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 (presented by the Commission pursuant to Article 149(3) of the EEC Treaty)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (87) 633
Vol. 1987/0301
 ---pagebreak--- Disclaimer
Conformément au règlement (CEE, Euratom) n° 354/83 du Conseil du 1er février 1983 concernant
l'ouverture au public des archives historiques de la Communauté économique européenne et de
la Communauté européenne de l'énergie atomique (JO L 43 du 15.2.1983, p. 1) modifié en dernier
lieu par le règlement (UE) 2015/496 du Conseil du 17 mars 2015 (JO L79 du 25. 3.2015, p. 1), ce
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In accordance with Council Regulation (EEC, Euratom) No 354/83 of 1 February 1983 concerning
the opening to the public of the historical archives of the European Economic Community and the
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In Übereinstimmung mit der Verordnung (EWG, Euratom) Nr. 354/83 des Rates vom 1. Februar
1983 über die Freigabe der historischen Archive der Europäischen Wirtschaftsgemeinschaft und
der Europäischen Atomgemeinschaft (ABI. L 43 vom 15.2.1983, S. 1), zuletzt geändert durch die
Verordnung (EU) Nr. 2015/496 vom 17. März 2015 (ABI. L 79 vom 25.3.2015, S. 1), ist dieser Akt
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Verschlusssachen als herabgestuft angesehen.
 ---pagebreak---   COMMISSION OF THE EUROPEAN COMMUNITIES
                                                   COM(87 ) 633 final
                                                   Brussels , 26" November 1987
                                 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
  ( presented by the Commission pursuant to Article 149(3 ) of the EEC Treaty )
C0M(87 ) 633 final
 ---pagebreak---                     Explanatory memorandum
The amended version of the proposal for a Council Directive on the
classification , packaging and labelling of dangerous preparations
( C0M(85)364 final ) was drawn up on the basis of the opinion delivered
by the European Parliament at its second October part-session 1987 .
The 23 amendments tabled were unanimously adopted without discussion ;
most of them (2 to 5 , 10 to 17 , 19 and 20 ) were acceptable
to the Commission both in subject and substance .
The new proposal take into account of these amendments and of the
progress in work within the Council ( proposal : July   1985 - start on
work within the Council : December 1985 ) and of changes in the order
of the articles .
 ---pagebreak--- THE COUNCIL OF THE EUROPEAN COMMUNTIES ,
- aving regard tc the Treaty establishing the European Economic Community , and
       particular Article 1 00 A thereof ,
- aving regard to the proposal from the Commission ,
 in cooperation with the European Parliament ,/ M
- aving regar'd to the Opinion of the Economic and Social Committee ^
 -.- ereas measures for the progressive establishment of the internal market
 c.er the period up to 31 December 1992 have to be adopted ; whereas the internal
 - arket comprises an area without internal frontiers in which the free mouvement
 of goods , persons , services and capital is guaranteed ;
    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 ,
    regulations and administrative provisions relating to the
    classification , packaging and labelling of dangerous substances ^ , as last
                                            (4)
    amended by Directive 79 / 831 / EEC          ;
    -- ereas rules on certain dangerous preparations having very specific uses have
    already been laid down :
    - in Council Directive 73 / 173 / EEC of 4 June 1973 on the approximation of the
       •laws , regulations and administrative provisions of the Member States relating
       to the classification , packaging and labelling of dangerous preparations
       : solvents ) ( 5 ) , as last amended by Directive 80 / 781 / EEC ^ ;
    - in Council Directive 77 / 728 / EEC of 7 November 1977 on the approximation of
       : ~e laws , regu.ations and administrative provisions of the Member States
        - elating to the classification , packaging and labelling of paints , varnishes ,
       printing inks , adhesives and similar products                os last amended by
                                 ( 8)
       Directive 83 / 265 / EEC       ;
           0J   No C Iti      . 28 .    7.1986 .
            JJ  No  T
                                16 . 8.1967 ,           1 .
                                                   P ·
            OJ  No L 2 5 9    , 15.10.1979 ,           10 .
                                                   P·
           0J   No L 189      . 11 . 7.1973 ,           7.
     6'                                            P·
           0J
  j7¡      OJ No
                No L 289
                    L 903 ,
                              , 30 . 8.1980 ,      P·  57 .
  )( e :' OJ No                 28.11 . 1977 ,     P■
                    L 1 -i 7 ,   6 . 6.1983 ,      P·  11 .
 ---pagebreak---                                            - 3 -
whereas despite the abovementioned Community measures the rules , if any ,
applying to dangerous preparations in the Member States exhibit considerable
differences as regards classification according to the degree of risk ;
whereas these differences constitute a significant barrier to trade and
directly affect the establishment and functioning of the common market ;
whereas it is therefore necessary to remove this barrier by approximating the
r elevant legislation existing in the Member States and incorporating in it the
Community rules at present in force ;
whereas this Directive must at the same time provide protection for the general
public , in parti cular, for persons who                come into contact with
dangerous preparations in the course of their work or in the pursuit of a
nobby ; and for consumers , especially children and the visually handicapped ,
and also for the environment . .
whereas provisions on the classification , packaging and labelling of the
preparations must be laid down at Community level ; whereas the provisions
concerning the information appearing on the label , the dimensions of the label
and the assignment of the various danger symbols . and risk and safety phrases have also to
 be brought into line with Directive 67 /548 / EEC .
 Whereas some preparations , although i they contain constituents which are dangerous
 to health , are not necessarily dangerous in the form in which they are placed on the
 market ; whereas there are exceptions , however , and whereas the latter must be the
 subject of special labelling , as appropriate , in accordance with the provisions
 of Directive 83 / 467/ EEC or of Annex II to this Directive ;
  Whereas the label constitutes a basic tool for users of the preparations by
  giving them the initial essential concise information that nevertheless needs
  to be supplemented by a two-fold system of more detailed information , one
  intended for professional users , and the second for the bodies appointed by
  the Member States and whose responsibility it is to give information reserved
  solely for medical purposes , both curative and preventive ;
 ---pagebreak--- *'hf-reas dangerous preparations may , although conforming to the provisions of this
lirective , nevertheless constitute a danger to health or the environment ; whereas it is
- herefors advisable to pbovide a procedure to reduce this danger ;
V.'hereas the Commission will , on the basis of information to be supplied
by the Member States ( wi thin 18 months of the Directive 's implementation),
 submit a report , within two years of implementation of this Directive ,
 concerning any inadequacies or loopholes in Directive               78 / 631 / EEC as
 compared with the present Directive ; whereas on the basis of this report ,
 the Commission will if appropriate submit the necessary proposals,
  HAS ADOPTED THIS DIRECTIVE :
 ---pagebreak---                                         5
                                    Article 1
1.         The purpose of this Directive is to approximate the laws ,
   regulations and administrative provisions of the Member States on
   the :
   - classification ,
   - packaging , and
   - labelling
   of preparations dangerous to man and the environment when they are
   placed on the market in the Member States .
2.         This Directive shall apply to preparations which are placed on
   the market in the Member States and
   - contain at least one substance classified as dangerous , within
       the meaning of Article 2 ;
   - or are regarded as dangerous within the meaning of Article 3 .
           This Directive shall also apply to the preparations listed in
   Annex II .
3.         This Directive shall not apply to provisions concerning :
   ( a ) medicinal or veterinary products as defined by
          Directive 65 / 65 / EEC ;
    ( b ) cosmetic products as defined by Directive 76 / 768 / EEC .
 ---pagebreak---                                       6
(c ) mixtures of substances which , in the form of waste , are
       covered >'y Council Directives 75 / 442 / EEC and 78 / 319 / EEC ;
 . d ) pesticides covered by Directive 78 / 631 / EEC ;
   e ) munitions and explosives placed on the market with a view
       to obtaining a practical effect by explosion or a pyrotechnic
       effect .
        In addition , this Directive shall not apply to :
   f ) foodstuffs in a finished stage intended for the final consumer
( g ) animal feedingstuf fs in a finished stage intended for the final
       consumer ;
( h ) the carriage of dangerous substances by rail , road , inland
       waterway , sea or air ;
( i ) preparations in transit which are under customs supervision
       provided they do not undergo any treatment or processing ;
 ---pagebreak---                                     7
                                Artide 2
     The definitions appearing in Article 2 of Directive 67 / 548 / EEC ,
with the exception of the definition in paragraph 1(d ) thereof ,
shall apply to this Directive .
 ---pagebreak---                                       Artide 3
        The general principles of the classification and labelling of
preparations shall be applied according to the criteria iri Annex VI t.o
Directive 67 / 548 /EEC save where the alternative criteria referred to below
are applied .
        The requisite physico-chemical properties for the classification of
preparations shall be determined by the methods specified in Annex V ( A ) to
Directive 67 / 548/EEC .
        Preparations shall be regarded as explosive , oxidizing , extremely
flammable , highly flammable or flammable when the results of the tests carried
out by the methods mentioned above comply with the definitions in Article 2
of Directive 67 / 548 and the specific evaluation criteria detailed in those
methods .
        By way of dérogation :
 ( a ) the determination of the explosive , oxidizing , extremely flammable , highly
       flammable or flammable properties is not necessary provided , however , that
       none of the constituents possesses such properties and that on the basis
       cf the information available to the manufacturer the preparation is
       unlikely to present dangers of this kind ;
( b ) the preparations placed on the market in the form of aerosols are
       subject to the flammability criteria specified in paragraphs 1.8 and
       2.2(c ) of the Annex to Directive 75/ 324 /EEC .
        The .health hazards of a preparation shall be determined by one or more
of the following methods :
( a ) by the conventional method described below using concentration limits ;
( b ) by determining the toxicological properties of the preparation
       necessary for an appropriate classification and label in accordance
       with the criteria in Annex VI to Directive 67/ 548 /EEC . The toxicological
       properties shall be determined by the methods specified in point B of
       Annex V to that Directive . Any one or more of the toxicological
       properties of the preparation which are not assessed by the method set
       out in Article 3(3 ) ( b ) shall be assessed in accordance with the conventional
       method .
 ---pagebreak---       Where a toxicological property has been established by both the methods above ,
che result of method ( b ) shall be used for classifying the preparation except
in the case of carcinogenic , mutagenic and teratogenic effects .
      Furthermore , where it can be demonstrated that :
- toxicological effects on man differ from those suggested by a toxicological
  determination or a conventional assessment , then the preparation shall be
  classified according to its effects on man ;
- owing to effects such as synergism or potentiation a conventional assessment
  would underestimate the toxicological hazard , these effects shall be taken
  into account in classifying the preparation ;
- owing to effects such as synergism or antagonism a conventional assessment would
  overestimate the toxicological hazard , these effects shall be taken into account
   in classifying the preparation .
 ---pagebreak---                                          10
     For preparations of a known composition classified in accordance with
method 3(b ) above a new health hazard assessment either by method 3(a )
or 3(b ) shall be performed whenever :
- changes of composition of the initial concentration , expressed as a
  weight / weight percentage , of one or more of the dangerous constituents are
   introduced by the manufacturer , in accordance with the following table :
     Initial concentration range             Permitted variation in initial
           of the constituent               concentration of the constituent
              < 2,5%                                 - 15%
     >   2,5 <Ci 0%                                  - 10%
     -> 10    ΐζ.25%                                 -  6%
     > 20     sí- 50%                                -  5%
     > 50     sí 100%                                -  2,5%
– changes of composition involving the substitution of one or more
  constituents , which may or may not be dangerous within the meaning of
  the definitions of this Directive , are introduced by the manufacturer .
 ---pagebreak--- 5.       In accordance with Article 3(3 ) ( a ), the health hazards shall be
    assessed by the conventional method described below , using individual
    concentration limits .
        Where the dangerous substances listed in Annex I to
   Directive 67 / 548 / EEC are assigned concentration limits necessary
   for the application of the method of evaluation described below ,
   those concentration limits shall be used .
        Where the dangerous substances do not appear in Annex I to
   Directive 67 / 548 / EEC or appear there without the concentration
   limits necessary for the application of the method of evaluation
   described below , the concentration limits shall be assigned in
   accordance with the specifications in Annex 1 to this Directive .
 ---pagebreak---                                              j : c.
         In that case ,
■'a ) The following preparations shall be regarded as very toxic :
       ( i ) Owing to their acute lethal effects , preparations containing
             one or more substances classified or regarded as very toxic
             in individual concentrations exceeding :
             - either the concentration specified in Annex I to
                 Directive 67 / 548 / EEC for the substance or substances
                 under consideration :
             - or the concentration specified at point 1 of Annex I
                 ( Table I ) 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 .
     ( ii ) Owing to their acute lethal effects , preparations containing
             more than one substance classified or regarded as very toxic
             in individual concentrations not exceeding the limits
             specified either in Annex I to Directive 67 / 548 / EEC or
             at 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 substance in the preparation
             by the limit specified for that substance is 1 or more , i.e.
                                     £
             where
             P,p + is the percentage by weight of each very toxic substance
                   in the preparation ,
             L^, + is the limit specified for each very toxic substance
                   expressed as a percentage .
 ---pagebreak--- ( iii ) Owing to their non-lethal irreversible effects after
          one exposure , preparations containing one or more
          dangerous substances that produce such effects in
          individual concentrations exceeding :
          - either the concentration specified in Annex I to
             Directive 67 / 548 / EEC for the substance or substances
             under consideration ,
          - or the concentration specified at point 2 of Annex I
             ( Table II ) to this Directive where the substance or
             substances under consideration do not appear in
             Annex I to Directive 67 / 548 / EEC or appear in it without
             concentration limits .
The following preparations shall be regarded as toxic :
  ( i ) Owing to their acute lethal effects , preparations containing
        one or more substances classified or regarded as very toxic ,
        toxic or in individual concentrations exceeding :
        - either the concentrations specified in Annex I to
           Directive 67 / 548 / EEC for the substance or substances
           under consideration ,
        - or the concentration specified at point l.a . of
           Annex I ( Table I ) 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 .
( ii ) Owing to their acute lethal effects , preparations containing
        more than one substance classified or regarded as very
        toxic or toxic in individual concentrations not exceeding
        the limits specified either in Annex I to Directive 67 / 548 / EEC
        or at 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 substance in the preparation
        by the toxic limit specified for that substance is 1 or
        more , i.e.
        whe re :
        P ^ + is the percentage by weight of each very toxic
               substance in the preparation ,
 ---pagebreak---          p    is the percentage by weight of each toxic substance in
              the preparation ,
         LT substance
              is the limit  specified for each very toxic or toxic
                         expressed as a percentage .
( iii ) Owing to their non-lethal irreversible effects after one
         exposure , preparations containing one or more dangerous
         substances that produce such effects in individual
         concentrations exceeding :
         - either the concentration specified in Annex I to
            Directive 67 / 548 / EEC for the substance or substances
            under consideration ,
         - or the concentration specified at point 2 of Annex I
            ( Table II ) to this Directive where the substance or
            substances under consideration do not appear in
            Annex I to Directive 67 / 548 / EEC or appear in it without
            concentration limits .
  ( iv ) Owing to their long-term effects , preparations containing
         one or more dangerous substances that produce such
         effects in individual concentrations exceeding :
         - either the concentration specified in Annex I to
            Directive 67 / 548 / EEC for the substance or substances
            under consideration ,
         - or the concentration specified at point 3 of Annex I
            ( Table III ) to this Directive where the substance or
            substances under consideration do not appear in
            Annex I to Directive 67 / 548 / EEC or appear in it
            without concentration limits .
The following preparations shall be regarded as harmful :
( i ) Owing to their acute lethal effects , preparations containing
      one or more substances classified or regarded as very toxic ,
       toxic or harmful in individual concentrations exceeding :
       - either the concentration specified in Annex I to
         Directive 67 / 548 / EEC for the substance or substances
         under consideration ,
       - or the concentration specified at point 1 of Annex I
         ( Table I ) 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 ;
 ---pagebreak--- ( ii ) owing to their acute lethal effects , preparations containing more than one
       of the substances classified or regarded as very toxic or toxic or harmful
       in individual concentrations not exceeding the limits specified either in
       Annex I to Directive 67/ 548/EEC or at 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 substance in the preparation by the harmful limit specified
       for that substance is 1 or more , i.e.
                                                          1
       where :
       P.p+ is the percentage by weight of each very toxic substance in the
            preparation ,
       PT is the percentage by weight of each toxic substance in the preparation,
       Pxn is the percentage by weight of each harmful substance in the preparation ,
       Lxn is the limit specified for each very toxic , toxic or harmful substance
            expressed as a percentage .
iii ) owing to their non-lethal irreversible effects after one exposure ,
       preparations containing one or more dangerous substances that produce such
       effects in individual concentrations exceeding :
       - either the concentration specified in Annex I to Directive 67/ 548/EEC for
          the substance or substances under consideration ,
       - cr the concentration specified at point 2 of Annex I ( Table II ) to this
          Directive where the substance or substances under consideration do not
          appear in Annex I to Directive 67/ 548/EEC or appear in it without
          concentration limits .
( iv ) owing to their long-term effects , preparations containing one or more
       dangerous substances that produce such effects in individual concentrations
       exceeding :
       - either the concentration specified in Annex I to Directive 67/ 548/EEC for
          the substance or substances under consideration ,
 ---pagebreak---                                            16
    - or the concentration specified at point 3 of Annex I ( Table III ) to this
      Directive where the substance or substances under consideration do not
      appear in Annex I to Directive 67 / 548/ EEC or appear in it without
      concentration limits .
v ) owing to their sensitizing effects by inhalation , preparations containing at
    least one dangerous substance to which is assigned phrase R 42 that produces
    such effects in individual concentrations exceeding :
    - either the concentration specified in Annex I to Directive 67 / 548 / EEC for
      the substance or substances under consideration ,
    - or the concentration specified at point 5 of Annex I ( Table V ) to this
      Directive where the substance or substances under consideration do not
      appear in Annex I to Directive 67 / 548 / EEC or appear in it without
      concentration limits .
 ---pagebreak---                                                 17
( d ) The following preparations shall be regarded as very corrosive for the
      skin :
        ( i ) Preparations containing one or more substances classified or regarded as
              corrosive to which is assigned phrase R 35 in individual concentrations
              exceeding :
              - either the concentration specified in Annex I to Directive 67/ 548 / EEC
                 for the substance or substances under consideration ,
              - or the concentration specified at point 4 of Annex I ( Table 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 .
      ( ii ) Preparations containing more than one substance classified or regarded
              as corrosive to which is assigned phrase R 35 in individual concentrations
              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 sum of the
              quotients obtained by dividing the percentage by weight of each
              corrosive substance in the preparation by the corrosive limit specified
              for that substance is 1 or more , i.e.
                              P,C , R 35
                                              1
                              LC , R 35
              where :
              P,
                C , R 35 is the percentage by weight of each corrosive substance in the
                          preparation ,
              L
                C , R 35 is the corrosive limit specified for each corrosive substance to
                          which is assigned phrase R 35 expressed as a percentage by
                          weight .
 ---pagebreak--- ( e ) The following preparations shall also be regarded as corrosive for the
      si<in :
        ( i ) Preparations containing one or more substances classified or regarded as
              corrosive to which is assigned phrase R 34 in individual concentrations
              exceeding :
              - either the concentration specified in Annex I to Directive 67 / 548 / EEC
                 for the substance or substances under consideration ,
              - or the concentration specified at point 4 of Annex I ( Table 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
                 1 imi ts .
      ( ii ) Preparations containing more than one substance classified or regarded
              as corrosive to which is assigned phrase R 34 in individual concentrations
              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 sum of the quotients obtained by dividing the percentage
              by weight of each corrosive substance in the preparation by the
              corrosive limit specified for that substance is 1 or more , i.e.
                                     C , R 35       PC , R 34
                                                               > 1
                                   J C , R 34       LC , R 34
              where :
              D
              " C , 9 35 is the percentage by weight of each corrosive substance to
                            which is assigned phrase R 35 in the preparation ,
              P
                C , R 34 is the percentage by weight of each corrosive substance to
                            which is assigned phrase R 34 in the preparation ,
                C , R 34 is the corrosive limit specified for each corrosive substance
                            to which is assigned phrase R 34 expressed as a percentage
                            by weight .
 ---pagebreak---                                                  19
( f ) The following preparations shall be regarded as liable to cause serious
      eye damage :
        ( i ) Preparations containing one or more substances classified or regarded as
              irritant and to which is assigned phrase R 41 in individual concentrations
              exceeding :
              - either the concentration specified in Annex I to Directive 67/ 548/ EEC
                  for the substance or substances under consideration ,
              - or the concentration specified at point 4 of Annex I ( Table 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 .
      ( ii ) Preparations containing more than one of the substances classified or
              regarded as corrosive or irritant to which is assigned phrase R 41 in
              individual concentrations 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 sum of the quotients obtained by dividing the
              percentage by weight of each substance in the preparation by the irritant
              limit specified for that substance is 1 or more , i.e.
                           P,
                             Xi , R 41      1
                           L
                             Xi , R 41
              where :
              P
                 Xi , R 41 is the percentage by weight of each irritant substance to which
                           is assigned phrase R 41 in the preparation ,
               L
                 Xi , R 41 is the irritant limit specified for each irritant substance to
                           which is assigned phrase R 41 expressed as a percentage by
                           weight .
 ---pagebreak--- ( g'i The following preparations shall be regarded as skin irritants :
        ( i ) Preparations containing one or more substances classified or regarded as
              corrosive or irritant to which is assigned phrase R 38 in individual
              concentrations exceeding :
              - either the concentration specified in Annex I to Directive 67 / 548 / EEC
                 for the substance or substances under consideration ,
              - or the concentration specified at point 4 of Annex I ( Table 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 .
      ( ii ) Preparations containing more than one of the substances classified or
              regarded as corrosive or irritant to which is assigned phrase R 38 in
              individual concentrations 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 sum of the quotients obtained by dividing the
              percentage by weight of each substance in the preparation by the irritant
              limit specified for that substance is 1 or more , i.e.
                                    PC , R 35             PC , R 34  ♦   Xi » R 38     \!
                                    LXi , R 38            LXi , R 38    LXi , R 38 /
              where :
              P
                C , ? 35 is the percentage by weight of each corrosive substance to which
                          is assigned phrase R 35 in the preparation ,
              P
                C , R 34 is the percentage by weight of each corrosive substance to which
                          is assigned phrase R 34 in the preparation ,
              P
                Xi , R 38 is the percentage by weight of each irritant substance to which
                            is assigned phrase R 38 in the preparation ,
              ^Xi , R 38 is the irritant limit specified for each corrosive or irritant
                            substance to which is assigned phrase R 38 expressed as a
                            percentage by weight .
       iii ) Owing to their sensitizing effects by skin contact , preparations containing
              at least one dangerous substance to which is assigned phrase R 43 that
              produces such effects in individual concentrations exceeding :
              - either the concentration specified in Annex I to Directive 67 / 548 / EEC
                  for the substance under consideration ,
                    •     . <• « ni.! al i <>; : spr-ci ficd ni pcint v            I ; Ta:..v V ; ••
                  Directive where the substance or substances do not appear in Annex I
                  to Directive 67 / 548 /EEC or appear in it without concentration limits .
 ---pagebreak--- ( h ) The following preparations shall be regarded as eye irritants :
        ( i ) Preparations containing one or more substances classified or regarded
              as irritant to which is assigned phrase R 41 or R 36 in individual
              concentrations exceeding :
              - either the concentration specified in Annex I to Directive 67 / 548 / EEC
                 for the substance or substances under consideration ,
              - or the concentration specified at point 4 of Annex I ( Table 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 .
      ( ii ) Preparations containing more than one of the substances classified or
              regarded as irritant to which is assigned phrase R 41 or phrase R 36 in
              individual concentrations not exceeding the limits specified in Annex I
              to Directive 67 / 548 /EEC or at point 4 of Annex I ( Table IV ) to this
              Directive if the sum of the quotients obtained by dividing the percentage
              by weight of each substance in the preparation by the irritant limit
              specified for that substance is 1 or more , i.e.
                                                         1
              where :
              P
                   , R 41 is the percentage by weight of each irritant substance which
                          is assigned phrase R 41 in the preparation ,
              P
                Xi , R 36 is the percentage by weight of each irritant substance to
                          which is assigned phrase R 36 in the prepration ,
                     R 36 is the irritant limit specified for each irritant substance
                          to which is assigned phrase R r41 or R 36 expressed as a
                          percentage by weight .
 ---pagebreak--- ( i ) The following preparations shall be regarded as irritants for the    t.hr respirat.ory
                                                                                resp i r;i I or -y
      system :
        ( i ) Preparations containing one or more substances classified or regarded as
              irritant to which is assigned phrase R 37 in individual concentrations
              exceeding :
              - either the concentration specified in Annex I to Directive 67 / 548 / EEC
                 for the substance or substances under consideration ,
              - or the concentration specified at point 4 of Annex I ( Table 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 .
      ( ii ) Preparations containing more than one of the substances classified or
              regarded as irritant to which is assigned phrase R 37 in individual
              concentrations 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 sum of the quotients obtained by dividing the percentage
              by weight of each substance in the preparation by the irritant limit
              specified for that substance is 1 or more , i.e.
                              PXi , R 37
                              LXi , R 37
              where :
              P
                Xi , R 37 is the percentage by weight of each irritant substance to
                          which is assigned phrase R 37 in the preparation ,
              ^Xi , R 37 is the irritant limit specified for each irritant substance to
                          which is assigned phrase R 37 expressed as a percentage by
                          weight .
 ---pagebreak--- ( j ) Preparations shall be regarded as :
         carcinogenic and classified at least as toxic if they contain
         a substance producing such effects , to which is assigned the
         standard phrase R 45, which denotes carcinogenic substances in
         category 1 and category 2 , in a concentration equal to or
         exceeding :
         - either the concentration specified in Annex I to
            Directive 67 / 548 / EEC for the substance under consideration ,
         - or the concentration specified at point 6 of Annex I ( Table VI )
            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 ;
 ( k ) Preparations shall be regarded as :
          suspect for humans owing to their possible carcinogenic
          effects and classified at least as harmful if they
          contain a substance producing such effects to which is
         assigned the standard phrase R 40 , which denotes carcinogenic
         substances in category 3 , in a concentration equal to or exceeding
         - either the concentration specified in Annex I to
            Directive 67 / 548 / EEC for the substance under consideration ,
         - or the concentration specified at point 6 in Annex I ( Table VI )
            to this Directive where the substance or substances under
            consideration do not appear in Annex I to Directive 67 / 548 / EEC
            or appear in it without concentration limits ;
 ---pagebreak---                                               - 24
 ( 1 ) Preparations shall be regarded as :
         mutagenic and classified at least as toxic if they contain a substance
         producing such effects , to which is assigned the standard phrase R 46
         which denotes mutagenic substances in category 1 , in a concentration equal
         to or exceeding :
         - either the concentration specified in Annex I to Directive 67/ 548/ EEC
            for the substance under consideration ,
         - or the concentration specified at point 6 of Annex I ( Table VI ) to this
            Directive where the substance or substances under consideration do net appear
            in Annex I to Directive 67/ 548/ EEC or appear in it without concentration limits
( in ) Preparations shall be regarded as :
       having to be treated as mutagenic and classified at least as harmful if they
       contain a substance producing such effects to which is assigned the
       standard phrase R 46 , which denotes mutagenic substances in category 2 ,
       in a concentration equal to or exceeding :
       - either the concentration specified in Annex I to Directive 67/ 548/ EEC
          for the substance under consideration
       - or the concentration specified at point 6 of Annex I ( Table VI ) to this
          Directive where the substance or substances under consideration do not appear
         m Annex I to Directive 67/ 548/EEC or appear in it without concentration limits ;
 ( n ) Preparations shall be regarded as :
       suspect for humans because of their possible mutagenic effects and
       classified at least as harmful if they contain a substance producing
       such effects to which is assigned the standard phrase R 40 , which
       denotes mutagenic substances in category 3 , in a concentration equal to or
        exceeding :
       - either the concentration specified in Annex I to Directive 67 / 548/ EEC
          for the substance under consideration ,
       - i r ike    > nceni ration specified at point. 6 of Annex I ( Table V T 1 to fh .
          Directive where the substance or substances under consideration do not appear
          in Ann'-x I to Directive 67 / 548/ EEC or appear in it without concentration
          limits .
 ---pagebreak---                                            25
( o ) Preparations shall be regarded as :
          teratogenic and classified at least as toxic if they contain
         a substance producing such effects , which is assigned the
         standard phrase R 47 , which denotes teratogenic substances
         in category 1 , in a concentration equal to or exceeding :
         - either the concentration specified in Annex I to
            Directive 67 / 548 / EEC for the substance under consideration ,
         - or the concentration specified at point 6 of Annex I ( Table VI )
             to this Directive where the substance or substances under
            consideration do not appear in Annex I to Directive 67 / 548 / EEC
            or appear in it without concentration limits ;
 ( p ) Preparations shall be regarded as :
          having to be treated as teratogenic and classified at least as
          harmful if they contain a substance producing such effects to
          which is assigned the standard phrase R 47 , which denotes
          teratogenic substances in category 2 , in a concentration equal
          to or exceeding :
           - either the concentration specified in Annex I to
              Directive 67 / 548 / EEC for the substance under consideration ,
           - or the concentration specified at point 6 of Annex I
              ( Table VI ) to this Directive where the substance or substances
              under consideration do not appear in Annex I to
             Directive 67 / 548 / EEC or appear in it v/ ithout concentration
              limits .
  ( q ) Preparations shall be regarded as :
           having specific effects on health not further defined and
           classified at least as harmful if they contain a substance which
          does not yet appear in Annex I to Directive 67 / 548 / EEC but to
          which is provisionally assigned the standard phrase R 40
          denoting such substances in a concentration exceeding t'^nt
          specified at point 6 of Annex I ( Table VI ) to this Directive .
 ---pagebreak---                                     26
       For preparations covered by this Directive :
( a ) No account shall be taken of substances whether or not listed
      in Annex I to Directive 67 / 548 / EEC , whether existing as
      impurities or as additives , if their concentration by weight
      is  less than :
      - 0,1% for substances classified as very toxic or toxic ;
      - 1,0% for substances classified as harmful , corrosive
         or irritant ,
      unless lower values have been specified in Annex I to
      Directive 67 / 548 / EEC .
( 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 that given at point ( a ) above shall
      be given concentration limits characterizing the health
      hazards .
                                                                             !
            Some substances may have more than one property harmful         j
      to health , e.g. harmfulness / irritation , corrosiveness /           J
      harmfulness / sensitization , etc ., each of these properties        I
      being characterized by its specific concentration limit .           /
            These concentration limits shall be determined     in
      accordance with Annex I to this Directive by the manufacturer
      or any other person who places such a preparation on the market .
 ---pagebreak---                                  Article 4
      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 down in Article 2 .    The preparations
shall be classified according to the greatest degree of hazard in
accordance with Article 8(2)(d ).
                                 Article 5
 1.       Member States shall take all necessary measures to ensure
     that the preparations cannot be placed on the market unless they
     comply with the provisions of this Directive .
2.       In this context , if there is any doubt , Member States may
    request information on the composition of the preparation and
    any other pertinent information .
3.       To this end , the manufacturer , or those responsible for placing
    the preparation on the market , shall hold the data used for the
    classification and labelling of the preparation at the disposal of
    the authorities of the Member States .
 ---pagebreak---      Member States shall take all the necessary measures toto ensure
                                                              ensure that
                                                                      that ::
iangercus preparations are not placed on the market unless their packaging
- eets the requirements of Article 15(1 ) of Directive 67/ 548/ EEC with respect
to their strength , leak-tightness and fastening systems ;
containers which contain dangerous preparations offered or sold to the gens~a=L
public do not have
( a ) either a shape and / or graphic decoration likely to attract or arouse r
      the active curiosity of children or to mislead consumers ;
, b ) or a presentation and / or a designation used for foodstuffs , medicinal
      or cosmetic products .
   Member States shall take all the necessary measures to ensure that containers
    containing certain categories of dangerous preparations offered or sold to
    the general public and defined in accordance with the procedure referred to
    in paragraph 3 :
    - are fitted with child-resistant fastenings ;
    - carry a tactile warning of danger .
 ---pagebreak---                                          c -* y * 29 -
 3.        The categories of dangerous preparations the packaging of which have to be
    fitted with the devices referred to in paragraph 2(b ) shall be defined by the
    procedure referred to in Article 21 of Directive 67/ 548/ EEC .
           The technical specifications relating to such devices are given in parts A
    and B of Annex IX to Directive 67/ 548/ EEC .
                                               Article 7
1 .        The following information shall be clearly and indelibly marked on any
    package :
    ( a ) the trade name or designation of the preparation ;
    ( b ) the names and full addresses including the telephone number of the person
          established in the Community who is responsible for placing the preparation
          on the market , whether it be the manufacturer , the importer or the distributor .
    ( c ) the chemical name of the substance or substances present in the preparation in
          accordance with the following detailed rules :
          c ( 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 concentrations
                     equal to or in excess of the lowest limit ( Xn limit ) for each of them
                     laid down in Annex I to this Directive or to Directive 67/ 548/EEC
                     must be taken into consideration ;
                  - in the case of preparations classified as C in accordance with
                     Article 3 , only C substances present in concentrations equal to or in
                     excess of the lowest limit ( Xi limit ) laid down in Annex I to
                     this Directive or to Directive 67/ 548/ EEC must be taken into
                     consideration ;
                  - in the case of preparations to which are assigned phrases R 42 or
                     R 43 , and/or R 42/43 in accordance with Article 3 , only substances
                    to which those phrases are assigned and which are present in
                    concentrations equal to or in excess of the limit laid down in
                    Annex I to this Directive or to Directive 67 / 548 / EEC need be taken
                    into consideration .
 ---pagebreak---          ïi  the préparation :
         - in accordance with Article 3 is assigned one of the standard
            phrases R 39 , R 40 , R 42 , R 43 , R 42 / 43 , R 45 , R 46 , R 47
            and / or R 4S , the . name of the substance or substances must be
            men t i oned
c ( 2 ) as a general rule a maximum of 4 chemical names shall suffice to
         identify the substances primarily responsible for the major health
         hazards which have given rise to the classification and the choice
         of the corresponding phrases referring to the risk involved .            In
         some cases , more than 4 chemical names may be necessary .
               The chemical name shall be one of the designations listed in
         Annex I to Directive 67 / 548 / EEC or an internationally recognized
         designation if it is not yet listed therein .
        Where a manufacturer can demonstrate that the disclosure of
 the chemical identity of a harmful substance not assigned one or more
 of the R phrases mentioned above on the label of a preparation will
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
 I'unctional chemical groups           . Where this is the case , the
manufacturer must inform the authorities of the Member State where
 the product is first placed on the market .         These authorities shall
 inform the Commission and the other Member States .
        Confidential information brought to the attention of the
 authorities of a Member State or of the commission shall be              treated
 in accordance with Article 11(4 ) of Directive 67 / 548 / EEC
 ---pagebreak---                                      'Ч \
( d ) the symbols , where specified in this Directive , for and indications
      of the dangers involved in the use of the preparation , in
      accordance with Article 16(2 ) ( c ) of Directive 67 / 548 / EEC read in
      conjunction with Annex II thereto , and , in the case of aerosol
      preparations , in accordance with points 1.8 . and 2.2(c ) of the
      Annex to Directive 75 / 324 / EEC as far as flammability hazards are
      concerned .
           Where more than one danger symbol has to be assigned to a
      preparation :
 \
      - the obligation to apply the symbol T shall make the
        symbols C and X optional ;
      - the obligation to apply the symbol C shall make the symbol X
        optional ;
      - the obligation to apply the symbol E shall make the symbols F
        and 0 optional .
( e ) one or more standard phrases indicating the special risks involved
      in the use of the preparation (R phrases ).
           The indications concerning special risks (R phrases )
      shall conform to the wording in Annex III to Directive 67 / 548 / EEC
      and shall be provided by the manufacturer or any other person
      placing the preparation on the market , in accordance with Annex I
      to this Directive and Annex VI , 11(d ) to Directive 67 / 548 / EEC .
           A maximum of four R phrases is generally sufficient to
      describe the risks ; for this purpose the combined phrases listed
      in the aforementioned Annex III shall be regarded as single phrases .
      If the preparation falls within more than one danger category ,
      however , these standard phrases must cover all the principal
      hazards associated with the preparation .
 ---pagebreak---                                                32
      I;' ■ preparation is classified as both harmful          rri irritant , it shall be
      labelled " harmful " and attention shall be drawn to ltB harmful and
      irritant characteristics by the appropriate R Phrasea .
      The standard phrases " extremely flammable " or " highly flammable " need
      not appear if they repeat an indication of danger used pursuant to
      paragraph ( a ) above .
( f ) one or more standard phrases giving safety advice on the use of the
      preparation (S phrases ).
      The indications giving safety advice (S phrases ) shall conform to the
      wording in Annex IV to Directive 67 / 548 / EEC and shall be provided by
      the manufacturer or any other person placing the preparation on the
      market , in accordance with Annex II to this Directive and Annex VI , 11(d )
      to Directive 67/ 548/ EEC .
      A maximum of four S phrases is generally sufficient to formulate the
      most appropriate safety advice ; for this purpose the combined phrases
      listed in the aforementioned Annex IV shall be regarded as single
      phrases .
      The package shall be accompanied by safety advice on the use of the
      preparation where it is physically impossible to include the advice                 *
      on the label cr - package itself .
       In “ he case of highly flammable afrid flammable oxidizing preparati ons ,
       there is no need to give a reminder of the special risks or the
      safety advice if the contents of the package do not exceed 125 ml .
      The same shall apply in the case of irritant preparations except
      where they contain substances that might cause sensitization .            In
       that case point 3 of Annex II shall apply .
! g ) the nominal quantity ( nominal mass or nominal volume ) of the contents
       in the : ase of preparations sold to the general public .
  The special provisions applicable to certain preparations are set out in Annex II .
  Article 3(6 ) ( a ) shall apply mutatis mutandis to labelling .
  Information such as " non toxic ", " not harmful " or any other statement indicating
          * h*- ■ • •• • • i •:» : r *. Jangei uus m,ty not appear on the packaging or
  labelling of the preparations referred to in this Directive .
 ---pagebreak---                                           33 -
                                      Artide 8
 1 . Where the particulars required by Article 7 appear _on a label , that label
     shall be firmly affixed to one or more surfaces of the packaging so that the
     said particulars can be read horizontally when the package is set down
     normally . The dimensions of the label shall be as follows :
     Capacity of the package
        Dimensions ( in millimétrés ) if possible
     - not exceeding 3 litres :
        at least 52 x 74
     - greater than 3 litres but not exceeding 50 litres :
        at least 74 x 105
     - greater than 50 litres but not exceeding 500 litres :
        at least 105 x 148
     - greater than 500 litres :
        at least 1 48 x 210 .
     Each symbol shall cover at least one tenth of the surface area of the label
     but shall not be less than 1 cm . The entire surface of the label shall
     adhere ^o the package immediately containing the preparation .
     These dimensions are intended solely for provision of the information
     required by this Directive and if necessary of any supplementary health or
     safety information .
2 . A label is not required when the particulars are clearly shown on the
     package itself , as specified in paragraph 1 .
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 clearly from it .
4 . Member States may make the placing of dangerous preparations on the market
     in the’ r territory subject to the use of their official language or
     languages for the purposes of labelling .
 ---pagebreak---   For the purpose of this Directive , labelling requirements shall be deemed to
  be satisfied :
 fa ) in the case of an outer package containing one or more inner packages , if
      the outer package is labelled in accordance with international rules on
      the transport of dangerous substances and the inner package or packages
      are labelled in accordance with this Directive ;
( b ) in the case of a single package , if such a package is labelled in
      accordance with international rules on the transport of dangerous
      substances and with Art ic le 7 ( 2 ) ( a ) , ( b ) , (c ), ( e ) and ( f ) and 7(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 .
 ---pagebreak---                                        Artide  9
1 . Member States may :
    a ) permit the Labelling required by Article 7 to be applied in some other
        appropriate manner on packages which are either too small or otherwise
        unsuitable for labelling in accordance with Article 9(1 ) and ( 2 );
    b ) by way of derogation from Articles 6 and 7 , permit the packaging of dangerous
        preparations which are neither explosive , very toxic nor toxic to be
        un label led or to be labelled in some other way if they contain such small
        quantities that there is no reason to fear any danger to persons handling
        such preparations or to other persons .
2 . If a Member State makes use of the options provided for in paragraph 1 , it
    shall forthwith inform the Commission thereof .
 ---pagebreak---                                  Article   10
The Menber States shall take the measures necessary to implement a
 system of specific information ( in safety data-sheet form ) relating
 to dangerous preparations .
 The detailed arrangements for this system shall be laid down in
 accordance with the procedure provided for in Article 21 of
 Directive 67 / 548 / EEC within a period of three years after the
 adoption of the Directive , raking into account the systems in force
 in   the  Member States .
 This information is principally intended for use by industrial
 users and must enable them to take the necessary measures for the
 protection of health and the safety at the place of work .
                                   Article  11
 The Member States shall appoint the body or bodies responsible
 for receiving information on dangerous preparations , including their
 chemical composition , placed on the market .
 The Member States shall take the necessary steps to ensure that the
 appointed bodies are able to provide all the requisite guarantees
 for maintaining the confidentiality of the information received .
 Such information may only be used to meet any medical demand by
 formulating preventive and curative measures , in particular in
 emergencies .
 ---pagebreak---  - The Member States shall ensure that the information is not used
   for other purposes
 - For existing products      the. Member States shall take measures to
       ,              .... __
   comply with this Directive within 2 years after the adoption of
   this Directive .
 - The Member States shall determine the detailed arrangements
   for the aforementioned exchange of information so as to ensure
   that the appointed bodies have all the information required for
   the tasks for which they are responsible .
                                   Article 12
     Member States shall not prohibit , restrict or impede , on the
grounds of classification , packaging or labelling as defined in this
Directive , the placing on the market of dangerous preparations which
satisfy the requirements of this Directive and Annex II thereto .
 ---pagebreak---                                                  38 -
                                        Artide     13
1 . Where a Meirtoer State has detailed evidence that a preparation , although
     satisfying the requirements of this Directive , constitutes a hazard
     by reason of its classification , packaging or labelling ,
      it may provisionally prohibit the sale of that hazardous preparation or subject it to
      special conditions in its territory . It shall immediately inform the
     Commission and the other Member States of such action and give reasons for
      its decision .
2 . The Commission shall consult the Member States concerned as soon as
     possible , then deliver its opinion without delay and take the appropriate
     measures .
3 . If the Commission considers that technical adaptations to this Directive are
     necessary , such adaptations shall be adopted in accordance with the
     procedure laid down in Article 21 of Directive 67 / 548 / EEC . In such a case ,
     Member States - which have adopted safeguard measures may maintain them
     until the adaptations enter into force .
                                      " Art ic le 14
Amendments         required to adapt the Annexes to technical progress shall be
adopted in accordance with the procedure laid down in Article 21 of Directive
67 / 548 / EEC .
 ---pagebreak---                                           Article 15
1.       Member States shall bring into force not later than eighteen              months after
   the adoption of this Directive the laws , regulations and administrative provisions
   necessary to comply with this Directive and shall forthwith inform the
   Commission thereof .
2.       Member States shall communicate to the Commission the text of the main
   provisions of national law which they adopt in the field covered by this
   Directive not more than six months later .
3.       On the date this Directive enters into force Directives 73/ 177/ EEC ( solvents )
   and 77 / 728/ EEC ( paints , varnishes and similar products ) shall be repealed .
   Nevertheless , preparations which are in conformity with 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 16
      This Directive is addressed to the Member States .
 ---pagebreak---                   Concentration limits to 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 subdivided 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 ,
- terato genesis .
      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 .
 ---pagebreak---                                                  41
                                           Table I
                                                   Classification of the Preparation
        Classification
        cf the substance
                                         T+                     T                 X
                                                                                    n
        T + with R 26 , R 27 ,
        R 28                         Cone . Ξ. 7%       1% 4 cone . < 7%  0 . 1% á- cone .  1%
        T with R 23 , R 24 ,
        R 25                                            Cone .2 25%       3% 4conc .       25%
        X    with R 20 , R 21 ,
          n                                                                     cone . 2 25%
        R 22
            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 .
 ---pagebreak---                                                  42
                                            TABLE II
                                   Classification of the preparation
   Classification
   of the substance                  T+                       T                     X
                                                                                      n
   T+ with R 39              cone .   10%           l%4_conc . 410%        0 . 1% icone .    1%
                             R 39 * obligatory      R 39 * obligatory      R 40 * obligatory
   T with R 39                                      cone . iT 10%          1% < cone .     10%
                                                    R 39 * obligatory      R 40 * obligatory
   X     with R 40                                                         cone . > 10%
     n
                                                                           R 40 * obligatory
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
                                               T                                X
     of the substance                                                             n
     T with R 48                     * cone . ^ 10%             * 1%  .4 cone . < 10%
                                        R 48 obligatory         R 4¿ obligatory
     X     with R 48                                            * cone . > 10%
       n
                                                                   R 48 * obligatory
     * In accordance with the labelling guide and depending on the classification ,
         the standard R phrases R 26 , R 27 , R 28 , R 23 , R 24 , R 25 , R 20 , R 21 , R 22 are
         ft' sc ! o be assigned to indicate route of admi nisrrat : on / expcsure .
 ---pagebreak---           4 . Corrosive and irritant effects
                     For substances that produce corrosive effect ;. (K 34 - R 33 )
              or irritant effects (R 36 , R 37 , R38 , R 41 ) the individual
              concentration limits specified in Table IV determine , when
              appropriate , the classification of the preparation .
                                       Table IV ( 1 )
! Classification         Classification of the preparation and standard risk phrase
; of the substance
    and/ or relevant     at least C     at least C       at least        at least XJ
. standard risk
                         with R 35 ,    with R 34        with R 41·      wi th R 36 , 37 , 38
i phrase
1 at least C             conc.^10%      5%4conc.<.lC%                    1% 4conc      3%
 j with R 35             R. 35 ;        R 34 ;                           R 36/ 38 ;
 i                       obligatory     obligatory                       obligatory
 : at least C                           conc .^ 10%                      5% < cone . < 10%
 ; with R 34                            R 34 ;                           R 36/ 38 ;
 ï                                      obligatory                       obligatory
    at least                                             cone . > 10%    5% -$:conc . < 10%
  i with R 41                                            R 41 ;          R 36 obligatory
                                                         obligatory
  : at least X2                                                          conc .> 20%
  : with R 36 , 37 , 38                                                R36 , H37 and R38
                                                                       are obligatory in
  ;                                                                    the light of the
                                                                       concentration
                                                                       present ±Γ tney
                                                                       apply to the
                                                                       substances under
                                                                       consideration
 ---pagebreak---    5 . Sensitizing effects
             Substances that produce such effects are classified :
       - at least as harmful (Xn ) and assigned R 42 if this effect can be
         produced by inhalation ;
       - at least as irritant ( X^) and assigned R 43 if this effect can be
         produced through contact with the skin ;
       - at least as harmful ( Xj^) and assigned R 42/43 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
Classification of            standard risk phrase
the substance
                             At least Xj^ and R 42            At least X¿ and R 43
At least X    and            Cone . ^ 1%
R 42       n                 R 42 obligatory
At least X. and                                               Cone . > 1%
R 43       1                                                  R 43 obligatory
At least X    and            Cone . > 1 %
R 42/43    n                 R 42/43 obligatory
   6 . Carcinogenic /mutagenic / tératogénie 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(l)(l)of Directive 83/467/EEC ,
       are provi sionally assigned the phrase H 40 , the concentration 1 irm ts laid down in
       Table VI shall determine , where appropriate , the classification of the prepa¬
       ration and the compulsory R phrase to be assigned to it .
 ---pagebreak---                                          45 -
                                 TaDle    VI
¡                                    Classification of the preparation and
1
                                     standard risk phrase
         Substance
                                     at least T            at least Xn
  At least T with R 45 for
  carcinogenic substances       > 0,1%
  of category 1 or 2                  R 45 obligatory
  At least Xn with R 40 for
  carcinogenic substances                                   ^ 1%
  of category 3                                                R 40 obligatory
  At least T with R 46 for
  mutagenic substances          > 0,1%
  of category 1                       R 46 obligatory
  At least Xn with R 46
  for mutagenic substances                                 > 0,1%
  of category 2                                                R 46 obligatory
  At least Xn with R 40 for
  mutagenic substances                                       } 1%
                                                               3 40 obligatory
  A.t least T with R 47 for
  teratogenic substances          ;>         0,5%
  of category 1                       R 47 obligatory
  At least Xn with R 47 for
  teratogenic substances                                    >        5%
  of category 2                                                R 47 obligatory
  At least Xn anJ ?. 40
i previ stonai ly in accordance                              > 1%
  with § 3.1.1 . of                                            R 40 obligatory
  Directive 83/467/EEC ( ¿ )
 ---pagebreak---                                                      46 -                             ANNEX II
                                  Special provisions on the labelling of
                                          certain preparations
1 . Preparations classified as very toxic , toxic or corrosive sold to the
    general public .
    1.1 The labels on packages containing such preparations shall bear the
         inscriptions S1 / S2 and S 49 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 milli­
           litres , the particulars may be as follows :
                      " Warning . Contains lead .".
3 . Préparations containing cy anoacry lates
    3.1 G lue s
         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 .
 ---pagebreak---     Préparations 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 S 23 and S 38 or S 23 and S 51 depending on the
    application criteria specified in Directive 83 / 467 / EEC .