18 December 2013 – The Tobacco Products Directive (2001/37/EC ) regulates the manufacture, presentation and sale of tobacco products in the EU 28 Member States. The future EU legislation of nicotine containing products (NCPs) including e-cigarettes is part of the ongoing discussion on the revision of the TPD . EPHA explains the basics of the ordinary legislative procedure, gives an overview about the TPD revision process and addresses some questions as regards e-cigarettes.
- Ordinary legislative procedure or co-decision?
The European decision making process is extremely complicated and often it takes several years before a legislative proposal becomes European law. The EU decision making procedure comes about as a result of decisions taken by the institutional triangle, made up of
- the Council (representing national governments),
- the European Parliament (representing the people) and
- the European Commission (a body independent of EU governments that upholds the collective European interest).
The EU’s standard decision-making procedure was known as co-decision. However, after the entry into force of the Lisbon Treaty on 1 December 2009, the Treaty on the Functioning of the European Union (TFEU) has become one of the principle legal sources of the primary law of the EU and it uses the term ‘ordinary legislative procedure’ (since it become the most common procedure for the majority of EU legislations). However, it is not incorrect to use the term ‘co-decision’ to describe the procedure in the common language.
An overview of the procedure is available as follows:
- Explanatory note on the ordinary legislative procedure / co-decision
- VIDEO How does the ordinary legislative procedure work?
- The Tobacco Products Directive (TPD) case study
Europe pays a hefty price for its slow action on tobacco, both in economic costs and harm to its citizens’ health and wellbeing. Tobacco is a major risk factor of cancer, (1) cardio-vascular disease (2) and other chronic diseases such as the Chronic Obstructive Pulmonary Disease (COPD) (3)
The Tobacco Products Directive (2001/37/EC ) regulates the manufacture, presentation and sale of tobacco products in the EU 28 Member States. This covers the use of health warnings on packs, the prohibition of descriptions such as ‘mild’ or ‘light’, the maximum tar, nicotine and carbon monoxide yields, and the prohibition of the sale of tobacco for oral use.
In February 2012, the Commission proposal was ready to go to impact assessment which has been finished in August 2012. The inter-service consultation started immediately, but additional review by the legal services through an explicit demand from the Commission Secretary General blocked the process. The resignation of Commissioner Dalli on 16th of October 2012 postponed the progress of the Directive even further.
During his hearing by the European Parliament, the Commissioner candidate, Tonio Borg, committed to prioritise the dossier once appointed. Officially nominated on 28th of November 2012, Commissioner Borg launched the inter-service consultation as soon as he was in post and promised to have the Commission proposal by the end of 2012. On 19th of December 2012, the European Commission proposal was released.
Ordinary Legislative Provedure and the TPD
The TPD is subject to ordinary legislative procedure which is still in the first reading procedure, as follows:
- The Commission submitted its proposal for the TPD to both the Council and the European Parliament on 20 December 2012
- The Council adopted its General Approach on 21 June 2013.
- The European Parliament, adopted by 560 votes to 92, with 32 abstentions, amendments to the proposal on its plenary session on 8 October 2013 and referred the file back to the main responsible ENVI committee which entered into negotiations with the Council in order to reach an agreement in the first reading.
Trilogue negotiations on the TPD
In order for the two co-legislators to come to an agreement, the so-called trilogue negotitations commenced in October 2013 between the Council, the European Parliament and the Commission. Four rounds of negotiations were held on (23 October, 12 November, 2 December and 16 December).
During the final trilogue meeting on 16 December, the negotiating parties came to a preliminary agreement which needed the approval of the Member States. On 18 December 2013, Members States approved this compromise during the meeting of the Permanent Representatives of Member States (COREPER) during the first reading procedure and it will not reach second reading. In practice, the TPD now remains to be approved by the European Parliament during plenary vote in order to come into effect. This is due to occur once translation of the text is completed and expected in March or April 2014.
– Further information about technical details
- Overview on the revision of the TPD
- European Legislative Observatory summarizing some key legislative steps
- VIDEO – How it works? Trilogue
- Questions & Answers about e-cigarettes
Nicotine Containing Products (NCPs) or electronic cigarettes?
Nicotine containing products (NCP) is the wider category, it contains different products (ex. patches, gum etc.) containing nicotine, including e-cigarettes. The e-cigarette is the narrower category which is (according to the latest proposal: ‘a product, or any components thereof including cartridges and the device without cartridge, that can be used for consumption of nicotine containing vapour via a mouth piece’)
Are e-cigarettes tobacco products?
We have to make a clear distinction between the logical and the legal way of assessment. Under the current EU legal framework, e-cigarettes are not considered as tobacco products since they do not contain pure tobacco as conventional cigarettes do. The assumption that nicotine as a substance was derived from tobacco does not mean automatically that e-cigarettes can be regarded as tobacco products.
However, the legal definition can be different. Regulating e-cigarettes similarly to tobacco products is just a method of codification. If the co-legislators find it appropriate, they can include e-cigarettes under the Tobacco Products Directive (TPD). In that case, e-cigarettes are treated as tobacco products and the specific legal rules laid down in the TPD apply to them.
Are the current e-cigarette EU market harmonised?
No. The legal fact that the General Product Safety Directive (GPSD) is applicable to them (among other EU rules) does not mean that there is an EU wide regulatory harmonisation of e-cigarettes. The situation is the opposite: since the GPSD is a complementary legal act, Member States are allowed to adopt more specific rules. That is why there are divergent regulations in different member states and some of them regulate e-cigarettes as human medicines (see the Annexes of the EPHA Briefing – Regulation of Nicotine Containing Products (NCPs) including electronic cigarettes)
What is the relevance of different national court decisions about single e-cigarette products?
There are several national legal cases where the national courts confirmed that a single e-cigarette product cannot be considered, as a human medicines (ex. in Germany or in Estonia). However, due to lack of EU level harmonisation, national courts can come to a different condusion, as well: a French court recently ruled that electronic cigarettes qualify as tobacco products and as such can only be sold by licensed tobacconists under French law, threatening to put specialist e-cigarette sellers across the country out of business.
What are the implications of such decisions?
As a result of lack of European harmonisation, national courts interpret the existing national law on e-cigarettes and the legal interpretation of national courts have limited legal impacts: the selected decisions only affect the specific product which is subject to the given procedure. Moreover, most European states follow the Roman law based legal system which means that case law does not settle the internal legal system and courts interpret legislation made by the national legislators.
An example of a court decision in the Netherlands
The Dutch court considered that a given e-cigarette product could not be classified as medicines in the Netherlands. The Dutch national authorities classified the e-cigarette subject to the legal proceeding as pharmaceutical products but the court overruled this decision. The judgment explains that the examined e-cigarettes cannot be considered as medicines either by presentation or by function. It says that the pharmaceutical effects on human beings are not strong enough since other products such as wine, coffee, conventional cigarette have similar effects. The court added that the examined e-cigarettes were not dangerous enough so they could not be classified based on public health arguments. The Court finished to say that such a regulation could be an obstacle for the internal market.
However, it is important to note that this decision concerns only the examined product in the Netherlands which was subject to the legal proceeding. The court stated that there is no unified European position on e-cigarettes which would have changed the outcome of the decision.
– See the list of similar cases on the ECITA website
Flavours of e-cigarettes
Some flavours are necessary to make e-cigarettes palatable. However there are concerns amongst the public health community regarding the appealing impact of flavours for children / young people.
What is an e-cigarette? Does one size fit all?
There are different types of e-cigarettes. The presentation of Dr Lynne Dawkins from the e-cigarette summit describes e-cigarettes and the different types and goes into how effective they are.
- Disposables (cigalikes)
- Rechargeables – with sealed units often similar to disposables or variants on the same product e.g. Vuse make a disposable and for smokers who carry on using longer-term a rechargeable which looks almost identical.
- Third generation cartomisers which are modular enabling the smoker to adapt them to their own needs as the refill is not sealed but can be adapted and which do not look at all like cigarettes.
Must-read documents, should you have further questions:
– EPHA Guide – The EU and Health This guide is designed to equip the reader with two strong skills – the ability to understand the role of the EU in shaping public health across the continent; and the capacity to identify the various areas in which Brussels works to advance everyone’s well-being.
– EPHA Briefing – Regulation of Nicotine Containing Products (NCPs) including electronic cigarettes – The future legislation of nicotine containing products (NCPs) including e-cigarettes is part of the ongoing discussion on the revision of Tobacco Products Directive (TPD). In light of the available regulatory options EPHA has identified and presented in a briefing document, EPHA recommends principles of future EU wide NCP legislation, public health requirements of NCPs, and policy recommendations for regulating NCPs.
(1) After circulatory diseases, cancer was the second most common cause of death in 2006, accounting for two out of ten deaths in women and three out of ten deaths in men, equating to approximately 3.2 million EU citizens diagnosed with cancer each year.
(2) Each year cardiovascular disease (CVD) causes over 4 million deaths in Europe and over 1.9 million deaths in the European Union (EU). CVD causes 47% of all deaths in Europe and 40% in the EU.
(3) The primary cause of COPD is tobacco smoke (through tobacco use or second-hand smoke). In Europe 4-10% of adults have COPD. The total COPD related expenses for outpatient care (= not in hospital) in the EU is approximately € 4,7 billion per year Inpatient care (=in hospital) generates costs of €2,9 billion followed by expenses in pharmaceutical of 2,7 billion per year
[EPHA Briefing] Regulation of Nicotine Containing Products (NCPs) including electronic cigarettes
EPHA Calls for Strong Tobacco Products Directive (TPD) without further delay
[EPHA position paper] Revision of the Tobacco Products Directive
