Draft act amending the Tobacco Act
Communication from the Commission - TRIS/(2016) 03765
Directive (EU) 2015/1535
Translation of the message 001
No abre el plazo - Nezahajuje odklady - Fristerne indledes ikke - Kein Fristbeginn - Viivituste perioodi ei avata - Καμμία έναρξη προθεσμίας - Does not open the delays - N'ouvre pas de délais - Non fa decorrere la mora - Neietekmē atlikšanu - Atidėjimai nepradedami - Nem nyitja meg a késéseket - Ma’ jiftaħx il-perijodi ta’ dawmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Neotvorí oneskorenia - Ne uvaja zamud - Määräaika ei ala tästä - Inleder ingen frist - Не се предвижда период на прекъсване - Nu deschide perioadele de stagnare - Nu deschide perioadele de stagnare.
1. Structured Information Line
MSG 002 IND 2016 0648 EE EN 13-12-2016 EE NOTIF
2. Member State
3. Department Responsible
Majandus- ja Kommunikatsiooniministeerium, siseturuosakond, siseturu toimimise talitus.
Harju 11, 15072 Tallinn.
tel: 00 372 6256 405 – faks: 00 372 6313 029
3. Originating Department
Sotsiaalministeerium, rahvatervise osakond.
Gonsiori 29, 15027 Tallinn
tel: 00 372 6269152; faks: 00 372 6992209
4. Notification Number
2016/0648/EE - X00M
Draft act amending the Tobacco Act
6. Products Concerned
7. Notification Under Another Act
8. Main Content
The draft act extends the area of regulation of the act by providing exceptions from requirements, similar to those applying to tobacco products, tobacco-related products or their packaging which a traveller brings in luggage or which are sent from a foreign country to a natural person for non-commercial use. The draft act adds composition and purity requirements for the nicotine-free liquid of electronic cigarettes to the Tobacco Act, and prohibits flavours other than the tobacco flavour in e-cigarettes. The draft act establishes a prohibition on domestic distance selling of tobacco products and tobacco-related products. Provisions on sales promotion in the effective Tobacco Act are also extended to tobacco-related products as well as the prohibition on selling a tobacco-related product in sales packaging which contains another product. In addition, prohibition is established on displaying tobacco products and tobacco-related products and their brands in retail outlets. An exception is made for specialised retail outlets, vessels of international lines and shops located in closed territories of airports and ports. Unless the person is clearly an adult or known to the seller, the seller must request a document from a buyer when purchasing a tobacco product or a tobacco-related product. The draft act gives the Tax and Customs Office the right to perform test purchases to identify the sale of illegal tobacco products. A similar right is also given to police officers to identify sales of tobacco products or tobacco-related products to minors, together with the right to involve persons at the minimum age of 16 years in the performance of test purchases. The draft act extends the current prohibitions and restrictions applicable only to smoking also to the consumption of an electronic cigarette. Under the draft act, the obligation to submit a notice of economic activities also applies to undertakings engaged in the sale of tobacco-related products. The draft act also extends the provisions on liability, proceeding from the extended requirements for tobacco products, to electronic cigarettes and other tobacco-related products. In addition, certain references (related to legislative drafting) to the implementing acts of Directive 2014/40/EU that have entered into force, are added to the draft act, and, for legal clarity purposes, the date for rotating the combined health warnings is specified. In 2017 this date is 20 May and will be 1 January from 2018.
9. Brief Statement of Grounds
The main purposes of the draft act are to protect human health, particularly the health of minors, including preventing initiation of consumption of tobacco products and alternative products, make these products less attractive, reduce passive smoking or passive consumption of e-cigarettes, and make tobacco products and their alternative products less accessible to minors. The purpose of the draft act is also to reduce and prevent addiction to tobacco products and their alternative products, as well as reduce and prevent related health damage and health risks in Estonian society.
Estonia has set itself the goal of treating tobacco products and their alternative products (e.g. electronic cigarettes) in the same manner as products used for similar purposes. Therefore, with the draft act, the intention is prohibit the use of flavourings in electronic cigarettes with or without nicotine from 1 January 2019. As an exception, it is permitted to use the tobacco flavour in e-liquids. In our opinion, flavoured e-liquids target children and young people in particular, and are an appealing way of getting them to start smoking. They do not help stop smoking, but rather favour the use of both products at the same time, and constitute a risk of intoxication above all for young children. According to the Health Board, which is the competent authority on reporting on tobacco products and e-cigarettes, notices of 7 335 different e-liquids marketed in Estonia had been submitted as of 6 December 2016. While in 2012, 10% of the Estonian adult population had used e-cigarettes, the proportion had increased to 15% by 2014. Among schoolchildren, already 35.7% of boys and 25.4% of girls had tried e-cigarettes in 2014. We find it absolutely necessary to prohibit flavours in order to reduce the initiation of consumption of this product among minors and reduce its general consumption among the population. In order to make tobacco products and other related products less attractive, the draft act provides for the prohibition on their display and presentation of their brands and additional restrictions on their sales promotion. In addition, the composition and purity requirements, provided for in Directive 2014/40/EU for e-cigarettes with nicotine content, are also extended to e-liquids without nicotine content. Besides, domestic distant sales of tobacco products and related products are prohibited in addition to cross-border sales, thereby reducing the risk of accessibility of these products to minors.
10. Reference Documents - Basic Texts
Reference(s) to basic text(s): Directive 2014/40/EU
The basic texts were forwarded with an earlier notification: 2014/253/EE
11. Invocation of the Emergency Procedure
12. Grounds for the Emergency
14. Fiscal measures
15. Impact assessment
Reducing the spread of consumption, attractiveness and accessibility of tobacco products and related products will reduce early mortality and morbidity caused by preventable chronic diseases related to the consumption of tobacco or alternative products, and reduce direct and indirect health care costs, as well as improve the quality of life of the population and therefore the national economic wealth.
16. TBT and SPS aspects
No - the draft is neither a sanitary nor a phytosanitary measure.
Contact point Directive (EU) 2015/1535
Fax: +32 229 98043
The TRIS website makes it easy for you or your organization to share your views on any given notification.
Due to the end of standstill we are currently not accepting any further contributions for this notification via the website.
New Nicotine Alliance (UK) is a charity which aims to improve public health by educating about and advocating for the use of reduced risk products (such as e-cigarettes) as a substitute for smoking.
We are concerned about this draft act because the grounds for it do not accord with current scientific thinking and we are worried about the consequences of the proposed prohibitions on flavours and domestic distance sales. The proposed restrictions on flavours will make e-cigarettes less appealing and the prohibition on postal sales will restrict their availability. This is not solely an EU trade issue, as it also has significant issues for health and health protection
The consumers we represent rely on the specialist knowledge offered by independent vape retailers and we are increasingly seeing these businesses closing as a result of the restrictions imposed by EU member states. We are concerned that in Estonia itself specialist vape outlets are only established in larger cities and a few towns so the banning of postal sales will restrict access to e-cigarettes to a significant proportion of consumers in Estonia.
Flavours are an important feature of e-cigarette use: flavours help people distance themselves from the taste of smoked tobacco and help them to continue with e-cigarettes and avoid a return to smoking. The ban on flavours will affect trade between Estonian retailers and manufacturers elsewhere in the EU. The ban far exceeds the stated aim of the TPD, which recommends that legislation introduced by member states should reflect the relative risk of e-cigarettes.
There is no justification for treating e-cigarettes and combustible cigarettes equally, as this amendment proposes to do. Public Health England produced an evidence review in 2015 which assessed the risk to health from using e-cigarettes to be at least 95% less than from smoking combustible cigarettes. A large body of evidence is amassing which shows that a significant proportion of smokers are quitting smoking using e-cigarettes, that there is only a very negligible take up amongst non-smoking youth, and that flavours are crucial to the effectiveness of e-cigarettes for most users. The grounds for this draft act are not evidence based but are (as is stated in the grounds itself) merely based on opinion. This amendment could have devastating consequences on health. ASH England recently released a report which states that the misinformation about the safety and risks of e-cigarettes is seriously affecting the take up rate by smokers, i.e. people are deterred from using e-cigarettes to quit smoking because they falsely believe that e-cigarettes are as harmful to health as combusted tobacco. This amendment will reinforce this misconception. Consumers will be forced to continue, or return to, smoking.
This act will create a precedent for other EU members who may wish to impose similar restrictions and the justifications are likely to be publicised by the media, which will have negative effects across the EU. It’s therefore likely that the amendment will undermine the TPD across the EU, not just in Estonia.
A key justification for the EU TPD was to “Ensure the smooth functioning of the internal market and also achieve a high level of health protection.” These amendments fail on both.
The EUC has a moral and legal obligation to challenge the introduction of any prohibitions and restrictions imposed by member states which are not supported by evidence and current science, or grounds for derogation. Not to do so is an abrogation of their responsibility to ensure citizens of the EU have reasonable access to products which offer significant risk reductions compared to combustible cigarettes.
 Public Health England: E-cigarettes an evidence update https://www.gov.uk/government/publications/e-cigarettes-an-evidence-update
 ASH, Use of electronic cigarettes (vapourisers) among adults in Great Britain http://ash.org.uk/information-and-resources/fact-sheets/use-of-electronic-cigarettes-vapourisers-among-adults-in-great-britain/
The General Director
Milan, March 14th, 2017
RE: Government of Estonia Tobacco law revision – retail display ban for the Tobacco products
We are the leading association of the industry in Italy, representing more than 140 companies, producing the 2.5% of the National GDP. Our role is the protection of the Intellectual Property Rights (IPRs) and for this reason we are a privileged observatory for all the infringements and the illicit trade of goods. We have developed in 30 years of presence on the market, both at national and international level, a deep knowledge in all the aspects directly and indirectly able to feed the rise of illicit trade.
Our core competency, the protection of the IPRs, is centered on what is representing the 42% of the EU GDP and the 28% of total workforce.
For this reason, we seriously consider every act potentially or directly influencing the IPRs.
IPRs are for the above mentioned reasons the key element in the EU economy. As well we consider the role the IPRs are playing for consumers. The brand is playing the role of the main element of trust directly influencing the customer’s choices. We don’t have to underestimate this point, as we need to evaluate the key role in the citizens choices as a priority for everyone.
In our action of defense of IPRs, we watch over all the regulations, both at national and at the EU level, affecting the IPRs.
We are now in this letter concentrating our attention to the Government of Estonia decision to reform the Tobacco law, introducing among the other measures the Retail Display Ban for Tobacco products. The measure is now, according to the EU Dir. 1535/2015, under the exam of the EU Commission.
The retail display ban is mainly a limitation of the IPRs, seriously affecting the right for consumers to be informed. Considering that consumers base their decision on the information available the ban of displaying information is de facto generating a definitive negative impact on the possibility of free choices.
On top of this, we consider that a similar measure introduced in one country, would affect also the legal market, representing a potential threat to the supply chain, to retailers, to the government itself (more illicit trade is representing less fiscal income) and moreover to the consumers.
Limiting on such this way the role of trademark and generally of the IPRs, is also contrary to international regulations and is potentially generating more risks for the consumers.
The introduction of the measure of the retail display ban for the Tobacco products would also generate consequences that are more dramatic. Depriving the brand on such this way of its power, it is also rising the possibility to lower the measure contrasting the introduction in the market of illicit products, mainly tobacco smuggled products as well as counterfeited ones,. With all the risks related to the health as well as on the advantage for the criminal organization to see their illicit business increasing.
We are seriously concerned by this possibility. As the “illicit whites” market demonstrates, the tobacco smuggling is facilitated by the possibility of reducing the role of trademarks for example reducing the possibility of immediate recognition. As well the impact on the free trade in the EU is something that has to be considered, also in this case representing in the Estonian law revision a violation to the TFEU.
Of course as citizens we are taking care of the human health and we welcome every measure able to improve the quality of life, but we need to highlight that in the specific case of Estonia, no one data and information are supporting the decision. This step must be mandatory before any intervention on regulations potentially impacting the safety of the channel and the fair competition as well as, not less important, the consumer’s right to be informed and to make a free choice based on the information available.
There is another aspect to take into consideration: the EU Dir 2014/40/ aims to guarantee “uniform conditions for implementation of this Directive” (considering n. 50) and to “avoiding disparities are liable to constitute a barrier to trade and to impede the smooth functioning of the internal market in tobacco products” (considering n.23) With the approval of the new tobacco Law Estonia will potentially have a unique market condition, different from those of the other Member States, a uniqueness that the Tobacco Directive wants to avoid and repeal.
We hope that the Government of Estonia will reconsider the decision to introduce this measure, as well as we strongly suggest the Commission to focus the attention on the role of the IPRs in all the industrial sectors and to all the potential risks to intervene with limited and partial considerations as Estonia would do.
We remain at your full disposal for any further discussion on this topic.
 The EUIPO/EPO report: “Intellectual property rights intensive industries and economic performance in the European Union” – October 2016
Si prenda cortese visione dell'allegato documento.
Please take notice of the attached comment.
I am writing you on behalf of Vape Business Ireland (VBI), a business alliance committed to an open debate about vaping products in Ireland. VBI’s membership spans the vaping product supply chain from manufacture to sale and we believe vaping products must be regulated in a responsible manner while upholding the principles of consumer choice for adults, particularly for adult smokers who wish to find an alternative to tobacco products. It has come to our attention that the Estonian Government has notified to the European Commission a draft Act which bans the use of flavourings in e-cigarettes, except for tobacco flavour. This draft Act has been notified under the TRIS procedure (2016/648/EE) and interested parties have until 14 March to submit comments on potential breaches of the EU internal market by the provisions of the Act.
We note that the Tobacco Products Directive 2014/40/EU (TPDII) expressly regulates electronic cigarettes differently from traditional cigarettes whereby it bans the use of characterising flavours in cigarettes and RYO tobacco products, but does not ban the use of flavours in e-cigarettes and even goes as far (recital 47) to state that ‘[i]t could be useful for Member States to consider allowing the placing on the market of flavoured products’. Art. 20(4)(b)(ii) explicitly mentions that electronic cigarette packaging, unlike tobacco products, can include information on the nicotine content and flavourings, which means that unlike tobacco products, flavourings are deemed to be a key information for consumers and their use in e-cigarettes is allowed as they can be indicated on the pack (although with some limitations).
Having said that, the key concern of VBI in this case is that, if adopted, the Estonian Act will deprive Irish companies who produce e-liquids for use in vaping products of the possibility to sell their products to Estonia.
As such, we would be grateful if the Irish Government could consider submitting a detailed opinion to the European Commission – under the TRIS procedure – which highlights that the draft Estonian Act, if adopted, will constitute an obstacle to the free movement of goods within the EU internal market because:
A. It violates the free movement requirements of Article 24 of the Tobacco Products Directive 2014/40/EU. E-cigarettes are products covered by TPDII. Article 24(1) provides that Member States cannot prohibit or restrict the placing on the market of products covered by TPDII that comply with its requirements. TPD2 does not require that flavours aside from tobacco flavour are banned in e-cigarettes - therefore e-cigarettes that are compliant with TPDII requirements and that contain flavours others than a tobacco flavour should not be prohibited or restricted by Estonia.
It appears that the Estonian Government are justifying the ban on the basis of Article 24(3) which provides an exemption to the free movement rule of 24(1). For the avoidance of doubt, pursuant to the EU Court of Justice ruling Case C-547/14, Philip Morris and BAT, a Member State may invoke Article 24(3) to ban the entire category of electronic cigarettes, but a Member State that allows electronic cigarettes (as is the case in Estonia) cannot ban specific types of e-cigarettes that are compatible with TPDII, such as e-cigarettes containing flavours other than tobacco flavour.
B. It violates Article 34 Treaty on the Functioning of the European Union (“TFEU”). This article prohibits “quantitative restrictions on imports and all measures having equivalent effect” between Member States and the Estonian Government has not demonstrated that its draft law could qualify for derogation under Article 36 TFEU2.
C. It violates EU Law
The Proposal violates e-cigarette manufacturers’ freedom to conduct a business under Article 16 of the EU Charter of Fundamental Rights.
We believe the arguments above prove the Estonia draft Act is in breach of the internal market and the rights of the Irish vaping companies to do business within the EU and would appreciate to meet to discuss this issue further.