CELEX: 51991PC0469
Language: en
Date: 1991-12-05
Title: Amendment to the proposal for a COUNCIL REGULATION ( EEC ) on the Evaluation and the Control of the Environmental Risks of Existing Chemicals

COMMISSION OF THE EUROPEAN COMMUNITIES
                                    C0M(91) 469 final - SYN 276
                                    Brussels, 5  December 1991
                   Amendment to the proposal for a
                       COUNCIL REGULATION (EEC)
               On the Evaluation and the Control of the
               Environmental Risks of Existing Chemicals
        (presented by the Commission pursuant to Article 149(3)
                           of the EEC-Treaty)
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                         EXPLANATORY MEMORANDUM
1.  In September 1990, the Commission submitted a proposal for a
    Council Regulation on the evaluation and the control of the
    environmental risks of existing substances. (Com (90) 227 final
    SYN-276) under Article 100A of the Treaty.
2.  After the first reading, the European Parliament adopted an opinion
    on the above proposal for a Regulation on 9th October 1991,
    approving a number of amendments to the text proposed by the
    Commission. In Its legislative resolution, the European Parliament
    called on the Commission to amend its proposal accordingly pursuant
    to Article 149(3) of the EEC Treaty.
3.  The Commission having considered the amendments approved by the
    European Parliament, agreed to Incorporate a number of them in a
    mod IfIed proposa I.
4.  Recital 12 has been amended to fix a deadline for the establishment
    of the first annual priority list of chemicals.
5.  Recital 16 has been modified to emphasize the importance of using
    alternative test methods wherever possible.
6.  A new recital 16 has been added, again to ensure that existing data
    is given consideration even if it has not to be generated according
    to established testing methods.
7.  Recital 17 has been modified to clarify that tests conducted before
    the advent of Good Laboratory Practice would not be discounted.
8.  The objectives laid down in Article 1 have been modified to make It
    clear, that man, in the context of this Regulation, includes
    workers and consumers.
9.  The definition of Importation in Article 2(c) has been clarified.
10. Articles 3 and 4 have been modified to make It clear that
    substances incorporated in preparations are also to be taken into
    account in this Regulation. In addition, the reference period for
    determining the obligation to report has also been clarified.
    Finally changes designed to avoid anima H testing have also been
    Included in these articles.
11. Article 7.1 now includes a requirement to establish the first
    priority lists within one year of the adoption of the Regulation.
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12. Article 8.1 has been changed to Include the obligation for wider
    consultation of Member States and Industry. Article 8.2 clarifies
    that further Information/testing can only be required If this
    serves to Improve the protection of man or the environment.
13. Article 9.3. now takes    Into account  substances  incorporated  in
    préparât ions.
14. Article 9.4 now stipulates that punitive sanctions can only be
    taken against companies that do not comply with the additional
    requirements imposed by the Regulation.
15. Article 12 has been amended      to clarify  a number   of  concerns
    relating to confidentiality.
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Modified Proposal for a Council Regulation on the evaluation and the
control of the environmental risks of existing substances.
The Commission, on   the basis of the opinion delivered by the European
Parliament in Its    first reading on 9th October 1991, modifies Its
original proposal   (J.O. C 276, 5.11.1990, p. 1) pursuant to Article
149(3) of the E.C.  Treaty as follows :
- Recital 12 to now read
Whereas on the basis, In particular of the information and data
submitted by manufacturers and Importers and of specific proposals by
Member States, it is necessary to draw up, at Community level, lists of
priority substances which require special environment, and whereas to
expedite this work, the Commission shall, not later than One Year
fol lowing the entry Into force of this Regulation, submit an initial
priority list based on existing priority lists In the Member States.
- Recital 16 to now read :
Whereas In the Implementation of this Regulation, It is appropriate to
reduce to a minimum the number of animals used for experimental
purposes in accordance with the provision of Council Directive
86/609/EEC of 24 November 1986 on the Approximation of law regulations
and administrative provisions of the Member States regarding the
protection of animals used for experimental and other scientific
purposes, and whereas wherever possible and In consultation with the
European Centre for Alternative Testing Methods, the use of animals
will be avoided by recourse to validated alternative procedures.
- Recital 16a (new)
Whereas, when evaluating existing data, results obtained using test
methods other than those described In Annex V to Directive 67/548/EEC
should also be taken Into consideration.
- Recital 17 to now read :
Whereas Council Directive 87/18/EEC of 18 December 1986 on the
harmonization of     laws, regulations and administrative provisions
relating to the application of the principles of good laboratory
practice and the verification of their application for tests on
chemical   substances specifies the Community principles of good
 laboratory practice which must be followed for tests on chemicals to be
carried out In the context of this Regulation.
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ABJJUCLES
- Article 1. to now read :
The purpose of this Regulation is to approximate the laws, regulations
and administrative provisions of the Member States on :
a)   the collection of Information on existing substances;
b)   the evaluation and the control of the risks of existing substances
     to man, including workers, and consumers, and the environment
which are listed in the European       Inventory of  Existing  Commercial
Substances EINECS.
This Regulation shall apply without prejudice to specific Community
 legislation concerning the safety and the protection of the health of
workers at work.
- Article 2 point (c) to now read :
 "c) importing means supplying, making available or using      substances
      from outside the Community territory."
- Article 3 to now read
Any manufacturer who has produced or any importer who has imported an
existing substance appearing In Annex 1       either on_I ts own or In a
préparât Ion. In quantities exceeding 1000 tonnes per year at least once
 In the three years preceding and/or one year following the adopt Ion of
 this Regulation, must submit        to the Commission     the fol lowing
 Information, in accordance with the data set laid down in Annex I i,
within six months of the Regulation entering Into force :
 (a) the name of the substance and the number on the EINECS inventory;
 (b) the quantity of the substance produced or imported;
 (c) the classification of the substance according to Annex I to
      Directive 67/548/EEC or the provisional classification according to
      Directive 67/548/EEC, including the class of danger, the danger
      symbol, the risk phrases and the safety phrases;
 (d) information on uses of the substances which are reasonably
      foreseeable
 (e)  data on physico-chemical properties of the substance;
 (f)  data on environmental fate and pathways;
 (g)  data on the ecotoxoclty of the substance;
 (h)  data on the acute and sub-acute toxicity of the substance;
 (I)  data on the carcinogenicity, mutagenicity and/or toxicity to
      reproduction of the substance;
 (j) any other Indication relevant to the risk evaluation of the
      substance.
Manufacturers and Importers are required to taKe all reasonable efforts
 to obtain the data referred to under poJnla l^LJo_CJJ^a^ov^x^oj«ej^ejifc
out additional    tests on animals for the purpose of submitting these
slala..
 ---pagebreak---                                    - 6 -
- Article 4 to now read :
1.   Any manufacturer who has produced or any importer who has Imported
     a substance appearing In the EINECS inventory but not listed In
     Annex I, either on Its own or In a preparation in quantities
     exceeding 1000 tonnes per year, at least once In the three years
     preceding and every year        following, the adoption of      this
     Regulation, must submit to the Commission the information referred
     to In Article 3, in accordance with the data set laid down In Annex
      II, within 18 months of the Regulation entering Into force.
2.   Any manufacturer who has produced or any Importer who has Imported
     a substance appearing In EINECS, either on Its own or In a
     preparation, in quantities exceeding 10 tonnes per year, but no
     greater than 1000 tonnes per year, at least once in the three years
     preceding and/or every year following the adoption of this
     Regulation,    must    submit  to   the  Commission  the   following
      Information, in accordance with the declaration form laid down in
     Annex III within a period of 18 months, to start once the
     Regulation has been in force for three years :
(a) the name of the substance and the number on the EINECS inventory;
 (b) the quantity of the substance produced or Imported;
 (c) the classification of the substance according to Annex I to
     Directive 67/548/EEC or the provisional classification according to
     Directive 67/548/EEC, including the class of danger, the danger
     symbol, the risk phrases and the safety phrases;
 (d) Information on uses of the substance which are reasonably
     foreseeable.
3.   The Commission, in consultation with the Member States, will
     determine the cases in which It is necessary to request the
     producers and importers of the substances declared In pursuance of
     paragraph 2, to submit additional information, in the framework of
     Annex II, on the physico-chemical properties, exposure, toxicity,
     and ecotoxicity of the substance and any other aspect relevant to
      the risk evaluation of the substance, provided that no recourse
     need be had to further animal experiments. The specific Information
     to be submitted and the procedure to be followed for this
     submission will be determined In accordance with the procedure laid
     down In Ar t i cIe II.
- Article 7.1 to now read :
 1.  On the basis of the information submitted by the manufacturers and
      importers in accordance with Articles 3 and 4, and on the basis of
     the national lists of priority substances, the Commission, in
     consultation with Member States, shall regularly draw up lists of
     priority substances or groups of substances requiring special
     attention because of the possible effects they may pose to man or
     the environment. These lists will be adopted in accordance with the
     procedure laid down in Article 11 and will be published by the
     Commission, In the first Instance within 1 year of the entry into
     force of this Regulation.
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- Article 8.1 to now read :
1.  For each substance on the priority lists, an appropriate Competent
    Authority of a Member State will be Identified as rapporteur for
    that substance after consultation with the Member State concerned.
    The rapporteurs will be designated in accordance with the procedure
    laid down In Article 11.
    The duty of the rapporteur will be to evaluate the Information
    submitted by the manufacturer(s) or importer(s) pursuant to the
    requirements of Articles 3, 4 and 6 and any other available
    Information, and to Identify, after hearing the parties concerned,
    whether, for the purpose of the risk evaluation, It would be
    necessary to require manufacturer(s) or Importer(s) of priority
    substances to submit further data and/or to carry out further
    testing.
- Article 8.2 to now read :
2.  In the case where the Competent Authority, acting as rapporteur,
    Identifies the need for further information and/or testing, In
    order to protect man and/or the environment from the harmful
    effects QÎ tùfi substances concerned. it shall           inform the
    Commission. The Commission will then submit, to the Management
    Committee referred to In Article 11, a proposal to request further
     Information and/or testing specifying the time limit within which
    the further Information and/or the results of the further tests
    shall be supplied. The decision to Impose such a request on
    manufacturer(s) or Importer(s) will be adopted in accordance with
    the procedure laid down in Article 11.
- Article 9.3 to read :
3.   in the case of a substance either on Its own or In a preparation
    produced or imported by several manufacturers or importers, the
    testing in pursuance of paragraphs 1 and 2 may be performed by one
    or more manufacturer(s) or Importer(s) acting on behalf of the
    other concerned manufacturer(s) or importer(s). The other concerned
    manufacturers or importers shall make reference to the tests
    carried out by that or those manufacturer(s) or Importer(s) and
    shall share the costs on a fair and equitable basis.
- Article 9.4 to read :
4.   in the event that the further Information and/or the results of the
    further testing are not supplied within the 11 me limits specified
     In Article 8(2) and adopted In accordance with the procedure laid
    down in Article 11, a decision to suspend the further marketing and
    use of the substance on the Community market will be adopted in
    accordance with the procedure laid down In Article 11 In respect of
    UPdertaKlngs Which have failed to submit the above-mentioned
     Information or test results and will remain in force until such
    time as the additional Information and/or the results of the
 ---pagebreak---                                  - 8 -
    further testing are supplied. The Commission will periodically
    review the cases of substances whose marketing and/or use has been
    suspended in accordance with this paragraph with a view to making
    proposals for harmonized permanent measures concerning restrictions
    on marketing and/or use in the framework of either Directive
    76/69/EEC or other appropriate Community measures.
- Article 12.1 now read :
Industrial and commercial secrecy shall not apply to :
    the name of the substance, as given In EINECS,
    the name of the manufacturer or Importer,
    the physico-chemical data concerning the substance,
    the summary results of the toxlcological and ecotoxIcologlcal
    tests,
    any Information relating to the safety of the substance and the
    emergency measures,
-   any   Information  which,   if  withheld.  miant   isad  LQ  animal
    experiments being carried out or repeated unnecessarily.
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                                                              COM(91) 469 final
                                                      DOCUMENTS
EN                                                                             14
                                Catalogue number : CB-CO-91-543-EN-C
                                                             ISBN 92-77-78060-6
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