No C 62/12 Official Journal of the European Communities 11. 3. 89 
II 
(Preparatory Acts) 
COMMISSION 
Amended proposal for a Council Directive on the approximation of the laws, regulations and 
administrative provisions of the Member States concerning the labelling of tobacco products (') 
COM(88) 845 final — SYN 116 
(submitted by the Commission in accordance with Article 149 (3) of the EEC Treaty on 15 
December 1988) 
(89/C 62/16) 
(') OJ No C 48, 20. 2. 1988, p. 9. 
ORIGINAL TEXT MODIFIED PROPOSAL 
THE COUNCIL OF THE EUROPEAN COMMUNITIES 
Having regard to the Treaty establishing the European 
Economic Community, and in particular Article 100a 
thereof, unchanged 
Having regard to the proposal from the Commission ('), 
In cooperation with the European Parliament, 
Having regard to the opinion of the Economic and 
Social Committee (2), 
Whereas there are differences between the laws, regu- unchanged 
lations and administrative provisions of the Member 
States on the labelling of tobacco products; whereas such 
differences are likely to constitute barriers to trade and 
to impede the establishment and operation of the internal 
market; 
Whereas those obstacles should accordingly be elim- unchanged 
inated and whereas to that end the marketing and free 
movement of tobacco products must be made subject to 
uniform rules concerning labelling; 
Whereas such common rules must take due account of unchanged 
public health protection; 
Whereas the European Council held in Milan on 28 and unchanged 
29 June 1985 stressed the importance of launching a 
European Action programme against cancer; 
(«) OJ No C 48, 20. 2. 1988, p. 8. 
(2) OJ No C 237, 12. 9. 1988, p. 43. 
11. 3. 89 Official Journal of the European Communities No C 62/13 
ORIGINAL TEXT 
Whereas the Council and the Representatives of the 
Governments of the Member States, meeting within the 
Council, in their resolution of 7 July 1986 ('), set for this 
programme the objective of contributing to an 
improvement of the health and quality of life of citizens 
within the Community by reducing the number of 
cancers; whereas they have for this purpose identified the 
fight against the use of tobacco products as their prime 
objective; 
Whereas the printing of health warnings on the 
packaging of all tobacco products concerning the risks of 
use of tobacco products are a vital factor in the 
protection of public health; 
Whereas, for the purpose of improving health protection, 
the indication of the tar and nicotine yield on cigarette 
packets is essential for the health information and 
education of the general public; 
Whereas this Directive calls for minimum provisions 
which will be reviewed on the basis of experience gained 
and the development of medical knowledge in this area, 
the objective being to achieve greater protection of indi­
viduals, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
The objective of this Directive is the harmonization of 
the laws, regulations and administrative provisions of the 
Member States concerning the medical warnings on the 
unit packet of tobacco products and the indication of the 
tar and nicotine yield on cigarette packets, taking as a 
base a high level of health protection. 
Article 2 
For the purposes of this Directive: 
1. 'tobacco products' means products for the purpose of 
smoking, sniffing, sucking or chewing, in as much as 
they are, even partly, made of tobacco; 
2. 'tar' means the raw anhydrous nicotine-free 
condensate of smoke; 
3. 'nicotine' means nicotinic alkaloids 
(') OJ No C 184, 23. 7. 1986, p. 19. MODIFIED PROPOSAL 
unchanged 
unchanged 
unchanged 
unchanged 
Whereas, finally, the initiatives set out in this Directive 
can only have a beneficial effect on public health if they 
are coupled with health education programmes beginning 
during the years of compulsory education and with 
periodic information and public awareness campaigns; 
Article 1 
The objective of this Directive is the harmonization of 
the laws, regulations and administrative provisions of the 
Member States concerning the warnings regarding health 
on the unit of packaging of tobacco products and the 
indication of tar and nicotine yield on cigarette packets, 
taking as a base a high level of health protection. 
Article 2 
unchanged 
No C 62/14 Official Journal of the European Communities 11. 3. 89 
ORIGINAL TEXT MODIFIED PROPOSAL 
Article 3 
1. The tar and nicotine yields to be indicated on 
cigarette packets shall be measured on the basis of the 
ISO 4387 and ISO 3400 methods respectively, or any 
other method which yields equivalent results. Article 3 
1. The tar and nicotine yields to be indicated on 
cigarette packets shall be measured on the basis of the 
ISO 4387 and ISO 3400 methods respectively. 
2. Indications on packets shall be considered 
acceptable where they do not differ by more than 1 mg 
from the results of tests carried out by the bodies 
designated for that purpose by the Member States. 2. The accuracy of indications on packets shall be 
verified in accordance with ISO standard 8243. 
3. The indications concerned shall be printed in the 
official language or languages of the consumer's country 
on the side of the packet or on a mobile part of the 
packet in clearly visible print on a contrasting back­
ground. 3. The indications concerned shall be printed in the 
official language or languages of the country of final 
marketing in clearly visible print on a contrasting back­
ground so that at least 4 % of the corresponding surface 
is covered. This percentage shall be raised to at least 6 % 
for countries with two official languages and to at least 
8 % for countries with three official languages. 
4. In January each year the Member States shall 
forward to the Commission lists of the tar and nicotine 
yields of the cigarettes sold on their markets. The 
Commission shall publish this information in the Official 
Journal of the European Communities. 
Article 4 
1. All units of packaging of tobacco products shall 
carry the following warning in the official language or 
languages of the consumer's country, on one of the two 
largest surfaces: 'Tobacco seriously damages health'. Article 4 
1. All unit of packaging of tobacco products shall 
carry the following warning in the official language or 
languages of the country of final marketing on the most 
visible surface: 'Tobacco seriously damages health'. 
2. With regard to cigarette packets, the other large 
surface shall carry in the official language or languages 
of the consumer's country a specific warning. 
For this purpose, each Member State shall draw up a list 
of warnings taken from those listed in the Annex. That 
list must include however the following warnings: 
(a) 'smoking causes cancer'; 
(b) 'smoking causes heart disease'. 2. With regard to cigarette packets, the other large 
surface shall carry in the official language or languages 
of the country of final marketing specific warnings alter­
nating in accordance with the following rule: 
— each Member State shall draw up a list of warnings 
taken from those listed in the Annex to this Directive; 
— the specific warnings selected shall be printed on the 
unit of packaging so as to ensure the appearance of 
each warning on an equal quantity of unit of 
packaging with a tolerance of around 5 %. 
Those warnings shall appear on the unit of packaging 
according to a formula adopted by each Member State 
in such a way as to guarantee an equal frequency of 
display for each warning. 
3. The warnings provided for in paragraphs 1 and 2 
shall be printed in letters of a minimum size of 3 mm and 
in such a way as to cover at least 2 % of the total 
surface of the corresponding side of the unit of 
packaging. 3. On cigarette packets the warnings provided for in 
paragraphs 1 and 2 shall cover at least 4 % of the total 
surface of the unit of packaging. This percentage shall be 
increased to at least 6 °/o for countries with two official 
languages and to at least 8 % for countries with three 
official languages. The required warnings on the two 
largest surfaces of each cigarette packet: 
11. 3. 89 Official Journal of the European Communities No C 62/15 
ORIGINAL TEXT MODIFIED PROPOSAL 
(a) shall be clear and legible; 
(b) shall be printed In bold letters; 
(c) shall not be printed in a place where they may be 
damaged when the package is opened; 
(d) shall not be printed on the transparent wrapper or 
any other external wrapping. 
4. The required warnings on the two sides of each 
unit of packaging: 
(a) shall be clear and legible; 
(b) shall be printed in bold letters; 
(c) shall be printed on a contrasting background; 
(d) shall not be printed in a place where they may be 
damaged when the packet is opened; 
(e) shall not be printed on the transparent wrapper or 
any other external wrapping. 4. In the case of tobacco products other than ciga­
rettes, the general warning laid down in paragraph 1 shall 
be printed or irremmovably affixed in a conspicuous place 
in such a way as to be easily visible, clearly legible and 
indelible. It shall not in any way be hidden, obscured or 
interrupted by other written or pictorial matter. 
Article 5 
Adaptation to technical progress in accordance with the 
procedure provided for in Article 6 shall be limited to the 
obligatory indications given on cigarette packets as 
provided for in Article 3 as well as to the health 
warnings laid down in Article 4. Article 5 
Adaptation to technical progress in accordance with the 
procedure provided for in Article 6 shall be limited to the 
methods of measurement of the obligatory indications of 
tar and nicotine yields on cigarette packets as provided 
for in Article 3. 
Article 6 
With a view to the adaptation to technical progress 
referred to in Article 5, the Commission shall be assisted 
by a committee of an advisory nature composed of 
representatives of the Member States and chaired by the 
representative of the Commission. Article 6 
unchanged 
Article 7 
The representative of the Commission shall submit to the 
committee a draft of the measures to be taken. The 
committee shall deliver its opinion on the draft, within a 
time limit which the chairman may lay down according 
to the urgency of the matter, if necessary by taking a 
vote. 
The opinion shall be recorded in the minutes; in 
addition, each Member State shall have the right to ask 
to have its position recorded in the minutes. 
The Commission shall take the utmost account of the 
opinion delivered by the committee. It shall inform the 
committee of the manner in which its opinion has been 
taken into account. Article 7 
unchanged 
No C 62/16 Official Journal of the European Communities 11. 3. 89 
ORIGINAL TEXT MODIFIED PROPOSAL 
Article 8 
Member States may not prohibit or restrict the sale of 
products which conform to this Directive. Article 8 
1. Member States may not, for reasons of labelling, 
prohibit or restrict the sale of products which conform to 
this Directive. 
2. The provisions of this Directive do not otherwise 
affect the right of the Member States to adopt, in 
accordance with the Treaty, rules concerning the sale and 
consumption of tobacco products which they deem 
necessary in order to protect public health, provided such 
rules do not imply any changes to labelling as laid down 
in this Directive. 
Article 9 
1. Member States shall adopt the laws, regulations 
and administrative provisions necessary to comply with 
this Directive before 31 December 1990. They shall 
forthwith inform the Commission thereof. However, 
products existing at that date which do not comply with 
this Directive may still be put on sale until 31 December 
1992. 
2. Member States shall communicate to the 
Commission the provisions of national law which they 
adopt in the field governed by this Directive. Article 9 
1. Member States shall adopt the laws, regulations and 
administrative provisions necessary to comply with this 
Directive before 1 July 1990. 
They shall forthwith inform the Commission thereof and 
communicate to it the provisions of national law which 
they adopt in the field governed by this Directive. 
The Commission shall publish in the Official Journal of 
the European Communities the national lists drawn up in 
accordance with Article 4, paragraph 2. 
2. Member States shall bring into force the above laws, 
regulations and administrative provisions before 31 
December 1991. 
However, products existing at that date which do not 
comply with this Directive may still be put on sale until 
31 December 1992. 
3. Member States which after 31 December 1991 
amend their lists drawn up in accordance with Article 4, 
paragraph 2 shall notify the Commission of that 
amendment eighteen months before its implementation. 
The Commission shall publish it in the Official Journal of 
the European Communites. 
Article 10 
This Directive is addressed to the Member States. Article 10 
unchanged 
ANNEX 
List of health warnings List of warnings 
I. Which must be included in the list of warnings to be drawn I. unchanged 
up by Member States: 
(a) Smoking causes cancer (a) unchanged 
(b) Smoking causes heart disease (b) unchanged 
11. 3. 89 Official Journal of the European Communities No C 62/17 
ORIGINAL TEXT 
II. Which may be included in the list of warnings to be drawn 
up by the Member States: 
(a) Smoking causes fatal diseases 
(b) Smoking can kill you 
(c) Smoking when pregnant can injure your baby 
(d) Stopping smoking reduces the risk of serious disease 
(e) Smoking causes lung cancer, bronchitis and other chest 
diseases 
(f) More than (. . .) people die each year in (name of the 
country) from lung cancer 
(g) Smokers die younger MODIFIED PROPOSAL 
II. unchanged 
(a) unchanged 
(b) Smoking kills 
(c) Pregnant women: smoking harms your baby 
(d) unchanged 
(e) Smoking causes lung cancer, chronic bronchitis and 
other chest diseases 
(f) unchanged 
(g) Smokers die prematurely 
(h) Smoking damages the health of those around you 
(i) Protect children from tobacco smoke — you yourself 
have the right to choose 
(j) Every year, . . . (nationality) are killed in road accidents 
. . . times more die from their addiction to smoking 
(k) Don't smoke if you want to stay healthy 
(1) Save money: stop smoking