I’ve spent months decoding Europe’s thick rulebooks so you don’t have to.
Pyrroloquinoline quinone (PQQ) can indeed be marketed in the European Union, but only as a regulated Novel Food ingredient in food supplements, capped at 20 mg per adult per day, packaged with strict purity, labeling, and traceability rules under Commission Implementing Regulation (EU) 2018/1011.
Those lines hide a maze of dossiers, safety checks, and translation quirks—but stick with me, and we’ll walk through every turn.
Is PQQ Officially a Novel Food in the EU?
European regulators love tidy categories more than Italians love espresso.
Since 2018, disodium salt of PQQ has held official Novel Food status, meaning brands may sell it in supplements if they follow the exact purity specs, intake limits, and post-market monitoring written into the authorization.
Anatomy of the green light
In 2017, EFSA’s NDA Panel issued a positive opinion on PQQ’s safety at up to 20 mg/day for adults. The opinion relied on 90-day rat studies, a human tolerance trial, and genotoxicity data showing no red flags. One year later, Brussels translated that science into law—Commission Implementing Regulation (EU) 2018/10111. The regulation listed:
- Chemical identity—PQQ disodium dihydrate
- Minimum purity—≥ 99 %
- Heavy-metal limits—lead < 0.5 mg/kg, arsenic < 0.5 mg/kg
- Use category—food supplements only
- Target group—adults (pregnant women excluded “as a precaution”)
- Daily maximum—20 mg
The Novel Food entry also triggered inclusion in the Union List, so every member state must accept imports that respect those terms. If you plan flavored chewables or liquid shots, fine—just keep them legally defined as “food supplements,” not “energy drinks.”
Milestone | Date | Regulatory Actor |
---|---|---|
Application filed | Jun 2015 | Mitsubishi Gas Chemical |
EFSA safety opinion | Sep 2017 | NDA Panel |
Regulation 2018/1011 | Jul 2018 | European Commission |
Union List updated | Aug 2018 | DG SANTE |
A trick I learned: print the regulation, highlight every “shall,” and treat it as a checklist—because customs officers certainly will.
What Conditions Must Brands Meet to Sell PQQ Supplements Legally?
A Certificate of Analysis alone won’t impress German inspectors.
Companies need EU-standard GMP manufacturing, certificates proving ≥ 99 % purity, stability data, bilingual labels that list “pyrroloquinoline quinone disodium salt” plus the exact daily dose, and a one-step recall plan to survive random audits.
The paperwork pyramid
At Santa Biotech, we start with the raw-material COA showing identity by HPLC retention time. We bundle that with ICP-MS heavy-metal results, a microbiology panel (TPC < 1,000 CFU/g), and peroxide value < 5 meq O₂/kg to nail freshness. Then comes HACCP documentation and a Food Business Operator number—mandatory for border clearance.
Labeling quirks trip up newcomers. “Recommended daily dose: 20 mg” must appear beside a “do not exceed” warning—yes, in the language of the country where the bottle lands. Italy? Add Italian. Belgium? French and Dutch. Leaving out one version can freeze pallets in bonded warehouses for weeks.
Mandatory Label Element | Why It Matters |
---|---|
Ingredient name (“pyrroloquinoline quinone disodium salt”) | Transparency; EU 1169/2011 |
Daily dose (mg) + % NRV* | Helps consumers gauge intake |
“Food supplement” designation | Distinguishes from medicines |
Batch/lot number | Recall traceability |
Country of origin | Customs valuation |
Allergen statement (“none”) | Consumer safety |
*No Nutrient Reference Value exists for PQQ, so state “NRV not established.”
Customs also ask for the “Responsible Person in the EU.” Many overseas exporters forget this and scramble for a local partner last minute. I keep a small Rolodex of consultants for such emergencies—worth every euro.
Can PQQ Appear in Functional Drinks or Snack Bars?
I wish I could say yes, but Brussels isn’t that flexible.
Under current authorization, PQQ may only be added to food supplements; putting it into beverages, protein bars, or yogurt requires a fresh Novel Food application—or a costly extension of the existing one.
Why the wall exists
EU regulators separate “food supplements” (concentrated sources of nutrients) from conventional foods to protect unsuspecting consumers who could down several cans a day. An “energy water” with 10 mg of PQQ looks harmless until someone guzzles six bottles and blows past safe limits.
Extending authorization means submitting:
- New stability data in the chosen matrix—pH 3 sport drink, baked bar, etc.
- Revised exposure assessment for high-consumption groups.
- Toxicological bridging to show no new interactions with caffeine, taurine, or whatever else hides inside your recipe.
Timeline? Expect 18–24 months and fees north of €80,000. For most startups, it’s cheaper to keep PQQ in a capsule and highlight synergy with your beverage line in cross-promotion.
Still tempted? Russia and parts of Asia allow PQQ in RTD drinks already, so global launches can start there while EU dossiers crawl.
How Do I Navigate Mutual Recognition When Shipping PQQ Across EU Borders?
Borders inside the EU feel invisible—until they’re not.
Thanks to the Union List, a PQQ supplement legally marketed in one member state can circulate freely across the bloc, yet local languages, VAT rates, and notification portals still demand brand-by-brand adjustments.
Picture this: You’ve registered your PQQ capsules in Spain, printed dual Spanish-English labels, and shipped pallets to Madrid. A month later, a Polish distributor calls. Do you need fresh paperwork? Not a full Novel Food application, but you must:
- Notify Poland’s Chief Sanitary Inspectorate through its online system.
- Add Polish language to leaflets.
- Update VAT classification—13 % instead of Spain’s 10 %.
Member State | Notification Portal | Fee (€) | Typical Lead Time |
---|---|---|---|
Germany | BVL Supplement Database | 0 | 1–2 weeks |
France | Teleicare | 190 | 3–4 weeks |
Czechia | SZPI | 35 | 1 week |
Ireland | FSAI | 0 | 3 days |
Ignore these micro-rules, and customs may block shipments under Article 24 checks—even if the product itself is lawful.
What Testing and Documentation Should a PQQ Supplier Provide?
Lab numbers are boring until regulators demand them—then they’re gold.
Suppliers must furnish full heavy-metal panels, residual solvent reports, microbial limits, allergen statements, and stability curves proving PQQ retains ≥ 95 % potency for two years under ICH Zone II conditions.
At Santa Biotech, every drum travels with a dossier so thick it could prop a door open. Here’s our template:
Document | Test Standard | Target |
---|---|---|
COA | In-house HPLC | ≥ 99 % purity |
Heavy metals | ICP-MS | Pb < 0.5 mg/kg; Cd < 0.3 mg/kg |
Microbiological | ISO 21527 | Yeast/mold < 100 CFU/g |
Residual solvents | USP 467 | ND |
Peroxide value | AOCS Cd 8-53 | < 5 meq O₂/kg |
Stability (6 M, 25 °C/60 % RH) | ICH Q1A | ≥ 95 % potency |
Need something custom—say, a gluten PCR test to calm celiac customers? We do that too. You can grab the latest spec sheet straight from our PQQ ingredient page.
What Health Claims for PQQ Are Allowed and Which Are Forbidden?
Marketing loves bold promises; EFSA loves evidence even more.
No authorized Article 13.1 or 13.5 health claims exist for PQQ, so brands may describe general roles like “supports normal energy-yielding metabolism” only if backed by proven science and phrased to avoid implying disease prevention or treatment.
Clinically, PQQ may enhance mitochondrial density and reduce fatigue markers, but EFSA’s health-claim gatekeepers have yet to bless such phrasing. You can say:
- “Contains PQQ, a compound found naturally in certain foods.”
- “Provides 20 mg of PQQ per capsule.”
You may not say:
- “Protects against Alzheimer’s.”
- “Reduces oxidative stress in athletes.”
Unless you submit a full dossier (human RCTs, meta-analyses, mechanistic data) and win EFSA approval2—an odyssey that has humbled many.
Tip: use structure-function wording3 allowed under U.S. DSHEA for American labels, then strip it for EU bottles. Saves artwork headaches.
Are Any Regulatory Changes on the Horizon for PQQ?
Regulations never sleep.
EFSA is reviewing long-term toxicity data that could relax the 20 mg limit, while stakeholder groups lobby for broader food uses, hinting that new draft regulations may emerge by 2027—and savvy brands should prepare dossiers now to ride the first wave.
Industry coalition NutraEurope filed a request in 2024 to bump the adult ceiling to 40 mg/day, citing multi-center safety trials with 12-month endpoints. At the same time, a Finnish startup launched a novel-food extension bid to put PQQ in plant-based yogurts; EFSA clock started in March 2025.
Regulatory gossip from Brussels suggests:
- Label harmonization—a pan-EU digital “supplement facts” QR code pilot.
- Sustainability clauses—carbon footprint reporting for fermentation-derived vitamins, including PQQ.
- Nanomaterial scrutiny—particle size declarations for ingredients under 100 nm.
Smart move: gather granular life-cycle data and set aside budget for dossier consultants now rather than scramble later.
Possible Change | Odds by 2027 | Impact |
---|---|---|
Daily limit raised to 30–40 mg | 60 % | Marketing boost |
Yogurt extension approval | 40 % | Opens functional-food channel |
Carbon footprint labeling | 70 % | Extra supply-chain paperwork |
Staying ahead means reading EFSA’s open meetings and joining trade bodies—boring, yes, but priceless when rumors turn into bulletins.
Conclusion
Follow the rules, keep documents ready, and PQQ can thrive on every EU shelf.
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Exploring this regulation will provide insights into the legal framework surrounding PQQ and its implications. ↩
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Learning about the EFSA approval process is crucial for anyone looking to market products in the EU, ensuring compliance and success. ↩
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Exploring structure-function wording can provide insights into compliant labeling practices for dietary supplements in the U.S. ↩