What Is a Dietary Supplement?

If you manufacture, import or sell concentrated nutrient products in Europe, you need to be certain how the law defines them. In the European Union, a food supplement (often referred to as a dietary supplement) is a concentrated source of vitamins, minerals or other substances with a nutritional or physiological effect, placed on the market in dose form such as pills, tablets, capsules or measured liquids [1][2]. The product is designed to supplement the normal diet, and its regulatory classification as a food – not a medicine – sets the boundaries for everything from ingredient choice to claims.

That fundamental definition, rooted in Directive 2002/46/EC, dictates exactly which ingredients you may use, how the label must read, and who bears responsibility for safety [2]. For European brands aiming to export supplements to North America, or North American firms entering the EU market, understanding this definition is the first compliance step.

What Is a Dietary Supplement? The Core EU Definition

At its simplest, a food supplement is any product intended to deliver nutrients or other physiologically active substances in a controlled, small-dose format. The legal definition states that food supplements are “concentrated sources of nutrients (or other substances) with a nutritional or physiological effect” and must be sold in dose form [1]. That form can be capsules, pastilles, tablets, powder sachets, liquid ampoules or drop-dispensing bottles [2][4].

Because they are considered food, supplements must meet general food law requirements [2]. However, specific harmonised rules apply on top of that, principally through Directive 2002/46/EC [2]. The directive’s aim is twofold: to protect consumers from health risks and to prevent misleading information [1].

The Regulatory Backbone: Directive 2002/46/EC and Beyond

Directive 2002/46/EC provides the harmonised framework for vitamins and minerals used in food supplements across the European Union [2]. It contains two critical annexes:

Annex I lists the vitamins and minerals that may be added for nutritional purposes [1].
Annex II lists the specific chemical substances (sources) from which those vitamins and minerals may be manufactured [1].

Trade in products containing vitamins or minerals not listed in Annex II has been prohibited since 1 August 2005 [1]. This absolute date means that any supplement containing an unrecognised vitamin source – even in trace amounts – is non-compliant and must be reformulated before entering the EU market.

For substances other than vitamins and minerals, there is no harmonised positive list at EU level. Instead, the regulatory status depends on several pieces of legislation. A botanical or novel compound may be subject to Regulation (EU) 2015/2283 on novel foods if it lacks a significant history of consumption in the EU before 15 May 1997 [2]. Ingredients added for technological purposes (sweeteners, colours, coating agents) must be authorised as food additives under Regulation (EC) No 1333/2008 [2].

Vitamins and Minerals: What You Can and Cannot Use

The permitted list in Annex I of Directive 2002/46/EC has been amended several times, most recently by Regulations (EU) 2017/1203, 2015/414, (EU) No 119/2014 and others [1]. Each amendment added new substances after a safety evaluation by the European Food Safety Authority (EFSA) [2].

Practically, this means you cannot freely use any nutrient source that looks chemically sound. You must verify the exact substance against Annex II. A common mistake is sourcing a mineral salt that is not on the list – even if the mineral itself is permitted – and discovering the hard way that the finished product cannot legally be placed on the market.

Substances Other Than Vitamins and Minerals

When you want to use amino acids, essential fatty acids, herbal extracts, fibre or other bioactive ingredients, the regulatory picture becomes more complex. In the absence of a harmonised EU list for such substances, national rules in individual Member States may apply, unless the ingredient falls under a specific EU regulation [2].

The European Commission maintains a list of substances whose use in foods is controlled because of known or suspected adverse health effects. This list is set out in Annex III of Regulation (EC) No 1925/2006, which covers the addition of vitamins and minerals and of certain other substances to foods [5]. Under Annex III, some substances are prohibited outright, while others are restricted or placed under Union scrutiny. Concrete examples from the annex include Ephedra herb and its preparations (prohibited), and Yohimbe bark (under scrutiny) [5]. Additionally, the Commission has initiated procedures to assess the safety of green tea catechins and alpha-lipoic acid, based on risk opinions from national food institutes [5].

If your formula includes a botanical that has not been widely consumed before 1997, you will almost certainly need to follow the novel food authorisation route under Regulation (EU) 2015/2283 [2]. Failing to do so can lead to a withdrawal from the market.

Labelling Requirements for Food Supplements

Supplement labelling goes well beyond standard food information. Under EU rules, every food supplement must display the following statements [4]:

The portion of the product recommended for daily consumption.
A warning not to exceed that recommended daily dose.
A statement that food supplements should not be used as a substitute for a balanced diet.
A statement that the product should be stored out of the reach of young children.

Equally important is what cannot appear on the label. The labelling, presentation and advertising of food supplements are strictly forbidden from claiming that the product prevents, treats or cures a disease [4].

Safety, Maximum Levels and the Manufacturer’s Responsibility

Because supplements are foods, it is the manufacturer, importer, supplier or distributor who is responsible for ensuring that a product placed on the market is safe [2]. Harmonised maximum and minimum levels for vitamins and minerals in supplements have not yet been set at EU level, despite years of discussion [1][2]. In the absence of binding maxima, EFSA has established tolerable upper intake levels (ULs) for individual micronutrients for different population groups. These ULs represent the maximum chronic daily intake unlikely to pose a risk of adverse health effects, and they serve as a scientific reference point for safety assessments [2].

For substances that raise safety concerns, the Commission can take action under Article 8 of Regulation (EC) No 1925/2006 to prohibit, restrict or place a substance under scrutiny [5]. The procedure has already been used for specific botanicals and compounds, as noted earlier.

A Cross-Continental Perspective: EU vs. US Regulation

When placing supplements on the US market, European brands face a fundamentally different regulatory philosophy. In the United States, dietary supplements are regulated by the FDA under the Dietary Supplement Health and Education Act of 1994 (DSHEA), a framework separate from both conventional foods and drugs [3]. The manufacturer must evaluate safety and labelling before marketing, and the FDA can take enforcement action only after a product is on the market if it is adulterated or misbranded [3].

This post‑market oversight contrasts with the EU’s structured ingredient pre‑approval system for vitamins and minerals. Understanding these differences early in product development can prevent costly reformulations and regulatory surprises on either side of the Atlantic.

Whether you need to verify that your vitamin sources appear in Annex II, assess the novel food status of a botanical, or align your labelling with the mandatory statements, knowing the EU definition of a dietary supplement is the entry point to compliance. The moment your product is classified as a food supplement under Directive 2002/46/EC, a specific chain of obligations for composition, safety and communication takes effect [2][4]. Getting those right from the start keeps your brand moving safely across borders.

Sources

[1] Food supplements (food.ec.europa.eu, accessed 2026-10-08)
[2] Food supplements | EFSA (efsa.europa.eu, accessed 2026-10-08)
[3] Dietary Supplements | FDA (fda.gov, accessed 2026-10-08)
[4] Food supplements – EU labelling rules - Your Europe (europa.eu, accessed 2026-10-08)
[5] Addition of vitamins and minerals (food.ec.europa.eu, accessed 2026-10-08)

Written by Nour Abochama, Quality & Regulatory Advisor, Care Europe | VP Operations, Qalitex. Learn more about our team

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What Is a Dietary Supplement? Defining Food Supplements Under EU Law