Cigarette packages labelled with images that can dissuade humans from smoking habit, which were distributed last summer, come as a result of a new European legislation on the manufacture, marketing and sale of tobacco and related products, namely the Directive 2014/40/EC. More specifically:
- Which products fall within the scope of the new Directive?
The new rules cover not only cigarettes, but also pipe tobacco, roll-your-own tobacco, water pipe tobacco, electronic cigarettes, as well as herbal products for smoking.
- What is the time schedule for the application of the Directive in the EU and Greece?
The Directive entered into force on 20 May, 2016, repealing previous Directive 2001/37/EC. Since Directives do not have immediate effect and each Member State must adopt national laws in order to implement them, the deadline for the Directive’s inclusion into the national legal regimes expired on the same date. It should be noted that the Directive foresees a transitional period. More specifically, tobacco products which have been produced or released and labelled before 20 May 2016 may be legally distributed until 20 May 2017.
- What was the objective of the European Legislator?
The European Legislator aims to remove the existing obstacles to the smooth functioning of the internal market of tobacco and related products and provide for a high-level health protection, especially for young people. According to the Directive, differences between national laws concerning terminology, labelling requirements, ingredients and emissions of the tobacco products had a negative effect on the free circulation of these products in the internal market. When drafting the new rules, the legislator took into account the fact that “tobacco products are ordinary commodities and in view of the particularly harmful effects of tobacco on human health, health protection should be given high importance, in particular, to reduce smoking prevalence among young people.”
- Which are the main provisions of the Directive?
- Clear & explicit definitions: The Directive introduces common definitions in order to make possible a uniform interpretation and application of the adopted rules in all EU countries.
- Adoption of maximum limits of specific substances: It encourages the establishment of reduced maximum emissions levels of tar, nicotine and carbon monoxide as well as of maximum limits for other hazardous substances as well as the verification provided by independent laboratories.
- Reporting obligations for ingredients and emissions: In order for Member States to perform their regulatory tasks, the Directive requires more information to be reported to the competent authorities (ingredients, emissions, additives etc according to art. 5,6,7) and promotes the application of a common mandatory reporting format. In this way, the legislator aims to facilitate the supervision by Member States and the Commission. However, Member States remain competent for approving or rejecting certain tobacco products, provided that these products comply with the provisions of the Directive.
- Products with a characterizing flavor and additives: Furthermore, it prohibits tobacco products with a characterizing flavor as well as the use of additives which create the impression that they are beneficial for humans (e.g by increasing mental alertness and physical performance).
- Tobacco products labelling/Combined warnings: The legislator revised the legal framework regarding the labelling of tobacco products with the aim of achieving a common level of consumers’ awareness. Taking the new scientific evidence as well as the FCTC (WHO Framework Convention on Tobacco Control) guidelines into account, the Legislator states as mandatory the use of combined warnings, including text warning and a corresponding color photograph, with fixed dimensions. Additionally, the same labelling requirements must apply to the water pipe tobacco, in order to make clear that the latter is not less dangerous than ordinary cigarettes. Last but not least, he prohibits the reference of words that may mislead consumers that some products are less harmful (such as “light”, “organic product” and the promotion of tobacco products with discount offers.
- Measures to eliminate illicit trade of tobacco products: The European legislator attempts to monitor and combat the illicit tobacco products, which undermine the free circulation of compliant products, and, consequently, put public health at risk. The FCTC has already set the fight against the illicit trade of tobacco products as a goal. For this reason, the legislator foresees the adoption of a unique identifier and security features as well as the development of an interoperable tracking and tracing system. Data collected through this system shall be stored by a third independent party, under a contract with the manufacturer. This party shall be approved by the European Commission and supervised by an independent external auditor.
- Cross-border electronic sales: The Legislator permits Member States to prohibit the cross-border electronic sales of tobacco products. In Member States, where the above prohibition is not foreseen, retail outlets engaging in cross-border distance sales of tobacco products will have to register with the competent authorities in the Member State, where the retail outlet is established, and in the Member State, where the actual or potential consumers are located. Furthermore, in this case, the outlets shall put into force an age verification system.
- What has the Greek State done in order to implement the Directive?
The deadline for adopting the Directive rules expired on 20 May 2016, but Greece did not at that time vote for the application law. Today, only the provisions regarding the elimination of illicit trade as well as distance sales of tobacco products have been implemented in the Greek legal regime, via Law No 4410/2016 published on 3 August 2016. This law concerns firstly the adoption of a Uniform Central Registry of Tobacco and Industrial Tobacco Supply Chain, the labelling of the products with a unique identifier and security features-with the aim to ensure traceability- as well as the storage of data regarding the supply chain by a third independent party. Furthermore, because of high risk to public health resulting from illicit trade, the national law foresees the establishment of a Coordination Operational Center. Secondly, the Law prohibits all cross border distance sales of tobacco products. As far as the rest Directive provisions are concerned, on Thursday, September 8th, the Greek Parliament voted for the draft legislation which, however, has not yet been published in the Government Gazette.
- Has the Directive caused any disputes? Are there Court Decisions on this issue?
Tobacco manufacturing and trade companies have brought cases before the Court of the European Justice in order to question the validity of the Directive, with the view to hindering its application. The ECJ, in response to a preliminary ruling by the British Courts (C-547/14), ruled that there is no reason for affecting the validity of the Directive provisions questioned by the Companies. In detail, the Court clarified that Member States are permitted to maintain or introduce further requirements in relation to aspects of the packaging of tobacco products which are not harmonized by this Directive. Furthermore, references of any information on the labelling of unit packets and on the outside packaging, as well as on the tobacco product itself, are prohibited even if the information concerned is factually accurate, on the grounds that it has been proved that these references are misleading in that they lead consumers to believe that certain cigarettes are less harmful than others. In the Court’s view, since tobacco consumers constitute a vulnerable group of consumers due to their addiction to nicotine, they should not be given any incentive to consume these products.
Our law firm’s comment:
By thoroughly reading the new legislation as well as the Court Decisions issued thereon, we conclude that all ΕU bodies aim at balancing the smooth market function with achieving high-level protection of public health. Following the goals set by the World Health Organization, the European Legislator moves a step forward. In recognizing the health risks of smoking for every individual citizen, active or passive smoker, as well as the negative effects on European population, as a whole, the new Law implements stricter harmonized rules in order to limit related to smoking diseases and the subsequent burden on national and global health care systems and structures.