Selling food supplements in the EU — notification, novel foods, labelling
Food supplements straddle food law, national notification requirements and the novel-foods regime. Each member state sets its own limits. This page covers what importers need before selling.
Supplements are foods, not medicines — but the regulatory stack is anything but simple. The novel-foods authorisation process alone can take over a year.
The questions
Which rules apply to food supplements in the EU?
Food supplements are regulated as foods, not medicines. The framework is Directive 2002/46/EC (labelling, vitamin and mineral lists), plus Regulation (EC) 1333/2008 (additives) and national implementing rules that vary by member state. GPSR does not apply to food — it has its own regime.
Source: Directive 2002/46/EC; Regulation (EC) 1333/2008. Checked: 4 September 2026.
Do I need to notify supplements before selling?
Yes — per product and per member state, before placing on the market. The notification goes to the national food authority with the label and formulation. Each country has its own system; selling in five countries means five notifications.
Source: Directive 2002/46/EC, Article 6; national implementing rules. Checked: 4 September 2026.
What is a novel food and does my ingredient need approval?
Any ingredient not significantly consumed in the EU before 15 May 1997 is a 'novel food' under Regulation (EU) 2015/2283 — and requires pre-market authorisation from the European Commission after an EFSA safety assessment. Check the Union List before importing; an unauthorised novel food is withdrawn from the market.
Source: Regulation (EU) 2015/2283; the Union List (Implementing Regulation 2017/2470). Checked: 4 September 2026.
How long does a novel food authorisation take?
Legally, EFSA must give its opinion within nine months and the Commission has seven months for the final decision. In practice, the process often exceeds a year due to the volume and complexity of safety dossiers. New application requirements took effect February 2025.
Source: Regulation (EU) 2015/2283, Articles 10-12; CIRS Group Q1 2026 update. Checked: 4 September 2026.
What must be on a supplement label?
The term 'food supplement', the names of the vitamins/minerals and their quantity per daily portion, the net content, the recommended daily dose, a warning not to exceed the dose, and the statement that supplements are not a substitute for a varied diet. Per member state, in the national language.
Source: Directive 2002/46/EC, Articles 6-9. Checked: 4 September 2026.
Are there maximum vitamin/mineral levels?
The EU sets maximum permitted levels for vitamins and minerals per member state — and they differ widely. Germany and the Netherlands have relatively generous limits; others restrict certain botanicals or dosages more aggressively. Check each target market's national rules before formulating one product for all of Europe.
Source: National implementing measures under Directive 2002/46/EC. Checked: 4 September 2026.
Who can help with this?
Food-supplement compliance is a specialist's job. Ask for
three introductions via the quote form — we connect you with the right expertise.
Source: Checked: 4 September 2026.