EU Food Supplements Readiness: Directive 2002/46/EC, Member-State Notification and the Article 8 Maximum-Level Vacuum

The directive harmonises four things and leaves the rest open. (1) The list of permitted vitamins and minerals — Annex I (substances) and Annex II (allowed chemical forms), updated by Commission regulations. (2) Mandatory labelling — name of the categories of nutrients, the portion size, a warning not to exceed the recommended dose, a statement that supplements should not be used as a substitute for a varied diet, and that they should be kept out of the reach of young children. (3) The principle that any ingredient claim must be substantiated under the Nutrition and Health Claims Regulation 1924/2006. (4) The notification-by-Member-State principle in Article 10. What it does NOT harmonise: maximum levels for vitamins and minerals (Article 5 says EFSA should propose them; twenty years later they still are not set at EU level), the status of botanicals (left to national lists — Belgium, France and Italy publish their own), and novel-form ingredients (which fall under Regulation 2015/2283 on novel foods instead).

Article 10 lets Member States require notification of a supplement before it is placed on the national market. Most do. The mechanics differ enough that a single Pan-European launch is really five-to-fifteen sequenced launches. Germany: §5 LFGB notification to BVL, label submitted in German, no formal review timeline but the Länder food inspectorates will challenge non-compliant products. France: télédéclaration to DGCCRF (TéléIcare since 2016), with a two-month implicit-acceptance window unless the product contains an ingredient on the Arrêté Plantes annexes I or II (then full DGAL evaluation). Italy: notification to Ministero della Salute with a 90-day clock and a unique authorisation number that must appear on the label. Spain: notification to AECOSAN with regional follow-up. Belgium: AR 29-08-1997 notification with a three-month clock. The dossiers overlap but are not identical — French TéléIcare wants ANSES-form ingredient justifications; Italian notification wants the Allegato 1 dose table; German notification wants a BfR maximum-level argumentation.

Article 5 instructed the Commission to set EU-wide maximum amounts of vitamins and minerals per daily dose, taking EFSA Upper Levels and population intake distributions into account. The Commission has never adopted these levels. Member States have filled the vacuum with national caps that do not match each other and sometimes do not match the EFSA UL either. A few canonical examples: vitamin B6 is capped at 3.5 mg in France (ANSES, after the peripheral-neuropathy review) and at 25 mg in much of the rest of Europe; vitamin D is capped at 100 µg/day in Germany (BfR) but the French recommendation is lower; selenium ranges from 50 µg in some markets to 200 µg in others. A formulation legal in Belgium can be non-compliant in France without changing a single ingredient.

Botanicals are explicitly outside the harmonised Annex I/II vitamin-and-mineral scope. Each Member State decides which plants and plant preparations are admissible in supplements. The BELFRIT project (Belgium, France, Italy) produced a 1,029-plant common list adopted into national regulation by Belgium (AR 31-08-2021), France (Arrêté du 24 juin 2014 modifié) and Italy (Decreto 10 agosto 2018), and is the closest thing to a multi-Member-State harmonised botanical list. Germany has no positive list — botanical assessment runs case-by-case under the food-supplement framework, often colliding with the medicinal-product borderline. The Netherlands operates a Warenwet-based prohibited list rather than a positive one. A botanical that is admissible in BELFRIT may be reclassified as medicinal in DE or AT, removing it from the food-supplement channel entirely.

Days 1–20: formulation gate — every ingredient checked against Annexes I/II (vitamins, minerals), BELFRIT (botanicals), 2015/2283 (novel foods), and each target Member State's maximum level. Days 21–45: label assembly per market — mandatory statements in the language of the market, claims aligned to the 1924/2006 register, allergen disclosure to FIC 1169/2011. Days 46–75: Member-State notification dossiers — BVL, DGCCRF/TéléIcare, Min. Salute, AECOSAN, FAGG/AFMPS as relevant. Days 76–100: per-market submission and acknowledgement tracking. Days 101–120: post-launch surveillance setup — RASFF monitoring, complaints intake, vigilance routing.