension of import |
| Failure to recall | ¥50,000–1,000,000 RMB fine; revocation of import licence |
Summary of Key China Compliance Actions for FlaxseedsPro¶
- Register overseas manufacturing facilities with GAC via Decree 248 (Category A — self-declaration)
- Ensure all flaxseed products meet GB 19641 limits (moisture, acid value, aflatoxin, heavy metals, pesticides)
- Prepare Chinese-language labels compliant with GB 7718 and GB 28050, including GAC registration number
- Arrange health certificates from competent authority in country of origin for each shipment
- Calculate and display accurate NRV% per Chinese NRV table (GB 28050)
- Classify products correctly — regular food for traditional flaxseed; seek health food registration (blue hat) only if making health claims
- Partner with a qualified Chinese importer who holds valid food business and import licences (SC/QS) and is registered with Customs
- Maintain traceability records for at least 2 years per GAC Decree 249
- Establish a recall plan compliant with Chinese requirements (48-hour recall notice)
- Monitor GB standard updates — especially GB 7718 revision (draft in consultation as of 2024–2026) and potential inclusion of flaxseed in Health Food Material Directory
Last Updated: July 2026 | Review Frequency: Annually or upon regulatory change