CELEX: 51991PC0336
Language: en
Date: 1991-09-18
Title: AMENDED PROPOSAL FOR A COUNCIL DIRECTIVE AMENDING DIRECTIVE 89/622/EEC ON THE APPROXIMATION OF THE LAWS, REGULATIONS AND ADMINISTRATIVE PROVISIONS OF THE MEMBERS STATES CONCERNING THE LABELLING OF TOBACCO PRODUCTS AND THE PROHIBITION OF THE MARKETING OG CERTAIN TYPES OF TOBACCO FOR ORAL USE

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;
 ---pagebreak---  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              Whereas other smoking tobacco products carry similar
health risks to those carried by cigarettes, but there are        health risks to those carried by cigarettes; whereas,
still reservations concerning their contribution to heart         however, the range of such products is more varied;
disease; whereas these products should therefore be               whereas such products should therefore be required to
required to carry the specific warnings selected for ciga-        carry specific warnings in an appropriate manner;
rettes and rolling tobacco, with the exception of the
warning concerning heart disease;
Whereas it has been proved that smokeless tobacco                 Whereas it has been proved that smokeless tobacco
products can provoke cancer and that, consequently,               products are a major risk factor as regards cancer;
they must be subject to a specific on tobacco products;           whereas they should therefore carry a specific warning
                                                                  of that risk;
(l) OJ No C 184, 23. 7. 1986, p.19.
O OJ No L 359, 8. 12. 1989, p. 1.
 ---pagebreak--- 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           Unchanged
addiction caused by tobacco consumption constitutes a
danger meriting a specific warning on every tobacco
product;
Whereas, moreover, new smokeless tobacco products,              Whereas, moreover, new tobacco products for oral use
moist snuff, designed for oral use, which have appeared         which have appeared on the market in certain Member
recently on the market in certain Member States,                 States are particularly attractive to young people;
exercise a particular attraction for young persons, and         whereas the Member States most exposed to this
whereas the Member States most exposed to this                  problem have already placed total bans on these new
problem have already placed total bans on these new              tobacco products or are about to do so;
tobacco products or are about to do it;
Whereas there are differences between the laws, regu-           Whereas, regarding such products, there are differences
lations and administrative provisions of the Member             between the laws, regulations and administrative
States in respect of oral moist snuff tobaccos, and             provisions of the Member States; whereas these products
whereas these products therefore need to be made                therefore need to be made subject to common rules;
subject to common rules;
Whereas there is a real risk that oral moist snuff              Whereas there is a real risk that those new products for
tobaccos could be used, particularly by young persons, as       oral use will be used, particularly by young people, and
substitutes for smoking tobacco products, causing               will thus lead to nicotine addiction, if restrictive
nicotine addiction, if restrictive measures are not taken       measures are not taken in time;
in time;
Whereas, in accordance with the conclusions of the              Whereas, in accordance with the conclusions of the
studies conducted by the international Agency for               studies conducted by the international Agency for
Research on Cancer, oral moist snuff tobaccos contain           Research on Cancer, tobacco for oral use contains
particularly large quantities of carcinogenic substances,       particularly large quantities of carcinogenic substances;
and whereas these new products cause cancer of the              whereas these new products cause cancer of the mouth
mouth in particular;                                            in particular;
Whereas, the sales bans for moist oral snuff already            Whereas, the sales bans on such tobacco already adopted
adopted by two Member States have a direct impact on            by three Member States have a direct impact on the
the establishment and operation of the internal market,         establishment and operation of the internal market;
hence the necessity to approximate the laws of Member           whereas it is therefore necessary to approximate Member
States in this subject taking as a base a high level of         States' laws in this area, taking as a base a high level of
protection, the only appropriate measure being a total          health protection; whereas the only appropriate measure
ban,                                                            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,
 ---pagebreak--- 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:                             2. The following point 4 shall be added to Article 2:
   (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 :
       '(4) "oral moist snuff tobaccos" means all                   '(4) Tobacco for oral use, for the purposes of Article
            products made wholly or partly of moistened                   8a, means all products for oral use, except those
            tobaccos, in finecut, ground or particulate                   intended to be smoked or chewed, made wholly
            form or in any combination of these forms,                    or partly of tobacco, in powder or particulate
            which are for oral use other than smoking;'.                  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:                             3. Article 4 shall be amended as follows:
   (a) Paragraph 2 is replaced by the following:                    A. In paragraph 2 the word 'Annex' shall be replaced
                                                                        by 'Annex P.
       '2.    Apart from the general warning referred to            B. A paragraph 2a shall be inserted as follows:
       in paragraph 1, tobacco product packaging shall
       carry specific warnings 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                 (a) on rolling tobacco packets, the specific
           tobacco, the other large surface of the packet                    warnings, of which each Member State shall
           shall carry specific warnings. To this end,                       draw up a list taken exclusively from the
           each Member State shall draw up a list of                         warnings listed in Annex I, shall be rotated in
           warnings taken exclusively from those listed                      such a way as to guarantee the successive
           in the Annex;                                                     appearance of each warning on an equal
                                                                             quantity of unit packets, with a tolerance of
                                                                             approximately 5 % ;
 ---pagebreak--- 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                (b) unit packets of cigars, cigarillos, pipe tobacco
            tobacco or other smoking tobacco products                        or other smoking tobacco products with the
            with the exception of cigarettes and rolling                     exception of cigarettes and rolling tobacco
            tobacco shall carry, in addition to the general                  shall carry a special warning from among
            warning provided for in paragraph 1, a                           those in Annex II, in such a way as to ensure
            specific warning. To this end, each Member                       that they are effectively rotated;
            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.
        (c) unit packets of    smokeless tobacco products                (c) unit packets of smokeless tobacco products
            shall carry, in     addition to the warning                      shall carry the following specific warning:
            provided for in    paragraph 1, the following                    "Causes cancer".
            specific warning:  "Can cause cancer."
                                                                             The specific warnings shall be printed on, or
            The specific warnings provided for in this                       irremovably affixed to, the unit packets in the
            paragraph shall be printed or irremovably                        official language or languages of the country
            affixed on the unit packets in the official                      of final marketing.'
             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. 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               '(5)     On tobacco products other than cigarettes,
            general warning provided for in paragraph 1                 the general warning provided for in paragraph 1
             and the specific warning provided for in                   and the specific warning provided for in paragraph
            paragraph 2 shall be printed in, or irre-                   2a shall be printed or irremovably affixed. Each
            movably affixed to, a conspicuous place on a                warning must, in each language used, cover at
            contrasting background and in such a way as                 least 1 °/o of the total surface of the unit packet, it
            to be easily visible, clearly legible and                   must, in any event, be easily visible, clearly legible
            indelible. The warnings shall not in any way                and indelible. The warnings must appear in a
            be hidden, obscured or interrupted by other                 conspicuous place on a contrasting background
            written or pictorial matter'.                               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:                       4. Article 5 shall be replaced by the following:
   'Article 5                                                       'Article 5
   The Commission shall adopt the measurement and                   The Commission shall adapt to technical progress, in
   verification methods referred to in Article 3 (1) and            accordance with Articles 6 and 7, the measurement
   (2) in accordance with the procedure provided for in             and verification methods referred to in Article 3 (1)
   Articles 6 and 7.'                                               and (2) and, if necessary, the definitions referred to in
                                                                    Article 2 (2) and (3).'
 ---pagebreak--- No C 260/12                           Official Journal of the European Communities                                5. 10.91
                     ORIGINAL PROPOSAL                                              AMENDED PROPOSAL
4. The following Article 8a is inserted:                        5. The following Article 8a shall be inserted:
    'Article 8 a                                                    'Article 8a
   Member States shall prohibit the release on the                  Member States shall prohibit the placing on the
   market of moist snuff tobacco products for oral use.'            market of tobacco for oral use as defined in Article 2
                                                                    (4)-'
5. The Annex is amended as set out in the Annex to this         6. The Annex shall be replaced by those attached to this
   Directive.                                                       Directive.
                          Article 2                                                      Article 2
1.    The prohibition of moist snuff tobacco products            1.   The prohibition referred to in Article 8 a of
shall enter into force before 1 July 1992.                      Directive 89/622/EEC shall enter into force before 1
                                                                July 1992.
2.    For the other amendments made by this Directive           2.     Member States shall, before 1 July 1992, take the
to Directive 89/622/EEC, Member States shall take the           necessary steps to comply with the other amendments
necessary steps to comply before 1 July 1992. They shall        made to Directive 89/622/EEC by Article 1 of this
immediately inform the Commission thereof and shall             Directive. They shall forthwith inform the Commission
send to it the provisions they have adopted.                    thereof and shall communicate to it the provisions of
                                                                national law which they have adopted.
When Member States adopt these provisions they shall            Unchanged
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       3.     Member States shall bring into force the provisions
referred to in paragraph 2 before 31 December 1992.             referred to in the first subparagraph of paragraph 2 by
Nevertheless, products existing at that date which do not        31 December 1992. However, products existing at that
comply with Article 1 (2) (a) may still be marketed until        date which do not comply with the requirements of
31 December 1993.                                               Article 4 (2) (a), (3) and (5) of Directive 89/622/EEC
                                                                may still be put on sale until 31 December 1994.
                          Article 3                                                      Article 3
1.    The Commission shall publish the national lists of         1.    The Commission shall publish in the Official
warnings provided for in Article 4 (2) subparagraph 1,          Journal of the European Communities the national lists of
point (a) for rolling tobaccos and point (b) for other          warnings provided for in Article 4 (2) (a) (a) of Directive
smoking tobaccos in the Official Journal of the European         89/622/EEC for rolling tobacco.
Communities.
 ---pagebreak--- 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,              2.     Member States which, after 31 December 1992,
modify their lists of warnings as provided for in Article 4     amend their list of warnings as referred to in paragraph
(2) (a) and (b) shall notify this modification 18 months         1 shall notify such amendment 18 months before its
before its application to the Commission, which shall           application to the Commission, which shall publish it in
publish it in the Official Journal of the European              the Official Journal of the European Communities.
Communities.
                           Article 4                                                        Article 4
This Directive is addressed to the Member States.               Unchanged
                           ANNEX                                                            ANNEX
1. The title of the Annex to the Directive shall be              ANNEX I
   worded as follows:
   'List of health warnings referred to points a and b of       List of health warnings referred to in Article 4 (2) and (2a) (a)
   subparagraph 1 of Article 4 (2).'
                                                                A. Warnings which must be included on the national lists:
2. In part B of the Annex, the following new warning,
   No 15, shall be added after warning No 14:                         1. Smoking causes cancer.
   '15. Smoking causes addiction.'                                   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.
 ---pagebreak--- 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.'