An updated overview of the regulatory landscape for food supplements in the European Union, including notification requirements, health claims, and labelling obligations.
The European Union maintains one of the most rigorous regulatory frameworks for food supplements in the world. For brands entering or operating in the EU market, understanding the applicable legislation is not optional — it is a prerequisite for legal market access. This guide provides an updated overview of the key regulations as they stand in 2026.
The primary EU legislation governing food supplements is Directive 2002/46/EC, which harmonises rules across member states for vitamins and minerals. This directive establishes permitted forms of vitamins and minerals, maximum and minimum levels, and labelling requirements. Beyond this directive, food supplements are also subject to Regulation (EC) No 178/2002 (General Food Law), Regulation (EC) No 1169/2011 (Food Information to Consumers), and Regulation (EC) No 1924/2006 (Nutrition and Health Claims).
In most EU member states, food supplements must be notified to the relevant national competent authority before they can be placed on the market. The notification process varies by country — some require only a product label submission, while others require full compositional data, safety assessments, and proof of compliance. Nuteo's regulatory team manages notifications across all 27 EU member states, the UK, and key international markets.
Regulation (EC) No 1924/2006 governs all nutrition and health claims made on food products, including supplements. Only claims that appear on the EU Register of authorised claims may be used. Generic claims such as 'supports immune health' are not permitted unless they reference a specific authorised claim. Brands must ensure that every claim on their label and marketing materials has a corresponding authorised claim in the EU Register, with the correct conditions of use met (including minimum nutrient levels).
Several ingredients popular in the supplement market are classified as Novel Foods under Regulation (EU) 2015/2283, meaning they require pre-market authorisation before they can be sold in the EU. CBD (cannabidiol) derived from hemp was classified as a Novel Food in 2019. Brands wishing to sell CBD supplements in the EU must either hold or reference a valid Novel Food authorisation. Nuteo works with partners to navigate Novel Food requirements for cannabinoid products and other novel ingredients.
EU food supplement labels must include: the name of the product, the names of the categories of nutrients or substances characterising the product, the recommended daily dose, a warning not to exceed the recommended daily dose, a statement that supplements should not be used as a substitute for a varied diet, a statement that the product should be kept out of reach of young children, and the net quantity. All mandatory information must appear in the official language(s) of the member state where the product is sold.
Nuteo's in-house regulatory team provides full compliance support for EU market entry, including label review and approval, health claim verification, product notification management, ingredient compliance assessment, and Novel Food guidance. We work with brands at every stage — from initial product concept through to post-market compliance monitoring.