EU Food Supplement Compliance & Market Entry

Start with the countries where you intend to sell. Assess the product category, exact ingredient specifications and daily dose, applicable restrictions, claims, label languages and responsible business arrangements. Then prepare notifications for markets that require them. An existing product should receive a gap assessment before production or artwork is committed.

There is no general EFSA approval certificate for every finished supplement. EFSA provides scientific assessments in areas such as novel foods and new health claims. A product still needs to comply with EU and applicable national rules, and national notification may be required. A novel ingredient or new claim can introduce a separate authorisation pathway.

There is no single EU-wide supplement registration. Notification requirements vary by member state. The review should identify where notification is required, the responsible applicant, documents and fees, and whether an acknowledgement has any significance for the proposed launch. Notification alone does not establish that the product is compliant.

Possibly, but this needs checking. A common formula may be feasible, while country-specific requirements can affect dose, botanicals, warnings, claims and product presentation. We can assess a shared formula against your priority markets and identify where a different version or a narrower launch plan would be more practical.

No automatic EU permission follows from an NPN or a US launch. The supporting formula and quality records are useful starting material, but ingredient eligibility, claims and label requirements need an EU assessment. Existing marketing language should be reviewed alongside the pack, rather than translated without checking.

No. An upper intake level is a scientific safety reference, not automatically a maximum permitted supplement dose. Relevant national requirements and the applicable scope of the safety reference must also be considered. The status of any future harmonised EU limits should be checked when the product is reviewed.

No. The catalogue is a non-exhaustive orientation tool. An absent entry does not establish eligibility. The ingredient identity, manufacturing process, intended use, history of consumption and any existing authorisation need to be considered. Uncertainty may require a formal status consultation.

Check the authorised entry in the EU Register and its conditions of use. Match the wording and meaning to the actual constituent, dose and product. Include required accompanying information. EFSA's scientific opinion and the legal authorisation are different steps; a study or favourable opinion alone does not establish permission to use a claim.

Do not treat an on-hold listing as approval. The 2025 Novel Nutriology judgment reinforces the need to establish whether a relevant transitional provision applies. Review the exact claim, evidence and target-market position before using it on packaging or in advertising.

A shared multilingual label can be practical if it meets each intended market's requirements and remains legible. We assess mandatory particulars, translations, warnings, claim wording and available space together. Additional languages do not compensate for an ineligible ingredient or an unsuitable claim.

The quote depends on the number of products and markets, ingredient complexity, available specifications, claims, label versions and filing scope. A focused label review is a different engagement from reformulation or a new novel food dossier. Fees, third-party costs and deliverables should be set out separately before work begins.

Timing depends on the route and completeness of the records. Separate consultant preparation time from laboratory work, supplier responses, translations and authority procedures. We propose milestones after reviewing the brief; a routine notification and a new novel food application should never be assigned the same generic timeline.

Yes. We connect regulatory review with formulation questions such as daily serving, active stability, excipient selection, sensory performance and packaging. Format alone does not settle classification. A drink mix, for example, may need a different assessment from a measured-dose supplement even when it contains similar ingredients.

Include the UK as a separate market in your brief. Great Britain and Northern Ireland need the appropriate route-specific assessment. Do not assume an EU ingredient authorisation, claim or label can be carried across unchanged. Our UK page explains the separate review scope.

Send your intended markets, product category, complete formula per daily serving, ingredient specifications, current artwork, desired claims and launch priorities. Add existing testing, stability information and any distributor or authority correspondence. A list of missing records is useful too; the project can start by identifying those gaps.