CELEX: 51974PC1189
Language: en
Date: 1974-07-25
Title: Proposal for a COUNCIL DIRECTIVE on the approximation of the laws of the Member States restricting the marketing and use of certain dangerous substances and preparations (submitted to the Council by the Commission)

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COM (74) 1189
Vol. 1974/0190
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 ---pagebreak--- COMMISSION OF THE BTOOEBAN COMMUNITIES
                                                  COM(74 ) 1189 final
                                                  Brussels , 25 July 1974
                                      Proposai for a
                                     COUNCIL DIRECTIVE
                        on the approximation of the laws of the
                        Mealier States restricting the marketing
                        and use of certain dangerous substances
                                    and preparations
                     ( submitted to the Council by the Commission)
   001.1(74 ) 11 RS final
 ---pagebreak---                               EXPLANATORY HEMOIL'JPUM
I.  GEEERAL OBSERVATIONS
    1.   There are a large number of dangerous substances and. preparalkins
    which are toxic , noxious , corrosive , irritant , explosive or readily
    inflammable and which may cause damage to man or to the environment .
    In order to protect the general public , and especially those who use
   them , from the risks attaching to dangerous substances and preparations ,
   the Council , acting on a proposal from the Commission, adopted on 27 June 19^7
    a Directive on the classification , packaging and labelling of dangerous
                1               ..                  „                           „,2
    substances , most recently rmended by the Council Directive of 21 Fay 1973 •
   To provide even more effective protection against the risks attaching
   to the use of dangerous substances and preparations , the Council adopted on
   4 June 1973 a. Directive on dangerous preparations used as solvents3 .
   It subsequently transpired that for seme dangerous substances and
   preparations , regulations governing classification , packaging and
   labelling were not sufficient ; it was also necessary to prohibit or
   restrict marketing and use under certain conditions .         Consequently a
   Directive to supplement Community provisions already existing in this
   field was necessary.
   Some    Member States have adopted provisions governing various sectors
   of this field .     These provisions show disparities and thus hinder the
   free movement of goods .        In order to eliminate these barriers , it is
   necessary to harmonize the existing provisions laid down by lav; in the
   Member States .
   2o    At Co'^inunity level , there are already Directives guaranteeing
   the free movement of goods and ensuring protection to human health and
   the environment .     They do not , however , form an adequate basis for the
   introduction of general restrictions on the marketing or use of
   dangerous substances and preparations .        Therefore it is necessary to
   adopt a Directive containing general restrictive provisions applying
   to fields which are not covered by other Directives , such as those on
     OJ îlo 196 , 15 August , 1967 . P-1 .
     OJ Ko L 167 , 25 June 1973, P 1 .
   30J Ko L 169 , 11 July 1973, P 7-
 ---pagebreak---                                  -2
the composition of petrol ( lead content ), the sulphur levels of fuels ,
 lead and cadmium in ceramics and dangerous substances in paints and
varnishes .
 3-  The Directive will also have the advantage of allowing more rapid
and effective implementation in the European Community of restrictions
recommended or adopted by other international organizations , such as
the decision by the Council of the Organization for Economic Cooperation
and Development ( OECD ) to restrict production and sale of chemical
products known as polychlorinated biphenyls ( PCBs ) the use of which
may contaminate human health and the environment .
4„   The tcsicity and j&rsistence of PCBs was noticed for the first
time in 1966 , when traces of these products were found in poisoned
fish and wild birds .    Accidents which occurred included the
contamination of chickens by PCBs present in plastic packaging materials ,
the discovery of fCBs.inwrappings of food products , as a result «f the
use of carbonless copying paper in the manufacture of paper pulp , and
the presence of PCB in cow 's milk due to absorption by these animals
from feeding^tuffs of PCBs arising from herbicide treatment or storage
silos .   In the most serious accident human beings were poisoned as a
result (fixi leakage of heat transfer liquid in a rice oil pasteurization
factory in Japan .
For these reasons , a restriction on the marketing and use of PCBs is
necessary .    Thus the only uses to remain authorized will be those
contained in a certain limitative list , consisting mainly of cases
where the non-inflammable nature of PCBs is an indispensable
characteristic .
5°   The main purpose    of the following proposal for a Directive is to
attain the following objectives of the Treaty establishing the
Community :
-   improved protection of the life and health of the general public ,
    and in particular of persons obliged by their occupation to be in
    contact with drngerous substances and preparations ;
 ---pagebreak---                                      -3-
     - guaranteeing of the free movement of goods in the European Community .
     A further purpose of the proposed Directive' is to help to protect the
     environment and to restore , maintain and improve the quality of life .
     6.   For these reasons provision is made for this Directive in "both
     the Council Resolution cf 17 December 1973 on industrial policy , and the
     Declaration of the Council and of the representatives of the Governments
     of the Member States meeting in the Council . of 22 November 1973 on the
     programme of action of the European Communities on the environment .
     7-   To leave open the possibility of extending the scope of the
     Directive to other dangerous substances and preparations or of
     determining or amending the details of the restrictions , a simple and
     rapid procedure was necessary .  To this end , the Committee on Dangerous
     Substances , established by the Council Directive of 21 May 1973 , will
     be consulted whenever the question of extending or amending    the
     Directive arises .
     8.  The proposal for a Directive has been drawn up with a view to
     complete harmonization , which means that Community provisions will
     replace national provisions existing in Member States .
     The oomplete harmonization solution has been adopted in this case having
     regard to the fact that these .substances and preparations are dangerous
     to human beings and may pollute the environment .
     9«  Finally , the proposed Directive is intended to encourage manufacturers
     of dangerous substances and preparations to replace these by equivalent
     products which are less dangerous to human health and the environment .
II . COMMENTS ON THE ARTICLES
     Article 1
     This governs the scope of the Directive and contains definitions .   The
     scope is restricted as little as possible in order that , in the future
 ---pagebreak--- restrictions may be laid dovm for all the dangerous substances and
 preparations meriting consideration , providing that these restrictions
 are prompted by a desire to safeguard health or the environment .
Article 2
This provision compels Member States to control the marketing and use
of the substances and preparations listed in the Annex in accordance
with the conditions laid down .
Article 3
This Article provides for a procedure for amending the Annex to the
Directive in the light of technical progress .   Amendments must be
adopted in accordance with the procedure laid dovm in the Council
Directive of 27 June 19^7 on      approximation of laws , regulations and
administrative provisions relating to the classification , packaging and
labelling of dangerous substances .
Some of the experts consulted were against this procedure since unanimous
agreement would not be required to supplement or amend the Annex .
Articles 4 and 5
These Articles are common to all Directives .
Anne ::
1.   The Annex contains at present only polychlorinated biphenyls ( PC3J
for which the restrictive conditions are the same as those laid dovm by
the Council of the Organization for Economic Cooperation and Development
( OECD ) cn 1 3 February 1973 .
 ---pagebreak---                                          - 5-
      The number of substances in the Annex has been reduced compared with
      the initial draft , for two reasons . Firstly, the substances removed
      from the Annex will be covered by particular Directives in which the ways
      and means of restricting them will be given and secondly, the Commission
      departments were not in possession of sufficient scientific information
      to decide upon immediate restrictions on a Community–wide scale .
      2 . The polychlorinated biphenyls (PCB) are a group of stable substances ,
      consisting theoretically of more than 200 compounds , many of which are
      wicSLy used , particularly on account of their dielectric properties and
      their non-inflammable nature .    They are at present obtained by
      chlorination of biphenyl , which '-gives rise to mixtures which are
      characterized by their mean chlorine contents. Because of the persistence
      and toxicity of some of these compounds , effects upon the environment
      have been observed and accidents which have been reported during the
      last few years have caused serious misgivings in various countries .
      That is why priority has been given to studying the need for , and
      possibility of , concerted action to conti'ol the use of PCBs .
      3.   According to Article 2 , the marketing and use of PCBs is prohibited
      except for a small number of categories listed in the Annex to the
      Directive , that is , " closed systems".
      The use of PCBs in closed systems may be defined as applications where
      the PCBs are recoverable . PCBs used in transformers , large capacitors ,
      heat transfer systems , hydraulic equipment and vacuum pumps are in-. theory .
      recoverable because , while they are being used , they are not generally
      dispersed into the environment .
III . CONSULTATI OF OP THE EUROPEAN" PARLIAMENT AND THE ECONOMIC AND SOCIAL COMMITTEE
      It is essential that these two institutions give their opinion in accordance
      with Article 100(2 ).
 ---pagebreak---                                   -1-
                      PROPOSAL FOR A COU1TCIL DIPJSCTIVE
           on the approximation of the laws of the Member States
           restricting the market ing and use of certain dangerous
                         substances ani preparations
THE COUNCIL OP THE EUROPE:IT COIIMUHITIES ,
Riving regard to the Treaty establishing the European Economic
Community , and in particular Article ICO 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 any rules concerning the placing on the market of dangerous
substances and preparations must aim at protecting the public , and
in particular workers using such substances and preparations ;.
Whereas they should also contribute to the restoration , preservation
and improvement of human life and to the protection against risks
to health caused by environmental pollution ;
Whereas dangerous substances and preparations are governed by rules
in the Member States , and whereas these rules differ as to the
conditions of their marketing and use ; whereas these differences
constitute an obstacle to trade and directly affect the establishment
and functioning of the Common Market ;
Whereas this obstacle should therefore be removed and whereas this
entails approximating the existing relevant laws in the Member States ;
Whereas the provisions relating to certain dangerous substances
and preparations have already boon provided for in Comnunit-r cHroctiv^r :
whereas it is still necessary to lay down rules for other products ;
in particular for those for which international organization have
established restrictions , for example , the Council of the OECD
                                                       • • •/• • •
 ---pagebreak--- decided on 13 February 1973 the restriction of the production and
use of the polychlorinated biphenyls (PCB) . This provision was
necessary to prevent the absorption of the PCB in the human body
and the resultant danger to human health ,
MS ADOPTED THIS DIRECTIVE :
                              Article 1
1.    Without prejudice to the implementation of other relevant
      Community provisions , this Directive is concerned with
      restricting the marketing and use of certain dangerous substances
      and preparations in the Member States of the Community, and
      in particular those which present characteristic of ecotorcicit'y ,
2.    This Directive docs not apply to :
      (a)  the carriage of dangerous substances and preparations
           by rail , road , inland waterway, sea or air ;
      (b)  dangerous substances and preparations exported to
           non-member countries ;
      ( c) substances and preparations in transit and subject
           to customs inspection, provided that they undergo
           no processing.
3.    For the purposes of this Directive :
      ( a) " substances" means
           Chemical elements and their compounds as they occur in
           the natural state or as produced by industry ;
      (b)  "preparations" means
           Mixtures or solutions composed of two or more substances .
                                                     • • •/• • •
 ---pagebreak---                                             –3–
                                      Article 2
  Member States shall take all necessary measures to ensure that the
  dangerous substances and preparations listed in the annex and subject
  to the conditions specified therein cannot be placed on the market
  or used , except for purposes of research or analysis .
                                      Article 3
  The amendments required to adapt the annex in the li/jht of technical
  progress shall bo adopted in accordance with the procedure laid down
  in Article 8 c of the Directive of 27 June 1967 ("7/54->f                ) cvncarninrf the
  r.pproj.:imt ion of laws , regulations rjail culoinist revt iva ' pxvsri sions relwiiiv?' to
  the classification. p">,c!c%ging • • ry\ l;,, 'b3lliiv» of •TnnLj,ercu8 sul.st uices . as last
  last anenC-od "by the Directive of 21 May 1973 ( 73/ 14 Vine ) .
                                    ."xtiole 4
- 1.     Member States shall adopt and publish the measures needed
         in order to comply with this Directive by 1 January 1976
         and shall forthwith inform the Commission thereof .               They
         shall apply these provisions from 1 October 1976 ,
  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 contemplate adopting in the field
         covered by this Directive .
                                      Article 5
  This Directive is addressed to the Ifember States .
 ---pagebreak---                                ΔΜΊΞΧ
Designation of the substance or            Conditions of restriction
preparation or groiips of substances
1 . Polychlorinated Biphenyls(PCl )  May not be used except for the
                                     following:
                                     Dielectric fluids for transformers
                                     or largo power factor correction
                                     capacitors ( ^ 1 kg);
                                     Heat transfer fluids ( other than
                                     in installations for processing
                                     of foods , drugs , feeds and
                                     veterinary products);
                                     Hydraulic fluids in mining
                                     equipment ]
                                     Small capacitors (     1 leg and
                                            42% CL ) ■