Communication from the Commission to the European Parliament pursuant to the second subparagraph of Article 251(2) of the EC Treaty concerning the Common Position of the Council on the adoption of a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC; and a Directive of the European Parliament and of the Council amending Council Directive 67/548/EEC in order to adapt it to Regulation (EC) No …/2006 (REACH) {SEC(2006)924}
Date: 2006-07-12
Institutions: European Commission
Subjects: Community certification, EU office or agency, chemical industry, chemical product, classification, environmental risk prevention, marketing, scientific report

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 12.7.2006 
COM(2006)375 final 

2003/0256(COD) 
2003/0257(COD) 

COMMUNICATION FROM THE COMMISSION  
TO THE EUROPEAN PARLIAMENT 

pursuant to the second subparagraph of Article 251(2) of the EC Treaty 

concerning the 

Common Position of the Council on the adoption of a Regulation of the European 
Parliament and of the Council concerning the Registration, Evaluation, Authorisation 
and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and 
amending Directive 1999/45/EC; and a Directive of the European Parliament and of the 
Council amending Council Directive 67/548/EEC in order to adapt it to Regulation (EC) 
No …/2006 (REACH) 

{SEC(2006)924} 

EN 

   EN 

 
 
 
  
 
 
2003/0256 (COD)  
2003/0257 (COD) 

COMMUNICATION FROM THE COMMISSION  
TO THE EUROPEAN PARLIAMENT 

pursuant to the second subparagraph of Article 251(2) of the EC Treaty 

concerning the 

Common Position of the Council on the adoption of a Regulation of the European 
Parliament and of the Council concerning the Registration, Evaluation, Authorisation 
and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and 
amending Directive 1999/45/EC; and a Directive of the European Parliament and of the 
Council amending Council Directive 67/548/EEC in order to adapt it to Regulation (EC) 
No …/2006 (REACH)  

1. 

PROCEDURE 

The proposal COM(2003)644 final1 was transmitted to the European Parliament and 
the  Council  on  3  November  2003  in  accordance  with  the  co-decision  procedure 
pursuant to Article 95 of the EC Treaty. 

The European Economic and Social Committee gave its opinion on 31.3.20042. 

The Committee of Regions gave an opinion on 23.2.20053. 

The  European  Parliament  gave  its  opinion  at  the  first  reading  in  session  on 
17.11.2005. 

The  Council  reached  unanimous  political  agreement  on  a  Common  Position  on 
13.12.2005. The Council adopted the Common Position formally on 27.6.2006. 

2. 

PURPOSE OF THE REGULATION AND DIRECTIVE 

The aims of the REACH Regulation are to ensure a high level of protection of health 
and  the  environment  as  well  as  the  free  circulation  of  substances  on  the  internal 
market while enhancing competitiveness and innovation.  

The  aim  of  the  Directive  is  to  amend  67/548/EEC  in  line  with  the  changes  to  the 
current chemicals management regime introduced by REACH. 

1 
2 
3 

OJ C 96, 21.04.2005, p.24. 
OJ C 112, 30.04.2004, p.92 
OJ C 164, 05.07.2005, p.78. 

2 

 
 
  
 
 
 
                                                 
3. 

COMMISSION COMMENTS 

3.1. 

General comments 

In addressing the Parliament immediately prior to the adoption of the First Reading 
of the REACH Regulation, the Commission stated that the Commission could accept 
totally, in part or in principle 169 amendments out of the 430 amendments proposed 
by Parliament in the first reading4.  

The tight timetable for political agreement meant that the Commission was not in a 
position to formally amend its proposal in the light of the First Reading. Nevertheless 
the Council was informed of the Commission’s position with regard to the European 
Parliament’s  amendments  and  was  asked  to take  the  Parliament’s  amendments  into 
account in the course of its decision5. Several changes were introduced at that stage 
which closely reflects the position of the Parliament. 

The  Council  agreed  unanimously  upon  its  Political  Agreement  on  both  legislative 
instruments on 13 December 2005. This followed intensive negotiations over a two 
year  period  on  a  wide  range  of  issues  related  to  scope,  registration,  especially  the 
question of low volumes, substances in articles, data sharing, evaluation, including a 
stronger  role  for  the  proposed  new  Chemicals  Agency  and  authorisation  and 
restriction of dangerous substances. 

The last, and  most difficult, issue to  be settled at the Council concerned aspects of 
authorisation of substances of high concern and substitution. In the end all Member 
States and the Commission, supported the final compromise proposal that had been 
developed,  having  accepted  it  as  a  fair  balance  between  those  concerned  about  the 
need  to  provide  greater  encouragement  to  the  substitution  of  dangerous  substances 
and those concerned about the impact on competitiveness and investment in Europe. 
Two of the main elements of the compromise were: i) applications for authorisations 
should always include an analysis of possible alternatives by the registrant and ii) for 
substances  of  very  high  concern  for  which  it  is  not  possible  to  determine  safe 
thresholds  with  current  methods,  a  review  of  these  methods  should  be  foreseen 
within  12  months  after  entry  into  force  of  the  regulation  based  on  work  in  the 
REACH implementation projects6.  

The  net  result  is  that  around  90%  of  the  European  Parliament’s  amendments  to 
REACH that the Commission could accept totally, in part or in principle have been 
incorporated in the Common Position, using identical or similar wording. In addition, 
the Political Agreement includes 43 amendments which the Commission did not state 
it could accept. In addition 38, including 7 relating to persistent organic pollutants of 
the  amendments  where  the  Commission  reserved  its  position  have  also  been 
included. 

Central to Parliament’s amendments was a compromise package on registration and 
pre-registration, all aspects of which the Commission said that it could support. Out 
of 47 amendments constituting this package, 37 are included in principle, in part or 

4 
5 
6 

Fiche suite a donner. 
Council Working Document 317/05 
Council Press Release n° 15168/05 of 13 December 2005 

3 

 
 
  
 
                                                 
in full in the Common Position. The Parliament adopted other compromise packages, 
of which 96 amendments are included in the Common Position. 

The Commission welcomes the adoption of the Common Position on 27 June 2006 
which responds to the aims that it has set for an agreement which will be consistent 
with  the  Lisbon  goals  as  regards  the  competitiveness  of  European  industry  and 
encouraging innovation, and which will achieve a marked improvement in health and 
environment to the benefit of Europe’s citizens. It considers that the principal aims of 
its  REACH  proposal7  are  safeguarded  in  the  Common  Position,  and  thus  fully 
supports the Common Position, as indicated to the Council at its special session on 
13 December 2005. 

Accompanying the political agreement on the common position the Commission and 
Member States made a number of important declarations. Reflecting the importance 
of  a  performing  European  Chemicals  Agency  and  the  need  for  it  to  become  fully 
operational before critical REACH procedures come into effect, the Council and the 
Commission made a joint statement on actions that are necessary for setting up the 
Agency (in Annex I). In that context also, the Commission takes the opportunity to 
stress the need for adequate budgetary provision for the increased costs falling on the 
Agency  arising  principally  from  much  increased  powers  and  responsibilities  of  the 
Agency and the decision of the European Council to locate the agency in Helsinki; it 
is recalled that in the initial three years the Agency will have little fee income and 
will  accordingly  need  to  rely  on  EU  subsidies  to  function  effectively.  The 
Commission will provide the relevant financial details to the Budgetary Authority. 

The Commission also made statements on special preparations (including alloys), on 
free  movement  (Article  127(2)  of  the  Regulation),  and  on  Article  56(f)  of  the 
Regulation (in Annex II).  

In addition, Denmark and Sweden made two declarations, jointly with Luxembourg 
on authorisation, and jointly with Germany on Article 2(2) of the Regulation. Poland 
and Ireland made a joint declaration on authorisation Poland made one on the effect 
of REACH on competitiveness and Germany made declarations on the income that 
Member  States  could  derive  from  fees  and on  the need for  a  general  discussion on 
the immunities of European agencies. 

3.2. 

Detailed comments (REACH) 

3.2.1.  Parliamentary amendments accepted by the Commission and incorporated in full, in 

part, or in principle in the common position 

3.2.1.1.  Parliamentary amendments accepted by the Commission in full 

Concerning recitals:  

amendment  4  highlights  the  global  goal  of  using  chemicals  so  that  they  do  not 
damage human health or the environment, and is included in principle in recital 4. 

amendment  8  clarifies  the  purpose  of  authorisation  and  is  included  in  principle  in 
recital 12. 

7 

COM(2003)644 final 

4 

 
 
  
 
                                                 
amendment  10  makes  clear  that  information  on  implementation  should  be  made 
easily  available,  particularly  to  help  SMEs  and  has  been  included  in  principle  in 
recitals 20 and 35. 

amendment  14  clarifies  that  the  Agency,  relying  on  Member  States’  competent 
authorities,  should  ensure  substances  are  evaluated  and  has  been  included  in 
principle in recital 16. 

amendments  16  emphasise  that  the  Agency  should  promote  broad  international 
consensus in the regulation of chemicals and account should be taken of existing and 
emerging international standards and has been included in principle in recitals 6, 43 
and 97. 

amendment 19 aligning the recital on substances in articles with the clearer and more 
focussed  provisions  in  the  operative  text  has  been  included  in  principle  in  recitals, 
the part referring to authorisation applying to SIA has not been included.  

amendment  26  underlines  the  importance  for  industry  of  sharing  information  and 
providing for fair compensation has been included in full as recital 47.  

amendment  39  refers  to  the  establishment  of  a  Community  rolling  action  plan  for 
substance evaluation and has been included in principle in recital 60.  

amendment 40 clarifies that decisions are agreed within the Agency’s Member State 
committee and has been included in full as recital 61.  

amendment 41 highlighting vulnerable populations who are to be taken into account 
when  protecting  human  health  has  been  included in principle in recital  63, the part 
referring  to the not  giving  an  authorisation if a substitute  exists  has  not been taken 
up.  

amendment 50 states that harmonised classification and labelling can be undertaken 
for a wide range of substances and has been included in principle in recital 103.  

amendment  53  affirming  the  applicability  of  the  Aarhus  Convention  as  concerns 
access  of  information  and  has  been  included  in  principle  in  recital  105,  that  part 
about information being available in the MS languages has not been taken up.  

Concerning operative text:  

amendments 63 and 64 are included in principle in the Common Position through its 
provisions  on  reduced  fees  for  Small  and  Medium  Size  Enterprises  (SMEs)  in  all 
cases  (Article  73(3)),  on  national  helpdesks  (Article  123),  and  on  the  Agency 
providing guidance and tools especially to help SMEs (Article 76(3)(c)). 

amendments 74 and 983 on which the Commission reserved its position are included 
in the Common Position by the specification that research and further development 
relate to a substance “on its own, in preparations or in articles”.  

amendment  79  is  included,  thereby  laying  down  the  definition  of  SMEs  as 
recommended in the Commission Communication on this issue. 

5 

 
 
  
 
amendment  81  is  included  in  principle  through  the  reference  in  Article  2(9)  of  the 
Common Position to certain Titles not applying to polymers.  

amendment 117 corrects an editorial mistake in reference to Article 27(8) and is fully 
included in the Common Position. 

amendment  119 which  corrects an editorial mistake in reference to Article 27(8) is 
also fully included in the Common Position. 

amendment  125  which  deletes  paragraph  4  of  article  23  is  included  in  full  in  the 
Common Position. 

amendment  128,  which  deletes  the  limitation  to  vertebrate  animals  is  included  in 
principle in the Common Position. 

amendment 148 is included in full in the Common Position. 

amendment  258  relating  to  the  role  of  the  Agency’s  Member  State  Committee  in 
Evaluation has been partially taken up in the Common Position. 

amendment  291  is  given  effect  to,  as  the  Agency  is  to  be  established  in  Helsinki, 
Finland.  

amendment  317  corrects  a  reference  in  the  Commission  proposal,  and  has  been 
included in full. 

amendment  324,  which  exempts  ores  and  concentrates  from  the  registration 
requirements if they are not chemically modified, is included in full in the Common 
Position. 

amendments  367  allowing  third  parties  to  represent  potential  registrants  in  pre-
registration has been taken up in principle in the Common Position in Article 4. 

amendments  369  rev  fixing  one  pre-registration  deadline  after  18  months  has  been 
taken up in principle in the Common Position in Article 28(2). 

amendment 371, on the publication of a list of substances following pre-registration, 
is included in principle in the Common Position. 

amendment  372  changing  the  definition  of  phase-in  substance  has  been  fully  taken 
up in the Common Position.  

amendment  373  requiring  registration  of  potential  PBTs  and  vPvBs  when  they  are 
manufactured or imported at or above 100 tonnes per year, in the form of substances 
classified as N: R50-53 has been fully taken up in the Common Position. 

amendment  375  limiting  GLP  requirement  to  new  laboratory  tests  involving 
vertebrate  animals  has  been  partially  taken  up  in  the  Common  Position  in  Article 
13(3). 

amendment  376  defining  exposure  scenarios  has  been  taken  up  in  principle  in  the 
Common Position. 

6 

 
 
  
 
amendment 377 defining use and exposure categories has been taken up in principle 
in the Common Position. 

amendment 378, adopted with amendment 160, requiring descriptions of risk and the 
related use and exposure categories, in addition to the relevant exposure scenarios to 
be appended to the SDS, has been taken up in principle in the Common Position in 
article 31(7) through Annex I. 

amendment 380 requiring information on use and exposure categories to be included 
in  the  technical  dossier  has  been  taken  up  in  principle  in  the  Common  Position  in 
Article 10 (a) (iii). 

amendment 381 requiring confirmation that a registrant submitting study summaries 
or robust study summaries, is the owner of the relevant studies, or has permission to 
access them. It has been taken up in principle in the Common Position. 

amendment  382  requiring  joint  submission  of  data  by  multiple  registrants  with  opt 
outs that need to be justified, allowing 3rd party representation, requires the Agency 
to produce guidelines to facilitate the process, and requires a proportionate fee to be 
paid  by  each  registrant  has  been  taken  up  in  principle  in  the  Common  Position  in 
Articles 11, 4, 76(2)(f) and 73. 

amendment  386  making  changes  to  the  PPORD  requirements  has  been  partially 
taken up in the Common Position.  

amendment  387  details  the  reduced  requirements  for  registration  of  non-prioritised 
substances  produced  in  the  1-10  tonne  and  the  increased  requirements  for  the 
substances prioritised in the same category. This amendment has been partially taken 
up in the Common Position. 

amendment 395 specifies where a substance at 1-10 tonnes is likely to be persistent, 
bioaccumulative  and  toxic,  or  very  persistent  and  very  bioaccumulative,  should  be 
subject  to  suitable  further  environmental  testing  if  appropriate  risk  management 
measures are not introduced and recommended. This amendment has been partially 
taken up in the Common Position through Annexes IIIand VII.  

amendments  65/  462rev/  463rev/  464rev/  465rev  are  partially  incorporated  in 
Article 2 of the Common Position which brings together a range of exemptions from 
the Regulation. 

Concerning Annexes 

amendment 327 is taken up in the Common Position in the guidance note to Annex 
IV’s  with  its’  statement  that  “Wherever  practicable,  registrations  should  be 
submitted jointly”.  

amendment  388  setting  out  the  criteria  for  registration  of  1-10  tonne  substances  in 
Annex 1b with a full Annex V set of information has been taken up in principle in 
the Common Position in Annex III. 

amendment  389  requiring  the  Commission  to  adopt  criteria  to  facilitate  the  use  of 
waiving criteria in Annex IX within 18 months has been taken up in principle in the 

7 

 
 
  
 
Common  Position.  Annex  IV  includes  categories  for  information  on  exposure  for 
substances, as proposed in amendment 413. 

Changes  and  refinements  to  the  testing  requirements  in  Annex  V  set  out  in 
amendments 390, 391, 392, 394 and 396 are included in part, principle or in full the 
Common Position. 

In  Annex  VI,  amendments  397,  398,  399,  400,  401,  402,  403,  404,  405,  406,  407, 
408,  409,  410,  411  and  412  are  all  included  in  part,  principle  or  in  full  in  the 
Common Position. 

amendment  322  adds  43  entries  to  Annex  II  (including  several  types  of  plant  oils, 
cellulose pulp, iron, oxygen, industrial gases, turpentine oil, noble gases, natural gas, 
crude  oil  and  coal,  etc.)  and  is  partially  included  -  in  the  Common  Position  in 
Annexes IV and V. 

3.2.1.2.  Parliamentary amendments accepted by the Commission in principle 

Concerning recitals 

amendment  11  that  introduces  a  ‘duty  of  care’  for  manufacturer,  importers  and 
downstream  users  is  integrated  in  principle  and  in  part  in  article  1,  as  amended  to 
state  that  chemical  substances  shall  not  adversely  affect  human  health  or  the 
environment.  

amendment 18 clarifies the duties of the registrant and has been included in part in 
recital 21.  

Concerning operative text  

amendment 59 adopted in conjunction with 419 on which the Commission reserved 
its position, stress that the provisions need to be in line with the international trade 
agreements, in particular within the WTO and it is included in principle in Common 
Position in Recital 3.  

amendment  67  introduces  a  reference,  in  the  definition  of  preparations,  to  metallic 
alloys as special preparations. It is included in the Common Position in principle in 
Annex I paragraph 0.11. 

amendment 68 introducing a definition of alloys has been included in the Common 
Position in full. 

amendment  83  introducing  an  exemption  from  registration  for  recycled  substances 
has been included in principle in the Common Position in Article 2(7)(d). 

amendment 97 deleting the requirement for registrants to indicate if their non-animal 
data can be shared has been taken up in full in the Common Position. 

amendment  108  requires  test  methods  to  be  reviewed  and  improved  and  gave  a 
particular role to ECVAM to inform when an alternative method was validated and 
for them to be added to the list of test methods. This was incorporated in principle in 
the  Common  Position  in  Article  13(2)  where  test  methods  must  be  revised  as 

8 

 
 
  
 
appropriate to refine, reduce or replace animal tests where ECVAM will have a role 
to play. 

amendments  116,  126  and  681  allowing  the  appointment  of  a  3rd  party  as  a 
representative  for  proceedings  under  Article  17  and  title  III  has  been  taken  up  in 
principle in the Common Position in Article 4. 

amendment  123  introduces  a  formal  modification  to  take  into  account  the  new 
provisions  on  the  mandatory  sharing  of  all  data  and  has  been  incorporated  in 
principle in the Common Position. 

amendments  142  and  147  on  the  publication  of  a  list  of  substances  following  pre-
registration,  on  participants  in  a  Substance  Information  Exchange  Forum  (SIEF) 
seeking to agree on the interpretation of information, are included in principle in the 
Common Position. 

amendment  149  deleting  the  references  to  vertebrate  animals  in  Article  28(1)  has 
been fully taken up in the Common Position. 

amendment 159 deleted the requirement for Safety Data Sheets to be supplied in the 
relevant  MS  language  only  on  request  of  a  Downstream  User.  This  has  been  fully 
taken up in Article 31(5) of the Common Position. 

amendment 171 reflected the enhanced role of the Agency in dossier evaluation. This 
has been taken on in principle in the Common Position in that the Agency has been 
given the responsibility for dossier evaluation. 

amendment 172 gives the Agency responsibility for dossier evaluation. This has been 
fully taken on in the Common Position. Amendments 183, 184, 186, 187, 190, 191, 
202 and 742, on which the Commission reserved its position reflecting the changed 
role  of  the  Agency  in  dossier  evaluation  have  also  been  fully  taken  on  in  the 
Common Position. 

amendment  175  reflects  the  changed  role  of  the  Agency  and  that  all  animal  tests 
require testing proposals. The changed role of the Agency has been taken on in the 
Common Position but the second part has not been integrated.  

amendment  193  requiring  the  list  of  substances  for  substance  evaluation  to  be 
publicly available on its website has been fully taken up in the Common Position in 
Article 43(2).  

amendment 205 referring to the action taken by the Agency after an evaluation has 
been partly taken up in the Common Position. 

amendment 211 regarding the Agency selecting one of a number of registrants to do 
a further test is taken on in principle in the Common Position.  

amendment 213 relating to the Agency publishing information on evaluations carried 
out on its website has been fully taken up in the Common Position. 

amendment  215  regarding  an  Annex  containing  candidate  substances  for 
authorisation has been taken up in principle in the Common Position in Article 58(1) 
and (10). 

9 

 
 
  
 
amendment  217  deleting  the  requirement  for  a  substance  of  equivalent  concern  to 
have serious and irreversible effects to humans or the environment has been partially 
taken up in the Common Position. 

amendments  221  and  235  setting  review  periods  not exceeding  5  years  for  all  uses 
has  been  partially  taken  up  in  the  Common  Position  Article  59(8)  that  requires 
reviews periods, set on a case-by-case basis, for all authorisations. 

amendment  235  requiring  authorisations  always  to  be  subject  to  review  and  to 
presentation of substitution plans, and possibly to other conditions: this amendment 
has been partially taken up in the Common Position as analysis of the alternatives is 
made mandatory while substitution plans remain voluntary. 

amendment  259  relating  to  the  role  of  the  Agency’s  secretariat  in  Evaluation  has 
been completely taken up in the Common Position. 

amendment 265 relating to the fee structure being transparent has been taken up in 
the Common position as under Article 73 the fees will be set out in a Commission 
Regulation. 

amendment 270 which allows the Management Board to additionally meet when 1/3 
of its members request has been fully taken up by the Common Position in Article 
80(1). 

amendment  293  expands  the  remit  of  the  Agency  to  develop  contacts  to  include 
animal  protection  organisations  has  been  taken  up  in  principle  in  the  Common 
position. 

amendment 297 requires the MS to submit a report every 5 years, instead of 10 years, 
has been fully taken up in the Common Position. 

amendment 299 deleting the words ‘non-confidential’ from Article 115 and requiring 
the  Agency  to  publish  information  on  its  website  has  been  fully  taken  up  in  the 
Common Position. 

amendment 301 deleting much of the operative procedures in relation to requests for 
further  information  under  Regulation  1049/2001  has  been  partially  taken  up  in  the 
Common Position. 

amendment 306 specifying that the competent Authority shall give advice to SMEs 
how  to  meet  their  obligations  under  REACH  has  been  taken  up  in  principle  in  the 
Common Position Article 123. 

amendment  323  and  476  rev  on  which  the  Commission  had  reserved  its  position, 
deleting  minerals  and  ores  from  requiring  registration,  in  Annex  III,  if  they  are 
dangerous  or  chemically  modified  has  been  partially  taken  up  in  the  Common 
Position. 

3.2.1.3.  Parliamentary amendments accepted by the Commission in principle and in part  

amendment 88 adopted in conjunction with amendment 357, where the Commission 
had reserved its position, on substances in articles, has been taken up in principle and 
in part in the Common Position.  

10 

 
 
  
 
The  same  amendment  adds  also  an  exemption  for  tobacco  ingredients  being 
registered  if  released  from  an  article  and  replaces  the  requirement  to  notify  a 
substance  if  it  was  unintentionally  released  from  an  article  with  one  requiring 
notification of substances of very high concern to the Agency. The latter part was in 
principle  taken  up  in  the  Common  Position  in  Articles  7(2)  and  (3)  while  the  first 
part has not been accepted 

amendment  89  adding  3rd  country  preparation  and  article  manufacturers  to  those 
allowed  to  appoint  an  only  representative  was  fully  taken  up  in  the  Common 
Position. 

amendment 104 requiring the agency to set a deadline for submission of information 
required when a substance reaches the next tonnage threshold has been taken up in 
principle in the Common Position.  

amendment  131  adopted  together  with  amendment  384  deletes  the  provisions  in 
art.24(5) and it is partially taken on in the Common Position. 

amendment 132 allowing a 3rd party representative to be appointed for the purposes 
of pre-registration has been taken up in principle in the Common Position in Article 
4. 

amendment  157  requiring Safety Data Sheets (SDS) for  PBTs and vPvBs has been 
fully  taken  up  in  the  Common  Position,  Article  31(1)(b)  and  (3)(b),  as  was  the 
change ensuring SDS were free of charge, also covered in Amendments 158 and 161, 
in  Article  31(8).  The  part  relating  to  SDS  for  CMRs  was  already  covered  in  the 
Commission  proposal.  The  part  relating  to  SDS  for  substances  identified  as  of 
‘equivalent  concern,  was  not  taken  up  by  the  Common  Position,  however  an  SDS 
may be needed in any case if the hazard is classifiable. 

amendment 158 that requires the SDS should be free of charge has been fully taken 
up in the Common Position. 

amendment  161,  adopted  with  amendment  710,  regarding  the  change  to  conditions 
when  a  SDS  needs  to  be  updated  has  been  partially  taken  up  in  the  Common 
Position. 

amendment 163 adding distributors to those who should transmit information down 
the supply chain, for substances not requiring a SDS, ensuring the information was 
free of charge, and changing to conditions when such information was required has 
been partially taken up in the Common Position. 

amendment  180  requires  a  deadline  to  be  set,  not  exceeding  6  months,  for 
information requested under compliance checking and the registration number to be 
withdrawn if this was not complied with. The part relating to a deadline being set has 
been taken up in principle in the Common Position in Article 40(4), while the second 
part has not been incorporated. 

amendment  181  requires  the  Agency  to  establish  an  annual  plan  for  dossier 
registration ensuring at least 5% of dossiers to be examined. The part relating to 5% 
of  dossiers  being  examined  has  been  taken  up  in  the  Common  Position  in  Article 
40(5). 

11 

 
 
  
 
amendment 185 that changes MS to Agency in Article 42(2) has been fully taken up 
in the Common Position.  

amendment  192  and  amendment  420,  where  the  Commission  reserved  its  position, 
adds a requirement for prioritisation under substance evaluation should also be on a 
risk  assessment  scheme  based  on  the  dose-effect  relationship  and  deletes  the 
requirement for MS to use the criteria in their national rolling plans. The first part of 
the amendment has not been included, while the latter part has been taken up in the 
Common Position as part of the general strengthening of the Agency’s role. 

amendment  195  and  amendment  739,  where  the  Commission  reserved  its  position, 
requires the Agency to establish a Community rolling plan on the basis of the Article 
43a  criteria  and  the  Agency  to  submit  the  plan  to  the  MS.  The  MS  may  provide 
comments on the plan or suggest other substances for the plan. The Agency will be 
responsible  for  the  evaluations  using  national  bodies  designated  by  the  MS.  The 
Agency  being  responsible  for  substance  evaluation,  drawing  up  the  rolling  plan, 
submitting  it  to  the  MS,  the  MS  commenting  and  suggesting  other  substances  has 
been fully taken up in the Common Position in Article 43 and 44. 

amendment  196  making  changes  related  to  the  Community  rolling  plan  and  the 
Agency’s responsibility, the amendment has been partially taken up in the Common 
Position. 

amendment 197 making changes related to the Community rolling plan regarding to 
MS comments on the Agency’s draft, this amendment has been taken up in principle 
in the Common Position in Article 43(2). 

amendment 199 making changes to when the Agency publishes the definitive rolling 
plan on its website due to the changed responsibilities has been fully taken up in the 
Common Position in Article 43(2). 

amendment 201 allowing MS to notify the Agency of substances where they have a 
suspicion  of  a  health  or  environmental  risk  and  for  the  Agency  to  add  them  to  the 
plan  if  justified  has  been  taken  up  in  principle  in  the  Common  Position  in  Article 
44(5). 

amendment  203  referring  to  national  bodies,  which  the  Commission  accepted  in 
principle, has been partly taken up in the Common Position in article 44(1). 

amendment  207,  208,  209  regarding  changes  to  the  agreement  procedure  to  reflect 
the  responsibilities  of  the  Agency  in  evaluation  have  been  fully  taken  on  in  the 
Common Position. 

amendment 236 and 359 on which the Commission had reserved its position, which 
makes consequential changes to amendment 235, has been partially taken up in the 
Common Position. 

amendment  285  makes  changes  to  increase  the  independence  of  the  Agency 
Committee  members  and  it  is  taken  up  in  part  and  in  principle  in  the  Common 
Position in Articles 84 and 85. 

12 

 
 
  
 
amendment 294 states that the Agency’s internal rules of procedure and documents 
related to the Authorisation process shall be publish on the Internet and is taken up in 
part and in principle in Article 63. 

amendment  320  adds  the  term  vulnerable  populations  and  a  number  of  additional 
factors to be taken into account when determining the DNEL to para 1.4.1 of Annex 
I. The first part has been taken up in the Common Position. 

3.2.2.  Amendments  accepted  in  full,  in  principle  or  in  part  by  the  Commission,  but  not 

incorporated in the common position 

Concerning recitals:  

The Commission said that it could accept amendments 34 and 36 in principle, which 
are not included in the Common Position. 

Concerning operative text:  

amendment  60  limits  the  producers,  importers  and  downstream  users  responsibility 
to  under  normal  or  foreseeable  conditions  could  be  accepted  in  principle  by  the 
Commission. 

The  Commission  said  that  amendment  76,  which  specifies  that  “unsupported  uses” 
of  downstream  users  need  to  be  justified  by  suppliers  on  the  basis  of  scientifically 
based arguments against the safety of the use, would be acceptable in principle and 
part. However, the Commission considers that it would be preferable to use the term 
“used advised against” which is already used in the SDS  and  in Annex  VI,  section 
3.7. 

The Commission said that it could accept in principle amendments 78 ,105 and 611, 
on  which  the  Commission  reserved  its  position,  which  introduce  the  idea  that 
tonnage calculation (except for new substances and when stated otherwise) should be 
the  average  of  the  three  preceding  calendar  years  during  which  the  substance  has 
actually been produced by the manufacturer. This amendment is not included in the 
Common Position. 

Amendment  139  provides  for  a  “list  of  uses  …  [intended  to  be  supported]  through 
registration”  to  be  published  by  the  Agency  following  pre-registration.  The 
Commission said that it could accept in principle this amendment provided that such 
information  will  only  be  preliminary  and  the  suppliers  will  be  able  to  make  their 
choice at the moment they register, but it is not included in the Common Position. 

Amendment  140  is  intended  to  avoid  the  repetition  of  animal  testing,  by  ensuring 
that  information  derived  from  animal  experiments  is  forwarded  promptly  to  the 
Agency. The Commission said that it could accept this amendment in principle. 

Amendment  176  requires  an  open  consultation  period  of  90  days  for  all  testing 
proposals.  The  Commission  said  that  it  could  accept  this  amendment  in  principle 
provided  that  the  consultation  is  limited  to  comments  on  availability  of  data  that 
renders  animal  testing  unnecessary  and  the  timeframe  is  appropriate,  on  that 
substance or on closely-related substances.  

13 

 
 
  
 
Amendment  198  deletes  the  procedure  for  when  2  or  more  MS  have  included 
substances in their draft rolling plans. The Commission said that it could accept this 
amendment in part and in principle. 

The Commission said it could accept in part and in principle amendment 200 which 
deletes  the  requirement  for  Competent  Authorities  to  evaluate  substances  on  their 
plans.  

The Commission said that it could accept amendment 273 in full which requires the 
Executive  Director  to  establish  and  maintain  contact  with  the  European  Parliament 
and  ensuring  that  a  regular  dialogue  is  held  with  that  body’s  relevant  committees. 
This amendment is not included in the Common Position.  

The  Commission  said  that  it  could  accept  in  principle  amendments  277  and  278 
which  reinforce  the  role  of  the  European  Parliament  in  the  Executive  Director 
selection process. These amendments are not included in the Common Position. 

The Commission said that it could accept amendment 276 in full which foresees that, 
once the general report and the programmes have been adopted by the Management 
Board,  the  Executive  Director  shall  forward  them  to  the  European  Parliament,  the 
Council,  the  Commission  and  the  Member  States,  and  shall  arrange  for  them  to  be 
published. This amendment is not included in the Common Position. 

The  Commission  said  that  it  could  accept  amendment 292  in  full  which  lays  down 
that the staff of the Agency shall be subject to the Staff Regulations of Officials of the 
European  Communities  and  the  Conditions  of  employment  of  other  servants  of  the 
European Communities laid down by Council Regulation (EEC, Euratom, ECSC) No 
259/68,  as  last  amended  by  Council  Regulation  (EC,  Euratom)  No  723/2004.  This 
amendment is not included in the Common Position. 

The Commission said that it could accept in full the following amendments: 

amendment  368  requires  during  pre-registration,  information  on  identified  uses,  at 
least  relevant  use  and  exposure  categories  has  not  been  taken  up  in  the  Common 
Position. 

amendment 370 allowing pre-registrants who do not pre-register within 18 months to 
still rely on the phase-in deadlines if they make use the extra 6 months as set out in 
amendment 369/rev has not been taken up in the Common Position. 

amendment 374 requiring registration of potential PBTs and vPvBs manufactured or 
imported at or above 1 tonne per year, in the form of substances classified as N: R50-
53 has not been taken up in the Common Position. 

amendment  379  requires  sharing  of  animal  and  non-animal  data  with  opt  outs  that 
can  be  assessed  by  the  Agency  if  requested  has  not  been  taken  up  in  the  Common 
Position. 

The Commission said that it could accept amendment 383 extending data protection 
to 15 years and accept in principle Parliament’s amendment 130 which refers to 10 
years  data  protection.  Council  decided  to  maintain  10  years  data  protection,  as 
proposed by the Commission. 

14 

 
 
  
 
amendment  385  extending  the  time  for  when  previous  registrants  have  to  be  asked 
for sharing of data from 10 to 15 years in Art. 25, para 1 has not been taken up in the 
Common Position. 

amendment  393  specifies  that  substances  which  are  likely  to  be  carcinogens  and 
mutagens should be subject to suitable further mutagenicity testing. This testing need 
not  be  done  if  appropriate  risk  management  measures  are  introduced  and 
recommended. This amendment is not included in the Common Position. 

Amendment 399 introducing the alternative of undertaking an in vitro micronucleus 
study  in  place  of  an  in  vitro  cytogenicity  study  was  not  included  in  the  Common 
Position.  

The Commission said that it could accept amendments, 121, 186, 204, 220, 248, 286 
and 300 in principle, which are not included in the Common Position. 

The Commission said that it could accept amendments 194, 290 and in principle and 
in part, which are not included in the Common Position. 

3.2.3.  Parliamentary amendments not accepted by the Commission or where it reserved its 

position. 

3.2.3.1.  Parliamentary amendments not accepted by the Commission and incorporated in the 

Common Position. 

Concerning recitals 

amendment  3 adds to the goal of REACH the safeguard of the  innovation capacity 
and competitiveness and states the need of implementing REACH in line with WTO 
rules. It is included in principle in Recital 3. 

amendment  7  clarifies  that  one  of  the  reasons  for  REACH  was  a  failure  to  protect 
public health and the environment and has been included in principle in recital 9. 

amendment 22 states that SMEs should be assisted to comply with REACH and has 
been included in principle in recital 35. 

amendment  44  calls  the  Agency  to  play  a  pivotal  role  in  coordinating  the 
communication around REACH has been included in principle in recital 84. 

Concerning operative text 

amendment 69 that changes the polymer definition has been taken up in principle in 
the Common Position. 

amendment 99 allowing the registrant to request that certain parts of his dossier were 
kept confidential has been taken up in principle in the Common Position in Articles 
9(a)(xi), 76(2)(d) and 118(2). 

amendments  134,  adopted  together  with  358,  and  136  provide  cost  sharing  criteria 
for  non  phase-in  substances  and  has  been  taken  up  in  part  and  in  principle  in  the 
Common Position which bases cost sharing also on fairness. 

15 

 
 
  
 
amendment  137  deleting  Article  26(1)(d)  has  been  fully  taken  up  in  the  Common 
Position. 

amendment 151 requiring that a potential registrant is prevented from registering if 
they fail to make available a study they have, has been taken up in principle in the 
Common Position. 

amendment 153 that requires if the owner of a study fails to make it available to the 
Agency  they  will  not  be  able  to  register  has  been  included  in  principle  in  Article 
30(3). 

amendment 154 deleting ‘on vertebrate animals’ in Article 28(2) has been fully taken 
up in the Common Position. 

amendment  162  requires  the  Commission  to  develop  guidelines  setting  minimum 
requirements for SDS and has been incorporated in principle in article 76(2)(f). 

amendment  164  allowing  information  required  by  Article  30  to  be  communicated 
electronically as well as in writing has been fully taken up in the Common Position. 

amendments  166  and  amendment  366,  on  which  the  Commission  reserved  its 
position,  requiring  information  on  Substances  in  Articles  have  been  taken  up  in 
principle in the Common Position in Article 32(4). 

amendment  178  and  amendment  729,  on  which  the  Commission  reserved  its 
position,  replacing  the  reference  to  ‘Competent  Authority’  with  ‘Agency’  in  the 
introduction of article 39(2) has been taken up in part the Common Position. 

amendment 174 states that all communications between registrants and Agency shall 
be  possible  in  any  language  chosen  by  the  applicant  and  has  been  taken  up  in 
principle in the Common Position in article 103. 

amendment  179  and  amendment  730,  on  which  the  Commission  reserved  its 
position,  replacing  the  references  to  ‘Competent  Authority’  with  ‘Agency’  and 
requiring the Agency to make any draft decision within 12 months of the substance 
being  put  on  the  annual  evaluation  plan  consisting  of  at  least  5%  of  the  dossiers 
received has been taken up in principle in the Common Position in Articles 40(3) and 
40(5). 

amendment 182 requiring the Agency to annually report on the evaluation of dossiers 
including  recommendations  for  future  registrants  has  been  taken  up  in  principle  in 
the Common Position in Article 52. 

amendment  189  setting  a  deadline  of  2  years  for  fulfilling  information  requests 
related  to  the  examination  of  testing  proposals  has  been  partially  taken  up  in  the 
Common Position in Article 39(2). 

amendment  206  makes  changes  MS  to  Agency,  with  some  consequent  changes,  in 
Article 49(1) and makes changes related to the use of national bodies in Evaluation. 
The first part has been incorporated in the Common Position. 

amendment  214  amending  the  aim  of  authorisation  so  that  substances  of  very  high 
concern  are  eventually  replaced  by  substitutes  and  to  ensure  that  if  no  substitute 

16 

 
 
  
 
exists  and  the  socio-economic  benefits  outweigh  the  risks  then  the  substance  is 
controlled, has been partially taken up in the Common Position in Article 54. 

amendment 216 clarifies that substances in Annex XIIIa have to be included without 
prejudice for existing and future restrictions and it has been taken up in part and in 
principle in the Common Position in Article 57. 

amendments  219  and  223  introduce  technical  changes  reflecting  the  concept  of 
having two separate Annexes under the Authorisation regime. They have been taken 
up in principle in the Common position in Article 58. 

amendment 226 allows restrictions on authorised substances in case of new scientific 
information  presented  to  the  agency  and  has  been  taken  up  in  principle  in  the 
Common Position in Articles 57(5) and 57(6). 

amendment 227 that deletes (d), (e) and (f) from the title of Article 56 has been fully 
taken up in the Common Position. 

amendment 229 modifies the procedure to include substances in Annex XIII(b) and 
gives  to  the  Commission  the  authority  to  take  a  decision  in  the  cases  where  the 
Member State Committee cannot reach the qualified majority. This amendment has 
been taken up in principle and in part in the Common Position. 

amendment  237  modifies  the  procedure  of  Authorisations  review  to  reflect  the 
changes  introduces  in  article  57  and  it  has  been  partially  taken  up  in  the  Common 
Position. 

amendments 241 requiring a Socio-Economic Analysis and an analysis of substitutes 
should always form part of the application for authorisation has been partially taken 
up in the Common Position in Article 61(4)(e). 

amendment 242 modifies the provisions on subsequent applications for authorisation 
to reflect the changes introduces in article 59 and has been taken up in principle in 
the Common Position. 

amendment  243  allowing  the  Socio-Economic  Committee  to  ask  for  an  analysis  of 
substitutes has been taken up in principle in the Common Position in Article 63(3). 

amendment 247 adopted with amendment 985 changes the 1 tonne limit for PPORD 
to the amount necessary for PPORD and it is taken up in part and in principle in the 
Common Position. 

amendments 260 adopted with 261 and 796 and 263 introduce a number of editorial 
and positional changes to the description of the Agency’s tasks and they are taken up 
in principle in the Common Position. 

amendment 266 that requires  a  multi-annual  plan  for  substance  evaluation  has  been 
taken up in principle in the Common Position in Art 77 and the requirements for the 
Management Board to draw up a multi-annual plan for the Agency's work. 

amendment  304  clarifies  that  the  confidentiality  of  information  about  the  link 
between  manufacturer  and  downstream  user  covers  both  directions  of  the  supply 
chain and all actors involved and has been taken up in the Common Position. 

17 

 
 
  
 
amendment  305  requires  the  Agency  to  draw  up  guidelines  on  how  to  inform  the 
general public about risks arising from substances and is taken up in principle in the 
Common Position in article 122. 

amendment  307,  adopted  with  amendment  816,  requires  the  Agency  to  draw  up 
guidelines on how Member states shall maintain a system of official controls and has 
been taken up in part and in principle in the Common Position in article 76(4). 

amendment 309 allowing Member States to maintain or introduce stricter measures 
for the purposes of worker protection has been taken up in principle in the Common 
Position in Article 127(2). 

The Commission fully supports these changes in the Common Position. 

3.2.3.2.  Parliamentary amendments not accepted by the Commission and not incorporated in 

the Common Position. 

The Commission did not accept amendments 1, 2, 5, 6, 9, 12, 13, 15, 17, 23, 24, 25, 
27, 28, 29, 30, 31, 32, 33, 35, 37, 38, 42, 43, 45, 46, 47, 51, 52, 54, 55, 56, 57, 58, 66, 
70, 71, 75, 77, 80, 82, 90, 96, 106, 109, 110, 112, 113, 114, 118, 129, 135, 138, 143, 
150, 155, 156, 168, 169, 170, 173, 177, 212, 218, 222, 224, 225, 228, 230, 231, 232, 
233, 234, 238, 239, 240, 244, 245, 246, 251, 252, 253, 254, 255, 256, 257, 262, 264, 
267, 269, 271, 272, 275, 279, 280, 281, 282, 283, 284, 287, 288, 289, 295, 296, 298, 
311, 312, 313, 314, 315, 316, 318, 319, 320, 321, 328, 329, 337 and 351 and these 
amendments are not included in the Common Position. 

3.2.3.3.  Parliamentary  amendments  on  which  the  Commission  reserved  its  position  and  are 

incorporated in the Common Position. 

Concerning recitals 

amendment 417 clarifies that REACH should align with SAICM, OECD and ICCA 
initiatives to reduce costs and has been included in part in recitals 6 and 97. 

amendment 363 calls Member States to adopt special assistance to SMEs regarding 
conducting texts and it is included in principle in Recital 8. 

Concerning operative text 

amendment  362  which  requires  Member  states  to  take  measures  to  support 
enterprises for the implementation of the Regulation is taken up in principle in article 
123 of the Common Position.  

amendment 418 which requires the Agency to promote the international acceptability 
of the REACH standards and take full account of existing standards established by 
other  international  institutions  is  taken  up  in  principle  in  the  Common  Position  in 
Recital 97. 

The  first  part  of  amendment  436  which  states  the  possibility  to  introduce  ‘use  and 
exposure categories’ in the preparation of exposure assessment has been taken up in 
the Common Position while the second part, which extends the 1 tonne threshold to 
manufacture’s or importer’s identified uses is not included. 

18 

 
 
  
 
amendment 466 rev and 467 rev that make changes to the position of exemptions in 
the text has been taken up in part and in principle in the Common Position in Articles 
2(5) and (7).  

amendment  468  rev that adds an exemption  from Registration has  been  fully  taken 
up in the Common Position. 

amendment  470  rev  that  deletes  the  reference  to  the  exemption  of  waste  from  the 
authorisation title is taken up in the Common position. 

the  first  part  of  amendment  471  rev  that  moves  the  exemptions  from  the 
authorisation  title  to  the  scope  title  is  taken  up  in  the  Common  position  while  the 
second part is not integrated. 

amendment  469  rev  deleting  Article  8  on  biocides  and  plant  protection  products 
being  considered  as  registered  has  been  partially  taken  up  in  the  Common 
Position.amendments 566, 567, 568, 571, 572 and 573 and 574 which maintain the 
relevant  Community  provisions  on  persistent  organic  pollutants  together  under 
Regulation  (EC)  850/2004/EC 
the  Stockholm  Convention  on 
implementing 
persistent organic pollutants have been fully taken up in the Common position. 

amendment 569 that deletes  Art  64(2)  has  been  fully  incorporated  in  the  Common 
Position. 

amendment  570  states  that  the  restriction  procedures  apply  without  prejudice  of 
Regulation (EC) 850/2004/EC and it has been taken up in principle in the Common 
Position in Article 2(2).  

amendment 719 providing that downstream users may submit information directly to 
the Agency to assist in the preparation of a registration has been taken up in principle 
in article 28(6) of the Common Position. 

amendment 733 replacing the references to ‘Competent Authority’ with ‘Agency’ in 
Article 42(3) has been fully taken up in the Common Position. 

amendment  734,  adopted  with  amendment  188,  requiring  the  list  of  registration 
dossiers  evaluated  for  testing  proposals  or  checked  for  compliance  is  to  be  made 
available to the MS has been fully taken up in the Common Position in Articles 40(2) 
and 41(4). 

amendments 744, 745 and 746 replacing the references to Competent Authority with 
Agency, and introducing the concept of ‘definitively’ ceased, in Article 48 have been 
partially taken up in the Common Position. 

amendment  789  requires  the  Agency  to  post  immediately  on  its  website  that  a 
Member  State  or  the  Commission  intend  to  instigate  a  restriction  process  and  to 
inform the registrant of the relevant substance. This amendment has been fully taken 
up in the Common Position. 

amendment 801, adopted with amendment 274, gives to the Executive Director the 
responsibility to conclude contracts with the National Institutes and to adopt the draft 
and definitive rolling plans of evaluation of substances. This is taken up in part and 
in principle in the Common Position in article 43. 

19 

 
 
  
 
amendment 814 that deletes  Article  116(2)(c)  has  been  fully  taken  up  in  the 
Common Position which however, by introducing a new provision in article 117(2), 
emphasises the confidential nature of precise tonnage.  

Amendment 822 that states that until the Agency Executive Director will assume his 
duties, the Commission on behalf of the Agency, and using the budget provided for 
the latter, may appoint personnel and conclude contracts it taken up in article 133(2) 
of the Common position. 

Concerning Annexes 

amendment  475  rev  which  adds  an  exemption  from  registration  for  cellulose  pulp, 
oxygen, neon, helium and xenon, amongst other changes, has been partially taken up 
in the Common Position in Annexes IV and V. 

amendments  477rev,  478rev  and  660  which  exempt  several  substances  from  the 
Registration provisions are partially taken up in the Common Position in Annex V. 

amendment  865  that  states  in  Annex  XI  that  Chemical  Safety  Assessments 
performed  by  downstream  users  shall  be  done  for  his  own  uses  and  only  for  those 
identified  uses  in  quantities  of  1  tonne  or  more  per  year is  taken  up  in  principle  in 
article 36 of the Common Position. 

The  Commission  supports  these  changes  in  the  Common  Position  and  the  relevant 
amendments. 

3.2.3.4.  Parliamentary  amendments  on  which  the  Commission  reserved  its  position  and 

which are not incorporated in the Common Position. 

The Commission reserved its position on amendments 416, 424, 361, 364, 479 rev, 
352, 433, 434, 435, 673, 676, 584, 593, 594, 595, 596, 575 rev, 600, 549, 615, 422, 
960, 365, 726, 795, 360, 1037, 472 rev, 473 rev, 808, 817, 818, 474 rev, 823, 831, 
965, 966 and 743/1 and these amendments are not included in the Common Position. 

The Commission rejects these amendments. 

3.2.4.  Additional changes made by the Council to the amended Proposal (REACH) 

Article  10  was  amended  to  introduce  a  requirement  for  the  registrant  to  indicate 
which  information  has  been  reviewed  by  an  assessor  for  purposes  of  Quality 
Assessment. 

Article 40 was changed to allow the submission of information by any third party on 
substances  appearing  on  the  list  of  substances  that  were  pre-registered  so  that  the 
Agency  can  take  this  into  account  in  particular  when  they  select  dossiers  for 
compliance checking. 

Article  59  was  amended  to  clarify  that  excluded  substances  meeting  the  criteria  in 
Article 56 (a), (b), (c) and (f) for which it is not possible to determine a threshold in 
accordance with Annex I, section 6.4 and substances meeting the criteria in Article 
56 (d) and (e) from the possibility to grant authorisations on the basis of ‘adequate 
control’. 

20 

 
 
  
 
Article  117  was  changed  to  better  reflect  the  operation  of  Regulation  (EC)  No. 
1049/2001  and  to  require  the  Management  Board  of  the  Agency  to  adopt  practical 
arrangements  for  implementing  it.  The  previous  list  of  always  confidential 
information was moved to Article 117 and it was clarified, to be more in line with the 
Aarhus  Convention,  that  these  would  normally  be  deemed  to  undermine  the 
protection of the commercial interests of the concerned person. 

Article  118  was  split  into  information  that  was  published  on  the  internet  and  those 
items  (degree  of  purity,  tonnage  band  in  which  the  substance  has  been  registered, 
study  summaries  and  robust  study  summaries)  where  registrants  would  be  able  to 
indicate  they  were  confidential  and  provide  a  justification  that  the  Agency  would 
assess.  

Article  123  was  amended  to  require  submission  of  information  by  competent 
authorities  on  substances  registered  in  accordance  with  Article  11(1)  where  the 
dossiers  do  not  contain  the  full  information  referred  to  in  Annex  V,  in  particular 
where monitoring and enforcement activities have identified a suspicion of risk. 

Article 137 was amended to include Annex I in the list of Annexes to be reviewed by 
the Commission within 12 months after the entry into force of the Regulation, with a 
view  to  proposing  amendments  to  establish  levels  for  adequate  control  of  non-
threshold carcinogenic and mutagenic substances. 

Annexes I and XV were amended to improved clarity, consistency and workability. 

The Commission supported these changes. 

3.3. 

Detailed comments (Directive) 

3.3.1.  Parliamentary amendments not accepted by the Commission or where it reserved its 

position. 

The Commission did not accept amendments 1, 2, 3, 4 and these amendments are not 
included in the Common Position. 

3.3.2.  Additional changes made by the Council to the amended Proposal (REACH) 

Article 3 was amended to align the repeal of the relevant articles of 67/548/EEC with 
the transitional arrangements in Title XIV of REACH.  

4. 

CONCLUSION 

In  its  assessment  of  Parliament’s  First  Reading  and  of  the  Council’s  Common 
Position  on  REACH,  the  Commission  has  taken  into  account  the  substantial 
convergence  of  the  positions  of  both  institutions  of  the  decision  making  process 
regarding the main elements. In addition, there is the need to bring to a close a very 
difficult  debate  on  REACH  on  which  the  Commission  considers  that  a  suitable 
balance has been found.  

This equilibrium covers especially what have been without doubt the most difficult 
and  the  most  critical  areas  of  REACH,  namely,  registration  and  authorisation  by, 
respectively, reducing the economic impact of registration of low volume substances 

21 

 
 
  
 
and by increasing the role of substitution in authorisation. The Commission believes 
that  Council  has  found  the  right  balance  in  these  two  areas  which  should  not  be 
disturbed. 

On  other  important  aspects  such  as  scope,  the  Council  has  addressed  Parliament’s 
concerns by providing for improved exemptions from registration, and by requiring a 
review of the annexes governing such exemptions within 12 months of the entry into 
force  of  the  regulation.  On  evaluation,  the  Council  has  taken  a  similar  line  to  the 
Parliament  by  significantly  increasing  the  role  of  the  Agency.  The  Commission 
believes  that  the  Council’s  approach  to  access  to  information  and  confidentiality  is 
also consistent with the intentions of Parliament and strikes the right balance.  

In  its  assessment  of  the  Common  Position  on  the  Directive,  the  Commission  has 
taken into account that it rejected the European Parliament amendments to it and the 
changes  made  to  align  the  transitional  arrangements  to  that  in  REACH.  The 
Commission fully supports the Common Position on the REACH regulation which it 
believes  is  a  reasonable  basis  for  achieving  agreement  on  this  key  piece  of 
legislation. The Commission calls upon Parliament and Council to facilitate an early 
adoption of the Regulation and the Directive such as will allow the Member States, 
the  Commission  and  the  enterprises  concerned  to  focus  their  efforts  on  the  very 
substantial challenges of preparation and implementation of the requirements. 

22 

 
 
  
 
ANNEX I 

Joint Council and Commission statement on the Agency 

“The  Council  and  the  Commission  note  the  key  role  of  the  European  Chemicals  Agency  in 
the implementation of the forthcoming REACH Regulation. They also acknowledge that the 
Agency needs to be operational before the application of the central REACH procedures, such 
as registration and authorisation, can be started. 

The  Council  welcomes  the  preparatory  work  by  the  Commission  in  supporting  the 
establishment  of  the  Agency.  It  acknowledges  the  wish  of  the  Commission  to  have 
commitment of the Member States to undertake the actions that are necessary for setting up of 
the Agency and enabling it to be operational within 12 months from the entry into force of 
REACH. 

The Commission has informed the Member States that the above timeframe is only possible if 
Council, Member States and the Commission undertake the following action: 

identify  the  members  of  the  Management  Board  as  soon  as  the  composition  of  the 

a. 
Management Board is politically agreed between the co-legislators; 

b. 
communicate  the  names  of  the  future  Management  Board  members  after  the  final 
decision on REACH but before entry into force and provide official nominations immediately 
after entry into force of REACH;  

ensure that the nominees agree that a series of (4) meetings of the Management Board 

c. 
can take place in the first 3 months after entry into force; 

agree  that  the  Management  Board  should  nominate  the  Executive  Director  and  the 

d. 
Accounting Officer within these 3 months; 

e. 
communicate to the Commission the names of the future members of the Committee 
established  under  Article  130  of  REACH  after  the  final  decision  on  REACH  and  provide 
official nominations at the entry into force of REACH; 

identify  at  an  early  stage  the  candidates  for  the  Member  State  Committee,  Risk 

f. 
Assessment Committee, Socio-economic Assessment Committee and the Forum. 

On  its  own  part  the  Commission  will  make  the  outmost  efforts  to  carry  out  the  following 
activities as soon as possible: 

a. 

nominate an interim Director, with exclusively administrative functions; 

b. 
publish  the  vacancy  notices  and  prepare  the  shortlist  of  candidates  for  Executive 
Director  and  Accounting  Officer  during  the  6  months  period  between  the  final  decision  on 
REACH and EIF; 

c. 
publish  the  vacancy  notices  and  prepare  the  shortlist  of  candidates  for  the  Board  of 
Appeal within 6 months after the decision on the requirements by the Comitology Committee; 

d. 
pre-select candidates for temporary agents of the Agency, as an interim Director can 
then organize the selection in order to establish reserve lists of candidates; the lists should be 
available 6 months after entry into force; 

23 

 
 
  
 
e. 

make available staff for at least 10 selection panels; 

f. 
recruit  and  train  interim  staff,  including  seconded  officials  and  contract  agents  hired 
in 2006,  to  serve  as  a  start-up  team  and  as  a  secretariat  for  the  Management  Board  and  to 
execute necessary other functions of the Agency during the implementation phase; 

ensure  preparation  of  implementing  legislation  necessary  for  the  operation  of  the 

g. 
Agency regarding fees and qualifications of the members of the Board of Appeal 

h. 
ensure  preparation  of  draft  implementing  rules  and  procedures  for  the  Agency, 
concerning  staff,  finance,  fees,  Board  of  Appeal,  internal  functioning,  etc  before  these  are 
handed over to the Agency during the implementation phase; 

i. 

ensure availability of infrastructure, including IT systems, and software 

after  the  final  decision  on  the  Regulation,  ensure  that  necessary  adaptations  will  be 

j. 
made to the IT-systems and to the draft technical guidance documents. 

Therefore,  the  Council  and  the  Commission  affirm  their  commitment  to  take  the  above 
actions, respective to their roles and responsibilities, for ensuring the timely setting up of the 
Agency.” 

24 

 
 
  
 
ANNEX II 

Commission Statement on special preparations (including alloys) 

"The  Commission,  in  close  cooperation  with  industry,  Member  States  and  other  relevant 
stakeholders,  will  develop  guidance  to  fulfil  the  requirements  under  REACH  related  to 
preparations (in particular with regard to safety data sheets incorporating exposure scenarios) 
including  assessment  of  substances  incorporated  into  special  preparations  –  such  as  metals 
incorporated  in  alloys.  In  doing  so,  the  Commission  will  take  full  account  of  the  work  that 
will  have  been  carried  out  within  the  framework  of  the  REACH  implementation  projects 
(RIPs) and will include the necessary guidance on this matter in the overall REACH guidance 
package. This guidance should be available before the entry into operation of the regulation." 

Commission Statement on free movement (Article 125(2)) 

"The Regulation harmonises completely the conditions of manufacture, placing on the market 
and use of the substances which it covers in terms of the points for which it provides. With 
regard  to  those  points,  the  lawfulness  of  the  manufacture,  placing  on  the  market  and  use  of 
substances  will  have  to  be  assessed  solely  in  the  light  of  the  criteria  laid  down  by  the 
Regulation. Consequently, national authorities will in future be able to restrict or impede such 
operations only: 

• 

through measures adopted within the framework of Article 95(4) to (6); 

through  measures  adopted  within  the  framework  laid  down  in  Article  126  of  the 

• 
Regulation." 

Commission statement on Article 54(f) 

"The  Commission,  in  close  cooperation  with  industry,  Member  States  and  other  relevant 
stakeholders, will develop guidance to clarify how Article 54(f), which relates to substances 
of equivalent concern to those listed in Article 54(a) to (e), is to be implemented. In doing so, 
the Commission will take full account of the work that will have been carried out within the 
framework of the REACH implementation projects (RIPs)." 

25