Tobacco Products Directive

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 was transposed into national legislation by the European Union (Manufacture, Presentation and Sale of Related Products) Regulations 2016 which came into effect on 20th May 2016 (S.I. 271/2016).

The aim of the Directive is to harmonise laws on tobacco and related products, to facilitate the smooth functioning of the internal market and to meet EU obligations under the WHO Framework Convention for Tobacco Control.

The Regulations provide for more stringent rules for tobacco and related products and, from a public health perspective, focuses on limiting their appeal, in particular to young people.  They include measures for labelling, ingredients, tracking and tracing, cross border distance sales and the regulation of electronic cigarettes, refill containers, herbal products for smoking and novel tobacco products.

The European Union (Manufacture, Presentation and Sale of Related Products)(Amendment) Regulations 2017 (S.I. No. 252 of 2017) amend the European Union (Manufacture, Presentation and Sale of Related Products) Regulations 2016 and give effect to three European Commission Implementing Acts related to the Directive.  The three Implementing Acts set down:

  • Uniform rules as regards the procedures for determining whether a tobacco product has a characterising flavour;
  • The procedure for the establishment and operation of an independent advisory panel assisting Member States and the Commission in determining whether tobacco products have a characterising flavour;
  • A priority list of additives contained in cigarettes and roll-your-own subject to enhanced reporting obligations

Certain sections of the Public Health (Standardised Packaging of Tobacco) Act 2015 also give effect in part to the Directive. Those sections came into force on 20 May 2016, as required by the Directive.

The HSE is the designated competent authority for the functions within the Regulations and are responsible for its enforcement. The Department and the HSE continue to work together on the implementation and enforcement of the Regulations.  The transitional period provided for in the Regulations ended on 20 May 2017 and since that date all tobacco products, e-cigarettes and herbal products must be in compliance with them.

TPD Track and Trace Provisions (Illicit Trade)

Articles 15 and 16 of the Tobacco Products Directive establish an EU-wide tracking and tracing and security feature system for all unit packets of tobacco products manufactured in or imported into the Union. The aim of this system, according to the EU Commission is to fight illicit trade in tobacco products, which undermines the free circulation of compliant products and the overall protection provided by tobacco control legislation.

Although the central requirements have been laid down in the Directive, Articles 15(11), 15(12) and 16(2) require the EU Commission to adopt secondary legislation (Commission Implementing Acts) to determine the technical details and key elements of the system, as well as to ensure aspects such as the system’s interoperability. These Implementing Acts were adopted by the Commission in December 2017 and must be transposed into Irish law. A Government decision of July 2018 designated the Office of the Revenue Commissioners as the competent authority for the purposes of implementing the EU-wide tobacco traceability and security feature systems and as the national administrator for the EU-wide traceability system

The above requirements shall apply to cigarettes and roll-your-own tobacco from 20 May 2019 and to tobacco products other than cigarettes and roll-your-own tobacco from 20 May 2024.