How EFSA health claim regulations work. Authorized claims under EU Regulation 432/2012 and what supplement labels can legally state in the European Union.
Some ingredients aren't restricted because they're dangerous — they're restricted because the EU hasn't had them on the market long enough to have a pre-1997 track record. Here's how the Novel Food framework actually works, using two real examples.
A supplement can cross into unauthorized medicinal-product territory through its marketing alone — even if every ingredient is perfectly legal. The EU legal doctrine behind that line, and why it's stricter than most brands assume.
Vitamin C has one of the longest lists of EU-authorized health claims of any nutrient — but the threshold that unlocks them, and the one claim with its own specific dose, are easy to get wrong.
The European Food Safety Authority (EFSA) is to supplements what the FDA is to pharmaceuticals. If a claim passes EFSA scrutiny, it has undergone the most rigorous review process in the world.
