Nearly 20 years after the EU directive that was supposed to set uniform vitamin and mineral limits, every member state still sets its own — and after two decades of delay, that's finally about to change.
A directive that was never finished
Directive 2002/46/EC, the EU's Food Supplements Directive, mandated that maximum and minimum levels of vitamins and minerals in supplements be set at EU level, based on safe upper intake levels, reference intakes, and total dietary exposure. More than two decades later, the European Commission has still never adopted these harmonised maximum levels — leaving each member state to set its own national limits in the meantime.
How different the national limits actually are
The gap between countries can be dramatic. Some EU countries allow vitamin C supplements at doses up to 1,000mg, while France has proposed a maximum as low as 208mg. For vitamin D, Germany has pushed for a daily limit of just 20 micrograms, far below the European Food Safety Authority's own tolerable upper intake level of 100 micrograms for adults. Countries like Belgium and Italy have hard, legally binding maximum levels; others, including France and Germany, work from recommendations and risk-assessment guidance that isn't always applied as strictly as a hard legal cap.
Why this creates real cross-border legal risk
A relevant European Court of Justice ruling confirmed that member states cannot simply set their own arbitrary maximum levels — any national limit must be grounded in an actual risk assessment, and the country must provide a route for products legal elsewhere in the EU to be evaluated for its own market, even if they exceed that country's default maximum. In practice, this hasn't stopped the patchwork: a multivitamin fully compliant with Dutch rules can still be legally problematic to sell in France or Germany without going through that separate national evaluation.
What's changing in 2026
After roughly two decades of stalled progress, EU member states pushed the Commission at a December 2025 Council meeting to finally present a formal harmonisation proposal. The Commission has since confirmed that a public consultation on genuinely harmonised maximum permitted levels for vitamins and minerals will open in the third quarter of 2026 — described by industry experts as potentially the most significant EU supplement regulation development since the 2006 health claims regulation itself. The proposed limits are expected to be anchored to EFSA's own conservative upper intake levels.
What this means for you right now
- If you buy supplements from an online retailer based in a different EU country, check that country's specific vitamin/mineral limits, not just your own country's rules.
- Be aware that a high-dose vitamin C or D product legal where it's sold may exceed what your own country would otherwise permit domestically.
- Watch for the Q3 2026 public consultation and eventual harmonised limits — this is likely to trigger reformulation of some existing products over the following months.
- If a specific product's dose seems unusually high compared to others you've seen, that's worth checking against your own country's national guidance specifically.
What this means practically
- There is currently no single EU-wide maximum dose for vitamins and minerals in supplements — each country sets its own, sometimes very differently.
- A product being legally sold somewhere in the EU doesn't guarantee it complies with your own country's specific limits.
- Genuine EU-wide harmonisation is finally moving forward in 2026, after roughly 20 years of delay since the original 2002 directive.
- Once harmonised limits are set, expect reformulation of some current high-dose products, particularly ones close to or above EFSA's upper intake levels.
Sources
- NutraIngredients — EU Council pushes for a 2026 harmonisation proposal on vitamin/mineral limits: nutraingredients.com
- Care Europe — Overview of Directive 2002/46/EC and the current national patchwork: care-europe.com
Related Kibbo Tools
- Official Regulators Directory — find your country's specific national supplement regulator.