Selling food supplements in the EU
Directive 2002/46/EC, national notification in Portugal and Germany, novel food status, labelling and language: what a supplement brand settles first.
Food supplements in the EU fall under Directive 2002/46/EC, which harmonises the vitamins and minerals they may contain and the particulars on their label. There is no EU pre-approval for a supplement as such. Instead, member states may require a notification before first sale, as Portugal does through DGAV and Germany through the BVL. Any ingredient without a significant history of consumption in the EU before 15 May 1997 is a novel food and needs authorisation first.
A supplement brand entering Europe therefore works on three layers: the EU rules, the national notifications, and the status of each ingredient.
What counts as a food supplement in the EU?
The European Commission describes food supplements as “concentrated sources of nutrients (or other substances) with a nutritional or physiological effect”, marketed to supplement the normal diet. They are sold in dose form, such as pills or capsules.
Directive 2002/46/EC sets the frame.
- Annex I lists the vitamins and minerals that may be used.
- Annex II lists the forms, or sources, in which they may be used.
- Since 1 August 2005, supplements containing vitamins or minerals not on those lists may not be sold in the EU, according to the Commission.
- Maximum and minimum amounts are not harmonised. The Commission notes that no proposal has been adopted, so member states still apply their own approaches.
- Other substances, such as botanicals, remain largely subject to national rules.
The absence of harmonised maximum levels is the main reason a formula accepted in one member state can meet questions in another.
Do food supplements need approval before sale in the EU?
Not at EU level. Article 10 of the directive allows member states to require the manufacturer, or the person placing the product on the market in their territory, to notify the competent authority “by forwarding it a model of the label used for the product.”
Notification is not approval. Two national examples show how it works.
| Country | Authority | Rule | What notification means |
|---|---|---|---|
| Portugal | DGAV, the Directorate-General for Food and Veterinary Affairs | Notify before selling in the national territory | No product assessment or label validation; the product may be placed on the market as soon as it is notified; no fee |
| Germany | BVL, the Federal Office of Consumer Protection and Food Safety | Section 5 of the NemV: the manufacturer or importer notifies at the latest at first placing on the market, with a sample of the label | A duty to notify, as the text of section 5 sets it out |
A brand selling in several member states checks each one it enters. A notification in one country does not replace a required notification in another.
How is a food supplement notified in Portugal?
DGAV states that food supplements must be notified to it before they are sold in Portugal. The operator sends a notification table, a copy of the label in PDF and, where one exists, the consumer information leaflet, by email to the address DGAV publishes.
Three points from DGAV’s page matter most.
- The operator may place the supplement on the market immediately once it has notified.
- DGAV charges no fee for the notification.
- DGAV does not assess the product or validate the label. The operator cannot conclude from a notification that the product is authorised. Compliance remains the operator’s responsibility, and products are subject to later official controls.
When is a supplement ingredient a novel food?
Under Article 3(2)(a) of Regulation (EU) 2015/2283, a novel food is any food “not used for human consumption to a significant degree within the Union before 15 May 1997”, that falls within one of the categories the regulation lists. Those categories include, for example, foods from microorganisms or algae, and foods produced with a process not used before that date.
A novel food may be placed on the market only once it is authorised and on the Union list. For a supplement brand, the question arises most often with botanical extracts, new ingredients and new forms of known ones. Evidence of consumption in the EU before May 1997 decides whether an ingredient is novel. The time to check is before the formula is fixed, not after stock is made.
What must a food supplement label show?
Article 6 of Directive 2002/46/EC sets supplement-specific rules on top of the general food labelling law.
- The product is sold under the name “food supplement”.
- The labelling, presentation and advertising may not attribute to it the property of preventing, treating or curing a human disease, or refer to such properties.
- The label bears the names of the categories of nutrients or substances that characterise the product, or an indication of their nature.
- It states the portion recommended for daily consumption.
- It carries a warning not to exceed the stated recommended daily dose.
- It states that food supplements should not be used as a substitute for a varied diet.
- It states that the products should be stored out of the reach of young children.
The general food information rules of Regulation (EU) No 1169/2011 also apply. On language, Article 15 requires mandatory food information to appear “in a language easily understood by the consumers of the Member States where a food is marketed.” A member state may require one or more official EU languages in its territory, and labels may carry several languages.
What does a supplement warehouse have to handle?
A supplement is a food with a shelf life, so the warehouse works to the label. Storage conditions printed on the pack apply in the warehouse too. Each batch is booked with its expiry date and picked first expired, first out.
Batch records on dispatch let the brand trace a problem to the orders that received it. Lot, batch and expiry control in an EU warehouse sets out how that works and which EU rules call for it.
A worked example
Suppose a brand from outside the EU sells a vitamin D and botanical capsule. It plans to hold stock in Portugal and sell to consumers in Portugal and Germany. The details are hypothetical, for the mechanics only.
Before production, it checks that the form of vitamin D it uses appears in Annex II of the directive. It asks its regulatory adviser whether the botanical extract was consumed to a significant degree in the EU before 15 May 1997. The adviser confirms it was, with evidence on file.
The label carries the name “food supplement”, the daily dose, the four mandatory statements, and text in Portuguese and German. No claim refers to preventing or treating a disease.
Before the first Portuguese sale, the brand notifies DGAV with the label and notification table. At the latest on first placing on the German market, it notifies the BVL with a sample of the label. Stock arrives in Portugal with batch and expiry data, and orders ship first expired, first out.
This is general information, not regulatory advice. The status of a formula and the notifications it needs are confirmed with the brand’s regulatory advisers.
What stays with the brand, and what does EFC handle?
Notifications, formula decisions, novel food questions and label content stay with the brand and its regulatory advisers. EFC does not notify supplements to any authority and does not assess formulations or labels. What EFC handles is the physical side at its base in Portugal, run with its logistics partner: storage, batch and expiry control, and dispatch, as described on warehousing. How that applies to this category is set out on supplements.
Sources
| Label | Value | Source |
|---|---|---|
| Food supplements in the EU | definition; Annexes I and II; unlisted vitamins and minerals barred since 1 August 2005; no harmonised maximum levels; national notification under Article 10 | European Commission, food supplements, opened 2026-08-14 |
| National notification | member states may require notification with a model of the label | Directive 2002/46/EC, Article 10, on legislation.gov.uk, opened 2026-08-14 |
| Labelling | name “food supplement”; no disease claims; five mandatory particulars | Directive 2002/46/EC, Article 6, on legislation.gov.uk, opened 2026-08-14 |
| Portugal, DGAV | notification before sale; immediate marketing; no fee; no product assessment or label validation | DGAV, procedimento de notificação de suplementos alimentares, opened 2026-08-14 |
| Germany, BVL | manufacturer or importer notifies at the latest at first placing on the market, with a label sample | Nahrungsergänzungsmittelverordnung, section 5, gesetze-im-internet.de, opened 2026-08-14 |
| Novel food | not used for human consumption to a significant degree within the Union before 15 May 1997 | Regulation (EU) 2015/2283, Article 3, EU text on legislation.gov.uk, opened 2026-08-14 |
| Union list | only authorised novel foods on the Union list may be placed on the market | Regulation (EU) 2015/2283, Article 6, EU text on legislation.gov.uk, opened 2026-08-14 |
| Language of food information | easily understood by consumers where marketed; member states may require official languages; several languages allowed | Regulation (EU) No 1169/2011, Article 15, EU text on legislation.gov.uk, opened 2026-08-14 |