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Expandly Blog

EU Vitamin and Mineral Dose Limits: Public Consultation Opens Q3 2026

The residual amount methodology is confirmed as the calculation basis, and high-dose B vitamins, vitamin D and sports nutrition are the categories most exposed.

In This Article

01 When the consultation opens
02 How the limits are calculated
03 Which products are most exposed
04 The national patchwork it replaces
05 What US brands should check

Key Takeaways

► Consultation opens Q3 2026. Draft regulation expected Q1 2028.
► High-dose B vitamins, vitamin D and sports nutrition most exposed.
► One EU-wide limit replaces three differing national systems.
► US dose levels may need EU-specific product variants.

The European Commission is proceeding with its public consultation on harmonised maximum permitted levels for vitamins and minerals in food supplements, confirmed for Q3 2026. A draft regulation is expected in Q1 2028. The consultation moves a long-running process into a formal regulatory track.

Q1 2028 When the draft regulation on harmonised EU vitamin and mineral maximum permitted levels is expected, following the Q3 2026 consultation.

The residual amount methodology has been confirmed as the calculation basis. This approach sets limits by considering total intake from all sources, covering food, fortified food and supplements, then setting the supplement limit at the residual available after accounting for dietary intake. For micronutrients where dietary exposure is already high, this methodology produces low supplement limits.

High-dose B vitamins, vitamin D and sports nutrition products have been identified as the product categories most affected. Industry concerns raised at the EHPM summit in July 2026 centred on the number of currently legal products that would require reformulation or withdrawal under harmonised limits.

The current situation across Expandly's primary EU markets is a patchwork. Germany, the Netherlands and Denmark each apply national limits that differ from one another. Harmonisation would replace this with a single EU-wide limit per nutrient. For some nutrients, the harmonised limit may be lower than what some member states currently permit.

For US supplement brands planning EU market entry, this regulation is not in force yet, but it will shape the product portfolio that is viable in Europe from 2028 onwards. Products formulated at the high dose levels that are standard in the US market may require EU-specific variants.

Assessing a supplement portfolio against EU limits before formulation and labelling decisions are locked in is where Expandly starts 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

EU dose rules are tightening US formulations need checking

The EU supplement regulatory environment is materially different from the US model, where supplements are presumed safe at label doses unless harm is demonstrated, and a single harmonised EU ceiling per nutrient may sit below what US brands routinely formulate at. For a brand entering Europe that means the portfolio question and the compliance question are the same question, because a product that cannot be sold at its US dose cannot simply be relabelled into the market. Expandly's compliance-first onboarding starts health and wellness brands with a product and label review against current national limits in Germany, the Netherlands and Denmark, before listings or stock commitments are made. Doing that review ahead of the Q1 2028 draft regulation turns a possible product withdrawal into a planned reformulation on the brand's own schedule.

  • The EFSA berberine review and the maximum permitted level harmonisation process are running in parallel, so the EU supplement environment is tightening on more than one track
  • US supplement brands entering Europe with high-dose formulations may need EU-specific variants regardless of the harmonisation outcome, simply to comply with existing national limits in Germany and Denmark
  • The draft regulation is expected in Q1 2028, which is the window brands have to assess and plan portfolio changes before the framework is finalised

German Collagen Search Growth

Demand for supplements in Germany is growing on its own terms rather than following US trends. That makes the German limits, and the harmonised limits that would replace them, a commercial constraint rather than a paperwork one.

+46%

Collagen supplement search interest in Germany, January to April 2026. Source: Google Trends, 2026

European Ecommerce Revenue

Europe is a large enough supplement market to justify EU-specific product variants where dose limits require them. 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.

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