Guide to the regulation of food supplements in the European Union

Launching dietary supplements in the European Union means entering a harmonized market, but one that still retains important national nuances. This article guides companies through the key aspects new brands must understand to stay safe, comply with regulations, and be ready for market entry.

Table of contents

• 1) What is a “food supplement” in the EU?

• 2) The legal pillars you should know

• 3) Formulation: what is allowed and how to justify safety

• 4) Labeling: the non-negotiable

• 5) Statement strategy: what you can (and can't) say

• 6) Market access and national crossings

• 7) Practical and realistic roadmap

• Common mistakes to avoid

• How does Belab help new brands succeed in the EU?

Guide to the regulation of food supplements in the European Union

1) What is a “food supplement” in the EU?

According to European legislation, food supplements are foods presented in dosage form (e.g., capsules, tablets, or liquids in measured units) designed to complement the normal diet. They are not medicinal products and cannot claim to prevent, treat, or cure diseases.

2) The legal pillars you should know

The European regulatory framework for food supplements ensures their safety, transparency, and consistency across the market. It defines which ingredients can be used, requires clear and verifiable labeling, regulates the use of nutrition and health claims, and requires the prior assessment of new ingredients not traditionally consumed in Europe. Although harmonization of maximum and minimum nutrient levels is planned, national differences continue to play a key role in market access requirements.

3) Formulation: what is allowed and how to justify safety

• Vitamins and minerals: Uses only nutrients and chemical forms authorized under the Food Supplements Directive. Purity criteria apply.

• Other substances (botanicals, bioactives): The Directive focuses on vitamins and minerals; other substances may be regulated nationally or under other European legislation (e.g., novel foods). Early assessment is essential.

• Safe intake levels: Build your safety case based on the Dietary Reference Values (DRVs) and Tolerable Upper Intake Levels (ULs) defined by EFSA, which provide guidance on safe daily intake levels.

4) Labeling: the non-negotiable

Beyond the general food labeling requirements, dietary supplements must display additional information intended to promote safe and informed consumption. Ensuring these elements are properly implemented requires the expertise of a qualified professional familiar with the specifics of dietary supplement regulation.

5) Statement strategy: what you can (and can't) say

Only authorized nutrition and health claims may be used, with their exact wording and under the established conditions of use (dosage, target population, etc.). Plan your formulation and daily dose from the start, taking into account the conditions of use associated with the claim you intend to use.

6) Market access and national crossings

Although EU legislation is harmonized, two critical issues remain for startups:

1. Maximum levels of vitamins and minerals are not yet harmonized at European level → some Member States apply their own limits or guidelines.

2. Notifications: Article 10 allows countries to require notification of the label to the competent authority upon first introduction of the product into their market.

7) Practical and realistic roadmap

1. Evaluate the formula: verify limits and compliance for use of minerals and vitamins; check novel food status; exposure to UL.

2. Define the declarations from the start and adjust the dosage/format to the authorized conditions of use.

3. Design the label according to the horizontal and plugin-specific rules.

4. Check national requirements (maximum level policies; notification where appropriate).

5. Prepare the documentation package: specifications, certificates of analysis, stability/shelf-life justification, and UL/DRV safety dossier.

Common mistakes to avoid

• Treat botanicals or bioactives the same as vitamins: different rules may apply (including those for novel foods).

• Designing the marketing strategy first, then the marketing statements can lead to non-compliance or the need for reformulation.

• Ignoring national notifications or local limits may delay market entry.

How does Belab help new brands succeed in the EU?

We transform regulatory complexity into a launch plan:

• Formula review and safety justification (Annex I/II approved forms, UL exposure, novel food evaluation).

• Declarations and labeling aligned with specific regulations.

• Market access by Member State (notification support; analysis of local specificities).

Ready to enter the European dietary supplement market with confidence? Let's build your compliant and secure route to market together.

Get in touch with our team of experts today.