## 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

1. Whether Directive 2002/46/EC imposed unjustified restrictions on the free movement of food supplements within the EU internal market.
2. Whether the Directive's limits and authorized substances list were supported by adequate scientific evidence.
3. Whether the EU had exceeded its powers under Article 114 TFEU by not respecting proportionality and subsidiarity.
4. 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.

Alliance for Natural Health v Secretary of State for Health (Joined Cases C-154/04 and C-155/04) [2005] ECR I-6451