CELEX: 51985PC0364
Language: en
Date: 1985-07-17
Title: 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

22. 8. 85~                                 Official Journal of the European Communities                                              N o C 211/3
                                                                  II
                                                           (Preparatory Acts)
                                                     COMMISSION
              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(85) 364 final
                                   (Submitted to the Council by the Commission on 29 July 1985)
                                                            (85/C 211/03)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                               — in Council Directive 7 8 / 6 3 1 / E E C of 26 J u n e 1978
                                                                            on the a p p r o x i m a t i o n of the laws of the M e m b e r
Having regard to the Treaty establishing the European                       States relating t o the classification, p a c k a g i n g a n d
Economic Community, and in particular Article 100                           labelling of d a n g e r o u s preparations (pesticides) ( 7 ), as
thereof,                                                                    last a m e n d e d by Directive 8 1 / 1 8 7 / E E C ( 8 );
Having regard to the proposal from the Commission,
                                                                       Whereas           despite      the     abovementioned          Community
Having regard to the opinion of the European Par-                      measures the rules, if any, applying t o d a n g e r o u s
liament,                                                               preparations in the M e m b e r States exhibit considerable
                                                                       differences as r e g a r d s classification a c c o r d i n g t o the
Having regard to the opinion of the Economic and                       degree of risk; w h e r e a s these differences constitute a
Social Committee,                                                      significant barrier to t r a d e a n d directly affect the
                                                                       establishment a n d functioning of the c o m m o n m a r k e t ;
Whereas rules on dangerous substances have already
been laid down in Council Directive 67/548/EEC of
27 June 1967 on the approximation of the laws, regu-                   W h e r e a s it is therefore necessary to r e m o v e this barrier
lations and administrative provisions relating to the classi-          by a p p r o x i m a t i n g the relevant legislation existing in the
fication, packaging and labelling of dangerous sub-                    M e m b e r States a n d i n c o r p o r a t i n g in it the C o m m u n i t y
stances ('), as last amended by Directive 79/831/                      rules at present in force;
EEC (2);
Whereas rules on certain dangerous preparations having                 W h e r e a s this Directive must also aim to improve
very specific uses have already been laid down:                        protection for the general public a n d , in particular, of
                                                                       persons w h o frequently c o m e into c o n t a c t with
— in Council Directive 73/173/EEC of 4 June 1973 on
                                                                       d a n g e r o u s preparations in the course of their w o r k o r in
     the approximation of the laws, regulations and
                                                                       the pursuit of a hobby, w h e r e a s it can also help to
     administrative provisions of the Member States
                                                                       improve p r o t e c t i o n for c o n s u m e r s , especially children
     relating to the classification, packaging and labelling
                                                                        and the visually h a n d i c a p p e d , t h r o u g h the provisions laid
     of dangerous preparations (solvents) (3), as last
                                                                        down;
     amended by Directive 80/781/EEC (4),
 — in Council Directive 77/728/EEC of 7 November
     1977 on the approximation of the laws, regulations                W h e r e a s provisions o n the classification, p a c k a g i n g a n d
     and administrative provisions of the Member States                 labelling of the preparations must be laid d o w n at
     relating to the classification, packaging and labelling            C o m m u n i t y level; w h e r e a s the provisions c o n c e r n i n g the
     of paints, varnishes, printing inks, adhesives and                 information a p p e a r i n g on the label, the dimensions of
     similar products (5), as last amended by Directive                 the label a n d the assignment of the various d a n g e r
     83/265/EEC (6),                                                    symbols have also to be b r o u g h t into line with Directive
                                                                        67/548/EEC;
 O OJNo 196, 16. 8. 1967, p. 1.
 O OJ No L 259, 15. 10. 1979, p. 10.                                    Whereas           dangerous         preparations         may,     although
 (3) OJNoL    189, 11.7. 1973, p. 7.                                    conforming to the                  provisions of this           Directive,
 (4) OJ N o L 229, 30. 8. 1980, p. 57.
 (5) OJ No L  303, 28. 11. 1977, p. 23.                                 (7) OJ No L 206, 29. 7. 1978, p. 13.
 (') OJ N o L 147, 6. 6. 1983, p. 11.                                   (") OJ No L 88, 2. 4. 1981, p. 29.
 ---pagebreak--- No C 211/4                               Official Journal of the European Communities                                  22. 8. 85
nevertheless constitute a danger to health or safety;               (i) containers which contain a preparation in the form
whereas it is therefore advisable to provide a procedure                 of gases compressed, liquified or dissolved under
to reduce this danger,                                                   pressure, excluding aerosols which comply with the
                                                                         requirements of Council Directive 75/324/EEC ( 7 );
HAS ADOPTED THIS DIRECTIVE:
                                                                    (j) munitions and explosives placed on the market with
                           Article 1                                     a view to obtaining a practical effect by explosion or
                                                                         a pyrotechnic effect.
 1.    The purpose of this Directive is to approximate the
laws, regulations and administrative provisions of the
Member States on the:
                                                                                               Article 2
— classification,                                                   The definitions appearing in Article 2 of Directive
                                                                    67/548/EEC, with the exception of the definition in
— packaging, and                                                    paragraph 1 (d) thereof, shall apply to this Directive.
— labelling
of preparations dangerous to man and the environment                                           Article 3
when they are placed on the market in the Member
States.                                                             1.    The requisite physico-chemical properties for the
                                                                    classification of preparations shall be determined by the
                                                                    methods specified in Annex V (A) of Directive 67/548/
2.     This Directive shall apply to preparations placed on         EEC.
the market in the Member States which contain one or
more dangerous substances as defined in Article 2.
                                                                    Preparations shall be regarded as explosive, oxidizing,
 3.    This Directive shall not apply to:                           extremely flammable, highly flammable or flammable
                                                                    when the results of the tests carried out by the methods
(a) medicinal or veterinary products as defined             by      mentioned above comply with the definitions in Article 2
     Council Directive 65/65/EEC (');                               and the specific evaluation criteria detailed in those
                                                                    methods.
(b) preparations     containing   at least one     radioactive
     substance;
                                                                    The determination of the explosive and oxidizing
(c) foodstuffs;                                                     properties is not necessary, however, if none of the
                                                                    constituents possesses such properties and if, on the basis
(d) animal feedingstuffs, their additives as defined in             of the information available to the manufacturer, the
     Council Directive 70/254/EEC (2), certain products             preparation is unlikely to present dangers of this kind.
     used in animal nutrition as specified in Council
     Directive      82/471 / E E C (3)    and        medicinal
     feedingstuffs for animals;                                     2.    The health hazards shall be assessed by the
                                                                    conventional method described below, using either
(e) the carriage of dangerous substances by rail, road,             hazard indices in accordance with Article 4 (2) of
     inland waterway, sea or air;                                   Directive 67/548/EEC, or individual concentration
                                                                    limits, or a combination of the two (hereinafter referred
(f) cosmetic products as defined by Council Directive               to as parameters).
     76/768/EECO;
(g) mixtures of substances in the form of waste, which              Where the dangerous substances listed in Annex I to
     are covered by Council Directives 75/442/EEC (5)               Directive 67/548/EEC are assigned parameters necessary
     and78/319/EEC(6);                                              for the application of the method of evaluation described
                                                                    below, those parameters shall be used.
(h) substances in transit which are under customs
     supervision provided they do not undergo any
     treatment or processing;                                       Where the dangerous substances do not appear in Annex I
                                                                    to Directive 67/548/EEC or appear there without the
                                                                    parameters necessary for the application of the method
(') OJ No 22, 9. 2. 1965, p. 369.
                                                                    of evaluation described below, the parameters shall be
(2) OJ No L 270, 14. 12. 1970, p. 1.
                                                                    assigned in accordance with the specifications in Annex I
O   OJ No L 213, 21. 7. 1982, p. 8.
                                                                    to this Directive.
(4) OJ No L 262, 27. 9. 1976, p. 169.
(») OJ No L 194, 15. 7. 1975, p. 39.
(•) OJ No L 84, 31. 3. 1978, p. 43.                                 O OJ No L 147, 9. 6. 1975, p. 40.
 ---pagebreak--- 22.8.85                                      Official Journal of the European Communities                                   NoC211/5
In that case:                                                           (b) The following preparations shall be regarded as toxic:
(a) The following preparations shall be regarded as very                     (i) Owing to their acute lethal toxic effects,
     toxic:                                                                       preparations containing one or more dangerous
                                                                                  substances if:
      (i) Owing to their acute lethal toxic effects,
           preparations containing one or more dangerous                          — for oral absorption the sum of the products
           substances if:                                                             obtained by multiplying the percentage by
                                                                                      weight of the dangerous substances in the
           — for oral administration the sum of the                                   preparation by their specific indices is
                products obtained by multiplying the                                  between 1 000 and 8 000, i.e.
                percentage by weight of the dangerous sub-
                stances in the preparation by their specific
                indices is greater than 8 000, i.e.                                           8 000 >    ^ (P x I ori ) >   1 000
                              2(PxIorl) >      8 000                              — for percutaneous absorption the sum of the
                                                                                      products obtained by multiplying the
                                                                                      percentage by weight of the dangerous sub-
           — for percutaneous administration the sum of
                                                                                      stances in the preparation by their specific
                the products obtained by multiplying the
                                                                                      indices is between 500 and 4 000, i.e.
                percentage by weight of the dangerous sub-
                stances in the preparation by their specific
                indices is greater than 4 000, i.e.                                            4 0 0 0 > £(PxIskn) >         500
                             I(PxIskn) >        4 000                             — for administration by inhalation the sum of
                                                                                      the products obtained by multiplying the
                for administration by inhalation the sum of                           percentage by weight of the dangerous sub-
                the products obtained by multiplying the                              stances present in the preparation by their
                percentage by weight of the various                                   specific indices is between 1 000 and 4 000,
                dangerous substances in the preparation by                            i.e.
                their specific indices is greater than 4 000, i.e.
                                                                                              4 0 0 0 > I(PxIihl) >         1000.
                              £(PxIihl) >      4 000,
                                                                             (ii) Owing to their non-lethal irreversible effects
           wh(                                                                    after one exposure, preparations containing one
                                                                                  or more dangerous substances that produce such
                   is the percentage by weight of each                            effects in individual concentrations greater than:
                   dangerous substance in the preparation,
                                                                                  — either the concentration specified in Annex I
           !orl    is the highest hazard index for oral                               to Directive 67/548/EEC for the substance
                   administration specific to each dangerous                          or substances under consideration,
                   substance present,
                                                                                  — or the concentration specified at point 2.2 of
                   is the highest hazard index for percu-
                                                                                      Annex I to this Directive where the
                   taneous administration specific to each
                                                                                      substance or substances under consideration
                   dangerous substance present,
                                                                                      do not appear in Annex I to Directive
           Ijhl    is the highest hazard index for inhalation                         67/548/EEC or appear in it without
                   specific to each dangerous substance                               parameters.
                   present.
                                                                            (iii) Owing to their long-term effects, preparations
      (ii) Owing to their non-lethal irreversible effects                         containing one or more dangerous substances
            after one exposure, preparations containing one                       that produce such effects               in individual
           or more dangerous substances that produce such                         concentrations greater than:
            effects in individual concentrations greater than:
                                                                                  — either the concentration specified in Annex I
           — either the concentration specified in Annex I                            to Directive 67/548/EEC for the substance
                 to Directive 67/548/EEC for the substance                            or substances under consideration,
                 or substances under consideration,
                                                                                  — or the concentration specified at point 2.3 of
           — or the concentration specified at point 2.2 of                           Annex I to this Directive where the
                Annex I to this Directive where the substance                          substance or substances under consideration
                 or substances under consideration do not                              do not appear in Annex I to Directive
                 appear in Annex I to Directive 67/548/EEC                             67/548/EEC or appear in it without
                 or appear in it without parameters.                                   parameters.
 ---pagebreak--- No C 211/6                                 Official Journal of the European Communities                                        22. 8. 85
(c) The following         preparations  shall he regarded as           (d) The following          preparations   shall be regarded as
     harmful:                                                               corrosive:
       (i) Owing to their acute lethal toxic effects,
            preparations containing one or more dangerous                    (i) Preparations containing one or more substances
            substances if:                                                        classified or regarded as corrosive in individual
                                                                                  concentrations exceeding:
            — for oral administration the sum of the
                products obtained by multiplying the
                percentage by weight of the dangerous sub-                       — either the concentration specified in Annex I
                stances in the preparation by their specific                            to Directive 67/548/EEC for the substance
                indices is between 100 and 1 000, i.e.                                  or substances under consideration,
                         1 0 0 0 > £(PxIorI) >       100                         — or the concentration specified at point 3.1 of
                                                                                        Annex I to this Directive where the substance
           — for percutaneous absorption the sum of the                                 or substances do not appear in Annex I to
                products obtained by multiplying the                                    Directive 67/548/EEC or appear in it
                percentage by weight of the dangerous sub-                              without parameters.
                stances in the preparation by their specific
                indices is between 100 and 500, i.e.
                                                                            (ii) Preparations        containing     more    than    one
                                                                                 substance classified or regarded as corrosive in
                          500 >    £(PxIskn)  >     100
                                                                                 individual concentrations not exceeding the
                                                                                 limits specified either in Annex I to Directive
           — for administration by inhalation the sum of                         67/548/EEC or at point 3.1 of Annex I to this
                the products obtained by multiplying the                         Directive if the sum of the quotients obtained by
               percentage by weight of the dangerous sub-                        dividing the weight percentage of each corrosive
                stances present in the preparation by their                      substance in the preparation by the corrosive
                specific indices is between 100 and 1 000, i.e.                  limit specified for that substance exceeds 1, i.e.
                                                                                                       p
                         1000 >     £(PxIihl) >     100.
                                                                                                   v — — > ]>
     (ii) Owing to their non-lethal irreversible effects
           after one exposure, preparations containing one                       where:
           or more dangerous substances that produce such
           effects in individual concentrations greater than:
                                                                                 P c o r is the weight percentage of each corrosive
           — either the concentration specified in Annex I                               substance in the preparation,
               to Directive 67/548/EEC for the substance
               or substances under consideration,
                                                                                 L c o r is the corrosive limit specified for each
           — or the concentration specified at point 2.2 of                              corrosive    substance     expressed    as    a
               Annex I to this Directive where the                                       percentage.
               substance or substances under consideration
               do not appear in Annex I to Directive
               67/548/EEC or appear in it without                     (e) The following          preparations   shall be   regarded as
               parameters.                                                 irritant:
    (iii) Owing to their long-term effects, preparations
                                                                           (i) Preparations containing one or more substances
           containing one or more dangerous substances
                                                                                 classified or regarded as irritant in individual
           that produce such effects in individual
                                                                                 concentrations exceeding:
           concentrations greater than:
          — either the concentration specified in Annex I                        — either the concentration specified in Annex I
               to Directive 67/548/EEC for the substance                               to Directive 67/548/EEC for the substance
               or substances under consideration,                                      or substances under consideration,
          — or the concentration specified at point 2.3 of
               Annex I to this Directive where the                              — or the concentration specified at point 3.1 of
               substance or substances under consideration                             Annex I to this Directive where the substance
               do not appear in Annex I to Directive                                   or substances do not appear in Annex I to
               67/548/EEC or appear in it without                                      Directive 67/548/EEC or appear in it
               parameters.                                                             without parameters.
 ---pagebreak--- 22. 8. 85                                   Official Journal of the European Communities                               N o C 211II
     (ii) Preparations containing more than one of the                 3.     For preparations covered by this Directive:
          substances classified or regarded as corrosive or
          irritant      in individual      concentrations    not
          exceeding the limits specified either in Annex I
          to Directivie 67/548/EEC or at point 3.1 of                  (a) No account shall be taken of substances whether or
          Annex I to this Directive if the sum of the                       not listed in Annex I to Directive 67/548/EEC,
          quotients obtained by dividing the weight                         whether existing as impurities or as additives, if their
          percentage of each substance in the preparation                   concentration by weight is less than:
          by the irritant limit specified for that substance
          exceeds 1, i.e.                                                   — 0 , 1 % for substances classified as very toxic or
                                                                                toxic,
                           P          P                                     — 1,0% for substances          classified as   harmful,
                           x         x
                             cor       irr                                      corrosive or irritant,
                                                                            unless lower values have been specified in Annex I to
          where:                                                            Directive 67/548/EEC.
          P c o r is the weight percentage of each corrosive
                  substance in the preparation,                        (b) Dangerous substances not listed in Annex I to
                                                                            Directive 67/548/EEC but used as constituents of a
                                                                            preparation in a concentration by weight higher than
          P; rr is the weight percentage of each irritant                   that given at point (a) above shall be given
                  substance in the preparation,                             parameters characterizing the health hazards.
                                                                            Some substances may have more than one property
                                                                            harmful to health, e.g.          harmfulness/irritation,
          Lj rr is the irritant limit specified for each
                                                                            corrosiveness/harmfulness/sensitization, etc., each of
                  corrosive or irritant substance expressed as
                                                                            these properties being characterized by its specific
                  a percentage.
                                                                            parameter: hazard index and/or concentration limit.
                                                                            These parameters shall be determined in accordance
                                                                            with Annex I to this Directive by-the manufacturer
(f) Preparations shall be regarded as carcinogenic if they                  or any other person who places such a preparation
     contain a substance listed in Annex I to Directive                     on the market on the basis either of toxicological
     67/548/EEC to which is assigned the standard                           data from the available literature or of information
     phrase R 45 denoting that particular hazard in a                       based on experience.
     concentration exceeding the limit specified in that
     Annex.
                                                                       (c) In the case of the substances referred to at (b) the
(g) Preparations shall be regarded as mutagenic if they                     manufacturer or his representative shall send as soon
     contain a substance listed in Annex I to Directive                     as possible to the authorities of the Member State in
     67/548/EEC to which is assigned the standard                           which the preparation is manufactured or placed on
     phrase R 46 denoting that particular hazard in a                       the market for the first time all the data used to
     concentration exceeding the limit specified in that                    establish the parameters specific to each substance
     Annex.                                                                 and/or the concentration limits.
(h) Preparations shall be regarded as teratogenic if they
     contain a substance listed in Annex I to Directive
     67/548/EEC to which is assigned the standard                      4. (a) By way of derogation from paragraph 2 the
     phrase R 47 denoting that particular hazard in a                          health hazards of a preparation can be assessed by
     concentration exceeding the limit specified in that                       determining the toxicological properties necessary
     Annex.                                                                    for the definition of an appropriate classification
                                                                               and labelling in accordance with the criteria in
                                                                               Annex VI to Directive 67/548/EEC.
(i) Preparations shall be regarded as having specific effects                  The toxicological properties shall be determined
     on health (carcinogenic, mutagenic or teratogenic)                        by the methods specified at point B of Annex V to
     without further definition if they contain a substance                    that Directive.
     which, although it does not yet appear in Annex I to
     Directive 67/548/EEC, has been provisionally
     assigned         the    phrase    R 40 xx     because     its
     concentration exceeds the limit specified in Annex I                  (b) For preparations of well-defined composition
     to this Directive.                                                        classified in accordance with this derogation, a
 ---pagebreak--- No C 211 /8                               Official Journal of the European Communities                                   22. 8. 85
        new toxicological assessment shall be performed                  shape and/or graphic decoration likely to attract or
        in accordance with the criteria set out at (a)                   arouse the active curiosity of children, nor an
        whenever:                                                        appearance resembling that of packagings generally
                                                                         used for foodstuffs.
        — changes of composition exceeding ± 5 % of
            the initial content of one or more of the
            constituents are introduced by the manu-
            facturer,                                                2.    Member States shall take all necessary measures to
                                                                     ensure that containers containing certain categories of
        — changes of composition involving the subs-                 dangerous preparations retailed to the general public and
            titution of one or more constituents, which              defined in accordance with the procedure referred to in
            may or may not be dangerous within the                   paragraph 3:
            meaning of the definitions of this Directive,
            are introduced by the manufacturer.
                                                                     (a) are initially closed with a seal in such a way that,
                                                                         when the package is opened for the first time, the
                           Article 4                                     seal is irreparably damaged;
 1.   The Member States shall appoint the authority or
authorities responsible for receiving and examining the              (b) are fitted with childproof fastenings;
information specified in Article 3 (3) (b) and in particular
all the data used to determine the parameters specific to
each of the health-endangering properties of every                   (c) carry a tactile warning of danger.
constituent in the preparation and the proposed
concentration limits.
                                                                     3.    Dangerous preparations the packagings of which
2.    To enable Annex I to Directive 67/548/EEC to be                have to be fitted with the devices referred to in
                                                                     paragraph 2 (b) and (c) shall be defined by the procedure
brought up to date by the procedure laid down in Article
                                                                     referred to in Article 21 of Directive 67/548/EEC.
21 thereof, the Member States shall forward to the
Commission upon request the information notified to
them pursuant to Article 3 (3) (b).
                                                                     The technical specifications relating to such devices are
                                                                     given in parts A and B of Annex IX to Directive 67/548/
                                                                     EEC.
                           Article 5
The classification of dangerous substances according to
the degree of hazard and the specific nature of the risks                                      ;4mc/e 8
involved shall be based on the definitions laid down in
Article 2. The substances shall be classified according to           1.    Member States shall take all necessary measures to
the greatest degree of hazard in accordance with Article             ensure that dangerous preparations are not placed on the
8(9).                                                                market unless the labelling on the package complies with
                                                                     the requirements set out in paragraphs 2 to 10.
                          Article 6
                                                                     2.    The following information shall be clearly and
Member States shall take all necessary measures to                   indelibly marked on any package:
ensure that the dangerous preparations referred to in
Article 2 are not placed on the market unless they
comply with the provisions of this Directive.
                                                                     (a) The trade name or designation of the preparation.
                          Article 7
                                                                     (b) The chemical name of the very toxic, toxic, harmful,
1.    The Member States           shall take   all   necessary           corrosive or irritant substance or substances in
measures to ensure that:                                                 accordance with the following procedures:
— dangerous preparations are not placed on the market                    — substances having specific effects         on  health
    unless their packaging meets the requirements of                         irrespective of their classification:
    Article 15 (1) of Directive 67/548/EEC with respect
    to strength, tightness and fastening system,                             the chemical name of the substance or substances
                                                                             together with the percentage concentration that
                                                                             requires the standard phrases R 45, R 46 or R 47
— containers which contain dangerous preparations                            to be shown on the label of the preparation in
    offered or sold to the general public do not have a                      accordance with Article 3 (2) (f) (g) (h),
 ---pagebreak--- 22. 8. 85                                   Official Journal of the European Communities                               N o C 211/9
    — very toxic or toxic substances:                                            the chemical name of the substance or substances
                                                                                 shall be stated if the preparation is classified as
         the chemical name of the substance or substances
                                                                                 irritant only;
         contained in a percentage exceeding 0 , 1 %
         together with the percentage concentration or the
         percentage zone on the following scale:
                                                                            — substances liable to cause sensitization:
                                                                                 the chemical name of the substance or substances
                                  cone. < 1 %                                    or the words specified at point 3 of Annex II to
                             1 < cone. < 5 %                                     this Directive.
                             5 < cone. < 20 %                                    The chemical name of the substance or subs-
                            20 < cone. < 50 %                                    tances need not be stated if the preparation is
                                   cone. > 50 %                                  classified   as extremely flammable,         highly
                                                                                 flammable, flammable, oxidizing or explosive.
     Indication of the name of the substance or subs-                       The chemical name shall be one of the designations
     tances shall not, however, be necessary if the                         listed in Annex I to Directive 67/548/EEC or an
     preparation is not classified as very toxic, toxic or                  internationally recognized designation if it is not yet
     harmful;                                                               listed therein.
                                                                        (c) The names and addresses of the person resident in
     — harmful substances:                                                  the Community who is responsible for placing the
         the name of the substance or substances present                    preparation on the market, whether it be the manu-
          if:                                                               facturer, the importer or the distributor.
         — their individual concentration is higher than
               that specified either for their acute non-lethal
               effects after a single exposure or for their             (d) Symbols where specified in this Directive and
               severe effects after repeated or prolonged                   indications of danger involved in the use of the
               exposure,                                                    preparation in accordance with Article 16 (2) (c) of
                                                                            Directive 67/548/EEC read in conjunction with
         — where they do not produce                  the effects           Annex II thereto, and, in the case of aerosol
               described        above,      their       individual          preparations, in accordance with points 1.8 and 2.2
               concentration exceeds 10%;                                    (c) of the Annex to Directive 75/324/EEC where
                                                                            flammability hazards are concerned.
          corrosive substances:
                                                                        (e) One or more standard phrases indicating the special
          the name of the substance or substances present
                                                                             risks involved in the use of the preparation (R
          if:
                                                                             phrases).
          — in the case of the substances that appear in
               Annex I to Directive 67/548/EEC, their
               individual concentration exceeds the limit               (f) One or more standard phrases indicating the safety
                specified in that Annex,                                     advice relating to the use of the preparation (S
          — in the case of substances that do not appear in                  phrases).
               Annex I to Directive 67/548/EEC, their
                individual concentration exceeds 10%,
                                                                        (g) The nominal quantity (nominal mass or nominal
          the words 'acidic character' or 'alkaline                          volume) of the contents in the case of preparations
          character' depending on the circumstances, where                   sold to the general public.
          the individual concentration of the corrosive
          substances present is lower than their specified
          corrosive limit, but where, taken together, they
           require      a    corrosive     classification.    This      3.     The indications concerning special risks (R phrases)
           specification is applicable to all corrosive subs-           shall conform to the wording in Annex III to Directive
           tances whether or not they appear in Annex I to              67/548/EEC and shall be selected by the manufacturer
           Directive 67/548/EEC;                                        or any other person placing the preparation on the
                                                                        market.
           irritant substances:                                         A maximum of four R phrases are generally sufficient to
          the chemical name of the substance or substances              describe the risks; in this connection the combined
           if their individual concentration exceeds the                phrases listed in the aforementioned Annex II shall be
           irritant limit specified in Annex I to Directive              regarded as single phrases. If the preparation falls within
           67/548/EEC,                                                   several danger categories, however, these standard
 ---pagebreak--- NoC211/10                                Official Journal of the European Communities                                   22.8.85
phrases must cover all the principal hazards associated                                      Article 9
with the preparation.
                                                                    1.     Where the particulars required by Article 8 appear
                                                                    on a label, that label shall be firmly affixed to one or
The standard phrases 'extremely flammable' or 'highly               more surfaces of the packaging so that the said parti-
flammable' need not be shown if they repeat an                      culars can be read horizontally when the package is set
indication of danger used pursuant to paragraph 2.                  down normally. The dimensions of the label shall be as
                                                                    follows:
4.      The indications concerning safety advice (S
phrases) shall conform to the wording in Annex IV to                Capacity of the package.
Directive 67/548/EEC and shall be selected by the
manufacturer or any other person placing the
preparation on the market.                                          Dimensions (in millimetres) if possible,
                                                                    — not exceeding 3 litres:
A maximum of four S phrases are generally sufficient to                 at least 52 x 74,
give the most appropriate safety advice; in this                    — greater than 3 litres but not exceeding 50 litres:
connection the combined phrases listed in the                           at least 74 x 105,
aforementioned Annex IV shall be regarded as single                 — greater than 50 litres but not exceeding 500 litres:
phrases.                                                                at least 105 x 148,
                                                                    — greater than 500 litres:
5.      The package shall be accompanied by safety advice               at least 148 x 210.
on the use of the preparation where it is physically
impossible for this to be given on the label or package
itself.                                                             Each symbol shall cover at   least one-tenth of the surface
                                                                    area of the label but shall  not be less than 1 cm2. The
                                                                    entire surface of the label   shall adhere to the package
6.      For highly flammable and flammable oxidizing                immediately containing the   preparation.
preparations, the special risks and safety advice need not
be stated if the package contains no more than 125 ml.
This shall also apply in the case of irritant preparations          These dimensions are intended solely for provision of the
except where they contain substances that might cause               information required by this Directive and if necessary of
sensitization. In that case point 3 of Annex II shall apply.        any supplementary health or safety information.
7.      The special provisions applicable         to   certain      2.     A label is not required when the particulars are
preparations are set out in Annex II.                               clearly shown on the package itself, as specified in
                                                                    paragraph 1.
8.      Article 3 (3) (a) shall apply mutatis mutandis to
labelling.                                                          3.     The colour and presentation of the label — or, in
                                                                    the case of paragraph 2, of the package — shall be such
                                                                    that the danger symbol and its background stand out
9.      Where more than one danger symbol is assigned to            clearly from it.
a preparation, the following shall apply:
— the obligation to indicate the symbol T makes the                 4.     Member States may make the placing of dangerous
     symbols C and X optional,                                      preparations on the market in their territory subject to
                                                                    the use of their official language or languages for the
                                                                    purposes of labelling.
— the obligation to indicate the symbol C makes the
     symbol X optional,
                                                                    5.     For the purpose of this Directive,          labelling
— the obligation to indicate the symbol E makes the                 requirements shall be deemed to be satisfied:
     symbols F and O optional.
                                                                    (a) in the case of an outer package containing one or
10.      If a preparation is classified as both harmful and              more inner packages, if the outer package is labelled
irritant, it shall be labelled 'harmful' and attention shall             in accordance with international rules on the
be drawn to its harmful and irritant characteristics by the              transport of dangerous substances and the inner
appropriate R phrases in accordance with paragraph 3                     package or packages are labelled in accordance with
above.                                                                   this Directive;
 ---pagebreak--- 22.8.85                                 Official Journal of the European Communities                               NoC211/ll
(b) in the case of a single package, if such a package is          preparation, although satisfying the requirements of this
     labelled in accordance with international rules on the        Directive, constitutes a hazard for man or the
     transport of dangerous substances and with Article 8          environment by reason of its classification, packaging or
     (2) (a), (b), (c), (e) and (f).                               labelling, it may provisionally prohibit the sale of that
                                                                   hazardous preparation or subject it to special conditions
For dangerous preparations that are not leaving the                in its territory. It shall immediately inform the
territory of a Member State, the labelling may be in               Commission and the other Member States of such action
accordance with national regulations instead of with the           and give reasons for its decision.
international rules on the transport of dangerous subs-
tances.                                                            2.    The Commission shall consult the Member States
                                                                   concerned as soon as possible, then deliver its opinion
                            Article 10                             without delay and take the appropriate measures.
1.     Member States may:                                          3.     If the Commission considers that technical adap-
                                                                   tations to this Directive are necessary, such adaptations
(a) permit the labelling required by Article 8 to be
                                                                   shall be adopted in accordance with the procedure laid
     applied in some other appropriate manner on
                                                                   down in Article 21 of Directive 67/548/EEC. In such a
     packages which are either too small or otherwise
                                                                   case, Member States which have adopted safeguard
     unsuitable for labelling in accordance with Article 9
                                                                   measures may maintain them until the adaptations enter
     (1) and (2);
                                                                   into force.
(b) by way of derogation from Articles 7 and 8, permit
     the packaging of dangerous preparations which are                                        Article 14
     neither explosive nor toxic to be unlabelled or to be
     labelled in some other way if they contain such small         Amendments required to adapt the Annexes to technical
     quantities that there is no reason to fear any danger         progress shall be adopted in accordance with the
     to persons handling such preparations or to other             procedure laid down in Article 21 of Directive 67/548/
     persons.                                                       EEC.
2.     If a Member State makes use of the options                                             Article 15
provided for in paragraph 1, it shall forthwith inform the
Commission thereof.                                                 1.    Member States shall bring into force not later than
                                                                    31 December 1986 the laws, regulations                   and
                             Article 11                             administrative provisions necessary to comply with this
                                                                    Directive and shall forthwith inform the Commission
For dangerous preparations retailed to the general                  thereof.
public, any Member State may, to facilitate prompt and
 effective medical treatment in the event of illness, require       2.    Member States shall communicate to the
 adequate information relevant to the substances                    Commission the text of the main provisions of national
 contained in the preparations to be made available to a            law which they adopt in the field covered by this
 body appointed for that purpose, which will ensure that            Directive not later than 30 June 1987.
 such information is used only for treatment purposes.
                                                                    3.    On the date this Directive enters into force,
                             Article 12                             Directives 73/177/EEC (solvents), 77/728/EEC (paints,
                                                                    varnishes and similar products) and 78/631/EEC
 Member States shall not prohibit, restrict or impede,     on       (pesticides) shall be repealed. Nevertheless, preparations
 the grounds of classification, packaging or labelling      as      which are in conformity with the specifications of the
 defined in this Directive, the placing on the market      of       abovementioned Directives may continue to be placed on
 dangerous preparations which satisfy the requirements     of       the market until . . . (one year after the date of entry into
 this Directive and Annex II thereto.                               force).
                             Article 13                                                       Article 16
  1.    Where a Member State has detailed evidence that a           This Directive is addressed to the Member States.
 ---pagebreak--- N o C 211/12                                Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s            22. 8. 85
                                                                     ANNEX        I
             Method of defining parameters characterizing the health hazards of a substance used as a constituent in a
                                                                     preparation
             Introduction
             Article 1 (2) states that the Directive is applicable to preparations containing one or more dangerous subs-
             tances that may or may not appear in Annex I to Directive 67/548/EEC.
             For dangerous substances that already appear in the abovementioned Annex, the parameters to be taken
             into account in assessing health hazards pursuant to Article 3 are also included.
             For dangerous substances that do not yet appear in Annex I to Directive 67/548/EEC, the parameters
             characterizing such substances shall be defined by the method described below.
             1. General criteria
                Aside from any synergetic or antagonistic phenomena, the health hazards of a preparation are a
                function of the hazards peculiar to each of the constituents and their concentration in the preparation.
                Accordingly, a systematic 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 subdivided into:
             Systemic effects including:
                — acute lethal effects,
                — non-lethal irreversible effects after a single exposure,
                — severe effects after repeated or prolonged exposure.
                Local effects including:
                — corrosive effects,
                — irritant effects,
                — sensitizing effects.
                Specific health effects including:
                — carcinogenesis,
                — mutagenesis,
                — teratogenesis.
                The systematic assessment of all the dangerous health effects is expressed by means of a hazard index, a
                concentration limit or a combination of the two.
            2. Assessment of systemic effects.
                2.1. Assessment of acute lethal effects (DL 50 /LC 5CI ).
                     These effects shall be characterized by a hazard index, which shall be determined in the light of the
                     results of the acute toxicity tests for each type of exposure, as follows:
                     For each dose/concentration range (LD 50 expressed in mg/kg or LC 5 0 in mg/1 4 h) there is an
                     acute lethal toxicity index specific to each type of exposure.
                     These indices are set out in Table I.
 ---pagebreak--- 22. 8. 85                                 Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                               N o C 211 / 1 3
                                                                    TABLE I
                      Dose/concentration ranges and corresponding indices for acute toxicity (LD50/LC50)
                               Dose/concentration ranges for each type of exposure and corresponding indices
            Categories and           LD50 oral                       LD50 percutaneous                         Inhalation LC50
                                                          liorl                                liskn                                Iiiw
             Subdivisions             (mg/kg)                             (mg/kg)                                 (mg/1 4 h)
          Very toxic      1                <        1 3 500                      <        2 1700                        <    0,02 1 700
                          2    >        1, <        3 1 100         >       2, <          6    600           >   0,02, <     0,06   600
                          3    >        3, <        9     400       >       6, <         18    200           >   0,06, <     0,18   200
                          4    >       9, <        25     130       >      18, <         50      70          >   0,18, <     0,5      70
          Toxic           1    >      25,  <       40       60      >     50,    <       80      30          >   0,5,   <    0,7      30
                          2    >      40,  <       70       35      >      80,   <      140      20          >   0,7,   <    1,0      20
                          3    >      70,  <     120        20      >    140,    <      230       10         >   1,     <    1,4      17
                          4    >     120,  <     200        12      >   230,     <      400        6         >   1,4    <    2        12
          Harmful         1    >    200,   <     350          7     >   400,     <      600        4         > 2,       <    3,5       7
                          2    >    350,   <     600          4     >   600,     <      900        3         > 3,5,     < 6            4
                          3    >    600,   < 1 100           2,5    >   900,     < 1 300           2,5 > 6,             < 11           2,5
                          4    > 1 100,    < 2 000            1,5   > 1 300,      < 2 000          1,5 > 11,            < 20            1,5
             2.2. Assessment of the non-lethal irreversible effects after a single exposure.
                  These effects shall be assessed on the basis of concentration limits.
                  For substances that produce such effects the individual concentration limit determining the classi-
                  fication of the preparation shall be specified as follows:
                  — substances classified as very toxic owing to such effects:
                             > 0,2%,        < 1%:        at least harmful,
                        > 1%,               <10%:        at least toxic,
                        > 10 % :                         very toxic;
                  — substances classified as toxic owing to such effects:
                             >   1%         <10%:        at least harmful,
                             > 10%:                      at least toxic;
                  — substances classified as harmful owing to such effects:
                             >10%:                       at least harmful.
             2.3. Assessment of severe effects after repeated or prolonged exposure.
                  These effects shall be assessed on the basis of concentration limits.
                  For substances that produce such effects the individual concentration limit determining the class-
                  ification of the preparation shall be specified as follows:
                  — substances classified as toxic owing to such effects:
                             >   1%         < 10 % :     at least harmful,
                             > 10%:                      at least toxic;
                  — substances classified as harmful owing to such effects:
                             > 10 % :                    at least harmful.
          3. Assessment of local effects
             For substances that produce such effects but do not yet appear in Annex I to Directive 67/548/EEC, the
             concentration limits specified below shall be taken into consideration when classifying the preparation.
             3.1. Corrosive effects:
                  For substances that produce such effects the individual concentration limit determining the classi-
                  fication of the preparation shall be specified as follows:
                            > 10%:       Corrosive,
                         5 — 10%:        Irritant.
 ---pagebreak--- N o C 211 / 1 4                                  Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s          22.8.85
                   3.2. Irritant effects:
                         For substances that produce such effects the individual concentration limit determining the classi-
                         fication of the preparation shall be specified as follows:
                                > 5 %:    Irritant to the skin,
                                > 2 %:    Irritant to the eyes.
                   3.3. Sensitizing effects:
                         For substances that produce such effects, the individual concentration limit determining the classi-
                         fication of the preparation shall be specified as follows:
                         — substances that produce a sensitizing effect by inhalation:
                                   > 1 %:      at least harmful
                         — substances that produce a sensitizing effect through contact with the skin:
                                   > 2 %:      at least irritant.
                   Note
                   Some substances may produce sensitizing effects in both these ways — through contact with the skin
                   and by inhalation. In this case the concentration limit assigned to such substances corresponds to the
                   concentration at which the first sensitizing effect occurs. A preparation containing such a substance in a
                   concentration exceeding 1 % shall be classified as harmful unless there are other effects that call for a
                   stricter classification.
                4. Assessment of specific health effects
                   In accordance with Directive 83/467/EEC, substances that produce such effects but do not yet appear
                   in Annex I to Directive 67/548/EEC shall be provisionally classified as at least harmful.
                   For substances that produce these effects, not more closely defined, the individual concentration limit
                   determining the classification of the preparation shall be specified as follows:
                         . . . %:   at least harmful.
                                                                          ANNEX       II
                                             Special provisions on the labelling of certain preparations
                1. The labelling or packaging of the preparations shall not carry information such as 'non toxic', 'not
                   harmful' or any other statement indicating that the preparation is not dangerous.
                2. Preparations classified as very toxic, toxic or corrosive sold to the general public.
                   2.1. The labels on packages containing such preparations shall bear the inscriptions S 1/S 2 and S 49 in
                         addition to the specific safety advice.
                   2.2. 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.
               3. Preparations containing one or more substances liable to cause sensitization.
                   The package label of preparations containing one or more substances liable to cause sensitization shall
                   show:
                   (a) the name of the substance or substances and the standard phrases (R 42, R 43, R 42/43) indicating
                        these particular risks if:
                       — in the case of substances that appear in Annex I to Directive 67/548/EEC, their individual
                             concentration exceeds the limits laid down in that Annex,
 ---pagebreak--- 22.8.85                               Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s              NoC211/15
               — in the case of substances that do not yet appear in Annex I to Directive 67/548/EEC, their
                    individual concentration exceeds 1 %.
           (b) the inscription 'Contains (a) sensitizing substance(s)' if their individual concentration is lower than
                the limits given above.
        4. Preparations containing lead.
           4.1. Paints and varnishes:
                 Labels on packages of paints and varnishes containing a quantity of lead exceeding / 0,5 % /
                 (expressed as weight of metal) in the total weight of the preparation shall bear the following
                 inscription:
                      'Contains lead. Must not be used on objects liable to be chewed or sucked by children.'
                 In the case of packages the contents of which are not more than 125 millilitres, the inscription may
                 be as follows:
                      'Warning. Contains lead.'
        5. Preparations containing cyanoacrylates.
           5.1. 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.
        6. Preparations containing isocyanates.
           The package labels of preparations containing isocyanates (as monomers, obligomers, prepolymers, etc.,
           or as mixtures thereof) shall bear the following inscriptions:
                      'Contains isocyanates.
                      See information supplied by the manufacturer.'
        7. Preparations containing epoxy constituents with an average molecular weight, < 700 shall bear the
           following inscriptions:
                      'Contains epoxy constituents.
                      See information supplied by the manufacturer.'
        8. Preparations intended for use by spraying.
           The package label on preparations intended for use by spraying shall bear the safety advice S 23 and
           S 38 or S 23 and S 51 depending on the application criteria specified in Directive 83/467/EEC.