COMMISSION STAFF WORKING DOCUMENT General Report on REACH
Date: 2013-02-05
Institutions: European Commission
Subjects: animal experimentation, chemical product, dangerous substance, disclosure of information, environmental protection, exchange of information, innovation, market approval, product safety, single market

EUROPEAN 
COMMISSION 

Brussels, 5.2.2013  
SWD(2013) 25 final 

COMMISSION STAFF WORKING DOCUMENT 

General Report on REACH 

Accompanying the document 

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE 
COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE 
COMMITTEE OF THE REGIONS 

in accordance with Article 117(4) REACH and Article 46(2) CLP, and a review of 
certain elements of REACH in line with Articles 75(2), 138(3) and 138(6) of REACH 

{COM(2013) 49 final} 

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TABLE OF CONTENTS 

PART I .  OPERATION OF REACH................................................................................. 3 

1.  GENERAL ISSUES.................................................................................................... 3 
1.1.  Scope and application ....................................................................................... 3 
1.2.  Definitions....................................................................................................... 17 

2.  REGISTRATION ..................................................................................................... 23 

3.  DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING ............ 33 
3.1.  Data sharing .................................................................................................... 33 
3.2.  Avoidance of unnecessary testing................................................................... 37 

4. 

INFORMATION IN THE SUPPLY CHAIN ........................................................... 46 

5.  DOWNSTREAM USERS ........................................................................................ 54 

6.  EVALUATION......................................................................................................... 60 

7.  AUTHORISATION.................................................................................................. 67 

8.  RESTRICTIONS ...................................................................................................... 76 

9.  ECHA........................................................................................................................ 82 
9.1.  Process, internal structure and operations....................................................... 82 
9.2.  Committees ..................................................................................................... 88 
9.3.  Fees and charges ............................................................................................. 93 

10.  COMPETENT AUTHORITIES ............................................................................... 97 

11.  ENFORCEMENT ................................................................................................... 103 

12.  INFORMATION..................................................................................................... 111 

PART II .  ACHIEVING REACH OBJECTIVES ......................................................... 116 

1.  HUMAN HEALTH AND ENVIRONMENT ........................................................ 116 
1.1.  Background and Introduction ....................................................................... 116 
1.2.  Registration ................................................................................................... 118 
1.3.  Requirements concerning information in the supply chain .......................... 120 
1.4.  Authorisation and restrictions ....................................................................... 122 
1.5.  Conclusions................................................................................................... 124 

2.  SINGLE MARKET, COMPETITIVENESS AND INNOVATION ...................... 127 
2.1.  Background ................................................................................................... 127 
2.2.  Single market ................................................................................................ 128 
2.3.  Competitiveness ............................................................................................ 131 
2.4. 
Innovation ..................................................................................................... 138 
2.5.  Perspective of SMEs ..................................................................................... 144 
2.6.  Summary and conclusions ............................................................................ 145 

PART III .  CLP ENFORCEMENT ACTIVITIES ........................................................ 148 

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Part I.  

OPERATION OF REACH 

1. 

GENERAL ISSUES 

1.1. 

Scope and application  

Article 1(1) of REACH sets out that the aim of the Regulation is to ensure a high level 
of  protection  of  human  health  and  the  environment,  including  the  promotion  of 
alternative  methods  for  assessment  of  hazards  of  substances,  as  well  as  the  free 
circulation of substances on the internal market while enhancing competitiveness and 
innovation. The legal basis for REACH is Article 114 TFEU (Article 95 of the former 
EC Treaty) relating to the establishment and the functioning of the internal market. 

As  set  out  in  Article  1(2),  REACH  applies  to  substances  and  mixtures.  This  Article 
states  further  that  REACH  provisions  apply  to  “the  manufacture,  placing  on  the 
market  or  use  of  such  substances  on  their  own,  in  mixtures  or  in  articles  and  to  the 
placing on the market of mixtures.”  

Article 138(6) sets out that: “By 1 June 2012 the Commission shall carry out a review 
to assess whether or not to amend the scope of this Regulation to avoid overlaps with 
other relevant Community provisions.” Article 138(6) further states that “On the basis 
of that review, the Commission may, if appropriate, present a legislative proposal.”  

During this review, in the analysis of the scope, the Commission services focused on 
practical  issues  where  potential  overlaps  with  other  relevant  EU  legislation  may 
appear. In fulfilling this task, different pieces of EU legislation were considered that 
may  be  related  to  REACH  provisions.  A  number  of  REACH  provisions  affect  the 
scope of REACH and its Titles, in particular Articles 2, 14, 15, 56, 58, 60, 61, 62 and 
67. Annexes I, II, XIV and XVII are also important in the context of discussions on 
scope  especially  as  they  have  points  of  contact  with  other  pieces  of  legislation. 
Overlaps, generally, were understood as situations where two pieces of EU legislation 
regulate the same situation which may lead to instances of legal uncertainty or where 
legal  requirements  lead  to  unnecessary  burdens  on  dutyholders  (e.g.  imposing  the 
same  or  similar  regulatory  requirements  twice  or  imposing  conflicting  requirements 
on  the  same  actors  pursuant  to  two  different  pieces  of  legislation).  The  purpose  of 
Article  138(6)  should  thus  be  understood  as  aiming  at  avoiding  these  negative 
overlaps and ensuring more efficient interactions between pieces of legislation at the 
EU level.  

Incidentally, comparing the scope of other pieces of EU legislation with the REACH 
scope also permits to identify certain synergies that can serve as inspiration for further 
work of the Commission and stakeholders. 

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Part I.  
Operation of REACH 

General Issues 

For  the  purpose  of  this  review,  155  EU  legal  acts  regulating  chemicals,  products, 
environmental protection, workers’ protection and food safety have been analysed1.    

The  instances  of  overlaps  or  potential  overlaps  between  REACH  and  other  EU 
legislation identified in the review pertain to REACH registration, information in the 
supply chain, authorisation or restrictions. Two instances of regulatory gaps identified 
by  the  review  are  also  outlined  in  this  section.  Some  examples  of  pieces  of  EU 
legislation concerned by synergies are listed at the end of this Title.     

Potential  overlaps  or  overlaps  with  registration  and  information  in  the  supply 
chain  

–  Safeners and synergists of plant protection products: a potential overlap regarding 
safeners  and  synergists  of  plant  protection  products  was  identified,  which  –  like 
active  substances  -  are  subject  to  Commission  approval  under  the  new  Plant 
Protection Products Regulation (PPPR)2 and for which a review programme will be 
established by 14 December 2014, but which are not regarded as registered for the 
purposes of REACH, as they are not mentioned in Article 15(1) REACH. Similar 
data  requirements  as  those  related  to  active  substances  should  be  defined  for 
safeners  and  synergists  in  the  PPPR  implementing  legislation.  Since  the  requisite 
implementing legislation under the PPPR has not yet been adopted, the degree of 
potential overlap is difficult to assess at this moment in time.  

–  Co-formulants in biocidal products: a potential overlap regarding co-formulants in 
biocidal  products  was  identified.  Article  15(2)  only  regards  active  substances 
included  in  the  Annexes  of  the  Biocidal  Products  Directive  (BPD)3  as  being 
registered  but  not  their  co-formulants.  As  a  consequence,  these  have  to  be 
registered  under  REACH.  Annex  VI  of  the  BPD  requires  a  risk  assessment,  
equivalent  the  one  carried  out  for  active  substances,  for  co-formulants  which  are 
substances of concern present in the biocidal product. Therefore the assessment of 
co-formulants which are substances of concern under both REACH and the BPD 
may result in a potential overlap. Duty-holders may have to perform a similar risk 
assessment twice. It must be noted that the BPD has just been replaced by a new 
Regulation4.  Similarly  to  the  BPD,  Annex  VI  point  5  of  the  Biocidal  Products 
Regulation  requires  a  risk  assessment  for  substances  of  concern.  However,  the 
relevant provision sets out that information submitted in the framework of REACH 

1   Study “Technical assistance related to the scope of REACH and other relevant EU legislation to 

assess overlaps” , Milieu, commissioned by European Commission, March 2012. 

2   Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 
concerning the placing of plant protection products on the market and repealing Council Directives 
79/117/EEC and 91/414/EEC, OJ L 309, 24.11.2009, p. 1. 

3   Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning 

the placing of biocidal products on the market, OJ L 123, 24.4.1998, p. 1. 

4   Regulation  (EU)  No 528/2012  of  the  European  Parliament  and  of  the  Council  of  22 May  2012 
concerning the making available on the market and use of biocidal products, OJ L 167, 27.6.2012, 
p.1. 

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Part I.  
Operation of REACH 

General Issues 

should be taken into account where appropriate. The potential overlap concerning 
co-formulants thus appears to be sufficiently addressed in the BPR.  

–  Pyrotechnic articles: The Commission services concluded that certain pyrotechnic 
articles,  considered  as  mixtures  under  REACH,  might  be  subject  to  a  double 
regulatory burden, at least as far as communication of the information in the supply 
chain  is  concerned.  In  such  a  case both  obligations  under  REACH  and  under  the 
Pyrotechnic  Articles  Directive5  would  apply  at  the  same  time.  According  to  the 
current  ECHA  guidance  on  requirements  for  substances  in  articles,  a  majority  of 
pyrotechnic  articles  should  be  regarded  as  packaged  mixtures,  whereas  they  are 
regarded  as  articles  by  the  technical  experts  in  the  responsible  CEN  Technical 
Committee  (TC  212)  and  also  by  some  competent  authorities  of  the  Member 
States.  The  Commission  services  will  investigate  whether  this  issue  requires 
specific  action,  including,  in  particular  in  the  Guidance  on  requirements  for 
substances in articles.   

–  Medical  devices6:  Article  2(6)(c)  of  REACH  exempts  medical  devices  which  are 
mixtures,  in  the  finished  state  and  intended  for  the  final  user  and  which  are 
invasive  or  used  in  direct  physical  contact  with  the  human  body,  from  the 
provisions of Title IV (Information in the Supply Chain), as long as the same level 
of information provision and protection is ensured for any substances or mixtures 
classified as dangerous as under Directive 1999/45/EC7.  The Commission services 
take the view that the Directives governing medical devices provide such a level of 
information  provision  and  protection.    The  exemption  however  does  not  apply  to 
medical devices in the form of articles (such as active implantable medical devices 
governed  by  Directive  90/385/EEC),  nor  does  it  apply  to  in  vitro  medical 
diagnostics governed by Directive 98/79/EC (as these are not used in direct contact 
with  the  human  body),  even  though  the  latter  Directive  expressly  provides  for 
labelling  in  line  with  Directives  67/548/EEC8  and  1999/45/EC.  The  scope  of  the 
exemption  therefore  appears  very  limited.  Such  articles  or  mixtures,  not  being 
subject to the exemption, would thus be potentially subject to an overlap in terms 
of information requirement. 

5   Directive  2007/23/EC  of  the  European  Parliament  and  of  the  Council  of  23  May  2007  on  the 

placing on the market of pyrotechnic articles, OJ L 154, 14.6.2007, p. 1. 

6   Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member 
States  relating  to  active  implantable  medical  devices,  OJ  L  189,  20.7.1990,  p.  17;  Council 
Directive  93/42/EEC  of  14  June  1993  concerning  medical  devices,  OJ  L  169,  12.7.1993,  p.  1; 
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro 
diagnostic medical devices, OJ L 331, 7.12.1998, p. 1. 

7   Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning 
the  approximation  of  the  laws,  regulations  and  administrative  provisions  of  the  Member  States 
relating  to  the  classification,  packaging  and  labelling  of  dangerous  preparations,  OJ  L  200, 
30.7.1999, p. 1. 

8   Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and 
administrative  provisions  relating  to  the  classification,  packaging  and  labelling  of  dangerous 
substances, OJ 196, 16.8.1967, p. 1. 

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Furthermore, the use of a substance in a medical device, and its risks to the safety 
of  patients  and  medical  professionals,  is  assessed  within  the  context  of  the 
Directives  on  medical  devices  and  the  subsequent  harmonised  standards.  Articles 
60(2) and 62(6) of REACH recognise this prior assessment in exempting SVHCs 
used in medical devices from the human health risk assessment in the authorisation 
process.  However,  during  the  REACH  registration  process,  substances  used  in 
medical  devices  are  subject  to  chemical  safety  assessment  for  all  intended  uses. 
This  constitutes  a  potential  overlap  as  a  risk  assessment  would  have  to  be 
performed both under REACH and the medical devices legislation.  

Under  the  REACH  risk  assessment,  safe  use  has  to  be  demonstrated  through  an 
exposure  assessment,  whilst  in  the  Directives  on  medical  devices  an  exposure 
assessment is performed and the identified risks then weighed against the benefits. 
There  is  thus  in  addition  a  potential  contradiction  in  that  a  substance  used  in  a 
medical device may not be considered as controlled under Article 14(6) of REACH 
and Annex I but the risks of the use of the substance may still be accepted under 
the medical devices legislation.  

An  overlap  was  identified  for  those  “Class  III”  medical  devices  incorporating,  as 
an  integral  part,  a  substance  which,  if  used  separately,  can  be  considered  to  be  a 
medicinal  product  and  which  is  liable  to  act  on  the  human  body  with  action 
ancillary  to  that  of  the  devices.    Such  Class  III  medical  devices  are  assessed  and 
authorised  in  accordance  with  Directive  93/42/EEC9,  but  the  quality,  safety  and 
usefulness of the substance must be verified by analogy with the methods specified 
in  Annex  I  to  Directive  2001/83/EC10,  which  covers  human  health  risks  and 
requires  an  environmental  risk  assessment  where  applicable.    The  substances 
concerned  do  not  benefit  from  the  exemption  of  Article  2(5)(a)  of  REACH,  as 
Article  1(5)(c)  of  Directive  93/42/EEC  excludes  medicinal  products  covered  by 
Directive  2001/83/EC11  from  its  scope,  although  the  assessment  they  undergo  is 
comparable to that under Directive 2001/83/EC. There is a potential overlap in that 
the substances used in these medical devices will be subject to REACH Titles II, 
V, VI and VII provisions as well as an assessment equivalent to the one set out in 
the medicinal products directive.  

–  Workplace  legislation:  There  is  certain  level  of  confusion  between  derived  no-
effect  levels  (DNELs)  under  REACH  and  various  occupational  exposure  limits 
(OELs)  developed  under  other  EU  legislation  (Chemical  Agents  Directive12  or 
Carcinogens  and  Mutagens  Directive13)  or  national  workers protection  legislation 

9   Article 1(4) of Directive 93/42/EEC. 

10   Annex I, section 7.4 of Directive 93/42/EEC. 

11   Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the 
Community code relating to medicinal products for human use, OJ L 311, 28.11.2001, p. 67. 

12   Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers 
from  the  risks  related  to  chemical  agents  at  work  (fourteenth  individual  Directive  within  the 
meaning of Article 16(1) of Directive 89/391/EEC), OJ L 131, 5.5.1998, p. 11. 

13   Directive  2004/37/EC  of  the  European  Parliament  and  of  the  Council  of  29  April  2004  on  the 
protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth 

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Part I.  
Operation of REACH 

General Issues 

and how these two potentially different values should be reflected down the supply 
chain in the SDS to be used by the employer. Because two sets of values have to be 
derived under the pieces of legislation, there is a potential overlap.  

As  far  as  registrant's  chemical  safety  assessment  is  concerned,  guidance  on 
deriving  DNELs  in  cases  when  the  EU  or  the  national  OEL  are  available  is 
provided  in  the  ECHA  Guidance  on  information  requirements  and  the  chemical 
safety assessment (Chapter R 8).  

The Commission services are of the view that OELs and DNELs (for both the same 
duration and the same route of exposure) may co-exist, and in some circumstances 
may  apply  simultaneously  to  some  work  activities.  In  certain  cases,  where  the 
guidance allows the registrant to use OEL instead of deriving DNEL, the problem 
of two different values would not arise. In other cases, it is the Commission's view 
that, in principle, the lowest level should be complied with by the employer. The 
binding OEL needs to be always complied with by the relevant employer. In cases 
when the DNEL is lower than the OEL, the compliance with DNEL is based on the 
premise  that  the  registrant  could  not  use  OEL  instead  of  deriving  DNEL  for  the 
same  exposure  route  and  duration,  as  he  has  obtained  new  scientific  information 
which indicated that the OEL does not provide  the appropriate level of protection.  

Annex II to REACH provides for an obligation to list the relevant applicable EU or 
national  OELs  in  Section  8  of  the  SDS  (exposure  controls/personal  protection. 
Therefore the Commission services consider that more guidance on the relationship 
between the DNEL and different OELs in the ECHA Guidance on the compilation 
of  SDS  would  be  helpful  for  dutyholders  to  fulfil  properly  their  obligation  to 
compile a SDS to avoid confusion between the two systems. The SDS itself could 
contain  some  explanation  how  those  two  values  should  be  considered  by  the 
downstream user as an employer.  

–  The  harmonised  classification  under  the  CLP  Regulation14:  Although  it  has  been 
reported  to  the  Commission  that  the  process  of  harmonised  classification  under 
Title  V  of  the  CLP  Regulation  and  the  REACH  process  of  identification  of 
substances for the candidate list under Article 59 constitutes an overlap with regard 
to  substances  classified  as  carcinogenic,  mutagenic  or  toxic  for  reproduction 
(CMR)  under  CLP,  the  Commission  services  do  not  concur  with  that  view.  The 
objectives  of  those  two  procedures  are  different,  same  as  the  legal  implications. 
The  harmonised  classification  and  labelling  of  the  substance  under  CLP  is  a 
different  risk  management  measure  comparing  to  the  REACH  authorisation. 
Whereas one of the objectives of CLP is to establish a list of substances with their 
harmonised classifications and labelling elements at EU level, the candidate list is 
the  first  step  in  the  authorisation  process  under  REACH.  The  purpose  of 

individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC), OJ L 
158, 30.4.2004, p. 50. 

14   Regulation  (EC)  No  1272/2008  of  the  European  Parliament  and  of  the  Council  of  16  December 
2008  on  classification,  labelling  and  packaging  of  substances  and  mixtures,  amending  and 
repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, 
OJ L 353, 31.12.2008, p. 1 

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Part I.  
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General Issues 

establishing  a  candidate  list  is,  according  to  Article  59,  the  eventual  inclusion  of 
substances  in  Annex  XIV,  i.e.  identifying  substances  to  be  subjected  to  the 
authorisation  requirement.  This  is  why  before  considering  the  inclusion  of  a 
substance in the candidate list, an assessment of the best risk management option 
under  REACH  is  performed  (see  [Title  7])  and  no  automatic  link  is  assumed 
between  the  classification  of  a  substance  as  a  CMR  and  its  inclusion  in  the 
candidate list. There is also a substantial difference in the procedure. Under Article 
37  CLP,  it  is  the  RAC,  composed  of  members  with  scientific  and  technical 
expertise,  assessing  in-depth  (within  18  months  of  receipt  of  the  proposal)  the 
proposal for harmonised classification and labelling of a substance. In the process 
of identification of substances for the candidate list under Article 59 REACH, the 
Committee  that  may  become  involved  is  the  MSC,  whose  composition  and  role 
differs  from  RAC.  The  assessment  under  this  process  is  expected  to  be  lighter, 
under  shorter  deadlines,  and  the  work  already  done  under  the  CLP  Regulation  is 
already taken into account, as the Annex XV dossier may be limited, if appropriate, 
to a reference to an entry in Part 3 of Annex VI of the CLP. 

–  End-of-waste criteria versus recovered substances: Concerns have been reported to 
the  Commission  regarding  the  potential  overlap  stemming  from  the  fact  that 
recovered  substances  are  subject  to  REACH  registration,  unless  covered  by  an 
exemption. Pursuant to Article 6 of the Waste Framework Directive15, in order for 
a  certain  specified  waste  to  cease  to  be  waste,  it  has  to  fulfil  the  end-of-waste 
criteria  developed  either  at  EU  level  or  at  Member  State  level.  Some  perceive  a 
potential overlap in risk assessment in that the derivation of end-of-waste criteria 
already  assesses  human  health  and  environmental  impact  of  the  material  (risk 
assessment carried out as part of the REACH registration for a recovered substance 
would amount to an overlap, as the same material would have already been subject 
to a risk assessment at the waste stage.) The Commission services, however, would 
like to stress that the assessment for the end-of-waste criteria under Article 6 of the 
Waste  Framework  Directive  is  of  a  different  nature  as  it  is  carried  out  by  the 
Member States authorities and it encompasses different elements. The environment 
and health impact assessment of the material is considered in determining end-of-
waste  criteria  to  the  extent  whether  the  material  in  question  merits  application  of 
the waste legislation. It is assumed that risks from the product of the recovery will 
be  covered  by  another  appropriate  legislation.  The  Commission  services  would 
thus conclude that this does not amount to an overlap and does not jeopardise the 
policy objectives of the two legislations.  

–  Cosmetics  and  animal  testing:  The  fact  that  Article  18  of  the  Cosmetics 
Regulation16  bans  animal  testing  for  finished  products  and  ingredients  or 
combination  of  ingredients  and  bans  placing  on  the  market  of  cosmetic  products 
containing  ingredients  or  combinations  of  ingredients  tested  on  animals  has  been 

15   Directive  2008/98/EC  of  the  European  Parliament  and  of  the  Council  of  19  November  2008  on 

waste and repealing certain Directives, OJ L 312, 22.11.2008, p. 3. 

16   Regulation No. 1223/2009 of the European Parliament and of the Council of 30 November 2009 

on cosmetic products, OJ L 342, 22.12.2009, p. 59. 

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General Issues 

reported to the Commission as an issue of a potential overlap with REACH. Article 
2(4)(b)  REACH  sets  out  that  REACH  applies  without  prejudice  to  the  cosmetics 
legislation as regards testing involving vertebrate animals within the scope of that 
legislation.  The Commission services continue reflecting on how this issue should 
be  best  addressed.  It  is  important  to  note,  in  this  respect,  that  REACH  envisages 
the vertebrate animal testing only as a last resort.  

Overlaps in restrictions  

A number of pieces of EU sector specific legislation provide for restrictions of certain 
substances or groups or categories of substances. It has been reported that it would be 
useful  to  have  a  publicly  available  database  that  would  serve  as  an  inventory  of  all 
restrictions  laid  down  in  EU  legislation  for  particular  individual  substances.  The 
Commission services do not consider, in general, as an overlap the situation where the 
same  substance  is  restricted  by  different  pieces  of  EU  legislation  provided  different 
uses are restricted by different pieces of legislation. However, the overlap may arise 
when the same use is restricted in two different pieces of legislation. 

Some double restrictions of the same use have been identified which are not entirely 
consistent. 

–   PCB/PCT  Directive17: The PCB/PCT Directive does not provide restrictions, but 
rather  complements  REACH  restrictions  with  the  rules  on  the  disposal  and 
decontamination of polychlorinated biphenyls and polychlorinated terphenyls. One 
minor  overlap  has  been  identified.  The  PCB/PCT  Directive  by  allowing  a  use  of 
PCBs  in  transformer  equipment  if  the  mixture  does  not  contain  more  than 
0.005%18  seems  to  be  in  contravention  to  the  absolute  restriction  of  the  use  of 
substances  or  in  mixtures  of  entries  24,  25  and  26  in  Annex  XVII  to  REACH 
which do not provide such a threshold.   

It  has  been  also  reported  that  there  may  be  an  inconsistency  with  respect  to  the 
PCB/PCT  Directive  allowing  transformers  in  which  the  fluids  contain  less  than 
0.05% PCBs to remain in use19, and the restrictions for the use of entries 1, 24, 25 
and 26 of Annex XVII. The Commission services are of the view that this is not an 
inconsistency,  as  most  of  the  transformers  would  be  considered  as  articles  under 
REACH  and  therefore  not  subject  to  the  restriction  of  use  as  a  substance  or  in 
mixtures in those entries.  

–  Toys  Safety  Directive20:  The  Toys  Safety  Directive  makes  it  clear  in  recital  (21) 
and in Annex III that REACH restrictions, when they exist for the use in toys, also 

17   Council  Directive  96/59/EC  of  16  September  1996  on  the  disposal  of  polychlorinated  biphenyls 

and polychlorinated terphenyls (PCB/PCT), OJ L 243, 24.9.1996, p. 31. 

18   Article 2a of the Directive 

19   Articles 3 and 9 of the Directive 

20   Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety 

of toys, OJ L 170, 30.6.2009, p. 1. 

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apply. However, the Commission services recognise the difficulty for stakeholders 
to  get  a  clear  picture  of  the  regulatory  framework  and  the  need  to  better 
communicate  on  it  to  ensure  compliance.  The  following  REACH  restrictions  are 
specifically addressed to toys: 

•  Entries  51  and  52  of  Annex  XVII  to  REACH  prohibit  the  use  of  several 
phthalates  in  toys  in  concentrations  greater  than  0.1%  by  weight  of  the 
plasticised material, and prohibit the placing on the market of toys containing 
these  phthalates.    The  Toys  Safety  Directive  does  not  address  phthalates  in 
toys specifically; however, some of the phthalates concerned are classified as 
toxic  to  reproduction  category  1B  and  CMRs,  in  general,  cannot  be  used  in 
toys,  components  of  toys  or  parts  of  toys,  subject  to  derogations  (Annex  II 
section III to the Toys Safety Directive).  The two instruments thus set out a 
ban  with  different  conditions  of  applications.  The  differences  in  criteria  and 
applicable  limits  may  lead  to  uncertainty  for  operators  concerned  as  to  their 
obligations. The Commission services are of the view that the more stringent 
restriction applies.  

•  Entry 43 of Annex XVII to REACH prohibits the use of azodyes in, inter alia, 
textile or leather toys which may come into direct and prolonged contact with 
the human body, if these azodyes may release certain aromatic amines above 
30 mg/kg (0.003% by weight) in the articles or their dyed parts.  The placing 
on  the  market  of  non-conforming  toys  is  prohibited.    The  Toys  Safety 
Directive  does  not  address  azodyes.  Operators  must  therefore  be  aware  of 
relevant restrictions in REACH. 

•  Entry  5  of  Annex  XVII  to  REACH  prohibits  the  use  of  benzene  in  toys  or 
parts of toys where its concentration in the free state is greater than 5 mg/kg 
(0.0005%) of the weight of the toy or part of toy.  The placing on the market 
of  non-compliant  toys  is  prohibited.    The  Toys  Safety  Directive  governs 
benzene  as  well:  since  benzene  is  classified  as  a  carcinogen  category  1A,  it 
cannot  be  used  in  toys,  components  of  toys  or  parts  of  toys,  subject  to 
derogations  (Annex  II  section  III  to  the  Toys  Safety  Directive).  The  two 
instruments  thus  set  out  a  ban  with  different  conditions  of  applications.  The 
differences  in  criteria  and  applicable  limits  may  lead  to  uncertainty  for 
operators  concerned  as  to  their  obligations.  The  Commission  services  are  of 
the view that the more stringent restriction applies.  

The following general REACH restrictions are also relevant for toys: 

•  Entry  27  of  Annex  XVII  to  REACH  prohibits  the  use  of  nickel  in  articles 
(including toys) intended to come into direct and prolonged contact with the 
skin,  if  the  rate  of  nickel  release  from  the  parts  coming  into  such  contact  is 
greater  than  0.5  μg/cm²/week.    The  placing  on  the  market  of  non-compliant 
articles is prohibited.  The Toys Safety Directive governs nickel as well: since 
nickel  is  classified  as  a  carcinogen  category  2,  it  cannot  be  used  in  toys, 
components of toys or parts of toys, subject to derogations (Annex II section 
III to the Toys Safety Directive); at the same time, and without prejudice to 
the  ban  and  derogations,  specified  nickel  migration  limits  from  toys  or 
components  of  toys  cannot  be  exceeded.    The  differences  in  criteria  and 

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applicable  limits  may  lead  to  uncertainty  for  operators  concerned  as  to  their 
obligations. 

•  Entry 23 of Annex XVII to REACH prohibits the use of cadmium in articles 
(including  toys)  produced  from  plastic  material  and  prohibits  the  placing  on 
the  market  of  such  articles  if  the  concentration  of  cadmium  is  equal  to  or 
greater  than  0.01%  by  weight  of  the  plastic  material.    Painted  articles 
(including  toys)  cannot  be  placed  on  the  market  if  the  concentration  of 
cadmium is equal to or greater than 0.1% by weight of the paint on the painted 
article.    The  Toys  Safety  Directive  governs  cadmium  as  well:  specified 
cadmium  migration  limits  from  toys  or  components  of  toys  cannot  be 
exceeded.    The  differences  in  criteria  and  applicable  limits  (especially 
concentration  limits  versus  migration  limits)  may  lead  to  uncertainty  for 
operators concerned as to their obligations. 

•  RoHS  Directive21:  Entry  23  of  Annex  XVII  to  REACH  prohibits  the  use  of 
cadmium  in  cadmium  plating  metallic  articles  or  components  for  a  certain 
number  of  applications  but  permits  it  for  electrical  contacts  in  any  sector  of 
use, where that is necessary to ensure the reliability required of the apparatus 
on which they are installed. The RoHS Directive prohibits the placing on the 
market of electrical and electronic equipment that contain more than 0.01% of 
cadmium by weight in homogenous materials. However, Annex III of RoHS 
provides  for  an  exemption  from  this  restriction  when  cadmium  and  its 
compounds  is  used  in  electrical  contacts.  This  exemption  from  restriction  is 
thus  broader  than  REACH  as  it  does  not  set  out  a  condition of  reliability  of 
the  apparatus  on  which  these  electrical  contacts  are  installed  in  order  to  be 
triggered.  The  differences  in  the  conditions  of  application  of  the  two 
exemptions  may  lead  to  uncertainty  for  operators  concerned  as  to  their 
obligations. 

Potential overlaps related to future restrictions:  

In  the  context  of  consideration  of  preparations  of  future  restrictions  under  REACH, 
the Guidance on the preparation of Annex XV dossiers states that a restriction under 
REACH  may  be  an  appropriate  measure  in  cases  where  the  proper  implementation 
and  enforcement  of  risk  management  measures  under  other  REACH  processes 
(notably registration) or under other legislation is not possible to achieve22. Other risk 
management  options  (RMOs)  using  other  sector  specific  EU  legislation  should  be 
explored in order to address the identified unacceptable risk in the most appropriate 
way. It is important to note that if a Member State or ECHA identifies, in the context 
of the preparation of the Annex XV dossier, that a measure under other EU legislation 
is more appropriate way of addressing the risk than a REACH restriction, this should 
be  documented  in  the  Annex  XV  dossier.  In  some  cases,  action  under  other  EU 

21   Directive  2011/65/EU  of  the  European  Parliament  and  of  the  Council  of  8  June  2011  on  the 
restriction of the use of certain hazardous substances in electrical and electronic equipment, OJ L 
174, 1.7.2011, p. 88. 

22   See Guidance on Annex XV for restrictions, p. 15.  

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legislation may be considered as a necessary  complementary  measure  to  a  proposed 
REACH  restriction.  These  findings  could  then  be  used  by  the  competent  authorities 
and the Commission to determine if action under other EU legislation is appropriate. 
The Commission  services recognize that it is important to avoid any possible future 
overlaps  or  inconsistencies  with  restrictions  laid  down  in  EU  sector  specific 
legislation.   

Potential overlaps with REACH authorisation 

The  Commission  services  recognise  that  there  is  risk  of  potential  overlap  once  the 
substance  is  included  in  the  REACH  authorisation  list  (Annex  XIV)  and  the 
exemptions for specific uses from the restrictions in different pieces of EU legislation, 
such as the RoHS Directive23, the End of Life Vehicles Directive24 and the Packaging 
Directive25. For uses of a substance which is restricted under sectoral legislation and 
at  the  same  time  subject  to  REACH  authorisation,  there  is  a  concern  that  operators 
would need to go through two separate and independent procedures in order to be able 
to continue to use the substance, i.e. one under REACH authorisation, and the other 
for the exemption to apply under the sectoral legislation. Even if the operator already 
successfully applied to the Commission for a time-limited exemption for a use under 
the  relevant  sectoral  legislation,  there  is  no  guarantee  that  the  authorisation  under 
REACH  would  be  eventually  granted  by  the  Commission  for  the  same  use.  The 
provisions  in  Article  58(2)  of  REACH  allow  to  exempt  uses  or  categories  of  uses 
from  authorisation  provided that  there  is  specific  EU  legislation  imposing  minimum 
requirements  relating  to  the  protection  of  human  health  or  the  environment  that 
ensures proper control of the risks.  There is only a limited experience with the use of 
the Article 58(2) exemption. Three of the current 14 substances in Annex XIV have 
exemptions  from  uses  based  on  this  provision  and  in  relation  to  the  EU  medicinal 
products  legislation.  It  nonetheless  needs  to  be  reviewed  how  these  criteria  are 
currently  applied  and  to  what  extent  they  can  be  used  for  the  exemption  of  uses 
covered by exemptions in specific sectoral legislation. 

Moreover, the Commission would need to consider how to best use Article 58(2) in 
order  to  avoid  potential  overlaps  in  other  cases,  e.g.  where  the  EU  workplace 
legislation sets a binding OEL that applies to a specific use. 

The  Commission  services  will  explore  on  a  case  by  case  to  what  extent  the  Article 
58(2)  exemption  from  authorisation  may  be  used  in  order  to  exempt  from  the 
authorisation  requirement  the  uses  that  have  been  already  specifically  considered  in 
the  context  of  another  EU  legislation.  More  generally,  the  Commission  already 
explores in the risk management options procedure whether it is appropriate to target 

23   Directive  2011/65/EU  of  the  European  Parliament  and  of  the  Council  of  8  June  2011  on  the 
restriction of the use of certain hazardous substances in electrical and electronic equipment, OJ L 
174, 1.7.2011, p. 88. 

24   Directive  2000/53/EC  of  the  European  Parliament  and  of  the  Council  of  18  September  2000  on 

end-of life vehicles, OJ L 269, 21.10.2000, p. 34. 

25  European  Parliament  and  Council  Directive  94/62/EC  of  20  December  1994  on  packaging  and 

packaging waste, OJ L 365, 31.12.1994, p. 10. 

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by  Annex  XIV  substances  that  are  already  restricted  in  many  other  pieces  of  EU 
legislation. 

Potential gaps 

Potential  gaps  were  also  identified  in  the  process  of  the  review.  They  are  outlined 
below.  

–  Animal  testing:  A  potential  gap  was  identified  regarding  the  Animal  Testing 
Directive26. This Directive defines live non-human vertebrate animals falling under 
its scope as including earlier forms of development such as ‘independently feeding 
larval forms’ and ‘foetal forms of mammals as from the last third of their normal 
development’.  Data  sharing  is  obligatory  under  REACH  for  data  generated  from 
the  testing  of  vertebrate  animals,  but  REACH  does  not  specify  that  vertebrate 
animals  include  larval  and  foetal  forms.  It  is  therefore  unclear  whether  earlier 
forms  of  development  of  vertebrate  animals  are  provided  the  same  level  of 
protection under REACH as under the Animal Testing Directive. The Commission 
services would recommend construing the term ‘vertebrate animal’ under REACH 
in the light of Directive 2010/63/EU so as to include larval and foetal forms.   

–  Use of cephalopods in animal testing: Another potential gap was identified in that 
the Animal Testing Directive, unlike REACH, covers live cephalopods. Data–sharing 
would  not  be  compulsory  under  REACH  if  the  data  is  generated  through  test  on  non 
vertebrate animals which includes cephalopods. The Commission services will investigate 
the possibility to subject cephalopods to the same regime as vertebrates.    

Synergies in the use of data:  

Potential  synergies  have  been  identified  that  relate  to  information  requirements 
imposed in the context of REACH and those stemming from regulatory requirements 
from sector specific legislation. Data collected by dutyholders pursuant to one piece 
of  EU  legislation  could  be  useful  in  the  context  of  REACH  and  vice-versa.  Some 
examples are listed below in bullet points, this list being not exhaustive: 

–  Quality  of  Petrol  Directive27:  metallic  fuel  additives  are,  in  principle,  substances 
subject to REACH registration, the information generated by the registrant for the 
CSA  (depending  on  annual  volumes)  can  support  the  Commission’s  risk 
assessment on fuel additives under the Quality of Petrol Directive.  

26   Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the 

protection of animals used for scientific purposes, OJ L 276, 20.10.2010, p. 33. 

27   Directive 2009/30/EC of the European Parliament and of the Council of 23 April 2009 amending 
Directive  98/70/EC  as  regards  the  specification  of  petrol,  diesel  and  gas-oil  and  introducing  a 
mechanism  to  monitor  and  reduce  greenhouse  gas  emissions  and  amending  Council  Directive 
1999/32/EC  as  regards  the  specification  of  fuel  used  by  inland  waterway  vessels  and  repealing 
Directive 93/12/EEC, OJ L 140, 5.6.2009, p. 88. 

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–  Textile Names Regulation28: Article 25 of this Regulation requests the Commission 
to  examine  possible  hazards  to  human  health  in  relation  to  allergic  reactions  and 
chemicals  in  textile  products.  To  this  end,  the  Commission  is  carrying  out  a 
scientific  study  to  evaluate  whether  there is  a  link  between  allergic  reactions  and 
chemicals  used  in  textile  products  and  propose  risk  management  measures,  if 
appropriate.  The  findings  of  this  study  would  support  the  REACH  risk 
identification  and  management  process;  among  others,  such  risk  management 
measures  may  include  labelling  to  indicate  the  presence  of  potentially  allergenic 
chemicals. In order to identify which substances could cause allergic reactions and 
are used in textiles products, the study will make use of the information produced 
under REACH for the registration, classification and use of substances. 

–  Paints Directive29: this Directive aims to limit the total content of VOCs in certain 
paints and varnishes and vehicle refinishing products in order to prevent or reduce 
air  pollution  resulting  from  the  contribution  of  VOCs  to  the  formation  of 
tropospheric ozone. These products are however also mixtures under REACH. The 
solvents  and  other  substances  making  up  these  mixtures  are  subject  to  REACH 
registration which means that chemical safety assessments will have to be carried 
out for these substances. Information available under REACH may thus be useful 
for  the  Commission  in  order  to  assess  whether  further  measures  to  address  VOC 
emissions  are  needed,  while  the  information  collected  under  the  Paints  Directive 
can inform exposure assessment under REACH CSA.  

–  POPs Regulation30: REACH registration requirements could help to identify POP 
substances that could be candidates for nomination as POPs under the Stockholm 
Convention.31  Substances 
the  Convention  will 
subsequently be added to the POPs Regulation.  

the  Annexes 

listed 

to 

in 

–  ELV32;  WEEE33,  Batteries34  and  RoHS35  Directives:  The  process  of  identifying 
additional  substances  of  concern  for  management  under  the  End  of  Life  Vehicle, 

28   Regulation (EU) No 1007/2011 of the European Parliament and of the Council of 27 September 
2011 on textile fibre names and related labelling and marking of the fibre composition of textile 
products and repealing Council Directive 73/44/EEC and Directives 96/73/EC and 2008/121/EC of 
the European Parliament and of the Council, OJ L 272, 18.10.2011, p 1. 

29   Directive  2004/42/EC  of  the  European  Parliament  and  of  the  Council  of  21  April  2004    on  the 
limitation of emissions of volatile organic compounds due to the use of organic solvents in certain 
paints and varnishes and vehicle refinishing products and amending Directive 1999/13/EC, OJ L 
143, 30.4.2004, p. 87. 

30   Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on 
persistent organic pollutants and amending Directive 79/117/EEC, OJ L 158, 30.4.2004, p. 7. 

31   Council  Decision  of  14  October  2004  concerning  the  conclusion,  on  behalf  of  the  European 
Community, of the Stockholm Convention on Persistent Organic Pollutants, OJ L 209, 31.7.2006, 
p. 1. 

32   Directive  2000/53/EC  of  the  European  Parliament  and  of  the  Council  of  18  September  2000  on 

end-of life vehicles, OJ L 269, 21.10.2000, p. 34. 

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Waste Electrical and Electronic Equipment, Batteries and Restriction of Hazardous 
Substances Directives should benefit from the information generated by REACH.  

–  Water  Framework  Directive36:  Data  generated  through  the  implementation  of  the 
Water Framework Directive and other water-related directives (monitoring, EQS) 
can  be  used  in  carrying  out  REACH  substance  evaluations  or  when  considering 
possible inclusion of a substance on the candidate list or restriction of a substance. 
Conversely, data from REACH registration dossiers and substance evaluations can 
be used when implementing the Water Framework Directive.  

–  Industrial  Emissions  Directive37:  Information  on 

the 
registration  and  authorisation  procedures  under  REACH  may  be  used  to  support 
the  development  of  BAT  reference  documents  developed  under  the  Industrial 
Emissions Directive. The CSA comprises the complete life-cycle of the substance 
and  therefore  includes  the  manufacture  and  use  of  these  substances  in  industrial 
installations  covered  by  this  Directive  and  measures  to  avoid  and  control 
emissions.  

the  substance  under 

–  Construction Products Regulation:38 basic requirements for construction works are 
defined    in  Annex  I  to  this  Regulation  to  be  the  basis  for  EU  standardisation. 
Accordingly,  harmonised  standards  to  be  adopted  or  updated  by  CEN  should 
reflect  basic  requirements  for  health  and  the  environment.    Such  harmonised 
standards  will  not  address  chemical  safety  as  such,  but  will  provide  test  methods 
allowing  manufacturers  to  show  compliance  with  relevant  chemicals  legislation 
(e.g.  REACH  restrictions  or  the  Water  Framework  Directive).    Information 
provided  in  accordance  with  Articles  31  or  33  REACH  respectively  may  allow 
compliance  to  be  shown  and  thus  obviate  the  need  for  testing  according  to 
harmonised  standards;  this  is  a  synergy  between  REACH  and  the  Construction 
Products Regulation. 

33   Directive 2002/96/EC of the European Parliament and of the Council of 27 January 2003 on waste 

electrical and electronic equipment, OJ L 37, 13.2.2003, p. 24. 

34   Directive  2006/66/EC  of  the  European  Parliament  and  of  the  Council  of  6 September  2006  on 
batteries  and  accumulators  and  waste  batteries  and  accumulators  and  repealing  Directive 
91/157/EEC, OJ L 266, 26.9.2006, p. 1. 

35   Directive  2011/65/EU  of  the  European  Parliament  and  of  the  Council  of  8  June  2011  on  the 
restriction of the use of certain hazardous substances in electrical and electronic equipment, OJ L 
174, 1.7.2011, p. 88. 

36   Directive 2000/60/EC of the European Parliament and of the Council establishing a framework for 

the Community action in the field of water policy, OJ L 327, 22.12.2000, p. 1–73 

37   Directive  2010/75/EU  of  the  European  Parliament  and  of  the  Council  of  24 November  2010  on 
industrial emissions (integrated pollution prevention and control), OJ L 334, 17.12.2010, p. 17.   

38   Regulation  (EU)  No 305/2011  of  the  European  Parliament  and  of  the  Council  of  9 March  2011 
laying  down  harmonised  conditions  for  the  marketing  of  construction  products  and  repealing 
Council Directive 89/106/EEC, OJ L 88, 4.4.2011, p. 5.  

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For the Commission, it will be particularly important to take into account REACH-
generated data, and DNELs in particular, in developing EU lowest concentration of 
interest  (LCI)  values39  in  the  context  of  the  Commission’s  EU-LCI  harmonised 
framework for construction products. 

Recommendations 

1.1.     All efforts should be made to minimise or avoid potential overlaps through adoption or 

amendment of implementing legislation of REACH or of other EU sector specific legislation, 
where possible 

1.2.     Whenever the change of the guidance may address overlaps identified ECHA should consider 

to carry out the necessary changes 

1.3.  ECHA should develop a database listing existing restrictions in the EU legislation on a 

substance base  

39   EU-LCIs are health-based values used to evaluate emissions after 28 days from a single product 
during  a  laboratory  test  chamber  procedure  (as  defined  in  the  CEN  TC  351  horizontal  standard) 
and are applied in product safety assessment with the ultimate goal to avoid health risks from long-
term exposure for the general population. JRC ECA report no. 29 “Harmonisation framework for 
health  based  evaluation  of  building  products  indoor  emissions  in  Europe  (EU-LCI)”  (Draft, 
November 2012). 

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1.2.  Definitions 

General Issues 

The  REACH  definitions  are  a  mix  of  well  established  notions  and  some  new 
concepts.  Although  few  of  them  have  been  subject  to  in-depth  discussions  by 
stakeholders and Member States it is important to clearly distinguish between 
issues  related  to  the  implementation  of  those  definitions  (which  can  be 
addressed  via  guidance  documents)  and  issues  related  to  the  definitions 
themselves. 

The definitions in REACH set out the information necessary to understand and apply 
REACH correctly. They provide legal clarity in particular in those cases where a term 
has several meanings in plain language, but must be understood in only one of them in 
the  context  of  REACH.  This  sub-title  describes  the  experience  acquired  with  the 
functioning  of  the  REACH  definitions  and  highlights  those  definitions  which  have 
been  subject  to  extensive  discussions  or  where  the  Commission  observes  potential 
issues  of  concern.  It  is  also  important  to  mention  that  the  definitions  in  Regulation 
(EC) No 1272/2008 (CLP)40 have been aligned with the REACH definitions. 

The  definition  of  substance  (Article  3(1))  is  the  cornerstone  of  REACH,  as 
substances  are  the  main  subject  of  REACH  provisions.  The  current  definition  has 
been well-established in EU law for about 20 years.  REACH took over the definition 
from  the  predecessor  chemicals  legislation  (Directive  67/548/EEC41  as  amended  by 
Directive  92/32/EEC42).  The  definition  of  substance  is  closely  related  to  the 
identification of each specific substance. This is a crucial precondition for the correct 
application of risk management measures under REACH (registration, authorisation, 
restrictions).  The  Commission  services  note  that  substance  identification  is  relevant, 
first, for the identification of the substance for regulatory purposes (e.g. authorisation, 
restrictions)  and,  second,  for  the  establishment  of  sameness  of  the  manufactured  or 
imported  substance,  mainly  in  the  context  of  registration  (in  establishing  Substance 
Information  Exchange  Forums  (SIEFs)  among  the  potential  registrants  of  the  same 
substance, joint submission or in the inquiry procedure)43. The Commission services 
observe  some  practical  problems  mainly  in  the  latter  area.  This  is,  however,  in  the 
Commission services' view not a problem of the definition of substance as such. The 
issue  is  rather  linked  to  the  rules  on  the  identification  of  the  substance  set  out  in 

40   Regulation  (EC)  No  1272/2008  of  the  European  Parliament  and  of  the  Council  of  16  December 
2008  on  classification,  labelling  and  packaging  of  substances  and  mixtures,  amending  and 
repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, 
OJ L 353, 31.12.2008, p. 1. 

41   Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and 
administrative  provisions  relating  to  the  classification,  packaging  and  labelling  of  dangerous 
substances, OJ 196, 16.8.1967, p. 1. 

42   Council  Directive  92/32/EEC  of  30  April  1992  amending  for  the  seventh  time  Directive 
67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to 
the classification, packaging and labelling of dangerous substances, OJ L 154, 5.6.1992, p. 1. 

43   Study  “Functioning  of  the  European  chemical  market  after  the  introduction  of  REACH”,  CSES 

commissioned by the European Commission, March 2012. 

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Annex VI, Section 2 to REACH and in the Guidance on substance identification44 and 
to their application in different contexts of REACH (e.g. registration, authorisation). 
The Commission services notes ECHA's invitation to consider issuing implementing 
legislation which would ensure that substances of significantly different composition 
are not merged into single dossiers45.  It has to be noted that substance identification 
has been given already considerable attention since the adoption of REACH and has 
been  dealt  with  within  different  guidance  documents,  frequently  asked  questions, 
other  ECHA  support  tools,  a  number  of  conferences  and  meetings  with  different 
industry  stakeholders.  The  Commission  services,  ECHA  and  stakeholders  will 
continue  to  explore  the  need  for  clarifying  the  existing  framework  for  substance 
identification.  In  the  registration  area,  part  of  the  problem  may  be  addressed  by 
Member State enforcement, in cases where it is evident that the provisions related to 
substance  sameness  have  not  been  complied  with.  In  summary,  the  Commission 
services  consider  that  the  efforts  in  this  area  (communications,  meetings)  should  be 
maintained  involving  stakeholders,  Member  States,  ECHA  and  the  Commission. 
Additional  clarifications  will  have  a  direct  and  positive  impact  on  all  REACH 
processes (registration, evaluation, authorisation and restrictions). 

The definition of mixture (Article 3(2)), apart from containing a circular reference to 
the  same  word  "mixture"  after  its  alignment  to  GHS46  terminology  through  the 
amendment  by  CLP,  is  equally  well-established  in  EU  law  and  does  not  appear  to 
raise problems in practice. Mixtures are formed by intentional mixing or blending of 
at  least  two  different  substances  and,  contrary  to  substances,  are  not  the  result  of  a 
chemical reaction. 

The definition of article (Article 3(3)) has been subject to many discussions (e.g. on 
candles,  printer  cartridges,  alcohol  testers,  glow  sticks)  addressing  borderline  cases 
between  substances/mixtures  in  containers  or  carrier  materials  on  the  one  hand,  and 
articles  on  the  other.  In  order  to  determine  whether  or  not  an  object  fulfils  the 
definition  of  an  article  under  REACH,  the  object’s  function  and  its  characteristics 
need to be assessed. This has been clarified to a large extent through the Guidance for 
substances  in  articles47  and  its  appendices,  also  on  the  basis  of  industry  providing 
specific examples. 

Another  interpretation  issue  with  respect  to  the  definition  of  article  arose  in  the 
context  of  provisions  of  Articles  7  and  33  with  respect  to  the  0.1%  threshold  for 
substances  of  very  high  concern  (SVHC)  in  articles  (see  [Title  2]).  It  has  been  also 
clarified that the definition of article does not cover buildings as long as they remain 
fixed to the land on which they stand. 

44   Guidance  for  identification  and  naming  of  substances  under  REACH  and  CLP,  Version  1.2, 

Europan Chemicals Agency, March 2012  

45   The Operation of REACH and CLP, European Chemicals Agency, 2011, p. 2 

46   Globally Harmonised System of Classification and Labelling of Chemicals. 

47   Guidance  on  requirements  for  substances  in  articles  -  Version  2,  European  Chemicals  Agency,  

2011 

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The definition of manufacturer (Article 3(9)) triggered discussions mainly as far as 
the  concept  of  toll  manufacturing  (subcontracting)  is  concerned,  as  there  may  be  a 
large  variety  of  different  business  arrangements  in  practice.  The  Guidance  on 
registration48  gives  the  basic  elements  as  to  the  correct  interpretation,  while  leaving 
some flexibility for industry in specific cases to determine who should be considered 
the manufacturer of a substance bearing the corresponding REACH obligations. The 
Commission services consider this solution adequate. 

The  definition  of  importer  (Article  3(11)),  linked  with  the  definition  of  import 
(Article  3(10)),  is,  at  times,  more  difficult  to  apply  to  the  multitude  of  practical 
arrangements  existing  in  practice.  The  definition  of  importer  is  linked  to  the 
responsibility for the physical introduction into the customs territory of the EU, which 
is  already  considered  as  placing  on  the  market  for  the  purpose  of  REACH.  The 
Guidance  on  registration  and  other  ECHA  tools  provide  help  on  the  correct 
interpretation  of  the  definition.  The  Commission  services  consider  this  solution 
adequate. 

It is important to bear in mind that the REACH definition of placing on the market 
(Article  3(12))  is  different  from  that  definition  in  more  recent  pieces  of  EU 
legislation,  where  placing  on  the  market  means  only  the  first  making  available  of  a 
product  on  the  EU  market.    Therefore,  the  concept  of  placing  on  the  market  under 
REACH applies at every step of the supply chain, unless otherwise specified (e.g. in 
several instances in Annex XVII). 

The  definition  of  distributor  (Article  3(14))  does  not  pose  problems  in  the 
implementation  of  REACH.  However,  it  should  be  noted  that  the  reference  to  a 
distributor acting for third parties is not interpreted to mean that this definition covers 
only operators acting on behalf of others. The definition applies to every operator who 
only stores and places on the market a substance, on its own or in a mixture. 

Industry  is  often  contesting  the  interpretation  of  the  definition  of  intermediate 
(Article  3(15)),  as  clarified  through  the  Guidance  on  intermediates49  in  April  2010. 
Differing  interpretations  of  this  particular  definition  may  have  had  an  impact  on 
registration  dossiers  submitted  before  the  first  registration  deadline.  ECHA’s 
screening  of  over  400  registration  dossiers  submitted  before  the  first  registration 
deadline of 201050 suggests that some registrants may have unduly benefited from the 
reduced registration requirements for intermediates set out in Articles 17 and 18. This 
may,  however,  mainly  be  an  issue  linked  to  the  application  of  the  criteria  of  the 
strictly  controlled  conditions  as  set  out  in  Articles  17  or  18,  and  not  necessarily  an 
issue of a broader interpretation of the definition. The lack of agreement with industry 
on the interpretation of the definition may have an impact when assessing whether a 
use  of  a  specific  substance  included  in  Annex  XIV  is  an  intermediate  use,  and 

48   Guidance on registration, Version 1.6, European Chemicals Agency, 2011 

49   Guidance on intermediates, Version 2, European Chemicals Agency, December 2010  

50  The Operation of REACH and CLP, European Chemicals Agency  2011, p. 14. 

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therefore not subject to the authorisation requirement. In that regard the Commission 
services share ECHA's view on the need to further clarify this issue, in particular to 
clarify  with  industry  which  applications  can  be  considered  intermediate  uses  of  a 
substance  in  accordance  with  the  interpretation  set  out  in  the  Guidance  on 
intermediates51. 

With  respect  to  the  definition  of  phase-in  substance  (Article  3(20)),  it  is  useful  to 
note that the criteria in subparagraphs b) and c) may be met only by certain operators, 
while  for  other  operators  the  same  substance  will  be  considered  as  non-phase-in 
substance.  The  correct  identification  of  the  status  of  the  substance  has  important 
implications for the registration obligations. In this respect, the Commission services 
highlight that a second corrigendum was published in the Official Journal concerning 
the criteria for so-called "no-longer-polymers" in Article 3(20)(c)52. 

It is useful to  recall  that  the  definition of  use (Article 3(24)) is broad, i.a. including 
storage or keeping of a substance. This was taken into account, e.g. when Annex XVII 
to  REACH,  as  taken  over  from  the  repealed  Directive  76/769/EEC53,  was  reviewed 
and amended by Regulation (EC) No 552/200954 and some restrictions were redrafted 
accordingly. 

The definition of exposure scenario in Article 3(37) is repeated in Annex I, Section 
0.7 in analogous, but not identical words, which may be considered as superfluous. A 
similar  issue  is  noted  with  respect  to  the  definition  of  use  and  exposure  category 
(Article 3(38)), which is not consistently used in Annex I. In practice, these issues do 
not pose any problems. 

The scope of the definition of substances which occur in nature (Article 3(39)) was 
further clarified through the Guidance for Annex V55, which states, in particular, that 
living or unprocessed dead organisms, or parts thereof, are not considered substances 

51  The Operation of REACH and CLP, European Chemicals Agency, 2011, p. 35-36. 

52  Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 
18  December  2006  concerning  the  Registration,  Evaluation,  Authorisation  and  Restriction  of 
Chemicals  (REACH),  establishing  a  European  Chemicals  Agency,  amending  Directive 
1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) 
No  1488/94  as  well  as  Council  Directive  76/769/EEC  and  Commission  Directives  91/155/EEC, 
93/67/EEC, 93/105/EC and 2000/21/EC, OJ L 36, 5.2.2009, p. 84. 

53   Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and 
administrative provisions of the Member States relating to restrictions on the marketing and use of 
certain dangerous substances and preparations, OJ L 262, 27.9.1976, p.201. 

54   Commission  Regulation  (EC)  No  552/2009  of  22  June  2009  amending  Regulation  (EC)  No 
1907/2006  of  the  European  Parliament  and  of  the  Council  on  the  Registration,  Evaluation, 
Authorisation  and  Restriction  of  Chemicals  (REACH)  as  regards  Annex  XVII,  OJ  L  164, 
26.6.2009, p. 7. 

55   Guidance for Annex V Exemptions from the obligation to register - version 1, European Chemicals 

Agency,  March 2010 

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under REACH. The definition of not chemically modified substance (Article 3(40)) 
was also further clarified through the Guidance for Annex V. 

It is important to note that even if the definition of the term alloy (Article 3(41)) does 
not specifically mention that an alloy is a mixture rather than a substance, recital (31) 
as well as Annex I, Section 0.11 and the Guidance on substance identification clarify 
that  alloys  are  special  mixtures.  Registration  obligations  related  to  substances  in 
alloys are explained in the Guidance on registration. 

At  this  juncture,  the  term  nanomaterial  is  not  defined  in  REACH,  as  it  is  not 
specifically  mentioned  in  the  REACH  text.  The  term  has  been  recently  defined  in 
Recommendation  2011/696/EU56  and  should  be  also  understood  to  apply  in  the 
context  of  REACH  practical  application  as  the  Recommendation  specifically  is 
addressed  to  Member  States,  the  Union  agencies  (including  ECHA)  and  economic 
operators.  

The  application  of  REACH,  in  particular  the  delimitation  of  the  REACH  scope  in 
Article  2,  depends  also  on  the  scope  of  some  terms  defined  in  other  EU  legal  acts, 
which  are  relied  on  in  the  interpretation  of  exemptions  from  the  scope  of  REACH 
(e.g.  the  terms  "food",  "waste",  "by-product",  "temporary  storage").  Therefore,  it  is 
not necessary to define them in REACH. 

Conclusions and recommendations 

Overall,  the  definitions  in  REACH  are  fit  for  their  purpose  and  function  well.  The 
problems  raised  by  some  stakeholders  concerning  the  definition  of  "substance"  are 
rather linked to the issue of substance identification than to the definition as such. 

The  main  difficulties  related  to  the  application  of  definitions  have  been  observed  in 
relation to the definitions of "article" and "intermediate", as their interpretation is not 
universally accepted by all stakeholders. The interpretation of the definition of article 
in  connection  with  the  obligations  under  Articles  7  and  33  is  not  accepted  by  some 
Member States and stakeholders. The interpretation of the definition of intermediate is 
not entirely shared by industry. The Commission services are prepared to contribute to 
the discussions with industry on the implementation of this definition. 

It  is  important  to  note  that  REACH  definitions  differ  to  a  certain  extent  from  the 
aligned reference provisions for the internal market for goods, as set out in Annex I to 
Decision  No  768/2008/EC57.  These  were  designed  for  EU  harmonisation  legislation 
for products (e.g. definitions of "placing on the market", "manufacturer", "importer" 
and  "distributor").  Recital  (5)  of  Decision  No  768/2008/EC  recognises  that 
specificities  of  sectoral  needs  may  justify  other  regulatory  solutions  and  explicitly 

56   Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomaterial, 

OJ L 275, 20.10.2010, p. 38. 

57   Decision  No  768/2008/EC  of  the  European  Parliament  and  of  the  Council  of  9  July  2008  on  a 
common framework for the marketing of products, and repealing Council Decision 93/465/EEC, 
OJ L 218, 13.8.2008, p. 82. 

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General Issues 

mentions  chemicals.  The  Commission  services  therefore  do  not  see  a  need  for 
reviewing whether alignment to those definitions would be appropriate or not at this 
point in time. 

Recommendations: 

1.2.1.  The  definitions  in  Article  3  have  been  found  to  be  fit  for  their  purpose  and  function  well. 

However, if at a later stage REACH will need amending for other reasons: 

a.  definitions will be reviewed with the view to ensure better coherence between the 

reference provision in Decision No 768/2008/EC and REACH, if compatible with 
REACH specific needs and those of Decision No 768/2008/EC. 

b.  consideration should be given to the introduction of the definition of a nanomaterial in 

line with Recommendation 2011/696/EU  

1.2.1.   Registrants are encouraged to apply the definition of intermediates, as set out in REACH and 

further explained in the Guidance on intermediates. 

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2. 

REGISTRATION  

Registration 

Despite  numerous  challenges  encountered  by  all  actors  involved,  the  first 
registration deadline should be recognised as a success. 

The "R" in REACH stands for Registration, one of the Regulation's core mechanisms. 
In general, it requires companies to register all substances manufactured or imported 
in  quantities  of  one  tonne  or  more  per  year.  Registration  shifts  the  burden  from  the 
regulator  to  the  industry  to  demonstrate  how  substances  can  be  used  safely.  The 
registration  obligation  seeks  to  address  the  concerns  detailed  in  the  Commission 
White  Paper58  regarding  the  lack  of  information  available  on  99%  of  the  volume  of 
chemicals on the market in the EU. Failure to register would result in a manufacturer 
or importer being unable to legally manufacture or/and import their substance. 

A  registration  dossier  should  demonstrate  that  the  risks  through  the  lifecycle  of  a 
substance  are  controlled.  The  amount  of  information  required  for  registration 
increases  along  with  the  volume  of  the  substance  manufactured  and/or  imported. 
Manufacturers and importers are required to submit a technical dossier for substances 
registered  in  quantities  of  one  tonne  or  more.  The  technical  dossier  contains 
information on the physicochemical, toxicological and ecotoxicological properties, on 
the uses and on the classification of a substance as well as guidance on safe use. For 
substances  registered  at  quantities  of  10  tonnes  or  more  per  year,  a  chemical  safety 
assessment  (CSA)  also  needs  to  be  conducted  and  documented  in  a  chemical  safety 
report (CSR) which accompanies the technical dossier. 

For substances in specified hazard classes as well as for all substances that meet the 
criteria  for  being  persistent,  bioaccumulative  and  toxic  (PBT)  or  very  persistent  and 
very bioaccumulative (vPvB) as set out in Annex XIII to REACH, the CSA includes 
the  development  of  exposure  assessment  and  risk  characterisation  for  manufacture 
and all the identified uses of the substance. 

REACH  provides  for  the  phased registration  of  substances  already  on  the  market  in 
the EU prior to REACH by the following deadlines, where the tonnages indicated are 
per individual manufacturer/importer (Article 23): 

•  by 30 November 2010: 

–  Substances  manufactured  or  imported  in  quantities  of  1 000  tonnes  or  more 

per year; 

–  Substances  meeting  the  criteria  for  classification  as  carcinogenic,  mutagenic 
or toxic to reproduction (CMR) category 1 or 2 (under Directive 67/548/EEC) 
manufactured or imported in quantities of one tonne or more per year; 

–  Substances  meeting  the  criteria  for  R50/53  (under  Directive  67/548/EEC) 

manufactured or imported in quantities of 100 tonnes or more per year; 

58   White  Paper  -  Strategy  for  a  future  Chemicals  Policy,  European  Commission,  {COM(2001)88 

final} 

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•  by 31 May 2013:  

Registration 

–  Substances manufactured or imported in quantities of 100 tonnes or more per 

year; and 

•  by 31 May 2018:  

–  Substances manufactured or imported in quantities of one tonne or more per 

year. 

In general, only companies who pre-registered their intention to register a substance at 
ECHA between 1 June and 1 December 2008 can benefit from these deadlines.  

Pre-registration  was  intended  to  facilitate  the  formation  of  Substance  Information 
Exchange  Forums  (SIEFs)  and  thus  to  increase  the  efficiency  of  the  registration 
system,  to  reduce  costs  and  to  avoid  duplication  of  testing,  especially  testing 
involving vertebrate animals, to allow downstream users to keep track of whether or 
not their substances are likely to be registered and also to allow ECHA to anticipate 
the volumes of registrations to be handled. 

Not  only  due  to  an  unexpectedly  high  number  of  pre-registrations  but  also  because 
registration  would  involve  a  large  amounts  of  companies  and  substances,  the 
Commission  followed  the  process  closely  during  the  first  years  of  implementing 
REACH.  Registration  contributes  to  meeting  the  aims  of  REACH  in  a  number  of 
ways, directly and indirectly. Through the gathering of data and identification of risk 
management  measures  on  substances  by  registrants,  better  information  on  risk 
management  can  be  communicated  throughout  the  supply  chain  notably  on 
occupational  safety,  fulfilling  one  the  REACH  objectives:  to  protect  human  health. 
Environmental  data  included  in  CSRs  can  also  help  companies  to  reduce  the 
environmental impact of their uses of substances, fulfilling another REACH objective: 
to achieve a high degree of protection of the environment. 

REACH introduced a harmonised set of rules for the management of chemicals in the 
EU. REACH also strives to streamline existing regulatory requirements on chemicals, 
making  the  circulation  of  chemical  substances  on  the  internal  market  easier  and 
seeking to remove national obstacles thereto. Several instruments, e.g. exemptions for 
research  and  development  or  the  tiered  information  requirements,  should  foster 
innovation. 

Pre-registration 

ECHA  reports  that  it  received  2.7  million  pre-registrations  for  146 000  phase-in 
substances.    The  number  of  pre-registrations  was  15  times  higher  than  expected59. 
However,  as  there  were  no  fees  for  pre-registration  it  appears  likely  that  many 
companies pre-registered substances before they were certain whether or not they had 

59   Originally it was estimated that 130 000 pre-registrations for 70 000 substances and intermediates 
would  be  received.    The  source  of  this  estimate  is  not  specified  in  ECHA’s  report  on  "The 
operation of REACH and CLP 2011".  

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registration obligations (i.e. may have adopted a “just in case” approach at this stage), 
e.g.  when  their  substances  were  re-imported,  recycled,  covalently  bound  during 
polymer reactions or intentionally released from articles. This approach was supported 
by  guidance  and  information  on  the  ECHA  websites  (FAQs).  Whatever  the  reason, 
the  high  number  of  pre-registrations  led  to  a  temporary  overload  of  the  ECHA  IT-
systems,  and  communications  with  industry  on  the  system  usability.    Nevertheless, 
ECHA managed to effectively process pre-registrations by reallocating resources60. 

It was noted that 82% of the pre-registering companies indicated that they were SMEs 
and  20 000  companies  indicated  an  intention  to  register  before  the  first  deadline 
(covering  approximately  250 000  pre-registrations).    However,  ECHA  reported  that 
only 10% of pre-registrations for the 2010 deadline actually resulted in registrations 
by  that  time.  The  large  number  of  pre-registrations  created  confusion  in  the  supply 
chain  as  to  the  actual  registration  intentions  and  concerns  among  some  downstream 
users for a discontinuation of a supply of substances. Following the first registration 
deadline,  the  Commission  has  not  been  presented  with  any  significant  evidence  in 
support of these concerns. 

Due to the high number of pre-registrations, there were a number of instances where 
discussions  in  SIEFs  proved  very  difficult.  In  some  cases,  communication  within 
SIEFs broke down altogether. ECHA therefore implemented two additional tools for a 
smoother functioning: the pre-SIEF, where potential registrants could discuss on the 
substance  identity  upfront  and  find  the  correct  SIEF  more  easily,  and  the  SIEF 
Formation Facilitator (SFF), who should initiate the first organisational discussions in 
the SIEF. Both tools proved to be helpful, although some difficulties were observed, 
especially with the SFF. The role of the SFF was often abused by certain actors, who 
had a purely commercial interest in providing their services to other members of the 
SIEF,  or  for  the  purposes  of  data  collection.  In  some  other  cases,  the  SFF  did  not 
show  signs  of  activity  which  meant  that  other  members  of  the  SIEF  had  to  initiate 
discussions in the SIEF. 

ECHA  reported  that  insufficient  evidence  had  been  collected  about  this,  making  the 
intervention of Competent Authorities (CAs) impossible in terms of enforcement; The 
Commission services are nevertheless of the opinion that industry should do its best to 
eliminate these practices. Within the context of the Directors’ Contact Group (DCG - 
see  below),  ECHA  also  pledged  that  it  would  investigate  the  possibility  to  improve 
the REACH-IT pre-SIEF functionality with regards to personal data protection61.  The 
Commission  services  would  support  further  efforts  by  ECHA  to  introduce 
possibilities  to  screen  abuses  of  REACH-IT  for  commercial  purposes.  The 
Commission services consider that the possibility for a SFF to be replaced by another 
member of the SIEF could help solving this problem. 

60   Study  “Review  of  the  European  Chemicals  Agency”,  PwC,  commissioned  by  the  European 

Commission, March 2012. 

61   See issue nr. 17 in "The Summary Paper on 28 issues and solutions" available on 

www.echa.europa.eu. 

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The  communication  in  many  SIEFs  was  especially  slow  in  the  beginning.  A  high 
percentage  of  members  did  not  respond  to  any  communication  at  all.  The  industry 
organisations  reacted  to  this  by  establishing  a  "voluntary  code",  giving  guidance  to 
SIEF  members  on  how  and  to  what  extent  they  needed  to  get  involved  in  the 
preparation of a joint submission62. This proved to be a helpful tool in supporting an 
organised and efficient SIEF process. 

In  order  to  address  i.a.  the  above  challenges,  the  Commission  invited  six  selected 
industry  organisations  and  ECHA  to  become  members  of  the  DCG.  The  DCG 
monitored  progress  towards  meeting  the  first  registration  deadline.  It  also  sought  to 
reduce  practical  obstacles  to  SIEF  formation  and  registration  of  substances  and  to 
address  foreseeable practical situations not detailed  in REACH. The  DCG    gathered 
important feedback on the industry’s daily work with REACH. 

Registration 

By  the  end  of  2011,  27 418  complete  registration  dossiers  had  been  submitted  to 
ECHA  for  3 676  phase-in  and  1 670  non-phase-in  substances,  so  in  total  5 346 
substances.  

By  June  2011,  ECHA  checked  approximately  400  intermediate  registrations  and 
concluded that in 86% of the cases the conditions that allow claiming the provision of 
reduced  information  requirements  had  not  been  sufficiently  demonstrated  or 
justified63. 

The vast majority of registration dossiers were submitted by large companies (87%). 
Medium-sized  companies  had  a  share  of  8%,  small  4%  and  micro-enterprises  only 
1%.  In  total,  19%  of  the  registrations  were  submitted  by  Only  Representatives  on 
behalf of non-EU manufacturers. ECHA assessed the evidence provided for reduced 
registration fees based on claimed SME status from 66 companies and found that 58% 
had wrongly identified themselves as SMEs64. 

Table 1  below  outlines the number of registered substances per year and by  type  of 
dossier. 

Table 1. Number of submitted dossiers 

Completed dossiers 

2008 

2009 

2010 

2011 

Total 

Registration of on-site isolated intermediates 

Registration of transported isolated intermediates 

Full registration dossiers 

Total registrations 

12 

46 

10 

68 

85 

1 373 

2 394 

3 864

196 

3 426 

546 

4 214 

217  18 969 

144 

19 340

498  23 768 

3 084 

27 418

Source: ECHA, The Operation of REACH and CLP, p. 10, Table 1. 

62   SIEF guidance – updated verson, CEFIC, September 2011, p. 19. 

63   The Operation of REACH and CLP, European Chemicals Agency, 2011, p. 14. 

64   Idem.. 

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Overall,  ECHA  evaluates  the  registration  process  to  date  to  have  been  a  success,  in 
part thanks to the well-functioning IT-system. For the next deadline, ECHA intends to 
further streamline the IT processes and to develop additional tools. The work of the 
DCG  showed  that  the  availability  of  the  relevant  (parts  of  the)  IT  tools  in  all  EU 
languages may be of importance to ensure access by companies, in particular SMEs, 
to  the  tools  needed  for  fulfilling  REACH  and  CLP  requirements.  In  addition,  the 
continuous  round-the-clock  availability  of  REACH-IT  in  the  period  close  to  the 
deadline will give companies additional work time to meet the deadline. 

Looking ahead to future registrations, some potential registrants have raised the issue 
of  the  capacity  of  testing  laboratories  in  the  run-up  to  the  next  phase-in  registration 
deadline65. 

Industry  also  reported,  notably  within  the  context  of  the  DCG,  that  stability  of 
guidance  documents  published  by  ECHA  was  an  important  issue.  As  guidance  is 
heavily relied on for compliance by industry, the Commission services also considers 
that it should remain stable in the months preceding any registration deadline. In that 
respect, ECHA introduced a six-month guidance moratorium on guidance documents 
ahead of the 2010 registration deadline as part of the DCG solutions. ECHA intends to 
respect such moratorium also for the next deadlines. 

An overview of the work of the DCG was published on ECHA’s website66. It consists 
of  practical  solutions  to  obstacles  to  registration  encountered  by  some  potential 
registrants in good faith ahead of the deadline. 

Inquiry 

ECHA's responsibility in the inquiry process is to bring together previous registrants 
and  new  potential  registrants  of  the  same  substance,  to  enable  most  efficient  data 
sharing. To do so, a potential registrant of a non-pre-registered phase-in substance or a 
non-phase-in  substance  has  to  submit  an  inquiry  to  ECHA.  In  2011  alone  ECHA 
received 1 970 inquiries, and managed to process about 2 100 (reducing the backlog 
from previous year). With an increasing number of registration dossiers this process is 
becoming  more  and  more  important  and  it  will  remain  so  especially  after  the  last 
deadline in 2018. 

ECHA  reported  that  close  to  the  first  registration  deadline  the  number  of  inquiries 
related  to non-pre-registered phase-in substances  suddenly peaked, while the quality 
of the information on substance identification dropped. This led ECHA to reject many 
inquiries. ECHA believes that some companies may have been acting under the false 
impression that a submitted inquiry would remedy the fact that their substances had 
not been pre-registered in due time67. 

65   Study “Technical assistance to prepare the Commission report on the operation of REACH”, RPA 

and Ökopol, commissioned by European Commission, p.32 

66   See Directors Contact Group webpage on [www.echa.europa.eu] 

67  The Operation of REACH and CLP 2011, ECHA, p. 18. 

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Industry members of the DCG reported that in some cases the inquiry process lasted 
more than three months, which was considered too long and an obstacle to companies 
to start the manufacture or import of substances. As a result, ECHA has streamlined 
its internal processes and further improved the communication with companies about 
required information, in particular on the substance identity. Inquiries were processed 
more quickly as a result of the implementation of these changes. 

ECHA is responsible for the decision regarding sameness of substances in the inquiry 
process.  In  order  to  fulfil  this  responsibility  ECHA  is  entitled  to  request  from  the 
inquirer all the information on the identity of the substance as specified in Annex VI, 
Section  2  to  REACH.  However,  bearing  in  mind  the  purpose  of  the  inquiry,  all  the 
formal requirements of Annex VI, Section 2 may not always be necessary to establish 
if  the  same  substance  has  already  been  registered.  The  Commission  services 
recommend  that  ECHA  takes  previous  registrants'  discussions  (e.g.  in  SIEFs)  into 
account when deciding on "sameness" under Article 26. Based on the observations so 
far, the Commission services invite ECHA to bear this in mind and further monitor, 
where  appropriate  and  feasible,  the  efficiency  of  the  inquiry  process  to  avoid  long 
waiting periods for industry upfront. 

Substances in articles 

The  definition  of  article  (Article  3(3))  has  given  rise  an  interpretation  issue  in  the 
context  of  provisions  of  Articles  7  and  33  with  respect  to  the  0.1%  threshold  for 
SVHC in articles. The Commission considers that the definition implies that objects 
which at a certain step in their life-cycle meet the definition of article under REACH 
cease to be individual articles once they are assembled into another article and should 
be  considered  as  components  or  parts  of  an  article  from  that  moment.  The 
Commission  therefore  does  not  consider  that  the  definition  allows  parts  of  a  more 
complex  article  to  be  articles  for  the  purpose  of  Articles  7  and  33.  This  view  is 
reflected in the Guidance on substances in articles. 

Nanomaterials 

Nanomaterials  are  a  heterogeneous  group  of  materials,  with  some  traditional  high 
volume  commodity  materials  (e.g.  carbon  black,  synthetic  amorphous  silica),  with 
newly developed medium volume applications such as paints or sunscreens, and with 
a wide range of new low volume technical and biomedical applications (e.g. catalysts, 
batteries, solar panels, tumour therapies). The total annual quantity of nanomaterials 
on  the  market  at  the  global  level  is  estimated  at  around  11  million  tonnes,  with  a 
market  value  of 
roughly  20bn  €.  Furthermore,  products  underpinned  by 
nanotechnology are forecast to grow from a volume of 200 bn € in 2009 to 2 trn € in 
201568. These applications will be essential for the competitiveness of a wide area of 
EU  products  in  the  global  market  and  can  provide  basis  for  further  innovation  in  a 

68 

Ireland’s  Nanotechnology  Commercialisation  Framework  2010  –  2014,  Forfas.  August  2010. 
available  on  www.forfais.ie.  The  figures  refer  to  the  value  of  products  into  which  nanomaterials 
are incorporated based on Lux Research. 

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wide range of other industries69. Currently, the direct employment in nanotechnology 
is  estimated  at  around  300  000  to  400  000  jobs  in  the  EU.70  There  are  also  many 
newly  founded  SMEs  and  spin-off  companies  in  this  high  technology  area. 
Nanotechnology has been identified as a key enabling technology (KET) by the High 
Level Expert Group (HLG) on Key Enabling Technologies.71  

For  a  sustainable  use  of  nanomaterials,  their safety  needs  to  be  ensured  in  line  with 
the  principles  of  REACH.  This  raises  the  question  whether  some  properties  of 
nanomaterials  are  linked  to  hazards  for  human  health  and  the  environment  not  yet 
addressed  by  REACH  and  whether  the  traditional  risk  assessment  and  management 
approaches  underlying  the  REACH  chemical  safety  assessments  are  applicable  to 
nanomaterials. This question is analysed in more detail in the Communication on the 
Second  Regulatory  Review  on  Nanomaterials  and  the  attached  Staff  Working  Paper 
on Nanomaterial Types and Uses, including Safety Aspects [insert quote]. 

The  Regulatory  Review  concluded  that:  “In  the  light  of  current  knowledge  and 
opinions  of  the  EU  Scientific  and  Advisory  Committees  and  independent  risk 
assessors,  nanomaterials  are  similar  to  normal  chemicals/substances  in  that  some 
may be toxic and some may not. Possible risks are related to specific nanomaterials 
and specific uses. Therefore, nanomaterials require a risk assessment, which should 
be  performed  on  a  case-by-case  basis,  using  pertinent  information.  Current  risk 
assessment  methods  are  applicable,  even  if  work  on  particular  aspects  of  risk 
assessment is still required.”  

On  that  basis,  the  Second  Regulatory  Review  on  Nanomaterials  concludes  that 
"Overall  the  Commission  remains  convinced  that  REACH  sets  the  best  possible 
framework for the risk management of nanomaterials when they occur as substances 
or  mixtures  but  more  specific  requirements  for  nanomaterials  within  the  framework 
have  proven  necessary.  The  Commission  envisages  modifications  in  some  of  the 
REACH Annexes and encourages ECHA to further develop guidance for registrations 
after 2013". Therefore the Commission services consider that the known hazard and 
exposure patterns of nanomaterials do not require amendments of the basic REACH 
rules or new legislation with a similar purpose as REACH.  

However,  while  experience  with  existing  registration  dossiers  shows  that  the  basic 
REACH chemical assessment framework is applicable and in principle can be used to 
demonstrate  the  safe  use  of  nanomaterials  there  is  a  need  for  more  clarity  in  the 

69  For  a  list  of  effects  and  property  improvements  through  nanotechnologies  see  Appendix  4  of 
Communication  From  The  Commission  […]  Second  Regulatory  Review  on  Nanomaterials, 
3.10.2012 {COM(2012)572}. 

70  Final  Report  of  the  High-Level  Expert  Group  on  Key  Enabling  Technologies,  European 

Commission, June 2011, p. 13. 

71  The High Level Expert Group on Key Enabling Technologies was established on 13 July 2010.  It 
was  comprised  of  27  members  including  representatives  from  EU  member  states,  relevant 
European industry, downstream industries, the research community and the European Investment 
Bank. The mandate of the High-Level Group was for one year. 

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registration  dossiers  on  how  the  safe  use  of  nanoforms  is  ensured.  As  a  first  step, 
ECHA has provided further guidance which is now available to companies. Moreover, 
based  on  available  information  on  technical  progress,  including  the  REACH 
the  current 
Implementation  Projects  on  Nanomaterials  and  experience  with 
registration dossiers, there is a need to assess relevant regulatory options in particular 
possible amendments of REACH Annexes to ensure clarity on how nanomaterials are 
addressed  and  safety  demonstrated  in  registration  dossiers.  This  should  take  into 
account in particular: 

•  current  knowledge  about  risks  of  nanomaterials  compared  to  conventional 

substances and potential risks due to lack of knowledge,  

• 

the  potential  negative  effects  of  unclear  regulatory  requirements  on 
environment and health,  

•  distorting  effects  on  competition  between  companies  resulting  from  unclear 

requirements,  

• 

identified  information  gaps  in  registration  dossiers  and  impacts  of  modified 
requirements, including on SMEs.  

For  that  reason,  the  Commission  services  will  carry  out  an  impact  assessment  to 
identify the most efficient measures to address those issues.  

Review of Registration requirements for substances in 1 – 10 tonnes 

The  Commission  has  reviewed  the  current  registration  requirements  for  substances 
registered in quantities greater than or equal to one tonne and less than 10 tonnes per 
year per manufacturer or importer (1 to 10 tonne substances).  These requirements are 
being assessed for their likely ability to identify hazardous properties of relevance to 
the protection of human health and the environment bearing in mind the impact on the 
innovation  and  competitiveness  of  the  EU  market.  This  assessment  includes 
consideration  of  the  identification  of  human  health  or  environmental  classification 
endpoints sufficient for classification under CLP, especially for CMR endpoints, plus 
consideration of the identification of potential PBT/vPvB substances. 

Options  for  the  adaptation  of  the  current  registration  requirements  have  been 
developed to reflect both increasing and reducing the registration requirements for 1 
to  10  tonnes  substances.  Reduced  requirements  include  considerations  about 
requirements set out for on-site isolated intermediates, and limiting the generation of 
Annex  VII  information  to  that  currently  available  or  capable  of  estimation  by 
alternative  methods  (including  read-across  and  (Q)SARs).    Increased  requirements 
include  the  addition  of  selected  Annex  VIII  endpoints  of  relevance  to  the 
identification  of  C,  M,  R,  P  and  B  properties,  and  the  adoption  of  the  registration 
requirements  for  10  to  100  tonne  substances  (Annex  VIII  with  and  without 
CSA/CSR).  

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Conclusion and recommendations 

Registration 

The Commission has reviewed the experience gathered during the pre-registration and 
first  registration  phases.  These  processes  were  new  for  all  stakeholders  involved  in 
REACH.  Both  industry  and  authorities  (in  particular  ECHA)  invested  considerably 
ahead  of  the  deadline  by  setting  up  tools  and  allocating  resources  to  meet  the 
challenge  of  the  first  registration  deadline.  The  first  registration  deadline  involved 
submission  of  a  high  number  of  dossiers  and  its  relative  success  reflects  good 
cooperation  and  goodwill  from  all  the  involved  parties.    Particularly  the  DCG  has 
given important feedback on the industry’s daily work with REACH. 

In  conclusion,  REACH  registration  was  a  success.  Registration  dossiers  were 
submitted  on  time,  showing  that  industry  complied  with  the  registration  obligation 
and  set  up  the  right  tools  to  prepare  for  registration.  ECHA  handled  the  first 
registration deadline effectively; a high number of registration dossiers were received 
and the IT system functioned well on ECHA’s side. However, together with industry 
(e.g. through the DCG) further improvements can be made in preparation of the next 
registration deadlines. 

Recommendations 

2.1. Concerning intermediates, as highlighted by ECHA, there is a need for awareness-raising across 

industry, including a need to encourage updating of registration dossiers. 

2.2. The  DCG  will  continue  to  monitor  preparedness  of  the  industry  ahead  of  the  next  registration 
deadline.  It  is  recommended  that  the  DCG  continues  to  examine  practical  issues  linked  with 
registration and falling under its mandate. 

2.3. Companies  should  continuously  monitor  and,  where  necessary,  update  their  registrations. 

Equally, any non-compliant dossiers must be brought into compliance. 

2.4. Without prejudice to the Commission's legal interpretation of the current legal text on substances 
in  articles  in  connection  to  Articles  7  and  33,  Member  States  and  stakeholders  are  invited  to 
provide  evidence  on  what  potential  environmental  or  other  problems  the  current  REACH 
provisions on substances in articles. 

2.5  Concerning  the  registration  requirements  for  substances  in  volumes  between  1  to  10  tonnes, 
there  is  currently  insufficient  evidence  to  justify  an  alteration  of  the  information  requirements. 
The  review  has  raised  a  number  of  issues  that  call  for  further  investigate  in  follow  up  to  the 
Communication on the review of REACH. 

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3. 

DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING 

3.1.  Data sharing 

Sharing of data served well both the animal welfare and economic objectives, 
however,  joint  registration  increased  the  risks  of  inappropriate  use  of 
substance sameness. 

One of the objectives of REACH is to avoid unnecessary testing, especially vertebrate 
animal testing, whilst generating the necessary information to identify the hazards of 
substances  and  manage  the  resulting  risks.  In  order  to  avoid  animal  testing,  tests  on 
vertebrate  animals  shall  only  be  undertaken  as  a  last  resort,  as  per  Article  25  of 
REACH.  To  meet  this  objective  as  well  as  to  increase  the  efficiency  of  registration 
and thus lower costs for enterprises, REACH provides for pre-registered and non-pre-
registered substances72 two similar data sharing mechanisms. 

Data must be shared for the same substance in the case of information involving tests 
on  vertebrate  animals.  Before  carrying  out  tests  on  vertebrate  animals,  a  potential 
registrant  must  make  sure  that  information  is  not  already  available  from  a  previous 
registrant. This is done in a Substance Information Exchange Forum (SIEF) for pre-
registered substances or through the inquiry process for non-pre-registered substances. 
Information not involving tests on vertebrate animals must be shared if requested by a 
potential registrant of the same substance. The data sharing mechanisms aim to ensure 
that  studies  which  are  already  available  are  shared  and  that  their  related  costs  are 
agreed and shared amongst potential and previous registrants in a fair, transparent and 
non-discriminatory  way.  Importantly,  in  the  case  of  lacking  data,  the  aim  of  the 
sharing mechanism is for potential registrants of the same substance to agree who will 
undertake the necessary testing to ensure that the test is carried out only once. 

In accordance with REACH, ECHA has set up procedures to assist in the resolution of 
data  sharing  disputes,  as  per  Article  27(7)  for  non-pre-registered  substances  and 
Article 30(5)  for  pre-registered  substances.  They  should  be  initiated  as  a  last  resort, 
i.e. after informal means of resolution have not brought results. 

Data  sharing  plays  a  crucial  role  in  REACH  implementation  as  it  facilitates 
registration,  thereby  fulfilling  the  aims  of  REACH.  The  Commission  examined 
several  steps  of  the  data  sharing  process.  Registrants  of  the  same  substance  under 
REACH  ideally  have  to  submit  their  registration  jointly,  in  line  with  the  so-called 
"one substance, one registration" (OSOR) principle. 

In  case  of  pre-registered  substances,  the  potential  registrants  first  must  form  a  SIEF 
and then designate a lead registrant. These two activities place a lot of responsibility 
on the industry as REACH does not prescribe any formal structure for SIEFs. In other 
words, it is up to the SIEF participants to decide on the sameness of their substance 
identity  and  set  their  internal  rules  and  organisation  while  respecting  EU  law 

72   Non-pre-registered substances can be: 1) phase-in substances which were not pre-registered, and 2) 

non-phase-in substances. 

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(especially competition law). As a third step, SIEF participants must ensure efficient 
sharing of test data for the purposes of registration. 

In  case  of  non-pre-registered  substances,  the  new  potential  registrant  has  to  contact 
ECHA  with  an  inquiry  providing,  i.a.,  relevant  information  on  the  identity  of  his 
substance, to enable ECHA to identify previous registrants for the purpose of sharing 
existing  data.  The  potential  registrant  may  use  any  study  summary  or  robust  study 
summary which has been submitted in the context of a registration at least 12 years 
previously without financially compensating the previous registrant(s). 

Substance identity and sameness 

The  determination  of  sameness  of  substances  based  on  their  individual  substance 
identities  following  the  requirements  of  Annex  VI,  Section  2  is  central  in  the 
establishment of SIEFs for phase-in substances and is applied in the inquiry process 
for  non-pre-registered  phase-in  and  non-phase-in  substances.  Since  one  of  the  main 
objectives of REACH for registration and the inquiry process is data sharing including 
the  reduction  of  testing  costs  and  avoidance  of  unnecessary  testing  in  general  and 
especially  on  vertebrate  animals,  it  follows  that  enabling  effective  data  sharing  is 
crucial in the process of determining the sameness of substance identity. 

Determination of sameness of the identity of two or more substances based solely on 
the strict comparison of the set of information gathered pursuant to Annex VI, Section 
2  often  creates  inefficiencies  as  to  the  transmission  of  information  on  substances. 
Smooth  and  efficient  data  sharing  should  be  the  main  objective  of  this  exercise. 
However,  each  registrant  needs  to  carry  out  an  appropriate  scientific  and  technical 
exercise  to  ensure  that  submitted  test  data  covers  the  hazards  and  risks  of  the 
substance in all the forms he manufactures, imports and places on the market for all 
his identified uses. 

Determining  substance  identity  and  sameness  has  proven  to  be  a  complex  task 
strongly  based  on  case-by-case  decisions.  The  Commission  services  will,  together 
with ECHA and industry, further work on more refined support to further enhance the 
identification of substances and the efficiency of data sharing. 

Expectations 

Expectations ahead of the first registration deadline pertained to how efficiently SIEFs 
were  managed  by  the  industry,  which  can  be  measured  concretely  by  the  actual 
reduction  of  tests  and  costs  that  SIEFs  achieved  and  by  the  number  of  disputes 
referred to ECHA. Another important area of expectation was the efficiency of SIEFs 
in  nominating  lead  registrants  and  the  efficiency  of  their  members  in  the  actual 
sharing  of  data.  On  this  last  point,  particular  attention  is  paid  below  to  the  ease  of 
availability and use of letters of access. 

Findings 

It  was  recognised  by  all  actors  that  difficulties  arose  in  the  designation  of  lead 
registrants and that a certain number of registration dossiers had been either subject to 

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opt-outs or submitted by registrants separately73. ECHA noted in particular that there 
had  been  difficulties  in  designating  lead  registrants  because  of  the  high  workload 
involved and a general lack of understanding of the lead registrant’s obligations. The 
late submission of lead dossiers also caused time pressure on other SIEF registrants. 
Several solutions outlined by the DCG were developed and implemented by ECHA to 
address these problems. 

The  Commission  services  consider  that  lead  registrant  issues  need  to  be  further 
monitored. ECHA indicated that it would focus its 2013 communication campaign on 
the  obligation  to  submit  registration  dossiers  jointly74.  In  addition,  ECHA  suggested 
that  lead  registrants  should  be  legally  obliged  to  make  themselves  known  to  ECHA 
ahead  of  registration  deadlines75.  The  Commission  services  would  support  a 
mechanism  to  make  lead  registrants  automatically  known  to  ECHA,  through  e.g.  an 
IT facility. 

After pre-registration, industry was required to form SIEFs and 2 176 lead registrants 
identified  themselves  voluntarily  to  ECHA.    ECHA  reports76  that  in  practice  SIEFs 
appear  to  have  suffered  due  to  the  large  number  of  (potential)  members,  making 
communication and cooperation complex and resource-intensive and causing delays. 
This assessment of the operation of SIEFs is shared by the DCG, which also indicates 
that SIEFs present specific additional challenges for SMEs who have fewer resources 
and,  hence,  are  more  vulnerable  to  unequal  treatment  and  language  barriers77. 
Moreover,  SMEs  generally  cannot  invest  as  much  time  in  REACH-related  work  as 
bigger  companies,  which  has  in  certain  cases  had  an  impact  on  the  functioning  of 
SIEFs. 

Only a small number of data sharing disputes have been forwarded to ECHA and all 
were resolved within the deadlines. ECHA believes that the existence of the dispute 
settling mechanism has encouraged data sharing in the SIEFs. However, ECHA notes 
that  penalising  breaches  of  data  sharing  obligations  is  difficult  due  to  the  different 
organisation  of  enforcement  authorities  in  the  Member  States.  Concerns  regarding 
breaches of competition rules and abuse of the dominant position of some companies 
within  SIEFs  and  in  consortia78  respectively  were  reported79,  but  could  not  be 
substantiated  by  robust  evidence.  Often  high  and  opaque  costs  of  letters  of  access 

73  The Operation of REACH and CLP, European Chemicals Agency, 2011, p. 11-12. 

74   Ibid., p. 13. 

75   Ibid., p. 18. 

76   Ibid., p. 1. 

77   Most SIEFs use English as the working language. 

78   Consortia  are  legal  constructs  based  on  a  contractual  agreement  between  the  parties  involved. 

REACH does not introduce this concept. 

79   Study  “Functioning  of  the  European  chemical  market  after  the  introduction  of  REACH”,  CSES, 

commissioned by the European Commission,. 

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were a particular concern for small firms, which can be mitigated by higher degree of 
transparency. 

It was reported that nearly 90% of all dossiers were submitted jointly, resulting in a 
total of 2 945 lead dossiers and 19 610 member dossiers (the average ratio of member 
to lead dossiers was 6.7), leading ECHA to consider the joint submission process to 
be generally working well. 

Opt-outs  from  joint  submission  for  one  or  more  endpoints  were  noted  in  135  cases 
across all dossiers. Of all dossiers in the range ≥ 1000 tonnes per year considered, 82 
dossiers covering 60 substances included opt-outs. Opt-outs related to a total of 1 437 
endpoints;  typically  two  opt-outs  were  included  per  dossier.  Furthermore,  ECHA 
received  either  multiple  joint  submissions  (of  lead  and  joint  dossiers)  or  more  than 
one individual (lead) dossier, as well as a joint submission for 250 substances and is 
investigating  the  reasons  for  this.  On  the  basis  of  these  outcomes,  the  Commission 
services  will  be  working  with  ECHA  to  identify  measures  to  eliminate  such 
duplications. 

Conclusions and recommendations 

The  data  sharing  provisions  fulfilled  the  expectations  with  regard  to  the  animal 
welfare and minimizing costs of data collection for the industry. However, there are 
particular difficulties in meeting the REACH objectives with regard to demonstrating 
safe use in cases where results of alternative methods are not sufficiently scientifically 
argued.  The  signals  of  misuse  of  the  position  of  lead  registrants  with  regard  to 
member applicants – in particular to SMEs are also of particular concern.   

The processes so far have shown also that the definition of substance identity and the 
determination of sameness of substances are some of the most challenging aspects of 
REACH.  The  Commission  services  will  keep  working  on  improved  practical 
implementation to further enhance the identification of substances and the efficiency 
of data sharing. 

Recommendations 

3.1.1.  As  to  the  difficulty  in  nominating  lead  registrants  in  SIEFs,  ECHA  is  invited  to  consider 
initiatives to promote early submission of lead dossiers and to raise the awareness of member 
registrants on the timing of dossier submission. 

3.1.2.  All  activities  by  ECHA  and  industry  are  welcome  that  help  to  disseminate  "best  practices"  in 
SIEFs,  including  developing  IT  solutions  for  improving  transparency  and  communication  within 
SIEFs. Specific support to SMEs is crucial and industry is invited to issue targeted guidance for 
these businesses. Efforts to make guidance available in more languages are also important for 
SMEs  to  be  able  to  fully  participate  to  the  data  sharing  process  under  REACH.  This  requires 
involvement of industry as well as of ECHA. 

3.1.3.  Industry  should  work  on  best  practices  concerning  the  transparency  of  costs  for  letters  of 
access and the functioning of consortia. As problems of compliance  with competition law  rules 
as  well  as  good  practice  as  to  the  dissemination  of  confidential  business  information  within 
SIEFs  have  also  been  identified,  it  is  recommended  that  industry  associations  work  on  raising 
awareness on these rules and principles to the benefit of their members. 

3.1.4.  ECHA  and  industry  are  invited  to  provide  further  guidance  to  companies  and  authorities  for 

substance identity and the determination of sameness. 

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3.2.  Avoidance of unnecessary testing 

Significant  amount  of  data  used  in  the  registration  exercise  did  not  require 
additional  testing  on  animals,  however,  progress  achieved  in  some  more 
elaborate alternative testing methods was slower then expected 

Article  25  provides  that  testing  on  vertebrate  animals  to  generate  information  may 
only be undertaken as a last resort and that it is necessary to take measures to limit the 
duplication of other tests.  It also provides that sharing and joint submission of data 
shall  concern  technical  data  and  in  particular  information  related  to  the  intrinsic 
properties of substances. Article 40 outlines the process for the examination of testing 
proposals for provision of information specified in Annexes IX and X for a substance. 

In  addition,  REACH  implements  the  principles  of  replacement,  reduction  or 
refinement  (3Rs)  as  set  out  in  Directive  2010/63/EU80  in  the  use  of  testing  and  test 
methods  involving  vertebrate  animals  laid  down  in  Regulation  (EC)  No  440/200881.  
These  tests  and  test  methods  are  used  to  provide  data  to  address  the  information 
requirements  for  substances  manufactured  or  imported  in  quantities  of  one  tonne  or 
more as set out in Annexes VII to X of REACH. 

Information  on  intrinsic  properties  of  substances  may  be  generated  by  means  other 
than tests, provided that the conditions set out in Annex XI are met. In particular for 
human  toxicity,  information  shall  be  generated  whenever  possible  by  means  other 
than vertebrate animal tests, through the use of alternative methods. 

Annex XI provides general rules for adaptation of the standard testing regime set out 
in Annexes VII–X where testing may not be scientifically necessary, including the use 
of existing data, weight of evidence such as the use of newly developed test methods 
recognised  by  the  Commission  or  Agency  as  being  equivalent,  (Q)SAR,  in  vitro 
methods and grouping of substances and read-across approach  There are also specific 
provisions for adapting information requirements as set out in Annexes VII-X. 

Expectations 

The provisions on mandatory data sharing of test data generated on vertebrate animals 
leading to joint submission of information were expected to make the biggest impact 
on the avoidance of unnecessary animal testing. Further impact was expected from the 
use of Annex XI and the submission of testing proposals prior to conducting new test 
on vertebrate animals. 

The  use  of  existing  data  was  expected  to  provide  the  most  instant  impact  on  the 
avoidance of unnecessary testing.  The major question in relation to existing data is its 
quality and subsequently its applicability to address information requirements. 

80   Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the 

protection of animals used for scientific purposes, OJ L 276, 20.10.2010, p. 33. 

81   Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to 
Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, 
Evaluation, Authorisation and Restriction of Chemicals (REACH), OJ L 142, 31.5.2008, p. 1. 

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Part I.  
Operation of REACH 

Data sharing and avoidance of unnecessary testing 

It  was  expected  that  the  use  of  weight  of  evidence,  in  vitro  methods  and  (Q)SAR 
would need to be developed and improved, and therefore would not make up a high 
percentage of the alternative methods approaches at this point in time82.  It was also 
expected  that  there  would  be  a  need  to  educate  and  further  develop  guidance  for 
registrants and regulators to support the use and preparation of justifications for such 
approaches and also to promote regulatory acceptance. 

Findings 

90% of registration dossiers were submitted jointly.  This confirms the success of the 
data sharing and joint submission schemes. 

Of the 14 875 dossiers for phase-in substances registered by end of February 2011 in 
amounts  of  1 000  tonnes  or  more  per  year,  there  were  only  19  opt-outs  concerning 
endpoints that would have required animal testing.  Endpoint study records show that 
for substances in volumes of 100 tonnes or more, registrants used data generated prior 
to the introduction of REACH as their main source of data83.  The second most used 
source of information was the application of read-across, especially for endpoints that 
would otherwise require longer-term animal studies. This indicates that the use of the 
remaining  alternative  methods  (see  figure  below)  to  address  endpoints  is  only  a 
developing  area  and  that  mainly  existing  data  is  used  to  fulfil  information 
requirements. 

Figure 1. Data Sources for Registration Dossiers84 

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Other approaches have been flagged by Registrants as "other information" but this has 
not been specified in the ECHA report. 

82   Commission Staff Working Paper, [REACH] Extended Impact Assessment, COM(2003)644 final, 

29.10.2003 

83   The 100 tonnes data was used as a reference point in the The Use of Alternatives to Testing on 
Animals for the REACH Regulation published in 2011 by ECHA [www.echa.europa.eu]  

84   Based on ECHA's Report "The use of alternatives to testing on animal for the REACH regulation"  

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Part I.  
Operation of REACH 

Data sharing and avoidance of unnecessary testing 

In  total,  574  testing  proposals  were  received  covering  1 175  tests,  of  which  711 
related  to  in  vivo  vertebrate  animal  studies.    The  operation  of  the  Member  State 
Committee  dealing  with  testing  proposals  was  successful.  ECHA  noted  that  a  main 
issue  is  information  quality  and  that  the  quality  of  justifications  for  not  conducting 
tests  (including  animal  tests)  may  be  insufficiently  robust  in  some  registration 
dossiers.    Furthermore,  ECHA  indicates  that  a  reduced  number  of  testing  proposals 
were  received  due  to  the  (inappropriate)  use  of  alternative  approaches.    ECHA  also 
reports  that  107  higher  tier  animal  tests  seem  to  have  been  conducted  without  prior 
submission of a testing proposal85. 

In  27  public  consultations  on  testing  proposals  conducted  by  ECHA  as  part  of  its 
dossier evaluation activities, no information was obtained from third parties that could 
be used to fulfil the respective data requirements86. 

The  percentage  of  endpoints  that  were  filled  with  information  from  experimental 
studies (ES), testing proposals (TP) or by use of alternative methods (AM) is provided 
in Table 2. The column “no data” (ND) applies when information is not required (e.g. 
because no positive test results triggered the need to conduct further tests). 

In summary, registrants have extensively used Annex XI of REACH to waive testing. 

Table  2.  Share  of  information  types  used  to  fulfil  obligations  for  the  different 
endpoints 

Endpoint 

Acute Toxicity 

Skin Irritation 

Eye Irritation 

Skin Sensitisation 

Repeated Dose Toxicity 

Genetic Toxicity In Vitro 

Genetic Toxicity In Vivo 

Toxicity To Reproduction 

Developmental Toxicity 

Bioaccumulation Fish 

Toxicity to Fish 

Long-term Toxicity to Fish 

85   Ibid. 

% ES87 

% TP 

% AM 

% ND 

85 

78 

75 

63 

67 

77 

41 

42 

47 

15 

75 

16 

- 

- 

- 

- 

7 

- 

- 

10 

10 

- 

- 

- 

15 

22 

25 

37 

26 

23 

32 

48 

43 

8588 

25 

8289 

- 

- 

- 

- 

- 

- 

26 

- 

- 

- 

- 

- 

86   Study “Technical assistance to prepare the Commission report on the operation of REACH” RPA 

and Ökopol, commissioned by the European Commission. 

87   Experimental studies include in vivo and, where validated, in vitro studies. 

88   Experimental studies on invertebrates were counted as alternative methods. 

89   Justification for omission. 

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Part I.  
Operation of REACH 

Data sharing and avoidance of unnecessary testing 

Long-term Toxicity to birds 

Long-term Toxicity to Mammals 

Toxicity to Other Terrestrial Organisms 

7 

1.8 

4 

- 

- 

- 

9290 

7 

4 

- 

91 

92 

Source: The Use of Alternatives to Testing on Animals for the REACH Regulation 2011, European Chemicals Agency, 
Section 3, pp. 45 – 47. 

Development and encouragement of alternatives 

ECHA is actively supporting the development of alternative methods by contributing 
to  and  hosting  the  OECD  QSAR  toolbox  and  by  cooperation  with  the  JRC 
Computational  Toxicology  Group  to  promote  the  use  of  computer-based  prediction 
methods.    The  Commission’s  Joint  Research  Centre  (JRC)  compiles  the  (Q)SAR 
models  and  administers  the  (Q)SAR  Model  Reporting  Format  Inventory  to  promote 
the use of alternative  methods.   The database is available at the JRC website and is 
free  of  charge.  ECHA  also  disseminates  information  from  the  endpoint  summary 
records  in  order  to  help  future  registrants  to  source  information  that  can  be  used  to 
predict the properties of their substances by read-across or (Q)SARs. 

In September 2010, ECHA organised a workshop to clarify uncertainty with regard to 
the use of non-test methods and develop a common understanding on the use of these 
methods  in  the  regulatory  context.    ECHA  did  not  provide  any  quantification  of  its 
support of the development of alternative methods91. ECHA is however conducting an 
ongoing programme looking at inter alia the evaluation of alternative test methods and 
participates  in  the  development  of  test  methods  and  guidance  documents  in  the 
context of the OECD. 

20 Member States appear to have made contributions from public funds to EU and/or 
OECD  work  on  the  development  and  validation  of  alternative  test  methods  with  17 
Competent  Authorities  (CAs)  providing  quantification,  as  set  out  in  Table  392.  
Overall  however,  due  to  inconsistencies  between  information  provided  by  different 
CAs, it was not possible to establish a robust estimate of the overall funding patterns 
for 3R research from the Member States reports discussed in [Title 10]. 

Table  3.  Member  State  funding  for  national  R&D  of  alternative  testing 
methodologies86 

Level of Funding (Euros per year) 

Member state 

0 to 10 000 

10 001 to 100 000 

100 001 to 1 000 000 

More than 1 000 000 

CY, LI, LV, PL, SI and IS 

BE and CZ 

BG, DK, ES, FR, NL, SE, UK and NO 

DE 

90   Currently the share of information provided by (Q)SARs is only 0.5% of all registration dossiers. 

91   The Operation of REACH and CLP, European Chemicals Agency, 2011.  

92   Study “Technical assistance to prepare the Commission report on the operation of REACH”, RPA 

and Ökopol, commissioned by the European Commission. 

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Part I.  
Operation of REACH 

Data sharing and avoidance of unnecessary testing 

Reflecting  its  strong  commitment  to  alternative  methods  to  animal  testing,  the 
Commission made available funding of about € 330 million in the years 2007 to 2011. 
Research activities account for the biggest part of the total budget with around € 290 
million spent on projects through the 6th and 7th Framework Programmes (FP6/FP7) 
and the LIFE+ Programme. These funds always needed to be complemented by own 
resources of the funded entities and, in addition, triggered the spending of further € 25 
million from industry through a public-private partnership initiative. 

Table 4. Overview of projects on alternative methods/approaches funded by the 
Framework Programmes (FP6/FP7) 

Name 

Total awarded grant  
[million €] 

Period 

2
0
0
4

2
0
0
5

2
0
0
6

2
0
0
7

2
0
0
8

2
0
0
9

2
0
1
0

2
0
1
1

2
0
1
2

2
0
1
3

2
0
1
4

2
0
1
5

FP6 

Predictomics 
CONAM 
NOMIRACLE 
TOXDROP 
ReProTect 
ACuteTox 
MODELKEY 
Sens-it-iv 
EXERA 
CAESAR 
VITROCELLOMICS 
MEMTRANS 
EUPRIM-NET 
carcinoGENOMICS 
NANOSH 
DIPNA 
NanoInteract 
Cellnanotox 
SCARLET 
InViToPharma 
INVITROHEARTEART 
LINTOP 
ForInViTox 
ARTEMIS 
COMICS 
OSIRIS 

FP7 

START-UP 
CONTAMED 
REEF 
NANOMMUNE * 
NanoTEST  * 
OpenTox 
DEER 
NEURONANO  * 
NANORETOX 
ESNATS 
PREDICT-IV 
NANODEVICE  * 
ENFIRO 
ENNSATOX  * 
ENPRA  * 

* 

EN 

2.3 
0.15 
10 
1.6 
9.1 
9.0 
8.4 
11.0 
2.2 
1.5 
2.9 
1.9 
4.8 
10.4 
2.4 
2.8 
3.3 
2.6 
0.11 
0.58 
2.7 
2.9 
0.29 
2.0 
2.2 
10.0 

0.32 
3.5 
2.9 
3.4 
3.0 
3.0 
3.5 
2.5 
3.2 
11.9 
11.3 
9.5 
3.2 
2.8 
3.7 

40

EN

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data sharing and avoidance of unnecessary testing 

Part I.  
Operation of REACH 

INLIVETOX  * 
NEPHH 
HINAMOX  * 
CADASTER 
RISKCYCLE 
SYSTEQ 
EUROECOTOX 
ACROPOLIS 
NANOHOUSE 
AXLR8 
CHEMSCREEN 
SCR&Tox  
HeMiBio  
DETECTIVE  
COSMOS  
NOTOX  
ToxBank  
COACH  

* 

** 
** 
** 
** 
** 
** 
** 

QNANO  * 
ModNanoTox  * 
NanoTranskinetics * 
Marina  * 
NanoValid  * 
Nanoreg  * 
NanoMile  * 
NanoSolutions  * 
Modern  * 
Mod-ENP-Tox  * 
NanoPuzzles  * 
PrenanoTox  * 
MembraneNanoPart  * 

Total FP6 + FP7 

2.4 
2.5 
2.3 
2.7 
1.0 
2.7 
1.0 
3.0 
2.4 
0.56 
3.5 
4.7 
4.7 
4.3 
3.3 
4.9 
1.6 
1.5 
7.0 

1.0 
1.0 
9.0 
9.6 
10.0 
9.6 
10.0 
1.0 
1.0 
1.0 
1.0 
1.0 

287.0 

The projects given above and marked with one or two asterisks form part of two research clusters as follows: 
* 
** 
the framework of FP7) and the European Cosmetics Association (COLIPA), each having awarded € 25 million. Thus, on 
top of the sum mentioned above (€ 196.9 million) COLIPA made available additional € 25 million. 

NANOSAFETY cluster 
SEURAT-1 cluster, the funding of which was realized via a joint venture between the European Commission (in 

The  second  most  important  fraction  (about  €  40  million)  was  spent  for  the 
Commission’s  European  Reference  Laboratory  (EURL)  for  Alternative  Methods  to 
Animal  Testing  (ECVAM),  hosted  by  the  Commission's  JRC.  Around  a  further  €  2 
million  went  into  various  other  test  methods-related  activities  of  the  Commission.  
Numerous alternative methods have already been developed and many of them have 
been validated by EURL ECVAM and/or accepted at international level (OECD). 

A  number  of  alternative  methods  have  been  developed  for  the  different  application 
fields and with the current advancement of toxicological sciences they emerge at an 
increasing  rate.  However,  the  development  of  non-animal  alternative  methods 
represents a considerable scientific challenge. 

During the period 2007-2011 EURL ECVAM received 48 test methods for evaluation 
and  finalised  the  validation  of  seven  alternative  methods.  At  present,  10  methods 
undergo validation studies for which ECVAM has the lead and additional six methods 
are validated by other organisations with the support of ECVAM. In the same period 
the  peer  review  of  15  methods  by  the  ECVAM  Scientific  Advisory  Committee 
(ESAC)  was  completed  and  the  peer-review  currently  is  in  progress  for  additional 
three methods. 

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Part I.  
Operation of REACH 

Data sharing and avoidance of unnecessary testing 

The  introduction  of  3  test  methods  into  Regulation  (EC)  N°440/2008  was 
accomplished  in  period  2007-2011  and  the  international  acceptance  of  6  test 
guidelines by the OECD Test Guidelines Programme was also achieved. They belong 
to  the  fields  of  acute  oral toxicology  (1),  genotoxicity  (1),  skin  sensitisation  (1)  and 
skin irritation (1) as well as eye irritation (2). Several other OECD Test  Guidelines, 
e.g.  in  the  fields  of  eye  corrosion/irritation  and  carcinogenicity,  are  under 
development. 

In some toxicological areas relevant to REACH, such as skin irritation and corrosion, 
full  replacement  has  been  achieved.  However,  other  more  complex  toxicological 
endpoints  still  lack  sufficient  alternatives  to  animal  testing  as  science  is  not  yet 
advanced  as  in  the  other  areas.  In  particular,  there  are  five  areas  of  concern,  i.e. 
toxicokinetics,  repeated  dose 
toxicity,  carcinogenicity,  skin  sensitisation  and 
reproductive toxicity, in which further efforts in research are needed. In the context of 
nanomaterials,  further  adjustment  of  the  OECD  Test  Guidelines    is  currently  being 
discussed  by  the  OECD  Working  Party  on  Manufactured  Nanomaterials  (WPMN). 
Eight  test  guidelines  have  been  identified  as  requiring  adaptation.    A  dedicated 
working  group  within  WPMN  is  examining  the  applicability  of  alternative  testing 
methods to nanomaterials. 

In addition, a gap between the outcome of research projects in terms of developed test 
methods and the fitness for application of such methods in practice is evident. Many 
new  methods  need  further  optimisation  and  adaptation  to  the  need  of  the  users.  A 
suitable  funding strategy  for optimisation  activities,  however,  is  lacking, both at  EU 
and Member State level. 

At the regulatory level, animal tests have a long history of application leading to much 
experience  in  interpreting  results.  In  contrast  to  this,  the  majority  of  in  vitro  and  in 
silico methods as well as the read-across approach referred to in Annex XI to REACH 
have  not  yet  reached  this  status.  It  will  therefore  take  further  efforts  to  build  up  the 
same  level  of  confidence  for  alternative  methods  and,  subsequently,  improve  the 
acceptance by regulators.  

Further gaps may become evident through the AXLR8 project93 that has the objective 
to  monitor  the  progress  of  EU-funded  FP6/FP7  research  projects  aimed  at  the 
development of alternative testing methods, to identify gaps in knowledge, to define 
priority research needs, and to prepare, publish and disseminate progress reports on an 
annual basis. 

Today,  toxicology  is  undergoing  a  transition  towards  a  more  mechanistic,  pathway-
based,  cell-  and  computer-based  approach  assessing  a  substance’s  toxic  mode  of 
action.  As  current  approaches  do  not  always  provide  the  complete  mechanistic 
information  on  how  the  chemicals  exert  toxicity,  large  uncertainties  remain  in 
extrapolating  data  across  dose,  species  and  life  stages.  It  is  therefore  necessary  to 

93   FP7 project "Accelerating the transition to a toxicity pathway-based paradigm for chemical safety 
assessment through internationally coordinated research and technology development (AXLR8)", 
http://axlr8.eu/  

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Part I.  
Operation of REACH 

Data sharing and avoidance of unnecessary testing 

develop  a  robust  understanding  of  the  networks  of  biological  pathways  –  many  of 
which are not yet described in full. Although several initiatives already focus on the 
pathway-based approach (e.g. the SEURAT-1 cluster94), much remains to be done in 
this  direction.    A  strategic,  international  and  cross-sectoral  approach  would  be  the 
most suitable manner of advancement. 

The European Partnership for Alternative Approaches to Animal Testing (EPAA) is a 
trade 
voluntary  collaboration  between 
associations, and companies from seven industry sectors. The aim of the EPAA is to 
pool knowledge and resources in order to accelerate the development, validation and 
acceptance  of  alternative  approaches  to  further  the  replacement,  reduction  and 
refinement (3Rs) of animal use in regulatory testing. 

the  European  Commission,  European 

Conclusions and recommendations 

There is good progress on the procedural side of data sharing and with submission of 
testing  proposals.    However,  there  are  concerns  regarding  the  robustness  of  the 
information  and  the  quality  of  justifications  submitted  to  address  information 
requirements, which may bring the dossier into non compliance with the information 
requirements.   

Overall, an allocation of € 330 million has been made available by the Commission to 
develop  and  evaluate  alternative  methods  in  the  period  2007-2011.    There  are  still 
fundamental gaps in providing alternatives for some complex toxicological endpoints.  
In addition some research outputs are produced which are not suitable for regulatory 
needs  or  which  require  further  education  of  users  and  regulators  to  ensure  their  use 
and acceptance. 

Recommendations 

3.2.1.  ECHA  should  take  measures    so  that  registrants  improve  the  quality  of  the  justifications 
supporting the alternatives to animal testing, so as to improve compliance of registered dossiers 
with the information requirements. 

3.2.2. ECHA should continue to provide guidance and training to registrants and regulators to assist in 
the use, preparation of justifications and regulatory acceptance for approaches such as weight of 
evidence, grouping of substances and read-across approach and the use of (Q)SAR and in vitro 
methods. 

3.2.3.  The  effectiveness  of  research  funding  for  the  development  of  alternative  methods  will  be 
enhanced  by  strategic  concentration.    It  is  also  of  value  to  coordinate  internationally  and  across 
sectors  to  avoid  the  repeat  of  alternative  method-related  projects  that  are  ongoing  in  other 
jurisdictions and sectors. 

3.2.4.  Alternative  method  development  will  be  further  targeted  to  regulatory  needs.  There  is  also  a 
need  to  advance  the  promotion  of  the  regulatory  acceptance  and  application  of  alternative 
methods. 

94   SEURAT-1  –  a  cluster  funded  via  a  joint  venture  between  the  European  Commission  (in  the 
framework of FP7) and the European Cosmetics Association (COLIPA), each having awarded € 25 
million.  

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Part I.  
Operation of REACH 

Information in the supply chain 

4. 

INFORMATION IN THE SUPPLY CHAIN 

REACH  promotes  cooperation  in  the  supply  chain,  at  significant  cost  for 
companies  however.  For  the  moment  it  is  too  early  to  detect  and  assess  the 
overall benefits of these provisions. 

Communication within the supply chain is a central cross-cutting theme of REACH. 
In the previous legislation the focus was only on the communication from the supplier 
down the supply chain. REACH has changed this fundamentally as downstream users 
(DUs)  and  distributors  have  to  communicate  up  the  supply  chain.  This  two-way 
communication aims at ensuring a more transparent and safer use of chemicals in the 
EU, leading to more innovation and benefits for health and environment. 

Some  elements  for  this  new  communication  approach  are  well-known,  some  have 
been newly introduced: 

–  Safety  data  sheets  (SDSs)  were  already  before  REACH  a  well-accepted  and 
effective  method to provide  recipients with information on safe storage, handling 
and disposal of substances and mixtures in the EU. With some adaptations they are 
also  an  integral  part  of  REACH.  One  of  the  major  adaptations  is  the  so-called 
“extended SDS” (eSDS), which is a SDS with relevant exposure scenarios from the 
Chemical Safety Report (CSR) attached (Article 31). 

–  The  new  obligation  to  provide  information  for  certain  substances  and  mixtures, 
which  do  not  require  a  SDS  (Article  32),  a  concept  that  was  already  applied 
voluntary before REACH in some industrial sectors and has now been extended to 
all sectors covered by REACH. 

–  The  new  duty  for  all  suppliers  of  articles  to  communicate  information  on 
substances of very high concern (SVHCs) present in articles above a concentration 
threshold  of  0.1  %  weight  by  weight  (Article  33)  to  any  recipient,  including 
consumers, who so request. 

–  The  new  duty  to  communicate  information  on  substances  and  mixtures,  e.g.  new 
information  about  risk  and  hazard,  up  the  supply  chain,  which  provides  the 
registrant  or  the  DU  with  a  more  comprehensive  picture  of  the  substances  he 
supplies and underlines the importance of cooperation between different actors in 
the REACH framework (Article 34). 

Safety data sheet and Article 32 information 

REACH requires that a SDS has to be provided not only for all hazardous substances 
and  mixtures,  but  also  for  those  substances  identified  as  persistent,  bioaccumulative 
and toxic (PBT) or very persistent and very bioaccumulative (vPvB) and/or included 
as  SVHC  on  the  candidate  list.  For  other  substances  and  mixtures,  under  specific 
conditions  described  in  Article  32  only  very  basic  safety  information  must  be 
provided. Although a particular format is not foreseen, in practice the general format 
of a SDS is also used in these situations. In general, recipients accept this approach, 
but  there  is  a  concern  that  it  may  lead  to  misunderstandings  for  the  recipients  and 

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enforcement authorities. This has been clarified so far in the Guidance on safety data 
sheets95, but should be further monitored. 

In  contrast  to  previous  legislation,  SDSs  can  now  be  provided  equally  in  paper  or 
electronically,  making  IT-solutions,  which  are  increasingly  being  applied  by 
companies,  easier  to  implement.  Although  the  use  of  modern  IT  solutions  is  highly 
recommended to streamline efficiently the communication requirements of  REACH, 
the practical implementation of electronic distribution systems is still a challenge. 

In general, REACH improved the awareness on communication about substances and 
especially  on  the  role  of  the  SDS.  As  a  result  of  increased  communication  many 
companies  have  integrated  a  chemicals  management  system  into  their  structures  for 
the first time. A wide range of resources are generally needed to set up such systems. 
It has been observed however that compared to bigger companies, in general, costs for 
SMEs are proportionally higher96. The Commission services will continue its effort to 
support SMEs and invites ECHA to continue with the development of relevant tools. 

The quality of the information provided has improved compared with the pre-REACH 
situation. Further improvements in data quality can be expected as a result of the next 
upcoming  registration  deadlines,  when  more  data  from  newly  submitted  registration 
dossiers will be available97, as well as of the adaptations from CLP and the revision of 
Annex II98, which will require certain important changes of newly supplied SDSs as 
well as those already circulating. 

On  average,  SDSs  have  doubled  in  length  and  are  now  12  to  20  pages  long.  The 
information  has  become  more  comprehensive  and  of  better  quality,  especially  for 
registered  substances.  However,  this  has  resulted  in  additional  workload,  as  the 
relevant information has to be extracted. Many companies made the observation that 
important  information  is  being  diluted  in  purely  formal  information99.  The 
Commission services invite ECHA to continue its work in this field. 

Providing  the  SDS  is  a  clear  duty  of  the  supplier.  However,  due  to  more  complex 
logistics  of  imports,  specific  difficulties  were  reported  in  the  field  of  handling 
mixtures, protecting confidential business information (CBI) and establishing efficient 

95   Guidance  on  the  compilation  of  safety  data  sheets,  Version  1.1,  European  Chemicals  Agency,  

December 2011. 

96   Study “Functioning of the European chemical market after the introduction of REACH”, CSES, 

funded by the European Commission. 

97   Study “The (nominal) risk caused by chemicals in 2012 compared to the 2007 baseline”, DHI and 

Ökoinstitut, funded by the European Commission, p. 1-4  

98   Commission  Regulation  (EU)  No  453/2010  of  20  May  2010  amending  Regulation  (EC)  No 
1907/2006  of  the  European  Parliament  and  of  the  Council  on  the  Registration,  Evaluation, 
Authorisation and Restriction of Chemicals (REACH), OJ L 133, 31.5.2010, p. 1. 

99   Study “Functioning of the European chemical market after the introduction of REACH”, CSES, 

commissioned by the European Commission, p.90. 

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communication between Only Representative and the DUs in his supply chain100. The 
Commission  services  invite  ECHA  to  continue  its  information  work  and  industry  to 
disseminate good practices. 

The extended safety data sheet 

The eSDS, a new communication tool, has not yet been widely used. According to the 
legal  obligation  to  update  the  SDS  without  delay,  this  has  been  expected  however, 
since  exposure  scenarios  are  clearly  new  information,  which  may  affect  risk 
management measures (Article 37(9)). The following reasons were reported: 

–  The first registration deadline in 2010, which was very demanding for companies 
per se and was the only source of the full required information, was given higher 
priority in matter of time and other resources. 

–  Many  existing  IT-systems  in  companies  were  not  fit  for  eSDSs  and  still  need 
fundamental  and  resource-consuming  adaptations.  Due  to  the  2010  registration 
deadline however, resources were concentrated on the registration. 

–  Supply chains can be very long and complex, so it can be assumed that in many of 

them the eSDS has not reached all recipients yet101. 

Despite limited experience, early evidence points out that eSDSs are too complicated 
and often too extensive. They are often 30 to 100 pages long and some of them are 
even up to 1 000 pages. IT-systems could support necessary data handling and reduce 
costs,  but  this  would  require  the  use  of  a  harmonised  format.  ECHA,  with  the  full 
support  of  the  Commission  and  in  cooperation  with  industry,  is  already  exploring 
possible technical solutions and guidance, which should allow an efficient exchange 
of information within supply chains. 

The existing use descriptor system102 has proven to be useful for large companies, but 
often  too  demanding  for  SMEs,  who  often  need  external  support  resulting  in  higher 
costs. In this context, significant differences between suppliers of the same substance 
and their use conditions were reported. This area requires better guidance, especially 
targeting SMEs and less experienced companies. 

In  contrast  to  substances,  there  is  no  clear  obligation  to  elaborate  and  provide  a 
mixture-specific  exposure  scenario  (ES).  Several  different  approaches  are  being 
applied for the time being. With the support of industry, ECHA has already started to 
work on a harmonised approach. This has to be finalised as a priority before the next 

100   Study “Impact of the REACH regulation on the innovativeness of EU chemical industry”, CSES, 
commissioned  by  the  European  Commission;  Study  “Functioning  of  the  European  chemical 
market after the introduction of REACH”, CSES, commissioned by the European Commission. 

101   Study  “Functioning  of  the  European  chemical  market  after  the  introduction  of  REACH”,  CSES, 

commissioned by the European Commission – Annex, p. 130. 

102   Guidance  on  information  requirements  and  chemical  safety  assessment,  European  Chemicals 

Agency - Chapter R.12: Use descriptor system. 

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registration  deadline  and  before  companies  have  implemented  their  own  internal 
standards. 

Language issues 

SDSs contain highly specialised information often in a sector-specific jargon. This is 
why translation costs can be relatively high with typical costs ranging from € 100 to € 
300 per SDS and language103, while costs for translating an eSDS are assumed to be 
significantly  higher  due  to  their  length.  These  costs  certainly  are  justified,  as  it  is 
necessary for recipients to have understandable information on the chemicals supplied 
to  them.  However,  suppliers  often  refuse  to  supply  the  SDSs  in  the  relevant  official 
language  despite  the  clear  legal  obligation  to  do  so.  Further  awareness-raising  and 
stricter enforcement in this context is advisable. 

Translations are often avoided due to liability concerns. For certain languages there is 
little experience within the translating sector104. In this respect, a wide standardisation 
of  information  similar  as  in  the  case  of  the  precautionary  statements  and  hazard 
statements of CLP could be considered. This would also help for the development of 
future  automatic  translation  systems  for  (e)SDS,  which  as  of  today  provide 
unsatisfactory results. 

Substances in articles  

Article  33  provides  that  suppliers  of  articles  containing  a  substance  included  in  the 
candidate list in more than 0.1% weight by weight have to provide recipients of the 
article with sufficient information to allow safe use of the article. Consumers may also 
request this information from suppliers of articles, in which case the information must 
be provided, free of charge, within 45 days of receipt of the request.  This provision 
seems to be a challenge for industry. The following difficulties have been reported: 

–  Six  Member  States  and  one  EEA  EFTA  State  disagree  with  the  current 
interpretation  of  the  0.1%  threshold  and  requested  ECHA  to  inform  industry  and 
other stakeholders about this divergence via the Guidance for articles. As a result, 
the objective of harmonisation of the internal market has been compromised, which 
makes communication on the presence of candidate list substances in articles even 
more  complex  and  confusing  for  companies  and  enforcement  authorities.  The 
Commission  services  stress  the  importance  of  a  harmonised  implementation  and 
have taken appropriate steps. 

–  Difficulties have been observed with regard to the lack of transitional periods after 
a substance has been identified as SVHC and included in the candidate list. Once a 
substance is on the candidate list, the information obligation applies immediately. 

103   Study “Functioning of the European chemical market after the introduction of REACH”, CSES, 

commissioned by the European Commission, p. 45. 

104   Study “Impact of the REACH regulation on the innovativeness of EU chemical industry”, CSES, 
commissioned by the European Commission, p. 72; Study “Functioning of the European chemical 
market  after  the  introduction  of  REACH”  ,  CSES,  commissioned  by  the  European  Commission, 
Annex, p. 132. 

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Although measures such as the introduction of ECHA’s Registry of Intentions and 
fixed dates for inclusion in the candidate list have already been implemented as a 
support, this should be further monitored. 

–  Potential  shortcomings  in  some  Member  States  and/or  sectors  were  reported  in 
respect  to  the  requirement  to  inform  consumers  on  SVHCs  included  in  the 
candidate  list  in  articles  on  request.  However,  retailers  and  producers  of  articles 
have already started to use SVHC-free articles as a marketing tool105. The means of 
communication  used  seem  to  be  highly  varied.  This  area  should  be  further 
monitored. 

To handle the massive information flow resulting from the information requirements 
for  substances  in  articles,  companies  and  sector  associations  have  developed  (or  are 
developing)  sophisticated  tools.  The  most  advanced  sectors  in  this  respect  are  the 
automotive  industry  and  plastics,  followed  by  aerospace  and  defence106.  The 
Commission services urge other sectors to study those examples and explore possible 
potential applications. 

Costs and benefits of supply chain communication 

Communication  requirements  in  the  supply  chain  were  expected  to  add  important 
costs to the industry; however, they were also expected to bring a number of business 
benefits on which companies could capitalise. 

E.g., it was envisaged that companies could build a greater customer confidence base 
by  referring  to  REACH,  and  although  consumers  are  not  (in  general)  aware  about 
REACH, some companies reported to use "REACH-compliance" as a marketing tool 
and claim that consumers have more confidence in their products. 

With  regard  to  these  possible  other  "marketing  advantages"  no  substantial  benefits 
from  intensified  communication  in  the  supply  chain  have  been  observed  yet.  With 
regard  to  risk  management  at  company  level,  many  companies  pointed  out  that 
REACH gave them more information about the substances they are using and led to 
an improvement of their risk management107. 

These  benefits  in  general  are  constrained  by  the  complexity  of  setting  up  ad-hoc 
systems  in  order  to  comply  with  REACH  information  requirements  and  related 
administrative complexity and other considerations: 

–  The  longer  and  more  complex  a  supply  chain  is,  the  more  negative  were  the 
experiences  described  by  the  industry.  A  very  high  degree  of  complexity  was 
reported  in  sectors  such  as  pharmaceuticals,  electronics,  aerospace,  defence  and 

105   Study “Impact of the REACH regulation on the innovativeness of EU chemical industry”, CSES, 

commissioned by the European Commission, p. 184. 

106   Study  “Functioning  of  the  European  chemical  market  after  the  introduction  of  REACH”,  CSES, 

commissioned by the European Commission - Annex, p. 130. 

107   Ibid., p. 88. 

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automotive108.  As  a  result  sectors  had  to  invest  in  IT  systems  to  support 
communication  activities  with  the  reported  cost  between  several  thousands  (for 
very  simple  databases)  up  to  €  16  million  in  some  cases109.  The  automotive 
industry  with  its  IT-supported  International  Material  Data  System  (IMDS)  is  the 
most advanced one. 

–  With  more  intensified  communication,  other  concerns  come  to  the  forefront:  EU 
competition  rules,  protection  of  intellectual  property  and  confidential  business 
information. Many companies who are in good faith complying with REACH may 
have  exposed  themselves  in  these  areas  -  this  is  especially  true  for  smaller  ones 
which  need  more  adequate  training.  Further  guidance  and  training  is  highly 
recommended. 

–  Non-EU  suppliers  consider  certain  information  requirements  under  REACH  as 
breaching  their  confidentiality  policies  and  often  do  not  share  this  information  - 
even  to  their  appointed  only  representatives  (ORs).  In  some  cases  non-EU-
suppliers have withdrawn from the EU market due to the demanding information 
obligations110. 

When  seen  in  total,  costs  arising  from  communication  requirements  are  seen  as  the 
second  largest  share  in  REACH  compliance  after  registration  costs.  The  costs  for 
SMEs seem to be relatively higher than for larger companies. Due to less knowledge 
and  expertise,  those  companies  have  to  rely  on  external  help  regularly.  A  practical 
example of a company selling 10 substances in five Member States has shown that the 
total  costs  for  developing  and  translating  SDSs  can  be  in  the  range  of  €  3 000  to  € 
5 000111. 

At  this  stage  the  Commission  services  consider  that  numerous  ways  for  costs 
optimisations  are  still  available.  E.g.,  a  significant  part  of  the  communication 
activities  was  induced  by  unclear  requirements  for  certain  actors.  Sometimes  it 
triggered  intense  flows  of  e-mails,  letters,  questionnaires  and  enquiries  etc.112.  The 
recurring  topics  were  SVHCs  in  articles  (candidate  list)  and  coverage  of  uses  in  the 
registration  dossier.  Clarifications  with  regard  to  any  remaining  uncertainties  would 
result in lower communication fatigue. 

Conclusions and recommendations 

REACH has promoted cooperation in the supply chain. Companies have implemented 
more sophisticated IT tools for communication and chemicals management thanks to 
REACH.  In  addition,  REACH  has  brought  small  companies  to  become  part  of  an 

108   Ibid., Annex, p. 130. 

109   Ibid.,, p. 45. 

110   Ibid.,, p. 65. 

111   Ibid., Annex, p. 114. 

112   Ibid., p. 101 and Annex, p. 132. 

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overall European chemicals management system. As a consequence, more than 60% 
of  companies  involved  have  established  dedicated  structures  (like  units)  and, 
therefore, manage their chemicals in a more structured way than before. However, this 
has increased costs for companies bearing a significant financial burden113. 

The  SDS  remains  the  central  communication  instrument,  but  has  been  further 
developed to become a more comprehensive source of data related to substances and 
mixtures.  Due  to  the  emerging  complexity  more  harmonisation  is  needed  on  the 
content so that IT solutions can be more easily implemented. Furthermore there is a 
need  for  more  clarity  on  different  aspects  (e.g.  translations,  role  of  ORs,  making 
available  in  an  electronic  form,  handling  of  mixtures,  confidential  business 
information, competition law). The further development of the eSDS, which is now in 
its phase-in stage, has to be followed closely. 

Information  requirements  for  SVHCs  in  articles  are  also  a  new  challenge. 
Furthermore  communication  in  practical  terms  needs  further  support,  while  lessons 
learned from different sectors are already available. The retail sector also needs to be 
more actively involved in the implementation of Article 33. 

Methodological  assessment,  communication  and  application  of  risk  management 
measures have been set into motion, but it is too early to detect and assess benefits at 
a general level. This is the reason why, at the moment, the costs are overshadowing 
the  benefits.    This  can  be  expected  to  change  with  the  next  upcoming  registration 
deadlines. 

Recommendations: 

4.1. Impact  on  costs  of  administration  will  be  monitored  and  technical/legal  support  especially  for 
SMEs  provided.  The  general  effects  concerning  communication,  cooperation  in  the  supply  chain 
and the quality of information will also be monitored. 

4.2. ECHA and MSCA should communicate and educate more about legal obligations of suppliers of 

(e)SDSs concerning language obligations. 

4.3. Industry  should  focus  on  further  knowledge-building  within  companies  concerning  REACH  in 
general  and  especially  about  issues  such  as  confidential  business  information,  EU  competition 
rules and protection of intellectual property. 

4.4. ECHA should  

• 

• 

• 

further promote (e)SDSs as the central risk  management tool and inform companies on this 
topic.  

promoting  better  understanding  of  the  role  of  OR,  including  by  reviewing  or  developing  new 
guidance if neededand  

improve guidance and support on the Use Descriptor System in particular for SMEs. 

4.5. ECHA together with the industry associations should continue developing REACH-related support 
such as multilingual databases for SDS-phrases, harmonisation tools for eSDS format, databases 
about  uses  of  SVHCs  and  IT  tools  for  the  communication  in  the  supply  chain.  Improve  practical 
usability  and  readability  of  (e)SDSs  by  cooperating  with  industry  stakeholders.  In  particular 
monitor development of eSDSs and ES for mixtures. 

113   Ibid., p. 39. 

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4.6. ECHA  and  MSCA  should  launch  support  activities  to  raise  awareness  on  Article  33  in  the  retail 
sector  and  to  improve  the  communication  in  this  respect.  In  order  to  help  small  retailers  in 
complying  with  Article  33,  list  relevant  non-confidential  information  on  uses  and  sectors  of 
application for every substance on ECHA's dissemination webpage. 

4.7. Action will be taken to ensure a harmonised interpretation of Articles 7 and 33 

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5. 

DOWNSTREAM USERS 

Downstream users 

With  REACH,  downstream  users  have  a  new  role  in  the  supply  chain  which 
requires  a  more  active  involvement  in  chemical  legislation  than  in  the  past. 
Overall, companies are positive that REACH will help to increase knowledge 
about  uses,  but  this  is  expected  to  mainly  materialise  after  the  next 
registration deadlines. 

As  a  novelty  in  chemical  legislation,  REACH  made  downstream  users  (DUs)  a 
distinct  category  of  dutyholders  and  gave  them  an  important  role  within  its 
framework. In this respect, it is important to note that in REACH the concept of use is 
very wide, covering a very broad area of industrial operations and processes extending 
far beyond the chemical industry. 

Through  rights  and  obligations  introduced  by  REACH,  DUs  became  active  players 
and  a  central  source  of  information  on  different  aspects  concerning  the  uses  of 
substances.  They  are  companies  spread  through  a  wide  range  of  sectors  (e.g. 
aeronautics,  electronics,  formulators)  and  can  be  very  different  types  of  businesses 
(e.g.  internationally  or  EU-wide  active  industry,  SME,  family  business).  They  may 
have  varied  levels  of  awareness  of  chemical  legislation  and  different  chemicals 
management structures, and due to the wide definition of a DU, they might not always 
be aware of REACH provisions. For these reasons, it is important to bear in mind that 
there is no "typical" DU. 

DUs  have  obligations  and  rights  stemming  from  many  REACH  titles:  registration, 
evaluation,  authorisation,  restriction,  communication  in  the  supply  chain.  These 
elements  are  discussed  in  the  corresponding  titles  in  more  detail.  The  discussion  in 
this title will mainly concentrate on Title V of REACH concerning downstream users. 

Role of downstream users 

Before REACH registration, knowledge of uses of substances and mixtures on the EU 
market was limited and the level of detail was varied between sectors. As described in 
[Title  2],  the  registration  process  requires,  i.a.,  an  inclusion  of  information  on 
identified  uses,  relevant  exposure  and  risk  management  measures.  This  information 
allows DUs to ensure safe use of the substances and mixtures. However, as parts of 
relevant information might not be available to the manufacturer or importer, the DUs' 
role  in  the  registration  process  can  therefore  be  to  support  the  gathering  of  all  the 
necessary information. DUs and distributors may provide information to assist in the 
preparation  of  a  registration  and  have  the  right  to  make  a  use  known  to  suppliers 
(Article 37). 

In  addition,  DUs  often  have  new  information  about  different  uses  and  ways  of 
exposure.  They  are  also  the  ones  who  apply  the  risk  management  measures 
communicated by the suppliers through the safety data sheet (SDS) or other relevant 
information  according  to  Article  32.  Their  practical  experience  with  the  substances 
can provide valuable information up the supply chain, especially about new hazardous 
properties, the appropriateness of risk management measures and new uses. 

One of the main instruments to support DU are national helpdesks established on the 
basis  of  Article  124  of  REACH  in  every  Member  State.  They  are  coordinated  by 

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ECHA  in  an  EU-wide  network  called  HelpNet,  with  the  aim  to  exchanging 
information  and  to  giving  fast,  harmonised  answers.  Some  of  these  answers  are 
eventually published on the ECHA website FAQ. 

Uses of substances 

One  of  the  most  important  obligations  of  DUs  is  set  out  in  Article  37(5).  This 
provision  requires  a  DU  to  identify,  apply  and,  where  suitable,  recommend 
appropriate measures to adequately control risks identified in SDSs supplied to him, 
in his own chemical safety assessment (CSA) and/or in any other relevant information 
on risk management measures supplied to him in accordance with Article 32. 

Usually  it  is  the  task  of  the  registrant  of  the  substance  to  carry  out  a  CSA,  to 
document it in the chemical safety report (CSR) and to reflect it in relevant exposure 
scenarios annexed to the SDS (eSDS). However, a DU shall prepare for his substance, 
on its own or in a mixture, an own CSR for any use outside the conditions described 
by the supplier or for any use his supplier advises against; alternatively he can report 
information  on  a  new  use  up  the  supply  chain  in  order  for  it  to  be  assessed  against 
risks for health and environment. 

Chemical safety report 

Once a DU decides to carry out a CSA, he has to consider a number of aspects. The 
requirements  are  usually  not  as  challenging  as  for  a  full  registration,  but  also  the 
expertise of a DU company might not usually be as high as that of a registrant. The 
same applies for experience in regulatory matters. 

If a DU decides to perform his own CSR, he must report certain information to ECHA 
within six month after receiving a registration number in a SDS. The CSR itself has to 
be performed within 12 month after receiving a registration number in a SDS. 

At the time of publishing this paper only a few notifications by DUs performing their 
own CSR were submitted to ECHA. One major reason might be that DUs have up to 
six  months  to  comply  with  the  reporting  obligations  after  receiving  the  eSDS. 
Therefore  it  is  still  rather  early  to  provide  a  detailed  view  on  this  topic.  One  has  to 
take  into  consideration  that  until  now,  it  is  mainly  substances  in  volumes  of  1 000 
tonnes or more per year that had to be registered. For these substances the knowledge 
gaps are relatively small  and  the suppliers have  more  or  less  an  exhaustive  view  on 
the  uses.  However,  this  can  be  expected  to  change  when  lower  quantity  substances 
will  be  registered.  For  these  substances  the  costs  related  to  CSR  obligations  can  be 
significant for DUs, in particular for SMEs. Depending on the individual case, costs 
are normally not more than € 25 000, but there are exceptional cases with costs up to 
€ 50 000114. These costs were estimated before the adoption of REACH at an average 
of € 8 963 and a maximum theoretical cost of € 35 850115, which is noticeably lower 
than reported now and should be further monitored. 

114   Ibid., Annex, p. 122. 

115   Study  “Assessment  of  the  Business  Impacts  of  New  Regulations  in  the  Chemicals  Sector”,  RPA, 

commissioned by the European Commission, June 2003, p. 67. 

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Fees are not foreseen in this context, so all major costs can be directly attributed to the 
cost for human resources, data collection and the actual drawing up of CSRs. Another 
factor  is  the  cost  of  external  consultants,  especially  for  SMEs.  The  mechanism  of 
drawing up a CSR is nevertheless only applicable for substances registered according 
to Article 6 and not as intermediates. Once a substance is registered as an intermediate 
only,  it  cannot  be  used  in  a  different  way. An  extension  to  non-intermediate  uses  is 
only possible, when the registrant agrees to make a registration according to Article 6. 
This  however  can  be  connected  to  more  data  requirements  and  higher  fees.  In  this 
respect  a  better  and  more  transparent  communication  in  the  supply  chain  will  be 
important  for  the  upcoming  registration  deadlines,  to  prevent  a  DU  from  using  a 
substance in a different way. This has been reported in discussions in the Directors’ 
Contact Group discussed in [Title 3]. 

There  are  also  concerns  that  registrants  are  carrying  out  exposure  modelling  using 
default  assumptions  only  and  that  this  is  resulting  in  some  cases  to  unrealistic 
recommendations  on  operating  conditions  and  risk  management  measures  for 
downstream users116. 

Registration deadline 2010 

ECHA published a list of all pre-registered substances at the end of 2008. One of the 
aims  of  the  list  was  to  give  DUs  a  possibility  to  gain  an  overview  whether  their 
substances  will  be  registered.  Due  to  the  fact  that  all  EINECS  substances  were  pre-
registered,  the  list  was  only  of  limited  use.  As  a  consequence,  before  the  first 
registration deadline in 2010 the Commission together with ECHA and industry took 
steps  to  gain  an  overview  of  all  substances  which  would  be  registered  for  that 
deadline. Especially DUs needed this information about the future availability of their 
substances for further planning. This screening was performed  within the context of 
the DCG and proved to be very useful in terms of transparency and further planning 
for DUs. 

Until now  there is no  indication  that relevant substances  have been withdrawn  from 
the market because of REACH. Certain changes in portfolios and suppliers have been 
reported  as  usual  business.  Nevertheless,  in  some  cases  REACH  has  facilitated  an 
ongoing phase-out117. 

It has been also observed that some DUs are willing to contribute to the registration 
costs  for  a  substance  that  is  critical  to  them.  This  is  done  in  different  ways,  e.g. 
through  direct  contributions  to  the  costs  of  a  registration  dossier  or  by  agreeing  on 
guaranteed  purchasing  periods  or  quantities118.  Withdrawal  of  substances  could 
become more relevant for later registration deadlines, making the monitoring work as 

116   Study "Assessment of the health and environmental benefits of REACH", RPA, commissioned by 

the European Commission, April 2012. 

117   Study  “Functioning  of  the  European  chemical  market  after  the  introduction  of  REACH”,  CSES, 

commissioned by the European Commission, March 2012, p. 60. 

118   Ibid., p. 60. 

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Downstream users 

performed in the DCG even more relevant, which is also a reason why organisations 
representing  DUs  from  different  stages  in  the  supply  chain  (e.g.  formulators  and 
producers  of  articles)  have  joined  this  group.  In  general  more  transparency  by 
registrants concerning their registration strategies would help DUs in further planning 
their  next  steps.  The  Commission  services  will  continue  to  monitor  progress  in  this 
area. 

Current situation and observations 

In  general  companies  are  positive  that  REACH  will  provide  more  knowledge  about 
uses, but this can be expected to a larger extent after the next registration deadlines. In 
addition,  studies  show  that  DUs  request  their  suppliers  to  avoid  SVHCs  and  other 
hazardous  substances,  which  could  be  a  potential  for  innovation.  Human  resources 
had  to  be  drawn  away  from  manufacturing  and  R&D  to  ensure  REACH-
compliance119. Innovation and business opportunities have not been reported yet, but 
might materialise at a later stage.  

The  situation  regarding  information  on  risks  and  hazards  seems  to  have  slightly 
improved  already  after  the  first  registration  deadline120.  However,  also  here 
companies expect to gain more information after the next registration deadlines. The 
same is valid for information on risk management measures, where more details and 
quality  are  already  being  observed.  One  of  the  major  benefits  in  this  regard  is  the 
growing  awareness  about  the  necessity  of  proper  chemicals  management  in  general 
and the role of SDSs as the central communication tool on risk management measures 
as discussed in the [Title 4] in more detail. 

Downstream users producing articles 

Producers of articles can be subject to new obligations introduced by REACH. One of 
these obligations relates to SVHCs included in the candidate list according to Article 
59.  This  can  have  impacts,  e.g.  the  need  to  communicate  information  according  to 
Article 33, which are highly relevant to those DUs who produce and supply articles. 

The impact on producers of articles varies strongly between sectors. Some sectors are 
already  familiar  with  similar  communication,  such  as  under  the  RoHS  Directive121, 
where  it  is  common  to  inform  customers  on  a  voluntary  basis  about  the  absence  of 
certain  substances  in  articles.  Other  sectors  are  only  now  confronted  with  such 
requirements.  However,  not  only  communication  requirements  have  an  impact.  The 
impact  of  providing  information  on  the  content  of  SVHC  sometimes  stretches  far 

119   Ibid., p. 98. 

120   Ibid.,  p.  88;  Study  “Assessment  of  health  and  environmental  benefits  of  REACH”,  RPA,  p.  13; 
Study “The (nominal) risk caused by chemicals in 2012 compared to the 2007 baseline”, DHI and 
Ökoinstitut, p. 1-4. 

121   Directive 2002/95/EC of the European Parliament and of the Council of 27 January 2003 on the 
restriction of the use of certain hazardous substances in electrical and electronic equipment, OJ L  
37, 13.2.2003, p. 19. 

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Downstream users 

beyond the legal requirements of REACH. E.g., some customers refuse to buy articles 
containing SVHCs. 

As described in more detail in [Title 7], the candidate list or even other, informal lists 
(e.g.  SIN-list122)  seem  to  work  in  certain  cases  as  a  blacklist,  with  the  effect  that 
customers are preferring articles free of SVHCs123. For the DU producing articles, this 
implies  finding  a  substitute  for  the  critical  substance(s).  Moreover,  when  using 
substances  already  included  in  Annex  XIV  (i.e.  requiring  an  authorisation),  EU 
producers are at disadvantage compared to the non-EU producers of articles, who are 
not bound by the authorisation requirement of REACH and often might be subject to 
less  stringent  requirement  under  their  national  (non-EU)  legislation.  This  effect  has 
been  acknowledged,  but  so  far  it  was  not  observed  in  practice,  also  because  the 
authorisation obligations will become fully functional at a later stage. 

Problems have been reported by the industry in the process of identifying SVHCs and 
listing  them  in  the  candidate  list.  The  process  was  claimed  to  be  too  quick  and 
unpredictable,  to  cause  problems  with  developing  substitution  plans  on  time  and  to 
demand  constant  monitoring.  These  issues  have  been  already  taken  up  and  the 
candidate list is now regularly updated at fixed dates twice a year.  

There  have  been  many  cases  of  companies  who  stated  having  greater  confidence  in 
EU products thanks to the requirements of REACH. 

Conclusions 

DUs  may  have  varied  levels  of  awareness  of  chemicals  legislation  and  different 
chemicals  management  structures.  It  has  also  been  reported  that  some  affected 
companies  might  not  have  knowledge  of  REACH  provisions  at  all,  which  is  a  non-
surprising consequence of the wide definition of DUs. 

Although REACH has led to additional administrative work in order to comply with 
its  requirements,  in  general  DUs  are  taking  responsibility  towards  REACH 
compliance.  An  important  contribution  comes  e.g.  from  industry  associations  and 
chambers  of  industry  and  commerce,  where  the  support  is  given  through  a  wide 
variety  of  tools,  starting  from  general  information  similar  to  information  obtained 
from  national  helpdesks  to  very  sector-specific  support,  which  is  often  going  far 
beyond  what  authorities  can  offer.  The  Commission  services  invite  industry 
stakeholders to continue developing tools designed to help DUs. 

The guidance provided so far by ECHA is perceived as sufficient, especially after the 
improvement  of  translation  activities  by  ECHA.  The  issue  of  DU-CSA  will  become 
more  relevant  in  the  near  future  and  it  should  be  monitored  to  which  extent  the 
existing  guidance  is  sufficient.  The  Commission  services  invite  ECHA  to  further 
develop its DU-targeted tools (e.g. ENES, CHESAR and the tools for SDSs). 

122   "Substitute It Now", a list published by Swedish NGO ChemSec. 

123   Study  “Functioning  of  the  European  chemical  market  after  the  introduction  of  REACH”,  CSES, 

commissioned by the European Commission, March 2012, p. 66 and 101. 

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Awareness  and  knowledge  on  REACH  among  smaller  DU  companies  is  sometimes 
very low or even non-existent. This is a matter of concern and should be monitored. 
Existing  channels  such  as  the  DCG,  the  Europe  Enterprise  Network,  industry 
stakeholders  (e.g.  UEAPME,  CEFIC,  DUCC  and  other  sectoral  organisations), 
national helpdesks or HelpNet are useful tools for this task and should be used by the 
Commission and ECHA, as they have been in the past on different occasions. 

Recommendations 

5.1. ECHA  and  Member  States  are  invited  to  support  further  awareness-raising  and  knowledge-
building  within  DU  companies.  Member  State  helpdesks  and  Competent  Authorities  (CAs)  are 
invited, based on lessons learned from industry examples, to provide sector-specific support. DU 
organisations and other existing networks in relevant discussions, notably at the level of the DCG 
will  continue  to  be  involved;  this  is  especially  relevant  for  the  upcoming  registration  deadlines  in 
2013 and 2018. 

5.2. Impacts on competitiveness, including on producers of articles will be monitored. 

5.3. Impacts on innovation, especially in respect to possible diversion of resources from R&D to legal 
compliance,  including  the  resources  needed  for  the  development  of  DU-CSR  (Annex  XII)  will 
continue to be monitored.   

5.4. Industry  is  invited  to  promote  more  transparency  within  the  supply  chain,  especially  about 

registration plans for specific substances and their uses. 

5.5. Industry is invited to further raise awareness on SDSs and eSDSs being central risk management 

tools with a view to disseminate good practices within supply chains. 

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6. 

EVALUATION 

Evaluation 

Dossier evaluation is a critical step for ensuring credibility of the registration 
process  and  is  serving  to  improve  the  quality  of  the  registrations  dossiers. 
However, much more was expected with regard of the commitment of Member 
States to the substance evaluation. 

E  in  REACH  stands  for  Evaluation.  As  the  safe  use  of  substances  under  REACH 
starts  with  compliant  high  quality  registration  dossiers 
industry’s 
responsibility, REACH provides for the follow-up to the registration by the possibility 
to evaluate these dossiers, assess their compliance and request additional information 
or order further tests when essential data is required. 

that  are 

Title  VI  of  REACH  describes  three  types  of  evaluation  under  REACH:  dossier 
evaluation,  comprising  compliance  check  and  the  examination  of  testing  proposals 
(Chapter 1: Articles 40 to 43), substance evaluation (Chapter 2: Articles 44 to 48) and 
the  evaluation  of  intermediates  (Chapter  3:  Article  49).  In  Chapter  4:  Articles  50  to 
54, the common provisions for functioning of evaluations, the adoption of evaluation 
decisions and the publication of information on evaluation are laid down. 

In examination of testing proposals, ECHA examines all testing proposals submitted 
by  the  registrants  for  provision  of  the  information  set  out  in  Annex  IX  or  X.  In 
compliance check, ECHA determines whether or not the information submitted in the 
selected subset of registration dossiers is in compliance with REACH. 

There  may  be  grounds  for  concern  that  a  specific  substance  represents  a  risk  for 
human  health  or  the  environment  but  the  concern  still  needs  to  be  clarified  before 
action  such  as  the  authorisation  or  restriction  procedure,  if  required,  is  considered. 
ECHA can then in cooperation with the Member States take the necessary steps for a 
substance to be placed in the Community Rolling Action Plan (CoRAP) and evaluated 
under substance evaluation. 

The general REACH provisions for dossier and substance evaluation do not apply to 
on-site isolated intermediates. However, where the Competent Authority (CA) of the 
site’s location has concern regarding serious risk to human health or the environment 
that  is  not  being  properly  controlled,  the  CA  can  require  the  registrant  to  provide  it 
with the information needed to assess this concern. Following its evaluation, the CA 
with concerns must inform ECHA which then informs other CAs and communicates 
the results. 

In terms of responsibility for the process, dossiers subjected to dossier evaluation are 
evaluated by ECHA. In substance evaluation, the evaluation is performed by the CA 
that  has  been  designated  to  perform  the  evaluation  in the  CoRAP.  In  both  cases  the 
prepared draft decision may be commented by the registrant(s) and the CAs; the latter 
may  propose  amendments  to  the  decision.  These  are  discussed  in  ECHA  Member 
State Committee (MSC) referred to in [Title 10]. When the MSC members agree by 
consensus,  the  final  decision  can  be  adopted  by  ECHA,  otherwise  the  matter  is 
referred to the Commission. All evaluation procedures run under strict deadlines that 
importantly determine the organisation and workload of ECHA, MSC as well as CAs. 

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Evaluation 

Examination of testing proposals ensures that the higher tier testing, including testing 
on vertebrate animals, addresses true information needs of REACH and that tests are 
not performed when the information is already available or in preparation, addressing 
prevention of unnecessary animal testing. 

Identifying  non-compliance  in  the  evaluated  dossiers  and  requiring  action  by 
individual  registrants  through  legally  binding  decisions  addresses  the  deficiency  of 
those  evaluated  dossiers  and  enables  enforcement,  but  also  more  widely  promotes 
compliance  and  the  respective  quality  of  dossiers  by  all  registrants.  Substance 
evaluation also enables the requirement of information that is not part of the REACH 
standard  information  requirements,  addressing  any  substance-specific  potential 
limitation  in  ensuring  the  provision  of  an  adequate  basis  for  risk  assessment. 
Evaluation is also often the first mechanism within REACH where an implementation 
issue or the scientific and technical process is identified that may trigger improvement 
of particular guidance or other activity. Through these features evaluation facilitates a 
level-playing field implementation of REACH and is an important enhancer of human 
health and environmental benefits. 

Dossier evaluation 

The requirement to perform compliance check on at least 5% of registration dossiers 
in each tonnage band and ECHA own targets lead to ca. 1 000 dossiers submitted by 
the first registration deadline to be checked for compliance by the end of 2013, with 
up  to  600  further  dossiers  annually  thereafter  for  an  unspecified  length  of  time.  In 
2011  only,  158  evaluations  were  initiated  and  146  completed  under  compliance 
check124. Dossiers to be evaluated are selected by ECHA on the basis of prioritisation 
criteria  outlined  in  Article  41(5),  as  well  as  on  the  basis  of  search  algorithms  that 
introduce  a  degree  of  randomness  to  substance  selection  and  also  allow  setting  the 
focus upon specific areas of concern that may be identified. 

In  its  annual  reporting  under  Article  54124,  ECHA  derives  some  statistics  of  the 
evaluation process. The 146 completed compliance checks in 2011 concluded in 105 
final decisions and 19 quality observation letters (QOBLs)125, with 22 closed without 
administrative  action  before  or  sometimes  even  after  the  draft  decision  was  issued. 
The  very  high  proportion  of  final  decisions  within  the  total  number  of  dossiers 
evaluated  is  due  to  the  large  number  of  targeted  compliance  checks  on  substance 
identity  that  were  triggered  by  concern  identified  during  examinations  of  testing 
proposals.  For  the  randomly  selected  dossiers  and  the  dossiers  selected  through 
concern-driven  selection,  the  percentage  resulting  in  final  decision  was  lower  (41% 
and  52%,  respectively).  Final  decisions  in  general  addressed  more  than  one 
information  item  to  bring  the  registration  into  compliance.  Main  information  items 
requested  were  on  substance  identity  (Annex  VI,  Section  2),  mutagenicity  (Annex 
VIII,  point  8.7.1),  prenatal  developmental  toxicity  (Annex  IX,  point  8.7.2)  and 
predicted  no-effect  concentration  as  part  of  the  environmental  hazard  assessment 

124   Evaluation under REACH, Progress Report 2011, European Chemicals Agency, 2011. 

125   In  certain  cases  ECHA  sends  a  letter  to  the  registrant  that  includes observation  on  the identified 

deficiencies in the dossier that had however not been included in the decision. 

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Evaluation 

(Annex  I,  point  1.4.1).  Main  identified  shortcomings  addressed  in  the  QOBLs126 
include  classification  and  labelling,  CSR-related  PNEC  or  DNEL  derivation,  and 
substance identity. 

The Commission services note that, while the representativeness of the sample to date 
as to the compliance status of dossiers in general is still limited, the initial analysis of 
decisions  identifies  principal  compliance  shortcomings  with  respect  to  substance 
identity,  justification  for  data  waiving  and  the  level  of  detail  within  robust  study 
summaries. These identified areas of concern were to an important extent anticipated 
due to the scope and newness of registration requirements. 

As regards the examinations of testing proposals, 80 out of 587 examinations in 2011 
were  closed  or  resulted  in  a  final  decision,  with  a  further  144  at  the  draft  decision 
stage. The vast majority (92%) of the examinations addresses the testing proposals for 
phase-in  substances.  Roughly  three-quarters  of  all  examinations  of  testing  proposals 
also include third party consultation as they cover testing on vertebrate animals, and 
in  2011  ECHA  received  481  comments  from  non-governmental  organisations, 
companies, industry or  trade  organisations and  individuals.  The  majority  (13)  of  the 
22 final decisions in 2011 cover the non-phase-in substances for which the deadline 
for the examination of testing proposals is six months, while the proposals for phase-
in substances submitted within the first registration deadline need to be evaluated by 1 
December 2012. 

Dossier evaluation procedures by all involved actors, and in particular ECHA, are by 
now well-established and are generating decisions at an accelerated rate. Scrutiny of 
ECHA work by MSCA is apparent through the fact that, e.g., 11 out of the 22 final 
decisions  adopted  in  2011  received  at  least  one  proposal  for  amendment  by  a  CA, 
triggering  discussion  in  the  MSC  before  adoption,  see  [Title  10].  To  date  however, 
the  only  issue  that  has  not  been  resolved  unanimously  within  MSC  and  for  which 
therefore the related decisions127 have been passed to the Commission, is on the study 
protocol to be used for addressing the information requirement of Annexes IX and X, 
point  8.7.3.  "Two  generation  reproductive  toxicity  study".  Some  members  were  in 
favour  of  requesting  the  OECD  TG  443  "EOGRTS"  study,  whilst  others  could  not 
agree  on  imposing  the  use  of  the  new  guideline  (also  in  light  of  the  existing  EU 
method  B.35)  or  could  only  accept  its  use  within  certain  specifications.  The 
Commission has until now not concluded its deliberation in these cases, so the dossier 
evaluation process in this last variation has not yet been tested in full. 

Registrants are kept informed about the dossier evaluation process, their rights, their 
obligations  and  the  possibilities  to  interact  with  ECHA  at  several  points  in  the 
procedure.  When  issues  are  referred  to  the  MSC,  representatives  of  the  registrants, 
and  when  agreed  by  the  registrant  also  the  stakeholder  observers  are  offered  a 
possibility  to  be  present  at  the  session  where  their  case  is  addressed,  see [Title  10]. 

126   Quality Observation Letters – for definition and further assessment see concluding paragraphs of 

this chapter. 

127   Four by February 2012. 

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Nevertheless, it has been reported that registrants often find the procedures complex 
and may misinterpret the objective or steps in the exercise. 

As regards the final decisions, only two had been appealed as of 15 April 2012 by the 
registrants. Both appeals are still pending. 

To  date  no  testing  proposal  has  been  rejected  on  the  basis  of  the  third  party 
information. 

Dossier  evaluation  has  until  now  processed  all  dossiers  within  the  prescribed 
deadlines. To ensure that the remaining almost 700 compliance checks to be carried 
out by the end of 2013 and that all examinations of testing proposals are processed in 
time,  dossier  evaluation  has  significantly  raised  its  throughput  in  2012,  and  the 
potential impact of this additional strain on the process is not yet apparent. Increase in 
efficiency  is  clearly  required.  It  is  pursued  through  repeated  re-examination  of  the 
process within MSC. Efficiency has also been the principal focus of the January 2012 
2nd Workshop on Dossier Evaluation. 

Dossier  evaluation  will  either  result  in  decision  or  be  concluded  without  any 
administrative  action  when  a  decision  is  not  required  or  cannot  be  made  at  the 
relevant  point  in  time.  An  additional  tool  used  in  the  evaluation  context  are  the 
QOBLs  in  which  ECHA  invites  registrants  to  revise  their  registration  dossiers  and 
address shortcoming not related to formal data gaps. The incentive of these letters is 
to  inform  registrants  and  CAs  on  quality  issues  in  registration  dossiers  that  raise 
concern.  The  letters  are  sent  alongside  evaluation  decisions  or  may,  in  compliance 
check cases, be the only communicated result. 

As the QOBLs require additional administrative effort but are not legally required nor 
contain legally binding obligations, their added value has been questioned. The initial 
assessment shows fair response by the addressed registrants, with appreciation of the 
provided  information  by  the  CAs  and  enforcement  authorities.  Bearing  in  mind  that 
the analysis work leading to the drafting of a QOBL is in any event carried out as part 
of the evaluation process, the Commission services believe that QOBLs provide real 
added value at little additional work. 

The Commission closely monitors the overall impact of the implementation of dossier 
evaluation on compliance and on the quality of registration dossiers, as this impact is 
a  direct  consequence  of  the  application  of  Article  41(5)  (including  the  >5% 
requirement) that can be modified in accordance with Article 133(4). At present, no 
robust conclusions can be drawn due to the still limited number of evaluations and the 
relatively short time of implementation. 

Progress  in  the  compliance  check  strategy  in  terms  of  selection  of  dossiers  and 
targeting of their evaluation to specific areas of concern, where automated tools can 
be exploited, can also contribute to the increase in efficiency and the achievement of 
goals  of  dossier  evaluation.  Innovative  approaches  had  already  been  discussed 
between  ECHA,  CAs  and  the  Commission  and  are  now  being  further  developed  by 
ECHA. 

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Substance evaluation 

Evaluation 

In  February  2012,  the  first  substance  evaluations  were  launched,  following  the 
adoption  of  the  first  CoRAP  covering  a  period  of  three  years  and  published  on  the 
ECHA website128. The CoRAP will be revised annually. 

Exacerbated  by  the  initial  uncertainty  in  the  exercise  and  the  eventual  intensity  of 
resources  required,  Member  States  have  been  reluctant  to  pledge  their  commitment 
for a significant number of substances for any of the first three years. 36 substances 
are being evaluated in 2012 by 17 Member States, with 90 substances assigned for the 
three-year  period.  This  is  significantly  lower  number  than  the  initial  expectation  of 
250  substances  (ca.  50  in  2012  and  100  substances  annually  thereafter).  In  some 
cases, two CAs have agreed to evaluate a substance together, with one CA in the lead. 

CAs now have 12 months after the publication to evaluate the substance and prepare a 
draft decision. The substance evaluation provisions of REACH have thus not yet been 
fully  implemented.  In  contrast  to  the  compliance  check,  where  a  single  dossier  is 
being evaluated, the CA under substance evaluation evaluates all dossiers in which the 
substance  is  covered,  and  the  decision  may  include,  stating  reasons,  information 
requirements that go beyond standard information requirements of Annexes VII to X 
to REACH. There are practical implementation aspects that were already discussed in 
several workshops.  

Following  evaluation,  CAs  are  required  to  inform  ECHA  of  whether  and  how  the 
results of the evaluation should be used, information that ECHA must then pass on to 
the registrant, the Commission and other CAs. 

During the preparation of the CoRAP, stakeholders had indicated lack of transparency 
in  the  identification  process  of  candidates  for  the  CoRAP  list.  There  has  even  been 
some  misunderstanding  that  substances  put  on  CoRAP  are  somehow  'blacklisted', 
though  placing  on  CoRAP  should  have  no  impact  per  se  on  the  substances  as  the 
outcome of the evaluation may be a confirmation or the refutation of a risk. 

With  the  first  CoRAP,  ECHA  also  provides  very  limited  information  on  the 
justification  for  the  selection  of  substances,  as  the  prepared  CA  justification 
documents have not been sufficiently assessed for sensitive information and therefore 
have to remain confidential. 

Experience with the preparation of the 2012 CoRAP indicates that improvements are 
needed in the selection process, in the access of IT tools by Member States and in the 
general coordination between ECHA and CAs. 

Evaluation of intermediates 

Supporting CAs, ECHA has in 2011, on the basis of its initial screening of dossiers on 
intermediates conducted in 2010, undertaken a new verification of intermediate status. 

128   Document  "Community  Rolling  Action  Plan  (CoRAP)",  29  February  2012  [available  on 

www.echa.europa.eu] 

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Evaluation 

A manual screening of approximately 400 selected dossiers of on-site and transported 
isolated intermediates identified several cases where the information contained within 
a  dossier  is  insufficient  to  check  if  reduced  registration  for  isolated  on-site  or 
transported  intermediates  was  justified  according  to  Article  17  or  Article  18, 
respectively. By the end of 2011, 40 letters related to 17 substances were sent to the 
registrants,  requesting  further  information  in  accordance  with  Article  36.  Further 
action  by  ECHA  may  follow  as  the  responses  to  the  letters  sent  in  accordance  with 
Article 36 are assessed in 2012.  

Conclusions and recommendations 

The Commission services note that dossier evaluation is on track, but acknowledges 
important  challenges  ahead.  While  it  is  as  yet  not  possible  to  identify  its  positive 
impacts (e.g. downwards trend in the proportion of non-compliance in the evaluated 
dossiers),  decisions  as  the  principal  output  of  the  process  are  being  produced  at  an 
accelerated  pace  and  with  scientifically  and  legally  sound  argumentation.  The  main 
challenge ahead is to ensure continuous quality of output while having a much higher 
throughput that is required already at present but also in the foreseeable future. 

The Commission services therefore support recommendations that have been brought 
forward  in  ECHA  Workshop  on  Dossier  and  Substance  Evaluation  31  Jan  -  1  Feb 
2012 to increase the efficiency of the process by: 

–  optimising  all  underlying  technical  support  such  as  IT  tools,  to  minimise 

administrative burden; 

–  even better interaction between main actors (ECHA, MSC and CAs), in particular 
in proactively addressing generic issues (e.g. application of new test method) and 
feedback  to  CAs  on  discussions  in  MSC  and  the  rationale  behind  the  decisions, 
resulting in streamlined commenting and proposals for amendments; 

–  optimisation of dossier selection and targeted compliance check, limiting in cases 
the  number  of  endpoints  addressed  and  focusing  on  few  identified  areas  of 
concern,  enabling  a  large  number  of  non-compliant  dossiers  to  be  addressed  by 
legally binding decisions thus maximising the regulatory impact. 

Some  of  these  recommendations  are  already  being  put  into  practice  by  ECHA.  The 
the 
Commission  services  will  continue 
implementation  of  dossier  evaluation  on  compliance  and  the  quality  of  registration 
dossiers and may in future propose modification of Article 41(5) if appropriate. 

the  overall 

to  monitor 

impact  of 

Follow-up to the dossier evaluation decisions is an emerging issue, as for example 42 
updates  of  dossiers  following  targeted  substance  identity  check  decisions  have  been 
received and the follow-up procedure initiated by ECHA. There are already situations 
where the update has not yet been received, although the deadline has expired. 

While it is too early to conclude about substance evaluation, it is clear that the number 
of  substances  committed  to  date  by  Member  States  is  below  the  initial  expectation. 
The  Commission  services  also  note  that  further  work  on  transparency  of  the 
evaluation process is required, between the registrants but also with stakeholders and 

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general  public,  probably  not  as  much  by  modifying  the  process  as  by  stepping  up 
communication and awareness-raising.  

Recommendations 

6.1  An assessment by ECHA and CAs of the benefits and resource implications of using QOBL within 

2 years is recommended. ECHA is encouraged to continue using QOBL where effective. 

6.2. ECHA  is  invited  to  re-examine  and  streamline  the  third-party  consultation  process,  for  example 
through standardised replies and further guidance to focus these contributions to further increase 
efficiency of the dossier evaluation. 

6.3. ECHA  is  invited  to  pay  specific  attention  to  the  follow-up  to  the  evaluation  decisions;  taking  into 

account resource implications and coordination with Member State enforcement actions. 

6.4. CAs are encouraged to enhance their capacity in relation to substance evaluation. ECHA is also 
invited  to  enlarge  the  number  of  substances  to  be  considered  for  inclusion  in  the  CoRAP  and 
provide support to CAs performing substance evaluation. 

6.5. ECHA  is  invited  to  make  future  substance  evaluation  justification  documents  public  while 

respecting the requirements of Articles 118 and 119 of REACH. 

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7. 

AUTHORISATION 

Authorisation 

The authorisation process is not yet fully operational, but important progress 
has been made in the preparation of Annex XV dossiers for substance of very 
high  concern  (SVHC)  identification,  in  populating  the  candidate  list  and  in 
including  substances  in  Annex  XIV.  Efforts  should  continue  to  possibly 
intensify the SVHC identification process. 

Selection of substances for the candidate list and Annex XV dossiers 

The first step of the authorisation process is the preparation of a so-called "Annex XV 
dossier" for SVHC identification by a Member State or ECHA (the latter on behalf of 
the Commission). 

SVHCs  are  substances  whose  intrinsic  properties  meet  one  of  the  following  criteria 
set out in Article 57: 

–  the criteria for classification as carcinogenic, mutagenic or toxic for reproduction 

(CMR) category 1A or 1B in accordance with Annex VI to CLP; 

–  Substances that are persistent, bioaccumulative and toxic (PBT) or very persistent 
and very bioaccumulative (vPvB) in accordance with the criteria of Annex XIII; 

–  Substances  that  give  rise  to  an  equivalent  level  of  concern  to  substances  of  the 
previous categories on the basis of scientific evidence of probable serious effects to 
human health or the environment. 

Until now, most Annex XV dossiers include CMRs and mono-constituent substances. 
In fact, the identification of a substance as SVHC is straightforward in case of mono-
constituent  CMR  substances  included  in  Annex  VI  to  CLP.  However,  Annex  XV 
dossiers are more complicated for substances with several constituents and substances 
of  unknown  or  variable  composition  or  biological  origin  (UVCBs)  because  of 
complex  substance  identity,  for  PBTs  and  vPvBs  because  of  the  absence  of  a 
classification according to CLP, and for substances of equivalent concern according to 
Article 57(f), which need to be identified on a case-by-case basis. 

By 1 June 2012 the candidate list contained: 

–  67 CMRs identified according to Article 57(a), (b) and (c); 

–  four PBTs identified according to Article 57(d); 

–  one vPvB identified according to Article 57(e); 

–  one  substance  of  equivalent  concern  identified  according  to  Article  57(f)  (as  an 

endocrine disruptor), added in December 2011. 

As  far  as  PBTs  and  vPvBs  are  concerned,  ECHA  established  an  ad-hoc  group 
composed of Member States, ECHA and Commission experts at the end of 2011 with 
the view to cover detailed scientific questions and issues related to PBT identification 
and therefore facilitate their identification. 

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The  procedure  foreseen  in  Article  59  for  SVHC  identification  proved  to  work  in  an 
efficient  way  for  the  seven  identification  exercises  conducted  from  October  2008  to 
December  2011.  During  that  period  the  members  of  the  Member  State  Committee 
(MSC)  were  always  able  to  get  unanimous  agreement  on  the  identification  of  the 
substances  and  the  Commission  was  not  asked  to  prepare  a  proposal  for  SVHC 
identification according to Article 59(9). 

As  indicated  above,  REACH  foresees  a  multiple  right  of  initiative  in  the  process  of 
SVHCs  identification:  any  Member  State  or  ECHA  (the  latter  on  behalf  of  the 
Commission)  may  submit  an  Annex  XV  dossier  and  no  platform  for  prior 
coordination  is  foreseen.  This  novelty,  together  with  the  introduction  of  the 
authorisation process as an addition to the pre-existing restriction process, made clear 
to  ECHA,  Commission  and  Competent  Authorities  (CAs)  a  need  to  identify  at  an 
early  stage  which  initiatives  were  taken  by  which  authorities  and  whether 
authorisation  and/or  restriction  are  an  appropriate  way  to  address  the  potential  risk 
posed by substance, as further explained in [Title 7 and 8]. A workshop organised by 
ECHA  in  January  2009129  recognised  the  need  for  close  coordination  among  the 
different  actors,  in  order  to  apply  a  coherent  approach  and  to  use  resources  in  an 
efficient way. At the same workshop, a risk management option (RMO) process was 
put  in  place  with  the  full  support  of  Member  States,  ECHA  and  the  Commission  to 
reach two main objectives: 

–  Discuss  the  different  regulatory  options  and  their  effectiveness  as  far  as  possible 

before proposing a substance for SVHC identification; 

–  Coordinate the activities of all the actors in charge of the process. 

From  2008  onwards,  possible  candidates  for  SVHCs  have  been  screened  looking 
mostly  at  substances  classified  as  CMR  category  1A  and  1B.  The  identification 
exercises  will  be  more  and  more  based  on  new  information  (from  2013-2018, 
registration dossier and evaluation activities) and on new approaches (application of 
Article 57(f) to substances of equivalent concern and of the amended Annex XIII for 
PBTs and vPvBs).  Information submitted by registrants in the CSR is critical for this 
exercise.  The  RMO  process  now  sets  the  framework  to  agree  on  a  common  and 
coordinated approach to the future selection of SVHCs. 

The  Commission  services  strongly  support  to  continue  working  in  a  common 
framework  for  the  screening  of  SVHCs  in  a  coordinated  way,  especially  for  the 
identification of substances of equivalent concern. The Commission services believe 
that identification of SVHCs according to Article 57(f) should take place by preparing 
Annex XV dossiers for specific cases, and, in parallel, by developing guiding criteria. 

The  Commission  services  believe  that,  in  the  process  of  Annex  XV  preparation, 
attention  should  be  dedicated  to  those  substances  for  which  the  identification  as 

129   See  document  "Workshop  on  the  Candidate  List  and  Authorisation  as  Risk  Management 
[available  on 

January  2009, 

Instruments,  Workshop  proceedings"  Helsinki,  21-22 
www.echa.europa.eu] 

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SVHC  is  not  straightforward  (complex  substances,  PBTs,  vPvBs  and  substances  of 
equivalent  concern).  A  common  understanding  should  be  developed  to  define  the 
information  needed  for  substance  identification  in  order  to  be  able  to  implement  all 
steps of the authorisation process. 

Looking at the activities in the medium term, the Commission services would support 
a roadmap in the framework of the RMO process, to achieve the objective to include 
all  relevant,  currently  known  SVHCs  in  the  candidate  list  by  2020.  The  milestones 
should include: 

–  Complete the screening of the classified CMRs to identify the relevant ones for the 

candidate list; 

–   Build  experience  and  develop  criteria  to  identify  the  substances  of  equivalent 

concern and include the relevant ones in the candidate list; 

–  Use the data from 2013 and 2018 registration dossiers and the results of evaluation 
activities  to  select  relevant  SVHCs  not  identified  with  the  previous  screening 
activities. 

The candidate list 

Once  the  MSC  has  agreed  on  the  identification  of  a  substance  as  a  SVHC,  ECHA 
places it on the candidate list, which is published on its website.  

It has been agreed by the Member States, ECHA and the Commission to launch the 
Article 59 procedure twice a year, in fixed periods. As a consequence, the candidate 
list is also updated twice a year, normally in June and December. 

A process for removing substances from the candidate list (e.g. in case of amendment 
of a classification) is not specifically foreseen in REACH. 

The number of substances on the candidate list has been increasing continuously from 
2008  onwards.  It  is  clear  that  the  actors  involved  gradually  gained  more  experience 
with  the  process  and  the  discussions  in  the  RMO  framework  helped  to  arrive  at  the 
SVHC identification phase with dossiers containing all available information. The rate 
at which substances are being added to the list is increasing. E.g. in December 2011, 
20  entries  (the  largest  increase  since  the  process  started)  took  the  number  of 
substances on the candidate list to 73. 

It  is  worthwhile  to  recall  the  Commission's  aim  to  have  136  substances  on  the 
candidate list by the end of 2012 and to have all relevant, currently known SVHCs on 
the candidate list by 2020. This objective has had the merit of stimulating an increased 
activity  of  Member  States  in  relation  with  the  submission  of  proposals  for  SVHC 
identification. The candidate list currently contains 84 substances and 54 substances 
are  being  considered  for  inclusion  by  the  end  2012  bringing  the  total  number  of 
substances up to 138, corresponding to or even exceeding the political commitment. 

The  Commission  services  will  continue  to  encourage  Member  States  to  contribute 
more  actively  to  the  process  of  SVHC  identification.  ECHA  and  the  Commission 

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services will continue to contribute by providing assistance, coordination and sharing 
experiences with the Member States. 

Quantitative  information  on  the  effects  of  the  candidate  list  is  still  scarce,  possibly 
because  the  process,  although  started  in  2008,  has  seen  a  significant  increase  in  the 
number of substances in the candidate list – including substances with high tonnages 
and many uses - only from 2010 on. 

To date, few cases of a "blacklist effect" of the candidate list were reported130 but the 
perception of many downstream users (DUs) is that, as soon as a substance is included 
in the candidate list, it will be banned from the market in the near future and it has to 
be  substituted  in  processes  and,  as  a  consequence,  in  articles.  Some  examples  have 
been  reported  of  governmental  public  procurement  which  in  the  selection  criteria 
excludes  articles  containing  substances  on  the  candidate  list.  This  may  be  due  to  a 
lack  of  clear  information  and  communication  to  the  parties  concerned  about  the 
obligations and the effects of the candidate list. In this context, the Commission and 
ECHA  are  considering  possible  information  activities  to  facilitate  the  understanding 
of  the  candidate  list  and  of  the  authorisation  process  in  general  among  all  actors, 
including DUs and consumers, and would encourage Member States to do the same. 

The  candidate  list  has  also  been  reported  as  one  of  the  instruments  of  REACH  that 
could  drive  innovation,  thanks  to  substitution  of  SVHCs  with  safer  substances.  It  is 
reported131 that the placing on the candidate list can lead, in some cases, to the launch 
of initiatives to develop new substances or to the reformulation of existing substances. 
However, the same study reports also that the substitution of substances that are well 
tested and well adapted to the process, with substances for which less information is 
available  and  which  might  not  have  been  tested  for  the  specific  process,  may  be  a 
challenge for the companies involved.  

The candidate list is not only the first step in the authorisation process. It also triggers 
obligations for article producers and importers to notify to ECHA, and for suppliers of 
articles to inform recipients on the presence of SVHCs in the articles, following the 
provisions of Articles 7(2) and 33 of REACH. These requirements might not be easy 
to meet, especially for complex articles (see [Title 4] for more details). 

As  stated  in  Article  59  of  REACH,  the  candidate  list  is  established  for  eventual 
inclusion  of  SVHCs  in  Annex  XIV.  According  to  the  requirements  of  Articles  7(2) 
and 33, the candidate list can also provide information on substances in articles. The 
candidate list has also to be seen as a way to officially identify substances that pose a 
hazard  for  which  no  agreed  criteria  are  available  (i.e.  endocrine  disruptors)  or  for 
which  no  official  classification  and  labelling  is  available  (i.e.  PBTs  and  vPvBs)132. 

130   Study “Impact of the REACH regulation on the innovativeness of EU chemical industry”, CSES, 

commissioned by the European Commission, March 2012. 

131  More in chapter 2.4 on innovation in part II of this paper (page 133).  

132   See  document  "Workshop  on  the  Candidate  List  and  Authorisation  as  Risk  Management 
[available  on 

January  2009, 

Instruments,  Workshop  proceedings"  Helsinki,  21-22 
www.echa.europa.eu]. 

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The  Commission  services  believe  that  there  is  a  need  for  a  common  view  among 
Member  States,  ECHA  and  the  Commission  on  the  use  of  the  candidate  list  for 
objectives other than the eventual inclusion of substances in Annex XIV. 

Taking  into  account  the  relatively  short  experience  in  this  area,  the  Commission 
services  believe  that  it  is  too  early  to  reach  a  firm  conclusion  on  the  positive  and 
negative  effects  of  inclusion  of  a  substance  in  the  candidate  list.  The  reported 
results133   can be considered as early indications of a trend, and they will need to be 
confirmed once the authorisation process is fully in place. More information will also 
be needed on the results of the implementation of Articles 7(2) and 33 of REACH. 

The  Commission  services  believe  that  the  possibility  of  a  "de-selection"  from  the 
candidate list should be considered. 

Prioritisation of substances for Annex XIV 

The  authorisation  requirement  is  laid  down  in  Title  VII  of  REACH.  Article  56 
prohibits the placing on the market and the use of substances listed in Annex XIV (on 
their  own,  in  mixtures  and  the  incorporation  of  substances  into  articles)  unless  an 
authorisation  has  been  granted  to  the  manufacturer,  importer  or  DU  for  the  use(s). 
Annex  XIV  currently  contains  14  SVHCs,  included  by  two  Regulations  adopted  in 
2011  and  2012134  respectively.  Of  the  14  substances  currently  in  the  Annex,  12  are 
carcinogenic,  mutagenic  and/or  toxic  for  reproduction  (i.e.  meeting  the  criteria  of 
Article  57(a),  (b)  and/or  (c)  of  REACH),  one  is  a  PBT  substance  (i.e.  meeting  the 
criteria  of  Article  57(d)),  and  one  is  a  vPvB  substance  (i.e.  meeting  the  criteria  of 
Article 57(e)). 

Based  on  the  procedure  set  out  in  Article  58  of  REACH,  substances  from  the 
candidate  list  are  prioritised  for  their  inclusion  in  Annex  XIV  to  REACH.  Article 
58(3) specifies a number of criteria for prioritisation (substances with PBT or vPvB 
properties,  with  wide  dispersive  use  or  used  in  high  volumes)  to  which  a  fourth 
criterion has been added, namely the regulatory effectiveness of the inclusion of the 
substance.  In  addition,  REACH  requires  that  the  number  of  substances  and  the 
transitional arrangements included in Annex XIV take into account ECHA’s capacity 
to handle applications in the time provided for. Based on ECHA’s recommendation, 
the  Commission  adopts  the  decision  to  include  substances  in  Annex  XIV,  in 
accordance with a comitology procedure. 

Of  the  substances  currently  in  Annex  XIV,  the  majority  (11  substances)  were 
prioritised  based  on  high  volume  together  with  the  wide  dispersive  use  criteria,  and 

133   Study "Impact of the REACH regulation on the innovativeness of EU chemical industry”, CSES, 

March 2012; RPA, Study “Assessment of health and environmental benefits of REACH”. 

134   Commission  Regulation  (EU)  No  143/2011  of  17  February  2011  amending  Annex  XIV  to 
Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, 
Evaluation, Authorisation and Restriction of Chemicals (‘REACH’), OJ L 44, 18.2.2011, p. 2 and 
Commission  Regulation  (EU)  No  125/2012  of  14  February  2012  amending  Annex  XIV  to 
Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, 
Evaluation, Authorisation and Restriction of Chemicals (‘REACH’), OJ L 41, 15.2.2012, p. 1. 

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two substances based on their PBT or vPvB properties together with the high volume 
and/or  wide  dispersive  use  criteria.  One  substance  was  prioritised  for  regulatory 
effectiveness reasons. 

As  indicated  by  ECHA135,  the  public  consultations  on  the  draft  recommendation  on 
inclusion of substances in Annex XIV has shown a need to improve the quality of the 
contributions from interested parties. Indeed, contributions are often made concerning 
aspects  which  are  not  relevant  for  the  prioritisation  of  a  substance,  such  as  the 
availability and feasibility of alternatives, or socio-economic aspects concerning uses 
of the substance being recommended. The Commission services agree with ECHA in 
its  assessment  that  there  is  a  need  to  remind  stakeholders  of  the  role  of  the  public 
consultation  at  this  stage  of  the  procedure,  and  of  the  relevant  information  for  the 
recommendation. With regard to the public consultation, it has also been pointed out 
in specific cases by stakeholders that the three-month period foreseen in Article 58(4) 
is not sufficient to be able to provide comments. In that regard it should be pointed out 
that  stakeholders  should  already  be  aware,  at  the  stage  of  the  public  consultation 
based on Article 59(4) with a view to the identification of a substance as a SVHC, that 
the  substance  may  be  included  in  the  candidate  list  (if  it  meets  one  of  the  intrinsic 
properties  listed  in  Article  57)  and  thereafter  be  subject  to  the  process  laid  down  in 
Article 58. In other words, stakeholders should see the identification of a substance as 
a SVHC as an “early warning”, to start gathering information with a view to the next 
stage  of  the  process.  Still  in  relation  to  public  consultation  on  the  draft 
recommendation,  it  should  be  noted  that  the  progressively  higher  number  of 
submissions by third parties has started to create some challenges to the management 
of the overall procedure and the capacity of the ECHA Secretariat and of the MSC to 
assess  and  digest  any  additional  information  provided  and  to  fairly  reflect  it  in  the 
recommendation. The Commission services support ECHA’s commitment to issue a 
recommendation  for  inclusion  in  Annex  XIV  every  year  as  it  increases  the 
predictability of the process. Nevertheless, the Commission services would suggest to 
ECHA,  based  on  the  experience  gained,  to  review  its  internal  procedures  to  ensure 
high quality recommendations. 

Application for authorisation 

An application  for  authorisation  must  be submitted to ECHA, whose Committee  for 
Risk  Assessment  (RAC)  and  Committee  for  Socio-economic  Analysis  (SEAC)  are 
required to adopt opinions on the application, and to send them to the Commission for 
a final decision to grant or refuse authorisation. 

An  important  step  in  the  implementation  of  Title  VII  was  the  adoption  of  the 
Guidance  on  the  preparation  of  an  application  for  authorisation136  and  the  Guidance 
on  socio-economic  analysis  -  Authorisation137,  both  aimed  at  assisting  applicants  for 

135   The Operation of REACH and CLP 2011, European Chemicals Agency, 2011, p. 35. 

136   Guidance on the preparation of an application for authorisation, Version 1, European Chemicals 

Agency, January 2011. 

137   Guidance  on  the  preparation  of  socio-economic  analysis  as  part  of  an  application  for 

authorisation, Version 1, European Chemicals Agency, January 2011. 

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authorisation  to  prepare  the  application  and  the  socio-economic  analysis  supporting 
the application. 

A  question  has  arisen  with  regard  to  the  applicability  of  the  substitution  plan 
requirement laid down in Article 62(4)(f) of REACH to applications for authorisation 
based  on  Article  60(4)  (the  so-called  “socio-economic  route”).  In  that  regard  the 
Commission  services  recognise  that  substitution  is  the  ultimate  objective  for  both 
routes to authorisation (i.e. the so-called “adequate control route” laid down in Article 
60(1)  and  the  “socio-economic  route”  foreseen  in  Article  60(4)).  The  Commission 
services are currently evaluating the appropriate procedure to reflect this requirement. 
In  the  meantime,  the  Guidance  on  authorisation  application138  clarifies  that  the 
robustness  of  the  analysis  of  alternatives,  and  in  particular  the  information  provided 
on research and development activities on alternatives, will be key in determining the 
length of the review period of the authorisation. The Guidance also recommends that 
"if  there  is  a  suitable  alternative  available  on  the  market  but  not  yet  ready  for  an 
immediate substitution (i.e. within the "sunset date") or another operator in the same 
market  has  already  or  will  switch  in  the  short  future  to  alternatives,  the  applicants 
should  explain  as  part  of  analysis  of  the  alternatives  the  actions  that  would  be 
required, as well as the time-lines, to switch to an alternative substance/technique."139 

A  question  has  also  been  raised,  concerning  whether  an  only  representative  (OR)  is 
legally entitled to apply for authorisation. In the Commission services’ view, even if 
that possibility has not been expressly foreseen in REACH, based on the principle of 
non-discrimination,  an  OR  should  not  be  deprived  of  this  right.  As  a  result  of  this 
interpretation,  ECHA  has  communicated  on  its  website  that  applications  for 
authorisation may also be submitted by an OR. 

is  preparing 

the  procedures  for 

ECHA 
the  handling  of  applications  for 
authorisation140, and the Commission services are setting up its internal procedures for 
the handling of the ECHA opinions and the decision-making to grant authorisations.  
In  particular,  questions  concerning  the  confidentiality  of  information,  the  format  of 
the  decisions  and  the  internal  Commission  procedures  to  handle  a  potentially  high 
number of application dossiers are being addressed. 

Interface between authorisation and restrictions 

In accordance with the provisions of Article 58(5) to (7), in principle there is no legal 
obstacle in REACH preventing the authorisation and restriction processes from being 
conducted in parallel for the same substance. However, ECHA141 acknowledges that, 
even where it is legally possible to launch the two processes in parallel, there may be 

138   Guidance on the preparation of an application for authorisation, Version 1, European Chemicals 

Agency, January 2011. 

139   Guidance on the preparation of an application for authorisation, Version 1, European Chemicals 

Agency, January 2011, p. 25. 

140   The Operation of REACH and CLP, European Chemicals Agency, 2011, p. 32. 

141   The Operation of REACH and CLP, European Chemicals Agency, 2011, p. 33. 

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other  reasons  not  to  do  so,  such  as  the  effective  use  of  resources  by  authorities  and 
industry,  legal  clarity  and  predictability.    While  sharing  this  view,  the  Commission 
services  acknowledge  that  there  may  be  cases  where  it  is  appropriate  to  launch  the 
two  processes  in  order  to  target  different  uses.  In  particular  it  is  evident  that  if  a 
substance poses an unacceptable risk that needs to be addressed on an EU-wide basis, 
the  restriction  process  must  be  used  through  an  amendment  of  Annex  XVII  to 
REACH.  The  possibility  for  both  the  authorisation  and  restriction  processes  to  take 
place  in  parallel  reinforces  the  need  for  communication  and  coordination  of  the 
activities of CAs, the Commission and ECHA in preparing proposals for identification 
of SVHCs and for restrictions, in order to seek a common view early in the process on 
the most appropriate risk management option for a specific substance. 

In view of the above, the Commission services intend to launch a reflection with CAs 
and ECHA on how to improve the coordination of work in the implementation of the 
authorisation and restriction processes, with a view to ensuring that legal certainty and 
predictability of the legal requirements is fully respected. 

Annex XIII to REACH 
Annex XIII was amended in 2011142 as a result of the review carried out pursuant to 
Article  138(5)  of  REACH.  The  new  Annex  XIII  has  not  yet  been  applied  for  the 
purpose of identifying PBT and vPvB substances as SVHCs under Article 59. For the 
purpose of registration of substances, a two-year transitional period was provided in 
the  Commission  Regulation  amending  Annex  XIII143,  in  order  to  allow  registrants 
sufficient time to update the registration dossiers. 

Recommendations 

7.1.  The  Member  States  and  ECHA  are  encouraged  to  continue  discussing  and  sharing  at  an  early 
stage  RMOs analysis  with the view to coordinate  activities in relation to identification  of SVHCs, 
including "substances of equivalent concern" for which no guiding criteria are available yet. 

7.2. The Commission services in cooperation  with ECHA will in the short term increase its efforts for 
identifying  additional  relevant  SVHCs  and  will  draft  a  roadmap  in  the  framework  of  the  RMO 
process  to include all relevant, currently known SVHCs in the candidate list by 2020  

7.3.  The  Commission  services  and  ECHA  will  consider  information  activities  to  facilitate  the 
understanding  of  the  authorisation  process  among  all  actors,  including  DUs  and  consumers. 
Member States are encouraged to do the same. 

7.4. Discussion should continue in order to obtain a common view on the use of the candidate list for 

objectives other than the eventual inclusion of substances in Annex XIV.  

7.5. ECHA should conduct information activities to improve the quality and the appropriateness of the 
information submitted during the public consultation on the draft recommendation for inclusion in 
Annex XIV. 

142   Commission  Regulation  (EU)  No  253/2011  of  15  March  2011  amending  Regulation  (EC)  No 
1907/2006  of  the  European  Parliament  and  of  the  Council  on  the  Registration,  Evaluation, 
Authorisation and Restriction of Chemicals (REACH) as regards Annex XIII, OJ L 69, 16.3.2011, 
p. 7. 

143   Ibid. 

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8. 

RESTRICTIONS 

Restrictions 

The REACH restriction process establishes clear deadlines for the adoption of 
EU-wide measures to control and manage unacceptable risks posed to human 
health and the environment. 

The restriction process (Title VIII) sets up a "safety net" to manage unacceptable risks 
to human health and the environment which are not adequately controlled by industry 
and need to be addressed at EU level. The decision-making lies with the Commission, 
which  is  empowered  to  adopt  EU-wide  restrictions  concerning  the  manufacture,  use 
and/or placing on the market of substances on their own, in mixtures and/or in articles 
under  the  comitology  procedure,  by  amending  Annex  XVII.  Restriction  measures 
could  take  the  form  of  a  total  ban  of  a  substance,  or  other  measures  to  control  and 
reduce  the  exposure  and  risk  from  the  use  of  a  chemical.  They  apply  equally  to  all 
products  put  on  internal  market,  regardless  of  their  origin,  thereby  being  fair  and 
transparent to both non-EEA and EEA manufacturers. 

REACH  establishes  clear  deadlines  which,  especially  when  compared  with  the 
previous legislative framework, were expected to considerably shorten the time from 
the  moment  the  risk  is  identified  to  the  adoption  of  the  EU-wide  measure  to  reduce 
and control such risk, resulting in a net gain in risk reduction. An EU-wide restriction 
process was already introduced by Directive 76/769/EEC, in order to address risks at 
Community level while removing the obstacles to trade created by different national 
rules  concerning 
the 
establishment and functioning of the internal market. Regulation (EEC) No 793/93144 
established rules in order to evaluate the risks of existing substances to human health 
and the environment. However this process had led to very long timelines, stretching 
over  a  number  of  years,  from  the  initial  risk  evaluation  until  the  adoption  of  the 
restriction.  REACH  addresses  those  shortcomings  by  streamlined  procedures,  in 
which ECHA plays a central role by coordinating the scientific and technical aspects 
of the restriction process, as well as by setting strict deadlines in which the different 
stages have to be accomplished by the different actors. 

the  marketing  and  use  of  chemicals,  which  affected 

Moreover,  transparency  is  expected  to  greatly  improve,  as  the  public  is  informed 
through  ECHA’s  Registry  of  Intentions  which  substances  are  under  scrutiny  for 
potential submission to the REACH restriction process. Once the process has started, 
public consultation is also required at different stages of the procedure. 

Finally the restrictions adopted under the previous legislative framework were taken 
over in Annex XVII of REACH145. 

144   Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks 

of existing substances, OJ L 84, 5.4.1993, p. 1. 

145   Following the adoption of REACH, Regulation (EC) No 552/22009 was adopted with the aim, in 
particular, to incorporate amendments to the restrictions adopted under Directive 76/769/EEC from 
1 June 2007 as well as to adapt the “old” restrictions to the terminology used by REACH. 

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The standard route 

Initiating the restriction process 

Restrictions 

Under the REACH restriction process, the Commission (Article 69(1)) or a Member 
State  (Article  69(4))  shall  initiate  the  process  leading  to  the  adoption  of  restriction 
measures, whenever they consider that the manufacture, placing on the market or use 
of a substance on its own, in a mixture or in an article poses a risk to human health 
and/or the environment that is not adequately controlled and needs to be addressed. 

In the case of substances on Annex XIV, under certain conditions, after the relevant 
sunset date ECHA has to initiate the restriction process (Article 69(2)). However, this 
provision has not been applied so far, as no sunset dates have passed yet. 

The  specific  procedure  set  up  by  REACH  in  which,  in  addition  to  the  Commission, 
Member  States  as  well  as  ECHA  are  given  responsibility  in  initiating  restrictions 
constitutes  a  novelty  approach.  This  approach  is  designed  to  ensure  that,  by 
cooperation  between  Commission,  Member  States  and  ECHA,  the  identified 
unacceptable risks to human health and the environment are adequately assessed and 
addressed at the appropriate level. 

The  Commission  has  the  responsibility  under  Article  69(1)  to  initiate  the  restriction 
process,  in  particular  in  cases  where  a  specific  risk  to  human  health  and/or  the 
environment  is  identified  under  EU  legislations  or  mechanisms  or  when  an  existing 
restriction needs to be completed or updated. 

Member  States  have  similar  obligation  under  Article  69(4).  Consideration  on  risk 
might  be  triggered,  for  instance,  by  the  registration  dossier  or  substance  evaluation 
(Articles  42  and  48  of  REACH),  as  well  as  by  any  other  concerns  identified  on  a 
national basis that would indicate the need for restricting the manufacture, placing on 
the market and/or use of a substance. Once an uncontrolled risk has been identified, 
Member States have to proceed under Title VIII. The obligation for Member States to 
inform ECHA and prepare an Annex XV dossier under Article 69(4) ensures that an 
assessment  is  done  prior  to  introducing  a  restriction  on  the  EU  or  national  level,  in 
order to avoid a distortion of the internal market as well as to address the risk at the 
appropriate level. 

Since the entry into effect of Title VIII in June 2009, four Annex XV dossiers have 
been prepared by Member States146 and one has been prepared by ECHA upon request 
of the Commission147. 

In  essence,  the  factor  triggering  the  restriction  process  is  similar  to  that  under 
Directive  76/769/EEC,  i.e.  an  assessment  of  the  inadequately  controlled  risk  arising 
from  the  use  of  a  substance  and  of  its  need  to  be  addressed  at  EU-wide  level. 
However,  there  is  much  more  information  available  to  perform  such  an  assessment 

146   Dimethylfumarate  and  lead  in  jewellery  (France),  five  phenylmercury  compounds  (Norway)  and 

four phthalates (Denmark). 

147   Mercury in measuring devices. 

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Restrictions 

under  REACH  than  within  the  previous  legal  framework.  In  fact,  the  registration 
dossiers  and  chemical  safety  reports  (CSRs)  provided  by  industry  have  to  contain 
extensive  information  on  substances  and  their  uses,  allowing  a  targeted  risk 
assessment  and  providing  a  more  extensive  set  of  information  as  support  to  the 
propose risk management measures. 

In addition, further data may be obtained through the stakeholders' involvement in the 
preparation of an Annex XV. The Guidance on Annex XV for restrictions148 calls on 
the  involvement  of  stakeholders  as  early  as  possible  when  preparing  the  Annex  XV 
dossier,  in  order  to  facilitate  the  collection  of  the  relevant  data  and  improve 
transparency. 

The conformity check  

The  Annex  XV  dossier  is  submitted  to  ECHA  and,  if  declared  conform  by  ECHA's 
Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC) (both 
discussed in [Title 10]) in line with Article 69(4), it is published on ECHA website 
for the public consultation (Article 69(6)). 

Regarding  the  conformity  check,  based  on  the  experience  gained  with  the  five 
dossiers submitted so far, it has become clear that for some cases this step is not easy 
to fulfil for the Committees. In fact, in some cases the lack or the insufficient level of 
information provided in Annex XV dossiers has caused problems to the Committees 
in concluding on the conformity of the dossiers. ECHA has developed explanations on 
conformity checks. However, the Commission services note that diverging views still 
exist in relation to the level of information required for the conformity (or not) of the 
submitted dossiers and ways to address this issue should be explored. 

ECHA Committees' opinion-making, interaction of the two Committees 

The RAC and SEAC undertake their analysis as described in Articles 70 and 71. The 
risk  assessment  is  performed  by  RAC  which  represents  under  REACH  the  risk 
evaluation body for chemicals, as explained in [Title 10]. 

REACH  expressly  requires  taking  into  account  the  socio-economic  impact  when 
adopting a restriction decision under the standard route. 

Opinions  of  RAC  and  SEAC  may  diverge  from  each  other  or  from  the  original 
proposal  included  in  the  Annex  XV  dossier.  It  is  important  that  opinions  clearly 
explain and justify why they present a different conclusion. This should be ensured by 
more interactions between the committees during the opinion making process. 

The  socio-economic  analysis  can  be  part  of  the  Annex  XV  dossier  prepared  by 
Member  States  with  the  potential  involvement  of  stakeholders.  In  any  event,  the 
interested parties have the possibility to submit relevant information or even a socio-
economic analysis during the mandatory consultations, as detailed below. 

148   Guidance  for  the  preparation  of  an  Annex  XV  dossier  for  restrictions,  European  Chemicals 

Agency, June 2007. 

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Public consultations 

Restrictions 

Public  consultations  are  needed  at  different  stages  of  the  process  to  ensure  the 
involvement of all interested parties as well as greater transparency. 

The  Annex  XV  dossier  is  open  to  public  consultation  for  a  period  of  six  months 
(Article 69(6)), allowing stakeholders to submit their comments, as well as additional 
information  in  particular  on  risk  assessment,  availability  of  alternatives  and  socio-
economic data. 

To  improve  the  efficiency  of  the  system,  ECHA  has  suggested  shortening  the  first 
consultation  period  from  six  to  three  months.  However,  the  Commission  services 
acknowledge  that  some  industrial  sectors  are  fragmented  and  collecting  information 
can  be  a  long  and  difficult  process  for  industry  associations  as  well  as  for  other 
stakeholders.  Also,  the  six-month  period  can  be  seen  as  very  short  when  specific 
studies would need to be launched by stakeholders. In that context, it appears evident 
to the Commission services that a time period of six months is the minimum needed 
to  allow  stakeholders  to  gather  data  and  compile  them.  This  has  to  be  seen  also  in 
relation to the situation experienced under the previous legislation, when stakeholders 
were  consulted  and  participated  in  the  Commission  working  groups  where  the 
restriction measures were discussed and that, in most of the case, well beyond a six-
month period. 

A  second  public  consultation  then  takes  place  on  the  draft  SEAC  opinion  (Article 
71(1)). 

The consultation under REACH is conducted with full transparency with regard to the 
comments submitted and the way they are taken into account by the dossier submitter 
or  RAC  or  SEAC,  respectively.  In  addition,  ECHA  becomes  the  central  point  of 
contact and coordination for all key players. 

Restriction decision and comitology 

The  final  restriction  decision  is  taken  by  the  Commission  through  the  comitology 
procedure. Given that it is based on the SEAC opinion, the performance of an impact 
assessment is not applicable. Until now, the Commission draft Regulations have not 
diverged from the opinions of the Committees. 

Simplified procedure for restrictions of CMR substances for consumer uses 

Article  68(2)  provides  for  a  simplified  procedure  where  the  Commission  proposes 
restrictions for a substance on its own, in a mixture or in an article classified as CMR 
category  1A  or  1B  which  could  be  used  by  consumers.  In  such  cases,  the  standard 
procedure  following  Article  69  of  REACH  (including  the  involvement  of  both 
Committees  and  preparation  of  Annex  XV  dossier)  does  not  apply.  The  simplified 
procedure should allow a streamlined process to address risks to human health. 

Such an approach is not new for substances and mixtures classified as CMR category 
1A and 1B which, since 1994, were not allowed to be sold to the general public. For 
the case of newly classified substances and mixtures that could be used by consumers, 
a  continuation  with  the  practice  of  the  past  is  suggested  as  a  general  line.  This  is 
justified  by  the  potential  wide  exposure,  possible  misuse  that  could  result  from  a 

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Restrictions 

CMR  substance  or  mixture  made  available  to  consumers  and  possible  combined 
exposure  from  different  sources.  Also 
in  the  case  of  existing  information 
demonstrating  that,  for  a  specific  application,  the  risk  is  negligible,  a  time-limited 
derogation  may  be  considered  with  the  view  to  provide  an  incentive  for  industry  to 
use  alternatives.  The  Commission  has  already  used  that  legal  basis  and  adopted  the 
Regulation No 109/2012 amending Annex XVII, entries 28 to 30149. 

The novelty concerns the application of this simplified procedure to CMR substances 
in consumer articles. At the moment, the Commission services are of the view that the 
simplified procedure of Article 68(2) as applied so far to CMRs on their own and in 
mixtures should not be applied in an identical way to CMR in consumer articles. This 
means  that  the  application  of  this  provision  should  not  result  in  a  systematic 
prohibition of the sale of all articles containing any newly classified CMR substances 
to the general public. In addition, the Commission has the sole right of initiative for 
these cases. 

The  Commission  services  are  still  exploring  possible  options  to  define  prioritisation 
criteria  that  would  ensure  that  Article  68(2)  is  implemented  in  a  pragmatic  and 
proportionate  way,  taking  in  full  account  the  need  to  preserve  a  scientific-based 
decision-making process. 

Transitional measures 

In  addition,  Article  137  of  REACH  provided  for  transitional  measures  to  allow  the 
work  initiated  under  Directive  76/769/EEC  to  be  finalised.  This  permitted  the 
adoption  of  two  amendments  to  Annex  XVII  concerning  acrylamide150  and 
cadmium151 in 2011. 

Conclusions 

The Commission services have drawn the following conclusions with relation to the 
experience gathered in the implementation of the restrictions: 

–  The REACH restrictions enable a faster processing of risk management activities 
on  chemicals  that  are  identified  as  giving  rise  to  risks  requiring  action  at  the  EU 

149   Commission  Regulation  (EU)  No  109/2012  of  9  February  2012  amending  Regulation  (EC)  No 
1907/2006  of  the  European  Parliament  and  of  the  Council  on  the  Registration,  Evaluation, 
Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII (CMR substances), 
OJ L 37, 10.2.2012, p. 1. 

150   Commission  Regulation  (EU)  No  366/2011  of  14  April  2011  amending  Regulation  (EC)  No 
1907/2006  of  the  European  Parliament  and  of  the  Council  on  the  Registration,  Evaluation, 
Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII (Acrylamide), OJ L 
101, 15.4.2011, p. 12. 

151   Commission  Regulation  (EU)  No  494/2011  of  20  May  2011  amending  Regulation  (EC)  No 
1907/2006  of  the  European  Parliament  and  of  the  Council  on  the  Registration,  Evaluation, 
Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII (Cadmium), OJ L 
134, 21.5.2011, p. 2. 

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Restrictions 

level than the previous legal framework. It has therefore a high potential to deliver 
health and environmental benefits. 

–  Although  there  is  a  net  gain  in  risk  reduction  that  can  be  attributed  to  REACH 

restrictions, it is still limited at this stage of the REACH implementation. 

–  With  REACH,  transparency  has  greatly  improved;  stakeholders  are  informed  of 
what  is  going  on  under  the  restriction  process  through  ECHA’s  Registry  of 
Intentions  and  website.  They  can  also  provide  input  through  the  public 
consultations required at different stages of the procedure. 

–  Diverging  views  still  exist  in  relation  to  the  information  required  for  the 

conformity (or not) of the submitted dossiers. 

–  Coordination between RAC and SEAC opinions should be clarified and improved. 

–  Implementation of Article 68(2) still needs further work. 

–  Based on the review findings, the Commission services recommend the following 
actions  or  measures  to  improve  the  degree  to  which  the  restriction  process  of 
REACH is delivering its intended benefits: 

Recommendations 

8.1. The Member States are encouraged to increase their participation in the preparation of restrictions 
dossiers and further coordinate their activities and ECHA is invited to continue supporting activities 
for Annex XV dossier submitted by Member States. 

8.2. Based on needs also identified in other legislative areas than REACH, the Commission services 
will  enhance  efforts  to  identify  and  prioritise  substance  and  their  uses  that  should  be  subject  to 
restrictions under Article 69(1). 

8.3. The  current  timeframe  for  public  consultation  to  ensure  high  transparency  and  stakeholders' 

involvement will be maintained. 

8.4. RAC and SEAC should improve their coordination. 

8.5. The  criteria  for  the  practical  implementation  of  Article  68(2),  in  particular  in  cases  of  consumer 

articles containing CMR substances will be considered. 

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9. 

ECHA 

ECHA 

9.1. 

Process, internal structure and operations 

ECHA  is  overall  effective.  ECHA  prioritised  effectiveness,  i.e.  delivering  the 
necessary output. In the Commission services’ view this was the right choice 
for an Agency with a central role in an ambitious new piece of legislation. 

Due  to  the  focus  on  delivering  output,  efficiency  was  not  maximal.  In  the 
Commission  services’  view  this  reflects  a  justifiable  prioritisation  by  ECHA. 
However,  the  Commission  services  believe  that  the  time  has  now  come  for 
consolidation  and  learning  from  the  experience  of  the  start-up  period,  for 
ECHA to become more efficient. 

ECHA  is  a  decentralised  agency:  it  draws  up  opinions  so  that  the  Commission  can 
enact legislative proposals (e.g. in the restrictions area) or take specific decisions (e.g. 
granting or refusing authorisations). It has, in addition, own decision-making powers 
allowing it to adopt individual decisions needing a defined technical expertise, under 
clearly and precisely defined conditions and without discretionary power (e.g. in the 
area of evaluation); however, it is not allowed to adopt legislative measures of general 
application.  The range of powers given to ECHA is in line with the principles of the 
EU legal order which impose constraints on the scope of the powers that can be given 
to Agencies152. 

ECHA was the  first Agency  to  be immediately established in its definitive location; 
other  comparable  Agencies  had  started  up  at  Commission  premises  in  Brussels  and 
moved  to  their  definitive  location  after  some  degree  of  organisational  maturity  had 
been reached. 

In  ECHA’s  start-up  period,  the  initial  team  consisted  of  38  seconded  staff  from  the 
Commission selected for their special skills and/or relevant experience; some of them 
stayed on in the Agency as temporary agents.  In addition, while the final stages of the 
co-decision process on REACH were ongoing, around 30 contract staff and 6 national 
experts joined the Commission and worked on the so-called REACH Implementation 
Projects  (RIPs)  referred  to  in  the  recitals  of  REACH,  contributing  to  such  essential 
preparatory activities as developing the draft guidance which was subsequently made 
available  to  ECHA,  setting  up  the  IT  systems  and  preparing  ECHA’s  operational 
structures.    A  number  of  these  contract  agents  and  national  experts  joined  ECHA 
afterwards.    The  overall  level  of  preparedness  and  ability  to  transfer  relevant 
experience were some of the key factors contributing to ECHA’s speedy and effective 
start-up. 

152   COM(2002)718 final, 11.12.2002, p. 8; COM(2008)135 final, 11.3.2008, p. 5. 

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ECHA 

The  study  supporting  the  ECHA  review153  confirms  ECHA’s  raison  d’être,  and 
accordingly  the  Commission  services  recommend  to  maintain  ECHA’s  current  role 
under REACH and CLP. 

The following observations can be made on ECHA’s internal structure: 

The Management Board 

All EU Agencies have a main governing body having a supervisory role, with general 
responsibility  for  budgetary  and  planning  matters  as  well  as  for  reporting  the 
Agency’s activities to the EU institutions.  ECHA’s Management Board appoints the 
Executive  Director,  the accounting  officer  and  the  members  of  the  Board  of  Appeal 
and the Committees and exercises disciplinary authority over the Executive Director.  
In addition, it adopts the internal rules and procedures as well as the financial rules of 
ECHA and ECHA’s work programmes and general reports.  It plays a key role in the 
budgetary procedures of the Agency, including adoption of the final budget before the 
beginning of the financial year.  Finally, it may approve appropriate co-operation with 
stakeholders, third countries and international organisations.  In this sense it exercises 
overall authority over the functioning of ECHA and provides strategic direction, but is 
not called to engage in regulatory chemicals policy. 

ECHA’s  Management  Board  comprises  27  Member  State  representatives  nominated 
by  the  Council,  three  Commission  representatives,  three  stakeholder  representatives 
appointed  by  the  Commission,  two  independent  persons  appointed  by  the  European 
Parliament  and  two  representatives  from  EEA  EFTA  States  (Norway  and  Iceland).  
Since  the  signing  of  the  Accession  Treaty  with  Croatia,  the  Management  Board  has 
decided  to  grant  Croatia  observer  status  and  to  invite  a  representative  of  Croatia  to 
attend  the  meetings  of  the  Management  Board  and  the  Committees.  After  having 
worked  under  a  more  intense  meeting  schedule  in  ECHA’s  start-up  period,  the 
Management Board now meets quarterly.   It has established a two-level governance 
structure  with  six  working  groups  which  look  into  particular  issues  and  meet 
independently and the plenary meetings of the Management Board. This is consistent 
with recommendation 10 of the Common Approach on decentralised agencies. 

Despite  overall  performance  being  satisfactory,  several  suggestions  have  been  made 
to  increase  cost-efficiency  of  the  functioning  of  the  Management  Board154,  such  as 
reducing its size (including by not requiring all Member States to be represented) and 
focusing  on  the  management  of  ECHA  rather  than  issues  related  to  the  day-to-day 
running  of  ECHA  or  regulatory  chemicals  policy,  as  well  as  more  detailed  practical 
suggestions.    However,  the  quality  of  decision-making  was  not  put  into  doubt.    For 
most  of  these  suggestions,  it  is  for  the  Management  Board  itself  to  consider  their 
usefulness and to decide whether to act upon them.  As for the suggestion to reduce 
the  size,  this  would  necessitate  an  amendment  of  Article  79(1)  REACH.    Although 
there  are  examples  of  EU  Agencies  with  smaller  Management  Boards  (especially 

153   Study “Review of the European Chemicals Agency”, PwC, funded by the European Commission, 

March 2012, p. 8-9 

154   Ibid., p. 45. 

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ECHA 

EFSA), the predominant model is that of representation of all Member States which 
has however been criticised as unnecessary, costly and ineffective155. 

The  Commission  services  encourage  the  Management  Board  and  the  ECHA 
Secretariat  to  explore  ways  to  increase  cost-efficiency  of  the  Management  Board’s 
functioning,  but  at  this  stage  sees  no  need  to  change  the  composition  of  the 
Management Board through an amendment of REACH. 

The Executive Director 

All  EU  Agencies  have  an  Executive  Director  who  acts  as  their  general  day-to-day 
manager.    ECHA’s  Executive  Director  represents  ECHA,  supports  the  Management 
Board including by submitting to it draft work programmes, draft general reports and 
draft documents relevant for budgetary procedures, deals with staff matters, manages 
ECHA’s resources, ensures the various parts of ECHA function well and in a timely 
manner,  and  where  appropriate  rectifies  ECHA  decisions  following  an  appeal.    The 
Executive Director is supported by an Executive Office. 

The  Management  Board  appoints  the  Executive  Director  on  the  basis  of  a  list  of 
candidates  proposed  by  the  Commission.    In  the  start-up  period  of  ECHA,  and  in 
recognition of the fact that a general manager was necessary even before the selection 
of candidates by the Commission and the Management Board’s establishment, which 
both necessarily took time, the Commission appointed an Interim Executive Director 
in  accordance  with  Article  134(2)(a)  of  REACH  as  part  of  the  Interim  Strategy 
towards  ECHA  operability.    The  fact  that  the  Management  Board  saw  this  Interim 
Executive Director as the most suitable candidate and appointed him to the position of 
Executive  Director  allowed  for  a  considerable  degree  of  continuity  in  ECHA’s 
management in the first years of its operation. 

A complaint was filed with the Ombudsman regarding the first selection process for 
candidates for the position of Executive Director conducted by the Commission.  The 
complainant felt that by proposing only two candidates to the Management Board, the 
Commission  did  not  provide  enough  choice  for  the  Management  Board.    After 
examination,  the  Ombudsman  closed  his  inquiry  with  a  critical  remark,  finding  an 
instance  of  maladministration  in  that  the  Commission’s  failure  to  document  the 
reasoning  underpinning  the  establishment  of  the  shortlist  of  candidates  made  it 
impossible  to  verify  that  the  Commission  did  not  unduly  and  arbitrarily  restrict  the 
range  of  candidates  for  the  post  of  ECHA  Executive  Director  and  did  not  abuse  its 
discretion in the matter. 

The  Commission  services  acknowledge  the  role  of  the  Executive  Director  and  his 
staff  in  the  successful  start-up  and  operation  of  ECHA.    The  Commission  services 
also acknowledge the central role and active interest of the Executive Director in the 
establishment  and  working  of  the  Directors  Contact  Group156.    The  Commission 

155   Study  "Evaluation  of 

the  EU  decentralised  agencies 

in  2009".  Rambǿll  management, 

commissioned by the European Commission, December 2009. 

156   See [Sub-Title 3.2]. 

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intends  to  continue  applying  the  highest  standards  in  any  future  selection  of 
candidates  and  encourages  the  Management  Board  to  do  the  same  in  any  future 
appointment process. 

The Secretariat 

ECHA’s  Secretariat  currently  comprises  more  than  500  staff  members  under  the 
leadership of the Executive Director and divided over seven Directorates.  They deal 
with  REACH  tasks  related  to  registration,  pre-registration  and  data  sharing, 
evaluation,  authorisation,  restrictions,  establishment  and  maintenance  of  databases, 
dissemination and communication, provision of technical and scientific guidance, (IT) 
tools  and  formats,  technical  and  scientific  support  to  Member  State  authorities  and 
helpdesks, technical and scientific support to international co-operation (at the request 
of the Commission) and notification of ECHA decisions.  In addition, they also deal 
with CLP tasks related to classification and labelling and dissemination.  The lists of 
REACH  and  CLP  tasks  show  that  the  role  of  the  Secretariat  is  not  purely 
administrative but goes deeply into technical-scientific issues; in that sense the name 
“Secretariat”  may  be  a  little  limitative  The  Secretariat  also  has  finance,  human 
resources,  corporate  services  and  legal  departments.    Specific  to  REACH,  the 
Secretariat also assures the secretariat for the Committees and the Forum. 

Currently, the Secretariat’s staff is mainly composed of temporary agents on five-year 
contracts  which  can  be  prolonged157.    There  are  limited  numbers  of  contract  agents 
(mainly support staff) and seconded national experts158. 

The  location  of  ECHA  in  Helsinki  is  reported  to  pose  a  particular  challenge  for 
staffing159.  In spite of considerable, and highly appreciated, efforts of Finland and the 
City  of  Helsinki  to  create  a  welcoming  environment  for  staff  members  and  their 
families, promising candidates have been reported to turn down offers of employment 
for reasons linked to the climatic conditions, the remoteness of the location compared 
to  the  rest  of  the  EU,  and  difficulties  for  spouses  and  partners  to  find  attractive 
employment. 

The  combination  of  the  high  workload  and  the  difficulties  to  recruit  sufficient 
numbers of highly qualified staff may well require particular attention, and possibly a 
strategy, from ECHA management to ensure that sufficient resources can be attracted 
and can be sufficiently motivated to stay.   

A continuing factor which has required reallocations of staff from other tasks has been 
the slower than planned progress in developing and implementing the IT system. This 
has  meant  that  on  the  one  hand  work  needed  to  be  done  with  less  IT  support  than 

157   The  establishment  plan  of  ECHA  has  456  temporary  agent  posts  of  which  447  were  filled  as  of 

31/12/2011. 

158   92 contract agents and 5 seconded national experts were part of the staff as of 31/12/2011. 

159   Study  “Review  of  the  European  Chemicals  Agency”,  PwC,  commissioned  by  the  European 

Commission, p. 65. 

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planned  and  that  more  resources  need  to  be  dedicated  to  the  development  and 
implementation of the IT systems.. 

The  ECHA  Secretariat  will  be  entrusted  with  new  responsibilities  under  the  new 
Biocidal  Products  Regulation,  and  under  the  upcoming  recast  of  the  Regulation  on 
export  and  import  of  dangerous  chemicals.    This  upcoming  extension  of  the 
Secretariat’s  tasks  is  testimony  to  the  credibility  and  authority  that  ECHA  built  up 
with the EU Institutions in the short years of its existence. 

The Commission services commend the achievements of ECHA which were possible 
thanks to the dedication and strong commitment of its staff and encourages ECHA’s 
management to continue seeking ways to optimise the allocation of available staff to 
tasks. 

ECHA  has  identified  a  need  for  heightened  internal  co-ordination  within  ECHA  to 
ensure coherence in the activities160.  The Commission services share this analysis and 
invites  ECHA  to  focus  on  pragmatic  means  of  co-ordination,  avoiding  the  need  for 
additional structures and horizontal services. 

The Forum 

No  other  EU  Agency  has  a  body  comparable  to  ECHA’s  Forum  for  Exchange  of 
Information  on  Enforcement.    The  increased  responsibility  of  operators  for  the  safe 
use  of  chemicals,  a  shift  in  mindset,  that  is  at  the  very  core  of  REACH,  meant  that 
enforcement of the legislation needed to be strengthened at EU level.  In this light it 
was considered appropriate to provide a more formal framework for the co-operation 
among  enforcement  authorities  which  had  emerged  under  the  previous  chemicals 
legislation161. 

The Forum consists of 27 members, each appointed by their Member State, who have 
relevant expertise and maintain contacts with their Competent Authorities (CAs).  In 
addition  there  are  three  members  appointed  by  Iceland,  Liechtenstein  and  Norway 
(EEA  EFTA  States)  respectively.    All  of  them  are  supported  by  the  scientific  and 
technical resources of their CA and ensure appropriate co-ordination with the work of 
their  CA.    However,  Member  States  cannot  give  instructions  to  Forum  members 
which  are  incompatible  with  their  individual  tasks  or  the  tasks  of  the  Forum.  
Although the Forum currently has no co-opted members, its expertise is broadened by 
the advisers that generally accompany members to Forum meetings.  The Forum has 
invited stakeholders’ organisations to attend some of its meetings.  The secretariat of 
the Forum is ensured by the ECHA Secretariat.  The role of the Forum is discussed in 
more detail in [Title 12]. 

ECHA  has  continuously  increased  the  personnel  in  ECHA  Forum  Secretariat;  the 
Commission services welcome this and invite ECHA to continue supporting improved 
cooperation between the CAs and the enforcement authorities. 

160   The Operation of REACH and CLP, European Chemicals Agency, 2011, p. 80-81. 

161   CLEEN – the Chemicals Legislation European Enforcement Network. 

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The Board of Appeal 

ECHA 

Only decision-making EU Agencies, which are a minority among the total number of 
EU Agencies, have a Board of Appeal which decides on appeals against the Agency’s 
decisions.    ECHA’s  Board  of  Appeal  has  strong  similarities  with  its  equivalents  in 
EASA, ACER, CPVO and OHIM.  ECHA’s Board of Appeal provides a possibility of 
legal  redress  which  is  quicker,  less  formal  and  less  expensive  than  an  action  to  the 
Court of Justice of the European Union.  Its composition of three members comprises 
not  only  lawyers  but  also  at  least  one  technically  qualified  member,  which  allows 
taking  the  technical-scientific  aspects  of  each  case  into  account  where  appropriate.  
The Board of Appeal is supported by a Registry, which is part of the Secretariat.  A 
party not satisfied with a Board of Appeal decision can seek second tier legal redress 
by bringing an action to the Court of Justice. 

Having  a  Board  of  Appeal  organisationally  within  an  Agency,  and  at  Agency 
premises,  in  charge  of  dealing  with  appeals  against  that  same  Agency’s  decisions 
poses  specific  challenges:  not  only  must  the  Board  of  Appeal,  and  its  Registry,  be 
independent from that Agency in its assessment and decision-making, but it also must 
be  seen  to  be  independent.    Both  the  Board  of  Appeal  itself  as  well  as  ECHA  have 
taken organisational measures to guarantee the requisite independence and the ECHA 
review  showed  that  the  Board  of  Appeal  is  perceived  as  a  credible,  independent 
organisation. 

In  accordance  with  REACH  requirements,  the  Commission  has  laid  down  the 
qualifications for the members162  and the rules of organisation and procedure163.  The 
Board  of  Appeal  currently  has  one  chamber  of  three  members,  but  its  rules  of 
organisation  allow  the  necessary  flexibility  for  it  to  be  able  to  draw  on  additional 
members to cope with any peaks in appeal numbers. 

As  of  15  April  2012,  nine  appeals  against  ECHA  decisions  had  been  filed  with  the 
Board  of  Appeal.    Two  appeals  were  withdrawn  by  the  appellants;  three  led  to 
rectifications of the ECHA decision by the Executive Director and were therefore not 
treated  on  substance  by  the  Board  of  Appeal;  two  led  to  extensively  motivated 
decisions  of  the  Board  of  Appeal  (one  finding  for  ECHA,  one  finding  for  the 
appellant); two cases are pending.  As a measure of good record, it should be noted 
that no actions against Board of Appeal decisions have been brought to the Court of 
Justice. 

The  Board  of  Appeal  assists  potential  appellants  through  the  publication  of  practice 
directions  and  other  useful  documents  on  a  special  dedicated  section  of  the  ECHA 
website, where appeal announcements and decisions are also published.  Appropriate 

162   Commission  Regulation  (EC)  No  1238/2007  of  23  October  2007  on  laying  down  rules  on  the 
qualifications of the members of the Board of Appeal of the European Chemicals Agency, OJ L 
280, 24.10.2007, p. 10. 

163   Commission Regulation (EC) No 771/2008 of 1 August 2008 laying down the rules of organisation 
and procedure of the Board of Appeal of the European Chemicals Agency, OJ L 206, 2.8.2008, p. 
5. 

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modalities  are  in  place  to  ensure  the  requisite  confidentiality  of  parts  of  the 
information.  In this way, an open but balanced approach to transparency is ensured. 

In  the  framework  of  its  review  of  the  rules  of  organisation  and  procedure,  the 
Commission  consulted  the  Board  of  Appeal  as  well  as  stakeholders  represented  in 
CARACAL  to  identify  possible  points  for  improvement.    Some  suggestions  were 
made,  which  have  been  further  examined  in  the  review  of  Regulation  (EC)  No 
771/2008.    As  for  other  aspect  relating  to  the  Board  of  Appeal,  the  very  limited 
experience  so  far  does  not  allow  drawing  definitive  conclusions.    Nevertheless,  the 
Commission services acknowledge the fact that an appropriate framework is in place 
to ensure the Board of Appeal’s independence from the rest of ECHA and shares the 
reported stakeholders’ assessment that it is a credible appeal body164. 

9.2.  Committees 

The  ECHA  Committees  have  been  successfully  established  with  active 
participation from MS and EEA EFTA State and have provided the expected 
input to the REACH and CLP processes.  

Risk  assessment  is  a  matter  for  scientific  experts,  who  are  called  to  formulate  an 
independent scientific opinion, based on scientific evidence.  The imposition of EU-
wide  risk  management  on  the  other  hand  is  a  matter  for  those  bearing  political 
responsibility, as it involves decisions regarding acceptability or non-acceptability of 
risk.    The  separation  is  organically  established  in  most  EU  legislation  designed  to 
address risks, by entrusting the risk assessment role to scientific committees or their 
equivalents,  and  the  risk  management  role  to  a  decision-making  authority,  generally 
the Commission. 

Under  pre-REACH  chemicals  legislation,  the  idea  of  separation  and  independent 
scientific  advice  was  already  applied  to  some  extent:  EU  risk  assessment  reports 
prepared  in  accordance  with  Regulation  (EEC)  No  793/93  were  evaluated  by  a 
Technical  Committee  of  New  and  Existing  Substances  composed  of  Member  State 
authorities’ representatives.  Where appropriate, the Commission invited the Scientific 
Committee on Health and Environmental Risks (SCHER) to give an opinion, not only 
for chemicals under Regulation (EEC) No 793/93, but also for other questions relating 
to  examination  of  the  toxicity  and  ecotoxicity  of  chemicals,  biochemicals  and 
biological  compounds  whose  use  may  have  harmful  consequences  for  human  health 
and the environment. 

ECHA’s Committees are today’s conceptual equivalents of the Scientific Committees 
managed by the Commission (e.g. SCHER, SCENIHR, SCCS) or the Committees and 
Panels operating in the context of comparable Agencies (e.g. EMA’s Committee for 
Medicinal  products  for  Human  Use,  EFSA’s  Panel  on  plant  protection  products  and 

164   Study  “Review  of  the  European  Chemicals  Agency”,  PwC,  commissioned  by  the  European 

Commission, p. 40. 

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their  residues).    Nevertheless,  specific  aspects  of  the  REACH  system  imply  that 
ECHA’s  Committees  present  some  original  features  compared  to  other  known 
committees.    As  explained  below,  the  Member  State  Committee  (MSC)  falls  nearly 
completely outside the classic committee paradigm. 

Members  of  the  Committee  for  Risk  Assessment  (RAC)  and  of  the  Committee  for 
Socio-economic  Analysis  (SEAC)  are  appointed  by  the  Management  Board,  upon 
nomination of candidates with relevant experience by Member States.  At least one, 
and no more than two members nominated by each Member State can be appointed in 
this way; the RAC currently has 41 members, the SEAC 30 members.  Members of 
the MSC are appointed directly by the Member States, each appointing one member; 
also Norway as an EEA EFTA State has appointed one member. 

All  Committee  members  are  supported  by  the  scientific  and  technical  resources  of 
their  Member  State,  who  must  provide  them  with  adequate  scientific  and  technical 
resources.  All Committee members ensure appropriate co-ordination with the work of 
their CA, who facilitate the Committees’ activities.  However, Member States cannot 
give instructions to Committee members which are incompatible with their individual 
tasks or the tasks, responsibilities and independence of ECHA.  The secretariat of the 
Committees is ensured by the ECHA Secretariat. 

The  close  link,  embedded  in  REACH,  between  Committee  members  and  CAs  may 
appear unusual.  The members of Scientific Committees like SCHER, SCENIHR and 
SCCS or EFSA’s Panels are nominated following a call from expressions of interest, 
without link to Member States.  On the other hand, the ECHA model for Committee 
membership is closely related to that of some of EMA’s Committees, whose members 
are  nominated  by  Member  States  and  supported  by  the  scientific  resources  of  CAs.  
The  ECHA  model  was  chosen  deliberately,  to  ensure  the  best  possible  combination 
between  ECHA  independence,  reliance  on  experience  with  the  previous  chemicals 
legislation,  and  avoiding  draining  national  authorities’  resources  towards  ECHA.  
Nevertheless, it is reported that some of the interventions in RAC and SEAC appear 
conditioned by the respective national chemicals policies, although this seems to have 
been somewhat mitigated as the Committees gained maturity165. 

In  addition  to  the  tasks  discussed  below  for  RAC  and  SEAC  specifically,  REACH 
envisages the possibility for those two Committees to draw up opinions on any other 
aspects  concerning  the  safety  or  use  of  substances  on  their  own,  in  mixtures  or  in 
articles, at the request of the Executive Director.  This possibility was prevailed upon 
a first time to request RAC to evaluate new scientific evidence regarding the use of 
boron compounds in photographic applications. Such evaluation was needed in order 
to  justify  any  derogation  from  the  ban  of  boron  compounds  classified  as  CMR  and 
supplied to the general public. More use of such possibility may be envisaged in the 
future to support the Commission decision-making process. 

165   Study  “Review  of  the  European  Chemicals  Agency”,  PwC,  commissioned  by  the  European 

Commission, p. 38. 

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All  ECHA  Committees  attach  great  importance  to  transparency  and  have  invited 
stakeholders’ organisations to attend and intervene in their meetings, although parts of 
meetings  where  issues  of  a  confidential  nature  are  discussed  are  held  behind  closed 
doors.  Criteria for the identification of relevant stakeholders were laid down by the 
Management Board in accordance with Article 108 of REACH and are being applied. 

The Committee for Risk Assessment 

The RAC’s core competence and expertise – risk assessment - come closest to those 
of  other  Scientific  Committees  and  Panels,  although  the  fact  that  it  plays  roles  of 
different  nature  under  different  pieces  of  legislation  (REACH  and  CLP)  is  unusual.  
Its  main  responsibilities  include  opinions  on  authorisation  applications  and  on 
proposals  for  restrictions  as  well  as  for  harmonised  classification  and  labelling  (the 
latter  under  CLP).    The  RAC‘s  opiniopns  are  prepared  by  a  rapporteur,  possibly 
assisted  by  a  co-rapporteur,  appointed  among  its  members.  CAs  are  paid  for 
rapporteurs’  work  (except  in  the  case  of  harmonised  classification  and  labelling)  in 
accordance  with  Article  74(4)  of  REACH  and  Article  14  of  Regulation  (EC)  No 
340/2008166.  The rapporteur’s draft opinion is discussed in a working group and then 
presented  to  the  plenary  meeting  and  the  final  opinion  adopted,  where  possible  by 
consensus,  otherwise  by  majority,  recording  any  minority  position,  and  taking  into 
account  stakeholders’  comments  in  line  with  the  applicable  REACH  or  CLP 
provisions. 

In  ECHA’s  start-up  phase,  opinions  of  RAC  were  not  called  for  very  often  and  this 
gave  the  Committee  ample  time  to  discuss  its  working  procedures  and  approaches, 
and debate in details all aspects of opinions.  With the exception of the authorisation 
process,  other  REACH  processes  where  RAC  plays  a  role  and  the  process  for 
delivering  opinions  on  proposals  for  harmonised  classification  and  labelling  under 
CLP are now more or less at cruising speed. This has meant a continuous increase in 
the  RAC’s  workload  which  is  anticipated  to  continue167.    The  workload  combined 
with the legal deadlines for delivery of opinions creates pressure on the RAC which 
needs to continue looking for more efficient ways of working and must be able to rely 
on strong support from the Member States towards their RAC members in particular 
for  opinions  concerning  harmonised  classification  and  labelling  under  the  CLP 
Regulation.  Proposals  for  improvement  are  being  examined  and  will  need  to  be 
implemented in the future.  

The  procedures  and  timetables  were  introduced  by  REACH  with  the  intention  to 
accelerate  the  procedures  as  compared  to  pre-REACH  and  pre-CLP  experience 
Therefore the Commission services believe that at this stage, the most promising way 
of  dealing  with  the  identified  workload  issues  appears  to  lie  in  improved  working 

166   Commission Regulation (EC) No 340/2008 of 16 April 2008 on the fees and charges payable to the 
European  Chemicals  Agency  pursuant  to  Regulation  (EC)  No  1907/2006  of  the  European 
Parliament  and  of  the  Council  on  the  Registration,  Evaluation,  Authorisation  and  Restriction  of 
Chemicals (REACH), OJ L 107, 17.4.2008, p. 6. 

167   Study  “Review  of  the  European  Chemicals  Agency”,  PwC,  commissioned  by  the  European 

Commission, p. 54. 

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practices and Member State support, rather than extending the legal deadlines which 
are already perceived by some stakeholders as excessively long. 

Another  concern that ECHA is  invited to  address  relates to  the  need  to improve the 
clarity for industry and other stakeholders on when and how they can  provide input 
into  the  processes  and  in  what  way  ECHA  reports  on  how  this  input  is  taken  into 
account. 

The Committee for Socio-economic Analysis 

No  other  Scientific  Committees  or  Panels  in  ECHA  deal  with  matters  within  the 
competency  and  expertise  of  the  SEAC  –  socio-economic  analysis.    Its  main 
responsibilities  include  opinions  on  authorisation  applications  and  on  proposals  for 
restrictions.  The SEAC's opinions are prepared by a rapporteur, possibly assisted by a 
co-rapporteur, appointed among its members.  CAs are paid for rapporteurs’ work in 
accordance  with  Article  74(4)  of  REACH  and  Article  14  of  Regulation  (EC)  No 
340/2008.  The rapporteur’s draft opinion is discussed in a working groups and then 
presented  to  the  plenary  meeting  and  the  final  opinion  adopted,  where  possible  by 
consensus,  otherwise  by  majority,  recording  any  minority  position,  and  taking  into 
account stakeholders’ comments in line with the applicable REACH provisions. 

Like  the  RAC,  the  SEAC  had  a  relatively  calm  start-up  period  with  time  to  discuss 
working  procedures  and  approaches  as  well  as  detailed  aspects  of  opinions,  but  its 
workload  has  increased  and  this  trend  is  expected  to  continue168.    The  workload 
combined  with  the  legal  deadlines  for  delivery  of  opinions  and  consultations,  and 
especially the  interface  with the RAC opinions and their timing, creates pressure on 
the  SEAC  which  needs  to  continue  looking  for  more  efficient  ways  of  working  and 
must be able to rely on strong support from the Member States towards their SEAC 
members. 

Like  for  the  RAC,  the  Commission  services  believe  that  at  this  stage,  the  most 
promising way of dealing with the identified workload issues for the SEAC appears to 
lie in improved working practices and Member State support.  Additional help could 
come  from  a  better  balance  of  the  members'  expertise  accumulated  within  the 
Committee  in  order  to  reduce  risks  of  crossing  into  the  domain  of  Risk  Assessment 
Committee. 

The Member State Committee 

The  MSC’s  role  and  nature  are  not  only  very  different  from  traditional  Scientific 
Committees  and  Panels,  but  also  from  RAC  and  SEAC.  Its  main  responsibilities 
include consensus-building on draft evaluation decisions, proposals for identification 
of  substances  of  very  high  concern  (SVHCs)  to  be  subjected  to  authorisation  and 
opinions on the ECHA recommendation for the inclusion of SVHCs in Annex XIV.  
With regard to evaluation, its role is not limited to providing an opinion; it also brings 
together in one assembly authorities from the Member States with a view to reaching 
consensus on a draft decision to be taken by ECHA in case one or more of the CAs 

168   Ibid., p. 54. 

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commented on the draft decision, in a field that under previous legislation belonged to 
the core competences of the CAs.  Similarly, with regard to decisions on identification 
of  SVHCs,  it  is  called  to  reach  consensus  among  the  authorities  from  the  Member 
States,  in  case  one  or  more  of  them  commented  on  the  proposed  identification, 
allowing ECHA to include substances into the so-called candidate list. 

Where  the  consensus  aimed  for  cannot  be  achieved,  ECHA  does  not  take  an 
evaluation  decision,  for  the  first  case,  nor  does  it  include  the  substances  in  the 
candidate list, in the second case.  Instead, the matter is referred to the Commission 
who takes the decision in accordance with the comitology procedure.  This referral to 
the  Commission  for  decision  is  another  illustration  of  the  extraordinary  role  and 
nature of the MSC which leads MSC members to some, perhaps too large, extent to 
engage  in  policy  discussions  rather  than  scientific-technical  discussions.    The  MSC 
has so far achieved consensus in nearly all cases; in the future it may need to consider 
accepting  that  consensus  is  sometimes  not  possible  and  allowing  the  matter  to  be 
referred to the Commission. 

The  MSC  plays  an  important  role  also  in  the  process  of  recommending  SVHCs  for 
inclusion in Annex XIV. Despite the fact that in this case the Committee does not take 
decisions but gives only an opinion to ECHA, this stage is fundamental to assess the 
reaction of the Member States to the information provided by the stakeholders during 
the public consultation, which is discussed in more detail in [Title 8]. The increasing 
number of comments received and the difficulties encountered to get unanimity within 
the  MSC  for  supporting  ECHA  recommendations  indicate  a  need  to  continue  the 
efforts  of  working  in  an  efficient  way  but  also  possibly  the  need  to  increase  the 
dialogue and the early information of the stakeholders to improve the quality and the 
appropriateness of their involvement into the public consultation process. 

Draft  evaluation  decisions  prepared  by  the  ECHA  Secretariat  are  submitted  to  the 
CAs  for  comments;  the  draft  decision  only  comes  to  MSC  when  amendments  are 
proposed, otherwise ECHA takes the decision in accordance with the draft.  However, 
as the evaluation as well as the authorisation process reach cruising speed, following 
the  first  registration  deadline,  the  upcoming  adoption  of  the  first  CoRAP  and  the 
fourth round of recommendations  for  inclusion  in  Annex  XIV,  the  workload  for  the 
MSC can be expected to increase like for the other Committees.  Also here there is a 
need to continue looking for more efficient ways of working, e.g. by communicating 
in more detail the rationale for decisions to CAs, so that comments are only triggered 
in truly necessary cases169. 

169   Ibid., p. 54. 

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9.3. 

Fees and charges 

ECHA 

Since 2010, ECHA is fully financed by fees paid by enterprises. The amounts 
of  the  fees  to  be  paid  by  enterprises  should  not  be  prohibitively  expensive, 
especially for SMEs.  

In principle, ECHA activity under REACH and CLP are set up to be largely financed 
from fees paid to it by operators.  An EU subsidy is integral part of its budget, but this 
is a balancing subsidy essentially meant to cover the start-up, when no or insufficient 
fees were coming in, as well as any income gaps caused by fee income fluctuations 
due to no- or low-income periods between registration peaks (although these should 
largely  be  mitigated  by  ECHA’s  responsible  management  of  the  large  incomes 
received  during  registration  peaks).  Following  this  system,  ECHA  has  been  self-
financed since 2010. The original Legislative Financial Statement published with the 
Commission’s REACH proposal foresaw a very simple fee structure (registration fees 
for  below  and  above  100  tonnes/year  and  authorisation  fees)170.  The  European 
Parliament  and  the  Council  introduced  a  number  of  individual  fee  items  and  also 
important  reductions  and  waivers  for  specific  cases  such  as  SMEs  and  consortia, 
leading to a Revised Legislative Financial Statement171. 

ECHA is expected to receive a balancing subsidy  for  REACH  and  CLP as  of 2014. 
The  Commission  proposal  for  the  Multiannual  Financial  Framework  2014-2020 
foresees rigorous cost savings and maximum efficiency at all levels. This also applies 
to  EU  Agencies.  Only  the  global  amount  per  heading  of  the  Multiannual  Financial 
Framework  was  included  in  the  documents  adopted  by  the  Commission  on  29  June 
2011. 

Taking  into  account  the  decision  on  the  MFF  and  the  experience  gained  from  the 
operation  of  the  Regulation,  the  long-term  resource  planning  as  established  by  the 
Legislative  and  Financial  Statement  of  the  REACH  Regulation  may  also  need  to  be 
examined 

The principle that ECHA is supposed to be largely self-financing is further laid down 
in  the  requirement  that  the  structure  and  the  amount  of  the  fees  take  account  of  the 
work  to  be  carried  out  by  the  authorities  and  be  fixed  at  a  level  ensuring  that  the 
revenue from fees combined with other sources of revenue, covers the cost of services 
to operators, in accordance with Article 74(3) of REACH. 

At the same time, there is a need to ensure that the amounts of the fees to be paid by 
operators  in  order  to  gain  or  maintain  market  access  do  not  become  prohibitively 
expensive,  notably  for  SMEs.    Another  element  is  that  fees  can  be  used  to  promote 
certain  policy  goals,  such  as  in  the  case  of  REACH  the  aim  of  joint  submission  of 

170   Commission Staff Working Paper, [REACH] Extended Impact Assessment, COM(2003)644 final, 

29.10.2003, p. 246. 

171   Communication  From  The  Commission  To  The  European  Parliament  […]  concerning  the 
Common Position of the Council on the adoption of [REACH], 12.7.2006, {SEC(2006)924}, p. 30. 

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registration  information.    Both  the  promotion  of  SMEs  and  of  joint  submission  of 
registration information are equally part of Article 74(3) of REACH. 

A balanced approach combining all the above elements was the guiding principle for 
the  Commission  in  adopting  Regulation  (EC)  No  340/2008  as  well  as  Regulation 
(EU) No 440/2010172 (on CLP fees).  Both Regulations provide for different fees for 
different  types  of  submissions  and  actions,  and  provide  for  reductions  for  medium, 
small and micro enterprises (who can benefit from reductions of 30%, 60% and 90% 
respectively),  as  well  as,  in  the  case  of  REACH  fees,  for  joint  submissions  of 
information;  moreover,  no  fees  are  due  for  registrations  for  substances  in  the  1-10 
tonne range where all the information required by Annex VII to REACH is provided.  
Special  guidance  has  been  made  available  allowing  companies  to  verify  if  they  are 
eligible  for  SME  reductions173.    Nevertheless,  when  special  reductions  are  possible, 
the  risk  of  abuse  or  accidental  misuse  is  always  present.    To  ensure  that  the  special 
facility  benefits  those  and  only  those  for  whom  it  is  meant,  namely  SMEs,  through 
significant  reductions,  Article  13  of  Regulation  (EC)  No  340/2008  and  Article  5  of 
Regulation (EU) No 440/2010 foresee the possibility for ECHA to demand the full fee 
as well as an administrative charge in case a company claims SME status but is unable 
to prove entitlement.  The legality of Article 13 of Regulation (EC) No 340/2008 is 
being contested in the Court of Justice of the European Union. 

Registration fees are levied through an invoicing system: operators are only required 
to  pay  when  they  receive  an  electronic  invoice  from  ECHA.    ECHA  conducts  the 
invoice process for registrations in parallel to the technical completeness check.  First 
an initial deadline for payment is set – generally 14 days or 30 days for pre-registered 
substances  less  than  two  months  before  the  applicable  registration  deadline.    If  no 
payment  is  received  within  the  deadline,  a  second  deadline  is  set.    If  no  payment  is 
received  within  the  second  deadline,  the  process  to  reject  the  dossier  is  initiated,  as 
Article  20(2)  of  REACH  requires  payment  of  the  registration  fee  for  a  registration 
dossier to be complete, but a short waiting period for verification is always allowed, 
to  ensure  that  ECHA  does  not  reject  registrations  because  of  delays  in  bank 
transactions.    If  a  registration  is  rejected  because  missing  information  was  not 
submitted or because the registration fee was not paid within the deadlines set, the fee 
is  not  refunded  or  credited,  in  accordance  with  Article  3(7)  of  Regulation  (EC)  No 
340/2008. 

Late payments of registration fees have been the object of two decisions of ECHA’s 
Board of Appeal.  Both decisions concerned cases where the registration fee had been 
paid after expiry of the second deadline set and, accordingly, the registration rejected.  
In  the  first  case,  the  appellant  requested  that  ECHA’s  decision  be  annulled,  a 
registration  number  assigned  and  the  registration  fee  accepted,  arguing  that  it  had 

172   Commission Regulation (EU) No 440/2010 of 21 May 2010 on the fees payable to the European 
Chemicals Agency pursuant to Regulation (EC) No 1272/2008 of the European Parliament and of 
the  Council  on  classification,  labelling  and  packaging  of  substances  and  mixtures,  OJ  L  126, 
22.5.2010, p. 1. 

173   See [Title 3]. 

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fulfilled its obligations but had paid the fee too late due to an internal mistake.  The 
Decision of the Board of Appeal of 7 October 2011 confirmed that ECHA had acted 
correctly in rejecting the registration.  In the second case, the appellant challenged the 
decision to the extent that ECHA decided not to reimburse the registration fee paid.  
The Decision of the Board of Appeal of 10 October 2011 found that ECHA had not 
provided clear enough information to the registrant on the deadline for payment of the 
fee, and ordered the refund of the registration fee.  Meanwhile ECHA has undertaken 
to carefully review its communications in the light of the latter decision, to make the 
deadline for payment absolutely clear as well as the consequences of late payment. 

REACH fees may be adapted to inflation.  The Commission had proceeded to annual 
reviews to decide whether an amendment of the amounts was due; up until now, no 
need  was  identified  to  adapt  amounts  to  inflation,  taking  into  account  the  relatively 
low inflation rate and the policy of the Commission to support economic operators, in 
particular SMEs in times of economic downturn. 

In line with Article 74(4) of REACH and Article 14 of Regulation (EC) No 340/2008, 
a proportion of the fees collected by ECHA is transferred to CAs for work related to 
substance  evaluation  and  rapporteurs'  work  in  the  RAC  and  the  SEAC.  The 
framework of these transfers is defined by a decision of ECHA's Management Board. 
The  scale  of  payments  is  based  on  Eurostat  data  using  price  level  index  (25%)  and 
gross annual earnings in industry and services (75%). This system is currently under 
review by the Management Board as the Board has observed a large variation between 
Member States in the scale of payments and the data used might not reflect correctly 
the average salary of scientific staff in Member States. 

ECHA  has  provided  the  following  suggestions  related  to  fees174:  (1)  establishing  a 
specific inquiry fee to avoid inquiry free riding; (2) requiring separate payments  for 
different confidentiality claims; (3) ensuring remuneration under CLP for rapporteurs 
for  harmonised  classification  and  labelling  proposals  that  are  based  on  registration 
dossiers;  (4)  achieving  a  desired  degree  of  self-financing  for  the  Board  of  Appeal 
through  appeal  fee  revenue;  and  (5)  ensuring  sufficient  coverage  of  all  regulatory 
resources needed for processes for which no subsidy is assumed to arrive.  Although 
the Commission services are still considering these suggestions in detail, it is asserted 
that changes in the fee regime do not justify a revision of REACH.  In any event, the 
Commission  is  in  the  process  of  reviewing  Regulation  (EC)  No  340/2008  by  1 
January 2013, with a view to amend it, if appropriate, taking into account in particular 
the  costs  of  the  Agency  and  the  related  costs  of  the  services  provided  by  the 
competent authorities of the Member States. 

The Commission services acknowledge the contribution of SMEs to the EU economy, 
including in the chemicals fields, and recommends to continue providing them special 
status through significant fee reductions. 

174   The Operation of REACH and CLP, European Chemicals Agency, 2011, p. 21, 24, 65, 68 and 81. 

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Recommendations 

9.1. ECHA has completed the transition to a mature organization; it now has to enhance its resource 

efficiency.  

9.2. The Committees of ECHA need to continue looking for more efficient ways of working and must be 

able to rely on strong support from the Member States. 

9.3. The review of the Fee Regulation needs to consider the suggestions made in the ECHA report. 

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10. 

COMPETENT AUTHORITIES 

Competent Authorities 

Comptetent  Authorities  are  important  players  in  the  implementation  of 
REACH.  All  Member  States  have  appointed  Competent  Authorities,  and 
fulfilled  their  tasks,  although  concerns  have  been  raised  in  relation  to 
adequacy of resources committed by MS.   

Article 117(1) of REACH states that “Every five years, Member States shall submit to 
the  Commission  a  report  on  the  operation  of  this  Regulation  in  their  respective 
territories,  including  sections  on  evaluation  and  enforcement  as  described  in  Article 
127. The first report shall be submitted by 1 June 2010.” 

This  section  summarises  the  responses  received  from  the  Member  States  and  EEA 
EFTA States by 1 June 2010.  However, although several Member States have more 
than  one  Competent  Authority  (CA),  the  responses  received  were  from  one  CA  per 
Member  State.    As  a  result,  in  most  instances  the  information  related  mainly  to  the 
activities  of  the  respondent  CA,  with  only  limited  information  on  the  roles  and 
activities of other CAs within the same Member State. 

Given that this was the first reporting activity under this obligation, the Commission 
will  discuss  how  future  reporting  can  ensure  that  information  on  the  entirety  of 
activities performed by all CAs within a Member State is captured. 

Competent Authorities: Coordination, cooperation and information exchange 

There are 40 REACH CAs operating in the EU Member States and EEA EFTA States 
(in this title collectively referred to as “Member States”), reflecting that seven of the 
Member  States  have  more  than  one  CA.    This  section  presents  a  summary  of  the 
analysis of the information from the first set of Article 117(1) reports submitted to the 
Commission by CAs. 

Figure 2. Areas of responsibilities of national institutions nominated as CAs. 

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Notes: Up to 3 main areas of responsibilities have been identified per individual CA. Only EU CAs have been taken into 
account. 

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Competent Authorities 

The  “Competent  Authorities  for  REACH  and  CLP  (CARACAL)”  is  a  Commission 
expert group that brings together all CAs to facilitate cooperation between CAs, and 
between CAs and the Commission and ECHA, on the implementation and functioning 
of REACH and CLP in their respective areas of responsibility.   

CARACAL is working effectively. Some Member States provide more resources than 
others, but this in some cases is simply a reflection of the resources available within 
Member States for their CA(s). 

However, the 15 CAs that provided comments expressed concerns that the resources 
allocated to them are inadequate or limited due to: 

–  an insufficient number of employees; and 

–  inappropriate skill sets (e.g. particular emphasis was placed on the lack of expertise 
in  socio-economic  analysis  and  risk  communication  and  of  senior  toxicology 
experts). 

The Commission services take note of this finding and intend to explore this further 
with Member States. 

Member States also have obligations in relation to ECHA Committees.  In addition, 
there  is  a  range  of  other  bodies  designed  to  facilitate  the  coordination,  cooperation, 
and information exchange related to specific functions of REACH (e.g. the Forum175  
and HelpEx176). 

ECHA, the CAs and the Commission services are positive about the quality of their 
interactions overall, both formal and informal.  According to the reports the work of 
the  Committees  was  considered  by  CAs  to  be  above  average  and  ECHA  is  largely 
positive regarding their communication with the Commission.  CAs in general felt the 
effectiveness  of  communication  and  collaboration  to  be  average  or  above,  between 
themselves and (number of CAs expressing this opinion): 

–  CAs of different Member States (28); 

–  ECHA (28); 

–  the Commission (30); and 

–  the ECHA Committees (30). 

Operation of REACH 

Member States were asked to report their experience in the following areas: 

175   See [Title 12]. 

176   HelpNet  Exchange  -  a  secure  web-based  discussion  platform  set-up  by  ECHA  which  allows 
members  of  the  helpdesk network  to  discuss  difficult  questions,  to  cooperate  and  to  support  one 
another on a daily basis 

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–  Risk  Communication  Network:  a  voluntary  body  of  CAs  organised  by  ECHA  to 
support  the  cooperation  obligation  as  set  in  Article  122  of  REACH,  the  Risk 
Communication  Network  (RCN)  focuses  on  risk  communication  to  the  general 
public. The six CAs that commented on the RCN felt that this was a well organised 
body that was an important and valuable venue for sharing expertise/experiences of 
‘risk  communication’  between  Member  States,  as  well  as  a  source  of  training 
(information volunteered by CAs and not asked in Member State questionnaire). 

–  Duty-holders (registrants): 12 CAs provided estimates of the total number of likely 
duty-holders for each of the years 2007 and 2008 and 15 CAs provided estimates 
for 2009.  The remaining CAs submitted either a blank response or stated that such 
data were not maintained/collected.  However, there are reasons to suppose that the 
data provided may not relate to a common metric, a view supported by the fact that 
CAs  had  not  been  provided  with  guidance  on  how  these  estimates  should  be 
calculated.  Hence no sound conclusions could be drawn. 

–  Information  in  the  supply  chain:  Member  States  were  not  asked  to  report  on  the 
activities of duty-holders regarding the supply and movement of information in the 
supply chain.  However, in their responses regarding helpdesk support provided to 
industry,  it  is  clear  that  advice  was  provided  by  Member  States  on  downstream 
user obligations, the operation of SIEFs and safety data sheets. 

–  Annex XV dossiers (authorisation): The identification of Substances of Very High 
Concern (SVHCs) is the key requisite for triggering the authorisation provisions of 
REACH.    21  CAs  indicated  that  their  Member  State  had  been  involved  in  some 
Annex  XV  dossier-related  activity  for  the  identification  of  SVHCs.    Activities 
range from developing full dossier to commenting on a dossier prepared by another 
Member State or ECHA. 

In  general,  CAs  felt  that  they  did  not  have  the  experience  to  comment  on  the 
“reasonableness” of the time spent following up Member State dossiers or acting as 
co-rapporteur.  However, the Danish and  Swedish CAs predicted that Annex XV 
dossier work  would  not  be  resource-demanding but stated that the time/resources 
requirements varied significantly between dossiers.  These comments applied to all 
Annex XV dossiers, not just those for the identification of SVHCs. 

Eight  CAs  indicated  that  industry  was  involved  in  the  preparation  of  Annex  XV 
dossiers for SVHC identification within their Member State.  However, the level of 
industry contribution varied greatly between Member States. 

–  Effectiveness of RAC and SEAC: The views on the effectiveness of the Committee 
for  Risk  Assessment  (RAC)  and  the  Committee  for  Socio-economic  Analysis 
(SEAC)  were  mixed,  with  respondent  CAs  commenting  on  the  usefulness  of  the 
secretariats and procedures whilst also raising concerns regarding the workload and 
availability of resources of the Committees. 

–  Annex  XV  dossiers  (restriction):  13  CAs  indicated  that  their  Member  State  had 
been involved in some Annex XV dossier-related activity.  However, the activity 
may  have  only  involved  commenting  on  a  dossier  prepared  by  another  Member 
State or ECHA. 

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–  Dossier  and  substance  evaluation:  Nine  CAs  reported  having  been  involved  in 
substance  evaluation.    However,  several  CAs  noted  that  as  substance  evaluation 
has not yet begun, they had not been involved. 

–  Alternative testing: Responses from all CAs indicate that 20 Member States have 
made contributions to EU and/or OECD work on the development and validation 
of alternative test methods by participating in relevant committees. 

17  CAs  provided  data  on  overall  public  funding  for  national  research  and  the 
development  of  alternative  testing  methodologies,  with  nine  CAs  reporting 
expenditure  of  more  than  €  100 000  per  year  each.    However,  from  comments 
provided  by  CAs  it  is  possible  that  the  expenditure  reported  for  some  Member 
States includes not only funding of national research projects but also contributions 
to EU and/or OECD work. 

Enforcement 

Administrative  structures  differ  between  Member  States  and  often  more  than  one 
authority  plays  a  role  in  the  enforcement  of  REACH,  which  can  bring  differing 
challenges.    Co-operation  between  CAs  and  enforcement  authorities  also  differs 
between  Member  States.  According  to  Member  States  reports  five  of  them  have  a 
single CA and a single enforcement authority and nine have several CAs and multiple 
enforcement authorities (national, regional, local). The rest typically has a single CA 
and several enforcement authorities. 

However, issues related to this area are discussed in [Title 11]. 

Guidance and support 

–  Helpdesk  organisation  and  resources:  All  CAs  manage  their  REACH  helpdesks 
internally, except for the Netherlands, which still, however, retains the control over 
the  Member  State  helpdesk.    A  further  six  CAs  indicated  that  they  outsourced  at 
least some helpdesk enquiries.   The greatest number of enquiries was received by 
e-mail and then by telephone with a small minority of Member States not having 
both of these options available.  22 Member State helpdesks also handle enquiries 
relating  to  CLP  and  18  helpdesks  provide  specific  advice  to  small  and  medium-
sized enterprises (SMEs).  No helpdesks receive funding outside of Member State 
governments. 

–  Member State helpdesk activities: The number of inquiries received by helpdesks 
varied  significantly.    However,  two-thirds  of  the  Member  States  receive  between 
100  and  1  000  inquiries  per  year.  The  greatest  number  of  inquiries  related  to 
registration  or  pre-registration,  the  majority  from  SMEs.    64%  of  inquiries  were 
considered  to  be  straightforward  with  36%  described  as  complex.    On  average, 
straightforward inquiries received a response within one week (and often within a 
day) while complex inquiries were dealt with within two weeks. 

–  Cooperation between Member State helpdesks: For the majority of Member States, 
the  level  of  cooperation  within  the  REACH  Helpdesk  Correspondents'  Network 
(REHCORN,  now  renamed  Helpnet)  was  significantly  greater  than  the  level  of 
cooperation  outside  of  REHCORN.    However,  six  CAs  felt  that  there  was  no 

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difference.    19  of  the  30  helpdesks  make  use  of  REACH  Helpdesk  Exchange 
Platform (RHEP, now renamed HelpEx) at least weekly. 

–  Awareness-raising  activities:  In  general,  CAs  employed  a  wide  range  of 
awareness-raising activities, with the greatest level of activity focused on the entry 
into force of REACH.  CAs found speaking events, telephone contact and leaflets 
most effective at awareness-raising. 

–  Member  State  websites:  All  Member  States  except  Austria  and  Greece  have  a 
REACH-specific  website  or  webpage(s).    Ten  Member  States  have  single 
webpages dedicated to REACH and the remaining 18 Member States have multiple 
such  webpages  as  part  of  their  website.  Topics  of  interest  comprised  REACH 
news/updates, 
from 
registration, authorisation, socio-economic assessment (IT only), classification and 
labelling and FAQs. 

company  obligations, 

(pre-)registration, 

exemptions 

–  REACH guidance documents: Effectiveness of Partner Expert Groups (PEGs): The 
majority of Member States had actively participated in PEGs.  A minority of CAs 
was supportive of the organisation of PEGs although with some reservations. 

REACH aims: Protection of human health and environment 

–  Article 129 of REACH: No MS indicated that they had made use of the safeguard 

clause of Article 129 REACH.    

–  Effectiveness  of  REACH  for  the  protection  of  human  health  and  environment: 
With  the  exception  of  Italy,  all  CAs  felt  that  the  effectiveness  of  REACH  in 
protecting human health and the environment was best assessed at the level of the 
EU rather than at a national level. 

REACH aims: Enhancing competitiveness and innovation and the single market 

All  CAs  except  Italy  stated  that  enhancing  competiveness  and  innovation  should  be 
assessed at the EU, not the national level.  

Suggestions for improving Article 117(1) reporting 

Responses from CAs (within and separate from Article 117(1) reports) and the legal 
requirements for Member States reporting set out in REACH were analysed with the 
intention  of  identifying  possible  improvements  to  the  content  and  format  of  future 
Article 117(1) reports. 

On  the  basis  of  this  first  reporting  experience  and  a  technical  analysis177  the 
Commission  services  see  a  need  to  improve  the  reporting  process  and  will  consider 
how this can be best achieved. 

177   Study “Technical assistance to prepare the Commission report on the operation of REACH”, RPA 

and Ökopol, commissioned by the European Commission, 2012 

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Conclusions and recommendations 

The  reporting  of  the  Member  States  provides  a  first  snapshot  of  the  functioning  of 
REACH.    Recommendations  and  conclusions  on  specific  aspects  e.g.  authorisation, 
are provided at those corresponding sections of this document. 

The  Commission  services  acknowledge  the  challenges  faced  in  this  first  reporting 
round and the efforts made by the CAs to fulfil this obligation.   

Recommendations 

10.1. The Member States should improve the reporting quality by exploring ways in which more robust 
information  can  be  provided  through  the  questionnaire.  It  will  be  examined  how  the  reporting 
process  (including  IT  tools  used  and  reporting  format)  can  be  made  more  user-friendly  for  the 
Member States. 

10.2 The Member States should explore if the resource constraints that appear to be acting on the CAs 
can be addressed by improved ways of working e.g. wider sharing of best practice across Member 
States. 

10.3. Further assistance to Member States and the CAs will be explored e.g. through development of 

tools for assessment of competiveness and innovation. 

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11. 

ENFORCEMENT 

Enforcement 

A strong and harmonised approach towards enforcement in the Member States 
is  vital  for  delivering  objectives  of  REACH  and  CLP  Regulations.  Achieving 
this  is  a  challenge  and  Member  States  are  actively  cooperating  within  the 
Forum to enhance compliance. 

The  aim  of  the  national  enforcement  systems  is  to  ensure  the  implementation  of 
REACH. A strong and uniform enforcement of REACH throughout the EU members 
and  EEA  EFTA  States  (in  this  title  collectively  referred  to  as  “Member  States”)  is 
vital for delivering its objectives 

REACH  places  different  enforceable  obligations  on  duty-holders.  They  can  be 
grouped according to the main REACH processes: registration-related duties, supply 
chain-related duties, authorisation and restrictions. 

Related to the obligations prescribed by REACH, CLP imposes additional obligations 
including the basic obligation of classification and requirements to label and package 
substances and mixtures according to hazard. 

The  enforcement  of  REACH  and  CLP  lies  with  the  Member  States.  The 
harmonisation  of  enforcement  amongst  Member  States  was  a  key  issue  during  the 
development  of  REACH.  The  REACH  preamble  stresses  the  importance  of 
strengthening enforcement178. The Forum (an ECHA body) was created to coordinate 
a network of Member State authorities responsible for the enforcement of REACH179. 
It is a unique body and may serve as an example for other legislation. 

Enforcement in Member States 

In  order  to  enable  REACH  to  operate  effectively  in  practice,  Member  States  are 
obliged  to  establish  the  necessary  arrangements  for  its  implementation.  REACH 
therefore requires the Member States to: 

–  maintain  “a  system  of  official  controls”  and  other  activities  as  appropriate  to  the 

circumstances (Article 125); 

–  lay  down  the  provisions  on  penalties  applicable  for  infringement  of  REACH  and 
take all measures necessary to ensure that they are implemented (Article 126); 

–  regularly report on enforcement (Article 127). 

The  Commission  as  the  "guardian  of  the  Treaties"  oversees  the  fulfilment  of  these 
obligations. 

As  reported  in  [Title  10],  the  administrative  structures  of  enforcement  authorities 
differ  from  one  Member  State  to  another  and  often  more  than  one  national 

178   Recital (105) of REACH. 

179   Article 76(1)(f) of REACH. 

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enforcement authority plays a role in the enforcement of REACH. For example in the 
Czech  Republic  the  Czech  Customs  Administration  checks  the  duties  of  importers, 
focusing on safety data sheets, and the Regional Public Health Authorities checks the 
duties of manufacturers, importers, downstream users and distributors.  However, the 
enforcement arrangements in many Member States, such as Germany, Spain and the 
UK, are more complex. 

Since  CAs  have  the  scientific  and  political  knowledge  and  national  enforcement 
authorities the necessary practical experience in implementation, a proper cooperation 
and  information  exchange  between  CAs  and  national  enforcement  authorities  is 
crucial to ensure the effective implementation of REACH. 

The Forum 

The  Forum  coordinates  the  network  of  Member  States  authorities  responsible  for 
enforcement of REACH. It is required to spread good practice, identify enforcement 
strategies,  set  up  harmonised  enforcement  projects  and  joined  inspections,  provide 
certain types of support to inspectors and liaise with industry and other stakeholders. 
In  addition  to  these  activities  which  came  into  play  "downstream"  for  provisions 
already  adopted,  the  unique  expertise  of  the  Forum  is  called  to  contribute  to  the 
quality  of  provisions  still  to  be  adopted  through  the  Forum's  upstream  advice  on 
enforceability of restrictions proposals. 

The formal structure of the Forum is further described in [Title 9].  While ECHA has 
no direct enforcement responsibilities, it does have a number of tasks that at first sight 
appear  to  be  enforcement,  and  in  particular  the  completeness  check  and  compliance 
check  of  the  registration  dossiers.  ECHA  may  indicate  to  Forum  members  issues  of 
concern  and  stimulate  Member  States  to  undertake  enforcement  actions  to  ensure 
compliance with REACH. The Commission services welcome the initiative of ECHA 
to inform Forum members on enforcement issues of concern (for example in case of 
QOBL or registration of intermediates). The Commission services encourage ECHA 
to  establish  a  more  systematic  and  regular  information  exchange  on  enforcement 
issues between the Forum and other parts of ECHA. 

The  Forum  conducts  many  of  its  activities  through  Working  Groups  addressing 
particular enforcement issues; until now 14 such working groups have been set up and 
benefit  from  the  strong  commitment  of  the  vast  majority  of  Member  State 
enforcement authorities. 

The  Forum  requires  national  enforcers,  some  of  whom  had  no  previous  experience 
with  coordination  work  at  the  EU  level,  to  discuss  with  their  counterparts  in  other 
Member States and jointly come to harmonised projects and strategies, thus increasing 
consistency  in  REACH  implementation  across  the  European  Union.  So  far  the 
Forum's work appears to have had limited influence on the practice in Member States 
with  strong  traditions  of  chemical  legislation  enforcement,  but  it  appears  to  be 
bringing real added value in others. Workload appears an issue for all members, who 
conduct their Forum work on top of their “day jobs”. 

Since  its  formation,  the  Forum  has  developed  several  documents  illustrating  its 
approach of enforcement. The main ones are: 

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–  the strategies for enforcement of REACH and CLP; 

–  the minimum criteria for REACH and CLP inspections; 

–  the documents related to Forum's EU/EEA EFTA harmonised enforcement projects 

(REACH-EN-FORCE projects) to check compliance with REACH. 

To  ensure  proper  cooperation  and  information  exchange  between  national  CAs  and 
national  enforcement  authorities,  the  Forum  has  established  a  working  group  to 
analyse the interlinks between ECHA, CAs and national enforcement  authorities for 
the  different  REACH  processes.  The  Commission  services  welcome  and  encourage 
the Forum initiative on this important issue. 

The  Forum’s  workload  is  increasing  and  its  members  should  receive  full  scientific, 
technical  and  administrative  support  from  Member  States.  Further  prioritisation 
efforts of enforcement and inspections across the European Union is needed in order 
to  target  the  limited  resources  of  national  enforcement  authorities  and  maximise  the 
benefits from compliance activities. 

The work already performed by the Forum is highly appreciated by the Commission 
and CAs. The Commission services are encouraging the Forum to further strengthen 
its  efforts  and  focus  on  delivering  its  core  tasks,  which  are  pursuing  harmonised 
enforcement projects, joined inspections, exchange of inspectors and practical help to 
local  inspectors.  The  Forum  should  also  consider  facilitating  exchange  programmes 
between  Member  States  to  allow  for  the  dissemination  of  best  practice  and  increase 
harmonisation of enforcement activities. 

Information exchange on enforcement  

The  key  element  of  coordination  of  enforcement  activities  within  and  between 
Member  States  is  the  exchange  of  information.  For  this  the  Forum  and  the  Member 
States have developed different systems. Some examples are: 

–  The  information  in  REACH–IT  databases,  e.g.  on  companies  and  substances,  is 
needed for enforcement purposes. For this reason, in June 2011 ECHA established 
a  REACH  information  portal  for  enforcement  authorities  (RIPE)  containing  a 
selection of the most essential information for the purpose of enforcement. Before 
RIPE was operational, some enforcement authorities had significant difficulties in 
the  planning  and  execution  of  their  duties  because  of  lack  of  a  direct  access  to 
relevant data. Currently almost all Member States (except two) have access to the 
REACH-IT system and can use it e.g. for enforcement activities. 

–  Ten  CAs  reported  receiving  enforcement  referrals  from  other  Member  States.  

However, in each case these were few in number. 

–  The  most  common  mechanism  used  to  share  information  (formal  or  informal) 
within  Member  States  is  the  organisation  of  meetings  between  CAs  and  national 
enforcement authorities (e.g. Austria holds two per year).  Furthermore, many CAs 
provide oversight to the activities of the enforcement bodies and most CAs provide 
training.    The  Commission  services  recommend  sharing  these  practices  among 
other Member States. 

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–  Information exchange on products posing a serious risk within Member States and 
between Member States is also ongoing via the notification by the authorities under 
the  Community  Rapid  Information  System  for  non-food  dangerous  products 
(known as “RAPEX”), as required under Regulation (EC) No 765/2008180. 

Enforcement activities 

Enforcement strategies 

A  proper  enforcement  strategy  should  allow  the  enforcement  activities  to  be  most 
effective, i.e. providing for the greatest output with regard to compliance by using the 
same amount of Member States resources. The Forum developed in 2008 a document 
on enforcement strategy concerning REACH and subsequently updated it (in 2011) to 
incorporate the CLP requirements as well. 

In  their  Article  117(1)  reports,  24  of  the  30  Member  States  indicated  that  they  had 
(an) enforcement strategy(ies) that were in line with those devised by the Forum.  Six 
national enforcement strategies were not fully in line but two were very close to it and 
one  was  reported  to  be  revised  to  meet  the  Forum  strategy.  Each  Member  State 
enforcement  strategy  was  unique  so  as  to  better  fit  with  different  administrative 
structures and based on their own experience from enforcing chemical legislation.  

The  Commission  services  consider  the  enforcement  strategies  would  become  more 
effective  by  giving  priority  to  assessing  compliance  of  the  exposure  scenarios, 
information  in  the  supply  chain  (safety  data  sheets)  and  substances  in  articles.  This 
would  allow  enforcement  authorities  to  assess  compliance  with  registration, 
authorisation, restriction and classification and labelling requirements. 

The information  generated  by  the  different REACH  requirements can  be relevant  in 
the enforcement of other EU legislation, including worker health and safety, industrial 
pollution control, product requirements, market surveillance and customs. Therefore, 
to  improve  efficiency  of  enforcement,  the  combination  and/or  coordination  of 
REACH  enforcement  activities  with  those  under  other  EU  legislation  should  be 
considered.  This  approach  is  also  confirmed  by  the  recent  study  on  inspection 
requirements for REACH and CLP181. 

Inspections and investigations 

For  reporting  purposes  Member  States  were  asked  for  data  on  the  number  of 
inspections  or  investigations  undertaken  during  2007,  2008  and  2009  “in  which 
REACH was discussed or enforced”.  However, it was clear that Member States use 
inspections and investigations in very different ways within their overall enforcement 
strategies and the Member States reports showed a high degree of variation between 

180   Regulation  (EC)  No  765/2008  of  the  European  Parliament  and  of  the  Council  of  9  July  2008 
setting out the requirements for accreditation and market surveillance relating to the marketing of 
products and repealing Regulation (EEC) No 339/93, OJ L 218, 13.8.2008, p. 30. 

181   Study  "Inspection  requirements  for  REACH  and  CLP”,  Millieu  Ltd,  commissioned  by  the 

European Commission, 2012. 

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them. Some Member States undertook tens of thousands of such actions per year and 
others  undertook  less  than  ten,  regardless  of  the  size  of  the  Member  State.  It  would 
appear likely that different Member States have different interpretations of the scope 
of investigations. 

Furthermore,  a  lack  of  consistency  in  the  answers  given  to  Article  117(1) 
questionnaires  showed  that  it  was  not  possible,  e.g.,  to  carry  any  type  of  statistical 
analysis  on  the  inspection  burden  to  duty-holders  of  different  types  and  sizes.  
However,  from  the  most  recent  data  available  (2009),  the  main  focus  for  inspection 
activities  up  to  that  time  would  appear  to  have  been  on  small  and  medium-sized 
enterprises (SMEs). For all these reasons, the Commission services see  as a  priority 
the  development  of  European  REACH  Enforcement  Indicators  which  would  help  to 
better know how REACH is implemented, help the Forum in fulfilling their tasks and 
help  Member  States  in  fulfilling  their  reporting  obligations.  For  this  exercise,  the 
Forum can play an important role. 

The  REACH-EN-FORCE-1  (REF-1),  a  Forum  harmonised  enforcement  project, 
found  that  approximately  4%  of  the  companies  inspected  were  not  complying  with 
their  registration  requirements.    Furthermore,  the  Forum  reported  that  9%  of 
companies  did  not  have  safety  data  sheets  available  for  inspection  while  the  safety 
data sheets provided by 16% of companies did not meet the requirements prescribed 
for safety data sheets.  Overall, the Forum found that 20% of companies were not in 
full  compliance  with  the  obligations  checked  in  REF-1.  The  ongoing  REF–2 
harmonised enforcement project is focusing on the obligation of downstream users – 
formulators  of  mixtures.  The  scope  of  the  planned  REF-3  project  will  include  the 
registration obligations for importers, manufactures and only representatives (ORs) as 
well as close cooperation with customs and compliance of ORs with their duties. The 
Commission services are of the view that all Member States should participate in and 
report to these harmonised enforcement project. 

Also with regard to restrictions under REACH, it is to be noted that the enforcement 
activities  varies  among  Member  States,  which  reflects  the  different  priorities  of 
Member  States  authorities  with  regard  to  certain  restrictions  over  others.  In  the 
Commission  services'  view,  Member  States  should  further  improve  prioritisation  of 
enforcement  actions,  exchange  of  information  among  enforcement  authorities  and 
cooperation  with  customs.  These  finding  are  confirmed  by  the  recent  Commission 
study on enforcement of restrictions182. 

Sanctions 

The Article 117(1) reports and the findings of the harmonised enforcement projects of 
the Forum (REF) describe a wide range of enforcement sanctions that are available to 
national  enforcement  bodies.  This  include  the  prohibition  to  a  company  to  place  its 
products  (substances,  mixtures  or  articles)  on  the  market,  large  fines  and/or  prison 
sentences,  and  the  confiscation  of  illegal  goods  for  those  found  guilty  of  breaching 

182   Study  “Implementation  and  enforcement  of  restrictions  in  Member  States”,  Milieu  Ltd, 

commissioned by the European Commission, 2012. 

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a(some) provision(s).  Enforcement actions and possible sanctions are  assessed on a 
case-by-case basis. 

The Member State systems typically describe a mixture of administrative and criminal 
measures available to their enforcement authorities but some enforcement bodies have 
only  administrative  measures  available.    The  punitive  measures  described  above  are 
typically  preceded  by  non-punitive  measures  designed  to  bring  companies  into 
compliance. 

Stakeholders 

Stakeholders,  at  a  first  instance,  can  approach  their  Member  State  enforcement 
authorities  to  discuss  their  concerns.  Furthermore,  they  can  regularly  attend  Forum 
meetings  where  they  can  bring  enforcement  issues  for  discussion  at  the  EU  level. 
Duty-holders have the possibility to address, as well, their national REACH and CLP 
helpdesks  which  also  have  their  regular  meetings  in  ECHA.  Furthermore,  the 
Commission  and  ECHA  regularly  organise  conferences  or  ad-hoc  meetings  for 
stakeholders  where  enforcement  issues  are  also  discussed  (for  example,  the 
Commission  Conference  on  REACH  and  CLP  Enforcement  held  in  Brussels  on  1 
March 2012). 

The survey on industry183 found that 45% of companies had as yet no experience of 
REACH inspection or enforcement.  The remaining companies were positive overall 
regarding their experience of such activities by regulators. 

Stakeholders commented on the significant differences in approach between Member 
States  with  regards  to  inspection  requirements,  penalties  and  the  role  of  customs, 
without  specifying  the  degree  and  experienced  impacts  of  these  differences.  The 
Commission  services  are  closely  following  these  issues  and  addressing  the 
appropriate  issues  at  the  appropriate  level.  Comments  were  also  received  regarding 
the  lack  of  resources  for  inspection  and/or  enforcement  available  to  authorities  in 
some Member States. 

Conclusions 

A  strong  and  harmonised  approach  towards  enforcement  of  REACH  throughout  the 
EU/EEA EFTA is vital for delivering its objectives. The enforcement of REACH lies 
with the Member States. In order to enable REACH to operate effectively in practice, 
Member  States  are  obliged  to  establish  the  necessary  arrangements  for  its 
implementation. 

The  practical  arrangements  for  enforcement  vary  between  one  Member  State  to 
another,  allowing  Member  States  to  operate  the  system  that  best  fits  with  their 
administrative  structures  or  legal  cultures.  Enforcement  authorities  typically  have  a 
mixture of administrative and criminal measures at their disposal. 

183   CSES was commissioned by the Commission to conduct an industry survey with the aim to study 
industry impacts of REACH. More than 1500 companies participated in the survey which ran over 
the period of July to September 2011. 

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The coordination of enforcement activities within Member States in order to integrate 
other  EU  legislation  is  considered  essential  to  maximise  the  effectiveness  of  the 
existing resources. 

The work already performed by the Forum has shown that the Member States found 
this  network  very  useful.  The  Commission  services  encourage  Member  States  to 
enhance  their  support  to  Forum  members  by  providing  full  scientific,  technical  and 
administrative assistance. Further prioritisation of enforcement and inspections across 
the EU is needed to focus the limited resources of national enforcement authorities in 
order to achieve the most benefits as regards compliance and objectives of REACH. 
The Forum is encouraged to further strengthen its efforts and focus on delivering its 
core tasks, which are pursuing harmonised enforcement projects, joined  inspections, 
exchange of inspectors and practical help to local inspectors. The Forum should also 
consider  facilitating  exchange  programmes  between  Member  States  to  allow  for  the 
dissemination of best practice and increase harmonisation of enforcement activities. 

Despite the fact that according to the reports available, Member States are undertaking 
their  tasks  entirely,  and  in  most  of  the  cases  through  common  strategy(ies),  a 
harmonised  enforcement  of  REACH  across  Member  States  continues  to  be  a 
challenge. 

More  consistent  and  comparable  data  from  Member  States  on  implementation  of 
REACH  would  allow  having  better  overview  and  assessment  of  the  actions  to  be 
taken. The Commission services consider that it will therefore assume a yet stronger 
overview  role  in  the  development,  use  and  analysis  of  the  European  enforcement 
indicators, thus leading to a more in-depth examination of meeting the requirements 
set up by REACH. 

Recommendations 

11.1 Member  States  should  further  focus  their  inspection/enforcement  activities  across  the  EU  to 

target limited resources where most benefit is to be expected. 

11.2 Member States should improve coordination of their inspection and enforcement activities under 

REACH/CLP and other EU legislation. 

11.3 Enforcement indicators will be developed in liaison with the Forum. This will help to a) have better 
knowledge of the implementation of REACH, b) Forum to better fulfil their activities and c) achieve 
a  more  harmonised  and  systematic  approach  concerning  the  collection  of  information  and 
reporting. 

11.4 The  Member  States  should  consider  the  Forum  as  a  single  point  of  discussion,  collation  and 

compilation of information on REACH / CLP enforcement activities. 

11.5 ECHA is invited to make more systematic use of information from all relevant ECHA activities to 

better enable targeted enforcement activities by the Member States. 

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INFORMATION  

Information 

Through ECHA’s dissemination activities the world is being transformed into 
“a  world  of  a  lot  of  knowledge  on  chemicals.”    However,  it  took  time  for 
ECHA to get to this stage. 

ECHA’s dissemination activities 

REACH is designed to lead to an unprecedented level of collection and generation of 
information on chemical substances.  Compiling a registration dossier and sending it 
to ECHA does not mean that the information is buried in a data cemetery, only to be 
mined  if  and  when  the  desire  or  need  of  Competent  Authorities,  ECHA  or 
Commission  arises.    As  explained  in  [Titles  2  and  6],  the  information  is  to  lead  to 
better management of chemical risks by registrants and downstream users themselves 
in the first place.  In addition, however, REACH aims to provide EU citizens with free 
and easy access to basic data on chemicals held in ECHA’s database, so as to allow 
them to make informed decisions about their use of chemicals (recital (117)).  Article 
119  of  REACH  lists  the  information  to  be  published  by  ECHA;  in  the  case  of 
information  listed  in  Article  119(2),  companies  can  make  justified  requests  for  the 
information not to be published.  Information listed in Article 118(2) is not published 
by  ECHA,  but  can  be  disclosed  when  urgent  action  is  essential  to  protect  human 
health, safety or the environment.  PPORD information is not published under Article 
9(9). 

In the first years of ECHA's operation, its website was not generally perceived to be 
user-friendly.  It was criticised for lacking clarity in the routing, making it sometimes 
difficult  to  find  documents  fast,  and  for  its  limited  search  facilities184.    The  ECHA 
website  was  revamped  towards  the  end  of  2011185,  improving  its  transparency  and 
accessibility. 

ECHA’s  current  website  (www.echa.europa.eu)  has  different  tools  and  facilities  to 
search  for  information  on  substances.    The  public  database  on  registered  substances 
was launched in December 2009186 and allows searching for substance properties and 
other information from registration dossiers.  As per 16 March 2012, information on 
4 326  substances  could  be  consulted187.    The  Classification  and  Labelling  Inventory 
foreseen  by  Article  42  of  CLP  took  longer  to  publish  than  expected,  including  by 
ECHA  itself188,  and  this  raised  concerns,  but  since  February  2012  it  is  available  for 
searching.  Data on candidate list substances in articles can be consulted as well, and 

184   Study  “Review  of  the  European  Chemicals  Agency”,  PwC,  commissioned  by  the  European 

Commission, p. 25 and 35. 

185   The Operation of REACH and CLP 2011, European Chemicals Agency, 2011, p. 24. 

186   Idem, p. 22. 

187  Current registration figures are available on ECHA website (www.echa.europa.eu)  

188   Study  “Review  of  the  European  Chemicals  Agency”,  PwC,  commissioned  by  the  European 

Commission,  p. 41. 

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is based on notifications submitted under Article 7(2) of REACH and on registration 
dossiers. 

In addition to the dissemination of basic data on chemicals, there are also publication 
activities as part of ongoing REACH processes.  The list of pre-registered substances 
was  made  available  at  the  end  of  2008,  in  accordance  with  Article  28(4);  see  also 
[Title 6].  Consultations through publication of testing proposals according to Article 
40(2) are part of the dossier evaluation process; see also [Title 4].  The first CoRAP 
was published on 29 February 2012 in accordance with Article 44(2), launching the 
first substance evaluations as further detailed in [Title 7].  Three recommendations for 
priority substances to be included in Annex XIV were published so far under Article 
58(4) and the publication of the candidate list itself is regularly updated in accordance 
with Article 59(4); see also [Title 8].  Notices regarding the preparation of Annex XV 
dossiers are published in accordance with Article 59(4) for authorisation, Annex XV 
dossiers  are  published  in  accordance  with  Article  69(6)  for  restriction,  as  are 
proposals for harmonised classification and labelling under Article 37(4) of CLP189. 

ECHA  also  publishes  information  to  assist  companies  in  the  fulfilment  of  their 
obligations  under  REACH.    The  results  of  the  screening  highlighted  in  [Title  6], 
which  aimed  at  gaining  an  overview  of  substances  intended  to  be  registered  by  the 
2010  deadline  to  enable  planning  of  downstream  users  (DUs),  were  made  available 
before  the  2010  registration  deadline.  Similarly,  a  list  of  substances  identified  for 
registration by 31 May 2013, compiled based on responses from individual companies 
to  a  survey,  is  available  for  consultation  so  as  to  allow  planning  of  manufacturers, 
importers  and  DUs  towards  this  upcoming  deadline.    Finally,  ECHA  also  publishes 
the Registry of Intentions, the role of which is further discussed in [Titles 2, 5 and 9], 
not  only  to  facilitate  timely  preparation  of  interested  parties  for  commenting  in  the 
later stages of Annex XV dossier preparations, but also to avoid duplication of work 
and encourage coordination between Member States. 

The  Commission  services  welcome  the  progress  made  in  ECHA’s  dissemination 
activities and encourage ECHA to continue finding new and improved ways to deliver 
transparency on chemicals information, so as to benefit all stakeholders – consumers, 
the general public, industry and downstream users alike. 

Policy about information published on ECHA's website 

Publishing large amounts of information related to chemical substances entails a risk 
that  the  publication  of  some  of  that  information  might  be  detrimental  for  the 
submitting  company,  as  it  is  sensitive  from  a  commercial  or  intellectual  property 
viewpoint.    On  the  other  hand,  there  is  an  interest  for  society  as  a  whole,  including 
many  companies  that  information  is  made  publicly  available.    The  inherent  tension 
between  both  interests,  that  of  confidentiality  and  that  of  transparency,  led  to 
discussions during the legislative process and resulted in the wording of Articles 118 
and  119,  as  well  as  references  to  them  in  several  other  articles  of  REACH  (e.g., 

189   Before the adoption of CLP, the format for such proposals was outlined in Annex XV to REACH.  

Accordingly, these proposals are also commonly referred to as “Annex XV dossiers”. 

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Articles  64(2),  69(6)  and  77(2)(e)).    The  application  of  Articles  118  and  119  has 
raised various issues in practice. 

First of all, several interpretation questions have been clarified: (1) The name of the 
registrant  can  be  published  by  ECHA,  unless  a  justified  confidentiality  request  has 
been made and accepted, as the registrant’s name is contained in the safety data sheet 
(SDS) and thus falls within the remit of Article 119(2)(d).  (2) ECHA, when dealing 
with  confidentiality  requests  regarding  the  registrant’s  name,  must  duly  take  into 
account  any  use  made  of  the  possibility  to  omit  the  part  of  the  registration  number 
referring to the individual registrant in the SDS.  (3) If a third party representative was 
appointed  pursuant  to  Article  4  of  REACH,  ECHA  has  no  discretion  to  refuse 
confidentiality requests regarding the registrant’s name.  (4) Article 119(2)(b) requires 
the publication of the sum of the individual tonnages for which registration dossiers 
have  been  submitted,  expressed  as  tonnage  band.    (5)  Confidentiality  requests 
regarding  tonnage  data  to  be  omitted  from the  publication  of  the  total  tonnage  band 
are  to  be  assessed  case-by-case,  but  are  likely  to  succeed  when  the  company 
requesting confidentiality is the only registrant for a given substance or, depending on 
the market structure, when there are a limited number of registrants. 

Secondly, issues related to confidentiality of and access to information generated an 
unexpectedly  high  workload  for  ECHA190.    Rules  needed  to  be  defined  to  decide 
which of the fields in a IUCLID dossier could be made available on the internet, and 
manual  intervention  for  publication  was  needed  until  March  2011,  when  automated 
dissemination  was  achieved191.    By  March  2011,  ECHA  had  received  some  1 300 
confidentiality  requests  foreseen  by  Article  119(2),  all  of  which  ECHA  aimed  to 
assess by the end of 2012.  ECHA’s Management Board adopted in 2008 a Decision 
establishing remedies for reviewing rejections of confidentiality requests pursuant to 
Article 118(3) of REACH192.  In addition, a strategy was developed and implemented 
to ensure that, in cases where the IUPAC name of the substance is kept confidential 
under Article 119(2)(f) and (g), a suitable “public” name for the substance is provided 
by the registrant to allow dissemination of substance information and consultation on 
testing proposals. 

Non-industry  stakeholders  are  reported  to  perceive  ECHA  as  too  stringent  when  it 
comes to releasing registrants names for dissemination purposes193.  The Commission 
services believe that as long as the clarification of the related interpretation questions 
was  pending,  the  approach  taken  by  ECHA  was  the  correct  one  under  the 
circumstances,  and  takes  note  of  the  fact  that  ECHA  is  now  working  in  accordance 
with  the clarification provided.  Non-industry stakeholders moreover are reported to 
believe that ECHA is too cautious when it comes to confidentiality of company data 

190   The Operation of REACH and CLP, European Chemicals Agency, 2011, p. 78. 

191   Idem, p. 22. 

192   Document MB/17/2008, amended by MB/17/2011 [available on www.echa.europa.eu]  

193   Study “Review of the European Chemicals Agency”, PwC, p. 25 and 42; note that the cut-off for 
the review period was and 2010, when interpretations questions (1) to (3) were not yet resolved. 

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and is not evaluating all confidentiality requests made due to resource constraints, but 
the  Commission  services  found  no  evidence  substantiating  this  claim194.    The 
Commission  services  note  ECHA’s  intent  to  assess  by  the  end  of  2012  all  1 300 
confidentiality requests received by March 2011. 

The  Commission  services  note  that  significant  progress  has  been  made  and 
encourages  ECHA  to  continue  on  its  path  of  dissemination  and  transparency,  while 
taking due notice of the various interests to be balanced as laid down in Articles 118 
and 119 of REACH. 

Cooperation with OECD and third countries 

International  co-operation  on  REACH  remains  an  important  component  of  the  EU's 
work. 

At the multilateral level, the main focus has been on strengthening cooperation with 
the OECD195.  The Commission, in association with the OECD, has further developed 
the  International  Uniform  ChemicaL  Information  Database  (IUCLID)  enabling  the 
exchange of data on intrinsic and hazard properties of chemical substances.  IUCLID 
is the key data exchange tool under the OECD's Cooperative Chemical's Assessment 
Programme.  In addition, ECHA has cooperated closely on two major OECD projects, 
namely the eChemPortal (Global Portal to Information on Chemical Substances) and 
the  QSAR  Toolbox.    The  Portal  now  provides  free  public  access  to  information  on 
chemical  substances  (including  those  published  on  ECHA's  website).    This  is  a 
significant  contribution  to  identify  and  make  information  on  chemical  properties 
available to citizens.  The QSAR Toolbox ensures that (Q)SAR technology is readily 
accessible,  transparent  and  less  demanding  in  terms  of  infrastructure  costs.    It  fills 
gaps  in  the  (eco)toxicity  data  needed  for  assessing  the  hazards  of  chemicals  and 
provides  a  common  framework  for  the  chemical  industry  (see  also  [Title  4]).  
Cooperation  with  the  OECD  extends  beyond  project  development  to  include  also 
participation  in  the  implementation  of  the  OECD  Programme  on  High  Production 
Volume Chemicals. 

At  bilateral  level,  much  investment  has  been  made  to  increase  the  knowledge  and 
understanding of REACH.  Numerous meetings and workshops have been convened 
within  and  outside  the  EU  in  an  effort  to  ensure  that  candidate  countries,  potential 
candidate countries and countries within the European Neighbourhood as well as third 
countries are informed about REACH implementation. In addition, several visits are 
organised  annually  in  Brussels  and  Helsinki  involving  third  country  governments, 
industry  representatives  and  academia.    REACH  has  also  frequently  been  on  the 
agenda of EU bilateral high-level meetings (Australia, Brazil, Canada, China, Japan, 
India,  Russia  and  USA),  while  every  effort  has  also  been  made  to  address  third 
country concerns in other fora (notably WTO-TBT meetings). 

194   The Operation of REACH and CLP, European Chemicals Agency, 2011, p. 47. 

195   Organisation for Economic Co-operation and Development. 

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In  recent  years  ECHA  has  further  extended  bilateral  scientific  and  technical 
cooperation.  It  signed  Statements  of  Intent  with  Japan  and  the  United  States  and 
Memorandums of Understanding with Canada and Australia.   

Recommendations 

12.1.  ECHA  is  encouraged  to  continue  finding  new  and  improved  ways  to  deliver  transparency  in 
chemicals  information  to  the  benefit  of  all  stakeholders,  while  taking  due  notice  of  the  various 
interests to be balanced as laid down in Articles 118 and 119. 

12.2. ECHA is encouraged to continue its fruitful cooperation with the OECD. ECHA is also invited to 
assess  its  general  international  activities  taking  into  account  its  broader  commitment  and  the 
added  value  of  its  involvement  and  the  international  activities  undertaken  by  the  EU.  Where 
justified ECHA should consider reassigning the related resources to other commitments. 

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ACHIEVING REACH OBJECTIVES 

1. 

HUMAN HEALTH AND ENVIRONMENT 

1.1.  Background and Introduction 

The EU industrial chemicals acquis started in 1967 and grew over the decades into a 
system of Directives and Regulations. In the late 1990s it was recognised that existing 
chemicals legislation needed to be improved to address the growing concern for the 
negative impacts chemicals had on human health and the environment. REACH was 
adopted in 2006 replacing the previous regulatory system where one of the objectives 
was  to  ensure  a  high  level  of  protection  of  human  health  and  the  environment.  The 
appropriate  implementation  of  its  provisions  are  also  the  key  elements  of  the  EU's 
commitment towards the implementation plan adopted at the 2002 World Summit on 
Sustainable Development (WSSD) which aims to achieve that, by 2020, chemicals are 
produced and used in ways that lead to minimisation of significant adverse effects on 
human health and the environment. 

The REACH objective of Environment and Health Protection was to be achieved by 
identifying  suitable  risk  management  measures  based  on  a  systematic  collection  or 
generation  of  information  on  the  hazards  of  chemicals,  including  testing.  For 
substances  at  or  above  10  tonnes  registrants  must  perform  a  chemical  safety 
assessment to check if additional risk reduction measures are necessary, beyond those 
required by the hazard classification. Through registration the registrants confirm the 
implementation  of  the  necessary  risk  management  measures  and  document  their 
decisions.  This  comprehensive  approach  would  not  only  improve  the  control  where 
this was  needed,  it would also identify those substances which needed no further  or 
even  less  controls.  The  REACH  restrictions  process  was  designed  to  control  risks 
which were not adequately controlled by measures already in place. The cumulative 
result of industry and authority risk management measures are expected to reduce the 
risks  to  the  environment  and  human  health,  including  workers,  consumers  and  the 
general public via the environment. The authorisation process aims at assuring that 
risks from substances of very high concern (SVHCs) are properly controlled and that 
these  substances  are  progressively  replaced  by  less  dangerous  alternative  substances 
or technologies where these are economically and technically viable. 

Protection  of  human  health  and  the  environment,  including  wildlife,  should  be 
balanced against the use of animals in laboratory experiments. Therefore, REACH 
provides for promoting the development of alternative methods for the assessment of 
hazards of substances. 

The health and environment objective of REACH is expected to be achieved through 
(1) better knowledge on the properties and uses of chemicals which results in better 
safety  and  control  measures,  reducing  exposure  and  hence,  the  negative  impacts  on 
human health and the environment; and (2) the use of less dangerous alternatives to 
those substances of very high concern. 

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In  2003,  the  Commission  carried  out  an  impact  assessment  of  its  REACH  proposal, 
where potential health and environment benefits were assessed196. 

First,  it  concluded  that  the  main  benefits  of  REACH  arise  from  the  application  of 
appropriate risk reduction measures – by industry in the first instance and mandated 
by  authorities  in  the  second  -  enabled  by  a  systematic  generation  of  information  on 
hazards and uses of chemicals. 

Second,  the  impact  assessment  provided  an  illustration  of  the  potential  scale  of  the 
expected  long  term  health  benefits  due  to  these  risk  reduction  measures.  It  was 
anticipated that the positive effects of REACH on public health would start to occur 
10  years  after  the  start  of  REACH  implementation,  i.e.  effectively  from  2018,  and 
would  be  fully  observed  after  another  20  years,  with  total  health  benefits  due  to 
REACH  in  the  order  of  magnitude  of  €  50  billion  over  the  30  years  period  (after 
discounting). The long-term benefits of REACH on the environment were estimated 
by  another  study  to  be  up  to  €  50  billion  over  the  25  years  period  (after 
discounting)197.  Notwithstanding 
the  overall 
conclusion was that the benefits of REACH far outweighed the costs. 

the  methodological  difficulties 

The  studies  launched  by  the  Commission  in  the  framework  of  this  review  have 
confirmed  that  5  years  after  the  entry  into  force  of  REACH,  it  is  still  too  early  to 
quantify human health and environment benefits. This review therefore looks at initial 
trends based on the examination of qualitative information and a representative set of 
quantitative indicators198 + 199. 

Assessment  of  the  degree  to  which  the  health  and  environmental  objectives  of 
REACH have been achieved started with the identification of the drivers of benefits 
within  REACH,  where  these  are  the  set  of  legal  provisions  which  are  expected  to 
trigger  direct  or  indirect  human  health  and/or  environmental  benefits;  and  the 
enhancers of these drivers, which are those provisions that help to realise the benefits 
through  support,  control  and  enforcement  and  thus  assist  or  ensure  compliance  with 
the main obligations. 

The  Commission  reviewed  those  key  drivers  which  are  already  operational  and  of 
particular  relevance  to  the  generation  of  human  health  and  environment  benefits, 
namely  registration,  requirements  concerning  information  through  the  supply  chain, 
authorisation  and  restrictions.  The  key  enhancers  of  these  benefit  drivers  (dossier 

196   Commission  Staff  Working  Paper,  [REACH]  Extended  Impact  Assessment,  29.10.2003 

{COM(2003)644 final}. 

197   Study “The impact of REACH on the environment and human health",  DHI, commissioned by the 

European Commission, September 2005. 

198   Indicators reported on by the REACH Baseline Study:  5 Years Update, Progress Report IV, Oko-
Institut, FoBiG, DHI and INERIS, commissioned by European Commission - Eurostat, December 
2011. 

199   Study “Assessment of health and environmental benefits of REACH” RPA, commissioned by the 

European Commission, April 2012. 

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evaluation,  provision  of  guidance,  inspections  and  enforcement  activities)  were  also 
looked at. It is also important to note that a number of key drivers were not considered 
in  this  review  as  they  have  only  just  started  or  are  still  to  come  (e.g.  registration 
deadlines  of  2013  and  2018,  substance  evaluation  in  2012;  first  applications  for 
authorisation in 2012). 

1.2.  Registration 

Registration under REACH requires collection, generation and assessment of hazard 
and  exposure  data,  risk  assessment  and  the  identification  of  risk  management 
measures to ensure the safe use of chemicals. In particular, the following elements are 
the key drivers for the control and reduction of harmful impacts on human health and 
the environment: 

–  The  preparation  of  Chemical  Safety  Assessments  (CSAs)  for  substances  which 
have hazardous properties should create benefits through a reduction in unsafe use. 

–  The  systematic  collection  of  data  and,  where  necessary,  the  generation  of  new 
(test)  data  should  lead  to  improved  information  on  the  properties  of  chemicals, 
improved  reliability  of  classifications  and  thus  improved  information  on  safe  use 
and handling.  It should also improve the information base for the implementation 
and enforcement of other legislation. 

–  The requirement to carry out a PBT assessment200 as part of the CSA should help 
ensure that substances are identified as potential SVHC and can be made subject to 
more detailed evaluation, authorisation or restriction. 

–  The  requirement  to  register  substances  will  create  benefits  for  human  health  and 
the environment where a substance is no longer supported by registrants due to its 
hazardous  properties  as  well  as  the  availability  of  suitable  alternatives,  and  is 
therefore withdrawn from the market. 

In addition, the evaluation of dossiers should act as an enhancer of benefits if it helps 
registrants  to  learn  how  to  improve  their  registration  dossiers.  Guidance  should  also 
act as an enhancer by providing tools for assessing safe use. Similarly, inspection and 
enforcement should act as enhancers by ensuring there is an incentive to comply with 
the registration provisions. 

From work carried out specifically for the REACH benefits study201 on a sub-set of 71 
substances  being  reviewed  as  part  of  the  REACH  baseline  study,  it  is  clear  that  the 
information  being  generated  from  REACH  is  resulting  in  changes  in  classification, 
with  the  majority  of  these  being  more  restrictive  classifications.  This  is  particularly 

200   Assessment of persistency, bioaccumulation and toxicity of substances. 

201   Study “Assessment of health and environmental benefits of REACH”. RPA, commissioned by the 

European Commission, April 2012. 

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noticeable for endpoints such as acute toxicity, sensitisation, reproductive toxicity and 
aquatic toxicity. Overall, the percentages classified after registration increased across 
all of the endpoints being considered. This suggests that classifications are becoming 
more reliable as more and improved information on substances properties is generated 
and  as  registrants  harmonise  classifications.  These  findings  are  important  as 
classifications  drive  the  need  for  the  development  of  exposure  scenarios  within  the 
CSA  and,  in  response  to  these,  for  registrants  to  put  forward  recommended  risk 
management  measures  in  their  extended  safety  data  sheets  (eSDS).  There  are  some 
outstanding  issues,  such  as  the  continued  existence  of  multiple  self-classifications 
which is giving rise to problems for formulators, but these should reduce over time as 
more substances go through registration. 

With  respect  to  the  duty  to  prepare  a  CSA,  the  findings202  confirm  that  this  should 
lead  to  safer  use  as  new  or  more  stringent  risk  management  measures  than  those 
currently in place are being recommended by registrants to their downstream supply 
chains. This should lead to benefits for workers, to the environment (through reduced 
emissions) and to the general public through reductions in environmental exposures, 
particularly as the substances produced and/or imported in less than 1000 tonnes per 
year go through registration. 

the  potential  costs  of  supporting 

 With  regard  to  substance  withdrawal,  there  is  evidence  that  substances  have  been 
“dropped”  from  the  market  or  otherwise  not  registered  due  to  their  properties  (in 
particular  CMRs203)  and/or 
through 
authorisation  as  well  as  registration204.  It  is  also  clear  though  that  substance 
withdrawal  may  be  taking  place  as  part  of  the  rationalisation  of  product  portfolios. 
The exact extent to which substances that have been withdrawn are replaced by a less 
hazardous  alternative  is  not  known  at  this  stage  of  REACH  implementation  but  it 
would  be  worth  investigating  in  future  research  in  order  to  avoid  unwanted 
withdrawal  of  substances  that  would  lead  to  no  additional  benefits  to  human  health 
and the environment. 

them 

There is a need for all actors to increase efforts to improve the quality of registration 
dossiers. The quality of information submitted by industry in registration dossiers has 
indeed  been  identified  by  ECHA205  as  being  of  concern,  leading  to  many  dossiers 
being found non-compliant or whose quality should be improved, as already described 
in [Title 6 of Part I].  An analysis of a sub-set of registered substances also suggests 
that registrants have not fully responded to the need to provide a clear assessment of 
PBT and vPvB properties. A preliminary conclusion is that bringing the registration 
dossiers  already  submitted  into  compliance  is  a  priority.  An  appropriate  scrutiny  is 
likely to become even more important in the next registration phases, as in the past the 

202   Idem. 

203   Carcinogenic, mutagenic, toxic for reproduction. 

204   Study “Assessment of health and environmental benefits of REACH”. RPA, commissioned by the 

European Commission, April 2012, . 

205   Evaluation Under REACH, Progress Report 2011, European Chemicals Agency, 2012 

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to 

the  fulfilment  of 

lower  volume  substances  had  generally  less  data  available  on  their  properties  than 
those  registered  in  the  first  phase.  It  is  therefore  evident  that  without  increasing 
industry  efforts  with  respect 
the  REACH  registration 
requirements, as well as ECHA and Member States not ensuring the compliance with 
legal requirement through the dossier evaluation and the enforcement inspections, the 
fulfilment of the health and environmental objectives of REACH will be jeopardised. 
The Commission services in liaison with ECHA will gather further practical evidence 
on  how  to  provide  the  best  possible  basis  for  the  identification  of  substances  and 
determination of "sameness". This will take into account experience gained from the 
current registration dossiers. Once there is a solid evidence basis the Commission may 
come  forward  with  a  proposal  which  could  be  legal  measures,  such  as  for  instance 
implementing  legislation  on  the  identity  of  substances,  in  order  to  improve  the 
compliance with REACH requirements. 

Finally, it has to be noticed that the monitoring of REACH performance carried out by 
Eurostat206  relating  to  the  quality  of  the  data  publically  available  for  chemicals 
assessment,  for  the  substances  already  registered,  shows  a  marked  increase  in  the 
quality of available data if compared with the pre-REACH situation. 

1.3.  Requirements concerning information in the supply chain 

Effective supply chain communication is essential for the functioning of REACH both 
in  terms  of  registrants  relying  on  information  for  the  assessment  of  risks  and  of 
downstream users relying on good information to implement safe use. Manufacturers 
and importers  of  hazardous substances are required to provide hazard, exposure and 
risk management information to their recipients, primarily via the eSDSs. In addition, 
suppliers  of  articles  containing  chemicals  identified  as  SVHCs  have  obligations 
(under Article 33) to provide information down the supply chain and to consumers, to 
enable the safe use of those articles. 

For  these  provisions,  the  health  and  environmental  benefits  are  generated  through 
three main mechanisms: 

–  The  communication  of  information  through  SDS  and  eSDS  creates  benefits 
because  new  information  is  passed  to  downstream  users  enabling  them  to  check 
their handling and use of chemicals. 

–  The requirement to communicate information upstream on operating conditions or 
risk  management  measures  (RMM)  creates  benefits  because  new  and  appropriate 
RMMs  are  identified  and  included  in  updated  safety  assessments  and  the  overall 
quality of SDS is improved. 

–  The  need  for  article  producers  to  communicate  the  presence  of  a  SVHC  on  the 
candidate  list  in  an  article  leads  to  benefits  by  helping  to  ensure  the  safe  use  of 
articles, triggering  requests from retailers for the phase-out of SVHCs in articles, 

206   REACH Baseline Study: 5 years update. Contribution to the Report of the Commission, European 

Commission – Eurostat, 2012. 

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and  enabling  consumers  to  take  the  presence  of  an  SVHC  into  account  in  their 
purchasing decisions. 

The  findings  of  the  Commission  services  confirm  that  the  new  obligation  on 
registrants to set out safe operating conditions (OCs) and RMMs as well as to provide 
such information to downstream users have already generated benefits during this first 
phase but is likely to be even more important for those substances about which there 
is currently less knowledge. 

Additionally, the monitoring activities conducted by Eurostat on reference substances 
show a marked decrease in the nominal risk associated with those already registered, 
due largely to REACH207. 

With respect to the quality and value of SDS and eSDS, the findings are twofold. The 
quality of SDSs have improved because the information on classification (and hence 
labelling)  contained  within  them  is  regarded  as  more  reliable.  In  addition,  the 
information being provided on DNELs208 is useful for workplace safety assessments 
(as a substitute for an OEL209) and can contribute to better targeted RMMs. However, 
there are problems with regard to the content and format of eSDS as currently being 
provided in supply chains. 

Formulators have an essential role in supply chain communication with regard to the 
information on safe use, because they have to provide their safety data sheet in a way 
that  it  gives  orientation  to  the  downstream  user  on  what  to  actually  do.  It  has  been 
reported  that  both  suppliers  of  substances  and  formulators  of  chemical  mixtures 
compile  large  amounts  of  information  in  their  eSDS  which  sometimes  leads  to 
confusion. Hence, there is a need for ECHA, in cooperation with industry, to progress 
their  work  on  CHESAR210  and  derive  from  that  the  core  information  structure  for 
communication on uses in order to facilitate respective supply chain communication. 
Structures  such  as  CHESAR  should  be  used  by  industry  to  develop  their  software 
tools  to  provide  safety  data  sheets.  There  is  also  a  need  for  a  revised  format  of  the 
exposure  scenario  for  supply  chain  communication  which  should  be  provided  in  a 
standardised IT format. 

Industry  continues  working  on  standard  phrases  for  conditions  of  use  and  RMMs. 
However,  it  appears  that  more  commitment  is  needed.  Downstream  users  should  be 
encouraged  to  provide  information  on  conditions  of  use  in  ECHA  information 
structure in a targeted way. 

At the same time, players at the bottom of the supply chain, such as article producers, 
have  still  already  benefited  from  an  increased  level  of  knowledge  on  the  properties 

207   Idem 

208   Derived No-effect Levels 

209   Occupational Exposure Level 

210   CHEmical Safety Assessment and Reporting tool 

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and/or the possible uses of chemical substances. This can only have been the result of 
supply  chain  communication  requirements.  The  same  is  true  for  end-users,  who 
confirmed  through  the  surveys  conducted  under  this  review  that  REACH  has 
increased  their  level  of  knowledge  on  the  properties  and/or  the  possible  uses  of 
chemicals. 

With  respect  to  communication  on  SVHCs  through  the  supply  chain,  substitution 
would be promoted through the “announcement effect” associated with the candidate 
listing of SVHC and the duty to provide information on SVHCs in articles contained 
in  concentrations  above  0.1%  to  users  of  articles.  Indeed,  the  candidate  listing  is 
leading  to  an  early  action  towards  substitution  by  formulators  and  demands  for 
substitution within their supply chains by article producers. Thus, it could be expected 
that the use of SVHCs will gradually reduce, particularly in consumer goods.  

Article producers and retailers are putting in place the necessary information systems 
to manage the necessary supply chain communication and in particular to undertake 
the  necessary  compliance  checks  through  product  and  supplier  inspections.  It  is 
important that these efforts are intensified to avoid supply disruptions as the candidate 
list grows in size. 

One of the problems identified relates to the 0.1% concentration threshold for SVHC 
present in articles. These are addressed in greater details in [Title 5] of Part I.  

1.4.  Authorisation and restrictions 

The  authorisation  provisions  within  REACH  are  aimed  at  ensuring  that  risks  from 
SVHCs are properly controlled, and that these substances are progressively replaced 
by  suitable  alternative  substances  or  technologies  where  these  are  economically  and 
technically viable. The identification of SVHCs is a hazard  based  concept,  although 
the prioritisation of SVHCs does take into account factors such as production volumes 
and  whether  there  is  wide-dispersive  use  of  the  substance  as  proxies  for  potential 
risks. 

REACH  also  includes  a  separate  provision  allowing  restrictions  on  the  manufacture 
(or  import),  placing  on  the  market  and/or  on  specific  uses  of  either  a  substance, 
mixtures and/or articles (subject to some  exemptions), where these  can be shown to 
pose  an  unacceptable  risk  to  human  health  or  the  environment  that  should  be 
addressed on an EU-wide basis. The restriction provisions are not dissimilar to those 
established under the earlier combination of Regulation (EC) No 793/93 and Directive 
76/769/EEC.  However, the restriction process under REACH is expected to speed up 
the  time  taken  for  measures  to  be  adopted  and  implemented  as  well  as  to  allow  for 
more targeted assessments. 

At the time of writing, 82 substances had been entered onto the candidate list, with 36 
substances prioritised for authorisation. From the information obtained in this review, 
it  is  clear  that  Annex  XIV  and  candidate  listings  are  having  their  desired  effect:  

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substances placed on the lists are being withdrawn from use and downstream users are 
moving  to  substitutes  where  possible211.  Thus,  this  process  is  beginning  to  deliver 
benefits  associated  with    removals  of  SVHCs  from  use  in  the  EU.  As  anticipated, 
substance withdrawal is taking place because some manufacturers and importers are 
reluctant  to  register  a  substance  that  may  be  subject  to  Authorisation,  which  would 
lead to further costs associated with having to make applications for continued use. 

Although an important increase in the number of substances included in the candidate 
list in 2011 and 2012 has been observed, there is still a need for more effort to achieve 
the  target  proposed  by  the  Commission.    This  is  that  all  relevant  currently  known 
SVHCs  will  be  included  in  the  candidate  list  and  so  contribute  to  the  2002  WSSD 
goal  that,  by  2020,  chemicals  are  produced  and  used  in  ways  that  do  not  lead  to 
significant  adverse  effects  on  human  health  and  the  environment.  This  suggests  that 
inadequate  resources  are  provided  to  maintain  the  candidate  list  process.  The 
Commission is striving to mobilise efforts in Member States to achieve the long-term 
objective as well as a mid-term target of 136 SVHC on the candidate list by end of 
2012. 

Achieving  these  targets  should  also  be  seen  in  the  context  of  the  Roadmap  to  a 
resource-efficient  Europe  which  was  adopted  by  the  Commission  on  20  September 
2011212. The roadmap sets an agenda for competitiveness and growth based on using 
fewer resources when we produce and consume goods and creating business and job 
opportunities  from  activities  such  as  recycling,  better  product  design,  materials 
substitution  and  eco-engineering.  Phasing  out  and  substituting  dangerous  chemicals 
with  safer  alternatives  can  help  protect  key  resources  like  soil  and  water,  and  make 
others, like materials, safer, easier and less costly to recycle and reuse. 

On the other hand, a need for increased transparency in the judgements underlying the 
decision-making  of  Member  States  and  the  Commission  when  deciding  which 
chemicals  should  have  dossiers  prepared  and  then  which  should  be  the  ones 
prioritised  has  been  reported.  Further  explanation  and  justification  could,  therefore, 
help address this issue and build understanding and trust between the regulators and 
the regulated. 

Moreover, there have been concerns reported that potential substitutes to SVHC listed 
already  on  the  candidate  list  may  not  necessarily  be  better  from  a  human  health  or 
environmental  perspective.  In  this  respect,  groups  of  substances  with  similar 
properties should be considered together when assessing substances for entry onto the 
candidate  list  to  avoid  downstream  users  of  these  chemicals  shifting  to  unsuitable 
alternatives.  There  may  also  be  a  role  here  for  ECHA  in  undertaking  work  to  help 
identify  substitutes,  following  listing  or  for  other  types  of  support  to  be  given  to 
smaller companies. 

211   Study “Assessment of health and environmental benefits of REACH”. RPA, commissioned by the 

European Commission, April 2012. 

212   Communication  from  the  Commission  […]  Roadmap  to  a  Resource  Efficient  Europe,  European 

Commission, 20.9.2011, {SEC(2011) 1067 final}, 

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Under REACH, four dossiers concerning risks to human health and the environment 
were  proposed  by  Member  States,  Norway  and  ECHA  (dimethylfumarate,  lead  in 
jewellery,  mercury  in  measuring  devices  and  phenylmercury  compounds)  and  the 
Commission will adopt restriction measures and amend Annex XVII. 

Other  Annex  XV  dossier  for  restriction  proposals  have  been  submitted  to  ECHA, 
mainly targeting human health  concerns. These target the use of chromium (notably 
an allergic and irritant substance) in leather articles and the use of phthalates in indoor 
applications and some articles. 

Particular  attention  continues  to  be  paid  to  substances  that  are  carcinogenic, 
mutagenic and toxic for reproduction (CMR). As under the previous legal framework, 
the Commission adopted Regulation (EU) No 109/2012 (under Article 68(2)) which 
bans the sale to the general public of substances that were newly classified under CLP 
as CMR category 1A or 1B and of mixtures containing them. 

The  restriction  procedure  provides  a  structured  and  transparent  procedure  to  tackle 
unacceptable risks to human health and environment which need to be addressed on 
an  EU-wide  basis.  The  initiation  of  the  process  is  a  shared  responsibility  among 
Commission  and  Member  States,  and  further  efforts  should  be  undertaken  to 
encourage initiatives in this area with the view to maximise the potential benefits of 
this measure. 

1.5.  Conclusions 

As  detailed  in  the  chapter  above,  some  progress  towards  meeting  the  human  health 
and  environment  objectives  of  REACH  is  materialising.  This  trend  is  expected  to 
accelerate as the remaining key benefit drivers and their associated enhancers become 
operational, conditional on the legislation being appropriately applied and adequately 
enforced. 

On that basis, the Commission services conclude that: 

–  Increased  information  is  resulting  in  changes  in  classification,  with  the  majority 
becoming more restrictive. This is valid across all hazard classes, but particularly 
noticeable  for  acute  toxicity,  sensitisation,  reproductive  toxicity  and  aquatic 
toxicity. 

–  The  overall  quality  of  available  data  for  the  chemical  assessment  of  registered 
substances has generally increased if compared with the pre-REACH situation. 

–  Increased information passed along the supply chain and the obligation to set out 
safe operating conditions and risk management measures is resulting in improved 
SDS, making them better risk management tools. 

–  Increased information in the supply chain has benefited end-users, such as article 

producers. 

–  Increased  obligations  on  SVHCs  through  the  candidate  listing  and  authorisation 

provisions has in some cases led to their withdrawal. 

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The Commission services also identified a number of key shortcomings hindering the 
achievement  of  the  health  and  environment  objectives  and  in  particular  the 
improvements set out above. These can be summarised as follow: 

–  ECHA  identifies  the  quality  of  information  submitted  by  industry  in  registration 

dossiers as being of concern leading to many dossiers found non-compliant. 

–  Analysis  carried  out  for  the  human  health  and  environment  study  on  selected 
registration dossiers suggests that registrants need  to improve their  assessment of 
PBT and vPvB properties. 

–  Industry indicates problems with regard to the content and format of the eSDS. 

Although  it  is  too  soon  to  have  a  complete  picture  of  the  extent  of  the  benefits 
generated  by  the  first  implementation  phase  of  REACH,  the  data  collected  so  far 
verifies  the  general  hypothesis  that  REACH  will  deliver  human  health  and 
environmental benefits. Nevertheless, there are areas where improvements should be 
made  if  the  expected  benefits  are  to  materialise.  The  Commission  services  have 
developed the following recommendations on actions or measures that could be taken 
to  improve  the  degree  to  which  REACH  is  delivering  human  health  and 
environmental benefits.   

Recommendations 

I.1.  

I.2 

I.3 

The Industry should improve the quality of dossiers to ensure that the information they submit 
adequately documents how they ensure the safety of their substances.  
Based  on  evidence  gathered  by  ECHA  relating  to  the  identification  of  substances  and 
determination  of  "sameness",  the  Commission  services  will  consider  options  to  improve  the 
situation, including legal measures. 
 In order to progress towards achieving the WSSD goal that by 2020 chemicals are produced 
and used in ways that lead to minimisation of significant adverse effects on human health and 
the environment, identification and phasing out of SVHCs as well as restrictions should both be 
encouraged. 

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2. 

SINGLE MARKET, COMPETITIVENESS AND INNOVATION 

REACH regulation affects all sectors of the economy where chemical substances are 
produced  or  used.  Businesses  that  manufacture  or  import  (from  outside  the  EU)  1 
tonne or more of any given substance each year (with limited exemptions) are subject 
to  registration.  Any  business  using  chemicals  will  have  to  apply  appropriate  risk 
management  measures  for  any  use  of  the  substance  and  respond  to  other  actors  on 
other aspects of REACH. Whilst acknowledging the wide and varied impact across all 
the  economy,  the  Commission  services  have  decided  to  focus  an  analysis  on  one 
sector  which  will  be  affected  first  and  by  all  processes  of  REACH  –  the  chemicals 
sector as a representative for all roles and types of impacts. 

2.1.  Background  

The  EU  chemical  industry  performed  well  during  the  past  decade,  but  its 
global  presence  decreased  from  ~30%  to  ~21%  of  the  world’s  chemicals 
market share as a result of vey high and continuous growth rates in emerging 
economies. 

The  chemical  industry  is  one  of  the  largest  EU  industrial  sectors  and  an  important 
source of direct and indirect employment in many regions of the EU. In 2009, the EU 
chemical  industry  comprised  some  29 000  enterprises  that  employed  around  1.2 
million employees representing 4% of the total employment in the EU manufacturing 
sector.  96%  of  the  companies  in  the  sector  are  SMEs  –  61%  with  less  than  nine 
employees.  They  account  for  28%  of  sales  and  35%  of  employment  of  the  sector. 
With  a  total  production  value  of  € 491  billion  in  2011,  the  chemical  industry's 
contribution to the EU gross domestic product amounted to 1.1% representing about 
7% of the EU manufacturing sector total. 

Between  2000  and  2010  the  chemical  industry  production  experienced  an  average 
growth rate of 0.7% – slightly higher than the 0.2% average growth rate for total EU 
manufacturing.  The  economic  crisis  of  2008  and  2009  has  sharply  decreased  the 
output to the levels last seen a decade ago but it recovered vastly in 2010 and with a 
greater pace then the rest of the manufacturing sector. 

In 2000 (when the preparation of the White Paper that led to REACH began), the EU 
was  regulating  a  market  of  close  to  30%  of  global  chemicals  production.  Together 
with NAFTA and Japan, where environmental and industrial policies also are closely 
observed and mirrored – these jurisdictions regulated 70% of global chemicals market 
sales. 

A decade later, the global economic outlook has changed dramatically. The centre of 
gravity  in  world  manufacturing  and  chemical  industry  alike  has  shifted  eastward:  in 
2010,  the  Asian  market  was  double  that  of  the  EU,  which  share  of  global  sales 
decreased  to  ~20%,  despite  growth  in  absolute  numbers.  REACH  as  a  regulatory 
model  has  consequently  a  somewhat  reduced  impact  worldwide,  even  though  the 

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generated  data  and  technology  changes  remain  important  for  chemical  safety  also 
outside  the  EU.  Also,  some  emerging  economies  were  inspired  by  the  REACH 
approach and are adopting similar regimes213. 

Figure 3. World sales of chemicals by dominant markets 

2000

2010

%
s
e
l
a
s
d
l
r
o
w

30

20

10

0

EU

NAFTA

Japan

China

Others

Source: CEFIC: Facts and Figures 2011,  www.cefic.eu 

The position of the EU chemical industry seems to be very solid, but when coupled 
with  the  changing  dynamics  of  global  competitiveness  over  the  course  of  the  past 
decade, it is important to review how the economic objectives of REACH have been 
met so far. 

2.2. 

Single market 

REACH  has  increased  the  harmonisation  of  the  EU  chemicals  market,  and 
therefore contributed to increased intra-EU trade, but in a rather limited scale 
at this stage as other important barriers still exist. 

The single market, with 500 million consumers, 220 million workers and 20 million 
entrepreneurs,  is  a  key  instrument  in  achieving  a  competitive  industrial  EU.  The 
single market has been one of the main motors of economic growth in the EU over the 
last 20 years. It has provided EU industry with considerable reductions in cross-border 
trading  costs,  increased  competition,  and  provided  considerable  economies  of  scale 
and  scope  from  the  availability  of  an  EU-wide  market.  However,  as  the  market  is 
constantly evolving, new barriers emerge and add up to the already identified barriers 
as well as to those yet to be discovered. 

213   The South Korean Ministry of the Environment conducted public consultations on a draft “Act on 
the  Registration  and  Evaluation  of  Chemicals”.  The  new  act  will  overhaul  the  current  Toxic 
Chemicals Control Act and will regulate both new and existing substances. In many dimensions is 
inspired  by  REACH  and  is  often  referred  to  as  'Korea  REACH'.  The  legislation  is  expected  to 
come into force in 2013. 

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REACH was designed to attempt reducing the number of barriers for intra-EU trade 
of chemicals and provide the Commission with tools preventing future fragmentation. 
Recital  (2)  provides  that  “[t]he  efficient  functioning  of  the  internal  market  for 
substances  can  be  achieved  only  if  requirements  for  substances  do  not  differ 
significantly from Member State to Member State". 

REACH  also  provides  a  set  of  unified  tools  for  EU-wide  distribution  of  chemical 
products: 

–  a  single  registration  process  with  unified  guidelines  and  unified  fee  structure, 

implemented by a single authority (ECHA); 

–  a single and directly applicable list of restrictions on marketing and use; and 

–  a single list of substances subject to authorisation. 

Complying with these administrative requirements (which are necessary for marketing 
in  a  company-based  market),  shall  give,  in  the  Commission's  intent,  an  instant 
administrative  green  light  to  distribute  EU-wide  –  therefore  being  completely 
transparent with regard to the single market. 

Figure 4. Composition of EU chemical sector sales by destination 

o
r
u
e
n
o

i
l
l
i

b

600

500

400

300

200

100

0

Extra-EU

Intra-EU

Domestic

1995

1998

2001

2004

2007

2010

Source: Eurostat and Cefic Chemdata International 

This can therefore be seen as a success of REACH. The data on intra-EU trade show 
an uninterrupted increase of the intra-EU trade as a share of the total EU market size 
over  the  past  15  years.  Although  the  direct  impact  of  the  introduction  of  REACH 
cannot be detectable yet, the fact that intra-EU trade has been growing faster than the 
overall  rate  of  the  manufacturing  industry  already  gives  a  solid  reassurance  that 
REACH has met its expectation in preventing regulatory fragmentation. 

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To verify this claim, companies were asked a question in a survey214 on their opinion 
of the role of REACH in entering other markets within the EU. About 10% answered 
that it already was (or would be in the future) a positive factor – which is a non-trivial 
share, given the relatively early stage in the implementation of REACH. 

However,  the  exact  mechanisms  by  which  REACH  impacts  intra-EU  trade  are  not 
evident  to  companies  at  this  stage.  For  example,  91.5%  of  companies'  respondents 
could  not  identify  any  particular  contribution  of  REACH  in  relation  to  trade.  This 
might  be  explained  by  the  fact  that  companies  answered  this  question  only  on  the 
basis of their direct experience with the registration process and that registration did 
not unify any pre-existing fragmented process (with regard to phase-in substances215), 
as  it  rather  established  a  unique  and  new  process.  Its  contribution  should  thus  be 
perceived  as  a  measure  to  prevent  market  fragmentation  in  anticipation  of  possible 
future similar schemes introduced by various legislations within the EU. 

Furthermore,  some  important  harmonisations  happened  on  less  visible  levels  of 
implementation.  Enforcement  is  key  for  the  credibility  of  any  legal  framework.  It 
fosters an equal level playing field for all economic operators and in all EU Member 
States.  Therefore,  it  enhances  the  single  market  and  increases  the  credibility  of  the 
responsible  industry.  The  establishment  of  the  Forum  has  allowed  enforcement 
authorities  to  intensify  their  cooperation,  as  well  as  exchange  best  practices  and 
mutual benchmarking. Transparency in their mutual performance via reports and joint 
projects established a sense of common goal and spurred creative imitation. 

In addition, Article 122 obliges Competent Authorities (CAs) to cooperate with each 
other  in  the  performance  of  all  of  their  tasks  under  REACH.  This  happens,  for 
instance, through the work of the Commission expert groups (e.g. CARACAL216) and 
the ECHA Committees. All of these platforms have facilitated information flow about 
new concerns in Member States, and helped disseminating best identified approaches 
to  assess  risks  and  select  the  most  appropriate  risk  measure.  In  result,  the  risk  of 
national  risk  management  measures  being  sought  by  Member  States  was  greatly 
reduced, but unfortunately, not completely eliminated217. 

Finally, some important harmonisation impacts come from the restrictions process – 
which only recently got operational by having the first case of a substance restriction 
fully  handled  under  REACH218.  Restrictions  are  a  known  and  well-recognised  risk 

214   CSES was commissioned by the Commission to conduct an industry survey with the aim to study 
industry impacts of REACH. More than 1 500 companies participated in the survey which ran over 
the period of July to September 2011. 

215   It  did  establish  an  improvement  for  new  substances,  but  the  vast  majority  of  the  value  of  the 

chemicals market constitute phase-in substances. 

216   Competent Authorities for REACH and CLP, see [Title 11] of Part I. 

217   For instance, in the field of unified approach to the enforcement of Article 33. 

218   Regulation  (EU)  No  412/2012  of  15  May  2012  amending  Annex  XVII  to  Regulation  (EC)  No 
1907/2006  of  the  European  Parliament  and  of  the  Council  on  the  Registration,  Evaluation, 
Authorisation and Restriction of Chemicals (REACH), OJ L 128/1, 16.5.2012, p.1. 

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management  tool.  They  provide  authorities  a  great  flexibility  as  they  may  target 
substances,  specific  uses  (e.g.  in  articles),  concentration  limits,  etc.  For  this  reason 
they  were  commonly  used  by  the  REACH  predecessor  Directive  76/769/EEC  and 
numerous  national  measures.  Harmonisation  potential  within  this  domain  was 
significant.  Some  solutions  were  “low  hanging  fruit”  like  the  direct  application  of 
REACH which reduced the timelag resulting from transposition into national law and 
eliminated the risk of going beyond that which was legally required. Others required 
more elaboration, like the development of common guidance for identification of risks 
to  ensure  that  all  concerns  of  Member  States’  priorities  (which  are  variable)  are 
addressed homogeneously. 

In conclusion, REACH is leading to harmonisation of the internal market. However, 
harmonisation  may  be  further  pursued  by  removing  remaining  pre-REACH  national 
measures, differences in administrative cultures, and the enforcement of REACH. 

2.3.  Competitiveness 

There  are  signs  that  the  functioning  of  the  market  is  improving,  but  in  the 
short term, the competitiveness of the EU chemical industry has been affected 
by the costs of registration which have been higher then expected. 

Competitiveness of the single market 

The  concepts  of  competitiveness  and  competitive  advantage  have  traditionally  been 
discussed  on  a  firm-  or  industry-base.  However,  it  may  also  be  applied  to  the 
“market”, in which case it relates to the efficiency of the given market in allocating 
resources. In the literature219, the ideal market is characterised by a very large number 
of  buyers  and  sellers,  equal  distribution  of  information,  lack  of  barriers  for  entering 
and exiting the market etc. REACH has affected some of these parameters, which are 
discussed in more detail below, such as (a) number of market players, (b) distribution 
of information and (c) barriers to market entry. 

With regard to number of market players, the Commission has anticipated an effect 
of concentration and analysed its potential costs in the original impact assessment. It 
was considered to give rise to more than half of all REACH-related costs (€ 2.8-3.6 
billion)220.  The  survey  found  confirmation  of  this  development.  Among  suppliers, 
around 25% of manufacturers and importers of chemicals stated that they decided to 
remove one or more substances from the market (usually representing a small share of 
their portfolio). Considering the reasons for the withdrawal of substances, by far the 
most common reason – according to the survey results – appears to be the registration 
costs that make the overall trading of the substance unprofitable. 

219   Stigler  J.  G.  (1987),  "competition,"  The  New  Palgrave:  A  Dictionary  of  Economics,  Ist  edition, 

vol. 3, p. 531–46. 

220   J. Canton, CH. Allen, A Microeconomic Model to Assess the Economic Impacts of the EU's New 

Chemicals Policy, DG Enterprise, 2003 

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The  survey  suggests  a  rather  wide  variation  in  terms  of  the  average  total  costs  per 
registration  (per  substance  and  per  registrant),  with  the  most  typical  value  falling 
within  the  range  of  €  50 000-100 000  and  70%  in  the  broader  range  of  €  25 000-€ 
250 000. For complex registration dossiers (for instance for substances with numerous 
uses  or  forms)  the  registration  costs  may  go  beyond  € 1 million221.  Analysis  of  the 
drivers of the registration costs reveals that ECHA fees often represent 50% or more 
of the total costs, especially in the case of simpler substances and smaller firms. In the 
case  of  more  complicated  substances,  data  collection,  costs  related  to  SIEF  and 
consortia  (including  management  and  other  fees)  are  the  main  cost  elements,  often 
exceeding € 100 000. 

In  global  terms,  the  original  impact  assessment,  and  subsequent  more  detailed 
calculations222,  have  tended  to  anticipate  a  cost  for  the  first  registration  deadline 
(which  passed  in  November  2010)  of  around  €  1.15  billion  (when  recalculated  into 
2011  prices)  for  the  industry.  The  results  of  the  survey  provide  an  estimate  of  the 
effective  cost  of  that  phase  with  a  total  of  around  € 2.1 billion.  A  large  part  of  the 
difference comes from firms reporting also on the sums paid to data holders for access 
to existing data. These costs were not considered in the impact assessment as they do 
not  represent  an  additional  cost  from  the  perspective  of  society.  Nonetheless,  as 
existing data represented 50% of all data collected in the first registration period (see 
Figure 1 in [Sub-Title 3.2] of Part I) this needs to be considered as an important cost 
factor from the registrant’s perspective. Another main reason behind the difference is 
significantly  lower  use  of  (Q)SAR  than  anticipated  as  a  mean  to  lower  the  cost  of 
acquiring new data. 

The  Substance  Information  Exchange  Forums  (SIEFs)  have  helped  in  reducing  the 
costs  –  as  confirmed  by  65%  of  surveyed  companies  in  the  survey  -  even  though  a 
variety  of  problematic  aspects  affecting  the  further  realisation  of  cost  savings  have 
been  identified.  E.g.,  communication  and  coordination  problems  were  mentioned  by 
75%  of  surveyed  companies.  At  the  same  time,  ways  of  improving  communication 
have  also  been  identified,  e.g.  by  establishing  consortia  (30%  of  consortia  members 
have positive view of the SIEF functioning, as compared to only 13% of firms who do 
not participate in any consortia). 

A more crucial point concerns the cost of letters of access223 that often represent more 
than 50% of the total costs of the registration and, as revealed by the survey, are often 
seen  by  SMEs  as  a  tool  used  by  large  firms  to  push  small  competitors  out  of  the 
market. In addition the survey analysis suggests that the main problem is the absence 
of a transparent approach in presenting the various cost elements and how the price of 
letters of access is set. It should be also noted that costs of letters are usually fixed and 

221   Study “The REACH contribution to the development, commercialization and uptake of products of 

emerging technologies". Gaia, commissioned by the European Commission. 

222   Commission Staff Working Paper, [REACH] Extended Impact Assessment, COM(2003)644 final, 

29.10.2003. 

223   A letter of access is a document issued by a lead registrant (or consortium) granting a company the 

right to refer to the registration dossier as a member registrant. 

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independent  of  effective  volume  –  in  effect  causing  smaller  companies  to  pay  more 
per  unit  of  trade.  This  issue  was  also  brought  up  in  the  Directors’  Contact  Group 
(DCG)  and  some  solutions  relating  to  transparency  were  already  suggested  to  the 
industry. Other options relating to the variation of prices of data sharing based on the 
indicative tonnage band of individual companies remain to be explored. 

As  for  the  impact  on  actors  down  the  supply  chain,  the  analysis  of  individual 
comments  to  the  survey  suggests  that  “experience  of  withdrawal”  usually  does  not 
mean  complete  loss  of  access  to  the  specific  substance,  but  rather  only  a  switch  to 
another supplier – be it within the EU or outside the EU. Such a switch must have had 
an  impact  on  the  costs  of  supplies  because  under  normal  circumstances  one  has  to 
assume  that  the  previous  supplier  was  the  most  economic  one.  For  those  substances 
that are no longer offered on the market at all, a number of downstream users (DUs) 
associations  reassured  that  they  had  been  in  the  last  stages  of  the  substance's 
economic  lifecycle,  and  had  been  expected  to  be  withdrawn  regardless  of  REACH. 
For those substances, REACH has only accelerated a natural trend. 

For  the  complete  withdrawals,  the  most  common  response  of  firms  was  to  identify 
substitutes  (53%  suggested  it  as  the  most  common  response).  Only  a  small  share  of 
DUs  (close  to  12%)  stated  that  they  had  decided  to  register  the  relevant  substance 
themselves, despite the fact that switching  to other suppliers can be troublesome. In 
the  survey,  companies  referred  to  substantial  resources  dedicated  to  identifying 
alternative suppliers of substances and to confirming continued supply in the future.  
For  certain  downstream  industries  (like  aerospace  or  defence)  alternatives  need  to 
pass internal certification procedures to guarantee performance. 

Nevertheless, the general picture is that so far the complete withdrawal of substances 
is not a widespread phenomenon and that there are only limited cases where this has 
been  problematic  for  firms  in  terms  of  their  access  to  essential  input  substances. 
Furthermore,  as  already  mentioned,  many  of  these  withdrawn  substances  were 
towards  the  end  of  their  economic  life-cycle  and  firms  were  already  preparing  for 
their  phase-out.  More  important  consequences  relate  to  partial  withdrawal,  which 
results in increased concentration and decreased competition among suppliers. 

With regard to the distribution of information, the main contribution from REACH 
is the provision of data from the chemical safety reports (CSR) via the extended (or 
standard) safety data sheets (eSDS). Another contribution comes from ECHA’s public 
dissemination  of  information  on  substances'  intrinsic  properties,  hazard  profiles, 
classification and labelling, safe uses and risk management measures associated with 
them. On 16 March 2012 ECHA published information on 4'326 substances224.  It will 
take  some  time  until  all  actors  in  the  supply  chain  learn  about  this  new  source  of 
information and take it into account in their market decisions. 

However, the flow of information among the chemicals market players has been also 
affected by the side-effects of formation of SIEFs and of working lists of substances 
pending assessment of the need for future risk management measures. 

224   The Operation of REACH and CLP, European Chemicals Agency, 2011, p. 22. 

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Through  an  abuse  of  the  tools  available  to  pre-registering  companies,  a  certain 
number of them  gained access to previously unavailable platforms to advertise their 
services  by  using  the  functionality  of  SIEF  Formation  Facilitators,  which  in 
consequence blocked genuine potential lead registrants from taking over the role. 

Moreover,  the  function  of  the  lead  registrants  has  created  opportunities  to  retrieve 
information  from  the  market  about  the  structure  of  the  competition.  This  does  not 
relate  to  systematic  breach  of  intellectual  property  or  confidential  information  (for 
which we have found no evidence whatsoever), but to the fact that participation in a 
SIEF provides important business information about the offer and the volume offered 
within the  supply chain. Especially companies who act as lead registrant for  a large 
number  of  substances  (which  constitute 
their  core  business)  received  an 
unprecedented  access  to  reliable  information  about  the  composition  and  structure  of 
their competition. 

Finally,  the  working  lists  of  substances  entering  the  assessment  for  possible  risk 
management  measures  (candidate  list,  ECHA’s  Registry  of  Intentions)  have  sent 
multiple  signals  to  the  market.  The  intent  was  to  increase  the  transparency  and 
predictability of REACH risk management processes, but they have also resulted in a 
demand  to  avoid  these  substances  even  before  their  risks  have  been  effectively 
assessed by the regulators. This goes beyond legal obligations and has already had a 
tangible  impact  on  the  market;  it  is  more  a  question  of  psychology  rather  than 
assessment of risks by end-users or customers. 

Concerning  the  barriers  for  entering  the  market,  the  impacts  of  REACH  can  be 
both  positive  and  negative225.  Positive:  by  the  harmonisation  efforts,  the  costs  of 
expanding into other EU markets were reduced. Negative: by costs of registration; for 
new  (and  existing)  supply-side  companies,  registration  will  be  mandatory  as  of  a  1 
tonne of annual manufacturing or import volume, subject to transition deadlines226. 

However,  REACH  does  not  seem  to  constitute  a  barrier  to  enter  the  market  for 
existing substances. It is rather a potential expansion barrier, since for companies who 
are  close  to  the  threshold,  an  analysis  of  the  marginal  cost  of  registration  has  to  be 
considered before companies decide to expand above the threshold227. In case of fast 
expansions, the decision may be obvious. But for slow and gradual expansions in low-
margin  markets,  the  registration  requirement  becomes  a  trap  effectively  preventing 
firms  from  continuing  their  gradual  growth  as  they  lack  capacity  to  build  a  new 
customer  base  large  enough  to  pass  the  range  of  uneconomic  volume.  The  survey 

225   The expectations for reducing barriers for expanding to other markets have been already discussed 

above [Sub-Title 2.2]. 

226   Where meeting criteria of Art. 3(20) of REACH. 

227   As already mentioned - a typical individual registration through a SIEF membership costs between 
€ 25 000 euro to € 250 000 euro. In addition, other REACH obligations imply additional work for 
the  company  staff.  For  SMEs  it  usually  requires  0.5-1  full  time  equivalent  for  REACH  related 
activities. Larger firms have usually established dedicated units with a typical occupancy of 1 to 5 
persons. 

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revealed that companies who have already found themselves close to the registration 
threshold  have  opted  to  downsize  rather  than  expand  (which  in  case  of  year  2010 
could anyway be rather difficult to achieve given the economic crisis) and therefore 
delay registration expenses228. 

External competitiveness of EU chemical industry 

The EU chemical industry has been performing well in the last decade, especially in 
comparison  to  other  traditional  global  competitors.  Particularly  well-performing  are 
sub-sectors such as specialty chemicals and consumer chemicals which increased their 
trade surplus with most of the EU’s main trading partners229.  These two sub-sectors 
in 2010 accounted for 70% of the extra-EU chemicals trade surplus. Basic inorganics 
experienced  a  trade  deficit  of  €  1.9  billion  –  but  this  is  the  only  sector  with  a  trade 
deficit since 1994. 

However, there are a number of indicators suggesting that the EU chemical sector is 
under increased pressure. Compared to 1999, the EU's share of world chemical sales 
has declined by 11 percentage points (from 32.1% in 1999 to 20.9% in 2010). While 
still in a strong position, the EU has lost its top ranking to Asia, mainly due to the rise 
of China and of the Middle East. 

It  appears,  therefore,  that  the  EU  chemical  industry  is  doing  much  better  in 
innovation-driven  sub-sectors  (e.g.  specialty  products)  than  in  more  cost-orientated 
sub-sectors (e.g. commodity products) or sub-sectors for which important downstream 
industries  have  moved  a  substantial  proportion  of  their  activities  out  of  the  EU.  In 
consequence, the competitiveness of the chemical industry is very much dependent on 
its  capacity  to  conduct  research  and  development,  commercialise  the  results  and 
ensure rapid uptake of innovation results230, as discussed in more detail in [Sub-Title 
2.4]. 

228   End of November 2010 the registration deadline passed for manufacturers and importers placing 
on  the  market  1000  tonnes  or  more  of  any  substance  per  year.  Those  who  scaled  below  1 000 
tonnes will have to undergo the registration process by May 2013 when the deadline passes for all 
manufacturers who place on the market 100 tonnes or more per year. 

The Commission has also learned that companies from countries outside the EU could have set up 
multiple  new  legal  entities  within  the  EU,  each  of  which  can  take  up  less  than  1 000  tonnes  to 
circumvent registration requirements. 

229   Facts and Figures 2011, CEFIC, [http://www.cefic.org]  

230   A. Stajano, Research, Quality, Competitiveness. EU Technology Policy for the Knowledge-based 

Society, 2009. 

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Figure 5. Export / import balance of EU chemical industry in the past decade. 

)

%
e
v

i
t
a

l

u
m
u
c
(

h
t

w
o
r
g
y
r
t
s
u
d
n

I

Extra-EU exports

Extra EU imports

150

120

90

60

30

0

0
9
9
1

4
9
9
1

8
9
9
1

2
0
0
2

6
0
0
2

0
1
0
2

Source: CEFIC, Facts and Figures 2011,  www.cefic.org  

The  positive  contribution  of  REACH  to  the  global  position  of  EU  industry  lies  in 
various  aspects  like  better  information  or  well-documented  sources  of  supplies.  The 
registration  and  authorisation  requirements,  and  resulting  reallocation  of  R&D231  as 
well  as,  in  some  fields,  impacts  on  marginal  cost  structure232  can  also  be  seen  as  a 
negative factor for some companies. 

Further improvement in the information flow within the value chains will expand EU 
industry's  competitive  advantage  with  regard  to  timely  response  to  changing  market 
needs.  The  development  of  more  advanced  supply  chain  management  practices  – 
including the use of IT tools – has been a response to REACH requirements that can 
bring important productivity results in the future. 

However,  at  this  stage,  these  benefits  are  generally  outweighed  by  the  costs  and 
challenges of supply chain communication. For the majority of the survey respondents 
(close  to  70%)  REACH  has  increased  the  costs  of  managing  information  exchange 
along  the  supply  chain.  Significant  human  resources  and  time  are  dedicated  to  the 
development, handling and extraction of the relevant information included in the SDS 
or,  if  applicable,  in  the  eSDS.  The  typical  costs  for  the  preparation  of  an  SDS  is 
around € 200 and over € 500 for an eSDS, but can reach up to € 2 500 in the case of 
translations  in  all  EU  languages.  IT  systems  are  also  often  purchased  by  firms  to 
support the handling of information with costs ranging from a few thousands to more 
than a million euro depending on the size of the firm and the extent of integration into 
overall resources management systems. 

Well-documented  source  of  supplies  and  reliable  information  on  properties  may 
provide a marketing advantage on external markets which require high reliability and 

231  Discussed in detail in [Sub-Title 2.4]. 

232  Study “The REACH contribution to the development, commercialisation and uptake of products of 

emerging technologies”, Gaia, commissioned by the European Commission, 2012. 

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stability  with  regard  to  requested  properties.  There  are  already  firms  declaring 
business gains by using their compliance with REACH in order to market a product 
outside the EU. One survey respondent from the Netherlands explained that REACH 
had made the firm re-position its business in the area of environment and safety and 
added: “Now we can show that we want to be a forerunner.” 

However, the survey responses indicate a considerable level of scepticism towards the 
potential  of  REACH  to  lead  to  improved  customer  confidence,  with  almost  80%  of 
respondents  disagreeing  with  the  idea  that  REACH  has  led  to  increased  customer 
confidence in chemicals in the EU.  

With regards to the negative contribution of REACH, restrictions on uses or the costs 
associated  with  registration  and  authorisation  requirements  may  result  in  replacing 
EU-based production or chemical processes by imported articles (either parts or final 
products)  which  are  outside  of  scope  from  many  provisions  of  REACH.  Feedback 
received to the survey revealed already individual cases of such relocation233. 

REACH treats imported  and  domestic products  in an equal manner, in line with the 
WTO  rules.  In  all  respects,  EU  legislation  ensures  that  when  suppliers  of  chemical 
substances  are  competing  on  the  EU  market,  they  are  treated  in  an  equal  manner. 
However, this does not necessarily create an equal basis for competition outside the 
EU.  Despite  export  being  exempted  from  many  provisions  of  REACH  (such  as 
restrictions,  when  related  to  placing  on  the  market)  very  few  companies  are 
exclusively  trading  outside  the  EU  and  REACH  costs  are  affecting  extra-EU  export 
activities in the same way as any intra-EU sales. 

Most  firms  and  associations  suggested  that  it  is  still  too  early  to  identify  long-term 
impacts  of  REACH  on  their  competitive  position.  In  the  short  term,  the  financial 
situation  of  most  firms  was  reported  to  be  negatively  affected.  The  severity  of  this 
impact depends on the type of product traded. For firms in highly competitive markets 
–  as  is  the  case  for  basic  chemicals  and  metals  that  are  treated  as  commodities  – 
already low profit margins appear  to have been further squeezed, as there is limited 
capacity to transfer these costs to customers through price increases. In other markets 
– such as certain segments of the specialty chemicals – firms appeared more confident 
of  their  capacity  to  increase  prices  and  maintain  profit  margins  without  seriously 
affecting their overall competitive position. 

233   Study  “Functioning  of  the  European  chemical  market  after  the  introduction  of  REACH”,  CSES, 

commissioned by the European Commission, March 2012. 

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2.4. 

Innovation 

Single Market, Competitiveness and Innovation 

REACH  fulfilled  its  objectives  with  regard  to  innovation.  However,  the 
persisting innovation gap compared to US and Japan and increasing pressure 
from emerging economies indicate a need for more ambitious objectives in this 
area. 

Innovation  has  been  placed  at  the  heart  of  the  Europe  2020  strategy  for  growth  and 
jobs.  It  has  been  noted  that  in  order  to  address  the  EU's  challenges  (like  an  ageing 
population) with strong competitive pressures from rising economies, the EU's future 
economic  growth  and  jobs  will  have  to  come  from  innovation  in  products,  services 
and business models. 

Innovation is a specific function of entrepreneurship, in either existing businesses, or 
new ventures. It is a process of creating new wealth-producing resources or improving 
existing  resources  which  enhance  potential  for  creating  wealth234.  On  a  micro  level, 
innovation is focused on a change in an economic or social potential of an enterprise, 
while  on  a  macro  level,  this  translates  into  jobs  and  prosperity.  In  addition, 
innovation,  with  the  support  of  adequate  regulation,  can  also  result  in  reducing 
impacts on the environment, enhancing resilience to environmental pressures by, e.g., 
a more efficient and responsible use of natural resources235. 

In  recent  studies  it  has  been  demonstrated  that  Member  States  with  a  strong 
innovation baseline have coped with the crisis much better than others236. It has also 
been  demonstrated  that  innovative  companies  consistently  perform  better  in 
generating  new  jobs  across  all  size  classes,  and  are  much  better  in  retaining 
employment  during  economic  downturns237.  In  addition,  an  often  overlooked  fact  is 
that young companies generate many more new jobs than  established companies. In 
the  period  2002  to  2010  SMEs  generated  85%  of  all  new  jobs  added  to  the  EU 
economy, but established SMEs (older than 10 years), as a group, lost jobs during that 
period).  This  implies  that  young  companies  not  only  added  new  jobs,  but  also 
compensated  for  the  loss  of  jobs  which  happened  in  the  group  of  established 
companies. This indicates that innovation, which is essential to all new businesses, is 
the backbone for social prosperity. 

Innovating in chemicals  

The  chemical  industry  experienced  an  innovation  boom  in  the  middle  of  the  last 
century on a scale similar to the current one in the IT sector.  From 1930 to the early 

234   Drucker P. F., The Discipline of Innovation, Harward Business Review, Issue May-June 1985. 

235   Communication  from  the  Commission  […]  Innovaton  for  a  sustainable  Future  –  The  Eco-
innovaton Action Plan (Eco-AP), European Commission, 15.12.2011, {COM(2011) 899 final}, p. 
2. 

236   Vroonho P. et al., Do SMEs create more and better jobs?, EIM Business & Policy Research, study 

funded by EU Competitiveness and Innovation Framework Programme. 

237   Ibid. 

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1980s,  there  were  63  major  (or  disruptive)  innovations  in  chemical  products238.  In 
subsequent  decades,  the  pace  of  innovations  gradually  declined.  Bringing  new 
products  to  the  market  became  increasingly  difficult  in  terms  of  time  and  resource 
requirements.  In  addition,  as  the  industry  was  increasingly  regulated,  it  shifted  its 
focus towards innovating with traditional substances rather then developing disruptive 
new ones. 

More recently however, there are signs that disruptive innovations may return to the 
chemical industry, for example, due to a necessity attributed to increased scarcity of 
natural resources and thanks to regulatory changes introduced by REACH. 

Efforts to avoid, where possible, use  of  chemicals that reduce future productivity  of 
key resources such as soil and water, and make waste materials more costly to recycle 
and  reuse  may  help  to  reduce  pressures  from  increasingly  scarce  natural  resources. 
REACH  helps  to  identify  opportunities  for  switching  to  safer  chemicals  or 
technologies  whenever  economically  feasible.  These  alternatives  will  improve  the 
quality of waste streams and thereby enhance recycling and reuse of the raw materials 
contained  in  these  streams.  These  opportunities  will  have  to  come  from  innovation 
into new manufacturing processes or chemicals. 

The Commission services believe that the EU chemical industry is well-positioned to 
face  these  challenges  as  it  has  been  strong  in  innovating  and  was  doing  better  than 
other  EU  sectors  in  many  aspects.  Indeed,  an  important  benchmark  comes  from  a 
Patent  Asset  Index  calculated  by  PatentSight239  which  measures  the  combined 
competitive  impact  of  all  patents  in  company  portfolios  and  therefore  an  overall 
technology strength. In this ranking, within the top-ten  chemical  companies  five are 
EU-based. 

Figure 6. Patent Asset Index for leading chemical companies 

BASF (EU) 
Bayer (EU) 
DuPont (US) 
Dow (US) 
Sumitomo (JP) 
Mitsubishi (JP) 
DSM (EU) 
Solvay (EU) 
Syngenta (CH) 
AkzoNobel (EU) 

0 

15000

30000

45000 

Source: PatentSight 2011, [http:// http://www.patentsight.com] 

238   Bennett,  M.  J.;  Kline,  C.  H.,  “Chemical:  An  Industry  Sheds  Its  Smokestack  Image”,  Technology 

Review 1987, July Issue, 36-45 

239   Ernst,  H.,  Omland,  N.,  “The  Patent  Asset  Index  -  A  New  Approach  to  Benchmark  Patent 

Portfolios”, (forthcoming) 

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This strong position of EU companies indicates that the climate for innovation in the 
EU has been favourable. 

Innovating in REACH 

As has been shown above, innovation in chemicals, in many ways, is different from 
innovation  in  other  sectors.  Its  specificity  requires  particular  attention  by  public 
policies. REACH, in that respect, plays an important role as it can affect (in positive 
and  negative  ways)  innovations  at  all  stages  of  the  innovative  process.  The 
Commission  has  analysed  the  effectiveness  of  REACH  in  achieving  innovation 
objective at the following three stages of the innovation process: 

–  invention (idea generation and evaluation); 

–  implementation (development/prototype, pilot application, testing); and 

–  marketing (production and market launch, market uptake). 

It is questioned by some that business activities driven by REACH mechanisms such 
as  registration,  the  candidate  list,  restriction  and  authorisation  can  be  considered  as 
drivers of future growth – an attribute of innovation as pursued by the Europe 2020 
strategy240.  In  support  of  that  view,  it  is  argued  that  innovation  must  respond  to 
market demands, while restriction and authorisation processes are, in effect, a result of 
lack of adequate market reactions. However, forced innovations may bring economic 
benefit  indirectly  via  improved  quality  of  waste  streams,  productivity  of  natural 
resources or by minimising external costs assumed by the society. 

In  addition,  it  has  been  brought  to  the  attention  of  the  Commission  that  40%  of 
chemical companies observed a shift of R&D or other innovative practices into health, 
safety and environmental protection areas that would not otherwise have taken place. 
Even more, a fundamental reappraisal of the research orientation had occurred within 
5% of surveyed companies241. 

Invention 

REACH  contains  a  number  of  mechanisms  which  impact  on  the  willingness  and 
determination  to  innovate.  These  are  mechanisms  which  (i)  mandate  or  induce 
substitution (like the candidate list), (ii) increase the costs and administrative burden 
for companies, (iii) generate new data and help identify customer needs. 

Firstly,  with  regard  to  the  substitution  mechanisms,  the  impact  of  REACH  on  the 
invention  stage  relates  to  the  uncertainty  around  the  candidate  list.  In  the  most 

240   Communication  From  The  Commission  -  Europe  2020  -  A  Strategy  For  Smart,  Sustainable  And 
Inclusive  Growth,  European  Commission,  3.3.2010,  {COM(2010)  2020},  p.  9:  "Smart  growth 
means strengthening knowledge and innovation as drivers of our future growth.” 

241  Survey  commissioned  by  the  European  Commission  and  conducted  by  CSES  Ltd.  in  September 
2011 on 500 chemical companies from EU (including manufacturers, downstream users and other 
actors  in  the  chemical  supply  chain)  –  further  in  the  document  referred  to  as  an  'Innovation 
Survey'.  

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common response from the industry it is pointed out that the research on substances to 
substitute identified SVHCs in the candidate list is hindered by uncertainty regarding 
the  status  of  potential  substitutes  which  may  be  included  into  the  candidate  list 
themselves later on. It is argued that a greater predictability would certainly help. 

Secondly,  concerning  costs  of  complying  with  obligations  under  REACH,  the 
Commission’s  original  Impact  Assessment  had  identified  a  concern  that  the 
requirements  of  the  REACH  regulation  could  divert  resources  from  other  research 
activities. Unfortunately, the Innovation survey242 revealed that this indeed happened 
as  confirmed  by  more  than  60%  of  respondents.  However,  nearly  half  of  them  also 
stated that there was an overall increase in expenditure on R&D to compensate for the 
compliance-related activities. 

Finally,  in  the  domain  of  availability  of  data,  REACH  introduced  industrial 
information  transfer  mechanisms  aimed  at  capturing  and  disseminating  data  across 
industries and throughout the supply chain to support and stimulate the development 
of safe chemicals and practices. This aspect is of particular interest for this stage of 
innovative process and will be looked in more detail below. 

The  main  mechanisms  for  data  capture  and  dissemination  are  SIEFs  and  consortia, 
SDS and eSDS, and CSR and the ECHA dissemination portal. 

in 

the 

respondents 

Innovation  Survey 

(including  a 
About  a  quarter  of 
disproportionately  large  share  of  SMEs)  indicated  that  they  had  found  the  SDS  of 
value  in  this  regard.  Registration  dossiers  with  technical  dossiers  and  CSRs  were 
found  useful  by  one  out  of  six,  and  SIEFs  by  one  out  of  ten.  This  suggests  that, 
although the overwhelming majority did not find any use in innovative processes for 
the new information, a noticeable share of companies did already benefit from these 
sources  –  in  particular  the  SDS  which  was  the  most  useful  tool  in  this  respect.  It 
should  also  be  noted  that  the  first  registration  period  dealt  with  large  volume 
substances  which  have  been  in  use  for  a  long  period  of  time  and  whose  properties 
tended to be well known. More new data are therefore expected to be revealed with 
the next registration deadlines when substances which are less well known are to be 
registered. 

An explanation why not more companies benefited from these additional information 
sources  may  be  found  in  the  results  of  the  survey  on  competitiveness  where  the 
experience from communication along the supply chain was reported as negative by 
44%  of  firms.  The  main  problem,  in  this  respect,  appeared  to  be  the  absence  of  a 
standardised format for eSDS and their size of often more than 100 pages. 

With  regard  to  the  quality  of  the  information  over  70%  of  participants  in  the 
Innovation survey considered that there had been an increase in access and scrutiny of 
the  information,  and  nearly  20%  indicated  it  increased  a  lot.  In  addition,  nearly  a 
quarter  of  respondents  stated  that  they  had  been  able  to  benefit  from  that  increased 
openness and scrutiny. 

242   Ibid. 

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important  market  opportunities  may 

An important stimulus for idea generation also came from the better awareness of the 
application and uses of the substances down the supply chain due to communication 
requirements. With the complex structure of the supply chains in the chemical sector, 
manufacturers of substances are often separated by a large number of intermediaries 
from the final recipient or user of the substance. Specific knowledge on the particular 
applicability of specific substances may therefore not have reached manufacturers or 
importers  and 
therefore  have  remained 
uncovered.  With  the  incentive  to  communicate  all  uses  up  the  supply  chain,  the 
manufacturers got a much better overview of the range of uses for the substances in 
their offer, and may react with optimised and improved offer. The Innovation Survey 
found  important  evidence  that  this  is  indeed  already  taking  place.  Companies 
indicated various ways in which they have innovated as a result of these processes: a 
better dialogue with major customers and learning new information about substances 
from the (e)SDS.  As a result, new applications can be realised in a better and safer 
way (for the customers). 

Implementation  

The implementation stage of the innovation process comes after an invention passes 
its  initial  business  evaluation.  It  involves  development  of  prototypes,  testing  and 
piloting.  REACH  introduced  some  changes  aimed  at  supporting  this  phase  of  the 
innovation  process,  it:  (i)  equalised  testing  requirements  for  new  substances  with 
those  already  existing,  (ii)  established  various  exemptions  (volume,  product  and 
process oriented research and development, polymers and intermediates) in support of 
research and development, (iii) allowed read-across of test results that would reduce 
costs of testing in general and the need to undertake animal testing in particular. 

With  regard  to  equal  treatment,  REACH  levered  conditions  for  both  new  and 
existing  (phase-in)  substances  to  undergo  testing  and  safety  assessment  within  the 
registration process. This requirement equalised the costs of developing new products 
based  on  new  substances  with  costs  of  continued  use  of  existing  substances.  The 
Innovation  Survey  confirmed  that  this  approach  is  effective:  nearly  half  of  the 
respondents  stated  that  this  was  a  problem  and  a  third  agreed  that  REACH  has 
effectively  addressed  it.  However,  interviews  with  the  industry  indicated  that  some 
barriers  for  research  activity  on  new  substances  under  REACH  still  exist.  For 
example, for non-phase-in substances in the low tonnage band (between 1-10 tonnes 
per year) one has to provide the standard test data of Annex VII while there is no such 
requirement  for  phase-in  substances  (except  if  they  meet  one  of  the  criteria  from 
Annex III). But despite these differences, ECHA has received as many registrations243 
for new substances as was estimated in the original Impact Assessment, thereby fully 
meeting the Commission's projections. 

With regard to exemptions under REACH, the  most  important is the exemption for 
substances used in pilot plant or production trials to test the production process or test 
the  fields  of  application  of  the  substance  (PPORD).  It  extends  to  registration, 

243   By  end  of  2011,  ECHA  received 1670  registrations  for  non-phase-in  substances, which  gives  an 
average  of  477  substances  per  year  (registration  obligation  under  REACH  was  effective  as  of  1 
June 2008) 

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authorisation  and  restrictions.  Until  January  2012,  there  have  been  around  800 
notifications  for  use  of  that  exception  from  registration  submitted  to  ECHA.  This  is 
rather a small number compared to the size of the chemical industry, which may be 
explained by the fact that currently only high volume substances have to be registered. 
The  Innovation  Survey  also  found  that  15%  of  interviewed  companies  have 
recognised  this  as  an  opportunity  to  intensify  their  R&D  activity  and  applied  for 
PPORD (of which 75% were large enterprises). At the same time, an important share 
of  companies  reported  that  the  duration  was  sufficiently  long  (5  years)  to  conduct 
necessary R&D.  Another exemption, from authorisation and restrictions, is available 
for  substances  used  in  scientific  experimentation,  analysis  or  chemical  research  in  a 
volume  of  less than one tonne per year.  Feedback from the survey suggests that the 
volume exemption may often be too low for the testing required. 

As regards exemptions for polymers it should be pointed out that the exemption was 
intended to maintain innovation within this domain, and consequently, the majority of 
surveyed  companies  were  of  the  view  that  this  did  not  contribute  to  increased 
innovation.  A  similar  response  was  provided  to  the  exemption  which  relates  to 
isolated intermediates (on-site or transported) 

With  regard  to  read-across  and  animal  testing  nearly  50%  of  survey  respondents 
indicated that provisions within REACH for the use of read-across as regards research 
testing  results  led  to  a  reduction  in  the  need  (and  costs)  for  testing.  However,  the 
survey responses also took a view that ECHA has used a very strict (precautionary) 
interpretation  of  their  testing  proposals  and  results,  lowering  the  impact  of  this 
measure on innovation. 

Marketing 

This  end  stage  of  the  innovation  process  involves  the  establishment  of  production, 
launch  of  products  and  market  uptake.  The  following  aspects  were  identified  as 
applicable  to  this  stage:  intellectual  property  protection,  patenting,  registration  costs 
and market uptake. 

The  main  areas  of  concern  identified  with  regard  the  protection  of  intellectual 
property were: (a) information requirements to downstream users through the (e)SDS 
(potentially leading to the disclosure of critical know-how related to the formulation 
technology used); (b) loss of key intellectual property where procedures cannot be (or 
were not) patented, and (c) concerns in relation to the required data and information 
sharing  among  SIEF  members.  In  relation  to  patenting,  there  were  questions  as  to 
whether the pre-publication requirements under REACH may result in difficulties in 
protecting new developments under patent law. 

The Innovation Survey found that some 75% of respondents did not think that there 
were  conflicts  as  regards  protecting  intellectual  property  and  making  information 
available  at  registration  and  throughout  the  supply  chain.  Among  those  that  did, 
conflicts tended to arise mostly in the context of SIEFs, and preparation of the SDS 
and  CSR.  Some  18%  of  surveyed  companies  asserted  that  REACH  provided  for 
sufficient protection of intellectual property to promote innovation, but 40% were of 
the opposite view (with another 40% having no opinion). A somewhat more positive 
assessment  was  given  to  the  provisions  intended  to  protect  confidential  business 

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information  –  with  nearly  20%  of  the  companies  stating  that  they  were  sufficient  to 
support innovation, versus 35% that had an opposite view. 

With  regard  to  registration  costs,  the  feedback  from  industry  points  out  that  new 
innovation  projects  are  more  highly  scrutinised  in  terms  of  costs,  risks  and  returns 
before  it  is  decided  to  go  ahead  with  launch  and  marketing  –  also  further  up  the 
pipeline – than it was before the implementation of REACH. This may be linked to 
the fact that over 40% of firms considered time to market as  being  increased, while 
over 10% expected a reduction of this time to market. It seems that some of the larger 
firms that would have submitted multiple notifications across several Member States 
prior  to  REACH  have  been  able  to  benefit  from  not  having  to  deal  with  this 
requirement at Member State level. 

With regard to market update, an expected gain has been reported by some 25% of 
respondents who indicated that compliance has contributed to a better acceptance of 
their new products and technologies by the market. 

2.5. 

Perspective of SMEs 

REACH  has  increased  concentration  on  the  market  by  various  mechanisms. 
Greater  specialisation  among  chemical  suppliers  and  new  compatible 
business  models  resulted  in  a  need  for  restructuring  the  supply  chain.  This 
opens  a  number  of  opportunities,  but  due  to  financial  and  organisational 
constraints, SMEs are less likely to succeed, if not properly supported. 

The population of SMEs is a highly diverse group of firms. They range from micro-
firms to mini-multinationals, and could fill one or several of the REACH roles. SMEs 
also  have  a  different  role  in  the  economic  structure  depending  on  the  economies 
involved.  And  while  only  14%  of  dossiers  in  the  first  registration  deadline  were 
submitted by SMES244, many more are expected to participate in the next registration 
deadline, or are already now concerned by other obligations of REACH.  

REACH  has  taken  into  account  the  specificity  of  SMEs  in  a  number  of  ways,  like 
reductions  in  registration  fees,  testing  requirements  increasing  progressively  with 
tonnage  band,  different  registration  deadlines  depending  on  the  tonnage,  etc.  But 
notwithstanding these measures, the feedback received from SMEs clearly shows that 
they  still  tend  to  be  disadvantaged  by  REACH  compared  to  large  firms.  The 
Commission has looked at the effects of REACH on SMES with regards to access to 
markets, innovation and protection of intellectual property. 

As regards access to supply markets, the key driver of accessibility is the effect of 
registration  costs,  whether  as  a  manufacturer,  a  formulator  or  a  distributor.  The 
Commission  has  been  informed  of  SME  having  problems  in  financing  letters  of 

244   Dossier Submission Report On 1 December 2010, ECHA, available at www.echa.europa.eu 

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access  to  participate  in  joint  submission,  or  having  to  review  business  relationships 
with long-standing suppliers pending appointment of an only representative. 

When  all  registration  costs  are  taken  into  account,  a  pattern  may  be  observed 
whereby,  despite  significant  fee  reductions,  micro-  and  small  firms  are  paying 
disproportionately more in relative terms to their sales due to the fixed costs incurred 
by REACH compliance (e.g. SDS and eSDS, translations, IT systems, legal services, 
letters of access). 

In  addition,  there  may  be  cases  where  SMEs,  would  be  more  impacted  due  to  their 
lower  abilities  to  pass  on  the  costs  via  the  increases  of  the  price  where  dominant 
market  players  are  larger  companies.  Furthermore,  SMEs  may  not  be  so  well 
equipped  for  the  expansion  to  other  customer  areas,  especially  if  e.g.  safety 
assessment requirements between respective regulatory areas differ considerably from 
each other. 

As  for  the  situation  of  “not  yet  existing  SMEs”,  it  should  be  recognised  that  the 
complexity of REACH, manifested by the existence of thousands of pages of various 
guidance  documents,  impacts  on  entrepreneurship  within  the  chemical  sector. 
Altogether,  these  factors  may  discourage  SMEs  from  starting  activities  implying 
REACH obligations. 

However,  with  regard  to  innovation,  small  firms  have  indicated  that  they  have 
benefited  proportionately  more  than  larger  firms  in  terms  of  conception  of  products 
resulting  from  increased  openness,  particularly  from  the  SDS.  On  the  other  hand, 
SMEs reported more often than larger companies that they had experienced a transfer 
of  resources  from  market-driven  innovative  projects  to  compliance-related  work. 
They more often saw this shift as permanent and more often reported concerns with 
regard  to  protection  of  confidential  business  information  or  intellectual  property 
protection under REACH. As a consequence, SMEs have so far made less use of the 
research exemptions under REACH than larger firms. 

2.6. 

Summary and conclusions 

REACH maintains its relevance in relation to both objectives of competitiveness and 
the  contribution  to  the  harmonisation  of  the  single  market.  Both  objectives  can  be 
served  by  the  effective  and  efficient  implementation  of  REACH  on  the  basis  of  the 
promotion of innovation in chemicals, the minimisation of the implementation costs, 
and the pre-emption of the creation of national regulations as regards chemicals that 
could lead to a fragmentation of the EU market. 

REACH as an EU Regulation is considered by the industry as positive in avoiding a 
possible  fragmentation  from 
introduction  of  separate  national 
legislations.  Despite  the  feedback  received  pointing  to  some  variation  in  the  way 
Member  States  monitor  or  enforce  REACH,  the  existing  coordination  structures 

the  potential 

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(CARACAL,  the  Forum,  enforcement  projects  and  RIPE245)  are  seen  as  having  a 
positive impact. 

The  compliance  requirements  of  REACH  introduced  sizeable  costs  for  almost  all 
firms in the chemicals market. The key drivers of compliance costs are, at this point, 
the  costs  of  registration  –  including  data  collection  and  ECHA  fees  –  as  well  as 
communication  and  exchange  of  information  along  the  supply  chain.  The  available 
data  suggest  that  the  costs  for  the  first  registration  period  incurred  by  suppliers  of 
chemicals  –  manufacturers  and  importers  of  chemicals  –  were  around  € 2.1  billion. 
This figure includes amounts paid for access to existing data which is not considered 
as a net cost for the industry (and was not accounted for in the Impact Assessment). 
However, with regard to the use of (Q)SAR as a low cost data collection method, the 
initial estimations were much more optimistic than the actual use by the industry; this 
contributed in part to higher overall cost than anticipated. 

So far, it can be concluded that the industry seems able to absorb the additional costs 
with, in general, no significant adverse effects on its overall competitiveness and with 
a general acceptance of the longer-term objectives. There is no evidence available at 
this stage indicating sizeable shifts in terms of both imports and exports of chemicals 
as a result of REACH. 

There  are  significant  deviations  in  terms  of  expected  impacts  and  certain  firms  or 
sectors appear more vulnerable than others in the process. The data analysis provided 
by  the  commissioned  surveys  indicates  that  small  firms,  firms  in  sectors  with  less 
integrated supply chains, or firms that rely on the use of chemicals on the candidate 
list often face greater challenges as a result of REACH. SMEs appear to lose part of 
their  market  share  either  as  a  result  of  the  costs,  or  as  a  result  of  withdrawals  of 
substances  from  the  market  or  reduction  of  production  levels.  This  is  because,  in 
relative terms, the costs of compliance with REACH tend to be partially independent 
from  the  volume  (e.g.  supply  chain  communication,  or  letters  of  access  costs).  In 
addition,  REACH  requirements  and  administrative  procedures  make  their  margins 
lower  in  comparison  to  non-EU  competitors  with  a  potential  longer  term  impact  in 
their capacity to compete inside and outside the EU. 

Fortunately, the analysis also indicates that there is significant scope for reducing the 
costs  of  compliance  without  a  detrimental  effect  on  other  objectives  of  REACH.  In 
addition,  further  addressing  differences  in  monitoring  and  enforcement  of  REACH 
could increase the harmonisation effect of the single market. 

With regard to impact on other industries, the implementation of REACH does have a 
certain  impact  on  the  availability  of  chemical  substances  used  by  DUs.  The 
withdrawal of substances is driven primarily by the registration costs, but also, for a 
smaller number of firms, by the inclusion of substances in the candidate list. There is 
no  evidence  at  this  stage  that  substance  withdrawal  has  had  an  impact  on  final 
customers  in  terms  of  the  variety  of  final  products  available  or  their  prices.  On  the 
basis  of  the  above  it  can  be  concluded  that  REACH  caused  some  reduction  in  the 

245   ECHA’s REACH Information Portal for Enforcement, see [Title 12]. 

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number  of  suppliers  of  chemicals  and,  in  consequence,  is  leading  to  a  greater 
concentration of the market. 

Recommendations: 

II.1. ECHA and industry associations should reinforce their efforts to reduce the overall costs incurred 

by the industry in complying with REACH. This should be done by: 
a.  simplifying and optimising guidance for businesses (taking into account costs of adaptation 

and familiarisation),  
facilitating transmission of best practices between companies, 

b. 
c.  providing information on the age of data in inquiry process, 
d. 

further development of QSAR, read across and other alternative hazard assessment 
methods, to enable their regulatory acceptability. 

II.2. ECHA and industry associations should reinforce their efforts to ensure protection of IP rights 
and confidential business information, in particular by simplifying and optimising guidance for 
businesses, in particular for SMEs, about existing possibilities under REACH to safeguard IP 
rights and confidential business information 

II.3. Provide additional support to SMEs. In particular the following means should be explored: 
a.  by ECHA - more specific guidance on transparency, non-discrimination and fair cost 

sharing. 

b.  within the scope of the review of the Fee Regulation246, consider further rebalancing the 

distribution of fees across various company size classes. 

c.  by national helpdesks and/or ECHA – guidance on effective integration of regulatory 

requirements into product development and commercialisation. 

II.4. The Enterprise Europe Network will be used to increase awareness of REACH along the supply 

chain and to improve the communication within the supply chain.  

246   Commission Regulation (EC) No 340/2008 of 16 April 2008 on the fees and charges payable to the 
European  Chemicals  Agency  pursuant  to  Regulation  (EC)  No  1907/2006  of  the  European 
Parliament  and  of  the  Council  on  the  Registration,  Evaluation,  Authorisation  and  Restriction  of 
Chemicals (REACH), OJ L 107, 17.4.2008, p.6.  

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CLP ENFORCEMENT ACTIVITIES 

Introduction 
The  CLP  Regulation247  sets  the  rules  for  classification,  labelling,  and  packaging  of 
chemical  substances  and  mixtures  at  EU  level.  Its  main  objectives  are  to  determine 
whether  a  substance  or  mixture  displays  properties  that  lead  to  a  classification  as 
hazardous and to harmonise the standard symbols, phrases and packaging conditions 
that should be used to inform users. The Regulation aligns previous EU legislation on 
classification, labelling and packaging of chemicals248 to the United Nations Globally 
Harmonised System of Classification and Labelling of Chemicals (GHS). It maintains 
the  previously  existing  level  of  protection  of  human  health  and  environment  and 
intends to facilitate EU internal as well as international trade in chemicals. 

CLP  entered  into  force  on  20  January  2009.  The  underlying  principle  of  this 
legislation, which applies to substances from 1 December 2010 and to mixtures from 
1  June  2015,  is  that  industry  is  responsible  for  classifying  and  labelling  substances 
and mixtures.  For substances with particularly severe hazards, national authorities or 
industry  propose  harmonised  classifications  on  which 
the  Risk  Assessment 
Committee  (RAC)  of  the  European  Chemicals  Agency  (ECHA)  provides  opinions. 
Based  on  those  opinions,  the  Commission,  if  found  appropriate,  includes  the 
harmonised  classifications  into  Annex  VI  to  CLP,  through  which  they  become 
mandatory. When a substance or mixture is classified for one or several hazards, the 
relevant information is communicated to other actors in the supply chain, including to 
consumers, via particular elements on the labels of products placed on the market and, 
where relevant, via safety data sheets.  

Manufacturers and importers are also obliged to notify the classification and labelling 
of the substances placed on the EU market after December 2010 to the classification 
and  labelling  inventory  (the  C&L  Inventory)  managed  by  ECHA.  It  contains  entries 
for  more  than  115  000  substances  and  a  public  version  is  available  on  ECHA’s 
website249. 

247  Regulation  (EC)  No  1272/2008  of  the  European  Parliament  and  of  the  Council  of  16  December 
2008  on  classification,  labelling  and  packaging  of  substances  and  mixtures,  amending  and 
repealing  Directive  67/548/EEC  and  1999/45/EC,  and  amending  Regulation  (EC)  No  1907/2006 
(OJ L 353, 31.12.2008, p.1). 

248  Directive  67/548/EEC  of  27  June  1967on  the  approximation  o  the  laws,  regulations  and 
administrative  provisions  relating  to  the  classification,  packaging  and  labelling  of  dangerous 
substances (OJ 196, 16.8.1967, p. 1) and Directive 1999/45/EC of the European Parliament and of 
the  Council  of  31  May  1999  concerning  the  approximation  o  the  laws,  regulations  and 
administrative  provisions  relating  to  the  classification,  packaging  and  labelling  of  dangerous 
preparations (OJ L 200, 30.7.1999, p. 1). 

249   http://echa.europa.eu/web/guest/information-on-chemicals/cl-inventory-database  

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Enforcement and reporting 

Enforcement  

In  general,  enforcement  of  EU  legislation  lies  within  the  responsibility  of  Member 
States.  In  order  to  ensure  an  effective  implementation  of  CLP,  Member  States  are 
obliged, among others, to: 

–  take all necessary measures, including maintaining a system of official controls to 

ensure that CLP is applied; 

–  introduce penalties for non-compliance with the Regulation and notify them to the 

Commission; 

–  regularly report on enforcement.  

This  chapter  is  mainly  focused  on  the  analysis  of  the  Member  States'  obligation  on 
regular  reporting.  Other  initiatives  that  could  play  a  role  in  CLP  enforcement  are 
mentioned solely to provide an overall picture. 

The  enforcement  of  CLP  is  closely  related  to  the  enforcement  of  REACH.  The 
classification and labelling of substances is part of REACH registration dossiers and 
Safety  Data  Sheets  required  under  the  REACH  Regulation  also  have  to  contain  the 
correct  classification  of  chemical  substances  or  mixtures.  Furthermore,  the  activities 
of  ECHA’s  Forum  for  exchange  of  information  on  enforcement  also  include  CLP. 
Further information on the Forum's work, information exchange and the Commission 
services' recommendations concerning enforcement of CLP and REACH are therefore 
to be found in [Title11 of Part I] of this paper. 

In addition, the consequences of the classification of chemical substances under CLP 
go  well  beyond  the  Regulation  itself.  Classification  is  often  used  as  a  reference  to 
trigger obligations or restrictions under many others pieces of legislation such as the 
Pressure  Equipment  Directive250,  Toys  Safety  Directive251,  Seveso  Directive252, 
Regulation on the EU Ecolabel253 and Regulation on Cosmetic Products254.  

Member States reporting 

Article 46(2) of CLP requires Member States to submit a report to ECHA every five 
years  by  1  July,  on  the  results  of  official  controls  and  other  enforcement  measures 
taken. The first report had to be submitted to ECHA no later than 20 January 2012. 

250   OJ L 181, 09.07.1997, p. 1. 

251  OJ L 170, 30.06.2009, p. 1. 

252   OJ L 10, 14.01.1997, p.13. 

253   OJ L 27, 30.1.2010, p. 1 . 

254   OJ L 342, 22.12.2009, p. 59. 

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ECHA shall  in  turn  make the  reports available to the Commission, which shall take 
them into account when preparing its general report under Article 117 of REACH. 

With  this  aim,  the  Forum  mandated  a  working  group  to  develop  a  template  and  a 
document with common issues on enforcement that should be reported under Article 
46(2) of CLP. The reporting template has been the main tool used by Member States 
to  submit  consistent  and  comparable  data.  ECHA  has  reviewed  the  information 
received  from  Member  States  and  evaluated  its  usefulness.  The  results  of  those 
observations has been summarised in a report sent to the Commission in March 2012 
together with the national reports.  

The reports cover national enforcement strategies, describe the co-ordination and co-
operation among national authorities and document enforcement activities during the 
reporting  period,  which  covers  the  time  between  the  entry  into  force  of  CLP  (20 
January 2009) and June 2011.  

Enforcement  activities  encompass  a  range  of  actions  an  authority  may  undertake  in 
order to assess, secure or promote duty holders’ compliance with CLP. Activities may 
be routine or non-routine and include inspections, investigations, monitoring as well 
as formal enforcement (i.e. issuing warnings, bringing legal proceedings by criminal 
or civil means). 

It should be noted that as a consequence of this having been the first reporting and the 
template having been made available only rather late in the process, it was difficult for 
Member  States  to  gather  data  during  the  enforcement  activities  that  could  then  be 
easily  adapted  to  the  level  of  detail  required  in  the  reporting  template.  It  was  also 
complex  to  differentiate  between  controls  of  products  classified  and  labelled 
according to the Directive on the classification and labelling of dangerous substances 
(which  was  still  possible  until  30  November  2010,  meaning  for  nearly  22  out  of  28 
months of the reporting period) and the Directive on the classification and labelling of 
dangerous  preparations  (which  is  still  applicable  until  2015)  or  according  to  CLP. 
Furthermore,  CLP-related  violations  cannot  always  be  distinguished 
from 
enforcement of other specific legislation, such as for toys, plant protection products, 
detergents, cosmetics, REACH, etc. Overall 26 Member States submitted reports and 
more than a half thereof contained quantified data for the reporting period. 

The  results  of  official  controls  and  other  measures  submitted  by  the  Member  States 
showed that in the short period that was covered in the first reporting exercise, it was 
not possible to carry out any type of statistical analysis on the results. However, from 
the data available some trends may be concluded:  

–  All  Member  States  appointed  authority/ies  for  the  enforcement  of  CLP.  The 
administrative structures of enforcement authorities differ from one Member State 
to  another  and,  often,  more  than one authority plays a role in the  enforcement of 
CLP.  The  level  of  enforcement  differs  between  Member  States  but  most  of  the 
Member  States  have  elaborated  specific  enforcement  strategy/ies  that  are  in  line 
with the strategy developed by the Forum. 

–  In most of the Member States there are mechanisms in place to ensure cooperation, 
coordination  and  exchange  of  information  on  enforcement  of  CLP.  This  is 

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achieved via a variety of instruments such as the performance of joint inspections, 
use  of  electronic  databases  (e.g.  ICSMS255,  REACH-IT,  HelpEx256),  participation 
in  coordinated  Forum  projects,  cooperation  with  national  Helpdesks,  dedicated 
workshops, training and meetings. 

–  The  information  provided  suggests  that  the  total  number  of  official  controls  on 
products  carried  out  by  enforcement  authorities  in  the  EU,  as  a  whole,  has 
increased during the three  years covered by the reporting period. From 38.778 in 
2009  to  46.815  in  2011,  with  a  total  of  127.436  official  controls  or  other 
enforcement measures during the period 2009-2011. The same increasing trend has 
been observed in many Member States. 

–  Accordingly, also the number of duty holders subject to enforcement has increased 
in  that  period.  Downstream  users  have  the  largest  share  in  the  number  of  duty 
holders  subject  to  enforcement,  followed  by  distributors,  importers  and  finally 
manufacturers.  The  size  of  duty  holders  subject  to  enforcement  activities  differs 
between  Member  States.  In  general,  mostly  small  and  medium  size  duty  holders 
were inspected. Even micro duty holders were the largest targeted group in several 
Member States 

–  The  official  controls  addressed  the  duties  concerning  the  following  categories  of 
issues:  hazard  classification,  hazard  communication  in  the  form  of  labelling, 
packaging, harmonisation of classification and labelling of substances, notification 
to  the  C&L  Inventory,  obligations  to  maintain  information  and  requests  for 
information,  and  other  CLP  obligations.  The  main  areas  where  cases  of  non-
compliance were found are the hazard classification and hazard communication in 
the form of labelling and packaging.  

–  In  terms  of  absolute  figures,  Bulgaria,  Estonia,  Finland,  Greece,  Hungary  and 
Poland  were  the  most  active  Member  States  of  those  who  submitted  reports  with 
quantified data. The data from Finland have the largest impact on the aggregated 
data  summarising  official  controls  of  products  for  the  Member  States  for  the 
reporting  period.  The  same  Member  State  also  reported  the  highest  number  of 
cases of non-compliance for all reference years followed by France for the last two 
reference years. 

–  Generally the compliance rates amount to 70%. About 20% of the official controls 
resulted  in  verbal  or  written  advice.  Less  than  8%  of  the  official  controls  led  to 
formal  enforcement  measures  such  as  enforcement  notices  or  administrative 
sanctions. Only less than 1% of controls led to legal proceedings. Out of those, five 
ended in convictions by a Court. 

These  figures  are  the  baseline  for  the  future  reporting  and  indicate  that  there  is  still 
substantial  room  for  improvement  of  compliance.  More  comparable  data  from 

255  Internet-supported  information  and  communication  system  for  the  pan-European  market 

surveillance of technical products 

256   Web-based discussion platform for national Helpdesks  

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Member States are needed in the future. This will be beneficial not only for Member 
States  but  also  for  the  Commission,  in  order  to  get  a  solid  basis  for  further 
development of a more harmonised approach of Member States towards enforcement 
of CLP.  

It should also be noted that the number of official controls on notification to the C&L 
Inventory, as required by Article 40 of CLP, has played a minor role when compared 
to the total number of official controls (around 4% of total controls). However, it is to 
be expected that the Inventory will play a bigger role in the next enforcement report to 
be received from the Member States in 5 years. The Inventory provides easy access to 
information  on  the  hazardousness  of  a  given  substance,  facilitating  the  task  to 
correctly  classify  and  label  substances  and  mixtures.  In  case  of  divergent 
classifications  for  the  same  substance,  industry  as  well  as  enforcement  authorities 
have  the  possibility  to  further  check  whether  the  classification  and  labelling  on  a 
given  products  is  correct  and  companies  having  notified  classification  and  labelling 
for the same substances are obliged to undertake all efforts to come to agreed entries 
or to identify the legitimate reasons for diverging classifications. 

Conclusions and recommendations 

CLP  sets  the  rules  for  classification  and  labelling  of  chemical  substances  and 
mixtures. The processes for its implementation are relatively recent. In order to ensure 
effective  implementation  in  practice,  Member  States  are  obliged  to  establish  the 
necessary  arrangements  for  enforcement.  Especially  a  strong  and  harmonised 
approach  towards  enforcement  of  CLP  throughout  the  EU  is  vital  for  delivering  its 
objectives. Despite significant efforts of Member States also within the Forum a more 
harmonised approach towards enforcement of CLP is still a challenge. 

The reports submitted by Member States for the first reporting period (2009 - 2011) 
showed  large  variations  in  the  level  of  detail  and  the  issues  addressed.  Differences 
were also apparent in results between the years and depending on the Member State. 
Inconsistencies  in  the  reporting  by  Member  States  further  complicated  the 
comparative analysis of the data. 

However,  from  the  data  received,  it  can  be  concluded  that  the  total  number  of 
inspections has increased over the last three years but that the compliance rate of the 
duty  holders  with  their  obligations  could  be  substantially  improved.  In  the 
Commission services' view, this can be achieved through, among others, harmonised 
and targeted enforcement projects focusing on the areas of detected non-compliance 
as  well  as  further  development  and  implementation  of  the  Forum  enforcement 
strategies  regarding  CLP.  Such  projects  should  always  incorporate  an  element  of 
awareness raising particularly focussed on SMEs, which, in fact, are the vast majority 
of duty holders under CLP. 

Enforcement  is  a  Member  States  led  activity  but  having  a  clear  picture  about 
enforcement of CLP on the basis of consistent and comparable data would be to the 
advantage of all. The Commission, alongside with Member States, in the Enforcement 
Forum, could have a role in developing enforcement indicators for reporting purposes 
[Title 11 of Part I] 

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The  enforcement  of  CLP  is  closely  related  to  the  enforcement  of  REACH.  Member 
States pursue their CLP inspections often jointly with REACH inspections. Therefore 
the recommendations related to enforcement of REACH in this paper are also relevant 
to CLP.  

This  applies  especially  to  the  Commission's  recommendation  addressed  to  Member 
States  to  enhance  their  support  to  Forum  members  by  providing  full  scientific, 
technical and administrative assistance, as well as the Commission's recommendation 
encouraging the prioritisation of enforcement and inspections across the EU in order 
to focus the limited resources of national enforcement authorities to achieve the most 
benefits as regards compliance. 

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