CELEX: 51987PC0633
Language: en
Date: 1987-11-25
Title: AMENDMENT TO THE PROPOSAL FOR A COUNCIL DIRECTIVE ON THE APPROXIMATION OF THE LAWS, REGULATIONS AND ADMINISTRATIVE PROVISIONS OF THE MEMBER STATES RELATING TO THE CLASSIFICATION, PACKAGING AND LABELLING OF DANGEROUS PREPARATIONS

30. 12. 87                                 Official Journal of the European Communities                               N o C 353/1
                                                                   II
                                                          (Preparatory     Acts)
                                                     COMMISSION
              Amendment to the proposal for a Council Directive on the approximation of the laws,
               regulations and administrative provisions of the Member States relating to the classification,
                                         packaging and labelling of dangerous preparations
                                                         COM(87) 633 final
                      (Submitted      by the Commission    pursuant to Article 149 (3) of the EEC Treaty on
                                                         25 November 1987)
                                                             (87/C 353/01)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                                     administrative provisions of the Member States
                                                                             relating to the classification, packaging and label-
 Having regard to the Treaty establishing the European                       ling of dangerous preparations (solvents) (5), as last
Economic Community, and in particular Article 100A                           amended by Directive 80/781/EEC( 6 ),
thereof,
                                                                       — in Council Directive 77/728/EEC of 7 November
 Having regard to the proposal from the Commission ( ! ),                    1977 on the approximation of the laws, regulations
                                                                             and administrative provisions of the Member States
 In cooperation with the European Parliament,                                relating to the classification, packaging and label-
                                                                             ling of paints, varnishes, printing inks, adhesives
Having regard to the opinion of the Economic and                             and similar products (7), as last amended by Direc-
Social Committee (2),                                                        tive 83/265/EEC( 8 );
Whereas measures for the progressive establishment of                  Whereas despite the abovementioned Community
the internal market over the period up to 31 December                  measures the rules, if any, applying to dangerous prep-
 1992 have to be adopted; whereas the internal market                  arations in the Member States exhibit considerable
comprises an area without internal frontiers in which                  differences as regards classification according to the
the free movement of goods, persons, services and capi-                degree of risk; whereas these differences constitute a
tal is guaranteed;                                                     significant barrier to trade and directly affect the estab-
                                                                       lishment and functioning of the common market;
Whereas rules on dangerous substances have already
                                                                       Whereas it is therefore necessary to remove this barrier
been laid down in Council Directive 67/548/EEC of
                                                                       by approximating the relevant legislation existing in
27 June 1967 on the approximation of the laws, regu-
                                                                       the Member States and incorporating in it the Com-
lations and administrative provisions relating to the
                                                                       munity rules at present in force;
classification, packaging and labelling of dangerous
substances (3), as last amended by Directive 79/831/
EEC( 4 );                                                              Whereas this Directive must at the same time provide
                                                                       protection for the general public, in particular, for
                                                                       persons who come into contact with dangerous prep-
Whereas rules on certain dangerous preparations                        arations in the course of their work or in the pursuit
having very specific uses have already been laid down:                 of a hobby; and for consumers, especially children and
— in Council Directive 73/173/EEC of 4 June 1973                       the visually handicapped, and also for the environment;
     on the approximation of the laws, regulations and
(J) OJ No C 211, 22. 8. 1985, p. 3.                                    s
                                                                         ) O J N o L 189, 11.7. 1973, p. 7.
(2) OJ No C 189, 28. 7. 1986.                                          6
                                                                         )  OJ No L 229, 30. 8. 1980, p. 57.
(3) O J N o L 196, 16. 8. 1967, p. 1.                                  7
                                                                         )  OJ No L 303, 28. 11. 1977, p. 23.
(4) OJ No L 259, 15. 10. 1979, p. 10.                                  8
                                                                         )  O J N o L 147,6.6. 1983, p. 11.
 ---pagebreak--- No C 353/2                          Official Journal of the European Communities                               30. 12. 87
Whereas provisions on the classification, packaging and        This Directive shall also apply to the preparations listed
labelling of the preparations must be laid down at             in Annex II.
Community level; whereas the provisions concerning
the information appearing on the label, the dimensions         3.    This Directive shall not apply to provisions con-
of the label and the assignment of the various danger          cerning:
symbols and risk and safety phrases have also to be
brought into line with Directive 67/548/EEC;                   (a) medicinal or veterinary products as defined by
                                                                   Directive 65/65/EEC;
Whereas some preparations, although they contain con-
stituents which are dangerous to health, are not necess-       (b) cosmetic products as defined by Directive 76/768/
arily dangerous in the form in which they are placed               EEC;
on the market; whereas there are exceptions, however;
whereas the latter must be the subject of special label-       (c) mixtures of substances which, in the form of waste,
ling, as appropriate, in accordance with the provisions            are covered by Council Directives 75/442/EEC and
of Directive 83/467/EEC or of Annex II to this Direc-              78/319/EEC;
tive;
                                                               (d) pesticides covered by Directive 78/631/EEC;
Whereas the label constitutes a basic tool for users of
                                                               (e) munitions and explosives placed on the market with
the preparations by giving them the initial essential
                                                                   a view to obtaining a practical effect by explosion
concise information that nevertheless needs to be sup-
                                                                   or a pyrotechnic effect.
plemented by a two-fold system of more detailed infor-
mation, one intended for professional users, and the
second for the bodies appointed by the Member States          In addition, this Directive shall not apply to:
and whose responsibility it is to give information
reserved solely for medical purposes, both curative and        (f) foodstuffs in a finished stage intended for the final
preventive;                                                        consumer;
                                                               (g) animal feedingstuffs in a finished stage intended for
Whereas dangerous preparations may, although confor-
                                                                   the final consumer;
ming to the provisions of this Directive, nevertheless
constitute a danger to health or the environment; where-       (h) the carriage of dangerous substances by rail, road,
as it is therefore advisable to provide a procedure to             inland waterway, sea or air;
reduce this danger;
                                                               (i) preparations in transit which are under customs
Whereas the Commission will, on the basis of infor-                supervision provided they do not undergo any treat-
mation to be supplied by the Member States (within 18              ment or processing.
months of the Directive's implementation), submit a
report, within two years of implementation of this
Directive, concerning by inadequacies or loopholes in
Directive 78/631/EEC as compared with the present                                       Article 2
Directive; whereas on the basis of this report, the Com-
mission will if appropriate submit the necessary pro-
posals,                                                       The definitions appearing in Article 2 of Directive 67/
                                                              548/EEC, with the exception of the definition in para-
                                                              graph 1 (d) thereof, shall apply to this Directive.
HAS ADOPTED THIS DIRECTIVE:
                        Article 1
1.    The purpose of this Directive is to approximate                                   Article 3
the laws, regulations and administrative provisions of
the Member States on the:                                     1.     The general principles of the classification and
                                                              labelling of preparations shall be applied according to
— classification,                                             the criteria in Annex VI to Directive 67/548/EEC save
— packaging, and                                              where the alternative criteria referred to below are
                                                              applied.
— labelling
of preparations dangerous to man and the environment          2.     The requisite physico-chemical properties for the
when they are placed on the market in the Member              classification of preparations shall be determined by
States.                                                       the methods specified in Annex V (A) to Direc-
                                                              tive 67/548/EEC.
2.    This Directive shall apply to preparations which
are placed on the market in the Member States and:            Preparations shall be regarded as explosive, oxidizing,
— contain at least one substance classified as danger-        extremely flammable, highly flammable or flammable
    ous, within the meaning of Article 2, or                  when the results of the tests carried out by the methods
                                                              mentioned above comply with the definitions in Article
— are regarded as dangerous within the meaning of             2 of Directive 67/548 and the specific evaluation criteria
    Article 3.                                                detailed in those methods.
 ---pagebreak--- 30. 12. 87                             Official Journal of the European Communities                                    N o C 353/3
By way of derogation:                                            health hazard assessment either by method 3 (a) or
                                                                 3 (b) shall be performed whenever:
(a) the determination of the explosive, oxidizing,
      extremely flammable, highly flammable or flam-                  changes of composition of the initial concentration,
      mable properties is not necessary provided, how-                expressed as a weight/weight percentage, of one or
      ever, that none of the constituents possesses such              more of the dangerous constituents are introduced
      properties and that on the basis of the information             by the manufacturer, in accordance with the follow-
      available to the manufacturer the preparation is                ing table:
      unlikely to present dangers of this kind;
                                                                                                               Permitted
                                                                                      Initial                   variation
 (b) the preparations placed on the market in the form                        concentration range               in initial
                                                                                of the constituent           concentration
      of aerosols are subject to the flammability criteria                                                 of the constituent
      specified in paragraphs 1.8 and 2.2 (c) of the Annex
      to Directive 75/324/EEC.                                                                <    2,5 %       ±   15 %
                                                                           >   2,5            <  10 %          ±   10 %
                                                                           > 10               <  25 %          ±    6 %
                                                                           > 20               <  50 %          ±    5 %
3.       The health hazards of a preparation shall be deter-               > 50               < 100 %          ±    2,5%
 mined by one or more of the following methods:
                                                                  — changes of composition involving the substitution
 (a) by the conventional method described below using
                                                                      of one or more constituents, which may or may not
      concentration limits;                                            be dangerous within the meaning of the definitions
                                                                      of this Directive, are introduced by the manufac-
 (b) by determining the toxicological properties of the               turer.
      preparation necessary for an appropriate classifi-
      cation and label in accordance with the criteria in
      Annex VI to Directive 67/548/EEC. The toxicologi-           5.      In accordance with Article 3 (3) (a), the health
      cal properties shall be determined by the methods           hazards shall be assessed by the conventional method
      specified in point B of Annex V to that Directive.          described below, using individual concentration limits.
      Any one or more of the toxicological properties of
      the preparation which are not assessed by the               Where the dangerous substances listed in Annex I to
      method set out in Article 3 (3) (b) shall be assessed       Directive 67/548/EEC are assigned concentration limits
      in accordance with the conventional method.                 necessary for the application of the method of evalu-
                                                                  ation described below, those concentration limits shall
                                                                  be used.
 Where a toxicological property has been established by
 both the methods above, the result of method (b) shall           Where the dangerous substances do not appear in
 be used for classifying the preparation except in the            Annex I to Directive 67/548/EEC or appear there with-
 case of carcinogenic, mutagenic and teratogenic effects.         out the concentration limits necessary for the appli-
                                                                  cation of the method of evaluation described below,
                                                                  the concentration limits shall be assigned in accordance
 Furthermore, where it can be demonstrated that:                  with the specifications in Annex I to this Directive.
       toxicological effects on man differ from those             In that case:
       suggested by a toxicological determination or a
       conventional assessment, then the preparation shall        (a) the following preparations shall be regarded as very
       be classified according to its effects on man,                  toxic:
                                                                       (i)   owing to their acute lethal effects, preparations
       owing to effects such as synergism or potentiation
                                                                             containing one or more substances classified
       a conventional assessment would underestimate the
                                                                             or regarded as very toxic in individual concen-
       toxicological hazard, these effects shall be taken
                                                                             trations exceeding:
       into account in classifying the preparation,
                                                                             — either the concentration specified in
       owing to effects such as synergism or antagonism                            Annex I to Directive 67/548/EEC for the
       a conventional assessment would overestimate the                             substance or substances under consider-
       toxicological hazard, these effects shall be taken                           ation,
       into account in classifying the preparation.
                                                                             — or the concentration specified at point 1 of
                                                                                    Annex I (Table I) to this Directive where
                                                                                    the substance or substances do not appear
  4.     For preparations of a known composition classi-                            in Annex I to Directive 67/548/EEC or
  fied in accordance with method 3 (b) above a new                                  appear in it without concentration limits;
 ---pagebreak--- No C 353/4                               Official Journal of the European Communities                                    30. 12. 87
    (ii) owing to their acute lethal effects, preparations                    or at point 1 of Annex I (Table I) to this
           containing more than one substance classified                      Directive if the sum of the quotients obtained
           or regarded as very toxic in individual concen-                    by dividing the percentage by weight of each
           trations not exceeding the limits specified either                 substance in the preparation by the toxic limit
           in Annex I to Directive 67/548/EEC or at                           specified for that substance is 1 or more, i.e.:
           point 1 of Annex I (Table I) to this Directive
           if the sum of the quotients obtained by dividing
           the percentage by weight of each very toxic                                       \ L-p      Lj /
           substance in the preparation by the limit speci-
           fied for that substance is 1 or more, i.e.:
                                                                              where:
                                                                              PT+        is the percentage by weight of each
                                                                                         very toxic substance in the prep-
                                                                                         aration,
                                                                              PT         is the percentage by weight of each
           where:                                                                        toxic substance in the preparation,
           PT+        is the percentage by weight of each                                and
                      very toxic substance in the prep-                       LT         is the limit specified for each very toxic
                      aration, and                                                       or toxic substance expressed as a per-
            LT +      is the limit specified for each very toxic                         centage;
                      substance expressed as a percentage;
                                                                        (iii) owing to their non-lethal irreversible effects
                                                                              after one exposure, preparations containing
     (iii) owing to their non-lethal irreversible effects                     one or more dangerous substances that produce
            after one exposure, preparations containing                       such effects in individual concentrations
            one or more dangerous substances that produce                     exceeding:
            such effects in individual concentrations
            exceeding:                                                        — either the concentration specified in
                                                                                   Annex I to Directive 67/548/EEC for the
            — either the concentration specified in                                substance or substances under consider-
                Annex I to Directive 67/548/EEC for the                            ation,
                substance or substances under consider-
                                                                              — or the concentration specified at point 2 of
                ation,
                                                                                   Annex I (Table II) to this Directive where
            — or the concentration specified at point 2 of                         the substance or substances under consider-
                Annex I (Table II) to this Directive where                         ation do not appear in Annex I to
                the substance or substances under consider-                        Directive 67/548/EEC or appear in it with-
                 ation do not appear in Annex I to                                 out concentration limits;
                 Directive 67/548/EEC or appear in it with-
                                                                        (iv) owing to their long-term effects, preparations
                 out concentration limits;
                                                                               containing one or more dangerous substances
                                                                               that produce such effects in individual concen-
                                                                               trations exceeding:
(b) the following preparations shall be regarded as
     toxic:                                                                    — either the concentration specified in
                                                                                   Annex I to Directive 67/548/EEC for the
     (i)    owing to their acute lethal effects, preparations                      substance or substances under consider-
            containing one or more substances classified                           ation,
            or regarded as very toxic, toxic or in individual                  — or the concentration specified at point 3 of
            concentrations exceeding:                                               Annex I (Table III) to this Directive where
                                                                                    the substance or substances under consider-
          — either the concentrations specified in                                  ation do not appear in Annex I to Directive
               Annex I to Directive 67/548/EEC for the                              67/548/EEC or appear in it without concen-
               substance or substances under consideration,                         tration limits;
          — or the concentration specified at point 1 (a)           (c) the following preparations shall be regarded as
               of Annex I (Table I) to this Directive where              harmful:
               the substance or substances do not appear
               in Annex I to Directive 67/548/EEC or                     (i)   owing to their acute lethal effects, preparations
               appear in it without concentration limits;                      containing one or more substances classified
                                                                               or regarded as very toxic, toxic or harmful in
                                                                                individual concentrations exceeding:
      (ii) owing to their acute lethal effects, preparations
            containing more than one substance classified                      — either the concentration specified in
            or regarded as very toxic or toxic in individual                        Annex I to Directive 67/548/EEC for the
            concentrations not exceeding the limits speci-                          substance or substances under consider-
            fied either in Annex I to Directive 67/548/EEC                          ation,
 ---pagebreak--- 30. 12. 87                            Official Journal of the European Communities                                   N o C 353/5
          — or the concentration specified at point 1 of                    — or the concentration specified at point 3 of
               Annex I (Table I) to this Directive where                         Annex I (Table III) to this Directive where
               the substance or substances do not appear                         the substance or substances under consider-
               in Annex I to Directive 67/548/EEC or                             ation do not appear in Annex I to
               appear in it without concentration limits;                        Directive 67/548/EEC or appear in it with-
                                                                                 out concentration limits;
    (ii) owing to their acute lethal effects, preparations
                                                                    (v)     owing to their sensitizing effects by inhalation,
          containing more than one of the substances
                                                                            preparations containing at least one dangerous
          classified or regarded as very toxic or toxic
                                                                            substance to which is assigned phrase R42 that
          or harmful in individual concentrations not
                                                                            produces such effects in individual concen-
          exceeding the limits specified either in Annex I
                                                                            trations exceeding:
          to Directive 67/548/EEC or at point 1 of An-
          nex I (Table I) to this Directive if the sum of                   — either the concentration specified in
          the quotients obtained by dividing the percent-                        Annex I to Directive 67/548/EEC for the
          age by weight of each substance in the prep-                           substance or substances under consider-
          aration by the harmful limit specified for that                        ation,
          substance is 1 or more, i.e.:
                                                                            — or the concentration specified at point 5 of
                                                                                 Annex I (Table V) to this Directive where
                                         Xn                                      the substance or substances under consider-
                                             >1                                  ation do not appear in Annex I to
                        J      J       J
                         Xn      Xn     Xn                                       Directive 67/548/EEC or appear in it with-
                                                                                 out concentration limits;
          whe:                                                  (d) the following preparations shall be regarded as very
                                                                    corrosive for the skin:
          PT+        is the percentage by weight of each
                     very toxic substance in the prep-               (i) preparations containing one or more substances
                     aration,                                             classified or regarded as corrosive to which is
          P
            T        is the percentage by weight of each                  assigned phrase R35 in individual concen-
                     toxic substance in the preparation,                  trations exceeding:
          P
            Xn       is the percentage by weight of each
                                                                          — either the concentration specified in Annex I
                     harmful substance in the preparation,                      to Directive 67/548/EEC for the substance
                     and                                                        or substances under consideration,
          LXn        is the limit specified for each very
                     toxic, toxic or harmful substance                    — or the concentration specified at point 4 of
                     expressed as a percentage;                                 Annex I (Table IV) to this Directive where
                                                                                the substance or substances do not appear
                                                                                in Annex I to Directive 67/548/EEC or
    (iii) owing to their non-lethal irreversible effects                        appear in it without concentration limits;
          after one exposure, preparations containing
          one or more dangerous substances that produce              (ii) preparations containing more than one substan-
          such effects in individual concentrations                       ce classified or regarded as corrosive to which
          exceeding:                                                      is assigned phrase R35 in individual concen-
                                                                          trations not exceeding the limits specified either
          — either the concentration specified in                         in Annex I to Directive 67/548/EEC or at point
                Annex I to Directive 67/548/EEC for the                   4 of Annex I (Table IV) to this Directive if the
                substance or substances under consider-                   sum of the quotients obtained by dividing the
                ation,                                                    percentage by weight of each corrosive sub-
                                                                          stance in the preparation by the corrosive limit
          — or the concentration specified at point 2 of                  specified for that substance is 1 or more, i.e.:
                Annex I (Table II) to this Directive where
                the substance or substances under consider-
                ation do not appear in Annex I to                                                 C, R35
                                                                                                         >1
                Directive 67/548/EEC or appear in it with-
                out concentration limits;                                                        X , R35
     (iv) owing to their long-term effects, preparations                  where:
          containing one or more dangerous substances
          that produce such effects in individual concen-                 p             is the percentage by weight of each
                                                                          1
          trations exceeding:                                                C, R35     corrosive substance in the prep-
                                                                                        aration, and
          — either the concentration specified in                           X , R35     is the corrosive limit specified for each
                Annex I to Directive 67/548/EEC for the                                 corrosive substance to which is assig-
                substance or substances under consider-                                 ned phrase R35 expressed as a per-
                ation,                                                                  centage by weight;
 ---pagebreak---  No C 353/6                                   Official Journal of the European Communities                                        30. 12. 87
 (e) the following preparations shall also be regarded as                              in Annex I to Directive 67/548/EEC or
     corrosive for the skin:                                                           appear in it without concentration limits;
      (i) preparations containing one or more substances                    (ii) preparations containing more than one of the
           classified or regarded as corrosive to which is                        substances classified or regarded as corrosive
           assigned phrase R34 in individual concen-                              or irritant to which is assigned phrase R41 in
           trations exceeding:                                                    individual concentrations not exceeding the
           — either the concentration specified in An-                            limits specified either in Annex I to Directive
                 nex I to Directive 67/548/EEC for the sub-                       67/548/EEC or at point 4 of Annex I (Table IV)
                  stance or substances under consideration,                       to this Directive if the sum of the quotients
                                                                                  obtained by dividing the percentage by weight
           — or the concentration specified at point 4 of                         of each substance in the preparation by the
                 Annex I (Table IV) to this Directive where                       irritant limit specified for that substance is 1 or
                 the substance or substances do not appear                        more, i.e.:
                 in Annex I to Directive 67/548/EEC or
                 appear in it without concentration limits;
                                                                                                            Xi, R41
      (ii) preparations containing more than one substan-                                                           >1
           ce classified or regarded as corrosive to which                                                J
                                                                                                            Xi, R41
           is assigned phrase R34 in individual concen-
           trations not exceeding the limits specified either
           in Annex I to Directive 67/548/EEC or at point
           4 of Annex I (Table IV) to this Directive if the                        where:
           sum of the quotients obtained by dividing the
           percentage by weight of each corrosive substan-                        p                 is the percentage by weight of each
                                                                                  1
                                                                                     Xi, R41
           ce in the preparation by the corrosive limit speci-                                      irritant substance to which is assig-
           fied for that substance is 1 or more, i.e.:                                              ned phrase R41 in the preparation,
                                                                                                    and
                                                                                  LXi,   R41        is the irritant limit specified for
                              c  R35   P                                                            each irritant substance to which is
                     V / ^ '         ,   c , R34 . >  1
                                                                                                    assigned phrase R41 expressed as
                            J
                              C, R34     -C, R34                                                    a percentage by weight;
                                                                        (g) the following preparations shall be regarded as skin
                                                                            irritants:
           where:
                                                                              (i) preparations containing one or more sub-
           ^ C , R3.5    is the percentage by weight of each                        stances classified or regarded as corrosive or
                         corrosive substance to which is assig-                     irritant to which is assigned phrase R38 in
                         ned phrase R35 in the preparation,                         individual concentrations exceeding:
                         is the percentage by weight of each
              C, R34                                                                — either the concentration specified in
                         corrosive substance to which is assig-                          Annex I to Directive 67/548/EEC for the
                         ned phrase R34 in the preparation,                              substance or substances under consider-
                         and                                                             ation,
            J
              C, R34     is the corrosive limit specified for each
                         corrosive substance to which is assig-                     — or the concentration specified at point 4 of
                         ned phrase R34 expressed as a per-                              Annex I (Table IV) to this Directive where
                         centage by weight;                                              the substance or substances do not appear
                                                                                         in Annex I to Directive 67/548/EEC or
                                                                                         appear in it without concentration limits;
                                                                              (ii) preparations containing more than one of the
(f) the following preparations shall be regarded as                                 substances classified or regarded as corrosive
     liable to cause serious eye damage:                                            or irritant to which is assigned phrase R38
                                                                                    in individual concentrations not exceeding the
                                                                                    limits specified either in Annex I to Directive
     (i) preparations containing one or more substances                             67/548/EEC or at point 4 of Annex I (Table IV)
           classified or regarded as irritant and to which is                       to this Directive if the sum of the quotients
           assigned phrase R41 in individual concen-                                obtained by dividing the percentage by weight
           trations exceeding:                                                      of each substance in the preparation by the
           — either the concentration specified in Annex                            irritant limit specified for that substance is 1
                 I to Directive 67/548/EEC for the substance                        or more, i.e.:
                 or substances under consideration,
           — or the concentration specified at point 4 of                                P
                                                                                            C , R35     P
                                                                                                          C , R34   P
                                                                                                                      X i , R38 . >
                 Annex I (Table IV) to this Directive where
                 the substance or substances do not appear                                J
                                                                                            Xi, R38      -Xi, R38     J
                                                                                                                        Xi, R38
 ---pagebreak--- 30. 12. 87                               Official Journal of the European Communities                                      N o C 353/7
           where:                                                                        *Xi, R41_       ^Xi, R36    . > 1
           p              is the percentage by weight of each
           1                                                                             *-Xi, R36       ^ X i , R36
               C, R35     corrosive substance to which is
                          assigned phrase R35 in the prep-
                          aration,
                                                                              •mere:
               C, R34     is the percentage by weight of each
                          corrosive substance to which is                     Xi, R41    is the percentage by weight of each
                          assigned phrase R34 in the prep-                               irritant substance which is assigned
                          aration,                                                       phrase R41 in the preparation,
                          is the percentage by weight of each                 Xi, R36    is the percentage by weight of each
               Xi, R38
                          irritant substance to which is assig-                          irritant substance to which is assigned
                          ned phrase R38 in the preparation,                             phrase R36 in the preparation, and
                          and                                               J            is the irritant limit specified for each
                                                                              Xi, R36
             J            is the irritant limit specified for                            irritant substance to which is assig-
               Xi, R38
                          each corrosive or irritant substance                           ned, phrase R41 or R36 expressed as
                          to which is assigned phrase R38                                a percentage by weight;
                          expressed as a percentage by
                          weight;
                                                                      the following preparations shall be regarded as irri-
    (iii) owing to their sensitizing effects by skin con-             tants for the respiratory system:
           tact, preparations containing at least one
           dangerous substance to which is assigned
           phrase R43 that produces such effects in indi-              (i) preparations containing one or more substances
           vidual concentrations exceeding:                                classified or regarded as irritant to which is
                                                                           assigned phrase R37 in individual concen-
           — either the concentration specified in                         trations exceeding:
                  Annex I to Directive 67/548/EEC for the
                  substance under consideration,
                                                                           — either the concentration specified in Annex
           — or the concentration specified at point 5 of                          I to Directive 67/548/EEC for the substance
                  Annex I (Table V) to this Directive where                        or substances under consideration,
                  the substance or substances do not appear
                  in Annex I to Directive 67/548/EEC or
                  appear in it without concentration limits;                       or the concentration specified at point 4 of
                                                                                   Annex I (Tabel IV) to this Directive where
                                                                                   the substance or substances do not appear
                                                                                   in Annex I to Directive 67/548/EEC or
                                                                                   appear in it without concentration limits;
(h) the following preparations shall be regarded as eye
    irritants:
                                                                           preparations containing more than one of the
    (i) preparations containing one or more substances                     substances classified or regarded as irritant to
          classified or regarded as irritant to which is                   which is assigned phrase R37 in individual con-
          assigned phrase R41 or R36 in individual con-                    centrations not exceeding the limits specified
          centrations exceeding:                                           either in Annex I to Directive 67/548/EEC or at
                                                                           point 4 of Annex I (Tabel IV) to this Directive
          — either the concentration specified in Annex                    if the sum of the quotients obtained by dividing
                 I to Directive 67/548/EEC for the substance               the percentage by weight of each substance in
                 or substances under consideration,                        the preparation by the irritant limit specified for
                                                                           that substance is 1 or more, i.e.:
          — or the concentration specified at point 4 of
                 Annex I (Tabel IV) to this Directive where
                 the substance or substances do not appear                                           Xi, R37
                 in Annex I to Directive 67/548/EEC or
                                                                                                   J
                 appear in it without concentration limits;                                          Xi, R37
     (ii) preparations containing more than one of the
          substances classified or regarded as irritant to                 where:
          which is assigned phrase R41 or phrase R36
                                                                           p              is the percentage by weight of each
          in individual concentrations not exceeding the                   1
                                                                                Xi, R37   irritant substance to which is assigned
          limits specified in Annex I to Directive 67/548/
          EEC or at point 4 of Annex I (Table IV) to this                                 phrase R37 in the preparation, and
          Directive if the sum of the quotients obtained                      J
                                                                                Xi, R37   is the irritant limit specified for each
          by dividing the percentage by weight of each                                    irritant substance to which is assigned
          substance in the preparation by the irritant limit                              phrase R37 expressed as a percentage
          specified for that substance is 1 or more, i.e.:                                by weight;
 ---pagebreak--- No C 353/8                               Official Journal of the European Communities                                  30. 12. 87
 (j) preparations shall be regarded as carcinogenic and                      not appear in Annex I to Directive 67/548/EEG
      classified at least as toxic if they contain a substance               or appear in it without concentration limits;
      producing such effects, to which is assigned the
      standard phrase R45, which denotes carcinogenic               (n) preparations shall be regarded as suspect for
      substances in category 1 and category 2, in a concen-             humans because of their possible mutagenic effects
      tration equal to or exceeding:                                    and classified at least as harmful if they contain a
                                                                        substance producing such effects to which is assig-
      — either the concentration specified in Annex I to
                                                                        ned the standard phrase R40, which denotes muta-
           Directive 67/548/EEC for the substance under
                                                                        genic substances in category 3, in a concentration
           consideration,
                                                                        equal to or exceeding:
      — or the concentration specified at point 6 of
           Annex I (Table VI) to this Directive where the               — either the concentration specified in Annex I to
           substance or substances do not appear in Annex                    Directive 67/548/EEC for the substance under
           I to Directive 67/548/EEC or appear in it with-                   consideration,
           out concentration limits;
                                                                        — or the concentration specified at point 6 of
                                                                             Annex I (Table VI) to this Directive where the
 (k) preparations shall be regarded as suspect for                           substance or substances under consideration do
      humans owing to their possible carcinogenic effects                    not appear in Annex I to Directive 67/548/EEC
      and classified at least as harmful if they contain a                   or appear in it without concentration limits;
      substance producing such effects to which is assig-
      ned the standard phrase R40, which denotes carci-
      nogenic substances in category 3, in a concentration         (o) preparations shall be regarded as teratogenic and
     equal to or exceeding:                                             classified at least as toxic if they contain a substance
                                                                        producing such effects, which is assigned the stan-
     — either the concentration specified in Annex I to                 dard phrase R47, which denotes teratogenic sub-
          Directive 67/548/EEC for the substance under                  stances in category 1, in a concentration equal to
          consideration,                                                or exceeding:
     — or the concentration specified at point 6 in                     — either the concentration specified in Annex I to
          Annex I (Table VI) to this Directive where the                     Directive 67/548/EEC for the substance under
          substance or substances under consideration do                     consideration,
          not appear in Annex I to Directive 67/548/EEC
          or appear in it without concentration limits;
                                                                        — or the concentration specified at point 6 of
                                                                             Annex I (Table VI) to this Directive where the
(1) preparations shall be regarded as mutagenic and                          substance or substances under consideration do
     classified at least as toxic if they contain a substance                not appear in Annex I to Directive 67/548/EEC
     producing such effects, to which is assigned the                        or appear in it wihtout concentration limits;
     standard phrase R46 which denotes mutagenic sub-
     stances in category 1, in a concentration equal to
     or exceeding:                                                 (p) preparations shall be regarded as having to be
                                                                        treated as teratogenic and classified at least as harm-
     — either the concentration specified in Annex I to                 ful if they contain a substance producing such effects
          Directive 67/548/EEC for the substance under                  to which is assigned the standard phrase R47, which
          consideration,                                                denotes teratogenic substances in category 2, in a
                                                                        concentration equal to or exceeding:
     — or the concentration specified at point 6 of
          Annex I (Table VI) to this Directive where the                — either the concentration specified in Annex 1 to
          substance or substances under consideration do                     Directive 67/548/EEC for the substance under
          not appear in Annex I to Directive 67/548/EEG                      consideration,
          or appear in it without concentration limits;
                                                                        — or the concentration specified at point 6 of
(m) preparations shall be regarded as having to be                           Annex I (Table VI) to this Directive where the
     treated as mutagenic and classified at least as harm-                   substance or substances under consideration do
     ful if they contain a substance producing such effects                  not appear in Annex I to Directive 67/548/EEC
     to which is assigned the standard phrase R46, which                     or appear in it wihtout concentration limits;
     denotes mutagenic substances in category 2, in a
     concentration equal to or exceeding:
                                                                   (q) preparations shall be regarded as having specific
     — either the concentration specified in Annex I to                 effects on health not further defined and classified
          Directive 67/548/EEC for the substance under                  at least as harmful if they contain a substance which
          consideration,                                                does not yet appear in Annex I to Directive 67/548/
                                                                        EEC but to which is provisionally assigned the
     — or the concentration specified at point 6 of                     standard phrase R40 denoting such substances in a
          Annex I (Table VI) to this Directive where the                concentration exceeding that specified at point 6 of
          substance or substances under consideration do                Annex I (Table VI) to this Directive.
 ---pagebreak--- 30. 12. 87                           Official Journal of the European Communities                             N o C 353/9
6.     For preparations covered by this Directive:                                       Article 6
(a) no account shall be taken of substances whether            1.     Member States shall take all the           necessary
     or not listed in Annex 1 to Directive 67/548/EEC,         measures to ensure that:
     whether existing as impurities or as additives, if
     their concentration by weight is less than:               — dangerous preparations are not placed on the mar-
                                                                    ket unless their packaging meets the requirements
     — 0,1 % for substances classified as very toxic or             of Article 15 (1) of Directive 67/548/EEC with
          toxic,                                                    respect to their strength, leak-tightness and fasten-
                                                                    ing systems,
     — 1,0% for substances classified as harmful, cor-         — containers which contain dangerous preparations
          rosive or irritant,                                       offered or sold to the general public do not have
                                                                    (a) either a shape and/or graphic decoration likely
     unless lower values have been specified in Annex I                 to attract or arouse the active curiosity of chil-
     to Directive 67/548/EEC;                                           dren or to mislead consumers,
                                                                    (b) or a presentation and/or a designation used for
(b) dangerous substances not listed in Annex I to Direc-                foodstuffs, medicinal or cosmetic products.
     tive 67/548/EEC but used as constituents of a prep-
     aration in a concentration by weight higher than
     that given at point (a) above shall be given concen-      2.     Member States shall take all the necessary meas-
     tration limits characterizing the health hazards.         ures to ensure that containers containing certain catego-
                                                               ries of dangerous preparations offered or sold to the
                                                               general public and defined in accordance with the pro-
     Some substances may have more than one property
                                                               cedure referred to in paragraph 3:
     harmful to health, e.g. harmfulness/irritation,
     corrosiveness/harmfulness/sensitization, etc., each
     of these properties being characterized by its specific   — are fitted with child-resistant fastenings,
     concentration limit.                                      — carry a tactile warning of danger.
     These concentration limits shall be determined in         3.     The categories of dangerous preparations the
     accordance with Annex I to this Directive by the          packaging of which have to be fitted with the devices
     manufacturer or any other person who places such          referred to in paragraph 2 (b) shall be defined by the
     a preparation on the market.                              procedure referred to in Article 21 of Directive 67/548/
                                                               EEC.
                                                               The technical specifications relating to such devices are
                           Article 4                           given in parts A and B of Annex IX to Directive 67/
                                                               548/EEC.
The classification of dangerous preparations according
to the degree of hazard and the specific nature of the
risks involved shall be based on the definitions laid                                    Article 7
down in Article 2. The preparations shall be classified
according to the greatest degree of hazard in accordance
                                                                1.    The following information shall be clearly and
 with Article 8 (2) (d).
                                                               indelibly marked on any package:
                                                                (a) The trade name or designation of the preparation.
                           Article 5                            (b) The names and full addresses including the tele-
                                                                    phone number of the person established in the Com-
 1.    Member States shall take all necessary measures              munity who is responsible for placing the prep-
to ensure that the preparations cannot be placed on the             aration on the market, whether it be the manufac-
market unless they comply with the provisions of this               turer, the importer or the distributor.
Directive.
                                                                (c) The chemical name of the substance or substances
                                                                    present in the preparation in accordance with the
2.      In this context, if there is any doubt, Member              following detailed rules:
States may request information on the composition of
the preparation and any other pertinent information.                (1) — in the case of preparations classified as T + ,
                                                                            T or Xn in accordance with Article 3, only
                                                                            T + , T and Xn substances present in concen-
3.      To this end, the manufacturer, or     those respon-                 trations equal to or in excess of the lowest
 sible for placing the preparation on the      market, shall                limit (Xn limit) for each of them laid down
 hold the data used for the classification     and labelling                in Annex I to this Directive or to Directive
of the preparation at the disposal of the     authorities of                67/548/EEC must be taken into consider-
 the Member States.                                                         ation,
 ---pagebreak--- No C 353/10                          Official Journal of the European Communities                               30. 12. 87
        — in the case of preparations classified as C in           Where more than one danger symbol has to be
              accordance with Article 3, only C substances         assigned to a preparation:
             present in concentrations equal to or in
             excess of the lowest limit (Xi limit) laid            — the obligation to apply the symbol T shall make
             down in Annex I to this Directive or to                    the symbols C and X optional,
              Directive 67/548/EEC must be taken into
              consideration,                                       — the obligation to apply the symbol C shall make
                                                                        the symbol X optional,
        — in the case of preparations to which are
              assigned phrases R42 or R43, and/or R42/             — the obligation to apply the symbol E shall make
              43 in accordance with Article 3, only sub-                the symbols F and O optional.
              stances to which those phrases are assigned
              and which are present in concentrations
              equal to or in excess of the limit laid down     (e) One or more standard phrases indicating the special
              in Annex 1 to this Directive or to Directive         risks involved in the use of the preparation
              67/548/EEC need be taken into consider-              (R phrases).
              ation.
                                                                   The indications concerning special risks (R phrases)
         If the preparation:                                       shall conform to the wording in Annex III to Direc-
                                                                   tive 67/548/EEC and shall be provided by the manu-
         — in accordance with Article 3 is assigned one
                                                                   facturer or any other person placing the preparation
              of the standard phrases R39, R40, R42, R43,
                                                                   on the market, in accordance with Annex I to this
              R42/43, R45, R46, R47 and/or R48, the
                                                                   Directive and Annex VI (II) (d) to Directive 67/548/
              name of the substance or substances must
                                                                   EEC.
              be mentioned;
    (2) As a general rule a maximum of 4 chemical                  A maximum of four R phrases is generally sufficient
         names shall suffice to identify the substances            to describe the risks; for this purpose the combined
         primarily responsible for the major health haz-           phrases listed in the aforementioned Annex III shall
         ards which have given rise to the classification          be regarded as single phrases. If the preparation
         and the choice of the corresponding phrases               falls within more than one danger category, how-
         referring to the risk involved. In some cases,            ever, these standard phrases must cover all the prin-
         more than 4 chemical names may be necessary.              cipal hazards associated with the preparation.
    The chemical name shall be one of the designations             If a preparation is classified as both harmful and
    listed in Annex I to Directive 67/548/EEC or an                irritant, it shall be labelled 'harmful' and attention
    internationally recognized designation if it is not yet        shall be drawn to its harmful and irritant character-
    listed therein.                                                istics by the appropriate R phrases.
    Where a manufacturer can demonstrate that the                  The standard phrases 'extremely flammable' or
    disclosure of the chemical identity of a harmful               'highly flammable' need not appear if they repeat
    substance not assigned one or more of the R phrases            an indication of danger used pursuant to paragraph
    mentioned above on the label of a preparation will             (d) above.
    put at risk his confidential property he shall be
    permitted to refer to that substance by means of a
    name that identifies the most important functional         (f) One or more standard phrases giving safety advice
    chemical groups. Where this is the case, the manu-             on the use of the preparation (S phrases).
    facturer must inform the authorities of the Member
    State where the product is first placed on the market.         The indications giving safety advice (S phrases) shall
    These authorities shall inform the Commission and              conform to the wording in Annex IV to Directive
    the other Member States.                                       67/548/EEC and shall be provided by the manufac-
                                                                   turer or any other person placing the preparation
    Confidential information brought to the attention              on the market, in accordance with Annex II to this
    of the authorities of a Member State or of the                 Directive and Annex VI (II) (d) to Directive 67/548/
    commision shall be treated in accordance with                  EEC.
    Article 11 (4) of Directive 67/548/EEC.
                                                                   A maximum of four S phrases is generally sufficient
                                                                   to formulate the most appropriate safety advice; for
(d) The symbols, where specified in this Directive, for            this purpose the combined phrases listed in the
    and indications of the dangers involved in the use             aforementioned Annex IV shall be regarded as single
    of the preparation, in accordance with Article 16              phrases.
    (2) (c) of Directive 67/548/EEC read in conjunction
    with Annex II thereto, and, in the case of aerosol             The package shall be accompanied by safety advice
    preparations, in accordance with points 1.8 and                on the use of the preparation where it is physically
    2.2 (c) of the Annex to Directive 75/324/EEC as far            impossible to include the advice on the label or
    as flammability hazards are concerned.                         package itself.
 ---pagebreak--- 30. 12. 87                           Official Journal of the European Communities                            N o C 353/11
    In the case of highly flammable and flammable              3.    The colour and presentation of the label — or, in
    oxidizing preparations, there is no need to give a         the case of paragraph 2, of the package — shall be such
    reminder of the special risks or the safety advice if      that the danger symbol and its background stand out
    the contents of the package do not exceed 125 ml.          clearly from it.
    The same shall apply in the case of irritant prep-
    arations except where they contain substances that         4.    Member States may make the placing of danger-
    might cause sensitization. In that case point 3 of         ous preparations on the market in their territory subject
    Annex II shall apply.                                      to the use of their official language or languages for
                                                               the purposes of labelling.
(g) The nominal quantity (nominal mass or nominal
    volume) of the contents in the case of preparations        5.    For the purpose of this Directive, labelling require-
    sold to the general public.                                ments shall be deemed to be satisfied:
2.     The special provisions applicable to certain prep-      (a) In the case of an outer package containing one or
arations are set out in Annex II.                                  more inner packages, if the outer package is labelled
                                                                   in accordance with international rules on the trans-
                                                                   port of dangerous substances and the inner package
3.     Article 3 (6) (a) shall apply mutatis mutandis   to         or packages are labelled in accordance with this
labelling.                                                         Directive.
4.     Informaton such as 'non toxic', 'not harmful' or        (b) In the case of a single package, if such a package is
any other statement indicating that the preparation is             labelled in accordance with international rules on
not dangerous may not appear on the packaging or                   the transport of dangerous substances and with
labelling of the preparations referred to in this Direc-           Article 7 (2) (a), (b), (c), (e) and (f) and Article 7
tive.                                                              (3).
                                                               For dangerous preparations that are not leaving the
                                                               territory of a Member State, the labelling may be in
                                                               accordance with national regulations instead of with
                                                               the international rules on the transport of dangerous
                                                               substances.
                          Article 8
                                                                                        Article 9
 1.    Where the particulars required by Article 7 appear
on a label, that label shall be firmly affixed to one or       1.    Member States may:
more surfaces of the packaging so that the said particu-
lars can be read horizontally when the package is set          (a) permit the labelling required by Article 7 to be
down normally. The dimensions of the label shall be                applied in some other appropriate manner on pack-
as follows:                                                        ages which are either too small or otherwise unsuit-
                                                                   able for labelling in accordance with Article 8 (1)
                                                                   and (2);
Capacity of the package (dimensions (in mm) if poss-
ible):                                                         (b) by way of derogation from Articles 6 and 7, permit
— not exceeding three litres: at least 52 x 74,                    the packaging of dangerous preparations which are
                                                                   neither explosive, very toxic nor toxic to be unlabel-
— greater than three litres but not exceeding 50 litres:           led or to be labelled in some other way if they
    at least 74 x 105,                                             contain such small quantities that there is no reason
— greater than 50 litres but not exceeding 500 litres:             to fear any danger to persons handling such prep-
    at least 105 x 148,                                            arations or to other persons.
— greater than 500 litres: at least 148 x 210.
                                                               2.    If a Member State makes use of the options pro-
                                                               vided for in paragraph 1, it shall forthwith inform the
Each symbol shall cover at least one tenth of the surface      Commission thereof.
area of the label but shall not be less than 1 cm 2 . The
entire surface of the label shall adhere to the package
immediately containing the preparation.
                                                                                       Article 10
These dimensions are intended solely for provision of          The Member States shall take the measures necessary
the information required by this Directive and if necess-      to implement a system of specific information (in safety
ary of any supplementary health or safety information.         data-sheet form) relating to dangerous preparations.
2.     A label is not required when the particulars are        The detailed arrangements for this system shall be laid
clearly shown on the package itself, as specified in           down in accordance with the procedure provided for
paragraph 1.                                                   in Article 21 of Directive 67/548/EEC within a period
 ---pagebreak--- No C 353/12                         Official Journal of the European Communities                              30. 12. 87
of three years after the adoption of the Directive, taking    classification, packaging or labelling, it may provision-
into account the systems in force in the Member States.       ally prohibit the sale of that hazardous preparation or
                                                              subject it to special conditions in its territory. It shall
This information is principally intended for use by           immediately inform the Commission and the other
industrial users and must enable them to take the             Member States of such action and give reasons for its
necessary measures for the protection of health and the       decision.
safety at the place of work.
                                                              2.    The Commission shall consult the Member States
                                                              concerned as soon as possible, then deliver its opinion
                         Article 11                           without delay and take the appropriate measures.
The Member States shall appoint the body or bodies            3.    If the Commission considers that technical adap-
responsible for receiving information on dangerous            tations to this Directive are necessary, such adaptations
preparations, including their chemical composition,           shall be adopted in accordance with the procedure laid
placed on the marked.                                         down in Article 21 of Directive 67/548/EEC. In such a
                                                              case, Member States which have adopted safeguard
The Member States shall take the necessary steps to           measures may maintain them until the adaptations enter
ensure that the appointed bodies are able to provide all      into force.
the requisite guarantees for maintaining the con-
fidentiality of the information received. Such infor-
mation may only be used to meet any medical demand                                     Article 14
by formulating preventive and curative measures, in
particular in emergencies.                                    Amendments required to adapt the Annexes to technical
                                                              progress shall be adopted in accordance with the pro-
The Member States shall ensure that the information           cedure laid down in Article 21 of Directive 67/548/EEC.
is not used for other purposes.
For existing products, the Member States shall take
measures to comply with this Directive within two                                      Article 15
years after the adoption of this Directive.
                                                              1.    Member States shall bring into force not later
The Member States shall determine the detailed                than 18 months after the adoption of this Directive the
arrangements for the aforementioned exchange of infor-        laws, regulations and administrative provisions necess-
mation so as to ensure that the appointed bodies have         ary to comply with this Directive and shall forthwith
all the information required for the tasks for which          inform the Commission thereof.
they are responsible.
                                                              2.    Member States shall communicate to the Com-
                                                              mission the text of the main provisions of national law
                         Article 12                           which they adopt in the field covered by this Directive
                                                              not more than six months later.
Member States shall not prohibit, restrict or impede,
                                                              3.    On the date this Directive enters into force Direc-
on the grounds of classification, packaging or labelling
                                                              tives 73/177/EEC (solvents) and 77/728/EEC (paints,
as defined in this Directive, the placing on the market
                                                              varnishes and similar products) shall be repealed.
of dangerous preparations which satisfy the require-
                                                              Nevertheless, preparations wich are in conformity with
ments of this Directive and Annex II thereto.
                                                              the specifications of the abovementioned Directives may
                                                              continue to be placed on the market until three years
                                                              after the date of entry into force.
                         Article 13
1.    Where a Member State has detailed evidence that                                  Article 16
a preparation, although satisfying the requirements of
this Directive, constitutes a hazard by reason of its         This Directive is addressed to the Member States.
 ---pagebreak--- 30. 12. 87                                  Official Journal of the European Communities                                     No C 353/13
                                                                 ANNEX   1
            CONCENTRATION LIMITS T O BE USED IN APPLYING THE CONVENTIONAL METHOD OF
                              ASSESSING HEALTH HAZARDS IN ACCORDANCE WITH ARTICLE 3 (5)
            An assessment must be made of all the health hazards that the use of a substance might entail. For that
            purpose the dangerous health effects have been subdivised into:
            — acute lethal effects,
            — non-lethal irreversible effects after a single exposure,
            — severe effects after repeated or prolonged exposure,
            — corrosive effects,
            — irritant effects,
            — sensitizing effects,
            — carcinogenesis,
            — mutagenesis,
            — teratogenesis.
            The systematic assessment of all the dangerous health effects is expressed by means of concentration limits
            in conjunction with the classification of the substance, i.e. the symbol and phrases denoting the risk.
            Therefore, given the symbol priority rule, it is important to consider, in addition to the symbol, all the
            phrases denoting specific risks which are assigned to each substance under consideration.
            1. Acute lethal effects
            The concentration limits fixed in Table I determine the classification of the preparation in relation to the
            individual concentration of the substance(s) present whose classification is also shown.
                                                                 TABLE I
                                                                     Classification of the preparation
              Classification of the substance               +
                                                          T                          T                           Xn
           T + with R26, R27, R28                 cone. > 7 %             1% < c o n c . < 7 %         0,1 % < cone. < 1 %
           T with R23, R24, R25                                           cone. > 25 %                 3 % < cone. < 25 %
           Xn with R20, R21, R22                                                                       cone. > 25 %
           The R phrases shall be assigned to the preparation in accordance with the following criteria:
           — The label shall include one or more of the abovementioned R phrases according to the classification used.
           — In general, the R phrases selected should be those applicable to the substance(s) present in the concentration
                which gives rise to the most severe classification.
           2. Non-lethal irreversible effects after a single exposure
           For substances that produce non-lethal irreversible effects after a single exposure (R39/R40) the individual
           concentration limits specified in Table II determine, when appropriate, the classification of the preparation
           and shall determine which particular standard R phrase is to be assigned.
                                                                 TABLE II
                                                                     Classification of the preparation
              Classification of the substance               +
                                                          T                          T                           xn
           T + with R39                           cone. >: 10 %            1% < c o n c . < 10%        0,1 % < cone. < 1%
                                                  R39(*) obligatory       R39(*) obligatory            R40(*) obligatory
           T with R39                                                     cone. > 10%                  l % < c o n c . < 10%
                                                                          R39(*) obligatory            R40(*) obligatory
           Xn with R40                                                                                 cone. > 10 %
                                                                                                       R40(*) obligatory
 ---pagebreak--- No C 353/14                              Official Journal of the European Communities                                                     30. 12. 87
          3. Severe effects after repeated or prolonged exposure
          For substances that produce severe effects after repeated or prolonged exposure (R48) the individual
          concentration limits specified in Table III determine, when appropriate, the classification of the preparation
          and shall determine which particular standard R phrase is to be assigned.
                                                                  TABLE III
                                                                            Classification of the preparation
              Classification of the substance
                                                                      T                                           Xn
          T with R48                                   (*) cone. 2 : 1 0 %                          (*) l % < c o n c . < 10%
                                                       R48 obligatory                               R48(*) obligatory
          Xn with R48                                                                               (*) cone. > 10%
                                                                                                    R48(*) obligatory
          (*) In accordance with the labelling guide and depending on the classification, the standard R phrases R26, R27, R28,
              R23, R24, R2.5, R20, R21, R22 are also to be assigned to indicate route of administration/exposure.
          4. Corrosive and irritant effects
          For substances that produce corrosive effects (R34/R35) or irritant effects (R36, R37, R38, R41) the individual
          concentration limits specified in Table IV determine, when appropriate, the classification of the preparation.
                                                                  TABLE IV
                 Classification                         Classification of the preparation and standard risk phrase
                of the substance
                and/or relevant
                                            At least C               At least C                At least Xi              At least Xi
                  standard risk
                     phrase                  with R35                with R34                   with R41             with R36, 37, 38
          At least C with R35          cone. > 10%           5 % < c o n c . < 10%                                1 % < cone. < 5 %
                                       R35 obligatory        R34 obligatory                                       R36/38 obligatory
          At least C with R34                                cone. > 10%                                          5 % < c o n e . < 10%
                                                             R34 obligatory                                       R36/38 obligatory
          At least Xi with R41                                                            cone. > 10%             5 % < c o n e . < 10%
                                                                                          R41 obligatory          R36 obligatory
          At least Xi with R36,                                                                                   cone. > 20%
          37,38                                                                                                   R36, R37 and R38
                                                                                                                  are obligatory in the
                                                                                                                  light of the concen-
                                                                                                                  tration present if
                                                                                                                  they apply to the
                                                                                                                  substances        under
                                                                                                                  consideration
          5. Sensitizing effects
          Substances that produce such effects are classified:
          — at least as harmful (Xn) and assigned R42 if this effect can be produced by inhalation,
          — at least as irritant (Xi) and assigned R43 if this effect can be produced through contact with the skin,
 ---pagebreak--- 30. 12. 87                                Official Journal of the European Communities                                       No C 353/15
           — at least as harmful (Xn) and assigned R42/43 if this effect can be produced in both these ways.
           The individual concentration limits specified in Table V determine, when appropriate, the classification of
           the preparation, and shall determine which particular R phrase is to be assigned.
                                                                  TABLE V
                                                              Classification of the preparation and standard risk phrase
               Classification of the substance
                                                          At least Xn and R42                           At least Xi and R43
           At least Xn and R42                        cone. > 1 %
                                                       R42 obligatory
           At least Xi and R43                                                                      cone. > 1 %
                                                                                                    R43 obligatory
           At least X n and R 4 2 / 4 3               cone. > 1 %
                                                      R 4 2 / 4 3 obligatory
           6. Carcinogenic/mutagenic/teratogenic effects
           For substances which produce such effects and for which specific concentration limits do not yet appear in
           Annex I to Directive 67/548/EEC and for those which, in accordance with paragraph 3 (1) (1) of Directive
           83/467/EEC, are provisionally assigned the phrase R40, the concentration limits laid down in Table VI shall
           determine, when appropriate, the classification of the preparation and the compulsory R phrase to be assigned
           to it.
                                                                  TABLE VI
                                                                  Classification of the preparation and standard risk phrase
                   Classification of the substance
                                                                       At least T                             At least Xn
           At least T with R45 for carcinogenic            >0,1%
           substances of category 1 or 2                   R45 obligatory
           At least X n with R40 for carcinogenic                                                   > 1 %
           substances of category 3                                                                 R40 obligatory
           At least T with R46 for mutagenic              >0,1%
           substances of category 1                        R46 obligatory
           At least Xn with R46 for mutagenic                                                       > 0,1 %
           substances of category 2                                                                 R46 obligatory
           At least Xn with R40 for mutagenic                                                       > 1 %
           substances of category 3                                                                 R40 obligatory
           At least T with R47 for teratogenic            > 0,5 %
           substances of category 1                        R47 obligatory
           At least Xn with R47 for teratogenic                                                     > 5 %
           substances of category 2                                                                 R47 obligatory
           At least Xn and R40 provisionally in                                                    > 1 %
           accordance with 3.1.1 of Directive 8 3 /                                                 R40 obligatory
           467/EEC
 ---pagebreak--- No C 353/16                           Official Journal of the European Communities                                       30. 12. 87
                                                            ANNEX     II
                        SPECIAL PROVISIONS O N THE LABELLING OF CERTAIN PREPARATIONS
          1.   PREPARATIONS CLASSIFIED AS VERY TOXIC, TOXIC OR CORROSIVE SOLD TO THE GEN-
               ERAL PUBLIC
          1.1. The labels on packages containing such preparations shall bear the inscriptions S1/S2 and S49 in addition
               to the specific safety advice.
          1.2. Where it is physically impossible to give such information on the package itself, packages containing
               such preparations shall be accompanied by precise and easily understandable instructions for use
               including, where necessary, instructions for the destruction of the empty package.
          2.   PREPARATIONS CONTAINING LEAD
          2.1. Paints and varnishes
               Labels of packages of paints and varnishes containing lead in quantities exceeding 0,25 % expressed as
               weight of metal, of the total weight of the preparation, as determined in accordance with ISO standard
               6503/1984 shall show the following particulars:
               'Contains lead. Should not be used on surfaces liable to be chewed or sucked by children.'
               In the case of packages the contents of which are less than 125 ml, the particulars may be as follows:
               'Warning. Contains lead.'
          3.   PREPARATIONS CONTAINING CYANOACRYLATES
          3.1. Glues
               The immediate packaging of glues based on cyanoacrylate shall bear the following inscriptions:
               'Cyanoacrylate
               Danger
               Bonds skin and eyes in seconds
               Keep out of the reach of children.'
               Appropriate advice on safety shall accompany the package.
          4.   PREPARATIONS CONTAINING ISOCYANATES
               The package labels of preparations containing isocyanates (as monomers, oligomers, prepolymers, etc.,
               or as mixtures thereof) shall bear the following inscriptions:
               'Contains isocyanates.
               See information supplied by the manufacturer.'
          5.   Preparations containing epoxy constituents with an average molecular weight 700 shall bear the following
               inscriptions:
               'Contains epoxy constituents.
               See information supplied by the manufacturer.'
          6.   PREPARATIONS INTENDED FOR USE BY SPRAYING
               The package label on preparations intended for use by spraying shall bear the safety advice S23 and S38
               or S23 and S51 depending on the application criteria specified in Directive 83/467/EEC.