EU Labeling Requirements for Dietary Supplements — What Must Appear on the Label

A supplement brand I worked with had invested significantly in premium packaging for their EU launch. The design was clean, the branding was strong, and the product itself was well-formulated. What the brand had not done was have the label reviewed against EU requirements before going to print. The result was a label that was missing mandatory declarations, included a health claim that was not authorised under EU law, and did not include the required warning statement. The packaging had to be reprinted before the product could legally be placed on the market.

Label compliance is not a detail to address at the end of the product development process. It is a legal requirement that affects every unit placed on the EU market, and errors discovered after packaging is printed are expensive to correct.

This article is for supplement brand owners, regulatory affairs managers, and marketing teams preparing EU-market labels. It explains what must appear on a EU dietary supplement label, what is prohibited, and how language requirements affect multi-market launches.

The Regulatory Framework

EU dietary supplement labeling is governed by two primary instruments:

Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements sets out specific labeling requirements for food supplements, including mandatory statements and prohibited claims.

Regulation (EU) No 1169/2011 on the provision of food information to consumers establishes the general food labeling framework that applies to all foods sold in the EU, including dietary supplements. This Regulation specifies requirements for mandatory particulars, legibility, language, and nutrition labeling.

These two instruments must be read together. A supplement label must comply with both the supplement-specific requirements of Directive 2002/46/EC and the general food labeling requirements of Regulation (EU) No 1169/2011.

Mandatory Label Particulars

Product name. The label must include the designation “food supplement” (or the equivalent in the language of the market). This designation must appear on the label as a mandatory particular.

Names of nutrient categories or substances. The label must identify the categories of nutrients or substances that characterise the product (e.g., “vitamin C and zinc supplement”) or an indication of the nature of those nutrients or substances.

Recommended daily dose. The label must state the recommended portion for daily consumption. This must be expressed in a way that is clear and unambiguous — for example, “take 2 capsules daily” or “take 10 ml daily.”

Warning: do not exceed recommended daily dose. Article 6(2)(a) of Directive 2002/46/EC requires a statement that the stated recommended daily dose should not be exceeded. This warning must appear on the label.

Dietary supplement not a substitute for a varied diet. Article 6(2)(b) requires a statement that food supplements should not be used as a substitute for a varied diet. This is a mandatory declaration, not optional marketing language.

Keep out of reach of young children. Article 6(2)(c) requires a statement that the products should be kept out of the reach of young children.

Nutrient reference values. Where vitamins and minerals are present, the label must declare the amount per recommended daily dose as a percentage of the Nutrient Reference Values (NRVs) established in Annex XIII of Regulation (EU) No 1169/2011. NRVs are fixed values — they are not the same as the US Daily Values, and the specific values differ for some nutrients.

Net quantity. The net quantity of the product must be declared in metric units (grams, millilitres, or number of units).

Best before date. The date of minimum durability must be declared. For supplements with a shelf life of more than three months, the minimum durability indication must include at least the month and year.

Lot number. A batch or lot number must appear on the label.

Name and address of the responsible food business operator. The name and address of the manufacturer, packer, or seller established in the EU must appear on the label.

Country of origin (where required). Country of origin labeling is mandatory where its omission might mislead the consumer.

Storage conditions. Where applicable, storage conditions must be declared.

Health Claims: What Is and Is Not Permitted

This is the area where North American brands most frequently encounter compliance issues.

Under Regulation (EC) No 1924/2006 on nutrition and health claims made on foods, health claims on food supplements must be authorised and must appear on the EU Register of authorised nutrition and health claims. The Register lists the specific wording of each authorised claim, the conditions of use, and any required accompanying statements.

Claims that are not on the Register are prohibited. This includes many structure/function claims that are routinely used on US supplement labels under the DSHEA framework. A claim such as “supports immune function” is only permitted in the EU if it uses the exact authorised wording and meets the conditions of use specified in the Register.

Disease risk reduction claims and claims referring to the development and health of children are subject to additional authorisation requirements under Article 14 of Regulation (EC) No 1924/2006.

Claims that a food supplement can prevent, treat, or cure a human disease are prohibited under both Directive 2002/46/EC and Regulation (EC) No 1924/2006. This prohibition is strictly enforced.

Language Requirements

Under Regulation (EU) No 1169/2011, mandatory food information must appear in a language easily understood by the consumers of the member states where the food is marketed. In practice, this means the label must be in the official language(s) of each member state where the product is sold. A product sold in France must have a French label; a product sold in Belgium must have labels in French, Dutch, and German (depending on the region).

For brands launching across multiple EU member states, this typically means either producing separate label versions for each market or using a multi-language label that includes all required languages. Multi-language labels must ensure that all mandatory particulars are present in each required language and that the label remains legible and not misleading.

Practical Action Step

Use this checklist when reviewing a supplement label for EU compliance:

Label compliance errors discovered after packaging is printed are costly. Invest in a label review before finalising artwork.

Care Europe provides EU supplement label compliance reviews for brands entering the European market, including health claim assessment and multi-language label adaptation. Contact us to discuss your labeling requirements.

EU Labeling Requirements for Dietary Supplements — What Must Appear on the Label