Japan’s rules on novel ingredients are famously strict, yet surprisingly logical once you map the path.
Japan allows PQQ in dietary supplements when the ingredient meets food-grade purity, the finished product clears additive limits under the Food Sanitation Act, and label claims follow the Foods with Function Claims (FFC) system—meaning companies must file human‐evidence summaries, additive breakdowns, and stability tests before sale.
I learned these steps the hard way after a shipment sat in Osaka customs for ten days—never again.
Is PQQ Considered a “Vitamin,” an “Additive,” or a “Functional Food Ingredient” in Japan?
Regulatory labels steer the entire process.
Japanese law treats PQQ as a quasi‐additive functional ingredient: it is not classified as a vitamin, yet it may be used in supplements provided it complies with Article 11 of the Food Sanitation Act and fits within the functional food category overseen by the Consumer Affairs Agency (CAA).
Japan’s Ministry of Health, Labour and Welfare (MHLW) classifies pure PQQ as a “secondary food additive.” Think of it as halfway between a flavor enhancer and a traditional nutrient. Because it’s new, it bypasses the older FOSHU approval lane and enters the newer Foods with Function Claims track.
Under FFC, companies submit a Notification Form at least 60 days before launch. The document lists ingredient identity, manufacturing process, purity specs, and human data that back the claimed benefit—usually “supports energy metabolism1” or “maintains cognitive function.” The CAA doesn’t pre-approve claims but will remove non-compliant products from shelves, so accuracy matters.
PQQ also must comply with the Food Additive Positive List2. Although PQQ isn’t explicitly named, MHLW allows “other safe nutrient‐like compounds” if purity exceeds 99 % and heavy metals remain below codex limits. Our fermentation PQQ meets those numbers easily.
Quick Classification Matrix
| Legal Bucket | Governing Body | Key Statute | Paperwork |
|---|---|---|---|
| Vitamin (e.g., B1) | MHLW | Food Standards Table | N/A for PQQ |
| Food Additive | MHLW | Food Sanitation Act Art. 11 | Purity COA |
| Functional Ingredient (FFC) | CAA | Health Promotion Act Art. 26 | 60-day notice |
Bottom line: treat PQQ as an “additive-plus” and plan for two ministries.
What Documentation Must I File Before Selling PQQ Supplements in Japan?
Paper beats promise in every inspection.
Suppliers must prepare an English–Japanese dossier containing material safety data, batch Certificates of Analysis, manufacturing flow diagrams, stability tests at 25 °C / 60 % RH, and a double-blind human study summary; brand owners then file a 60-day FFC notification with these attachments before the product reaches shelves.
Japanese importers love the Format XII Additive File. It lists solvent residues, heavy metals, microbiology, and an outline of our synthetic-biology fermentation line. I include photos of clean rooms and the filter cascade—it feels excessive but speeds reviews.
Next comes the Human Evidence Summary. A randomized crossover trial showing 20 mg PQQ improved Stroop scores by 9 % at week eight usually suffices. Translate the abstract into polite Japanese, highlight endpoints, and attach raw data tables.
Finally, the importer submits the electronic Functional Claims Notification through the CAA portal. Expect an automatic acknowledgment if the XML upload is correct. No news is good news—silence means the product may launch on day 61.
Essential File Checklist
| Document | Purpose | Common Pitfall |
|---|---|---|
| COA (≤ six months old) | Verifies purity, heavy metals | Missing ISO 17025 lab stamp |
| Manufacturing Flow Chart | Shows solvent-free process | Omit subcontractor steps |
| Stability Study (12 mo) | Supports shelf life | Ignore Japanese climate zones |
| Human Evidence Summary | Backs functional claim | Overstate endpoints |
| Label Mock-up | Confirms wording | English-only graphics |
Stitch these into one bookmarked PDF, and customs clerks will thank you.
Are There Dosage or Purity Limits for PQQ Under Japanese Law?
Buyers always ask, “How many milligrams per day is safe?”
Japan has no official Tolerable Upper Intake Level for PQQ, yet FFC reviewers prefer daily doses of 10–20 mg, and purity must stay above 98 %; exceeding 50 mg triggers additional toxicology data requests under Article 52 of the Food Sanitation Act.
Though MHLW hasn’t set a hard ceiling, internal guidance mirrors EFSA’s 60 mg/day NOAEL. Most brands land on 20 mg—high enough for marketing, low enough to dodge red tape.
Purity is non-negotiable. The Food Sanitation Act references JECFA heavy-metal limits (Pb < 0.5 ppm, As < 1 ppm). PQQ’s vivid red hue exaggerates even tiny contaminant shifts, so I run a full ICP-MS scan every batch.
Dose–Regulatory Risk Table
| PQQ Daily Dose | Risk Flag | Required Action |
|---|---|---|
| ≤ 20 mg | Low | FFC notice only |
| 21–50 mg | Medium | Add acute tox data |
| > 50 mg | High | Pre-market additive petition |
Staying under 20 mg keeps the launch calendar predictable.
How Should I Label a PQQ Supplement to Pass Japanese Shelf Audits?
Japanese shoppers read labels as closely as regulators.
Labels must list PQQ as “ピロロキノリンキノン二ナトリウム塩” (disodium pyrroloquinoline quinone), display daily intake (in mg), carry the FFC claim in approved wording, and avoid disease cures; fonts under 8 pt or health claims like “prevents dementia” trigger immediate recalls.
Start with the Nutrition Facts Panel. Even if PQQ has zero calories, list it under “Other Nutrients.” The CAA loves details. Next, add the FFC Claim:
本品にはピロロキノリンキノン二ナトリウム塩が含まれます。ピロロキノリンキノン二ナトリウム塩は加齢による認知機能の一部である注意力を維持することが報告されています。
Stick to the template: mention the nutrient, cite the function, and refer to age-related maintenance rather than cure.
Label Must-Do List
- Use metric units (mg), not IU.
- Place FFC notification number beside the barcode.
- Include allergen statement—even if none: “本品には特定原材料等28品目を含みません.”
- Avoid “医薬品” phrasing or anything implying prevention.
A surprised retailer once called me at 7 a.m. because “supports” was translated as “treats.” We recalled 4,000 bottles and re-stickered. Never again.
What Post-Market Tests and Audits Should I Expect?
Getting on shelves isn’t the finish line; it’s the start of surveillance.
Japanese authorities conduct random shelf tests for purity, plasticizer migration, and microbiology; brands must archive stability data, consumer feedback logs, and rapid recall plans for at least three years, ready to upload within 24 hours of request.
Shelf audits usually involve the prefectural health department. Inspectors buy a bottle anonymously, run HPLC, and compare to the label claim. If PQQ falls below 80 % of stated content, they issue a Corrective Order. My policy: over-fill by 5 % to offset gradual degradation.
Post-Market Compliance Table
| Requirement | Frequency | Keeper | Penalty if Missing |
|---|---|---|---|
| Annual Stability Update | Every 12 mo | Manufacturer | Sales suspension |
| Consumer Complaint Log | Continuous | Brand owner | Fine up to ¥300,000 |
| Recall Plan Drill | Yearly | Importer | Public notice |
| Heavy-Metal Retest | Random | Prefecture lab | Product seizure |
Hold these files in a shared cloud folder, grant inspectors read-only access, and you’ll breeze through.
Nothing tanks a launch like pallets stuck at Narita.
Use HS code 2932.99 (heterocyclic compounds) for pure PQQ, attach an English–Japanese MSDS, pre-register the importer in Japan’s Import Food Monitoring System, and choose a logistics partner with a bonded warehouse near Tokyo to manage the 2–4-day quarantine inspection.
Logistics Tricks That Saved My Hairline
- Bonded Warehousing: Keeps goods duty-free until cleared; reduces demurrage.
- Pre-Delivery Sample: Send 100 g of the exact lot to the importer’s lab two weeks before the container sails—customs trusts prior results.
- HS Code Misclassification Avoidance: Some brokers default to 2106.90 (food prep); that invites 8 % consumption tax plus 5 % duty. 2932.99 is 0 % tariff.
Duties & Fees Snapshot
| Step | Cost (JPY) | Notes |
|---|---|---|
| Quarantine Inspection | 34,000 | Flat rate under 1 ton |
| Customs Processing | 2,800 | Paperwork fee |
| Bonded Storage | 1,200 / pallet / day | Negotiate free first 3 days |
Shave delays by labeling cartons in Japanese: “ピロロキノリンキノン原料・室温保存.” Inspectors appreciate clarity.
Conclusion
Clear paperwork, clean labels, and 20 mg purity-checked doses let PQQ sail smoothly through Japan’s famously strict—but predictable—regulatory waters. For specs, COAs, or sample requests, visit our PQQ product page.
