Opinion of the Commission pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, on the European Parliament's amendment to the Council's common position regarding the proposal for a Directive of the European Parliament and of the Council amending for the twenty-third time Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations (substances classified as carcinogens, mutagens or substances toxic to reproduction - c/m/r)
Date: 2002-12-27
Institutions: European Commission
Subjects: amendment, dangerous substance, health legislation, health policy, interinstitutional relations (EU)

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 27.12.2002
COM(2002) 768 final

2001/0110 (COD)

OPINION OF THE COMMISSION

pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty,
on the European Parliament's amendment
to the Council's common position regarding the
proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

amending for the twenty-third time Council Directive 76/769/EEC
relating to restrictions on the marketing and use of certain dangerous substances
and preparations (substances classified as carcinogens, mutagens
or substances toxic to reproduction – c/m/r)

   
2001/0110 (COD)

OPINION OF THE COMMISSION

pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty,
on the European Parliament's amendment
to the Council's common position regarding the
proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

amending for the twenty-third time Council Directive 76/769/EEC
relating to restrictions on the marketing and use of certain dangerous substances
and preparations (substances classified as carcinogens, mutagens
or substances toxic to reproduction – c/m/r)

1.

STATE OF PROCEDURE

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The  above  mentioned  proposal  [COM(2001) 256  final]  was  adopted  by  the
Commission  on  14th May  2001  and  then  transmitted  to  the  Council  and
European Parliament.

The  European  Economic  and  Social  Committee  gave  its  Opinion  on
12 September 2001.

The European Parliament approved the proposal with amendments in the first
reading on 5 February 2002.

The Commission rejected the European Parliament’s amendments.

The Council adopted its Common Position on 3 June 2002.

The  European  Parliament  approved  the  proposal  with  an  amendment  in  the
second reading on 10 October 2002.

2.

OBJECTIVE OF THE DIRECTIVE

The  Proposal,  which  is  based  on  Article 95  of  the  Treaty,  has  the  following  two
objectives:

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to  preserve  the  Internal  Market  by  introducing  harmonised  provisions  with
regard  to  the  marketing  and  use  of  substances  classified  as  carcinogens,
mutagens or substances toxic to reproduction (c/m/r);

to  provide  a  high  level  of  protection  of  health  and  the  environment  by
restricting  the  marketing  and  use  of  substances  classified  as  carcinogens,
mutagens or substances toxic to reproduction (c/m/r).

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3.

OPINION OF THE COMMISSION ON THE AMENDMENT PROPOSED BY
THE EUROPEAN PARLIAMENT

3.1.

Summary of the Commission’s position

The  Commission  cannot  accept  the  amendment  proposed  by  the  European
Parliament.

3.2.

Amendment

The European Parliament proposed that the “Commission should submit as soon as
possible a proposal to prohibit the use of products containing such substances, when
there  is  scientific  evidence  that  they  are  released  from  these  products  leading  to
exposure of the general public”.

The  current  restrictions  relating  to  points  29,  30  and  31  of  Annex  I  of  Directive
76/769/EEC  as  well  as  the  Commission's  proposal  for  the  23rd  amendment  of
Directive  76/769/EEC  cover  substances  and  preparations.  By  including  both
substances  and  preparations  within  the  scope  of  the  proposal  the  situations  most
likely to lead to exposure of consumers to CMR substances are covered. Examples of
preparations used by consumers are glues, detergents, household cleaning products,
etc.

It is obvious that CMR substances incorporated in products will pose lower risks than
CMR  substances  in  preparations.  Therefore,  the  Commission  is  of  the  opinion  that
the  risk  assessment  procedure  should  be  the  essential  and  necessary  basis  for
restrictions on CMR substances in products.

As  regards  the  general  issue  of  reduction  of  risks  from  dangerous  substances,  the
Commission  would  also  draw  attention  to  the  important  changes  which  will  be
brought about under the new chemicals strategy and which are of direct relevance in
meeting the objectives sought by the proposed amendment.

These  changes  will  involve  the  registration  of  some  30.000  substances  through  a
process  where  industry  will  have  to  submit  data  including  a  preliminary  risk
assessment  for  each  of  those  substances.  In  addition,  the  authorisation  procedure
which  will  apply  in  the  case  of  substances  of  very  high  concern,  including  CMRs,
will involve more stringent requirements. The proposals are at an advanced stage of
preparation and will soon be presented to the Council and the Parliament.

4.

CONCLUSION

Taking  account  of  the  above,  the  Commission  delivers  a  negative  opinion  on  the
amendment.

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