CELEX: 51977PC0718
Language: en
Date: 1977-01-05
Title: Proposal for a COUNCIL DIRECTIVE amending Directive 73/173/EEC on the aporoximation of Member States' laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous preparations (solvents)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (77) 718
Vol. 1977/0224
 ---pagebreak--- Disclaimer
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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
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 ---pagebreak--- COMMISSION OP THE EUROPEAN COMMUNITIES
                                                 COM(77 ) 718 final
                                                 Brussels , S January 1978
                               Proposal for a
                              COUNCIL DIRECTIVE
            amending Directive 73 / * 73 / EEC on the aporoximation
            of Member States' laws , regulations and administrative
            provisions relating to the classification , packaging and
                  labelling of dangerous preparations ( solvents )
 COM ( 77 )  71 8 final
 ---pagebreak---                                               EXPLANATORY M5M 0 RAND Lift
•      ι -.       Ν ί. ,,ΗΠ.ν ^
    ;*' "* Jun®                 tl,e Council adopted a ch'rective on the approximation of the
    «. aus , requlations and sdm ni st rat i ve provisions of the fier.ber btates relating
    yj lpg clossi i i cat ion , packaqinn and label lin$i of dangerous preparations
    (-OiVwtsMl ). In this context , e solvent is understood to be a liquid
    vol - tile substance capable of absorbing ether substances , with which it
    merely forr.,r, a lipoid phase without any chemical reaction .
   A number of amendments now have to be made to the text of the directive in
   oraer to sd-.pt it to the state of the art in science ssnd technology and brinq
                          w *, th the basic -i recti ve on danyerous substances of 27 June
    1.6 / ( 2 /, as lost amended by the directive of 14 July 1976 ( 3 ).
   It has also been found that the scope of the " solvents " directive needs to
   be extended , since it is very limited and there are lartje " numbers of danoerous
   substances wn -. ch are not _ covered by the directive . Furthermore , that directive
  nee^s co be clearly distinguished from ether existing directives relating
  to oroducts which likewise contain solvents .
  it vs^Uo necessary to provide greater protection for the public and
  espec i a I ly for persons who frequently cone into contact with dangerous
  solvents in tne course of their work or their hobby by compelling manu-
  . r'CLurcrs lo notify the composition of toxic solvtnt mixtures to the poisons
  mrormat ion centres , thereby ensuring that prompt and effective aid can be
  roncered in tne event of poisoning accidents .
  The necessary _ amendments to the Annex to the Directive ( list of dangerous
  socvents ) will be effected under the procedure laid down in Article 10 of
 tne directive , i.e. through the Coir-nittee on Adaptation to Technical Progress .
 Dangerous preparations which do not come within the scope - of this directive
 will           covered by another directive now in the course of preparation . This
              close the last gap in the labelling of dangerous substances and
-"r - p -ir - tiGMS.
( 1 ) C.J. Mo L 139, 11.7.1973 , p. 7
(?? G.j . No 196, 16 . S. 1967, o . 1
( 3 ) O.J. No L 36C, 30.12.1976 , p. 1
 ---pagebreak--- .   PE " . ASKS ON THE  INDIVIDUAL ARTICLES
   Arti de 2
    Paragraph 1 extends the scope of the directive to cover mixtures of solvents
                    Listed in the directive with other nor, - hazardous substances .
                  . Hitherto , the directive has covered only mixtures of solvents
                    with other solvents ; hence the directive could easily be circum­
                    vented by adding other non-hazardous substances to mixtures of
                    this kind .
   Paragraphs 2 and 3 draw a clear distinction frorc existing directives reU.tin
                    to products that also contain solvents ( e.g. cosmetic articles ).
                    Horeover , the text is adapted to that of the " dangerous substanc
                    directive of 27 June 1967 .
                                                                                     ι
   Article 3
   Tms article gives a precise definition of the impurities and additives that
  do not have to be taken into account . It provides for tha deletion of the
   final column of the table , which is superfluous and has merely led to
   confusion .
   It stipulates that corrosive , irritant , easily flammable and flammable:
   solvents shall likewise come within the scope of the directive and lays
  down exact nomenclatures for those danger categories .
                                                                                       ι
  Article 4
   This refers to the        dangerous substances" directive of 27 June 1967 with a
  view to harmonizing the provisions on packaging and closures .
  Article 5
  This sets out the requirements as regards the inforinet ion appearing on the
   label and provides for the assignment of the various danger symbols .
  /-. rticles 6 and 7
  These are intended to ensure that the particulars stated on the label and
  certain exceptions in the ratter of labelling are in accord with the
  provisions of the " dangerous substances " directive .
  Article 8
  This requires the manufacturer to notify the poisons information centre of
  the composition of toxic solvent Mixtures and requires the member state to
  notify the lists of thepoisorss information centres to the Commission and the
  other Member States .
 ---pagebreak---                                              - 3 -
III . ? 'T-?:»ATIor' OF THE PROPOSAL FOP A DIRECTIVE
      The proposr.L for r directive was drafted in consultation with a working
      :> r.riy composed of experts in the fields of public health , hygiene , industrial
       safety , industry and trade , and in close cooperation with the relevant
      professional organizations .
 IV . CG*-SliLTATTO.M OF TUE CUPOPEAN PARLIAMEI-T AND THE ECONOMIC AND SOCIAL COMPI ITT E E
      As the implementation of the provisions of this proposal for r directive
      involve the amendment of legislation in the Member States , the Opinion of
      both these bodies is required pursuant to the second paragraph of Article 100
      of the EEC Treaty .
 ---pagebreak---                                       -  H -
                          Proposal for a Council Directive?
                 amending          Directive 73/ 173 / EEC
               ^ on the approximation of Member States' laws,' regulations
                 and admini strative provisions relating to the classification ./
                 packaging and labelling of dnnuerous preparations ( solvents )
THE COUNCIL OF THE EUROPEAN COMMUNITIES ,
Having regard to the Treaty establishing the European Economic Community ,
and in particular ; Article 100 thereof ;
Having regard to the proposal from the Commission ;
Having regard to the Opinion of the European Parliament ;
Having regard to the Opinion of the Economic and Social Committee ;
Whereas , for the better protection of the general public and in particular
of persons who come into contact with dangerous solvent preparations in the
course of their work or in the pursuit of a hobby , it is necessary to extend
the scope of the existing Directive of 4 Juno 1973 ( 73 / 173 / EEC ) on the
approximation of Member States' laws , regulations and administrative
provisions relating to the classification , packaging and labelling of
dangerous preparations ( solvents ) ( 1 );
Whereas the Directive will henceforth apply not only to mixtures of two or
more solvents but also to mixtures of solvents with other non-dangerous
substances when they are intended to be used as solvents ; whereas corrosive ,
irritant and easily flammable solvents are now likewise brought within the
scope of the Directive ;
Whereas it is desirable that the scope of the Directive be more clearly
defined with respect to other Di recti ves relating to products which likewise
contain solvents ;
( 1 ) O.J. No L 189, 11.7.1973 , p. 7
 ---pagebreak---   Whereas certain provisions of the Mrective have also to bo brought into Line
  with       Council Directive 67/ 548/ F: EC of 27 June 1967 on the approximation of
 Member States' laws , . regulations and administrative provisions relating to
  the classification , packaging and labelling of dangerous substances ( 1),as
  last arrended by        Directive 76 / 907 / EEC ( 2 ), notably in respect of the
  infornation appearing on the Label , the dimensions of the Label and the
 assignment of the various danger symbols ;
 '•Jhereas it is furthermore necessary to impose upon manufacturers the obligation
to notify the poisons information centres of the composition of toxic
solvent mixtures in order that prompt and effective aid may be rendered in
the event of accidents ;
Uhereas the necessar / amendment and amplification of the Annex to the Council
Directive 73 / 173 / EF.C of 4 June 1973 ( solvents ) will be effected under the
procedure provided for in Article 10 thereof ,
HAS ADOPTED THIS DIRECTIVE :       .
( 1 ) O.J. No 196 of 16.8.1967, p. 1
( 2)  O.J. No L 360 of 30.12.1976 , p. 1
 ---pagebreak---                                               Article 1
            Council Directive 73/ 173/ EEC of 4 June 1973 is amended in accordance with
      the following Article ?.
                                              Article 2
  1 . Article 1 ( 1 ), < 2 ) and ( 3 ) a ) shall be replaced by the following :
                                                                                    i
( 1 ) This Directive concerns :
      - the classif i cation ,
      - the packaging , and
      - the labelling
      of the following preparations which are placed on the market in the Member
      States of the Community and are regarded as dangerous within the meaning of
      Article 2 of this Directive :
      ( a ) Preparations intended for use as solvents and containing only the con­
            stituents listed in the Annex hereto , including those which contain -
            impurities in quantities exceeding the limits laid down in Article 2 ( 5 );
      ( b ) preparations intended for use as solvents and containing , in addition to
            the constituents listed in the Annex hereto , other non~dangerous substances
            within the meaning of Article 2 ( 2 ) of Council Directive 67/ 548 / EEC of
            27 June 1967 ( hereinafter referred to as " the Directive of 27 June 1967").
                                                          ι
( 2 ) This Directive shall not apply to cosmetic products if they come under
            Council Directive 76/ 768/ EEC of 27 July 1976 ( 1 ).
( 3 ) furthermore , this Directive shall not apply to the following :
      medicines , narcotics , radioactive preparations , fuels , foodstuffs , plant health
      products and pesticides , insofar as their classification , packaging and
      labelling are governed by an appropriate Directive .
      ( 1 ) O.J. No L 262 of 27.9.1976 , p. 169
 ---pagebreak---  Article 1 ( 3 ) sh?»ll bo supplemented by a new subparagraph f ) worded as follows :
 "( f ) Articles 4 to 6 of this Directive shall not apply to containers for
        qas'Jous preparations which are compressed , liquefied or dissolved under
        pressure , with the exception of aerosols , which are governed by
         Directive 75/ 324/ EEC ." ( 1 )
                                           Article 3
                                                   ■
 The first sentence of Article 2 ( 1 ) shall bo replaced by the following text :
"( 1 ) Dangerous substances within the meaning of the Directive of 27 June 1967
        which are used as solvents shall be divided into classes and sub-classes
        in accordance with the Annex hereto ."
The last column of the table in Article 2 ( 1 ) ( Concentration limit to qualify
for exemption £% ) shall be deleted .
Article 2 ( 5 ) shall be replaced by the following text :
" Substances listed in the Annex hereto which are present , whether as impurities
or as additives , in the preparations governed by this Directive shall not be
taken into account if their concentrations do not exceed the following values :
- 0.2% in the case of Class I substances ;
- 1% in tho case of Class II substances or substances classified as corrosive ;
- 2% in the case of substances classified as irritant
The following paragraphs shall be inserted after Article 2 ( 5 ):
"( 6 ) Preparations shall be considered corrosive if they contain one or more
        of the substances classified as corrosive in the Annex hereto in
        concentrations exceeding the limit specified therein .
                              •          ·           .
( 1 ) O.J. No L 147 of 9.6.1975 , p. 40
 ---pagebreak---    ( 7 ) Preparations shall be considered irritant if they contain one or more of
          the substances classified as irritant or corrosive in the Annex hereto
          in an individual concentration exceeding the limit specified therein in
          a total concentration exceeding 25% .
          If there ore facts to justify the assumption that a preparation containing
          at least two irritant substances is corrosive , or if such has been found
         to be the case in practice , tests shall be carried out to determine the
          category to which the preparation belongs in accordance with the
         procedure described in Annex VIII of the Directive of 27 June 1967 ( 1 ).
         The preparation shall be classified according to the results obtained .
   ( 8 ) Preparations shall be considered easily flammable if they are in liquid
         form and their flash point , as determined by the method laid dowri in :
         Anne* V to" the Directive of 27 June 1967, is below 21°C .
  ( 9 ) Preparations shall be considered flammable if they are in liquid form and
         their flash point,' as determined by the method referred to above , is •
         between 21 and 55°C .                                   ,
(-10) Preparations in the form of aerosols shall be subject to the f lair.mabi lity
         criteria set out in item 1.8 of the Annex to Directive 75 / 324/ EEC ."
( 11 ) For the purpose of this Directive " market " means " common market ".
                                       Article 4
  Artict6'4 shall be replaced by the following ;
        "Member States shall take all necessary measures to ensure that deingerous
         preparations ( solvents ) cannot be placed on the market unless their
         packagings and closures satisfy the requirements of Article 5 of the
         Directive of T? June 1967 ."
  ( 1 ) The proposal for a sixth amendment of the Directive of 27 June 1967
         transmitted to the Council on 20 September 1976 contains Annex VIII .
 ---pagebreak---                                            Article 5
Article 5 ( 1 ) to ( 4 ) shall be replaced by the following :
 ( 1 ) Member St'"Jt3s shall take all necessary measures to ensure that preparations
        classified as dangerous in accordance with Article 2 cannot be placed on
        the market unless the labelling on the package fulfils the following
        conditions .
( 2 ) The following information shall be clearly and indelibly inscribed on the
       P'- CK age of any preparation classified as dangerous in accordance with
       Article 2 :
       ( a) the trade name or designation of the preparation ;
       ( b) - the chemical name(s ) of the toxic ingredient(s ) and the percentage
                contained ;                                                 • '
                the chemical name(s ) of the harmful ingredient Cs ) if the concen­
                tration thereof exceeds the following lvalues :
                     in the case of  class  Il/ a substances         3% by weight -
                     in the case of  class  Il/b  substances         6% by weight
                     in the case of  class  XI /c substances        10% by weight
                     in the case of  class  Il/d  substances .    . 20% by weight ;
               the chemical name of the corrosive ingredient ( s ) if the concentration
               thereof exceeds the lowest values mentioned in the Annex-
            ~ the inscription irritant solvents" if the preparation contains
               irritant ingredients in a concentration exceeding the value specified
               in Article 2 ( 7) and if, furthermore , it contains no toxic, harmful
              •and/or corrosive ingredients *
      The chemical name shall be the designation listed in Annex I to the
      Directive of 27 June 1967 .
      The chemical name(s ) of the ingredient(s ) need not be stated if the
     preparation, is classified merely as easily flammable or flammable .
 ---pagebreak---                                           - 10 -
      ( c ) the r ? mc and address of tr.e manufacturer or of any other person placing
            the preparation on the market ;
      ( d ) symbols where specified in this Directive , and indication of danger
             in accordance with Article 6(2 ) ( c ) of the Directive of 27 June 1967, read i
                                               /
             conjunction with Annex V thereto / and , in the case of aerosol prepar­
             ations , in accordance with item 1.8 of the Annex to Directive 75 / 324 / EEC
             where f lammability hazards are concerned ;
      Ce ) one or more standard inscriptions indicating the nature of any special
             risks involved in the handling of the preparations . In the case of
            harmful , irritant or easily flammable preparations , such special risks
            need not be indicated if the content of the package does not exceed
            125 ml ;
      ( f ) in the case of toxic preparations , the notice : " The full composition
            of this preparation has been notified to the poisons information
            centre(s ) under the following reference :        " X>
( 3 ) The notice concerning special risks shall be furnished by the manufacturer
      or any other person marketing the preparation , according to the importance
      of . the principal hazards .                       .
(     The notice shall conform to the wbrding in Annex III to the Directive of
      27 June 1967 .
      No more than four . standard inscriptions need be furnished . If the prepar­
      ation falls within several danger categories , the notice shall cover all
      the principal hazards associated with the preparation .
( 4 ) The packaging shall be accompanied by safety advice relating to the use
      of the substance where it is materially impossible for this to be given
      on the label or package itself . Such advice shall be selected by the
X ) The full address and telephone number of the centre<s ) must be given .
 ---pagebreak---                                            11
         manufacturer or any other person placing the preparation on the jnerka't.
         from among the items set out in Annex IV to the Directive of 27 June 1967."
?. The following paragraphs shall be added to Article 5 :
    (6) Whon more than one danger symbol is assigned to o preparation, the following
         shall apply :
           whore the symbol T has to be affixed, the symbol C is generally not required
           rnd the symbol X is never required;                   '
           where the symbol C has to be affixed, the symbol X is not required.
   ( 7) If a preparation is classified as both harmful and irritant, it shall be
        labelled harmful and attention shall be drawn to its harmful and irritant
        characteristics by appropriate warnings in accordance with Annex III to
        the Directive of 27 June 1967."                                          '
                                      Article 6
  Article 6 shall be replaced by the following :
  "Article 7 of the Directive of 27 June 1967 shall be applicable in respect
  of the labelling details ." ,   .                       ■' .?
                                                            ' ' t              <                   *
                                                                           '•      y ' •
                                     Article 7
  Article 7 shall be replaced by the following:
 "Article 8 of the Directive of 27 June 1967 shall be applicable in respect
 of derogations from the labelling requirements *"•        4
                                                                   .! i        ; I''        ..   -
                                                                             <           *
                                                                        *           '         •
                *                                              *
                    . \ • : 'V7 '            I,  ' • *' . V-.' : ' ' , • t ,   i*          * ^ •
 ---pagebreak---                                          - 12 -
                                        Article 8                     >
The following paragraphs shrill be added to'Article 8 :
"(2    Member States shall take all necessary measures to ensure that the
       manufacturer or any other person marketing a toxic preparation notifies
       its composition to the poisons information centres designated by the
       competent authorities .
 ( 3 ) Each Member State shr*ll notify to the other Member States and to the
       Commission the following :
       -a     list of the Poisons Information Centres designated to receive the
          Information referred to in the second paragraph ;
       - any subsequent change in such list .
       These lists shall be published for ihformstion purposes in the Official Journal
       of the European Communities . 11
                                     Articte 9
       Article 10 shall be replaced by the following :
       " Annexes to this Directive shall be adopted in accordance with Article 8(c )
       of the Council Directive of 27 June 1967 ."
                                     Article 10
 ( 1 ) Member States shall adopt .and publish within 12 months from the
       notification of the first   Di rective based on Article 10 of this Directive
       the laws ,regulations and administrative provisions needed to comply with
       this Directive .
       They shall apply these provisions within 18 months from the notification
       of the first Directive based on Article 10 of this Directive .
 ( 2 ) On notification of this Directive , Member States shall Inform the
       Commission , in time to enable it to put forward Its comments , of all
       draft laws , regulations or administrative provisions which they intend
       to adopt in the field covered by the Directive .
                                        Article 11
       This Directive 1s addressed to the Member States .