Directive 2001/37/EC of 5 June 2001 concerning the manufacture, presentation and sale of tobacco products was published in the Official Journal of the European Communities on 18 July 2001. It was introduced in the national legislation of the 15 European Union (EU) Member States on 30 September 2002. The Directive contains provisions on maximum yields, warning labels, reporting requirements, misleading descriptors, traceability, monitoring and review. This paper discusses the provisions on packaging and labelling and assesses their impact.