Food Supplement Manufacturerfor EU Brands

Launching a food supplement in Europe is not the same as launching one in the United States. The EU regulatory environment is layered, prescriptive and enforced by national competent authorities (DGCCRF in France, BVL in Germany, NVWA in the Netherlands, Ministero della Salute in Italy, and the MHRA/FSA in the United Kingdom). Every product we manufacture for European brands is reviewed against four foundational pieces of EU law before it ever leaves our facility.

EFSA Directive 2002/46/EC is the cornerstone. It harmonises food supplement definitions across the EU, establishes positive lists of permitted vitamins and minerals (and their chemical forms), and sets the framework for maximum permitted levels. No vitamin or mineral substance can be used in an EU food supplement unless it appears on Annex I and Annex II of the Directive. Our R&D team cross-checks every proposed formula against these lists before sampling begins.

Nutrition and Health Claims Regulation (EC) 1924/2006 governs what you are allowed to say about your product. Only health claims authorised on the EU Register may appear on packaging or marketing — unauthorised claims are one of the top three enforcement categories across European markets. Our labelling review cross-references every nutrient against its approved claim wording and flags any copy that would trigger rejection. “Contributes to normal immune function” (vitamin C) is authorised; “boosts your immune system” is not.

Food Information to Consumers Regulation (EU) 1169/2011 sets the rules for labelling mandatory particulars. Every EU food supplement label must carry: the product name, net quantity, best-before date, storage instructions, name and address of the responsible Food Business Operator in the EU (or UK for post-Brexit UK-bound goods), allergen declarations in bold, nutritional reference values (NRV) expressed as a percentage, recommended daily portion, and a warning not to exceed the stated daily dose. We prepare this artwork in any EU language as part of the standard scope.

Novel Food Regulation (EU) 2015/2283 applies to any ingredient not significantly consumed in the EU before 15 May 1997. Ingredients that look obvious in the US market — such as some mushroom extracts, CBD, and certain botanicals — require full Novel Food authorisation before they can be legally sold in the EU. We maintain an up-to-date Novel Food catalogue reference and will flag any ingredient in your brief that requires dossier work, then guide you through the compliance pathway.

Finally, national-level rules sit on top of EU legislation. France requires DGCCRF notification via the Téléicare portal before a supplement is placed on the market. Italy requires Ministero della Salute notification for every “integratore alimentare.” Germany scrutinises health claims unusually strictly through the BVL and can escalate to court cases over borderline wording. Our EU compliance team handles these national notifications as part of the production pack.