The European health supplement market exceeds EUR 10 billion and is growing at above-market rates across Germany, France, Netherlands and the Nordics. For US supplement brands, EU expansion is a significant revenue opportunity, but the regulatory framework governing food supplements in the EU is materially different from the US environment. This guide covers what US supplement brands need in place before placing a product on the EU market in 2026.

EU food supplements are regulated under Directive 2002/46/EC, supplemented by Novel Food regulation under Regulation (EU) 2015/2283 and health claims regulation under Regulation (EC) 1924/2006. Unlike the US, where supplement brands operate under the Dietary Supplement Health and Education Act (DSHEA) with relatively flexible ingredient and claims frameworks, EU supplement regulation requires positive evidence of ingredient safety or a history of safe use before market entry. For US brands with supplement products containing novel ingredients, such as adaptogens, specialized probiotic strains or proprietary botanical extracts, the first compliance question is whether the ingredient requires Novel Food authorization before any product can be placed on the EU market.

Health claims are the second major difference. The EU operates a positive list of permitted health claims under Regulation (EC) 1924/2006, and claims not on the list cannot be made in EU marketing, labeling or packaging for food supplements. US supplement brands whose marketing is built around health benefit claims need to map every claim in their existing materials against the EU permitted list before entry. Claims that are standard in US supplement marketing, such as energy support, immune support and gut health, may have no equivalent on the EU permitted list, or may be permitted only in specific formulations or at specific dosages. In 2026, three additional areas are active: the Novel Food Catalogue update (34 probiotic strains reclassified as not novel), member state ashwagandha restrictions (Denmark ban, Netherlands intent), and EU PPWR packaging documentation requirements.

• Novel Food status: any supplement ingredient without a documented history of EU consumption before May 15, 1997 requires Novel Food authorization, or Catalogue reclassification, before EU market entry
• Health claims: only claims on the EU permitted list under Regulation (EC) 1924/2006 can be used in EU supplement labeling and marketing, so US-standard claims must be mapped and replaced before launch
• Ingredient restrictions: some ingredients face member state restrictions (ashwagandha in Denmark and the Netherlands) and EU-level advisory opinions, so ingredient-level regulatory mapping is required before product range commitment
• Labeling: EU supplement labels must comply with FIC Regulation (EU) 1169/2011, and nutrient reference values, allergen declarations and language requirements differ from US FDA formats
• PPWR packaging documentation: all packaging placed on the EU market must comply with Regulation (EU) 2025/40, and supplier declarations must reference the new regulation

EU supplement market entry is a compliance-first process with a defined sequence: Novel Food status verification, health claims mapping, ingredient-level member state restriction review, labeling adaptation, and packaging documentation, all before any product can be placed on the EU market. Expandly manages the full sequence for US supplement brands, from ingredient regulatory mapping through documentation, marketplace setup, and EU-local fulfillment from our Netherlands warehouse.