Notification Detail

‘Amendments to Law 4419/2016 (Government Gazette 174/A) - Article 96 – Harmonisation of Greek law with 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’

Notification Number: 2019/94/GR (Greece)
Date received: 05/03/2019
End of Standstill: 06/06/2019

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Message 002

Communication from the Commission - TRIS/(2019) 00606
Directive (EU) 2015/1535
Translation of the message 001
Notification: 2019/0094/GR

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.

(MSG: 201900606.EN)

1. Structured Information Line
MSG 002 IND 2019 0094 GR EN 05-03-2019 GR NOTIF


2. Member State
GR


3. Department Responsible
ΕΛΟΤ, ΚΕΝΤΡΟ ΠΛΗΡΟΦΟΡΗΣΗΣ ΟΔΗΓΙΑΣ 98/34/Ε.Ε, ΚΗΦΙΣΟΥ 50, 121 33 ΠΕΡΙΣΤΕΡΙ, ΑΘΗΝΑ, Τ/Φ: + 30210- 2120304, Τ/Ο: + 30210- 2120131


3. Originating Department
ΥΠΟΥΡΓΕΙΟ ΥΓΕΙΑΣ, ΓΕΝΙΚΗ Δ/ΝΣΗ ΔΗΜΟΣΙΑΣ ΥΓΕΙΑΣ & ΠΟΙΟΤΗΤΑΣ ΖΩΗΣ, Δ/ΝΣΗ ΑΝΤΙΜΕΤΩΠΙΣΗΣ ΕΞΑΡΤΗΣΕΩΝ, ΤΜ. Β' - ΛΟΙΠΩΝ ΕΞΑΡΤΗΣΕΩΝ, Αριστοτέλους 19, 104 33 Αθήνα, Τηλ.: 2132161418, Αρμ.: Ε. Σκοπελίτης, e-mail: exartiseis_b@moh.gov.gr


4. Notification Number
2019/0094/GR - X00M


5. Title
‘Amendments to Law 4419/2016 (Government Gazette 174/A) - Article 96 – Harmonisation of Greek law with 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’


6. Products Concerned
Provisions relating, inter alia, to the placing of electronic non-nicotine delivery systems on the Greek market, packaging of novel tobacco products and the prohibition of the placing on the market of certain tobacco and tobacco-related products.


7. Notification Under Another Act
-


8. Main Content
The draft law relates to ‘amendments to Law 4419/2016 – Article 96 - Harmonisation of Greek law with 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 relates to the placing of electronic non-nicotine delivery systems on the Greek market, the packaging of novel tobacco products and the prohibition of the placing on the market of certain tobacco and related products’ (Government Gazette 174/A) and in particular:
Paragraphs 1 to 6 amend certain definitions in Directive 2014/40/EU on tobacco and related products, without changing the precise content thereof for the purposes of the directive. For example, “novel tobacco product” now includes devices which allow such products to be used, and electronic cigarettes and refill containers now includes nicotine-free liquids.
In addition, certain new definitions are added such as:
– nicotine-containing liquid
– nicotine-free liquid
– tobacco substitute
– related products.

Paragraph 9 introduces a prohibition on the placing on the market of certain tobacco products (chewing tobacco and nasal tobacco) and tobacco substitutes (which are defined), which are not included in Directive 2014/40/EU.

Paragraph 10 regulates the issue of notification of novel tobacco product devices, which are now covered by the procedure outlined in Directive 2014/40/EU.

Paragraph 11 regulates aspects of the packaging of novel tobacco products when they are not put on the market inside the same packaging as the novel tobacco products themselves.

Paragraph 17 regulates the content of electronic non-nicotine delivery systems based on the provisions which apply for electronic nicotine delivery systems to the extent that they are applicable and are unrelated to nicotine itself. For example, it covers the prohibition on certain additives and certain ingredients hazardous to human health which must be notified to the European Commission in accordance with the procedure specified for nicotine-containing delivery systems. Specifications are laid down to protect against use by children and requirements are also laid down about the leaflet, packaging and health warnings they must bear.

In the same way as the directive does for nicotine-containing products, paragraph 18 prohibits advertising, sponsorship and promotion in printed publications, on the radio, online and on TV, etc. and lays down additional requirements for manufacturers/importers of electronic non-nicotine delivery systems identical to those for electronic nicotine delivery systems and extends to them the prohibition on cross-border remote selling contained in the directive. Lastly, it lays down particular specifications about the form in which said products can be sold to consumers, as is partially the case for nicotine-containing products, and introduces a prohibition on the sale of individual ingredients and flavours to be used by consumers in refill liquids for electronic cigarettes (do-it-yourself). It also lays down a transitional period for placing on the market all such products and novel tobacco product devices which do not comply with the requirements of the legislation.


9. Brief Statement of Grounds
As for paragraph 1, the amendment to the definition of “novel tobacco products” in Directive 2014/40/EU is considered necessary to implement the instructions given at the 8th Conference of the Parties to the Framework Convention on Tobacco Control pursuant to Decision FCTC/COP8(22), “Novel and emerging tobacco products”, according to which
the Parties are invited to implement the measures which are in force that must be applied to novel and emerging tobacco products and the devices via which those products are consumed, i.e. to prevent claims of reduced harm to health, to take measures against advertising, promotion and sponsorship, to take measures on the regulation and on the disclosure of content, and also to prohibit or restrict the production, import, distribution, presentation, sale and use thereof.
By extending the concept of novel tobacco product beyond the tobacco product itself to the device, it also extends all other provisions of Law 4419/2016, which transposed Directive 2014/40/EU into Greek law, as well as those of Law 3730/2008 and all pieces of legislation which apply to it, insofar as each provision is applicable. The specific provision is required by a rule of international law, following the example of many countries, especially EU Member States, which have acted similarly, since the regulatory lacuna that existed was at the international and domestic level and was being used in many cases to bypass the existing legislation which prohibits advertising, promotion and sponsorship and prohibits health benefit claims or claims of reduced risk on the packaging, and other restrictions imposed by the national, European and international framework of anti-smoking legislation. Clearly there was, and —as long as the lacuna exists— is, an issue of protecting public health, which shows how vital the domestic arrangements are.

Paragraphs 2 to 4 expand the basic definitions in Directive 2014/40/EU for electronic cigarettes and refill containers to cover non-nicotine versions. In order to regulate the placing on the market of electronic cigarettes, which were completely banned at the national level in 2008 and which ban was partially lifted in 2016 with the transposition of Directive 2014/40/EU solely and exclusively in relation to nicotine-containing products, “electronic cigarette” and “refill container” are redefined along the lines of Article 2 of the directive, and definitions are introduced for nicotine-containing and nicotine-free vaping fluids.

Paragraph 5 defines those cases which could in the future concern national regulatory authorities, since they relate to products which, although similar to tobacco and related products as defined in the directive and the law, do not fall into any of the specific categories (tobacco products, electronic cigarettes, novel tobacco products, herbal products for smoking) since practice has shown that the market is constantly changing, creating challenges for tobacco control authorities. In this way, all possible cases are categorised, since classification in the existing categories in the directive is precluded.

Paragraph 6 defines products related to tobacco, since although the term is mentioned many times in the directive, it is missing from the definitions in Article 2. Under this provision, both products defined in the directive (electronic nicotine delivery systems/electronic cigarettes and herbal products for smoking) and those defined in national law (electronic non-nicotine delivery systems and tobacco substitutes) which do not contain tobacco are defined as “related products”.

At the same time, given that tobacco substitutes are not included within the regulatory scope of the directive, those products are now prohibited if they fall within the definition in paragraph 9.
The same prohibition also covers the categories of chewing tobacco and nasal tobacco. The option to prohibit those categories, which falls within the regulatory scope of Directive 2014/40/EU, is contained in Article 24(3), which stipulates that a Member State may also prohibit a certain category of tobacco or related products on grounds relating to the specific situation in that Member State and provided the provisions are justified by the need to protect public health, taking into account the high level of protection of human health achieved through this directive, following relevant approval or tacit acceptance by the European Commission within six months of such notification.
The specific categories have been subject to much discussion at the European level by regulatory authorities, due (a) to the outstanding similarities to tobacco for oral use (snus) which is banned by the directive and the difficulty of distinguishing them from it, and (b) rising consumption levels compared to traditional tobacco products. In Greece, tobacco consumption, which was traditionally high and continues to be so to a large degree, has seen a rise in the circulation of such products in recent years, especially chewing tobacco, and there have also been reports from the regulatory authorities after physico-chemical checks of their content about products which, despite having been declared as products for use as chewing tobacco, are more like tobacco for oral use. The prohibition for which a transitional six-month adjustment period applies will be notified to the European Commission in accordance with the provisions, along the lines of quite a few Member States which have done so in the past or are expected to do so.

Under paragraph 10, novel tobacco product devices, which will now fall within the definition of novel tobacco products, must, insofar as is technically feasible, be notified on the EU CEG portal; in any event, that obligation exists for novel tobacco products. In this way, even if the full characteristics of the overall novel tobacco product are notified via the authorisation procedure that has been put in place, they will be easily accessible and processable by the competent national authorities at the time of submission, which will be at least six months prior to planned placing on the market and three months prior to submission of the authorisation dossier.

Paragraph 11 specifically regulates the issue of the packaging of novel tobacco product devices. If they are sold separately, the amendment to the definition introduced — and the inclusion of devices within that definition — means that the specifications for separate packaging within which the devices are sold must be regulated accordingly in the context of the directive’s regulatory scope and Decision FCTC/COP8(22), “Novel and emerging tobacco products”.
Given that, by analogy, novel tobacco product devices are electrical or electronic devices which strongly resemble electronic cigarettes, in terms of their mechanical parts, the provisions of Article 20(4) of the directive and subparagraphs (a)(i) and (a)(vi) apply, namely the requirement for them to have a brochure with instructions on how to use and store the product and also a statement that use of the product by young people and non-smokers is not recommended, as well as the contact details of the manufacturer or importer and the legal or natural person who is the point of contact within the European Union.
Moreover, the packaging must include a recommendation in Greek to keep the product far from children and must not include elements or features (including texts, symbols, names, trademarks, figurative or other signs, without that list being exhaustive) referred to in Article 13 of the directive, namely no element or feature which:
a) promotes a tobacco product or encourages its consumption by creating an erroneous impression about its characteristics, health effects, risks or emissions;
b) suggests that a particular tobacco product is less harmful than others or aims to reduce the effect of some harmful components of smoke or has vitalising, energetic, healing, rejuvenating, natural, or organic properties or has other health or lifestyle benefits;
c) refers to taste, smell, or any flavourings or other additives or the absence thereof;
d) resembles a food or cosmetic product;
e) suggests that a certain tobacco product has improved biodegradability or other environmental advantages. Moreover, unit packets and all external packaging must not indicate economic advantages by bearing printed vouchers, discount offers or free distribution or by including two-for-one or other similar offers.
This provision is vital given that these novel tobacco products are rapidly developing not just internationally but in Greece in particular, especially among young people, and it is more than obvious especially in Greece that there is an effort being made to bypass the prohibitions on advertising, promotion and sponsorship using devices in which those products are consumed; this calls into doubt the effective implementation of the provisions of the Framework Convention on Tobacco Control, which is the reason why the relevant decision was taken at the 8th Conference of the Parties.
Where the devices are sold on the domestic market in a package along with other tobacco products, in any event the strict provisions of the 2014 Directive on packaging and labelling will apply.

Paragraph 17 introduces a provision into Law 4419/2016 concerning the content of electronic non-nicotine delivery systems, to be read in conjunction with paragraph 18. That provision is vital since despite the prohibition on the placing on the market of electronic cigarettes in general from 2008, up to the partial lifting of the ban on electronic cigarettes, which was regulated by the 2016 directive (namely for nicotine-containing products), in reality for more than a decade products which fall into that category have in fact been placed on the market. In fact, many of those products were placed on the market and may be circulating on the Greek market without standards, as is clear from relevant complaints and reports that have been received. Electronic non-nicotine delivery systems, which are also prohibited under the current legal framework, are being promoted on the market mainly as scented liquids which in most cases contain sweeteners, sugars and similar substances that are considered by modern scientific research and by relevant expert reports to be particularly harmful to health (see recent studies by the Universities of North Carolina and Norchester, New York, 2018; the WHO Experts Report FCTC/COP/7/11, entitled “Electronic Nicotine Delivery Systems and Electronic Non-Nicotine Delivery System”; and the report from the Office of the US Surgeon General entitled “E-Cigarette Use Among Youth and Young Adults: A Report of the Surgeon General”, 2016).
By lifting the prohibition on electronic nicotine delivery systems when the directive was implemented, confusion in the marketplace increased further since many believed there had been a total lifting of the prohibition, meaning that electronic non-nicotine delivery systems not only continue to be placed on the market but there are no special standards about packaging, volume, form of sale, additives they can contain and so on. In fact, cases have been observed — and continue to be observed — of advertising, sponsorship and promotion of such products (which, even if they are nicotine-free, are very similar in terms of use to traditional cigarettes) and nicotine-containing products to which the strict standards in the directive apply.
So given (i) the conditions that have emerged in the market and (ii) the particular blow to effective implementation of the provisions of Decision FCTC/COP/6(9) of the 6th Conference of the Parties on strict control of all aspects of ENNDS (electronic non-nicotine delivery systems) until they are banned, the provisions of this article are considered necessary in order to bring the provisions of the directive into line with the example set by quite a few Member States.
More specifically, the provisions of Article 20 of the directive will also apply to electronic non-nicotine delivery systems, and in particular to paragraph 2 on the dispatch of information as allowed by the European Commission, paragraph (3)(c), (d), (e) and (g), and paragraph 4 apart from point (b)(iii), which relates to health warnings for electronic nicotine delivery systems. Instead, there will be another warning with the same technical specifications which will state the potential harm to health but fully in keeping with the data available so far from independent scientific research. The specific warning is not related to, and must not be confused with, the other label required by Regulation (EC) No 1272/2008 (CLP) about individual chemical substances that may be included in nicotine-free liquids, which remains in force.

Paragraph 18 lays down the conditions for placing on the market of electronic non-nicotine delivery systems, whose prohibition is lifted in order to complete the regulatory framework relating to them. The provisions of Article 20(5) of the directive, which prohibit advertising, sponsorship and promotion irrespective of the medium (press, internet, television, radio, etc.), are extended to electronic non-nicotine delivery systems, with the same legal consequences which also apply to electronic nicotine delivery systems. The specific provision is considered necessary to avoid confusion of consumers, deliberate or otherwise, especially after the total lifting of the ban, and also to avoid derogation from the ban on nicotine delivery systems under the directive via promotional, advertising and commercial moves relating to non-electronic nicotine delivery systems. If one takes into account that the said products are very popular (especially those with flavours) among young age groups and could, from the models of behaviour which emerge, constitute a gateway to nicotine-containing and/or traditional tobacco products, the specific provision is of decisive importance.
The obligation for manufacturers, importers and distributors deriving from Article 20(9) is also extended to non-electronic nicotine delivery systems for safety and information reasons specific to such systems. And the provisions of paragraph 11 of the directive are extended, with the exception of the obligation to inform the European Commission about them.
Lastly, the provisions of Article 20(6) of the directive, as incorporated into national law, are also extended to electronic cigarettes, which prohibit the cross-border distance selling of electronic cigarettes from abroad to Greece; however, under the same conditions which apply to electronic nicotine delivery systems, the cross-border distance selling in Member States is permitted. Taking into account the rapid growth in the market globally, it is necessary to introduce this provision given that it is not just the presence of nicotine which counts but other factors as well, which are considered harmful to the protection of health against the use of electronic cigarettes.
Very strict restrictions are also introduced on the form in which nicotine-free liquids can be sold, namely in special containers or in disposable electronic cigarettes or single-use cartridges, without the specific quantitative restrictions the directive lays down for electronic nicotine delivery systems. This provision, and the one which prohibits the separate sale and distribution to end consumers of ingredients, including flavours, intended to allow them to make electronic cigarette refill liquids on their own, are vital to effectively address a widespread problem which exists in Greece too: namely, the practice of users mixing ingredients and do-it-yourself electronic cigarettes. It is in keeping with the conclusions in the Commission’s report COM (2016) final 269 which proposes suitable legislative measures to be implemented at the national level in conjunction with Directive 2014/40/EU. Given that the prohibition only relates to the intended use of electronic cigarette refill liquids and not to other uses and not to specific retail outlets, the provisions are considered to be adequate and proportional to the objective sought, and there is an adequate six-month transitional period for all provisions relating to the placing on the market of electronic non-nicotine delivery systems to allow the market to adjust without problems. The same transitional period is also given for the prohibitions on tobacco and related products which are mentioned.

It should also be noted that given the content of Article 24 of Law 4419 (which refers, inter alia, to electronic cigarettes and novel tobacco products without being more specific to which the general prohibitions and restrictions on sale, use, advertising, promotion, etc. and Directive 2003/33/EC on printed media, the radio and the Information Society apply), the exact same provisions will apply to both novel tobacco product devices and electronic cigarettes which will fall into the relevant definitions.


10. Reference Documents - Basic Texts
Reference(s) to basic text(s): Law 4419/2016 (Government Gazette 174/Α) on harmonisation of Greek law with 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


11. Invocation of the Emergency Procedure
No


12. Grounds for the Emergency
-


13. Confidentiality
No


14. Fiscal measures
No


15. Impact assessment
-


16. TBT and SPS aspects
TBT aspect

No - the draft has no significant impact on international trade.

SPS aspect

No - the draft has no significant impact on international trade.

**********
European Commission

Contact point Directive (EU) 2015/1535
Fax: +32 229 98043
email: grow-dir2015-1535-central@ec.europa.eu

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