Amended proposal for a Directive of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products (recast version) - (presented by the Commission pursuant to Article 250(2) of the EC Treaty)
Date: 2000-06-28
Institutions: European Commission
Subjects: approximation of laws, consumer information, labelling, public health, tobacco industry

28.11.2000

EN

Official Journal of the European Communities

C 337 E/177

Amended proposal for a Directive of the European Parliament and of the Council on the approxi-
mation of the laws, regulations and administrative provisions of the Member States concerning the
manufacture, presentation and sale of tobacco products (recast version) (1)

(2000/C 337 E/30)

(Text with EEA relevance)

COM(2000) 428 final (cid:15) 1999/0244(COD)

(Submitted by the Commission pursuant to Article 250(2) of the EC Treaty on 6 July 2000)

(1) OJ C 150 E, 30.5.2000, p. 43.

INITIAL PROPOSAL

AMENDED PROPOSAL

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Unchanged

Having regard to the Treaty establishing the European
Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of
Committee,

the Economic and Social

Having regard to the opinion of the Committee of the Regions,

Acting in accordance with the procedure laid down in Article
251 of the Treaty,

Whereas:

(1) Council Directive 89/622/EEC of 13 November 1989 on
the approximation of the laws, regulations and adminis-
trative provisions of the Member States concerning the
labelling of tobacco products and the prohibition of the
marketing of certain types of tobacco for oral use (1) was
amended substantially by Directive 92/41/EEC (2). Since
further amendments are to be made to those Directives,
as well as to Council Directive 90/239/EEC of 17 May
1990 on the approximation of the laws, regulations and
administrative
States
concerning the maximum tar yield of cigarettes (3), all
those Directives should be recast in the interests of clarity.

the Member

provisions

of

(2) There are substantial differences between the Member
States’ laws, regulations and administrative provisions on
the manufacture, presentation, and sale of
tobacco
Such manufacture, presentation and sale
products.
transcend the borders of
the Member States and the
differences in question are likely to give rise to barriers
tobacco
to the movement between Member States of
products,
thereby
competition,
as
impeding the functioning of the nternal arket.

as well

distort

___________
(1) OJ L 359, 8.12.1989 p. 1.
(2) OJ L 158, 11.6.1992 p. 30.
(3) OJ L 137, 30.5.1990 p. 36.

(2) There are substantial differences between the Member
States’ laws, regulations and administrative provisions on
the manufacture, presentation, and sale of
tobacco
Such manufacture, presentation and sale
products.
transcend the borders of
the Member States and the
differences in question are likely to give rise to barriers
tobacco
to the movement between Member States of
products,
thereby
competition,
as
impeding the functioning of the Internal Market.

as well

distort

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INITIAL PROPOSAL

AMENDED PROPOSAL

(3) Those barriers should be eliminated and, to this end, the
rules relating to the manufacture, presentation and sale of
tobacco products should be approximated, whilst leaving
Member States
introducing, under
certain conditions, such requirements as they consider
necessary in order to guarantee the protection of
the
health of individuals.

the possibility of

(3) Those barriers should be reduced and over time elim-
inated and, to this end, the rules relating to the manu-
facture, presentation and sale of tobacco products should
be approximated, whilst leaving Member States the possi-
such
bility of
requirements as they consider necessary in order
to
guarantee the protection of the health of individuals.

introducing, under certain conditions,

(4) In accordance with Article 95(3) of

the
Commission is obliged,
in its proposals under Article
95(1) concerning health, safety, environmental protection
and consumer protection, to take as a base a high level of
protection, .

the Treaty,

(4) In accordance with Article 95(3) of

the
Commission is obliged,
in its proposals under Article
95(1) concerning health, safety, environmental protection
and consumer protection, to take as a base a high level of
protection, taking account in particular of any new devel-
opment based on scientific facts.

the Treaty,

(5) Directive 90/239/EEC established maximum limits for the
tar yield of cigarettes marketed in the Member States with
effect from 31 December 1992. The carcinogenic nature
of tar makes it necessary further to reduce the levels of
tar in cigarettes.

Unchanged

(6) Directive 89/622/EEC established a general warning to be
carried on the unit packaging of all tobacco products,
together with additional warnings exclusively for ciga-
rettes and,
for
additional warnings to other tobacco products.

from 1992, extended the requirement

(7) Directive 89/622/EEC prohibited the sale in the Member
States of certain types of tobacco for oral use. Article 151
of the Act of Accession of Austria, Finland and Sweden
grants the Kingdom of Sweden a derogation from the
provisions of that Directive in this regard.

(8) Cigarettes have been shown to produce amounts of
carbon monoxide which are hazardous to human health
and capable of contributing to heart disease and other
ailments. Differences
carbon
monoxide are liable to constitute barriers to trade and
to impede the smooth operation of the Internal Market.

concerning

rules

in

(8) Cigarettes have been shown to produce amounts of
carbon monoxide which are hazardous to human health
and capable of contributing to heart disease and other
ailments. Differences
carbon
monoxide could constitute barriers to trade and impede
the smooth operation of the Internal Market.

concerning

rules

in

(9) There are differences between the laws, regulations and
administrative provisions of the Member States on the
limitation of the maximum nicotine yield of cigarettes.
Such differences are liable to constitute barriers to trade
and to impede the smooth operation of the nternal arket.
Member States and scientific authorities have raised
specific problems of public health in a field which has
already been the subject of prior harmonisation measures,
which the Commission has examined.

(9) There are differences between the laws, regulations and
administrative provisions of the Member States on the
limitation of the maximum nicotine yield of cigarettes.
Such differences are liable to constitute barriers to trade
and to impede the smooth operation of
the Internal
Market. Member States and scientific authorities have
raised specific problems of public health in a field
which has already been the subject of prior harmonisation
measures, which the Commission has examined.

(10) Those obstacles should accordingly be eliminated and to
that end the release for free circulation, marketing and
free movement of cigarettes should be made subject to
common rules concerning maximum nicotine and carbon
monoxide levels.

Unchanged

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INITIAL PROPOSAL

AMENDED PROPOSAL

of

tendency

(11) The size of the nternal arket in tobacco products and the
increasing
to
concentrate production for the whole of the Community
in only a small number of production plants within the
Member States, calls for legislative action to achieve the
smooth operation of the nternal arket of tobacco products
to be carried out at Community rather than national level.

tobacco manufacturers

tobacco manufacturers

(11) The size of the Internal Market in tobacco products and
the increasing tendency of
to
concentrate production for the whole of the Community
in only a small number of production plants within the
Member States, calls for legislative action to achieve the
smooth operation of
tobacco
products to be carried out at Community rather than
national level.

the Internal Market of

(11a) The establishment of world-wide standards for tobacco
the
products is also the subject of negotiations for
creation of a World Health Organisation Framework
Convention on Tobacco Control.

(12)

In applying this Directive provision should be made for
establishing time-limits which allow, on the one hand,
completion to a maximum degree of efficiency of the
conversion already begun by Directive
process of
90/239/EEC, and, on the other, consumers and manu-
facturers to adapt to products with a lower tar, nicotine
and carbon monoxide yield.

Unchanged

(13)

In Directive 90/239/EEC Greece was granted a derogation
from the time-limits for the implementation of maximum
tar yields. That derogation is still in force.

and

substances

(14) Tobacco products have been shown to contain and emit
many noxious
known carcinogens
hazardous to human health when burnt. The consumer
has the right to be informed of the presence of these
substances when purchasing or consuming the product
and to have such information conveyed in a clear,
the most
legible and comprehensible manner. One of
effective methods of presenting this
information is
through the medium of warning labels on tobacco
product packaging.

(14a)

In recent years, scientific knowledge of the dangers of
passive smoking has been increased. It has been proven
that smoking in babies’ presence is a cause of sudden
infant death and that smoking during pregnancy is
should
harmful
therefore point to the dangers to others,
in particular
children.

unborn child. Warnings

the

to

(15) Experience of the application of the labelling provisions
of Directive 89/622/EEC has shown that the requirements
laid down therein are insufficient to meet their objective,
particularly given the hazardous,
including addictive,
nature of
tobacco products, and the complexity and
amount of information to be supplied,

(15) Experience of the application of the labelling provisions
of Directive 89/622/EEC has shown that the requirements
laid down therein are insufficient to meet their objective,
particularly given the hazardous,
including addictive,
tobacco products, and the complexity and
nature of
information to be supplied, as well as the
amount of
consumers
in the
targeted, 80 % of new smokers
European Union being under 18 years of age.

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INITIAL PROPOSAL

AMENDED PROPOSAL

Unchanged

(16) The presentation of warning labels and yields has
continued to remain variable in the different Member
States. As a consequence, consumers in one Member
State may be better informed as to the risks of tobacco
products than in another. Such differences are unac-
ceptable and are liable to constitute a barrier to trade
and to impede the operation of the internal market in
tobacco products. It is necessary that the existing legis-
lation be strengthened and clarified. A high level of health
protection should be ensured.

(17) These obstacles should accordingly be eliminated and, to
that end, the release for free circulation, marketing and
free movement of tobacco products should be subject to
clearer and strengthened rules on warnings and yields.

(17a) The Community and the Member States must encourage
research and technical progress with a view to estab-
lishing methods for accurate and reliable measurement
of the tar, nicotine and carbon monoxide yields of ciga-
rettes
Provisionally,
reference should be made to the standards ISO 4387,
ISO 10315 and ISO 8454, which are the only inter-
nationally recognised standards.

products.

tobacco

other

and

(17b) There are no internationally recognised standards or tests
for quantifying and assessing the yields of constituents in
cigarette smoke other than tar, nicotine and carbon
therefore, a procedure for development of
monoxide;
is necessary.
such standards,

in consultation with ISO,

(18) A number of the Member States have neither existing
legislation nor voluntary agreements in place on the
ingredients and additives used in the manufacture of
tobacco products. Several Member States in which such
legislation or voluntary agreements exist
receive no
information from tobacco manufacturers on the quantities
of such ingredients and additives present
in particular
tobacco products on a brand name by brand name basis.

Unchanged

States

the relevant authorities

(19) This lack of information together with the lack of toxico-
in the
logical data prevents
in any meaningful
Member
manner the toxicity of and hazards posed to the health
of the consumer by tobacco products. This is inconsistent
with the obligation placed on the Community to ensure a
high level of protection for human health.

from assessing

rights of

(20) The Community and the Member States have an obli-
the commercial and intellectual
gation to ensure that
are
tobacco manufacturers
property
protected under national and international law. Provision
should therefore be made for confidential treatment of
product data in so far as this is compatible with the
public interest

the

rights of

(20) The Community and the Member States have an obli-
the commercial and intellectual
gation to ensure that
are
tobacco manufacturers
property
protected under national and international law. Provision
should therefore be made for confidential treatment of
product data in so far as this is compatible with the
public interest, health protection and the objectives of
this directive.

the

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INITIAL PROPOSAL

AMENDED PROPOSAL

(21) Technical and scientific progress in the field of tobacco
products calls for regular re-evaluation of the provisions
and application in the Member States of this Directive.
Therefore,
reports by the
for
Commission is provided for.

a procedure

regular

Unchanged

(21a) The Community and the Member States must encourage
in establishing the
research and technical progress
substances
exposure
to toxins
caused by the use of
in order to
ensure a high level of health protection through the
regulation of such products and to provide meaningful
information to consumers. The Community Tobacco
Fund provides a means for undertaking such research.

and other harmful
tobacco products,

(21b) The measures to be taken for the implementation of this
Directive should be adopted in accordance with Council
Decision 1999/468/EC of 28 June 1999 laying down the
procedures for the exercise of
implementing powers
conferred on the Commission (1).

(22) Council Directive 89/552/EEC (2), as last amended by
Directive 97/36/EC of the European Parliament and of
the Council (3), prohibits all forms of television advertising
tobacco products. Directive
for cigarettes and other
98/43/EC of
the
the European Parliament
Council (4) regulates direct and indirect advertising of
tobacco products, including sponsorship.

and of

Unchanged

(23) The Council Resolution of 26 November 1996 on the
reduction of smoking in the European Community (5)
called upon the Commission to take particular account,
in its policies in various fields in so far as they have
relevance to tobacco or tobacco products, of the detri-
mental effect of smoking on the health and quality of life
same Council
the Community. The
of
Resolution called upon the Commission to examine
further the possible measures which might be taken by
the Community and the Member States directed towards
the reduction of smoking.

citizens of

(23a) The Commission Communication to the Council and the
European Parliament on the present and proposed
Community role in combating tobacco consumption (6)
makes a large number of proposals as to the action that
might be taken at Community level to combat the use of
tobacco products; among other things, it encourages the
Member States to make use of the opportunities available
to them to tax tobacco products more heavily. The price
tobacco products can influence to a large extent
of
whether
such products begins or
ceases, particularly as regards youngsters.

consumption of

___________
(2) OJ L 298, 17.10.1989, p. 23.
(3) OJ L 202, 30.7.1997, p. 60.
(4) OJ L 213, 30.7.1998, p. 9.
(5) OJ C 374, 11.12.1996, p. 4.

___________
(1) OJ L 184, 17.7.1999, p. 23.
(6) COM(96) 609 final.

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INITIAL PROPOSAL

AMENDED PROPOSAL

(23b) In particular, as was recommended in this Commission
Communication, all necessary steps must be taken to
implement an effective information and prevention
strategy and to promote research and studies in this
area. Such a strategy must be aimed at those sections
of the population in Europe that are most at risk, with
particular reference to young people and women. Socio-
economic direct and indirect costs of active and passive
tobacco use should also be regularly evaluated and made
available to the public.

(24) The Commission Communication to the Council and the
European Parliament on the present
and proposed
Community role in combating tobacco consumption
called for further review of maximum permitted tar and
nicotine limits. The Communication advocated a review of
existing warning label requirements and called for action
on the definition of the description Dlow tarE considering
that such descriptions may mislead consumers by under-
stating the dangers to health of such products. The
Communication noted the lack of any Community legis-
lation to evaluate or regulate the toxicity and health
consequences arising from the use of additives
in
tobacco products. There is Community legislation on
in a wide range of other
additives and ingredients
products which may have health consequences for the
consumer.

and nicotine

the description Dlow tarE

(24) This Communication also called for further review of
maximum permitted tar
limits. The
Communication advocated a review of existing warning
label requirements and called for action on the definition
such
of
descriptions may mislead consumers by understating the
dangers to health of such products. The Communication
noted the lack of any Community legislation to evaluate
or regulate the toxicity and health consequences arising
from the use of additives in tobacco products. There is
Community legislation on additives and ingredients in a
wide range of other products which may have health
consequences for the consumer.

considering that

Unchanged

into believing that

(25) The use of terms such as Dlow tarE on cigarette packaging
can mislead the consumer
such
products are inherently safer than other types of ciga-
rettes. National rules on the definition of such cigarettes
are not reflected in Community law, leading to potential
internal market obstacles, and to a gap in measures to
ensure a high level of public health protection in this
context. Certain smokers ingest higher levels of tar than
those indicated on Dlow tarE cigarette packets because of
the nature of their smoking behaviour.

(26) The European Parliament Report of 4 November 1997 on
the Commission Communication calls for any substance
added to tobacco to be non-toxic and proven not to have
any harmful effects on health in burnt or unburned form.
The Report supports initiatives aimed at making the
health warnings more prominent and clearly legible,
printed in black on white.

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INITIAL PROPOSAL

AMENDED PROPOSAL

(27)

that

effects on health of

the Helsinki
In its Recommendation arising out of
the High Level
Consensus Conference on Tobacco,
Cancer Experts Committee recommended (1)
the
Community should take action to regulate the toxicity
and harmful
ingredients,
including additives,
in cigarettes and considered that a
nicotine limit should be introduced for cigarettes as
soon as possible. The Committee recommended that the
labelling provisions for cigarettes should be strengthened
and made more prominent and that accurate information
about smoking and its health consequences be given to
the consumer.

the

(28) This Directive should be without prejudice to the obli-
gations of the Member States concerning the time-limits
for transposition and for application of the Directives set
out in Annex III.

(28) This Directive should be without prejudice to the obli-
gations of the Member States concerning the time-limits
for transposition and for application of the Directives set
out in Annex II.

HAVE ADOPTED THIS DIRECTIVE:

Unchanged

Article 1

Object

The objective of this Directive is the approximation of the laws,
regulations and administrative provisions of the Member States
concerning the tar yields of cigarettes and the warnings
regarding health to appear on packets of tobacco products,
together with the approximation of the laws, regulations and
administrative provisions of
the Member States concerning
carbon monoxide and nicotine yields and the ingredients of
tobacco products,
taking as a base a high level of health
protection.

The objective of this Directive is the progressive approximation
of the laws, regulations and administrative provisions of the
Member States concerning the tar yields of cigarettes and the
warnings regarding health to appear on packets of tobacco
products, together with the approximation of the laws, regu-
lations and administrative provisions of
the Member States
concerning carbon monoxide and nicotine yields and the
ingredients of tobacco products, taking as a base a high level
of health protection.

Article 2

Definitions

Unchanged

For the purposes of this Directive:

1.

DTobacco productsE: means products for the purposes of
inasmuch as they
smoking, sniffing, sucking or chewing,
are, even partly, made of tobacco;

2.

DTarE: means the raw anhydrous nicotine-free condensate of
smoke;

3.

DNicotineE: means nicotinic alkaloids;

4.

DTobacco for oral useE: means all products for oral use,
those intended to be smoked or chewed, made
except
wholly or partly of tobacco,
in powder or in particulate
form or in any combination of these forms G particularly
those presented in sachet portions or porous sachets G or
in a form resembling a food product;

___________
(1) Final Annex to COM(96) 609.

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INITIAL PROPOSAL

AMENDED PROPOSAL

5.

DIngredientE: means any substance except for natural tobacco
leaf or its plant parts used as an additive in the manufacture
or preparation of a tobacco product and still present in the
finished product, even if in altered form

5.

DIngredientE: means any substance except for natural tobacco
leaf or its plant parts used as an additive in the manufacture
or preparation of a tobacco product and still present in the
finished product, even if in altered form, including paper,
filter, inks and adhesives.

Article 3

Unchanged

Cigarettes: tar, nicotine and carbon monoxide levels

The tar yield of cigarettes released for free circulation,
1.
marketed or manufactured in the Member States shall not be
greater than 10 mg per cigarette as of 31 December 2003;

The nicotine yield of cigarettes released for free circu-
2.
lation, marketed or manufactured in the Member States shall
not be greater than 1.0 mg per cigarette as of 31 December
2003;

3.
The carbon monoxide yield of cigarettes released for free
circulation, marketed or manufactured in the Member States
shall not be greater
than 10 mg per cigarette as of 31
December 2003;

4. Member States may apply this Article in respect of ciga-
rettes other than those released for free circulation or marketed
in the Member States from December 2004 but must apply the
provisions thereof by December 2006 at the latest.

Article 4

Derogation

Unchanged

For Greece, as a temporary derogation, the limit value of tar
yields and date of implementation shall be 10 mg of tar as of
31 December 2006.

This derogation may not be used to justify controls at the
Community’s internal frontiers.

Article 5

Measurement methods

1.
The tar, nicotine and carbon monoxide yields referred to
in Article 3, which must be indicated on cigarette packets, shall
be measured on the basis of ISO methods 4387 for tar, 10315
for nicotine, and 8454 for carbon monoxide.

1.
The tar, nicotine and carbon monoxide yields referred to
in Article 3 shall be measured on the basis of ISO methods
4387 for
tar, 10315 for nicotine, and 8454 for carbon
monoxide.

The accuracy of the indications on the packets shall be verified
in accordance with ISO standard 8243.

The accuracy shall be verified in accordance with ISO standard
8243.

2. Member States may require that the tests referred to in
paragraph 1 be carried out by a testing laboratory approved for
the purpose by the relevant Member State authorities.

2. Member States shall require that the tests referred to in
paragraph 1 be carried out or verified by a testing laboratory
approved for the purpose by the relevant Member State au-
thorities.

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INITIAL PROPOSAL

AMENDED PROPOSAL

3. Member States may also require tobacco manufacturers
or importers to carry out any other such tests as may be laid
down by the appropriate national authorities in order to assess
the yields of other substances produced by their
tobacco
products on a brand name by brand name basis. They may
also require that such tests be carried out in approved testing
laboratories as laid down in paragraph 2.

Unchanged

4.
the
The results of all such tests carried out under
provisions of paragraph 3 shall be disclosed to the relevant
national authorities annually.

4.
the
The results of all such tests carried out under
provisions of paragraph 3 shall be disclosed to the relevant
national authorities whenever
there is a change in the
composition of a tobacco product.

The Member States shall take such steps as are necessary
the trade secrecy of all data and information

5.
to protect
submitted pursuant to the requirements of this Article.

The Member States and the Commission shall ensure that
5.
the results of
referred to in this article are
disseminated by any appropriate means in order to inform
consumers, without prejudice to measures intended to protect
the confidentiality of information on manufacturing processes.

the tests

The Member States shall supply all data and information
6.
submitted pursuant to this Article to the Commission not later
than 31 May of each year.

Unchanged

Article 6

Labelling

The tar, nicotine and carbon monoxide yields of cigarettes
1.
shall be printed on one side of the cigarette packet in the
official language or languages of the Member State where the
product is placed on the market, so that at least 10 % of the
corresponding surface is covered.

The maximum authorised tar, nicotine and carbon
1.
monoxide yields of cigarettes referred to in Article 3(1) shall
be printed on one side of the cigarette packet in the official
language or languages of the Member State where the product
is placed on the market, so that at least 30 % of the corre-
sponding surface is covered.

This percentage shall be raised to 12 % for countries with two
official
languages and 15 % for countries with three official
languages.

This percentage shall be raised to 35 % for countries with two
official
languages and 40 % for countries with three official
languages.

Each unit packet of

2.
for
smokeless and oral tobacco products, shall carry one of the
following general warnings:

tobacco products,

except

Unchanged

G DSmoking killsE.

G DSmoking can killE.

Each unit packet of
smokeless
tobacco products,
warning taken exclusively from Annex I.

tobacco products, except for oral and
an additional
carry

shall

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INITIAL PROPOSAL

AMENDED PROPOSAL

Oral tobacco products, where they are permitted to be placed
on the market pursuant to the provisions of Article 9, and
smokeless tobacco products shall carry the warning in Annex
II. This warning shall be placed on the most visible surface of
the unit packet, and on any outside packaging used in the retail
sale of the product. Member States shall have the right to
determine the positioning of the warning on this surface in
order to accommodate language requirements.

Oral tobacco products, where they are permitted to be placed
on the market pursuant to the provisions of Article 10, and
smokeless tobacco products shall carry the warning: This
tobacco product can damage your health and create addiction.
This warning shall be placed on the most visible surface of the
unit packet, and on any outside packaging used in the retail
sale of the product. Member States shall have the right to
determine the positioning of the warning on this surface in
order to accommodate language requirements.

3.
The general warning referred to in the first subparagraph
of paragraph 2 shall be printed on the most visible surface of
the unit packet, and on any outside packaging used in the retail
sale of the product. Member States shall have the right to
determine the positioning of the warning on this surface in
order to accommodate language requirements.

Unchanged

The warning referred to in the second subparagraph of
paragraph 2 shall be printed on the other most visible
surface of
the unit packet, and on any outside packaging
used in the retail sale of the product. Member States shall
have the right to determine the positioning of the warning
language
on these
requirements.

to accommodate

in order

surfaces

The text of warnings and yield indications required under

4.
this Article, shall be:

The text of warnings and maximum yield indications

4.
required under this Article, shall be:

G printed in black Helvetica bold type on a white back-
ground. In order to accommodate language requirements,
the Member States shall have the right to determine the
point size of the font, provided that the font size specified
in their legislation is such as to occupy the greatest possible
proportion of the area set aside for the text required;

G printed in black Helvetica bold type (full shading or 100 %
intensity) on a white background. In order to accommodate
language requirements, the Member States shall have the
right to determine the point size of the font, provided that
the font size specified in their legislation is such as to
occupy the greatest possible proportion of
the area set
aside for the text required;

G in lower case type except for the first letter of the message;

Unchanged

G centred in the area in which the text is required to be

printed, parallel to the top edge of the packet;

G surrounded by a black border not less than 3mm in width
and not more than 4mm in width which does not in any
way interfere with the text of the warning or information
given;

G in the official language or languages of the Member State

where the product is placed on the market.

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AMENDED PROPOSAL

5.
The printing of the texts required by this Article on the
underside or on the tax stamps of unit packets shall be
prohibited. The texts required pursuant to this Article shall
be irremovably fixed, indelible and shall not in any way be
hidden, obscured or interrupted by other written or pictorial
matter, nor by the opening of the packet.

5.
The printing of the texts required by this Article on the
tax stamps of unit packets shall be prohibited. The texts
required pursuant to this Article shall be irremovably printed,
indelible and shall not in any way be hidden, obscured or
interrupted by other written or pictorial matter, nor by the
opening of the packet. In the case of tobacco products other
than cigarettes, the texts may be affixed by means of stickers,
provided that such stickers are irremovable.

The general warning required pursuant

6.
to the first
subparagraph of paragraph 2 and the warning for smokeless
and oral tobacco products referred to in the third subparagraph
of paragraph 2 shall cover not less than 25 % of the external
area of the corresponding surface of the unit packet of tobacco
on which it is printed. This percentage shall be increased to
languages and 30 % for
27 % for countries with two official
countries with three official languages.

The general warning required pursuant

6.
to the first
subparagraph of paragraph 2 and the warning for smokeless
and oral tobacco products referred to in the third subparagraph
of paragraph 2 shall cover not less than 30 % of the external
area of the corresponding surface of the unit packet of tobacco
on which it is printed. This percentage shall be increased to
languages and 35 % for
32 % for countries with two official
countries with three official languages.

The

7.
second
additional warning referred to in the
subparagraph of paragraph 2 shall cover not less than 25 %
of the external area of the corresponding surface of the unit
is printed. This percentage shall be
packet on which it
increased to 27 % for countries with two official
languages
and 30 % for countries with three official languages.

The

7.
second
additional warning referred to in the
subparagraph of paragraph 2 shall cover not less than 40 %
of the external area of the corresponding surface of the unit
is printed. This percentage shall be
packet on which it
increased to 45 % for countries with two official
languages
and 50 % for countries with three official languages.

These additional warnings shall be rotated in such a way as to
guarantee the successive appearance of each warning on an
equal quantity of unit packets. A tolerance of 5 % shall be
permitted.

These additional warnings shall be rotated in such a way as to
guarantee their regular appearance.

In the case of unit packets intended for products other
8.
the most visible surface of which exceeds
than cigarettes,
100 cm2 in area,
the warnings referred to in Article 6(2)
shall cover an area of at least 25 cm2 on each surface. This
area shall be increased to 27 cm2 for countries with two
official
for countries with three
official languages.

languages and 30 cm2

9.
To ensure product traceability, the tobacco product batch
number shall be indicated on each unit packet in any appro-
priate manner enabling the origin of
to be
identified.

the product

Article 7

Unchanged

Further product information

Not later than 31 December 2003, Member States shall
1.
require all manufacturers and importers of tobacco products to
submit to them a list of all ingredients, and quantities thereof,
used in the manufacture of their tobacco products by brand
name. This list shall be accompanied by a statement setting out
the
and
inclusion of
constituents in their tobacco products.

such ingredients

reasons

the

for

shall

require

all manufacturers and
1. Member States
importers of tobacco products to submit to them a list of all
ingredients, and quantities thereof, used in the manufacture of
their tobacco products, to be sold in that Member State, by
brand name and type. This list shall be accompanied by a
statement setting out the reasons for the inclusion of such
ingredients and constituents in their tobacco products, and
by the toxicological data on those ingredients in burnt and
unburned form, and their effects on health taking into
account, inter alia their addictiveness.

C 337 E/188

EN

Official Journal of the European Communities

28.11.2000

INITIAL PROPOSAL

AMENDED PROPOSAL

Member States shall also require manufacturers and importers
to provide all data on these non-tobacco ingredients in burnt
the said
and unburned form, and to demonstrate that
ingredients are safe for the health of
the consumer when
used as intended in their tobacco products. This information,
together with that referred to in the first subparagraph shall be
submitted for the first time on 1 January 2004 and on an
annual basis thereafter.

2.
The Member States shall take such steps as are necessary
to protect the trade secrecy of all such data and information
submitted pursuant to the requirements set out in paragraph 1.

The Member States shall supply all toxicological data and
to the

3.
information submitted pursuant
Commission no later than 31 May of each year.

to this Article

This
information shall be submitted on a yearly basis,
beginning no later than one year after the date referred to in
Article 13(1).

2.
The Member States and the Commission shall ensure that
the information and data referred to in paragraph 1 are
disseminated by any appropriate means in order to inform
consumers, without prejudice to measures intended to protect
the confidentiality of information on manufacturing processes.

The Member States shall supply all toxicological data and
3.
information submitted pursuant
to the
Commission no later than 31 May of each year, which shall
take account thereof in drawing up the reports referred to in
Article 11.

to this Article

Article 8

Product descriptions

Unchanged

1.
The use of the terms Dlow tarE, DlightE, Dultra lightE, DmildE or
any other similar terms which have the aim or the direct or
indirect effect of conveying the impression that a particular
tobacco product is less harmful than others shall be prohibited,
unless such terms have been expressly authorised by the
Member States where the products in question have been
marketed or manufactured.

The Member States which authorise the use of such terms
2.
shall notify the Commission thereof,
together with the
conditions applied to such authorisation. The Commission
shall present
this information in the report referred to in
Article 10.

including indication of

The use of the terms Dlow tarE, DlightE, Dultra lightE, DmildE or
1.
the yields,
any other similar terms,
which have the aim or
indirect effect of
conveying the impression that a particular tobacco product is
less harmful than others shall be prohibited, unless such terms
have been expressly authorised by the Member States where
the products in question have been marketed or manufactured.

the direct or

The Member States which authorise the use of such terms
2.
shall notify the Commission thereof,
together with the
conditions applied to such authorisation. The Commission
shall present this information in the reports referred to in
Article 11, together with any proposals for remedial action
required to resolve Internal Market disparities which have
been identified.

Article 9

Committee procedure

The measures to be taken for the implementation and adap-
tation to scientific and technical progress of
the Directive
concerning:

G definitions (Article 2);

G measurement methods (Article 5);

G warnings to be printed on cigarette packets and their

rotation (Article 6);

shall be adopted by means of the regulatory procedure referred
to in Article 5 of Council Decision 1999/468/EC, having regard
to Articles 7 and 8 thereof.

The period provided for
1999/468/EC shall be three months.

in Article 5(6) of Decision

28.11.2000

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Official Journal of the European Communities

C 337 E/189

INITIAL PROPOSAL

Article 9

Oral tobacco

AMENDED PROPOSAL

Article 10

Oral tobacco

The Member States shall prohibit the placing on the market of
tobacco for oral use, without prejudice to the provisions of
Article 151 of the Act of Accession of Austria, Finland and
Sweden.

Unchanged

Article 10

Report

Article 11

Report

submit

the Council

and the Economic

than 31 December 2005, and every two years
Not
later
to the European
the Commission shall
thereafter,
and Social
Parliament,
Committee a report on the application of this Directive and,
to devel-
if necessary, make further proposals to adapt
opments in the field of
to the extent
necessary for the establishment and operation of the internal
market, and taking account of any new development based on
scientific facts.

tobacco products,

it

submit

the Council

and the Economic

than 31 December 2004, and every two years
Not
later
to the European
the Commission shall
thereafter,
and Social
Parliament,
Committee a report on the application of this Directive and,
if necessary, make further proposals to adapt
to devel-
opments in the field of
to the extent
necessary for the establishment and operation of the internal
market, and taking account of any new development based on
scientific facts, and developments on internationally agreed
product standards.

tobacco products,

it

For the first report,
the Commission will attach particular
importance, with a view to improving the operation of the
internal market, to:

(a) Methodologies for more realistically assessing and regu-

lating toxic exposure and harm;

(b) Subsequent reduction of the yields laid down in Article 3(1)
and development of standards for products other than ciga-
rettes;

(c) Evaluation of

tobacco products which may have the

potential to reduce harm;

(d) Evidence-based improvements in health warnings, in terms

of size, position and wording;

(e) The question of the criteria used for approving the testing

laboratories referred to in Article 5;

(f) The possibility of drawing-up a common list of

the

ingredients referred to in Article 7.

In drawing up the report, the Commission shall call upon
recognised scientific and technical expertise.

Article 11

Article 12

Import, sale and consumption of tobacco products

Import, sale and consumption of tobacco products

1. Member States may not, for considerations of limitation
of the tar, nicotine or carbon monoxide yields of cigarettes,
labelling, or other requirements of this Directive prohibit or
restrict the import, sale and consumption of tobacco products
which comply with this Directive.

Unchanged

C 337 E/190

EN

Official Journal of the European Communities

28.11.2000

INITIAL PROPOSAL

AMENDED PROPOSAL

2.
This Directive shall not otherwise affect the right of the
Member States to adopt, in accordance with the Treaty, more
stringent rules concerning the import, sale and consumption of
tobacco products they deem necessary in order to protect
public health.

Article 12

Implementation

Article 13

Implementation

for

1. Without prejudice to the provisions of Article 13, as
regards
shall
time-limits
bring into force the laws,
regulations and administrative
provisions necessary to comply with this Directive by 31
December 2001 at the latest. They shall forthwith inform the
Commission thereof.

transposition, Member States

for

1. Without prejudice to the provisions of Article 14, as
regards
shall
time-limits
bring into force the laws,
regulations and administrative
provisions necessary to comply with this Directive by 31
December 2001 at the latest. They shall forthwith inform the
Commission thereof.

transposition, Member States

When Member States adopt these provisions, they shall contain
a reference to this Directive or be accompanied by such a
their official publication.
reference on the occasion of
Member States shall determine how such reference is to be
made.

Unchanged

2.
Products existing at the date of entry into force of this
Directive which do not comply with this Directive may
continue to be marketed for two years thereafter.

3. Member States shall communicate to the Commission the
text of the provisions of national law which they adopt in the
field covered by this Directive.

Article 13

Repeal

Article 14

Repeal

Directives 89/622/EEC, 90/239/EEC and 92/41/EEC are
repealed, without prejudice to the obligations of the Member
transposition and
time-limits
concerning the
States
application set out in Annex III.

for

Directives 89/622/EEC, 90/239/EEC and 92/41/EEC are
repealed, without prejudice to the obligations of the Member
transposition and
time-limits
concerning the
States
application set out in Annex II.

for

References to the repealed Directives shall be construed as
references to this Directive and shall be read in accordance
with the correlation table in Annex IV.

References to the repealed Directives shall be construed as
references to this Directive and shall be read in accordance
with the correlation table in Annex III.

Article 14

Entry into force

This Directive shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
European Communities.

Unchanged

Article 15

Addressees

This Directive is addressed to the Member States.

Unchanged

Article 15

Entry into force

Article 16

Addressees

28.11.2000

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Official Journal of the European Communities

C 337 E/191

INITIAL PROPOSAL

AMENDED PROPOSAL

ANNEX I

Tobacco products other than smokeless and oral tobacco

List of additional health warnings referred to in Article 6(2)

Additional health warnings which must be included on the national
pursuant to the second subparagraph of Article 6(2)

lists

Deleted

1. Smokers die younger

Unchanged

2. Smoking causes heart disease and strokes

3. Smoking causes cancer

Additional warnings from amongst which the Member States may choose

Deleted

1. Smoking when pregnant harms your baby

4. Smoking when pregnant harms your baby

2. Protect children: don’t make them breathe your smoke

5. Passive smoking harms those around you, especially children

3. Your doctor can help you stop smoking

6. Your doctor can help you stop smoking

4. Smoking is addictive

7. Smoking is addictive

5. Stopping smoking reduces the risk of serious disease

8. Stopping smoking reduces the risk of serious disease

9. Smoking kills half a million persons each year in the European

Union

10.

If you smoke, you are killing yourself

11. Get help to stop smoking:

(Telephone; P.O. Box No.;

Internet

address; Consult your doctor/pharmacist)

ANNEX II

Deleted

Oral and smokeless tobacco products

Smokeless (or oral, as appropriate) tobacco can damage your health

C 337 E/192

EN

Official Journal of the European Communities

28.11.2000

INITIAL PROPOSAL

ANNEX III

Time-limits for transposition and for application of repealed Directives

(referred to in Article 13)

AMENDED PROPOSAL

ANNEX II

Time-limits for transposition and for application of repealed Directives

(referred to in Article 14)

Directive

Time-limits for transposition

Time-limits for application

89/622/EEC

(OJ L 359, 8.12.1989, p. 1)

1 July 1990

90/239/EEC

(OJ L 137, 30.5.1990, p. 36)

18 November 1991

92/41/EEC

(OJ L 158, 11.6.1992, p. 30)

1 July 1992

(1) For all the Member States except Greece.
(2) Ibid.
(3) Derogation applying to Greece only.
(4) Ibid.
(5) Ibid.
(6) Ibid.

31 December 1991
31 December 1992
31 December 1993

31 December 1992 (1)
31 December 1997 (2)
31 December 1992 (3)
31 December 1998 (4)
31 December 2000 (5)
31 December 2006 (6)

1 July 1992
1 January 1994
31 December 1994

28.11.2000

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Official Journal of the European Communities

C 337 E/193

INITIAL PROPOSAL

ANNEX IV

CORRELATION TABLE

This Directive

Directive 89/622/EEC as
amended by Directive
92/41/EEC

Directive
90/239/EEC

Other Acts

Article 1

Article 1

Article 1

Partly new

Article 2 points
1, 2 and 3

Article 2(1), (2)
and (3)

Article 2(1)

Article 2(4)

Article 2(2)

Article 3(1)
and (2)

Article 2(3)

Articles 3 and
4

Article 2,
point 4

Article 2,
point 5

Article 3(1)

Article 3(2)

Article 3(3)

Article 4

Article 5(1)

Article 5(2)
to (6)

Article 6(1)

Article 3(3)

Article 6(2)
first
subparagraph

Article 6(2)
second
subparagraph

Article 6(2)
third
subparagraph

Article 6(3)

Article 4(1)

Article 4(2a)(a)

Article 4(1)
(2a)(c)

and

Article 4(1)
(2a)(a)

and

Article 6(4)

Article 4(4)

Article 6(5)

Articles 4(4) and
4(5)

Article 6(6)

Article 4(4)

Article 4(4)

Article 4(2)
second indent

Article 8(a)

Article 6(7)
first
subparagraph

Article 6(7)
second
subparagraph

Article 7

Article 8

Article 9

Article 10

Article 11(1)

Article 8(1)

Article 7(1)

New

Partly new

New

New

Partly new

Partly new

New

Partly new

Partly new

Partly new

Partly new

Partly new

New (except
final indent)

for

Partly new

Partly new

Partly new

New

New

Partly new

New

Partly new

Act of
Accession for
Sweden

C 337 E/194

EN

Official Journal of the European Communities

28.11.2000

This Directive

Directive 89/622/EEC as
amended by Directive
92/41/EEC

Directive
90/239/EEC

Article 11(2)

Article 8(2)

Article 7(2)

Other Acts

Article 12(1)

Article 9(1)

Article 8(1)

Partly new

Article 12(2)

Article 9(2)

Article 8(2)

Article 12(3)

Article 9(1)

Article 8(3)

Article 13

Article 14

Article 15

Annex I

Annex II

Article 10

Article 9

Annex 1

Annex 2

AMENDED PROPOSAL

ANNEX III

CORRELATION TABLE

This Directive

Directive 89/622/EEC
as amended by Directive
92/41/EEC

Directive
90/239/EEC

Other Acts

Article 1

Article 1

Article 2
points 1, 2 and 3

Article 2(1), (2)
and (3)

Article 2, point 4 Article 2(4)

Article 2, point 5

Article 1

Article 2(1)

Article 2(2)

Article 3(1)
and (2)

Article 2(3)

Articles 3 and
4

Article 3(1)

Article 3(2)

Article 3(3)

Article 4

Article 5(1)

Article 5(2)
to (6)

Article 6(1)

Article 3(3)

Article 6(2)
first
subparagraph

Article 6(2)
second
subparagraph

Article 6(2)
third
subparagraph

Article 6(3)

Article 4(1)

Article 4(2a)(a)

Article 4(1)
(2a)(c)

and

Article 4(1) and
(2a)(a)

Article 6(4)

Article 4(4)

Article 6(5)

Articles 4(4)
and 4(5)

Article 6(6)

Article 4(4)

New

Partly new

Partly new

9

Partly new

New

Partly new

New

New

Partly new

Partly new

New

Partly new

Partly new

Partly new

Partly new

Partly new

New (except
final indent)

for

Partly new

Partly new

28.11.2000

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Official Journal of the European Communities

C 337 E/195

This Directive

Directive 89/622/EEC
as amended by Directive
92/41/EEC

Directive
90/239/EEC

Other Acts

Article 4(4)

Article 4(2)
second indent

Article 6(7)
first
subparagraph

Article 6(7)
second
subparagraph

Article 7

Article 8

Article 9

Article 10

Article 8(a)

Article 11

Article 12(1)

Article 8(1)

Article 12(2)

Article 8(2)

Article 13(1)

Article 9(1)

Article 13(2)

Article 9(2)

Article 13(3)

Article 9(1)

Article 7(1)

Article 7(2)

Article 8(1)

Article 8(2)

Article 8(3)

Article 14

Article 15

Article 16

Annex I

Article 10

Annex 1

Article 9

Act of
Accession for
Sweden

Partly new

New

New

New

Partly new

New

Partly new

Partly new

New

Partly new