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)
Date: 1999-11-16
Institutions: European Commission
Subjects: approximation of laws, consumer information, labelling, public health, tobacco industry

30.5.2000

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Official Journal of the European Communities

C 150 E/43

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 manu-
facture, presentation and sale of tobacco products (recast version)

(2000/C 150 E/03)

COM(1999) 594 final (cid:151) 1999/0244(COD)

(Submitted by the Commission on 7 January 2000)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF
THE EUROPEAN UNION,

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 provisions of the Member States concerning
the maximum tar yield of cigarettes (3), all those Directives
should be recast in the interests of clarity.

Such manufacture, presentation and

(2) There are substantial differences between the Member
States’ laws, regulations and administrative provisions on
tobacco
the manufacture, presentation,
products.
sale
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
thereby
competition,
as
products,
impeding the functioning of the internal market.

and sale of

as well

distort

(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 the possibility of introducing, under certain
conditions, such requirements as they consider necessary
in order to guarantee the protection of the health of indi-
viduals.

(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.

(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,

(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.

(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 cigarettes
and, from 1992, extended the requirement for additional
warnings to other tobacco products.

(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

(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
to
movement of cigarettes
common rules
and
carbon monoxide levels.

concerning maximum nicotine

should be made subject

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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

(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
receive no
legislation or voluntary agreements exist
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.

(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.

the relevant authorities

(19) This lack of information together with the lack of toxico-
logical data prevents
in the
Member States from assessing in any meaningful 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.

(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
known carcinogens
many noxious
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,
legible and comprehensible manner. One of
the most
effective methods of presenting this
information is
through the medium of warning labels on tobacco
product packaging.

rights of

(20) The Community and the Member States have an obli-
gation to ensure that
the commercial and intellectual
are
property
tobacco manufacturers
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

(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

(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.

(22) Council Directive 89/552/EEC (1), as last amended by
Directive 97/36/EC of the European Parliament and of
the Council (2), prohibits all forms of television advertising
tobacco products. Directive
for cigarettes and other
98/43/EC of
the
the European Parliament
Council (3) regulates direct and indirect advertising of
tobacco products, including sponsorship.

and of

(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.

(23) The Council Resolution of 26 November 1996 on the
reduction of smoking in the European Community (4)
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
the Community. The same Council
life of citizens 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.

(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.

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

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(24) The Commission Communication to the Council and the
European Parliament on the present
and proposed
Community role in combating tobacco consumption (1)
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 (cid:145)low tar(cid:146) 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
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.

arising from the use of additives

into believing that

(25) The use of terms such as (cid:145)low tar(cid:146) 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 ’low tar’ 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.

that

effects on health of

(27) In its Recommendation arising out of
the Helsinki
Consensus Conference on Tobacco,
the High Level
Cancer Experts Committee recommended (2)
the
Community should take action to regulate the toxicity
and harmful
ingredients,
in cigarettes and considered that a
including additives,
should be introduced for cigarettes as
nicotine limit
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

(1) COM(96) 609 final.
(2) Final Annex to COM(96) 609.

for transposition and for application of the Directives set
out in Annex III.

HAVE ADOPTED THIS DIRECTIVE:

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
taking as a base a high level of health
tobacco products,
protection.

Article 2

Definitions

For the purposes of this Directive:

1.

(cid:145)Tobacco products(cid:146): means products
for
smoking, sniffing, sucking or chewing,
are, even partly, made of tobacco;

the purposes of
inasmuch as they

2.

(cid:145)Tar(cid:146): means the raw anhydrous nicotine-free condensate of
smoke;

3.

(cid:145)Nicotine(cid:146): means nicotinic alkaloids;

4.

(cid:145)Tobacco for oral use(cid:146): means all products for oral use, except
those intended to be smoked or chewed, made wholly or
partly of tobacco, in powder or in particulate form or in
any combination of
- particularly those
these forms
presented in sachet portions or porous sachets - or in a
form resembling a food product;

5.

(cid:145)Ingredient(cid:146): 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.

Article 3

Cigarettes: tar, nicotine and carbon monoxide levels

1.
The tar 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;

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

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

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

Article 4

Derogation

Each unit packet of

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

tobacco products,

except

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.

(cid:151) (cid:145)Smoking kills(cid:146).

(cid:151) (cid:145)Smoking can kill(cid:146).

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.

The accuracy of the indications on the packets 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.

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.

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

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

tobacco products, except
shall

carry

for oral and
an additional

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.

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.

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

to accommodate

in order

surfaces

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 text of warnings and yield indications required under

4.
this Article, shall be:

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

Article 6

Labelling

(cid:151) 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;

1.
The tar, nicotine and carbon monoxide yields of cigarettes
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.

(cid:151) in lower case type except for the first letter of the message;

(cid:151) centred in the area in which the text is required to be

printed, parallel to the top edge of the packet;

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(cid:151) 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;

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

(cid:151) in the official language or languages of the Member State

where the product is placed on the market.

Article 8

Product descriptions

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.

The use of the terms (cid:145)low tar(cid:146), (cid:145)light(cid:146), (cid:145)ultra light(cid:146), (cid:145)mild(cid:146) or
1.
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 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

second
additional warning referred to in the
7.
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.

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.

Article 7

Further product information

1.
Not later than 31 December 2003, Member States shall
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

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 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.

Article 9

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.

Article 10

Report

submit

the Council

and the Economic

than 31 December 2005, and every two years
Not
later
to the European
the Commission shall
thereafter,
Parliament,
and Social
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.

tobacco products,

it

Article 11

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.

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.

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Article 12

Implementation

Article 13

Repeal

for

1. Without prejudice to the provisions of Article 13, as
shall
time-limits
regards
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
reference on the occasion of
their official publication.
Member States shall determine how such reference is to be
made.

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.

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

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.

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.

Article 15

Addressees

This Directive is addressed to the Member States.

ANNEX I

Tobacco products other than smokeless and oral tobacco

Additional health warnings which must be included on the national

lists pursuant to the second subparagraph of Article 6(2)

1. Smokers die younger

2. Smoking causes heart disease and strokes

3. Smoking causes cancer

Additional warnings from amongst which the Member States may choose

1. Smoking when pregnant harms your baby

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

3. Your doctor can help you stop smoking

4. Smoking is addictive

5. Stopping smoking reduces the risk of serious disease

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ANNEX II

Oral and smokeless tobacco products

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

ANNEX III

Time-limits for transposition and for application of repealed Directives

(referred to in Article 13)

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

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
1 December 1994

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

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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
point 1, 2 and 3

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

Article 2(1)

Article 2(4)

Article 2(2)

Article 2(3)

Article 3 and 4

Article 3(1)
and (2)

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 4(1)

Article 4
(2a)(a)

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

Article 6(3)

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

New

New

Partly New

Partly New

New

Partly New

Partly New

Partly New

Partly New

Partly New

New (except for
final indent)

Partly New

Partly New

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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 8(a)

Article 10

Article 11(1)

Article 8(1)

Article 7(1)

Article 11(2)

Article 8(2)

Article 7(2)

Partly New

New

New

Partly New

New

Partly New

Act of
Accession
for Sweden

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

Article 10

Article 9

Annex I

Annex 1

Annex II

Annex 2

New

Partly New

Partly New