29.4.2014 Official Journal of the European Union L 1271 | (Legislative acts) DIRECTIVES DIRECTIVE 2014/40/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 53(1), 62 and 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (?), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) Directive 2001/37/EC of the European Parliament and of the Council (* lays down rules at Union level concerning tobacco products. In order to reflect scientific, market and international developments, substantial changes to that Directive would be needed and it should therefore be repealed and replaced by a new Directive. (2)  In its reports of 2005 and 2007 on the application of Directive 2001/37/EC the Commission identified areas in which further action was considered useful for the smooth functioning of the internal market. In 2008 and 2010 the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) provided scientific advice to the Commission on smokeless tobacco products and tobacco additives. In 2010 a broad stakeholder consultation took place, which was followed by targeted stakeholder consultations and accompanied by studies by external consultants. Member States were consulted throughout the process. The European Parliament and the Council repeatedly called on the Commission to review and update Directive 2001/37/EC. (3)  In certain areas covered by Directive 2001/37/EC, Member States are legally or in practice prevented from effec- tively adapting their legislation to new developments. This is in particular relevant for the labelling rules, where Member States have not been permitted to increase the size of the health warnings, change their location on an individual packet (‘unit packet’) or replace misleading warnings on the tar, nicotine and carbon monoxide (TNCO) emission levels. () OJ C 327, 12.11.2013, p. 65. (3 OJ C 280, 27.9.2013, p. 57. (®) Position of the European Parliament of 26 February 2014 (not yet published in the Official Journal) and decision of the Council of 14 March 2014. (*) Directive 2001/37/EC of the European Parliament and of the Council of 5 June 2001 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products (O] L 194, 18.7.2001, p. 26).