Ergothioneine in the EU: Novel Food or Cosmetic Ingredient?

I never expected a single amino-acid antioxidant to lead me down Europe’s regulatory rabbit hole, yet here we are.

Ergothioneine sits in a quirky EU gray zone—officially a “novel food” in supplements and a listed cosmetic ingredient, each tag carrying strict dosage, purity, and labeling demands that trip up first-time importers.

Still, understanding these rules unlocks big market gains without the headaches.

Why Does Ergothioneine Catch Brussels’ Eye?

Curiosity struck me: why does the EU care so much about a compound found naturally in mushrooms and fermented grains?

Because ergothioneine isn’t habitually consumed in large amounts within Europe, EU regulators insist on safety dossiers, caps on daily intake, and dedicated cosmetic listing—making paperwork as crucial as purity.

The Power—and the Peril—of Novelty

When EFSA evaluated ergothioneine in 2016, the panel combed through toxicity, bioavailability, and metabolism data. Their conclusion: safe up to 30 mg/day for adults. That seemingly simple verdict set off a chain of new-product launches but also created tight fences for anyone exceeding that cap or pitching children’s formulas.

I remember talking to a supplement start-up in Berlin that thought “novel food approval¹” was a one-and-done stamp. A month later customs seized their shipment because the label promised 50 mg capsules. Lesson learned: in the EU, dosage isn’t a suggestion—it’s gospel.

Novel Food 101 (Without the Legal Jargon)

The EU Novel Food Regulation² (EU) 2015/2283 covers any nutrient not widely eaten before May 1997. Manufacturers must file a dossier or piggyback on an existing authorization. In ergothioneine’s case:

• Single-ingredient capsules: ≤ 30 mg/day.
• Multi-ingredient blends: total ergothioneine intake still ≤ 30 mg/day.
• No use in foods for infants, toddlers, or pregnant women without extra proof.

One bright spot? You can cite the standing authorization (Commission Implementing Decision 2017/1712) instead of drafting a fresh 1,000-page dossier. I’ve done this for clients to slash approval timelines from 18 months to about six.

A Quick-Glance Table

Is Ergothioneine Really a Novel Food?

Whenever I introduce ergothioneine to European partners, someone asks, “Can’t we call it natural if it’s in mushrooms?” Good question.

Under EU law, “novel food” doesn’t judge how natural an ingredient is; it simply asks if Europeans ate it routinely before 1997. Ergothioneine failed that history test, so it earns the novel badge despite its organic roots.

My Coffee-Shop Analogy

Imagine the EU food catalog as a menu that froze in 1997. If your exotic Thai dish wasn’t on that menu, you must convince the maître d’ (EFSA) it’s safe, set portions, and note any age exclusions. Only then can it appear on new menus continent-wide.

Practical Steps I Follow for Novel Food Compliance

1. Reference the existing authorization. Saves legal fees.
2. Match our Santa Biotech spec—99.9 % purity, fermentation-derived, solvent-free—to the EFSA file.
3. Issue a “Same Source Statement.” Customs loves this phrase.
4. Label daily intake clearly: “Do not exceed 30 mg ergothioneine per day.”
5. Keep batch dossiers handy for random spot checks.

Those five bullets have shepherded pallets of our ergothioneine through Hamburg, Rotterdam, and Marseille without so much as a raised eyebrow.

Can I Use Ergothioneine in EU Cosmetics?

Formulators often beam when I say, “Yes, and without novel-food headaches—just different ones.”

Ergothioneine appears in the EU COSING database as a skin-conditioning agent, allowing leave-on products like serums and creams, provided purity, residual-solvent profiles, and cosmetic GMP are crystal-clear.

The Cosmetics Playbook

Being on COSING doesn’t absolve you from safety assessment. Every notification through the Cosmetic Products Notification Portal (CPNP) still needs:

• Physicochemical spec sheet (ours fits right in).
• 26-week stability data in final formula.
• Safety assessment under Annex I of Regulation 1223/2009.

I once helped a Paris indie brand launch an “Urban Shield Serum” with 0.2 % ergothioneine. Their biggest hurdle? Proving no nitrosamine risk from residual fermentation nitrates. We supplied third-party nitrosamine-free certificates³ and the product sailed through.

Dosage Range and Trends

Most EU skincare sticks to 0.1–0.5 %. Higher doses cause tinted formulas, which some luxury brands spin into a “peach glow.” Personally, I keep to 0.3 %—it balances efficacy with clear gels that Instagram loves.

How Do Supplement Brands Handle Dosage and Labels?

Label rules feel dull until your batch is detained. I learned this the hard way with a 2020 shipment stuck in Milan for six weeks.

EU labels must show daily intake, warnings for vulnerable groups, and an easy-to-read ingredient list using the novel-food name “L-ergothioneine.” Missing even one trigger word can prompt border rejection.

My Five-Second Label Checklist

• “Food supplement – not a substitute for a varied diet.”
• “Recommended daily dose: 1 capsule equals 30 mg L-ergothioneine.”
• “Not recommended for children, pregnant or nursing women.”
• Batch number and best-before date.
• EU address of the responsible operator.

Add a scannable QR code linking to our ergothioneine spec and you build instant trust.

Story Time: The Milan Mishap

Customs flagged our pallet because “L-ergothioneine” sat in the middle of a complex botanical list, not highlighted. They interpreted it as an unauthorized medicinal claim. After a frantic weekend redesigning the label hierarchy—larger font, bold type—the batch cleared. Since then, I treat label hierarchy like life insurance.

What Paperwork Do Importers Really Need?

Paperwork doesn’t sell bottles, but lack of it can stop sales cold.

A compliant Certificate of Analysis (COA), supply-chain traceability, and a “same source” declaration are the holy trinity that convinces EU authorities your ergothioneine mirrors the EFSA-authorized version.

Building the Dossier

Below is my go-to documentation kit:

I keep these in a shared cloud folder named “EU Ready.” When a client pings me at 2 a.m.—time zones are merciless—I share the link, they forward it to customs, and panic turns into a polite “Shipment released.”

A Final Note on Brexit

If you’re shipping into the UK, remember: despite leaving the EU, London adopted the same novel-food decision on ergothioneine. The only twist is using the UK’s Submit a Safety Assessment portal instead of CPNP for cosmetics. Double filings, double coffee.

Conclusion

Ergothioneine thrives in Europe when you master the novel-food script and the cosmetic scorecard—paperwork first, profits second.