EU gummy launch guide
A practical framework for private-label gummy launches targeting the EU and UK markets. Covers the regulatory stack, claims wording, notification routes and documentation requirements — written for brand teams who are early in planning.
What this guide covers
- → EU Food Supplement Directive 2002/46/EC — mandatory fields and language rules
- → EFSA health claims regulation 432/2012 — permitted wording and the authorisation requirement
- → Novel Food Regulation (EU) 2015/2283 — applicability to gummy formats with novel ingredients
- → Food Information to Consumers Regulation 1169/2011 — allergens, nutrition declaration, supplement Facts panel
- → UK MHRA notification route post-Brexit — parallel requirements for Great Britain
- → Documentation stage map — what is needed at brief, specification and post-production gates
Who this is for
- → Brand teams planning a first EU or UK private-label gummy launch
- → Operators evaluating existing formulations for EU market compliance
- → Category managers reviewing the claim wording and notification timeline for a new SKU
- → Founders assessing contract manufacturer capability for multi-country EU rollout
This guide does not replace a regulatory consultant. It is the starting point for internal planning — the documentation and final filings are confirmed per project inside the DAT portal.
Mapping out your EU launch plan?
Drop your work email and a DAT team member will follow up with the specific documentation requirements for your target market and claim positioning.
Key points in the guide
Authorised claims vs. disease claims
EFSA Regulation 432/2012 authorises specific health claims for foods and food supplements. Disease claims ("treats", "prevents", "cures") are prohibited under 2002/46/EC Article 13 regardless of whether the ingredient is authorised. Claim wording is reviewed per project — the starting point is the published EFSA register.
Novel Food — when it applies
Novel Food Regulation (EU) 2015/2283 requires pre-market authorisation for foods with no significant history of consumption in the EU before 1997. Gummy formats with certain botanicals, bioengineered ingredients or specific mineral forms may require a Novel Food application. The guide flags the key triggers — final determination is confirmed per formulation.
Documentation route to market
Mandatory documentation for EU launches: product specification, batch-specific Certificate of Analysis, notified product registration (where applicable), label artwork review against the claims register and FIIC regulation. Each gate releases the next layer — no document is promised before the brief is in place.
How this connects to the project wizard
After reviewing this guide, the next step is the DAT project wizard. The brief captures your target markets, route (white-label, semi-custom or custom) and quantity range — these inputs determine which documentation gates apply to your project.
DAT responds with format-fit notes and a project roadmap the same working day. The documentation package builds alongside the formulation, not before it.
Ready to start a project?
The DAT project wizard takes the brief and routes it through the right manufacturing gate. Pick the route that matches where you are in planning.