Sundheds- og Forebyggelsesudvalget 2013-14
KOM (2012) 0788 Bilag 14
Offentligt
2.10.2013
Amendment 170
Frédérique Ries, Rebecca Taylor, Chris Davies
on behalf of the ALDE Group
Peter Liese
on behalf of the PPE Group
Martin Callanan
on behalf of the ECR Group
Report
Linda McAvan
Manufacture, presentation and sale of tobacco and related products
COM(2012)0788 – C7-0420/2012 – 2012/0366(COD)
Proposal for a directive
Article 18
Text proposed by the Commission
1.
The following
nicotine-containing
products may only be placed on the market
if they were authorised pursuant to
Directive 2001/83/EC:
Amendment
A7-0276/170
A7-0276/2013
1. Nicotine-containing products may only
be placed on the market
in accordance
with the notification procedure set out in
Article 17 of this Directive.
Member States shall ensure that nicotine-
containing products comply with all
relevant Union legislation, and in
particular with Directive 2001/95/EC on
general product safety.
(a) products with a nicotine level
exceeding 2 mg per unit, or
(b) products with a nicotine concentration
exceeding 4 mg per ml or
(c) products whose intended use results in
a mean maximum peak plasma
concentration exceeding 4 ng of nicotine
per ml.
2.
The Commission shall be empowered to
adopt delegated acts in accordance with
Article 22 to update the nicotine
quantities set out in paragraph 1 taking
into account scientific developments and
marketing authorisations granted to
AM\P7_AMA(2013)0276(169-170)_EN.doc
2.
Nicotine-containing products that are
presented as having properties for treating
or preventing disease may only be placed
on the market if they were authorised
pursuant to Directive 2001/83/EC.
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nicotine- containing products
pursuant to
Directive 2001/83/EC.
3.
As regards nicotine-containing
products to be placed on the market in
accordance with paragraph 1, Member
States shall ensure that:
(a) nicotine-containing products with a
nicotine level exceeding 30 mg/ml are not
placed on the market;
(b) manufacturers and importers of
nicotine-containing products submit to
the competent authorities a list of all
ingredients contained in and emissions
resulting from the use of the product, by
brand name and type, including quantities
thereof, as well as any changes. Member
States shall then ensure the dissemination
of this information on a website with due
regard to the protection of trade secrets.
Manufacturers and importers shall also
report to the authorities about national
sales volumes by brand name and type;
(c) nicotine-containing products with
additives listed in Article 6(4) are not
placed on the market;
(d) the unit packet of nicotine-containing
products includes a leaflet with
instructions for use, including that the
reference that the product is not
recommended for use by non-smokers,
contra-indications, warnings for specific
risk groups, reporting of adverse
reactions, place of manufacture and
contact details of the manufacturer or
importer;
3. each unit packet and any outside
packaging of nicotine containing products
below the thresholds set out in paragraph
1 shall
carry the following health warning:
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(e) each unit packet and any outside
packaging of nicotine-containing products
carry the following health warning:
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"This product contains nicotine
and can
damage your health".
"This product
is intended for use by
existing smokers. It
contains nicotine
which is a highly addictive substance";
(f) the sale of the product is restricted in
line with the legal age for sale of tobacco
products in the relevant Member State; in
any case it should not be allowed under
the age of 18;
(g) the products are available to be sold
outside pharmacies;
(h) flavourings are allowed in the
products;
(i) the limitations on advertising,
sponsorship, audiovisual commercial
communication and product placement
for tobacco products as set out in
Directive 2003/33/EC and Directive
2010/13/EC shall apply to nicotine-
containing products;
(j) cross-border distance sales of nicotine-
containing products are regulated in
accordance with Article 16;
(k) tobacco trademarks, brand names and
symbols are not used on nicotine-
containing products.
4. The health warning referred to in
paragraph 3 shall comply with the
requirements specified in Article 10(4).
In
addition, it shall:
(a) be printed on the two largest surfaces
of the unit packet and any outside
packaging;
(b) cover 30 % of the external area of the
corresponding surface of the unit packet
and any outside packaging. That
proportion shall be increased to 32 % for
Member States with two official
languages and 35 % for Member States
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4. The health warning referred to in
paragraph
3(e)
shall comply with the
requirements specified in
Article 10.
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with three official languages.
5.
The Commission shall be empowered to
adopt delegated acts in accordance with
Article 22 to adapt the requirements in
paragraphs 3 and 4 taking into account
scientific and market developments and to
adopt and adapt the position, format,
layout, design and rotation of the health
warnings
5.
Member States shall monitor the
development of the nicotine-containing
products market, including any evidence
of gateway use among young people and
report their findings to the Commission.
Based on the evidence submitted as well
as scientific studies the Commission shall
submit a report to the European
Parliament and the Council on nicotine-
containing products five years after entry
into force of this Directive. The report
shall assess if amendments to this
Directive or any further legislation are
necessary.
Or. en
Justification
A notification procedure will ensure a better control of E-cigarettes at EU level and at the
same time it will maintain the availability of this nicotine-containing product which help
people stop smoking and is much less harmful than any tobacco products.
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