Regina v. Secretary of State for Health (Case C-491/01)

The case concerned Council Directive (EC) 2001/37, which established Europe-wide guidelines for warning labels on, and acceptable tar levels in, tobacco products. The EC had based the directive on two articles of the EC Treaty:

• Article 95 EC, which empowers the EC to protect public health.
  • ¶ 1: "The Council shall adopt the measures for approximation of the provisions laid sown by law, regulation or administrative action in Member States which have as their object the establishment and functioning of the internal market."
  • ¶ 3: "The Commission, in its proposals envisaged in paragraph 1 concerning health, safety, environmental protection and consumer protections, will take as a base a high level of protection, taking account in particular of any new development based on scientific facts. Within their respective powers, the European Parliament and the Council will also seek to achieve this objective."
  • ¶ 5: "If, after the adoption by the Council or by the Commission of a harmonisation measure, a Member State deems it necessary to introduce national provisions based on new scientific evidence relating to the protection of the working environment, it shall notify the Commission of the envisaged provisions as well as the grounds for introducing them."
• Article 133 EC, which empowers the EC to establish uniformity among its member states in the interest of furthering the common market.
  • ¶ 1: "The common commercial policy shall be based on uniform principles, particularly in regard to the achievement of uniformity in measures of export policy and measures to protect trade."
  • ¶ 3: "Where agreements with one or more States or international organisations need to be negotiated, the Commission shall make recommendations to the Council, which shall authorise the Commission to open necessary negotiations."
  • ¶ 4: "In exercising the powers conferred upon it by this Article, the Council shall act by a qualified majority."
  • ¶ 5: "The Council may extend the application to international negotiations and agreements on services as they are not covered by these paragraphs."

Article 234 EC allows national courts to challenge the validity of EC acts before the Court of Justice of the European Communities in Luxembourg. This was such a case: the government of the United Kingdom, on the application of British American Tobacco, Imperial Tobacco, and Japan Tobacco, questioned the Secretary of State for Health on the validity of the law, and the question was then brought to the ECJ.

The tobacco companies identified two problems. First, the policies of Directive 2001/37 overstepped the bounds of the EC Treaty: in other words, they were illegal because the member states had not given the EC the authority to implement them. The other problem was that it was unclear whether the regulations in question applied strictly to tobacco products sold within the European Union, or whether the regulations would also apply to exported tobacco products.

The Court, on December 10, 2002, held that:

1. The directive had a valid basis: "the aim of the measure adopted was to prevent the emergence of future obstacles to trade resulting from multifarious development of national laws." The court argued that "since the public was increasingly conscious of the dangers to health posed by the consumption of tobacco products, it was likely that member states would unilaterally adopt rules to discourage the consumption of those products. By forbidding member states from preventing the sale or consumption of tobacco products which did not comply with the standards it set, the directive genuinely had as its object the improvement of the conditions for the functioning of the internal market."
2. By citing two articles as the basis of the directive, the EC had not violated the procedural law for creating legislation. "While a directive could not have both arts 95 and 133 EC as a simultaneous legal basis," the court said, "art 95 EC constituted the only legal basis of the directive and the objective of the implementation of the common commercial policy pursued under art 133 EC was secondary to the aim and content of the directive as a whole." Even though the Commission had cited 133 EC as a second legal basis, the court said that this "was no more than a purely formal defect which had not given rise to an irregularity in the co-decision procedure."
3. Proportionality was not an issue, either: "The aims pursued by the directive had required action at Community level and could not have been achieved by the member states individually, as had been demonstrated by the multifarious development of national law."
4. Tobacco companies had protested that they could no longer use words such as "low-tar," "mild," or "light" in their product names, which amounted to a violation of their trademark rights. The court said that this was not a legal issue: "In the instant case, a manufacturer of tobacco products might continue {to} distinguish its product by using other distinctive signs."
5. The law did not extend to tobacco products marked for export, since they have no effect on the internal market of the EU.