Today, the 20th of May 2016, the new Tobacco Products Directive enters into force. European Union Member States finally have clear guidance and requirements requirements on electronic cigarettes, traceability, the use of additives in tobacco products and standardised packaging.
Some countries such as Ireland, the UK and France have gone far beyond the minimum stipulation in the new Directive and have opted for plain packaging measures, others such as Hungary, Belgium and Slovenia have announced that they are following suit.
With the new Directive we will see an improvement in tobacco control through greater information on health effects, larger graphic warnings with clearer messages, as well as a specific ban on almost all flavouring: tobacco will taste of tobacco and not strawberry, chocolate or vanilla. Electronic cigarettes are now regulated in the same way tobacco products are, improving their reliability and avoiding their unrestrained promotion, while new tr
aceability provisions will allow to effectively
I sincerely believe that this will be a day to remember. Public Health benefits have prevailed over the tobacco industry’s economic interests. The measures provided in the Tobacco Products Directive are proven to reduce and they will further reduce the smoking prevalence in Europe, especially among our youth.
On behalf of ENSP, I would like to congratulate and thank the Commission, the Parliament and all European governments, but above all, the citizens of the European Union. This historic moment will have a large impact on health, culture and the lives of millions of people for the years to come.
Congratulations Europe on celebrating a Public Health victory!
ENSP welcomes the transposition of the EU Tobacco Products Directive to national law on 20 May 2016. On May 19 the Directive has been completely transposed in Germany, Italy, Malta, Portugal and Slovenia while Belgium, Estonia, Lithuania and the United Kingdom have partly adopted the Directive. The main provisions of the Directive concern:
Restriction of additives
The Directive bans the use of additives that give a characterising flavour (like strawberry, chocolate or vanilla) other than tobacco. Menthol is considered such a characterising flavour and will be banned as of 20th May 2020.
This prolongation is grounded in the Directive’s phase-out period of four years foreseen for all products with more than a 3% market share in the EU.
The ban on characterising flavours applies to cigarettes and roll-your-own tobacco, while other tobacco products are exempt from the provision. Additives that are necessary for the manufacturing of tobacco products are not included in the provision.
The Directive lays down a series of reporting obligations on ingredients and emissions of tobacco products (Article 5). It obliges the Commission to develop a priority list of additives used in tobacco products and the independent Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has identified 48 single chemicals to be placed on the list. These additives should be subject to further reporting obligations (Article 6).
While Member States still will be able to decide on certain aspects related to e-cigarettes, e.g. the regulation of flavours and advertising without cross-border effects, the TPD introduces a number of provisions applicable to consumer e-cigarettes placed on the EU market.
These concern a maximum nicotine concentration level for e-cigarettes (20 mg/ml) and maximum volumes for cartridges, tanks and containers of nicotine liquids. Containers should be childproof and only ingredients of high purity may be used in the nicotine-containing liquid. Furthermore, e-cigarettes will be required to deliver consistent levels of nicotine. E-cigarette packages must carry health warnings, instructions for use, information on addictiveness and toxicity and lists of all substances contained in the product.
The TPD aims to ensure that only products complying with the Directive are sold in the EU. Traceability of tobacco products will be ensured through an EU-wide tracking and tracing system for the legal supply chain as well as by the means of physical features facilitating the detection of illicit products. The tracking and tracing provisions apply to cigarettes and roll-your-own tobacco (Article 15).
New packaging of tobacco products
According to the provisions in the TPD, tobacco product packages should feature health warnings in picture and text covering 65% of the front and the back of cigarette packs. 50% of the sides of packs must be covered with health warnings to be placed on the top edge of the package. These obligations replace the current textual warning of tar, nicotine and carbon monoxide (TNCO) levels.
The slim cigarette packs are no longer allowed and cigarette packs must have a cuboid shape, with each pack containing a minimum of 20 cigarettes. The packs must contain no promotional or misleading elements such as reference to taste or lifestyle benefits. Roll-your-own tobacco packs equally have to carry 65% combined health warnings on the front and the back in addition to the textual warnings.
EU Members States may go beyond the minimum stipulations in the new Directive. Britain, France and Ireland have decided to adopt plain packaging for tobacco products, while Hungary and Slovenia plan to adopt the measure.
Directive 2014/40/EU of 3 April 20104
Revision of the Tobacco Products Directive
SCENIHR final Opinion on Additives used in tobacco products