Ref. Ares(2017)1723149 - 31/03/2017
Note du Pr Bertrand DAUTZENBERG 9/12/2012
sur la note du 6 décembre sur l’article 18 du projet de directive
La commission avec son projet du 6 décembre fait des propositions en cohérence avec le vote
majoritaire du parlement pour les objectifs prioritaires qui sont :
-
de protéger de l’utilisation du produit par les adolescents et les non-fumeurs,
-
d’éviter la renormalisation du tabac dans la société.
OK
En revanche la commission méconnait totalement que c’est le tabac qui tue alors que les craintes
(dont le principe est justifié) sur l’e-cigarette et les e.liquides ne sont exprimés que par précaution.
La parlement tout comme les acteurs de santé publique réunit au sein de l’EPHA ont exprimé le
désir que la e.cigarette soit au minimum aussi accessible que les produits du tabac et que le
rapport bénéfice/risque de l’e.cigarette ne soit pas évalué indépendamment des risques du tabac
qui a une chance sur deux de les tuer.
La commission ne peut au nom de la santé mettre des freins au commerce de l’e.cigarette et à son
accès aux fumeurs qui soient plus sévères que celles imposés au tabac, un produit infiniment plus
dangereux. En voici 4 exemples :
a) Electronic cigarettes do not contain nicotine in excess of
[20 mg/ml and 10 mg/unit
];
Si la concentration de 20mg/ml est tout à fait acceptable, Au nom de la sécurité la commission
voudrait interdire plus de 10 mg par e.cigarette quand un paquet de cigarette contient 300 mg de
nicotine et en délivre 60 mg aux fumeurs.
UNE MESURE PLUS SEVERE POUR LES E.CIGARETTE QUE
POUR LE TABAC
f) electronic cigarettes with refillable cartridges or tanks are not placed on the market;
Au nom de ce risque on ferme le marché aux cigarettes pouvant être remplis avec des petits flacons
de 10 ml quand on laisse des pots de 500 grammes de tabac en vrac contenant 75 000 mg de
nicotine et en libérant 2 000 mg quand ils sont fumées après qu’ils aient été roulés ou tubés, par
leurs consommateurs.
UNE MESURE PLUS SEVERE POUR LES E.CIGARETTE QUE POUR LE TABAC g) that only electronic cigarettes are placed on the market that cannot be operated or
opened by children
Au nom de ce risque on exige que les e.cigarettes ne puissent âtre manipulées par les enfants (ce qui
est une bonne chose), alors que les produits du tabac le sont pleinement.
.
UNE MESURE PLUS
SEVERE POUR LES E.CIGARETTE QUE POUR LE TABAC
c) Only ingredients of high purity and free from contaminants are used in the manufacture
of the liquid for electronic cigarettes;
d) Only ingredients of high purity and free from contaminants are used in the manufacture
of the liquid for electronic cigarettes that do not have toxic properties in heated or unheated
form with the exception of nicotine.
La commission exige pour les e.liquides une haute pureté (un terme flou) et l’absence de
contaminant (La fumée de tabac comprend de la dioxine, de l’arsenic, du mercure, du benzopyrène
et plus de 40 produits classes cancérogènes et des centaines de contaminants) :
AUCUN PRODUIT
DU TABAC NE PASSE CETTE EXIGENCE.
UNE MESURE PLUS SEVERE POUR LES E.CIGARETTE QUE
POUR LE TABAC
NB : Les données sur la toxicité de la nicotine qui sont une des bases des mesures ci-dessus datent de
1906 alors que l’accumulation de faits récents conduit à multiplier par environ 20 la dose toxique de
nicotine calculée en 1906. Alors que les 700 000 morts annuels du tabac sont bien de 2013.
6. Presidency / Commission suggested text 6 December
2013 – secret
[Scope]
1. Electronic cigarettes
may be placed on the market if they comply with the
relevant provisions of this Directive and with all other relevant Union legislation.
This Directive is not applicable to products which are subject to an authorisation
requirement under Directive 2001/83/EC
[Notification]
2. Manufacturers and importers of electronic cigarettes shall notify the products with the
competent authorities of the Member States in which the product is intended to be placed on
the market. The notification shall be submitted in electronic form 6 months before the
intended placing on the market. For electronic cigarettes already placed on the market on
the date referred to in paragraph 1 of Article 25, the 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 the following information:
a) name and contact details of the manufacturer,
a responsible legal or natural
person within the European Union, and, if applicable, the importer into the European
Union;
b) list of all ingredients contained in and emissions resulting from the use of the product,
by brand name and type, including quantities thereof;
c) toxicological data regarding these ingredients
and their emissions, including when
heated, referring in particular to their effects on health of consumers and taking
into account, inter alia, any addictive effect;
d) information on nicotine dosing when used under reasonable and foreseeable conditions;
and
e) description of the components of the electronic cigarette.
Where Member States consider that data are incomplete, they are entitled to
request the completion of such data.
Proportionate fees may be charged by Member States for receiving, storing, handling and
analysing the information submitted to them.
[Obligations of manufactures and importers]
3. Member States shall require manufacturers and importers of electronic cigarettes to bear
full responsibility for the quality and safety of electronic cigarettes placed on the market and
when used under reasonable and foreseeable conditions.
Member States shall require manufacturers and importers of electronic cigarettes to establish
and comply with the following requirements:
a) to design and manufacture in accordance with the safetyrequirements set out in this
article;
b) to have procedures in place for series production
to ensure to remain in conformity
with the requirements
set out in this article;
c)
to undertake and have available for the competent authorities, a safety
assessment of
electronic cigarettes, prior to placing on the market, with information on
the
chemical composition of the
liquid microbiological quality, impurities and traces,
toxicological profile
including when heated, mechanics, electronics and adverse
effects;
[Product related requirements]
4. Member States shall require manufacturers and importers to ensure that:
a) Electronic cigarettes do not contain nicotine in excess of
[20 mg/ml and 10 mg/unit
];
b) Electronic cigarettes with additives listed in paragraph 4 of Article 6 are not placed on
the market;
c) Only ingredients of high purity and free from contaminants are used in the manufacture
of the liquid for electronic cigarettes;
d) Only ingredients of high purity and free from contaminants are used in the manufacture
of the liquid for electronic cigarettes
that do not have toxic properties in heated or
unheated form with the exception of nicotine;
e) electronic cigarettes deliver the nicotine doses uniformly and consistently;
f) electronic cigarettes with refillable cartridges or tanks are not placed on the market;
and only non re fillable cartridges are placed on the market.
g)
that only electronic cigarettes are placed on the market that cannot be
operated or opened by children.
[Packaging and labelling, consumer information ]
h) Unit packets of electronic cigarettes include a leaflet with information instructions for
use, including a reference that the product is not recommended for use by young people and
non-smokers, contra-indications, warnings for specific risk groups, information on possible
adverse effects,
on addictiveness and toxicity, and contact details of the manufacturer or
importer
and a legal or natural contact person within the European Union;
i) Unit packets and any outside packaging of electronic cigarettes
i. include a list of all ingredients contained in the product in descending order, and an
indication of nicotine content and delivery per dose;
ii. do not include elements or features referred to in Article 12, with the exception of
paragraph 1(a) of Article 12 concerning the nicotine content;
iii. do not use tobacco trademarks, brand names and symbols;
iv. carry
one of the following health warning:
This product contains nicotine which is a highly addictive substance. It is not recommended
for use by non-smokers.
or
“This product contains nicotine which is a highly addictive substance.”
Member States shall determine which of these health warnings are used.
j) the health warnings shall comply with the provisions in paragraph 2 of Article 11.
[Advertising, promotion and cross-border distance sales]
5. 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;
b) commercial communications with the aim or direct or indirect effect of promoting
electronic cigarettes which are prohibited pursuant to Art. 18 par. 5, lit. a) are prohibited in
information society services as defined in Article 1(2) of Directive 98/34/EC;
c) commercial communications with the aim or direct or indirect effect of promoting
electronic cigarettes are prohibited in the radio;
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;
f) audiovisual commercial communications falling under Directive 2010/13/EU are
prohibited for electronic cigarettes;
g) cross-border distance sales of electronic cigarettes are regulated in accordance with
Article 16.
[Reporting and monitoring obligation]
6. Member States shall require manufacturers and importers of electronic cigarettes to
submit to competent authorities on an annual basis comprehensive data on sales volumes,
by brand name and type, as well as information on preferences of various consumer groups,
including young people, non-smokers and main types of current users, as well as the mode
of sale of the products. They shall also submit executive summaries of any market surveys
carried out in respect of the above, including an English translation thereof.
Member States shall monitor the development of the electronic cigarette market, including
any evidence of gateway use among young people.
[Disclosure and information exchange]
7. Member States shall ensure the dissemination of information received pursuant to
paragraph 2 on a website with due regard to the protection of trade secrets.
Member States shall make available, upon request, all information received pursuant to this
Article to the Commission and other Member States. Member States and the Commission
shall ensure that trade secrets and other confidential information are treated in a confidential
manner.
[Market surveillance]
8. Member States shall require that manufacturers, importers or distributers establish and
maintain a system to collect information about all suspected adverse effects. If any of these
operators considers or has reason to believe that electronic cigarettes, which are in its
possession and are intended to be placed on the market, are not of good safety or quality or
is otherwise not in conformity with this Directive, the operator shall immediately take the
corrective action necessary to bring that product into conformity, to withdraw it or recall it,
as appropriate. In such a case the operator shall also be required to immediately inform the
market surveillance authorities of the Member States in which the product is made available,
giving details, in particular, of the risk to health and safety and of any corrective action
taken, and of the results of such corrective action. Member States may also request
additional information from the operator, for example on safety and quality aspects or any
adverse effects.
[Re delegated acts]
9. The Commission shall also be empowered to adopt delegated acts to adapt the wording of
the health warning in paragraph 4
(j).
When adapting that health warning, the
Commission shall ensure that it is factual.
The Commission shall adopt by means of implementing acts a common notification format
pursuant to paragraph 2.
Citations
Having regards to the Treaty on the Functioning of the European Union, and in particular
Articles 53(
1), 62* and 114 thereof,
* Addition of the Articles 53(1) and 62 TFEU is related to the legal basis for the Directive
2003/33/EC on advertising and sponsorship of tobacco products.
Recitals
(a)
Electronic cigarettes appear to allow certain consumers to switch away
or reduce tobacco consumption to consumption of this new product.These
products should be regulated within this Directive, unless they are subject to
Directive 2001/83/EC. Electronic cigarettes simulate smoking behaviour. From a
public health perspective they are a concern if they 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.
(b) Refillable cartridges or electronic cigarettes with refillable tanks are considered to
pose a risk to public health. Such products 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
and can lead to poisoning or abuse.
(c) Given the risk that electronic cigarettes can develop into a gateway to
nicotine
addiction and ultimately traditional tobacco consumption, and considering that they
mimic and normalise the action of smoking, Member States should
consider laying 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.
Therefore, it is necessary to approximate the
national rules on advertising and sponsoring of electronic cigarettes, taking as a
base a high level of health protection. Electronic cigarettes can develop into a
gateway to normal cigarettes, as they mimic and normalise the action of
smoking. For this reason, it is appropriate to adopt a restrictive approach to
advertising of electronic cigarettes.
(f)
This Directive does not harmonise all aspects of electronic cigarettes,
and leaves for example the regulation of flavours in electronic cigarettes to the
Member States. Member States may consider allowing flavours in electronic
cigarettes which they authorise for nicotine replacement therapies, bearing in
mind that some flavours may develop toxic properties when heated. Member
States are encouraged to take measures in this area to limit the appeal of
electronic cigarettes to young people and non smokers.
(g) This Directive does not harmonise rules on
smoke-free environment, or 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.
(h) 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
and encourage parallel use of traditional cigarettes
and electronic cigarettes.
Their use 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.
Articles
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.
Article 20
[on cooperation of competent authorities]
The competent authorities of the Member States shall cooperate with each other and with
the Commission to ensure the proper application and due enforcement of this Directive and
shall transmit to each other all information necessary with a view to applying this Directive
uniformly.
Article 21a new
[on designation of competent authorities and change title into "Committee procedure and
competent authorities" ]
Member States shall designate the competent authorities within the period of 3 months after
the transposition pursuant to Article 25. Member States shall, without delay, inform the
Commission about the identity of the competent authorities responsible for enforcement of
obligations provided for in this Directive. The Commission shall publish that information in
the Official Journal of the European Communities.
Article 23
[to add new point (g) inArticle 23, paragraph 2]
(g) market developments in electronic cigarettes considering, inter alia, information received
under Article 18,
including uptake by young people and non-smokers and impacts
on cessation efforts;