Facts
- The European Court of Justice (ECJ) examined the validity of Directive 2002/46/EC, which set minimum and maximum limits for vitamins and minerals in food supplements, and created a list of authorized substances.
- The Directive aimed to protect consumers by reducing health risks from imbalanced nutrient intake.
- The Alliance for Natural Health and others challenged the Directive, claiming its measures were overly restrictive and interfered with the free movement of goods within the EU.
- The challengers argued that the Directive lacked a sufficient scientific basis and did not account for different dietary needs across Member States.
- They emphasised the principle of subsidiarity, contending that national laws could better address consumer protection in this sector.
Issues
- Whether Directive 2002/46/EC imposed unjustified restrictions on the free movement of food supplements within the EU internal market.
- Whether the Directive's limits and authorized substances list were supported by adequate scientific evidence.
- Whether the EU had exceeded its powers under Article 114 TFEU by not respecting proportionality and subsidiarity.
- Whether less restrictive measures could have achieved the Directive's consumer protection aims.
Decision
- The ECJ confirmed the EU’s competence to legislate on food supplements under Article 114 TFEU.
- The Court held that EU legislative measures must comply with the principle of proportionality and not exceed what is necessary to achieve policy objectives.
- The ECJ found that while consumer protection was a legitimate aim, certain restrictions in Directive 2002/46/EC were not supported by sufficient scientific evidence.
- The Court noted that alternative, less restrictive measures could have achieved an equivalent level of protection.
- As a result, the Directive was required to be amended, with the Commission obligated to provide stronger scientific justification for its restrictions.
Legal Principles
- EU measures harmonizing the internal market must respect the principle of proportionality, requiring that actions not exceed what is needed for their objectives.
- Substantial scientific evidence must underpin restrictions limiting the marketing or sale of products.
- The precautionary principle may justify regulatory action where there is scientific uncertainty over risks to human health.
- The balance between consumer protection and free movement of goods is central to the legitimacy of EU regulatory measures.
- Subsidiarity requires that, where possible, Member States address issues that do not require EU-level intervention.
Conclusion
The Alliance for Natural Health ruling clarified that while the EU may harmonize laws for consumer protection, such measures must be proportionate and scientifically justified; the decision reinforced the importance of balancing public health, market freedoms, and Member State autonomy in EU regulatory law.