A company placing a food supplement on the market does not file one application for a Union authorisation of the product. A supplement is a food. Directive 2002/46/EC approximates the rules on vitamins and minerals and on part of the labelling. It names amino acids, essential fatty acids, fibre, plants and herbal extracts, and it does not put them on a positive list. The notice in Article 10 — if a Member State requires one at all — goes to the competent authority of that State, with a model of the label. It is not an application to the European Commission. This page is for a manufacturer, an importer or a distributor. It is not advice on what to take.
What “regulated” means for a supplement
Several acts apply before a sale, not one licence. Regulation (EC) No 178/2002 defines food as any substance or product intended to be, or reasonably expected to be, ingested by humans (Article 2). Food shall not be placed on the market if it is unsafe (Article 14). The food business operator ensures that food satisfies the requirements of food law relevant to its activities and verifies that those requirements are met (Article 17). That is an operator duty, not a Commission decision on the SKU.
Directive 2002/46/EC concerns food supplements marketed as foodstuffs and presented as such. They reach the ultimate consumer only pre-packed (Article 1). A food supplement is a foodstuff meant to supplement the normal diet, a concentrated source of nutrients or of other substances with a nutritional or physiological effect, marketed in dose form: capsules, pastilles, tablets, pills, sachets of powder, ampoules of liquids, drop-dispensing bottles and similar forms of small measured quantities (Article 2(a)). “Nutrients” in this Directive means only vitamins and minerals (Article 2(b)). The name under which the product is sold is “food supplement” (Article 6(1)).
The Directive does not apply to medicinal products as defined by Directive 2001/83/EC (Article 1(2)). This page does not decide the supplement–medicine line for a given SKU. Article 3 requires Member States to allow marketing only where the product complies with the Directive — with what the Directive actually harmonised, which is a narrow slice.
Vitamins and minerals: annexes, not EU doses
Directive 2002/46/EC does not authorise every ingredient. Only vitamins and minerals listed in Annex I, in the forms listed in Annex II, may be used in manufacture (Article 4(1)). The derogation in paragraph 6, which until 31 December 2009 let States tolerate certain forms outside the annexes, has expired. The consolidated text of 26 November 2025 (CELEX 02002L0046-20251126) is still a list of vitamins, minerals and their forms, not a list of plants.
Article 5 says maximum amounts per daily portion recommended by the manufacturer shall be set, taking account of upper safe levels and of intake from other sources, and that minimum amounts shall be set as appropriate. Paragraph 4 gives adoption of those amounts to the Commission. The consolidation of 26 November 2025 contains no figures: it contains the duty to adopt them.
As at 30 September 2026 the Article 5 amounts have not been adopted. The Commission “Food supplements” page, read that day, says that no proposal has yet been presented. Council note 15839/25 of 9 December 2025 states that no such maximum levels have thus far been set, and calls for them to be set in 2026. The note is not a legislative act. No act amending the Directive and inserting those amounts has followed the consolidation of 26 November 2025. Until such an act exists, Article 11(2) leaves in place national provisions applicable because those acts are absent, without prejudice to the Treaty, in particular Articles 28 and 30 as the Directive still numbers them. This page states no country’s figure: that figure is not in a Union act.
Article 1(2) of Regulation (EC) No 1925/2006 says the provisions of that Regulation on vitamins and minerals do not apply to food supplements covered by the Directive. Amounts for a supplement, when they exist, will be the Article 5 amounts, not Article 6 of Regulation 1925/2006. The fortification line: fortified food and other substances.
Ingredients that are not vitamins or minerals
Recital 6 lists amino acids, essential fatty acids, fibre, plants and herbal extracts. Recital 7 limits the first stage to vitamins and minerals: a supplement that contains both a vitamin and another ingredient must still meet the vitamin rules. Recital 8 postpones specific rules for the other substances and, until then, allows national rules where no Community rule has been adopted. Article 4(8) required a report by 12 July 2007. The Commission prepared that report. Annexes I and II are still vitamins and minerals. The report is not an authorisation of a plant.
For an ingredient that is not a vitamin or a mineral there is no menu of three licences. The facts are classified. Directive 2002/46/EC is none of the gates. Two Union gates can both be open; three applications are not filed in reserve.
Novel food is food that was not used for human consumption to a significant degree in the Union before 15 May 1997 and that falls under a category in Article 3(2)(a) of Regulation (EU) 2015/2283. A national list of “other substances” does not replace that status. An EFSA opinion is not an entry on the Union list. The procedure: novel food and supplements. A vitamin on Annex II can still be novel food if a production process not used before 15 May 1997 was applied, or if it is an engineered nanomaterial (Article 3(2)(a)(ix)).
Article 8 of Regulation (EC) No 1925/2006 applies where a substance other than vitamins or minerals is added to foods so that intake would greatly exceed the amount reasonably expected from a normal diet, or would otherwise represent a risk. The Commission may, after an assessment by the Authority (EFSA), place it in Annex III: Part A is a prohibition, Part B is conditions, Part C is persisting scientific uncertainty. The opinion does not make the listing and is not an authorisation. Within four years of a Part C listing a decision is taken to allow the use or to move the substance to Part A or B (Article 8(5)). The worked example, not repeated here: berberine and Article 8.
Where the Union has not adopted a rule, national rules under recital 8 remain. They do not replace novel food or an Annex III entry.
Claims and labelling
Claims are Regulation (EC) No 1924/2006, which takes the Directive’s definition of a food supplement (Article 2(1)(b)). A health claim is prohibited unless it is authorised and included in the lists in Articles 13 and 14 (Article 10(1)). An Annex II entry, a novel-food authorisation and a national notice do not unlock a claim. The register is not restated here. The rules: health claims on supplements.
Article 6(2) of the Directive prohibits labelling, presentation and advertising from attributing to a supplement the property of preventing, treating or curing a human disease, or referring to such properties. Article 7 prohibits any mention stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients in general. That is the Directive’s ban, alongside Regulation 1924/2006, not a digest of the register.
The Directive’s labelling particulars are in Articles 6 to 9. Horizontal food information is Regulation (EU) No 1169/2011. The sales name in Article 6(1) is “food supplement”. The label states the nature of the substances, the daily portion, a warning not to exceed that dose, a statement that supplements should not be used as a substitute for a varied diet, and storage out of the reach of young children (Article 6(3)). The amount is declared in numerical form per daily portion (Article 8). References to Directives 2000/13/EC and 90/496/EEC are read, from 13 December 2014, as references to Regulation 1169/2011 (its Article 53). Reference intakes are in Annex XIII.
Notification is national, and optional for the Member State
Notification is not filed with the European Commission. Article 10 says that, to facilitate monitoring, Member States may require the manufacturer or the person placing the product on the market in their territory to notify the competent authority by forwarding a model of the label used for the product. “May” means the Directive does not impose the duty: a State either introduces it or it does not. The addressee is that State’s authority, not the Commission. Companies search for “registration” of a supplement. In EU law that search lands on this same step: a national notice with a label model, not an entry in a Commission register.
Which of eight countries has the step is on the notification map. The map is not redrawn here. For a first placing on the Polish market, the authority’s procedure is in the GIS notification note. The notice is not a novel-food authorisation and not a claims authorisation.
A second Member State
Article 11(1) prohibits restricting trade in a product that complies with the Directive, for reasons of composition, manufacturing specifications, presentation or labelling. Paragraph 2 leaves standing national provisions applicable in the absence of acts adopted under the Directive. A national maximum that exists because Article 5 has not been carried out does not disappear because the product is lawful in the first State.
Regulation (EU) 2019/515 applies mutual recognition to goods lawfully marketed in another Member State: goods that comply with the rules of that State, or are not subject to any such rules there, and are made available to end users (Article 3(1)). It concerns a decision based on a national technical rule covering an aspect that is not harmonised at Union level (Article 2(2)(a)). Novel food and health claims are harmonised. A breach of Regulation 2015/2283 or 1924/2006 is not cured by Regulation 2019/515. A prior authorisation procedure is not itself a national technical rule (Article 2(4)). The Regulation does not confer a right to sell in every Member State.
Manufacture: food hygiene, not medicines GMP
The phrase “nutraceutical processing” does not name a Union act. A supplement, as food, is under Regulation (EC) No 852/2004 at production, processing and distribution. Responsibility for safety rests with the operator. Operators after primary production comply with the hygiene requirements in Annex II (Article 4) and keep a permanent procedure based on the HACCP principles (Article 5). Guides to good practice under Articles 7 to 9 help meet those duties (Article 1(1)(e) and Article 4(6)). They are not the principles of good manufacturing practice for medicinal products.
Those principles for human medicines are Commission Directive (EU) 2017/1572. It covers products whose manufacture or import requires the authorisation in Article 40 of Directive 2001/83/EC (Article 1). Article 15 of Directive 2017/1572 repealed Directive 2003/94/EC. An industry GMP guide for supplements does not become that regime by its title. This page does not classify a plant as a medicines site.
What to settle before the first sale
| Step | Rule | Where the rest is |
|---|---|---|
| Vitamin or mineral | Annex I, and a form in Annex II. Off the list, it may not be used as a vitamin or mineral source (Article 4(1)). The paragraph 6 derogation ended on 31 December 2009. | Consolidated Directive, CELEX 02002L0046-20251126 |
| Other substance | Classify first: novel food, Article 8, or — where neither bites — national rules under recital 8. | Fortification and other substances |
| Novel food | No significant consumption before 15 May 1997, and a category in Article 3. An EFSA opinion does not replace the list entry. | Novel food and supplements |
| Article 8 | Annex III, Part A, B or C. The opinion is not the listing. | Berberine as the Article 8 example |
| Claim | A health claim only from the Article 13 and 14 lists of Regulation 1924/2006. Otherwise it is not on the label or in advertising. | Health claims |
| Label | Articles 6 to 9 of the Directive and the mandatory particulars of Regulation 1169/2011, including Annex XIII reference intakes. | CELEX 02002L0046-20251126 and CELEX 32011R1169 |
| Notice | Only where the State has used Article 10. National authority, label model, not the Commission. | Map of eight countries · Poland, GIS |
Questions that come back in briefs
Which EU laws apply to a food supplement?
178/2002 (food), 2002/46/EC (vitamins, minerals, part of the label), 1924/2006 (claims), 1169/2011 (information), 852/2004 (hygiene). An ingredient that is not a vitamin or a mineral: national rules, 2015/2283, or Article 8 of Regulation 1925/2006 — on the facts, not on the operator’s choice.
Does Directive 2002/46/EC authorise every ingredient?
No. Only vitamins and minerals in Annex I, in Annex II forms. It does not authorise botanicals.
Is notification filed with the European Commission?
No. Article 10 sends the label model to the State’s authority, and only if that State has introduced the duty.
Are maximum vitamin and mineral levels set by the EU?
No, as at 30 September 2026. Article 5 is a duty to adopt amounts, not a figure. National provisions applicable in that absence remain (Article 11(2)).
Is manufacture of a supplement pharmaceutical GMP?
No. Hygiene and HACCP are in Regulation 852/2004. GMP for human medicines is Directive (EU) 2017/1572.
A call about the file
Placing a formula under the right act — the vitamin annex, novel-food status, Article 8, the claim, the label, and notification in a State that requires it — is work for a manufacturer, an importer or a distributor. Book an initial call. The call qualifies the scope. It is not a free legal opinion and it is not an offer to a consumer.
Primary sources
- Directive 2002/46/EC, consolidated 26 November 2025 — CELEX 02002L0046-20251126; ELI eli/dir/2002/46. Articles 2, 4, 5, 6–10 and 11.
- Directive 2002/46/EC, original text — recitals 6 to 8 (CELEX 32002L0046).
- Regulation (EC) No 178/2002 — consolidated 1 January 2026, Articles 2, 14 and 17.
- Regulation (EU) 2015/2283 — novel food, Article 3(2)(a), including point (ix).
- Regulation (EC) No 1925/2006 — Article 1(2) and Article 8, consolidated 26 November 2025.
- Regulation (EC) No 1924/2006 — Article 10(1), consolidated 13 December 2014.
- Regulation (EU) No 1169/2011 — Article 53; Annex XIII.
- Regulation (EC) No 852/2004 — Articles 1, 4 and 5.
- Regulation (EU) 2019/515 — Articles 2 and 3.
- Commission Directive (EU) 2017/1572 — medicines GMP, Articles 1 and 15.
- European Commission — Food supplements — no proposal yet on maximum amounts; the Article 4(8) report; Article 10.
- Council note 15839/25, 9 December 2025 — maximum levels not yet set.