CELEX: 51981PC0573
Language: en
Date: 1981-10-19
Title: Proposal for a COUNCIL DIRECTIVE amending for the seventh- time Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substance and preparations (submitted to the Council by the Commission)

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DE LA COMMISSION
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DOCUMENTS "COM"
COM (81) 573
Vol. 1981/0175
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIE
                                               COM(81)573 final
                                               Brussels / 19 October 1981
                                     Proposal for a
                                    COUNCIL DIRECTIVE
              amending for the seventh- time Directive 76 / 769 / EEC on the
              approximation of the laws, regulations and administrative
              provisions of the Member Statesrelating to restrictions
                                              • v\
               on the marketing and use of certain dangerous substance
                             . ^ and preparations
                                     *
                     ( submitted to the Council by the Commission )
COM ( 81 ) 573 final
 ---pagebreak---                                     - 1 -                    Cc^ £r5
                           EXPLANATORY" MEMORANDUM
GEM ERA L                                                      •        '
1 . This proposal for a directive provides for additions to the Annex to
    Directive 76/769/EEC^ relating to restrictions on the marketing and use
    of certain dangerous substances and preparations . Current scientific
    knowledge , indicates that the use of five chemical substances should
    be prohibited in the manufacture of specific products , since these
                    /
    substanoes can be regarded as , a health risk .
2 . The two products in questionare fire-retardant and their use is prohibited
    in textiles in the Federal Republic of Ge,rmanya The first TEPA, gives a
    positive reaction in several mutagenesis tests and reveals a sub­
    stantial degree of cutaneous absorption , the second , the PBBs , are .
    persistent and similar in behaviour to the PCBs which are already largely
    prohibited .
3 . The presence of 3»3' –dimethoxybenzidine has been demonstrated in .
     sneezing powder . This product has been prohibited in France and Canada
     for use in the manufacture of sneezing powder because of its
     structural similarity with benzidine , a known carcinogen ,- even though
                      A
     its mutagenic      and carcinogenic properties could not be formally
     established . Children , who are the main users of these novelty and joke
      products , and who , moreover , are more sensitive as a group than adults
      to toxic substances should not be exposed to this risk .
 4 . Ammonium polysulphides are used in stink bombs . They release noxious
      vapours which have a corrosive effect . They may cause serious injury ,
      particularly to the eyes . Relatively slight quantities may cause
       inflamation of the skin or the eyes . The United Kingdom has already
      prohibited the marketing of re-usable stink bombs .
                                                          v.
       1 OJ No L 262 , 27.9.1976 , p. 201
 ---pagebreak--- 5 . It has also prohibited tear-gas capsules containing methyrbromoacetate ,
    which are sold as novelty or joke toys , since they can have a harmful
    effect on the respiratory system and the eyes .
6 . The Scientific Advisory Committee on the Toxicity and Ecotoxioity
    of Chemical Compounds ( CSTE) was clearly in favour of the restrictions
    set out in the proposal for a directive when consulted "by the Commission .
7 . In addition to the protection of human life and health , this proposal
    for a directive is also concerned with the efficient operation of the
    Common Market . Since the adoption of different unilateral measures
    limiting the use of certain chemicals may create distortions in the
    Community market and directly 'affect its operation , a Community
    solution should "be found involving the approximation of the relevant
    national legislation in this field .
    Lastly , the proposal for a directive seeks to induce manufacturers to
    replace the dangerous substances used in their products "by chemicals
    posing less of a health risk .
COMMENTS ON THE ARTICLES
Article 1
This Article provides for the addition of five chemical products to the
Annex to Directive 7 6/? 69/EEC • Use of these products is restricted because
of the health risk which they represent .
Article 2 and 3
These Articles appear in all directives .
 ---pagebreak---                                        - 3 -
III .  PREPARATION OF THE DRAFT DIRECTIVE
      The proposal for a directive was drawn up in response to notification
      from two Member States after consultation of     working party
      consisting of experts in the fields of publio health , hygiene ,
      industrial safety , industry and commerce and consultation with the
      CSTE and the industrial and "professional organisations poncerned .
 TV . CONSULTATION OF THE EUROPEAN PARLIAMENT AND THE ECONOMIC AND
                     Jw $                           1
      SOCIAL COMMITTjgj;
      Since implementation of provisions set out in the proposal for a
      directive would entail amendments to existing legislation in the
      Member States , | he opinion of these two bodies is indispensible and
                      •%
      should be obtained in accordance with the second paragraph of Article 100
      of the EEC Treaty .
 ---pagebreak---                                           - 4 -
                            PROPOSAL FOR A COUNCIL DIRECTIVE
                  amending for the seventh time Directive 76/769/EEC on
                  the approximation of the laws , regulations and. administrative
                  provisions of the Member States relating to restrictions
                                     and use
                  on the marketing / of certain dangerous substances and
                  preparations
  THE COUNCIL OP 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 ,
                              opinion of the
  Having regard to the /Economic and Social Committee ,
  Whereas the use of tri-( 2,3-d.ibromopropyl )-phosphate to fireproof
  textile articles             was prohibited by Council Directive 79/663/eEC ^"
  because of the health risks it involves and whereas subsequent exami­
  nations have shown that two other f ire-retardant products ,
  tris-(aziridinyl )-phosphinoxide ( TEPA ) and polybrominated biphenyls ( PBB ),
  are harmful to health and , consequently , should not be employed in
text i Le art i c les whi ch come into contact with the skin ;
  Whereas 3,3' dimethoxybenzidine is used in the manufacture of sneezing
                                   though
  powder and whereas , even / the information concerning the mutagenic
  and carcinogenic properties of this substance is not conclusive , the
  affinity of this substance to benzidine , which has a definitely
  established carcinogenic effect on man , suggests that great caution should
  be exercised in respect of its potential risks to human health ; whereas
  it is clear that sneezing powder is mainly used by children who , in
 principle , represent a group which is sensitive to toxic chemicals and
  who should , consequently , receive special protection against health
  hazards ; whereas , therefore , the use of this substance should be
  prohibited in sneezing powder ;
  1 0J No L 197 , 3.8.1979 , P. 37
 ---pagebreak---                                         - 5 -
 Whereas airimonium polysulphides have a corrosive effect and may cause .
  serious , lasting damage , part icularly to the eyes ; whereas these
 compounds , which are sold in particular to children as novelties or jokes
 in containers that can be re–used , are especially dangerous and whereas
 their use should , consequently , be restricted ;
 Whereas methylbromoacetate is used as tear gas ; whereas it has an irritant
 effect     upon          "the respiratory system and the eyes ; whereas , in
 strong concentrations , it produces a corrosive effect and can cause irre­
 versible damage to the eyes ; whereas it should not be used by children
and            its emplcynmt as a novelty or joke should , therefore , be
 prohibited ;                 ,
Whereas the restrictions already introduced by some Member States in
                                                directly
 respect of the abovementioned substances/ affect the establishment -or
^functioning of the Common Market and whereas it is therefore necessary
to harmonize existing legislation in this field in the Member States and
                                                                       1
 to amend accordingly the Annex to Council Directive 76/769/EEC >
HAS ADOPTED THIS DIRECTIVE
                                     Article 1
 The following items are added to the Annex to Directive 76/769/ EEC :
 "8 . Tris-( aziridinyl )-phosphinoxide ( TEPA )   )  may not be used in textile
                                                   )   articles intended to come into
   9 . Polybrominated biphenyls ( PBB )       ^    )  contact with the skin
 10 . 3,3'-dimethoxybenzidine                          may   not be used in
       CAS No 119-90-4                      *          sneezing powder
 11# Ammonium polysulphide                             may . not be used in containers
                                                      which may be employed several
                                                      times as novelties or jokes
 12 . Methylbromoacetate                               may   not be used in novel–
       CAS No 96-32–2                                 ties , jokes or hoaxes "
 1 0J No L 262 , 27.9.1976, p. 201
 ---pagebreak---                                 - 6 -
                             Article 2
Member States shall bring into force the provisions necessary to
comply with this Directive before 1 July 1982 . Th^y shall forthwith
inform the Commission thereof .
                             Article 3
This Directive is addressed to the Member States .