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Supplements & Nutraceuticals Compliance

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    Supplements & Nutraceuticals Compliance

    EU market access for food supplement brands. Novel Food, health claims, per-country notifications — all handled.

    • Legal Representation

      Mandatory EU-based legal address for your product labels and manuals.

    • Compliance Verification

      Systematic review of your technical files to ensure full adherence to EU law.

    What You Need

    Food supplements sold in the EU are regulated as food under Directive 2002/46/EC. You need to comply with permitted vitamin and mineral forms, maximum dosage levels (which vary by EU country), health claims regulations (EC 1924/2006), labelling requirements, and pre-market notification in each country where you sell. If your product contains novel ingredients, the Novel Food Regulation (EU 2015/2283) applies — requiring a lengthy authorisation process before you can sell.

    • EU Market Access
    • Surveillance Liaison
    • Labeling Review
    • Regulatory Support

    What We Do

    We serve as your EU Responsible Person and coordinate market access across EU countries. We review your formulation against EU permitted lists, check health claims compliance, coordinate per-country notifications, review labelling for EU requirements, and advise on Novel Food implications for novel ingredients. We handle the EU presence requirement so your products can be listed on Amazon EU and other marketplaces.

    Supplements compliance starts at €2,490/year for EU representation plus coordination. Per-country notification fees additional. Book a call for a custom quote.