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A food supplement formula is legal in the EU or it is not, and the answer has nothing to do with how well the product sells elsewhere. It depends on what is in the capsule: each ingredient, in the form you use, at the amount you use, in this category of food. The cheapest moment to find out is before you order raw materials from a contract manufacturer; the most expensive is after the first production run, with the labels printed and the pallets waiting.
No authority approves your formula before you launch, so the check is yours. In our experience a food supplement formula fails for a short list of reasons: a vitamin salt that is not on the list, a restricted plant extract, a novel food, or an additive that is not permitted in supplements. Our guide to selling food supplements in the EU covers the route to market, from notification to labelling; here we stay on the formula itself.
What a legal food supplement formula has to pass
First, what the product is. Directive 2002/46/EC defines food supplements as foods that supplement the normal diet and consist of concentrated sources of nutrients or other substances with a nutritional or physiological effect, sold in dose form and delivered to the consumer pre-packed. If your product fits, run five checks on the recipe: vitamins and minerals, other substances, novel food status, additives, and the national rules for botanicals. Claims and notification come afterwards and do not change what the formula may contain.
Vitamins and minerals: the substance and the form
Under Article 4(1) of the Directive, only the vitamins and minerals listed in Annex I may be used, and only in the forms listed in Annex II. Annex I names the nutrients; Annex II names the chemical sources you may buy (magnesium bisglycinate and magnesium oxide are on it, for example). A raw material that supplies the right nutrient in an unlisted source is not a legal ingredient, however common it is in the United States or Asia, and the European Commission notes that trade in such products has been prohibited since 1 August 2005.
Do not rely on a supplier’s specification sheet instead of the current list: Annex II has been amended many times, and the consolidated text of 26 November 2025 already includes changes adopted on 5 November 2025. Some entries also carry a footnote that points to the Union list of novel foods (calcidiol monohydrate and magnesium L-threonate are two), so you need to read the entry there as well.
The amount is part of the formula too. Article 5 provides for maximum and minimum amounts of vitamins and minerals per recommended daily dose, but the Directive itself contains no figures, so check whether an EU measure setting them has been adopted before you rely on a national limit. Where there is no EU measure, national provisions apply (Article 11(2)). So fix the daily dose first, calculate every nutrient against it, and check the result against the rules of your first market.
Other substances: Annex III of Regulation 1925/2006
Amino acids, coenzymes, plant extracts and similar ingredients fall outside the Directive’s positive lists. Regulation (EC) No 1925/2006 excludes food supplements from its vitamin and mineral rules (Article 1(2)), but not from its rules on other substances. Under Article 8, a substance ingested in amounts far above a normal diet, or that carries another health risk, can be entered in Annex III: Part A prohibits it, Part B allows it only under conditions, and Part C places it under Union scrutiny.
The entries are concrete. In the consolidated text of 26 November 2025, Part A includes Ephedra herbs, Yohimbe bark and their preparations. Part B covers green tea extracts containing EGCG, with less than 800 mg of EGCG per daily portion and mandatory warnings, and monacolins from red yeast rice, with less than 3 mg per daily portion, also with warnings. Annex III changes, so check the current text. Natural is not a defence, and a formula that says only «green tea extract» is incomplete: the rule attaches to the EGCG content.
Beyond Annex III there is no EU list of permitted «other substances»: Article 4(8) of the Directive only asked the Commission to report on whether to create one. National law fills the gap. Spain’s Royal Decree 1487/2009 allows, in Article 3(2), the substances in its annex (fatty acids, amino acids, coenzymes, flavonoids and carotenoids among them), with maximum daily amounts and, for some, a mandatory label warning. If your ingredient is not in that annex, do not assume it is allowed (the consolidated text we checked was last amended in 2018, so confirm the current annex).
Novel food: the check that can end a project
Regulation (EU) 2015/2283 defines a novel food as any food not used to a significant degree for human consumption in the Union before 15 May 1997, in one of several categories that include food from microorganisms, fungi or algae, material of mineral origin, and plants or parts of plants, with limited exceptions. The test is consumption inside the EU, so a plant with a long tradition in Asia or South America can still be new here.
Article 4 puts the duty on you: check whether the food falls within the Regulation and, if you are unsure, consult the Member State where you first intend to market it. Article 6(2) sets the consequence: only novel foods on the Union list may be sold, under the conditions of use and labelling requirements it specifies. The list, Implementing Regulation (EU) 2017/2470, gives for each novel food the food categories where it may be used, a maximum content, extra labelling requirements and a specification. Read the entry, not just the name: your extract has to meet the specification and your dose has to stay inside the limit. The Commission’s Novel Food Catalogue helps as a first orientation, but the legal test is Article 3(2)(a). Our Spanish-language guides on importing supplement ingredients and on novel food controls go deeper.
Additives and excipients: the part people forget
Sweeteners, colours and many other excipients added for a technological purpose are food additives (the definition in Article 3(2)(a) has exceptions, so check each excipient), and Regulation (EC) No 1333/2008 allows only those on its Union list, under the conditions stated there (Article 4(1)). Food supplements have their own category (17 in Annex II, Parts D and E), solid or liquid, excluding those for infants and young children. Conditions attach to individual additives: some are limited to chewable supplements, some to syrups, and E 410, E 412, E 415, E 417 and E 425 cannot be used in dehydrated supplements meant to be rehydrated on ingestion. Additives can also arrive inside a vitamin premix, and Annex III of the same Regulation lists those allowed in nutrients and other additives (Article 4(2) and (4)), so ask suppliers for the full composition of every premix.
Botanicals: no EU list, so check by country
For plants, no harmonised positive list exists at EU level: the Directive contains positive lists for vitamins and minerals only. Ask three questions of every botanical: is the plant, or the part you use, a novel food; is the substance in Annex III; and what does the country of sale say about that plant, that part and that type of extract? We are not reproducing a list of allowed plants here: lists that circulate online go out of date and differ between countries, and a food supplement formula built on one of them can be illegal in the market you actually want.
What the formula does not settle: claims and notification
A legal formula does not tell you what you may say about it. Under Regulation (EC) No 1924/2006, health claims are prohibited unless authorised and included in the lists provided for in Articles 13 and 14. Notification is separate too: Article 10 of the Directive lets Member States require it, and in Spain Article 9 of Royal Decree 1487/2009 requires it, with a copy of the label, before or at the first placing on the market, from the manufacturer, the person responsible for that first placing or, for third-country products, the importer. Omitting it is classed as a serious infringement, and the label copy has to match the formula you manufactured.
Frequently asked questions
Is a formula that is legal in the US or Asia legal in the EU?
Not automatically. The permitted forms of vitamins and minerals, Annex III, the novel food list and the additive list are EU-specific, so each ingredient has to be checked against them.
Does my contract manufacturer check this for me?
A manufacturer will typically confirm that it can produce the formula, which is not the same as confirming it is legal in your market. Ask for the full composition of every raw material and check the food supplement formula before the purchase order.
How ASC Services helps with the formula
If you want to start the conversation with your manufacturer from a defined formula, our cosmetic formulation service, which also covers food supplement formulas, delivers the formula only: ingredients with percentages, checked against current EU rules by a technician before it reaches you. Labelling, claims and market notification are separate. After almost twenty years assessing the safety and compliance of cosmetics and food supplements, our advice is to run these checks before the first purchase order. To discuss your product, write to us through our contact page.