Tuesday December 3
14:30 - 15:00
E-cigarettes and the state of play of the tobacco products directive
Brussels, Altiero Spinelli building (ASP) - 5G2
Frédérique RIES (ALDE, BE)
They just don’t get it – Commission proposal for the regulation of e-cigarettes
Article from: www.CliveBates.com
Late last week the European Commission circulated a confidential new proposal for regulating e-cigarettes. The document was sent only to those negotiating the future of e-cigarettes behind closed doors in Brussels – representatives of the European Parliament and European Council. This isn’t a final proposal, but it provides the negotiators with something to discuss. The Nicotine Science and Policy website has obtained the document, and it is here. It is quite frankly appalling – lacking any legitimacy in public health or internal market policy-making… Make no mistake, if implemented this proposal bans every product on the market today and would severely limit options for future products - and may make it commercially unviable to develop in future.
Read full article:
http://www.clivebates.com/?p=1655#comments |
| From www.Clivebates.com |
The following are my "notes and highlights" from the proposed document mentioned above.
Article 2
[definition of Electronic cigarettes]
Electronic cigarette means 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.
Highlights from the proposal:
Article 18 – Electronic cigarettes
2.b
. . . notification shall be submitted within 6 months of that date. A new notification
shall be submitted for each substantial modification of the product.
The notification shall include at least the following information:
b. list of all ingredients contained in and emissions resulting from the use of the
product, by brand name and type, including quantities thereof;
Proportionate fees may be charged by Member States for receiving, storing, handling and analysing the information submitted to them.
3.c,d
. . . Member States shall require that manufacturers and importers of electronic cigarettes to establish and comply at least with the following manufacturing requirements:
c) a safety assessment prior to placing on the market, with information on the composition of the product, microbiological quality, impurities and traces, toxicological profiles, and adverse effects;
d) a legal or natural contact person within the European Union.
Member States shall ensure that electronic cigarettes with refillable cartridges or tanks are not
placed on the market. Only single use cartridges can be placed on the market.
4.c
Member States shall require manufacturers and importers to ensure that:
c) Only flavours which are authorized for use in nicotine replacement therapies can be used in
electronic cigarettes, unless such a flavour is particularly attractive to young people and non-smokers;
5.a,d,e
Member States shall ensure that:
a) commercial communications with the aim or direct or indirect effect of promoting
electronic cigarettes are prohibited in the press and other printed publications, with the
exception of publications that are intended exclusively for professionals in the trade of
electronic cigarettes and for publications which are printed and published in third countries,
where those publications are not principally intended for the European Union market;
d) any form of public or private contribution to radio programmes with the aim or direct or
indirect effect of promoting electronic cigarettes is prohibited;
e) any form of public or private contribution to any event, activity or individual with the aim
or direct or indirect effect of promoting electronic cigarettes and involving or taking place
in several Member States or otherwise having cross-border effects is prohibited;
Recitals
a) Electronic cigarettes are a tobacco related product and should be regulated within this
Directive. They simulate smoking behaviour and are increasingly used and marketed to young
people and non-smokers. Diverging legislation exists in Member States to regulate these products requiring action at Union level to improve the functioning of the internal market. Other nicotine containing products are not covered by the provisions of this Directive. Electronic cigarettes which are presented as having properties for treating or preventing disease in human beings should not fall under this Directive. They can only be placed on the market if duly authorised under Directive 2001/83/EC. For electronic cigarettes that fall under this Directive, the definition of medicinal products according to Article 1.2.b of Directive 2001/83/EC does not apply. This clarifies the legal situation of this product in the light of Article 2.2 of Directive2001/83/EC.
b) Refillable cartridges or electronic cigarettes with refillable tanks are considered to pose a risk to public health. Such products would for example allow for a circumvention of the flavour
regulation, they would increase the risk of contamination and they would lead to the wider
availability of larger quantities of nicotine containing liquids, which can be a risk to
inexperienced users or children.
c) Given the risk that electronic cigarettes can develop into a gateway to normal cigarettes, and considering that they mimic and normalise the action of smoking, Member States should lay down age limits for their sale to consumers and their use, and shall ensure that their labelling displays sufficient and appropriate information on safe use, in order to protect human health and safety.
d) Responsibility for ensuring that electronic cigarettes comply with the essential safety
requirements should rest with manufacturers. If manufacturers are not established in the European Union, the natural or legal person who imports electronic cigarettes into the European Union should bear the responsibility.
e) Disparities existing between national practices on electronic cigarettes advertising and
sponsorship impede the free movement of goods and the freedom to provide services and create an appreciable risk of distortions to competition. Without further action at Union level, the existing disparities are likely to increase in the coming years, considering also the growing
market for electronic cigarettes. European legislature should therefore approximate national
legislation on the advertising and sponsoring of electronic cigarettes. Article 114(3) of the Treaty on the Functioning of the European Union requires the Commission, in its proposals for the establishment and functioning of the internal market concerning health, to take as a base a high level of protection. In this light, restrictions on the advertising of electronic cigarettes is intended to protect public health by regulating the promotion of these products, which can develop into a gateway to normal cigarettes, and which mimic and normalise the action of smoking. This Directive does not harmonise rules on domestic sales arrangements or advertising, nor does it introduce an age limit for electronic cigarettes. Member States are free to regulate such matters in their own domain.
f) Brand names have the potential to attract consumers and maintain their brand loyalty. The
to public health. Such products would for example allow for a circumvention of the flavour
regulation, they would increase the risk of contamination and they would lead to the wider
availability of larger quantities of nicotine containing liquids, which can be a risk to
inexperienced users or children.
c) Given the risk that electronic cigarettes can develop into a gateway to normal cigarettes, and considering that they mimic and normalise the action of smoking, Member States should lay down age limits for their sale to consumers and their use, and shall ensure that their labelling displays sufficient and appropriate information on safe use, in order to protect human health and safety.
f) Brand names have the potential to attract consumers and maintain their brand loyalty. The
strength of tobacco brands names could lead to attracting people – especially young people - to buy and use electronic cigarettes marketed under the same brand. Moreover the use of tobacco trademarks, brand names and symbols for electronic cigarettes could indirectly promote smoking, facilitate the shift of users from one category to the other. It could also undermine national legislation limiting the advertising for tobacco products. Therefore the use of tobacco trademarks, brand names and symbols for electronic cigarettes is prohibited under this Directive.
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