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Selling food supplements in the EU

In the EU, food supplements are food. Directive 2002/46/EC lists the vitamins and minerals they may contain and the sources those may come from, and the general food labelling, claims and novel food rules apply on top. There is no EU-wide approval of each product, but a member state may ask to be notified.

Updated · Each section links to the official source it comes from

Main text
Directive 2002/46/EC on food supplements
Vitamins and minerals
Those in Annex I, from the sources in Annex II
Product approval
None EU-wide; a member state may ask to be notified
Claims
Only those in the EU Register of claims
Who enforces
Competent authorities in each member state

Before a product goes on sale

The questions to answer, in the order they usually come up.

  1. 1Are the vitamins and minerals, and their sources, on the Annex lists? Read more
  2. 2Is any other ingredient a novel food that needs authorisation? Read more
  3. 3Which claims can the label and the marketing make? Read more
  4. 4What has to be on the label, including caffeine where added? Read more
  5. 5Does a member state you sell in ask to be notified? Read more
  6. 6Which contaminant limits apply to the ingredients? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

What a supplement may contain

The vitamins and minerals a supplement may use, and the rule for ingredients new to the EU.

  • Annex I of the Directive lists the vitamins and minerals that may be added for nutritional purposes; Annex II lists the permitted sources they may be made from.
  • Trade in products containing vitamins and minerals not listed in Annex II has been prohibited since 1 August 2005.
  • Maximum and minimum amounts of vitamins and minerals are foreseen by the Directive, but the Commission has not yet proposed them.
  • An ingredient not consumed to a significant degree in the EU before 15 May 1997 is a novel food and needs authorisation first.

How we help: Compliant Always reads your formula against the Annex lists and the novel food status of each ingredient, and keeps the evidence for each with the product. Ask about this

Nutrition and health claims

What a label, website or advert may say about what the supplement does.

  • Nutrition and health claims are allowed only where authorised and listed in the EU Register of claims, under the conditions set for each.

How we help: Compliant Always sets the claims on your label beside the authorised wording and its conditions of use, with the register entry for each. Ask about this

Labelling

The general food labelling rules, with additions for supplements.

  • The mandatory particulars of Article 9 of Regulation (EU) No 1169/2011 apply, including allergens emphasised in the ingredients list.
  • Where caffeine is added for a physiological purpose, the label carries "Contains caffeine. Not recommended for children or pregnant women", with the caffeine content per daily portion (Annex III).

How we help: Compliant Always sets what the label has to show beside what yours shows, with the article for each. Ask about this

National notification

How a member state keeps track of supplements sold there.

  • Member states may, for monitoring purposes, ask to be notified when a food supplement is placed on their market (Article 10 of the Directive).
  • The Commission publishes the list of competent authorities to notify.

How we help: Compliant Always keeps a record of where each product was notified and when, with the confirmation on file. Ask about this

Contaminants and general food law

Limits on contaminants, and the responsibilities every food business carries.

  • Maximum levels apply to metals such as lead, cadmium, mercury and arsenic, to mycotoxins and to other contaminants.
  • Primary responsibility for the safety of the food rests with the food business operator, who must withdraw or recall unsafe food and notify the authorities.

How we help: Upload a certificate of analysis and Compliant Always reads it against the limits that apply, with the source beside each one. Ask about this

Who answers for what

WhoWhat they answer forHow we help
BrandThe formula, the label, the claims and any national notification.Formula, label and claims checked against the lists, with the paperwork behind each.
Contract manufacturerHygiene, traceability and what goes into each batch.Certificates of analysis and specifications kept by batch, ready for a customer's form.
Ingredient supplierThe identity and permitted source of each vitamin, mineral or other ingredient.Specifications and certificates collected once and shown to each customer that asks.
Importer into the EUThe food information where the brand is not established in the EU.The supplier's documents read and dated before the goods arrive.

Member states

The Directive is applied through national law, and member states may ask to be notified when a supplement goes on sale there. Amounts of vitamins and minerals are not yet set at EU level.

Selling in more than one member state means meeting the EU text and the national additions of each.

Questions businesses ask

Do food supplements need approval before they are sold in the EU?
There is no EU-wide approval of each product. The Directive lists the vitamins and minerals, and their sources, that supplements may contain, and a member state may ask to be notified when one goes on sale there.
Which vitamins and minerals can a supplement contain in the EU?
Those listed in Annex I of Directive 2002/46/EC, made from the sources listed in Annex II. Products with vitamins and minerals not listed in Annex II have been prohibited since 1 August 2005.
Are there maximum amounts of vitamins and minerals in EU supplements?
The Directive foresees maximum and minimum amounts, but the Commission has not yet presented a proposal.
Does a botanical or other new ingredient need authorisation?
If it was not consumed to a significant degree in the EU before 15 May 1997, it is a novel food and needs authorisation under Regulation (EU) 2015/2283 before it goes on sale.
Can a supplement label make a health claim in the EU?
Only a claim authorised under Regulation (EC) No 1924/2006 and listed in the EU Register of nutrition and health claims, under the conditions set for it.
How is added caffeine labelled on a supplement?
With "Contains caffeine. Not recommended for children or pregnant women", in the same field of vision as the name, and the caffeine content per portion recommended for daily consumption (Annex III, Regulation (EU) No 1169/2011).
Do I have to notify each member state where I sell a supplement?
Only where that member state asks for it. Article 10 of the Directive lets member states request notification to their competent authority, for monitoring.
Which contaminant limits apply to supplements?
The EU maximum levels in Regulation (EU) 2023/915 cover metals such as lead, cadmium, mercury and arsenic, mycotoxins and other contaminants.
Who answers for a supplement's label in the EU?
The business under whose name it is sold or, if that business is not established in the EU, the importer into the EU (Article 8, Regulation (EU) No 1169/2011).
How does Compliant Always help with selling in the EU?
Our team reads the rules for the markets you sell in. Compliant Always shows which apply to your product, keeps the documents behind each one ready, and watches the sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

Tell us what you make, and we will show you the rules for it.

Name the product and the markets you sell in. We will come back to you with what applies in the EU and what your paperwork needs to show.

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