5. 10. 91 Official Journal of the European Communities No C 260/7 
II 
(Preparatory Acts) 
COMMISSION 
Amended proposal for a Council Directive amending Directive 89/622/EEC on the approxi­
mation of the laws, regulations and administrative 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 
(91/C 260/06) 
COM(91) 336 final — SYN 314 
(Submitted by the Commission pursuant to Article 149 (3) of the EEC Treaty on 24 September 
1991) 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, Unchanged 
Having regard to the Treaty establishing the European 
Economic Community, and in particular Article 100 a 
thereof, 
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, 
Whereas there are differences between the laws, regu­
lations and administrative provisions of the Member 
States on the labelling of tobacco products; whereas 
these differences are likely to constitute barriers to trade 
and to impede the establishment and operation of the 
internal market; 
Whereas these possible barriers should be eliminated and 
whereas, to that end, the marketing and free movement 
of tobacco products should be made subject to common 
rules concerning labelling; 
Whereas such common rules must take due account of 
public health protection, and of the protection of young 
persons in particular, taking as a base a high level of 
protection, according to Article 100 a (3) of the Treaty; 
No C 260/8 Official Journal of the European Communities 5. 10.91 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
Whereas the Council and the representatives of the 
Governments of the Member States, meeting within the 
Council, in their resolution of 7 July 1986 on a 
programme of action of the European Communities 
against cancer ('), 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 and whereas they have for this 
purpose identified a fight against the use of tobacco 
products as their prime objective; 
Whereas, for the purposes of providing objective infor­
mation on the risks entailed in tobacco consumption, 
Council Directive 89/622/EEC (2) established a general 
warning to be carried on the unit packaging of all 
tobacco products, together with additional warnings 
exclusively for cigarettes; 
Whereas the Commission, at the request of the Council, 
undertook to propose an amendment to Directive 
89/622/EEC so as to establish additional warnings to be 
carried on the unit packaging of tobacco products other 
than cigarettes; 
Whereas scientific experts are of the opinion that all 
tobacco products carry health risks; 
Whereas, in relation to their effects on health and for the 
purposes of their labelling, a distinction needs to be 
made between smoking tobacco products and smokeless 
tobacco products; 
Whereas rolling tobaccos carry the same health risks as 
cigarettes and it is therefore appropriate that the specific 
warnings selected for cigarettes should also apply to 
rolling tobaccos; 
Whereas other smoking tobacco products carry similar 
health risks to those carried by cigarettes, but there are 
still reservations concerning their contribution to heart 
disease; whereas these products should therefore be 
required to carry the specific warnings selected for ciga­
rettes and rolling tobacco, with the exception of the 
warning concerning heart disease; Whereas other smoking tobacco products carry similar 
health risks to those carried by cigarettes; whereas, 
however, the range of such products is more varied; 
whereas such products should therefore be required to 
carry specific warnings in an appropriate manner; 
Whereas it has been proved that smokeless tobacco 
products can provoke cancer and that, consequently, 
they must be subject to a specific on tobacco products; 
(l) OJ No C 184, 23. 7. 1986, p.19. 
O OJ No L 359, 8. 12. 1989, p. 1. Whereas it has been proved that smokeless tobacco 
products are a major risk factor as regards cancer; 
whereas they should therefore carry a specific warning 
of that risk; 
5. 10.91 Official Journal of the European Communities No C 260/9 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
Whereas scientific experts are of the opinion that the 
addiction caused by tobacco consumption constitutes a 
danger meriting a specific warning on every tobacco 
product; Unchanged 
Whereas, moreover, new smokeless tobacco products, 
moist snuff, designed for oral use, which have appeared 
recently on the market in certain Member States, 
exercise a particular attraction for young persons, and 
whereas the Member States most exposed to this 
problem have already placed total bans on these new 
tobacco products or are about to do it; Whereas, moreover, new tobacco products for oral use 
which have appeared on the market in certain Member 
States are particularly attractive to young people; 
whereas the Member States most exposed to this 
problem have already placed total bans on these new 
tobacco products or are about to do so; 
Whereas there are differences between the laws, regu­
lations and administrative provisions of the Member 
States in respect of oral moist snuff tobaccos, and 
whereas these products therefore need to be made 
subject to common rules; Whereas, regarding such products, there are differences 
between the laws, regulations and administrative 
provisions of the Member States; whereas these products 
therefore need to be made subject to common rules; 
Whereas there is a real risk that oral moist snuff 
tobaccos could be used, particularly by young persons, as 
substitutes for smoking tobacco products, causing 
nicotine addiction, if restrictive measures are not taken 
in time; Whereas there is a real risk that those new products for 
oral use will be used, particularly by young people, and 
will thus lead to nicotine addiction, if restrictive 
measures are not taken in time; 
Whereas, in accordance with the conclusions of the 
studies conducted by the international Agency for 
Research on Cancer, oral moist snuff tobaccos contain 
particularly large quantities of carcinogenic substances, 
and whereas these new products cause cancer of the 
mouth in particular; Whereas, in accordance with the conclusions of the 
studies conducted by the international Agency for 
Research on Cancer, tobacco for oral use contains 
particularly large quantities of carcinogenic substances; 
whereas these new products cause cancer of the mouth 
in particular; 
Whereas, the sales bans for moist oral snuff already 
adopted by two Member States have a direct impact on 
the establishment and operation of the internal market, 
hence the necessity to approximate the laws of Member 
States in this subject taking as a base a high level of 
protection, the only appropriate measure being a total 
ban, Whereas, the sales bans on such tobacco already adopted 
by three Member States have a direct impact on the 
establishment and operation of the internal market; 
whereas it is therefore necessary to approximate Member 
States' laws in this area, taking as a base a high level of 
health protection; whereas the only appropriate measure 
is a total ban; whereas however, such a ban should not 
affect traditional tobacco products for oral use, which 
will remain subject to the provisions of Directive 
89/622/EEC, as amended by this directive, applicable to 
smokeless tobacco products; 
Whereas, finally, the initiatives set in this Directive will 
have an even more beneficial effect on public health if 
they are coupled with health education programmes 
during the years of compulsory education and with 
information and public awareness campaigns, 
No C 260/10 Official Journal of the European Communities 5. 10.91 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
HAS ADOPTED THIS DIRECTIVE: HAS ADOPTED THIS DIRECTIVE: 
Artikel 1 Article 1 
Directive 89/622/EEC is hereby amended as follows: Directive 89/622/EEC is hereby amended as follows: 
1. The following shall be added to the title and to 
Article 1: 
'and the prohibition of the marketing of certain types 
of tobacco for oral use.' 
1. Article 2 is amended as follows: 
(a) point 1 is replaced by the following: 
'(1) "tobacco products" means products for the 
purpose of smoking, sniffing, sucking or 
chewing, with the exception of oral moist 
snuff tobaccos, inasmuch as they are, even 
partly, made of tobacco;' 
(b) the following point (4) is added : 2. The following point 4 shall be added to Article 2: 
'(4) "oral moist snuff tobaccos" means all 
products made wholly or partly of moistened 
tobaccos, in finecut, ground or particulate 
form or in any combination of these forms, 
which are for oral use other than smoking;'. '(4) Tobacco for oral use, for the purposes of Article 
8a, means all products for oral use, except those 
intended to be smoked or chewed, made wholly 
or partly of tobacco, in powder or particulate 
form or in any combination of these forms — 
particularly those presented in sachet portions or 
porous sachets — or in a form resembling a food 
product.' 
2. Article 4 is amended as follows: 
(a) Paragraph 2 is replaced by the following: 
'2. Apart from the general warning referred to 
in paragraph 1, tobacco product packaging shall 
carry specific warnings as follows: 3. Article 4 shall be amended as follows: 
A. In paragraph 2 the word 'Annex' shall be replaced 
by 'Annex P. 
B. A paragraph 2a shall be inserted as follows: 
'2a. In addition to the general warning referred 
to in paragraph 1, unit packets of tobacco 
products other than cigarettes shall carry specific 
warnings as follows: 
(a) With regard to cigarette packets and rolling 
tobacco, the other large surface of the packet 
shall carry specific warnings. To this end, 
each Member State shall draw up a list of 
warnings taken exclusively from those listed 
in the Annex; (a) on rolling tobacco packets, the specific 
warnings, of which each Member State shall 
draw up a list taken exclusively from the 
warnings listed in Annex I, shall be rotated in 
such a way as to guarantee the successive 
appearance of each warning on an equal 
quantity of unit packets, with a tolerance of 
approximately 5 %; 
5. 10. 91 Official Journal of the European Communities No C 260/11 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
(b) the unit packets of cigars, cigarillos, pipe 
tobacco or other smoking tobacco products 
with the exception of cigarettes and rolling 
tobacco shall carry, in addition to the general 
warning provided for in paragraph 1, a 
specific warning. To this end, each Member 
State shall draw up a list of warnings taken 
exclusively from those listed in the Annex, 
with the exception or warning No 2 in Part A 
of the Annex. (b) unit packets of cigars, cigarillos, pipe tobacco 
or other smoking tobacco products with the 
exception of cigarettes and rolling tobacco 
shall carry a special warning from among 
those in Annex II, in such a way as to ensure 
that they are effectively rotated; 
(c) unit packets of smokeless tobacco products 
shall carry, in addition to the warning 
provided for in paragraph 1, the following 
specific warning: "Can cause cancer." 
The specific warnings provided for in this 
paragraph shall be printed or irremovably 
affixed on the unit packets in the official 
language or languages of the country of final 
marketing, in such a way as to guarantee, in 
the cases referred to in points (a) and (b), the 
appearance in rotation of each warning on an 
equal quantity of unit packets with a 
tolerance of 5 %'. (c) unit packets of smokeless tobacco products 
shall carry the following specific warning: 
"Causes cancer". 
The specific warnings shall be printed on, or 
irremovably affixed to, the unit packets in the 
official language or languages of the country 
of final marketing.' 
C. Paragraph 3 shall be replaced by the following: 
'3. Member States may stipulate that the 
warnings referred to in paragraphs 1, 2 and 2a be 
combined with the indication of the authority that 
is their author.' 
(b) Paragraph 5 is replaced by the following: D. Paragraph 5 shall be replaced by the following: 
'(5) Without prejudice to paragraph 4, the 
general warning provided for in paragraph 1 
and the specific warning provided for in 
paragraph 2 shall be printed in, or irre­
movably affixed to, a conspicuous place on a 
contrasting background and in such a way as 
to be easily visible, clearly legible and 
indelible. The warnings shall not in any way 
be hidden, obscured or interrupted by other 
written or pictorial matter'. '(5) On tobacco products other than cigarettes, 
the general warning provided for in paragraph 1 
and the specific warning provided for in paragraph 
2a shall be printed or irremovably affixed. Each 
warning must, in each language used, cover at 
least 1 °/o of the total surface of the unit packet, it 
must, in any event, be easily visible, clearly legible 
and indelible. The warnings must appear in a 
conspicuous place on a contrasting background 
and must not in any way be hidden, obscured or 
interrupted by other written or pictorial matter.' 
3. Article 5 is replaced by the following: 
'Article 5 
The Commission shall adopt the measurement and 
verification methods referred to in Article 3 (1) and 
(2) in accordance with the procedure provided for in 
Articles 6 and 7.' 4. Article 5 shall be replaced by the following: 
'Article 5 
The Commission shall adapt to technical progress, in 
accordance with Articles 6 and 7, the measurement 
and verification methods referred to in Article 3 (1) 
and (2) and, if necessary, the definitions referred to in 
Article 2 (2) and (3).' 
No C 260/12 Official Journal of the European Communities 5. 10.91 
ORIGINAL PROPOSAL 
4. The following Article 8a is inserted: 
'Article 8 a 
Member States shall prohibit the release on the 
market of moist snuff tobacco products for oral use.' 
5. The Annex is amended as set out in the Annex to this 
Directive. 
Article 2 
1. The prohibition of moist snuff tobacco products 
shall enter into force before 1 July 1992. 
2. For the other amendments made by this Directive 
to Directive 89/622/EEC, Member States shall take the 
necessary steps to comply before 1 July 1992. They shall 
immediately inform the Commission thereof and shall 
send to it the provisions they have adopted. 
When Member States adopt these provisions they shall 
contain a reference to this Directive or shall be accom­
panied by such reference at the time of their official 
publication. The procedure for such reference shall be 
adopted by Member States. 
3. Member States shall bring into force the provisions 
referred to in paragraph 2 before 31 December 1992. 
Nevertheless, products existing at that date which do not 
comply with Article 1 (2) (a) may still be marketed until 
31 December 1993. 
Article 3 
1. The Commission shall publish the national lists of 
warnings provided for in Article 4 (2) subparagraph 1, 
point (a) for rolling tobaccos and point (b) for other 
smoking tobaccos in the Official Journal of the European 
Communities. AMENDED PROPOSAL 
5. The following Article 8a shall be inserted: 
'Article 8a 
Member States shall prohibit the placing on the 
market of tobacco for oral use as defined in Article 2 
(4)-' 
6. The Annex shall be replaced by those attached to this 
Directive. 
Article 2 
1. The prohibition referred to in Article 8 a of 
Directive 89/622/EEC shall enter into force before 1 
July 1992. 
2. Member States shall, before 1 July 1992, take the 
necessary steps to comply with the other amendments 
made to Directive 89/622/EEC by Article 1 of this 
Directive. They shall forthwith inform the Commission 
thereof and shall communicate to it the provisions of 
national law which they have adopted. 
Unchanged 
3. Member States shall bring into force the provisions 
referred to in the first subparagraph of paragraph 2 by 
31 December 1992. However, products existing at that 
date which do not comply with the requirements of 
Article 4 (2) (a), (3) and (5) of Directive 89/622/EEC 
may still be put on sale until 31 December 1994. 
Article 3 
1. The Commission shall publish in the Official 
Journal of the European Communities the national lists of 
warnings provided for in Article 4 (2) (a) (a) of Directive 
89/622/EEC for rolling tobacco. 
5. 10.91 Official Journal of the European Communities No C 260/13 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
2. Member States which, after 31 December 1992, 
modify their lists of warnings as provided for in Article 4 
(2) (a) and (b) shall notify this modification 18 months 
before its application to the Commission, which shall 
publish it in the Official Journal of the European 
Communities. 2. Member States which, after 31 December 1992, 
amend their list of warnings as referred to in paragraph 
1 shall notify such amendment 18 months before its 
application to the Commission, which shall publish it in 
the Official Journal of the European Communities. 
Article 4 
This Directive is addressed to the Member States. Article 4 
Unchanged 
ANNEX 
1. The title of the Annex to the Directive shall be 
worded as follows: 
'List of health warnings referred to points a and b of 
subparagraph 1 of Article 4 (2).' 
2. In part B of the Annex, the following new warning, 
No 15, shall be added after warning No 14: 
'15. Smoking causes addiction.' ANNEX 
ANNEX I 
List of health warnings referred to in Article 4 (2) and (2a) (a) 
A. Warnings which must be included on the national lists: 
1. Smoking causes cancer. 
2. Smoking causes heart disease. 
B. Warnings from amongst which Member States may choose: 
1. Smoking causes fatal diseases. 
2. Smoking kills. 
3. Smoking can kill. 
4. Smoking when pregnant harms your baby. 
5. Protect children: don't make them breathe your 
smoke. 
6. Smoking damages the health of those around 
you. 
7. Stopping smoking reduces the risk of serious 
disease. 
8. Smoking causes cancer, chronic bronchitis and 
other chest diseases. 
9. More than (...) people die each year in 
(name of country) from lung cancer. 
No C 260/14 Official Journal of the European Communities 5. 10. 91 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
10. Every year, ... people are killed in road 
accidents in (name of country) — ... times more 
die from their addiction to smoking. 
11. Every year, addiction to smoking claims more 
victims than road accidents. 
12. Smokers die younger. 
13. Don't smoke if you want to stay healthy. 
14. Save money: stop smoking. 
15. Smoking causes addiction. 
ANNEX II 
List of health warnings referred to in Article 4 (2a) (b) 
1. Smoking causes cancer. 
2. Smoking causes fatal diseases. 
3. Smoking damages the health of those around you. 
4. Smoking causes heart disease.'