European Union · Supplements

EU Food Supplements Directive

A practical guide to EU Food Supplements Directive for supplements sold in the European Union: who it applies to, what to prepare, and the mistakes that cause rejection.

Who needs it

Brands and importers of food supplements and nutraceuticals; Online sellers listing supplements for buyers in the European Union

Authority

European Commission

Legal basis

Directive 2002/46/EC

Local representative

A local notifying entity is required

Timeline

Before sale; notification review takes weeks

Cost

Dossier and testing costs vary by ingredient

If you do not comply

Seizure, fines, and listing removal

Who needs this

Brands and importers of food supplements and nutraceuticals
Online sellers listing supplements for buyers in the European Union

Documents you need

Ingredient and dosage review
Product information file
GMP certificate
Local-language label artwork

Compliance checklist

Tick each item as you collect it. Saved in this browser only.

Ingredient and dosage review
Product information file
GMP certificate
Local-language label artwork

How to comply

Check whether ingredients are permitted locally
Prepare the product information file
Register or notify where required
Label with permitted claims

Brief for your lab or agent

Copy this into an email, then edit the product and channel.

Request: EU Food Supplements Directive — European Union
Product category: Supplements
Authority: European Commission
Legal basis: Directive 2002/46/EC

Documents we already have:
  1. Ingredient and dosage review
  2. Product information file
  3. GMP certificate
  4. Local-language label artwork

Questions:
  1. Does our product fall under EU Food Supplements Directive in the European Union?
  2. Which test standards or evidence do you accept?
  3. What is the current fee and lead time?
  4. Is a local representative required, and can you act as one?

Cost and timeline

Before sale; notification review takes weeks.

Dossier and testing costs vary by ingredient.

Common rejection reasons

Ingredient not permitted
Claims too strong for the category
Label missing required warnings
GMP certificate missing

Registration, notification, or certification is not the same as approval. Keep the technical file current and make sure the label, listing, and submitted data match.

Official sources

FAQ

Who needs EU Food Supplements Directive in the European Union?

Brands and importers of food supplements and nutraceuticals. Online sellers listing supplements for buyers in the European Union. The importer of record normally holds the evidence.

What documents do I need for EU Food Supplements Directive?

Ingredient and dosage review; Product information file; GMP certificate; and local-language label artwork.

What is the first step for EU Food Supplements Directive?

Check whether ingredients are permitted locally, then prepare the product information file. Before sale; notification review takes weeks.

How long does EU Food Supplements Directive take?

Before sale; notification review takes weeks.

How much does EU Food Supplements Directive cost?

Dossier and testing costs vary by ingredient.

What happens if I sell without it?

Seizure, fines, and listing removal.

Who regulates EU Food Supplements Directive in the European Union?

European Commission.