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Expandly Blog

EFSA Finds No Safe Level for Berberine at Any Dose: EU Prohibition Is Now the Likely Outcome

The preliminary Article 8 finding is unusually definitive, and the hydroxycitric acid review is running alongside it on a similar track.

In This Article

01 What EFSA actually concluded
02 When the final opinion lands
03 How long until withdrawal
04 The parallel hydroxycitric acid review
05 Your reformulation window

Key Takeaways

► No safe level at any dose is a pre-prohibition signal.
► EFSA's final opinion is expected in early 2027.
► Required withdrawal likely falls in 2028 to 2029.
► Reformulation planning should start ahead of the final opinion.

The European Food Safety Authority has concluded that no safe intake level for berberine can be established at any dose. The preliminary Article 8 review is the latest update in an ongoing safety assessment that has been tracking berberine alongside hydroxycitric acid, fennel seed and EGCG since 2026.

Early 2027 When EFSA's final opinion on berberine is expected. If the preliminary position holds, an EU-wide prohibition in food supplements follows.

If the preliminary position is maintained, the practical consequence is an EU-wide prohibition on berberine in food supplements. Brands would be required to withdraw currently compliant products from EU distribution before the prohibition takes effect.

Berberine is widely used in health and wellness supplements for blood glucose management, cardiovascular support and metabolic health. It is a substantial ingredient category in the US market. US brands that sell berberine-containing products and are considering EU expansion face a direct product viability question.

The Article 8 process is a routine safety assessment triggered when an ingredient's safety profile is in question. For berberine, the preliminary outcome is unusually definitive. No safe level at any dose is not a call for more data. It is a pre-prohibition signal.

The formal prohibition process, if triggered after the 2027 final opinion, requires member state implementation. That typically takes 12 to 24 months from final opinion to required withdrawal, which places the likely withdrawal window in 2028 to 2029. The reformulation window is open, but it is defined.

The hydroxycitric acid review, covering the active compound in Garcinia cambogia, is proceeding in parallel. Multi-ingredient metabolism and weight management products may face a compound impact if both reviews reach similar conclusions.

Reviewing an EU supplement range ingredient by ingredient, before listings and stock commitments are made, is where Expandly begins a health and wellness market entry.

Expandly helps US ecommerce brands expand into Europe — compliance, marketplaces and fulfilment, all handled. We’ve supported 2,000+ brands make the move.

Find out more
  • VAT registration handled across UK, Germany, Netherlands and all EU markets
  • EPR compliance managed from day one — packaging, WEEE, batteries and beyond
  • Product label review and Responsible Person service for EU and UK market entry
  • EU fulfilment from our Netherlands warehouse — fast access to the whole continent
  • Dedicated onboarding, compliance and success team alongside the platform
  • 17 years' experience, 2000+ brands expanded — Andy Hooper, Founder

The bigger picture

The EU assesses ingredients differently US legality proves nothing

The Article 8 process reflects an increasingly precautionary EU approach to botanical ingredients, where positive safety evidence is required rather than presumed, and berberine is the clearest current example of where that leads. For a US brand it means an ingredient selling freely at home can be restricted or prohibited across every EU market at once, which makes the product question and the market entry question the same question. Expandly's compliance-first onboarding starts health and wellness brands with an ingredient-by-ingredient regulatory review and a label and Responsible Person check before any EU listing goes live. Running that review while the reformulation window is still open is what stops a prohibition arriving as a forced withdrawal of stock already sitting in Europe.

  • Berberine is a significant example, but the Article 8 review list includes several other high-volume supplement ingredients currently in assessment
  • The EU's maximum permitted levels for vitamins and minerals are also under active revision, with a public consultation opening in Q3 2026, which adds a second regulatory track relevant to supplement brands
  • US brands entering Europe with supplement lines need ingredient-by-ingredient regulatory review as a baseline rather than an afterthought

German Collagen Search Growth

European supplement demand is growing on its own terms rather than following the US market. That makes a reformulated EU-compliant range worth building rather than a market worth skipping.

+46%

Collagen supplement search interest in Germany, January to April 2026, an EU-led trend rather than a US one. Source: Google Trends, 2026

European Ecommerce Revenue

Europe is large enough to justify an EU-specific formulation where an ingredient is restricted. The cost of reformulating sits against a market growing at 7.7% a year.

US$895bn

European ecommerce revenues in 2026, growing at 7.7% CAGR. Source: ECDB E-Commerce in Europe 2026 Report

EU Responsible Person, Included

Cosmetics, supplements and electronics sold in the EU require a designated Responsible Person. Expandly provides this designation as part of your compliance setup, with no separate service or third party required.

2,000+

brands expanded with Expandly

If this sounds like your world,
let's talk.

Expandly helps US ecommerce brands expand into Europe — compliance, marketplaces and fulfilment, all handled.

Self-Serve

  • £1,150/month
  • Platform-led with email support
  • Best for: $1M–$5M brands

Guided

  • £3,000/month
  • Dedicated Account Manager
  • Best for: $5M–$20M brands

VIP

  • £5,000/month
  • Dedicated VIP Consultant
  • Best for: $20M–$50M+ brands
See full pricing and what's included