Amendment to the proposal for a COUNCIL REGULATION ( EEC ) on the Evaluation and the Control of the Environmental Risks of Existing Chemicals
Date: 1991-12-05
Institutions: European Commission
Subjects: chemical product, consumer protection, dangerous substance, exchange of information, health control, health risk

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) 

^ 

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. 

-  3 

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. 

-  4 -

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. 

-  5 -

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 
existing  substance  appearing  In  Annex  1 
préparât Ion.  In quantities exceeding  1000 tonnes per year 
In the three years preceding  and/or  one  year  following 
this  Regulation,  must  submit  to  the  Commission  the 
Information,  in  accordance  with  the  data  set  laid  down  in 
within six months of  the Regulation entering  Into force : 

importer  who 
either  on_I 

has  imported  an 
ts  own  or  In a 
at  least once 
the adopt Ion of 
fol lowing 
Annex  I i, 

(a) 
(b) 
(c) 

(d) 

the name of  the substance and the number on the EINECS  inventory; 
the quantity of  the substance produced or  imported; 
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; 
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 

reproduction of  the substance; 

(j) any  other  Indication  relevant  to  the  risk  evaluation  of 

substance. 

to 

the 

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.. 

- 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. 

-  7 

-  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  : 

tùfi  substances 

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 
the 
effects  QÎ 
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. 

concerned. 

it  shall 

inform 

-  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 

- 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. 

KSN 0254-1475 

COM(91) 469 final 

DOCUMENTS 

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Catalogue number : CB-CO-91-543-EN-C 

ISBN 92-77-78060-6 

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