COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Commission Regulation 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 Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances
Date: 2018-12-03
Institutions: Directorate-General for Environment, European Commission
Subjects: chemical product, environmental protection, market supervision, marketing standard, nanotechnology, product safety, public health

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 3.12.2018  SWD(2018) 474 final  COMMISSION STAFF WORKING DOCUMENT  IMPACT ASSESSMENT  Accompanying the document Commission Regulation  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 Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances   {C(2018) 7942 final} - {SEC(2018) 478 final} - {SWD(2018) 475 final}  
 
 
TABLE OF CONTENTS 

1 

INTRODUCTION ....................................................................................................................................... 6 

1.1  Definition of Nanomaterials ..................................................................................................................... 6 

1.2  Uses of nanomaterials and size of the market ........................................................................................... 6 

1.3  Hazards and risks of nanomaterials ......................................................................................................... 7 

1.4  The EU regulatory framework for the risk assessment and risk management of nanomaterials .............. 8 

1.5  Two impact assessments on nanomaterials ............................................................................................ 10 
Scope and purpose of the two impact assessments ........................................................................ 10 
The political discussion leading to the two impact assessments ................................................... 11 
Cross-relationship between the two impact assessments ............................................................... 12 

1.5.1 
1.5.2 
1.5.3 

2 

PROBLEM DEFINITION ........................................................................................................................ 14 

2.1  Policy context: the Registration process within REACH ........................................................................ 14 

2.2  The problem requiring action and its drivers ......................................................................................... 14 
2.2.1 
The problem and its consequences ................................................................................................ 14 
2.2.2  Magnitude of the problem ............................................................................................................. 15 
Initiatives undertaken .................................................................................................................... 16 
2.2.3 

2.3  What are the underlying causes of the problem? .................................................................................... 19 

2.4  How will the problem evolve?................................................................................................................. 23 
2.4.1  Nanomaterials as nanoforms of phase-in substances..................................................................... 23 
2.4.2  Quality of the dossiers ................................................................................................................... 23 
Industry, SMEs and innovation ..................................................................................................... 24 
2.4.3 

2.5  Who is affected and how? ....................................................................................................................... 24 

2.6  The EU's right to act and justification .................................................................................................... 25 

3 

OBJECTIVES – WHAT SHOULD BE ACHIEVED? ........................................................................... 25 

3.1  General objective .................................................................................................................................... 25 

3.2  Specific objectives ................................................................................................................................... 26 

3.3  Operational objectives ............................................................................................................................ 26 

4 

POLICY OPTIONS ................................................................................................................................... 26 

4.1  Option 1: No change ............................................................................................................................... 27 

4.2  Option 2: Clarifying the existing information requirements ................................................................... 28 

4.3  Option 3: Soft law measures ................................................................................................................... 29 

4.4  Option 4: Scientific-technical recommendations tailoring information requirements ........................... 30 

4.5  Option 5: Reduced information requirements......................................................................................... 30 

4.6  Option 6: Exhaustive information requirements ..................................................................................... 31 

4.7 

Interrelationship between options ........................................................................................................... 31 

4.8  The Baseline............................................................................................................................................ 33 

4.9 

Industry appeals to ECHA decisions on registration of substances with nanoforms .............................. 34 

5 

ANALYSIS OF IMPACTS ....................................................................................................................... 36 

5.1  Public Consultation ................................................................................................................................ 36 

5.2  Economic impacts ................................................................................................................................... 37 

2 

 
 
5.2.1 
5.2.2 
5.2.3 
5.2.4 

Conduct of business ...................................................................................................................... 37 
Impact on SMEs ............................................................................................................................ 44 
Innovation and research ................................................................................................................ 46 
Competitiveness, trade and investment flows ............................................................................... 48 

5.3  Health impacts ........................................................................................................................................ 49 
Introduction ................................................................................................................................... 49 
5.3.1 
5.3.2  Option 1 ......................................................................................................................................... 51 
5.3.3  Option 2 ......................................................................................................................................... 51 
5.3.4  Option 3 ......................................................................................................................................... 51 
5.3.5  Option 4 ......................................................................................................................................... 52 
5.3.6  Option 5 ......................................................................................................................................... 52 
5.3.7  Option 6 ......................................................................................................................................... 52 

5.4  Environmental impacts ........................................................................................................................... 52 
5.4.1 
Introduction ................................................................................................................................... 52 
5.4.2  Option 1 ......................................................................................................................................... 53 
5.4.3  Option 2 ......................................................................................................................................... 54 
5.4.4  Option 3 ......................................................................................................................................... 54 
5.4.5  Option 4 ......................................................................................................................................... 54 
5.4.6  Option 5 ......................................................................................................................................... 54 
5.4.7  Option 6 ......................................................................................................................................... 54 

5.5  Animal testing ......................................................................................................................................... 54 

5.6  Classification and Labelling (CLP) ........................................................................................................ 56 

5.7  Summary of the impacts .......................................................................................................................... 56 
5.7.1  Option 1 ......................................................................................................................................... 56 
5.7.2  Option 2 ......................................................................................................................................... 57 
5.7.3  Option 3 ......................................................................................................................................... 57 
5.7.4  Option 4 ......................................................................................................................................... 58 
5.7.5  Option 5 ......................................................................................................................................... 58 
5.7.6  Option 6 ......................................................................................................................................... 59 
Schematic summary ...................................................................................................................... 60 
5.7.7 

6 

COMPARING THE OPTIONS ............................................................................................................... 60 

6.1  Qualitative comparison ........................................................................................................................... 60 

6.2  The choice of the preferred option .......................................................................................................... 62 

6.3  The costs of the preferred option ............................................................................................................ 65 

6.4  Conclusion .............................................................................................................................................. 68 

7  MONITORING AND EVALUATION .................................................................................................... 72 

8 

9 

GLOSSARY ............................................................................................................................................... 72 

APPENDIXES............................................................................................................................................ 76 

9.1  APPENDIX I: Detail of the measures ..................................................................................................... 76 
9.1.1  Overview of the measures in option 2 ........................................................................................... 76 
9.1.2  Overview of the measures in option 3 ........................................................................................... 77 
9.1.3  Overview of the measures in option 4 ........................................................................................... 78 
9.1.4  Overview of the measures in option 5 ........................................................................................... 79 
9.1.5  Overview of the measures in option 6 ........................................................................................... 83 

9.2  APPENDIX II: Monitoring and evaluation ............................................................................................ 88 

9.3  APPENDIX III: Ex-post assessment of 2010 registration dossiers ........................................................ 89 

9.4  APPENDIX IV: Ex-post assessment of the REACH impacts to companies ............................................ 91 

9.5  APPENDIX V: Summary of the Public Consultation .............................................................................. 92 

3 

 
 
Context .......................................................................................................................................... 92 
9.5.1 
9.5.2 
Typology of respondent ................................................................................................................ 92 
9.5.3  Main observations ......................................................................................................................... 93 
9.5.4 
Specific observations ..................................................................................................................... 96 
9.5.5  Assessment of the measures ........................................................................................................ 100 

9.6  APPENDIX VI: Undertaken actions to ensure the quality of the registration dossiers ........................ 106 

9.7  APPENDIX VII: 2013 BiPRO report: costs and benefits for industry of option 4 ............................... 108 
Costs of the measures .................................................................................................................. 108 
Benefits of the measures ............................................................................................................. 109 

9.7.1 
9.7.2 

9.8  APPENDIX VIII: Nanoforms, sets of nanoforms and the importance of characterisation ................... 110 

9.9  APPENDIX IX: Assessment of non-significant impacts ........................................................................ 112 
Functioning of internal market and competition ......................................................................... 112 
Impacts on consumers ................................................................................................................. 113 
Public authorities ......................................................................................................................... 113 
Employment and labour markets ................................................................................................. 113 
Standards and rights related to job quality .................................................................................. 114 

9.9.1 
9.9.2 
9.9.3 
9.9.4 
9.9.5 

9.10 

APPENDIX X: Summary of the Matrix Study .................................................................................. 117 
Methodology .......................................................................................................................... 117 
Problem Definition ................................................................................................................. 117 
Options Development and Refinement ................................................................................... 118 
Cost Analysis .......................................................................................................................... 119 
Impact Analysis ...................................................................................................................... 120 
Impact on SMEs ..................................................................................................................... 120 
Options Comparison ............................................................................................................... 120 
Conclusions ............................................................................................................................ 121 

9.10.1 
9.10.2 
9.10.3 
9.10.4 
9.10.5 
9.10.6 
9.10.7 
9.10.8 

9.11 

APPENDIX XI: Matrix report: impacts on competitiveness ............................................................ 122 
Option 2 .................................................................................................................................. 122 
Option 4 .................................................................................................................................. 123 
Option 5 .................................................................................................................................. 124 
Option 6 .................................................................................................................................. 126 

9.11.1 
9.11.2 
9.11.3 
9.11.4 

9.12 

APPENDIX XII: Measures included in the preferred option (initial Commission proposal) .......... 129 
The 3-step decision process towards the preferred option ...................................................... 129 
Detail of the final measures within the preferred option ........................................................ 130 

9.12.1 
9.12.2 

9.13 

APPENDIX XIII: Analytical models used in preparing the impact assessment – Costing methodology
133 

9.13.1 
9.13.2 
9.13.3 
9.13.4 
9.13.5 
9.13.6 
9.13.7 
9.13.8 

Main assumptions ................................................................................................................... 133 
General methodology and discussion in detail ....................................................................... 134 
Input tables ............................................................................................................................. 138 
Characterisation costs ............................................................................................................. 143 
Adaptations, tiered approaches and administrative costs ....................................................... 145 
Additional costs scenarios ...................................................................................................... 147 
Additional costs scenarios including the preferred option ...................................................... 149 
Additional illustrative cases .................................................................................................... 151 

9.14 

APPENDIX XIV: REACH in brief .................................................................................................... 156 
REACH .................................................................................................................................. 156 
The Registration process ........................................................................................................ 157 

9.14.1 
9.14.2 

9.15 

APPENDIX XV: Procedural information ........................................................................................ 159 
9.15.1 
Procedural issues and consultation of interested parties ......................................................... 159 
9.15.2 
Consultation of the Regulatory Scrutiny Board ...................................................................... 159 
9.15.3 
Update of the information following the discussions and partial modification of the 
Commission proposal in the REACH Committee ..................................................................................... 163 

9.16 

APPENDIX XVI: Sensitivity analysis ............................................................................................... 174 
Cost per nanoform .................................................................................................................. 174 

9.16.1 

4 

 
 
 
9.16.2 
9.16.3 
9.16.4 
9.16.5 

Grand total costs ..................................................................................................................... 176 
Cost for the registrant ............................................................................................................. 178 
Alternative Methodology for cost calculation ........................................................................ 179 
Sensitivity analysis –  summary ............................................................................................. 183 

5 

 
 
1 

INTRODUCTION 

Definition of Nanomaterials  

1.1 
According to Commission Recommendation 2011/696/EU1, a nanomaterial is:  

“A  natural,  incidental  or  manufactured  material  containing  particles,  in  an  unbound 
state  or  as  an  aggregate  or  as  an  agglomerate  and  where,  for  50  %  or  more  of  the 
particles in the number size distribution, one or more external dimensions is in the size 
range 1 nm-100 nm." 

Due  to  their  small  particle  size,  some  nanomaterials  show  different  mechanical,  electrical, 
optical and other properties than the same material in bigger size. This effect can be used to 
increase the performance of materials in products or achieve entirely new functions.  

Nanomaterials  need  to  be  distinguished  from  the  broader  term  ‘nanotechnology’,  which  in 
addition to nanomaterials refers to other nanostructured materials, including larger materials 
with  surface  or  internal  structures  at  the  nanoscale.  Most  nanotechnology  innovation  is  on 
such nanostructured materials, e.g. nanoelectronics. However, the health and safety discussion 
focuses  on  nanomaterials  because  the  small  size  of  nanoparticles  means  they  can  pass 
membranes and body cells where larger particles cannot. One implication of this is that tests 
of materials made up of particles in larger size in some cases will not identify hazards of the 
nanoforms of a substance.  

The  2011  Commission  Recommendation  on  the  definition  of  nanomaterial  is  currently 
undergoing a review2. This may result in a revision of the Commission Recommendation in 
2018  Based  on  the  current  analysis  and  feedback  from  stakeholders,  this  review  will  most 
likely  only  concern  clarification  of  details  and  will  not  alter  the  current  definition  in  a  way 
that would lead to substantial differences for this Impact Assessment3.   

1.2 

Uses of nanomaterials and size of the market  

Most nanomaterials on the market in terms of volume are commodity materials, some of them 
having  been  in  widespread  use  for  decades.  In  2012,  the  total  annual  quantity  of 
nanomaterials  on  the  market  at  the  global  level  was  estimated  at  around  11  million  tonnes, 
with  a  market  value  of  roughly  20  billion  EUR4.  This  estimate,  however,  excluded  most 

1   Commission Recommendation on the definition of nanomaterial, COM/696/EU, 18 October 2011 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:275:0038:0040:EN:PDF  

2  The  Joint  Research  Centre  (JRC)  performed  compiled  an  extensive  amount  of  information  concerning  the 
experience with the definition, including a targeted survey and a stakeholder workshop. It then performed an 
assessment of the collected information concerning individual elements of the definition. In this context, three 
reports were published: 

    a) Compilation of information concerning experience with the definition (EUR 26567 EN) 
    b) Assessment of collected information concerning the experience with the definition (EUR 26744 EN) 

c) Scientific-technical considerations to clarify the definition and to facilitate its implementation (EUR 27240 
webpage: 

EN). 
report 
http://ec.europa.eu/environment/chemicals/nanotech/faq/definition_en.htm 

accessible 

review 

Links 

from 

the 

to 

3 The main effect of the possible changes to the definition would be that possible provisions in revised annexes 
to  REACH  would  apply  to  a  few  more  or  a  few  less  nanoforms  but  it  would  not  affect  the  nature  of  those 
provisions and the costs or benefits per affected nanoform. 

4   Communication  on  the  Second  Regulatory  Review  on  nanomaterials,  COM(2012)  572  final,  http://eur-
lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52012DC0572&from=EN;  and  Staff  Working  Paper 
on  Types  and  Uses  of  Nanomaterials,  including  Safety  Aspects,  SWD(2012)  288  final,  http://eur-

6 

 
 
                                                 
 
pigments,  cosmetics  ingredients  and  plant  protection  products.  In  one  way  or  the  other, 
nanomaterials  are  contained  in  a  very  large  number  of  manufactured  products,  certainly 
reflecting a market value of trillions5 of euros.  

Among the commodity materials, carbon black (e.g. in tyres) and synthetic amorphous silica 
(used  in  a  wide  variety  of  applications  including  food  additives,  paper,  plastics,  detergents, 
toothpaste, inks,  paints,  adhesives, insulation materials in  construction etc.) represent  by  far 
the  largest  volume  of  nanomaterials  currently  on  the  market.  There  are  many  pigments, 
cosmetics  ingredients  and  substances  used  in  plant  protection  products  which  fulfil  the 
nanomaterial definition. They have been produced and marketed in high volumes6 and for a 
long time without having been intentionally designed as nanomaterials7.  

Some  nanomaterials  are  the  subject  of  intensive  and  worldwide  research  and  development 
with  a view to  creating  breakthrough innovations, e.g. in  medicine, information  technology, 
energy (e.g. batteries), environment (e.g. water treatment), transport, security, space etc. The 
benefits of innovation in nanomaterials range from saving lives, enabling new applications or 
reducing environmental impacts to improving the function of everyday commodity products. 
A  number  of  different  nanoforms8  may  be  developed  from  the  same  chemical  substance  by 
modifying shape, physical or particle-surface characteristics of the substance at nanoscale.  

Typical  nanomaterials  where  such  nanoforms  have  been  developed  include  certain  carbon 
allotropes (e.g. carbon nanotubes, fullerenes, graphene), nanotitanium dioxide, nanozinc oxide 
and nanosilver. Some of those materials  have experienced strong  growth in  the past  up to a 
certain  market  size.  Nevertheless,  none  of  those  has  so  far  created  disruptive  innovation,  as 
this was predicted in the past. Still, there are nanomaterials such as graphene that are currently 
under development and are seen as having high innovation potential.  
There  is  a  range  of  available  information  sources  on  nanomaterials  markets  and  uses9, 
including various market studies, national registries, research projects etc. Nevertheless, this 
information  is  incomplete,  and  not  easily  accessible  to  non-experienced  users.  Part  of  this 
information is confidential. 

1.3 

Hazards and risks of nanomaterials 

Nanomaterials  may  not  only  have  unique  technical  properties  but  also  their  toxicological 
profile  and  their  interaction  with  the  environment  may  differ  significantly  from  the  same 
material in bigger particle size. There is a wide range of available scientific studies on effects 

lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52012SC0288&from=EN.  For  updated  information 
on nanomaterials, their uses, hazards and risks see European Union Observatory for Nanomaterials. 

5   The  estimate  is  based  on  studies  by  Lux  Rearch  referred  to  in  the  Second  Regulatory  Review  on 
estimate 
Nanomaterials,  http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52012DC0572.  That 
suggested  a  market  value  of  2  trillion  €  for  products  containing  nanomaterials  in  2015.  Nevertheless,  this 
number does not reflect the fact that a wide range of pigments are nanomaterials. Due to the widespread use of 
pigments in products, the likely range of products containing nanomaterials will be substantially higher. 

6   However clearly lower than those of carbon black and silica 
7   In fact, just employing and improving certain manufacturing processes that also led to particles with size in 

the nanoscale range 

8   For  the  purpose  of  this  impact  assessment  and  the  parallel  impact  assessment  on  transparency  measures  for 
nanomaterials,  a  nanoform  shall  be  understood  as  a  form  of  a  substance  that  fulfils  the  definition  of  a 
nanomaterial.  

9   For  an  over  view  see  Staff  Working  Paper  on  Types  and  Uses  of  Nanomaterials,  including  Safety  Aspects, 
http://eur-lex.europa.eu/legal-

SWD(2012) 
content/EN/TXT/PDF/?uri=CELEX:52012SC0288&from=EN  

final, 

288 

7 

 
 
                                                                                                                                                         
of  nanoparticles10.  The  OECD  has  produced  a  number  of  publications  on  the  properties  of 
selected  nanomaterials11  and  is  in  the  process  of  adjusting  existing  Test  Guidelines  and 
developing new ones as well as specific Guidance Documents.  

From the existing scientific information, it is clear that nanoparticles may to some extent pass 
body membranes, enter into blood circulation, reach body organs and cells, and cause impacts 
in  these  organs  and  cells.  These  impacts  seem  to  be  partly  reversible,  as  the  body  is  to  a 
certain degree capable of eliminating nanoparticles but bioaccumulation may not be excluded. 
Under  experimental  conditions,  the  most  commonly  observed  effects  of  exposure  to 
nanoparticles, particularly following inhalation, are oxidative stress,  inflammatory responses 
and  in  some  cases  genotoxic  effects12.  The  nature  and  dimension  of  these  effects  suggests 
significant  risks,  especially  in  the  context  of  worker  protection,  unless  appropriate  risk 
management  measures  are  taken.  However,  beyond  this  specific  context,  there  are  no 
indications that nanomaterials are on average more or less toxic than other chemicals13. There 
is  no  evidence  of  widespread  serious  and  acute  human  health  incidents  related  to 
nanomaterials, despite the extensive use of many nanomaterials over decades. This said, for 
nanomaterials as for other chemicals, the link between them and their effects in human health 
and the environment is not easy to establish. Data on potential long-term impacts is limited to 
a few studies only (e.g. on carbon black14).  

1.4 

The EU regulatory framework for the risk assessment and risk management of 
nanomaterials15 

The  EU  regulatory  framework  for  managing  the  health  and  environmental  risks  of 
nanomaterials is made up of a mixture of requirements to identify and communicate chemical 
hazards and risks, as well as specific requirements for measures reducing chemical risks.  

REACH  is  the  main  legal  instrument  assessing  the  risks  of  chemical  substances,  including 
their  nanoforms,  and  requiring  risk  management  measures  to  ensure  their  safe  use16.  Under 
REACH,  chemical  substances  on  their  own,  in  mixtures  or  in  articles  manufactured  or 

10 For a critical review of  several thousands of publications, see e.g. Harald Krug,  Nanosafety  Research—Are 

We on the Right Track?, http://onlinelibrary.wiley.com/doi/10.1002/anie.201403367/abstract  

11 http://www.oecd.org/env/ehs/nanosafety/publications-series-safety-manufactured-nanomaterials.htm 
12 There is a discussion on the validity of a significant part of the studies, as many studies have used high doses 
and have not been conducted at standard conditions allowing reproducibility. Work reassessing the validity of 
past studies and establishing a more reliable scientific framework for future studies is ongoing inter alia in the 
NanoREG  project  financed  under  the  EU´s  7th  Research  Framework  Programme.  Nevertheless,  it  is  beyond 
doubt that serious effects related to inhalation of nanoparticles can occur. 

13  Scientific  Committee  on  Emerging  and  Newly  Identified  Health  Risks,  ‘Risk  Assessment  of  Products  of 
Nanotechnologies’, 19 January 2009: “nanomaterials are similar to normal chemicals/substances in that some 
may be toxic and some may not, yet specific nanomaterials and specific uses of these nanomaterials may carry 
specific health and environmental risks.” 

14  Hodgson,  J.T.  and  Jones,  R.D.  1985,  A  mortality  study  of  carbon  black  workers  employed  at  five  United 
Kingdom  factories  between  1947  and  1980,  Archives  of  Environmental  Health,  vol.  40,  pp.  261-  268; 
Sorahan,  T.,  Hamilton,  L.,  van  Tongeren,  M.,  Gardiner,  K.  and  Harrington,  J.M.  2001,  A  cohort  mortality 
study  of  U.K.  carbon  black  workers,  1951-1996,  Am  J  Ind  Med,  vol.  39,  pp.  158-170;  those  studies  are 
inconclusive. 

15 Further details on the applicable legal framework are given in Appendix XIV to this impact assessment 
16  Regulation  (EC)  No  1907/2006  concerning  the  Registration,  Evaluation,  Authorisation  and  Restriction  of 
http://eur-

Chemicals 
establishing 
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1907:EN:NOT 

(REACH), 

Chemicals 

European 

Agency; 

a 

8 

 
 
                                                 
imported in the EU, meeting certain conditions (e.g. tonnage levels), must be registered with 
the European Chemicals Agency (ECHA).  Before a substance is manufactured or placed on 
the EU market, its safe use must be demonstrated in the registration dossier. The registration 
dossiers of certain  substances may be subject  to  evaluation17. Depending  on their properties 
and  the  level  of  risks,  substances  may  be  subject  to  authorisation  or  restriction.  REACH 
applies  equally  to  substances  for  which  all,  some  or  no  forms  are  nanoforms,  i.e. 
nanomaterials. 

Many substances exist in different forms (solids, suspensions, powders, nanomaterials, etc.). 
Under REACH, different forms can be considered within a single registration of a substance. 
The registrant must always demonstrate safe use and provide adequate information to address 
all  different  forms  in  the  registration,  including  the  chemical  safety  assessment  and  its 
conclusions  (e.g.  through  different  classifications  where  appropriate).  The  information 
requirements of REACH registration apply to the total tonnage of a substance, including all 
forms. Beside this general obligation, there is no specific provision to undertake specific tests 
for  each  different  form,  or  to  spell  out  the  way  in  which  the  different  forms  have  been 
addressed  in  the  registrations,  although  the  REACH  dossier  structure  allows  this  and  the 
technical advice in the guidance provided by ECHA encourages it. 

Although a wide range of commodity nanomaterials has been registered and tested, this has 
often been done without specific attention being paid to the effects at the nanoscale, as those 
materials  were  considered  as  normal  chemical  substances  and  assessed  like  any  other 
substance.  In  practice,  REACH  registration  dossiers  often  contain  a  variety  of  different 
studies, without clear explanation to which forms the information is related, and whether the 
information is relevant for other forms/nanoforms of the substance. 

According  to  Article  9  of  the  Regulation  on  classification,  labelling  and  packaging  of 
substances  and  mixtures  (the  “CLP  Regulation”)18,  hazard  classification  of  substances  and 
mixtures  must  take  into  account  "the  forms  or  physical  states  in  which  the  substance  or 
mixture is placed on the market and in which it can reasonably be expected to be used". This 
in principle requires taking into account specific hazards of nanoforms. However, as testing is 
regulated  under  REACH  and  the  CLP  Regulation  on  its  own  does  not  require  testing  of 
substances, this may be done on the basis of available information, which in turn might not be 
detailed enough to identify hazards specific to particular nanoforms. 

Nanomaterials are also subject to a number of provisions in product-specific legislation. This 
includes pre-market notification of nanomaterials which are cosmetics ingredients to the EU 
Cosmetics Notification Portal. A catalogue of such nanomaterials was due for publication in 
2014 
at 
until 
http://ec.europa.eu/DocsRoom/documents/23861)  due  to  numerous  unclear  and  obviously 
wrong  notifications.  The  Scientific  Committee  for  Consumer  Safety  may  assess  notified 
nanomaterials and identify relevant conditions to ensure their safe use in cosmetics. 

catalogue 

delayed 

2017 

(see 

was 

but 

The Biocidal Products Regulation requires specific risk assessments for nanoforms of biocidal 
substances. The Food Additives Regulation stipulates that a significant change in particle size 
of  a  substance  requires  a  new  entry  in  the  list  of  authorised  substances  or  a  change  in 

17 Either compliance check, i.e. verification of completeness by ECHA or substance evaluation, i.e. verification 

of scientific and technical content by Member States. 

18  Regulation  (EC)  No  1272/2008  on  classification,  labelling  and  packaging  of  substances  and  mixtures, 

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:353:0001:1355:en:PDF 

9 

 
 
                                                 
specifications. Other legal instruments such as the legislation for plant protection products and 
medicinal  products  have  general  authorisation  requirements  for  the  products  within  their 
scope, including nanomaterials, however without specific provisions on nanomaterials. 

Ingredient  lists  are  required  for  products  for  which  the  composition  is  most  relevant  for 
consumers.  Labelling  requirements  in  the  form  of  ‘(nano)’  after  the  substance  name  in  the 
ingredient  list  are  currently  applied  for  cosmetics,  food  and  biocides.  The  information 
‘(nano)’ is provided in  a similar way as for other ingredients, thus not suggesting a specific 
difference  from  other  ingredients.  This  form  of  labelling  was  in  general  supported  by  the 
Second Regulatory Review on Nanomaterials19. 

Conversely,  the  Second  Regulatory  Review  did  not  propose  nano-specific  labelling 
requirements for products without ingredient lists because such requirements were considered 
disproportionate  and  potentially  misleading.  This  is  because  such  labelling  might  suggest 
specific  risks  even  when  there  is  no  indication  for  such  risks.  As  this  was  conclusively 
covered in the Second Regulatory Review, the question of product labelling was not further 
assessed in the present impact assessments. 

Further  relevant  legislation  includes  worker  protection  legislation  and,  if  found  warranted, 
nanomaterials may be the object of specific workers protection provisions under the relevant 
EU  legal  instruments20,21.  So  far  guidance  has  already  been  published22  on  how  to  apply 
existing legal provisions to nanomaterials. Without specifically mentioning nanomaterials, the 
General  Product  Safety  Directive  2001/95/EC  is  intended  to  ensure  a  high  level  of  product 
safety for consumer products that are not covered by specific sectorial legislation. 

1.5 

Two impact assessments on nanomaterials 

1.5.1 

Scope and purpose of the two impact assessments  

This impact assessment concerns the amendment of Annexes to REACH for the registration 
of  nanomaterials23.  It  is  closely  linked  with  a  parallel  impact  assessment  on  transparency 
measures for nanomaterials on the market.  

The overarching objective of the two initiatives is to contribute to increasing trust in the safe 
use of nanomaterials (1) by providing transparent information on nanomaterials, their use and 
their  safety,  adapted  to  the  needs  of  target  audiences  and  (2)  by  improving  risk  assessment 
and  risk  management  of  nanomaterials  through  requiring  more  specific  health  and 
environmental information to demonstrate the safe use of nanoforms of substances. 

The  purpose  of  this  impact  assessment  is  to  assess  relevant  regulatory  options,  in  particular 
possible amendments of REACH Annexes, to ensure further clarity on how nanomaterials are 
addressed  and  safety  demonstrated  in  REACH  registration  dossiers.  The  scope  is  limited  to 

20  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 

21  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  individual  Directive 
within  the  meaning  of  Article  16(1)  of  Council  Directive  89/391/EEC),  (codified  version),  (Text  with  EEA 
relevance), OJ L 158, 30.4.2004, p.50 

22 Find the relevant links at EU-OSHA dedicated website: https://osha.europa.eu/en/themes/nanomaterials 
23 For all procedural aspects of this impact assessment, please refer to Appendix XV 

10 

 
 
                                                 
 
measures  that  can  be  proposed  via  the  Committee  procedure24,  i.e.  restrained  to  certain 
amendments  of  the  REACH  Annexes  for  nanomaterials,  as  the  Commission  in  the  General 
Report  on  the  REACH  Review25  concluded  that  "Some  needs  for  adjustments  have  been 
identified, but balanced against the interest of ensuring legislative stability and predictability, 
the  Commission  concludes  that  changes  to  the  enacting  terms  of  REACH  will  not  be 
proposed".  

The  purpose  of  the  impact  assessment  on  transparency  measures  is  to  assess  the  most 
adequate  way  to  provide  information  on  markets  and  uses  of  nanomaterials  and  products 
containing  nanomaterials  to  policy  makers,  consumers  and  workers  and  closely  linked  with 
the  present  impact  assessment.  The  purpose  of  the  impact  assessment  on  transparency 
measures is to assess the most adequate way to provide information on markets and uses of 
nanomaterials  and  products  containing  nanomaterials  to  policy  makers,  consumers  and 
workers. 

It is closely linked with a parallel impact assessment for a possible amendment of Annexes to 
REACH for registration of nanomaterials.  

1.5.2 

The political discussion leading to the two impact assessments 

In the late 1990’s and early 2000’s, nanotechnology and nanomaterials were increasingly seen 
as a major innovation opportunity26. At the same time, concerns arose that nanomaterials may 
be linked to hazards and risks which were not covered by existing risk assessment practices 
and  regulation.  Responding  to  those  concerns,  the  Commission  issued  in  2008  a 
Communication  on  Regulatory  Aspects  of  Nanomaterials27,  arguing  in  essence  that  existing 
legislation  is  sufficient  to  address  regulatory  concerns  on  nanomaterials.  Following  this 
Communication,  the  European  Parliament  issued  a  Resolution28  calling  on  the  European 
Commission, inter alia to establish a definition of nanomaterials, to review relevant legislation 
on its applicability to nanomaterials and to establish an inventory of nanomaterials, including 
aspects of their safety. 

At  that  stage,  nanomaterials  were  largely  perceived  as  a  limited  number  of  innovative 
substances  which  so  far  had  been  untested,  and  which  may  exhibit  unpredictable  hazard 
properties  and  risks  to  consumers  and  workers.  This  perception  was  fuelled  by  a  diffuse 
debate  on  the  nature  and  definition  of  nanomaterials,  and  unsuccessful  attempts  to  obtain 
more information on nanomaterials on the market via voluntary notification schemes, such as 
those developed in the United Kingdom29 and Germany. Against this background, there were 
calls  by  some  Member  States  and  non-governmental  organisations  to  set  up  mandatory 
registration  schemes  to  provide  information  on  products  containing  nanomaterials.  In 
September 2010, following a high-level event on the regulatory framework for nanomaterials, 
the  Belgian  Presidency  of  the  Council  of  the  European  Union  recommended  that  action 

24 In accordance with Article 131 of REACH 
25 

General 

on 
content/EN/TXT/PDF/?uri=CELEX:52013DC0049&from=EN ), p. 13 

COM(2013)49 

REACH, 

Report 

(http://eur-lex.europa.eu/legal-

26  See  inter  alia:  Towards  a  European  Strategy  for  Nanotechnology,  COM(2004)  338  final  of  12  5  2004;  and 
Nanosciences and nanotechnologies: an action plan for Europe 2005 – 2009; COM(2005) 243 final of 7 6 200 

27 COM (2008) 366, 17.6.2008 

https://ec.europa.eu/research/industrial_technologies/pdf/policy/comm_2008_0366_en.pdf 

28 European Parliament Resolution on Regulatory Aspects of Nanomaterials (2008/2208(INI), 24.4.2009 
29  Department  for  Environment,  Food  and  Rural  Affairs,  'UK  Voluntary  Reporting  Scheme  for  engineered 
nanoscale materials', February 2008, http://archive.defra.gov.uk/environment/quality/nanotech/documents/vrs-
nanoscale.pdf  

11 

 
 
                                                 
should be taken "to develop harmonised compulsory databases of nanomaterials and products 
containing nanomaterials" and that "such databases must be the base for traceability, market 
surveillance,  gaining  knowledge  for  better  risk  prevention  and  for  the  improvement  of  the 
legislative  framework"30.  Later  on,  France,  Belgium  and  Denmark  introduced  national 
nanomaterial notification schemes. 

During  the  legislative  process  leading  to  the  adoption  of  REACH,  specific  provisions  on 
nanomaterials  had  not  been  included,  as  too  little  was  known  on  nanomaterials  to  take  this 
into  account  in  the  already  very  complex  negotiations.  However,  soon  after  REACH  was 
adopted, discussions  started on its implementation for nanomaterials,  and a subgroup of the 
REACH Competent Authorities expert group (“CASG Nano”) was set up. 

the  general  applicability  of  REACH  and  other  existing 

As  a  reaction  to  the  Parliament  Resolution,  the  Commission  adopted  the  definition  of 
nanomaterials  in  201131  and  a  Communication  on  the  Second  Regulatory  Review  of 
Nanomaterials in 201232. The Communication concluded that nanomaterials were much more 
common,  widespread  and,  at  least  for  many  of  the  substances  analysed  in  an  attached  Staff 
Working  Document33,  less  toxic  than  the  public  debate  suggested.  The  Communication 
to 
reaffirmed 
nanomaterials.  In  line  with  previous  scientific  opinions34,  it  also  confirmed  that,  while  risk 
assessment  methodologies  were  generally  applicable  to  nanomaterials,  a  case-by-case 
approach was still warranted to provide the necessary information for different nanomaterials. 
It recognised that REACH was not clear enough to ensure sufficiently specific information on 
nanoforms in registration dossiers. As a follow-up and due to the expected significant impacts 
of  the  considered  changes35,  the  Communication  on  the  Review  of  REACH  in  2013 
announced  an  impact  assessment  for  a  possible  amendment  of  Annexes  to  REACH  for 
registration of nanomaterials36. 

legislation 

Concerning  the  calls  for  mandatory  registration  schemes,  the  Commission  did  not  take  a 
stance  but  announced  an  impact  assessment  to  identify  and  develop  the  most  adequate 
means  to  increase  transparency  and  ensure  regulatory  oversight.  In  addition,  the 
Commission launched an online portal with available information on nanomaterials and their 
uses (the 'JRC Web Platform on Nanomaterials')37. 

1.5.3  Cross-relationship between the two impact assessments 

The  two  Impact  Assessments  complement  each  other  and  provide  responses  on  how  to 
improve  information  on  nanomaterials  in  their  respective  areas,  as  identified  in  the  Second 

30 Belgian Presidency of the Council of the European Union, 'Conclusions of the High level event “Towards a 

regulatory framework for nanomaterials’ traceability”', 14 September 2010, 
http://www.health.belgium.be/filestore/19064475_FR/fr_12129319.pdf  

31 Commission Recommendation of 18 October 2011 on the definition of nanomaterial, 2011/696/EU; see Annex 

4 for a glossary of definitions 

33 Staff Working Paper on Types and Uses of Nanomaterials, including Safety Aspects, SWD(2012) 288 final, 

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52012SC0288&from=EN 

34 http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_023.pdf, p. 52 and p. 56.  
35 Review of REACH  - Thematic studies - REACH contribution to the development of emerging technologies  

(http://ec.europa.eu/DocsRoom/documents/11897) 
36 Review of REACH, COM(2013)49, available at:  

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52013DC0049&from=EN ). 

37 https://ihcp.jrc.ec.europa.eu/our_databases/web-platform-on-nanomaterials  

12 

 
 
                                                 
 
 
Regulatory  Review.  There  are  however  important  differences  in  the  type  of  information 
concerned, the target audience, the degree and nature of the problem to be addressed, and the 
potential options that could be used (see table 1-1 below).  

The  impact  assessment  on  the  REACH  Annexes  covers  scientific  information  necessary  to 
improve  risk  assessment  and  risk  management  of  nanomaterials.  This  should,  for  the 
substances covered by the scope of REACH:  

  provide  clarity  on  which  nanoforms  of  the  substance  are  covered  by  the  registration 

dossier; 

 

identify relevant hazard properties; 

  show how the safe use of the nanoforms will be ensured; 

 

identify the main use categories in general terms.  

However, this information will only cover part of the perceived lack of information and it will 
remain at  a technical  level  that is  only understandable for specialists.  Its  scope is  limited to 
actions  which  can  be  undertaken  by  adaptations  to  technical  and  scientific  progress  under 
REACH. 

The  impact  assessment  on  transparency  measures  is  broader  than  REACH,  and  evaluates 
which  information  on  nanomaterial  markets  and  uses  is  needed  for  policy  makers, 
enforcement authorities, consumers and workers. It excludes however scientific and technical 
information38,  which  is  assessed  as  part  of  the  REACH  Annex  impact  assessment,  and  thus 
the  outcome  of  the  REACH  Annex  impact  assessment  is  part  of  the  baseline  of  the  impact 
assessment on transparency measures. Due to  its broad scope, new regulatory provisions on 
this  matter  would  require  different  legislation,  which  would  need  to  be  adopted  in  ordinary 
legislative procedure. 

Table  1-1:  Differences  between  the  impact  assessments  on  REACH  Annexes  and  transparency 
measures 

REACH Annexes 

Transparency measures 

Scope 

Substances subject to REACH 

Manufactured nanomaterials in general 

Nature of 
information 
concerned 

Substance  properties  for  hazard  and  risk 
assessment 
of 
the 
nanomaterials 

safe 

and 

use 

Markets  and  uses  of  nanomaterials  and 
products containing nanomaterials39 

Main target 
audience 

Risk 
assessment 
authorities, companies, etc.)  

specialists 

(public 

Policy  makers, 
consumers, workers 

enforcement 

authorities, 

Degree of 
problem 

Type of 
procedure 

High  degree  of  consensus  on  the  problem 
as  such  and  the  need  to  address  it  by  a 
possible  amendment  of 
the  REACH 
Annexes 

Possible  add-on  to  REACH  Annex  revision; 
no  consensus  on  the  need  for  additional 
market information 

Comitology (REACH) 

Co-decision for the legislative option (beyond 
the scope and purpose of REACH)  

38 With some exceptions which are explained in the impact assessment on transparency measures. 
39 One option is also linked to safety information from available sources, including REACH dossiers; however, it 

would not generate self-standing information generation on substance properties. 

13 

 
 
 
                                                 
required 

2 

2.1 

PROBLEM DEFINITION  

Policy context: the Registration process within REACH 

The Registration, Evaluation, Authorisation and Restriction of Chemicals REACH Regulation 
replaced the previous legislation, with the aim to ensure the protection of human health and 
the environment from the risks of chemicals, including the promotion of alternative methods 
for assessment of hazards of substances (mainly in order to reduce animal testing), as well as 
the  free  circulation  of  the  substances  on  the  internal  market  while  enhancing  the 
competitiveness of the EU chemicals industry.  

The  overall  purpose  of  the  registration  under  REACH  is  that  the  registrant  must  ensure  the 
safety of the intended uses of a chemical (in all forms)and provide sufficient information to 
this  effect.  In  order  to  meet  the  objectives  of  the  legislation,  REACH  imposes  registration 
obligations  on  companies  and  at  the  same  time  provides  for  a  tiered  tonnage  based 
information  requirements,  risk  based  approach  to  exposure  assessment  and  staggered 
registration  timelines  in  order  to  allow  necessary  flexibilities  to  companies  to  comply  with 
REACH  obligations.  In  other  words,  the  depth  and  level  of  detail  of  the  information 
requirements  depend  on  the  volume  of  the  substance  placed  on  the  market  and  the  risks  it 
poses.  

2.2 

The problem requiring action and its drivers 

2.2.1 

The problem and its consequences 

The Commission, in close collaboration with ECHA, assessed in 2011 how nanomaterials had 
been  addressed  in  REACH  registration  dossiers  submitted  before  December  2010.  The 
assessment found that, in the absence of a definition of nanomaterial before October 2011 and 
of  specific  ECHA  guidance  (published  only  in  April  2012),  most  registration  dossiers  for 
substances known to have nanoforms8 do not mention clearly which forms are covered or how 
the  provided  information  relates  to  the  nanoform.  As  of  August  2015,  13  substance 
registrations40  and  108  CLP  notifications41  had  selected  "nanomaterial"  as  a  form  of  the 
substance for at least one form documented in the registration dossier/notification. Only little 
information  was  specifically  addressing  safe  use  of  the  specific  nanoforms  supposed  to  be 
covered  by  the  registration  dossiers.  The  registration  dossiers  therefore  did  not  document  if 
and  how  registrants  ensured  the  safe  use  of  the  substance  with  nanoforms  covered  by  the 
registration. 
In  order  to  attain  the  aims  of  REACH42,  the  Commission  identified,  based  on  the  above 
mentioned  assessment,  a  necessity  for  more  specific  requirements  for  the  registration  of 

40 5 were registered in 2010, 4 in 2013 and 4 non-phase-in have been registered after 2013. Update as of March 

2018: total number of registered substances with nanoforms: 21. 

41 The number of notifications in the C&L Inventory that have nanomaterial reported as the form of the substance 
(i.e. nanoform) has increased from 18 in June 2013 to 108 in August 2015; for comparison, during the same 
time the total number of notifications in the database increased from 3.2 to 6.4 million. 

42 According to its Article 1.1, the purpose of REACH 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. 

14 

 
 
                                                 
substances with nanoforms ensuring further clarity on how they are to be addressed and safety 
demonstrated in registration dossiers.  
In case of inaction, the potential results can be:  

i)   Insufficient  demonstration  of  safe  use  in  the  REACH  registration  dossiers,  resulting  in 
increased risk for health and the environment, due to potentially poor risk management 
and  safety  measures,  ultimately  leading  to  harmful  use  and  negative  economic 
consequences43. 

ii)  Uncertainties  for  companies  on  what  needs  to  be  included  in  the  REACH  registration 
dossiers,  resulting  in  ineffective  implementation  and  consequently  increased  costs, 
affecting  innovation,  investment  decisions  and  impaired  competitiveness  on  global 
markets.  

The problem and its consequences are illustrated in the figure below: 

Figure 2-1: The problem and its consequences: 

2.2.2  Magnitude of the problem  

The magnitude of the problem can be determined by two factors: i) the extent of deficiencies 
in demonstration of safe use of nanoforms of a substance and the subsequent consequences, 
and  ii)  the  size  of  the  market  of  registered  nanomaterials  that  is  affected  by  the  REACH 
provisions.  Whereas  the  first  factor,  and  in  particular  the  deficiencies  in  the  registration 
dossiers  of  substances  containing  nanoforms  are  qualitatively  explained  above,  it  is  very 
difficult to quantify the magnitude of the problem due to the many variables and uncertainties 
involved.  The  figures  related  to  the  size  of  the  market  shown  in  section  1.2  Uses  of 
nanomaterials  and  size  of  the  market  are  very  general.  The  exact  size  of  the  market  at  EU 

43  Potential  accidents  related  to  nanomaterials  may  affect  the  consumer  confidence  in  products  containing 

nanomaterials, and thus harming the sector overall. 

15 

 
 
 
                                                 
level  is  not  known  with  precision,  even  less  the  proportion  between  the  part  of  the  market 
subject  to  registration  (i.e.  quantities  of  the  registered  substances  in  nanoforms  are  above  1 
ton  per  year)  and  the  substances  in  nanoform  that  would  not  be  subject  to  registration 
requirements.  
Nevertheless,  what  is  known  is  that  21  substances  were  registered  as  occurring  (also)  as 
nanoforms  as  of  March  2018.  The  figures  from  the  French  notification  system44  (FNS) 
suggest  that  most  of  the  nanomaterials  may  have  been  registered  as  substances  already  (in 
2014,  171  out  of  287  substances  i.e.  60%  notified  under  the  FNS,  with  an  additional  5% 
anticipated  to  be  registered  by  2018).  It  is  therefore  sensible  to  assume  that  most  of  the 
nanoforms are not being registered as such but have either not yet explicitly been indicated as 
being  nanoforms  in  the  registration,  or  are  being  registered  jointly  with  bulk  forms  of  the 
substance without yet declaring so.  
The remaining 35% from FNS could be an indicator of the number of substances below the 1 
tonne threshold, but does not indicate the proportion of the number of nanoforms of the non-
registered substances with nanoforms to the total number of nanoforms on the market, or the 
proportion of the actual size of the market in volumes or in the value of products. In terms of 
volume,  the  information  from  the  work  on  transparency  measures  (benefiting  again 
principally from the FNS information) is that the vast majority can be attributed to nanoforms 
in some commodity products (e.g. pigments). 

2.2.3 

Initiatives undertaken 

There have been important developments that have had an impact on the identified problem 
since the first registration round in 2010:  

  Recommendation 2011/696/EU adopted by the Commission on October 2011 sets out 
a definition of the term nanomaterial. The definition clarifies terminology, but in itself 
does not provide clarity to the registrants on how to address nanomaterials in REACH 
registrations.  The  Commission  is  currently  reviewing  the  nanomaterial  definition.  A 
three-part  report  addressing  scientific-technical  aspects  of  the  definition  has  been 
published45  by the Joint Research Centre  and the  Commission  will  consider these  as 
input  in  the  review  of  the  definition,  scheduled  to  be  finalised  in  2018.  The 
Commission  might  conclude  to  revise  certain  aspects  of  the  abovementioned 
Recommendation. Such a potentially revised Recommendation will be fully integrated 
in  the  changes  to  the  REACH  Annexes  to  ensure  coherence  with  other  Regulations. 
The  potential  changes  might  influence  some  of  the  assumptions  used  in  this  impact 
assessment.  Based  on  the  review  performed  so  far,  it  is  reasonable  to  assume  that 
clarification of the definition of the text rather than changes in content would be taking 

44 R-Nano.fr Declaration of nanomaterials, https://www.r-nano.fr 
45 Towards a review of the EC Recommendation for a definition of the term "nanomaterial - Part 1: Compilation 

of information concerning the experience with the definition” from May 2014  
http://publications.jrc.ec.europa.eu/repository/bitstream/111111111/31515/1/lbna26567enn.pdf  
Towards a review of the EC Recommendation for a definition of the term "nanomaterial" Part 2: Assessment 
of collected information concerning the experience with the definition” from September 2014  
http://publications.jrc.ec.europa.eu/repository/bitstream/111111111/32544/1/jrc_nm-
def_report2_eur26744.pdf   
Towards a review of the EC Recommendation for a definition of the term “nanomaterial” – Part 3: Scientific-
technical evaluation of options to clarify the definition and to facilitate its implementation"  from June 2015 
http://publications.jrc.ec.europa.eu/repository/bitstream/JRC95675/towards%20review%20ec%20rec%20def
%20nanomaterial%20-%20part%203_report_online%20id.pdf 

16 

 
 
                                                 
place. In any case, the revision of these assumptions would not affect the nature of the 
options in this impact assessment, but may impact the number of nanoforms to which 
the  requirements  of  REACH  (and  the  related  changes  to  the  Annexes)  apply.  If  a 
material in  a specific form is considered a nanoform before and after the revision of 
the  nanomaterial  definition,  the  REACH  requirements  introduced  by  the  changes  to 
the Annexes would apply in exactly the same way, whilst this would not be the case if 
a material was no longer a nanomaterial after the modification of the definition.  

  The  Commission  conducted  the  comprehensive  REACH  Implementation  Project  on 
Nanomaterials  (RIPoN)  to  provide  advice  on  key  aspects  of  the  implementation  of 
REACH with  regard to  nanomaterials  concerning  Information  Requirements (RIPoN 
246) and Chemical Safety Assessment (RIPoN 347). A third report of the RIPoN project 
relates to Substance Identity (RIPoN148). In April and May 2012, ECHA updated with 
three  new  appendices  the  Guidance  on  Information  Requirements  and  Chemical 
Safety Assessment (IR & CSA) and on registration, in order to take into account the 
recommendations from the RIPoN 2 and 3 projects. In February 2013, ECHA updated 
its advice on Nanomaterials in IUCLID from June 201049. 

  ECHA established in  May  2012 a nanomaterials working  group (ECHA-NMWG) to 
discuss scientific and technical questions relevant to REACH and CLP processes and 
to  provide  recommendations  on  strategic  issues.  It  is  an  informal  advisory  group 
consisting  of  experts  from  Member  States,  the  European  Commission,  ECHA  and 
accredited  stakeholders  organisations,  with  the  mandate  to  "Provide  informal  advice 
on any scientific and technical issues regarding implementation of REACH and CLP 
legislation in relation to nanomaterials." 

  ECHA  has  finalised  13  decisions  on  the  compliance  of  the  registrations  of  8 
substances  with  nanoforms  requesting  further  actions  from  addressed  registrants  in 
order  to  bring  their  registration  dossiers  into  compliance  with  REACH  information 
requirements.  5  out  of  these  (concerning  titanium  dioxide,  silic  acid  and  aluminium 
sodium  salt)  have  been  appealed  before  the  ECHA  Board  of  Appeal50.  These  cases 

46 Specific Advice on Fulfilling Information Requirements for Nanomaterials under REACH (RIPoN2), 1 July 

2011. http://ec.europa.eu/environment/chemicals/nanotech/pdf/report_ripon2.pdf  

47 Specific Advice on Exposure Assessment and Hazard/Risk Characterisation for Nanomaterials under REACH 

(RIPoN3), 7 July 2011. http://ec.europa.eu/environment/chemicals/nanotech/pdf/report_ripon3.pdf  
48 REACH Implementation Project Substance Identification of Nanomaterials (RIPoN1), March 2011. 

http://ec.europa.eu/environment/chemicals/nanotech/pdf/report_ripon1.pdf  
49 IUCLID 5 Guidance and Support – Nanomaterials in IUCLID 5, February 2013. 

http://www.google.lu/url?sa=t&rct=j&q=&esrc=s&frm=1&source=web&cd=1&ved=0CB8QFjAA&url=http
%3A%2F%2Fiuclid.echa.europa.eu%2Fdownload%2Fdocuments%2Fusermanual%2FIUCLID_User_Manual
_Nanomaterials_v2.0.pdf&ei=9XrCVN6mGIT6PISMgdgP&usg=AFQjCNHgLzwy9EbQ4fPdPZXcE4esI0T6
uQ  

50  Appeal  A-011-2014  against  ECHA's  Decision  CCH-D-0000004804-72-03/F  from  16  September  2014  for 

titanium dioxide.  BoA decision published on 2 March 2017.  
https://echa.europa.eu/documents/10162/a3beed31-ab30-dcf1-1f86-7467f6b09a20 
Appeal  A-011-2015 against ECHA's Decision  CCH-D-0000005201-89-02/F from 16 March 2015 for silicic 
acid, aluminum sodium salt.  
http://echa.europa.eu/documents/10162/13574/a_011_2015_announcement_en.pdf  
Appeal  A-008-2015 against ECHA's Decision  CCH-D-0000005199-66-02/F from 16 March 2015 for silicic 
acid, aluminum sodium salt. 
http://echa.europa.eu/documents/10162/13574/a_008_2015_announcement_en.pdf 

17 

 
 
                                                 
 
will provide valuable information regarding the interpretation of the current REACH 
information requirements in relation to the registration of substances with nanoforms. 
The first four closely related decisions of the Board of Appeal (regarding the cases A-
008-2015, A-009-2015, A-010-2015 and A-011-2015)51 were published on 12 October 
2016. The Board annulled ECHA compliance check decisions and returned them to re-
evaluation, as it found that the contested decisions are unclear regarding certain of the 
terminology used therein which gave ground to the appellant's claim that it is not clear 
how to comply with the decision. While the Board of Appeal decisions only refer to 
the  specific  drafting  used  by  ECHA  in  these  decisions,  the  Board  of  Appeal's 
observations  also  confirm  the  underlying  problems  as  set  out  in  section  2.3  that  the 
measure accompanied by this impact assessment intends to address, i.e. that REACH 
information requirements are not clear enough for the registration of substances with 
nanoforms.  The  Board  of  Appeal's  decision  of  2  March  2017  on  the  appeal  A-011-
2014  regarding  the  compliance  check  on  titanium  dioxide  annulled  the  ECHA 
compliance  check  decision,  with  the  principal  argument  that  under  the  current 
provisions  in  REACH,  ECHA  cannot  request  information  on  the  characterisation  of 
nanoforms as part of the substance identity information (Annex VI.2 of REACH), as 
the elements listed are exhaustive and adding new information requirements requires 
amending the REACH Annexes.  

  Member States have started Substance Evaluation of some substances with nanoforms 
in  the  Community  Rolling  Action  Plan  (CORAP)  due  to  concerns  related  to 
nanoforms.  The  Decision  regarding  silica  has  been  agreed  by  consensus  in  the 
information  on 
in  December  2014 
Member  States  Committee 
physicochemical  properties (including surface-treated nanoforms),  additional toxicity 
studies  for  four  specific  forms  (representing  different  ranges  of  characterisers  of  the 
registered forms), all toxicological information on surface-treated forms and the uses 
of the individual forms. The decision has been challenged by two groups of registrants 
in front of the Board of Appeal.50  

requiring 

  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. 

It is reasonable to assume that the above mentioned initiatives, and in particular the RIPoNs 
and the subsequent nano-specific ECHA guidance as well as ECHA Decisions have addressed 
some aspects of the identified problem. Of the thousands of dossiers which were submitted by 

Appeal  A-009-2015 against ECHA's Decision  CCH-D-0000004724-72-03/F from 16 March 2015 for silicic 
acid, aluminum sodium salt. 
http://echa.europa.eu/documents/10162/13574/a_009_2015_announcement_en.pdf 
Appeal  A-010-2015 against ECHA's Decision  CCH-D-0000004722-76-03/F from 16 March 2015 for silicic 
acid, aluminum sodium salt. 
http://echa.europa.eu/documents/10162/13574/a_010_2015_announcement_en.pdf 
Substance evaluation:  
Appeal A-014-2015 against Decision on substance evaluation for silicon dioxide of 11 March 2015 
https://echa.europa.eu/documents/10162/13574/a_014_2015_announcement_en.pdf 
Appeal A-014-2015 against Decision on substance evaluation for silicon dioxide of 11 March 2015 
https://echa.europa.eu/documents/10162/13574/a_015_2015_announcement_en.pdf 

51 https://echa.europa.eu/about-us/who-we-are/board-of-appeal 

18 

 
 
                                                                                                                                                         
 
the second registration deadline on 1 May 2013, only four indicated to cover nanomaterials52 
ECHA has not yet reviewed the many thousands new registrations in depths; by July 2017, 21 
substances with nanoforms have however additionally identified nanoforms in the registration 
dossiers.  The  on-going  review  of  the  Nanomaterial  definition  has  identified  technical 
difficulties that may have partly influenced registrants’ approaches in the registration dossiers.  

Thus, the exact magnitude of the problem at present has multiple facets; assessing it in-depth 
would require significant additional resources and time. Nevertheless, it can be deducted that 
there  is  a  need  to  further  address  the  problem.  Furthermore,  the  results53  of  the  public 
consultation conducted for the purpose of this impact assessment indicated that the majority 
of  the  stakeholders  considered  the  current  provisions  on  information  requirements  for  the 
registration of nanomaterials  as not  clear. Member States, NGOs as well as part of industry 
were of that opinion. 

2.3 

What are the underlying causes of the problem? 

Preparation  and  handling  of  registration  dossiers  for  substances  with  nanoforms  requires 
expert knowledge as many obligations or specific information requirements are derived from 
more general obligations for substances in general. A registration dossier with one or several 
nanoforms requires a detailed knowledge of REACH, the comprehensive ECHA guidance and 
in  some cases  even  familiarity  with  policy documents published by the  Commission  setting 
out the principles for the registration of nanomaterials.  

While  it  is  undisputed  that  REACH  covers  nanomaterials  by  virtue  of  its  focus  on 
'substances',  nanomaterials  are  not  specifically  mentioned  and  there  are  many  factors  that 
have led to a lack of understanding of how REACH should function for nanomaterials in the 
actual registration process.  

In  a  simplified  form,  the  most  important  causes  to  the  problems  can  be  illustrated  by  the 
following graph: 

Figure 2-2: The causes to the problem: 

The following key underlying causes have been identified explaining why the current system 
has not delivered as expected by the Commission: 

i.  No nanomaterial definition at the time of the registration  

52 The 5 registrations from 2010 and the 10 that registered by the 2013 registration deadline or after.  
53  Please refer to Appendix 10 of the Matrix report (Public consultation summary). 

19 

 
 
 
 
                                                 
Until October 2011, there was no definition that could be used to distinguish nanomaterials as 
forms different from other forms of the same substance54. This made it open to each company 
to  decide  if  their  production  also  covered  nanomaterials  warranting  specific  attention  when 
registered  as  a  nanoform(s)  together  with  other  forms  of  the  same  substance.  The  cause  for 
confusion or uncertainty is now partly resolved with the Commission Recommendation but it 
is a challenge in some cases to determine whether a material is or is not nanomaterial due to 
lagging  progress  in  determination  methods.  However,  the  definition    is  still  not  an  integral 
part  of  REACH  and  it  does  not  provide  an  answer  to  how  to  distinguish  between  different 
nanoforms. Furthermore, for the registration dossiers submitted by the 2010 deadline, which 
were  assessed  by  the  Commission,  the  definition  of  nanomaterials  was  not  available.  Many 
substances  were  considered  by  registrants  as  bulk  substances  before  the  introduction  of  the 
nanomaterial definition. These companies did not explicitly identify registered substances (in 
their  respective  forms)  as  nanomaterials,  and  no  major  update  of    the  dossiers  has  been 
observed folowing the introduction of the nanomaterial definition.  

ii. 

The physico-chemical properties are not extensively listed 

The  physico-chemical  properties  of  the  substance  must  be  described  in  the  REACH 
registration dossier as they directly influence its toxicological and ecotoxicological properties, 
distribution and fate. For nanoforms, the relevance of some properties is limited, while other 
properties are not specifically listed, potentially leading to issues with the characterisation, as 
forms  with  importantly  different  risk  profiles  may  have  not  even  been  differentiated  at  the 
onset  of  risk  assessment.  The  same  applies  to  the  requirements  to  provide  sufficient 
information on test materials, as it is the only way to assess the applicability of the test results.  

Concrete  examples  of  material  characterisers,  relevant  in  the  nanoscale,  are  the  size  of 
particles, their shape and their surface coating/functionalisation. As the size gets smaller, the 
effects  of  particle  surface  and  whatever  might  be  attached  to  it  become  more  prominent  in 
comparison to the volume (mass)55. In addition, the scale of nanoparticles is in the same order 
of magnitude as the molecular tools driving the biological processes in organisms and more 
characteriser-selective  binding  of  proteins  to  the  surface  (also  known  as  corona)  may 
influence biological recognition and signalling in cells. 
These  differences  may  lead  to  differences  in  risk  assessment  conclusions56  or  in  the  risk 
management recommendations57. 

54 In October 2011 the Commission published a Recommendation for the definition of nanomaterial.  
55  While  volume  and  thus  mass  is  reduced  proportionally  to  the  3rd  power  of  the  particle  size,  surface  area  is 
reduced  only  by  the  2nd  power.  So  when  particle  size  is  reduced  by  a  factor  of  10,  for  example  from  a 
micrometer to 100nm particle size, the ratio between area and size increases by a factor of 10. Further quantum 
effects may occur in specific cases, usually at very small sizes or sharp-edged shapes. 

56  For  example,  SCENIHR  2014  on  nanosilver  identifies  that  "delivery  route  for  Ag-NP  that  is  different  from 
what is known for dissolved species of silver …the release of ionic silver has been found to be the main cause 
of toxicity (in humans, in the environment and in hygienic applications), nevertheless an increasing number of 
". 
studies 
http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_039.pdf 

release  cannot  alone  account 

toxic  effects  observed. 

found 

that 

this 

the 

for 

57 Few examples:  

- NIOSH recommendation for TiO2 occupational exposure limit is 2.4 mg/m3 while 0.3 mg/m3 for ultrafine 
(i.e. nano) TiO2, http://www.cdc.gov/niosh/docs/2011-160/pdfs/2011-160.pdf; 
- IARC recommendation for classification of the particular carbon nanotube MWCNT-7 as "possibly 
carcinogenic to humans (Group 2B) while assigning Group 3 for other carbon nanotubes, 
https://monographs.iarc.fr/ENG/Classification/ClassificationsGroupOrder.pdf ;  
- SCCS opinion on TiO2 scopes its conclusion by defining TiO2 purity, crystalline phases, range of particle 

20 

 
 
                                                 
 
iii. 

There is uncertainty about the applicability of test methods to nanomaterials 

The OECD notes that "the approaches for the testing and assessment of traditional chemicals 
are  in  general  appropriate  for  assessing  the  safety  of  nanomaterials,  but  may  have  to  be 
adapted to the specificities of nanomaterials." 58 Indeed, for many years it has been discussed 
and analysed whether nanomaterials (i.e. substances in nanoform) can be tested by using the 
test methods used for other substances. Both the EU's scientific committees and the OECD59 
have recommended that existing methods should be applied also for nanomaterials, while care 
should be given to how the nanomaterials are prepared and dosed in the test systems60.  
The  scientific  debate  has  also  raised  questions  whether  new  additional  endpoints61,  in 
particular  in  view  of  possible  different  modes  of  action  may  be  needed  for  (certain) 
nanomaterials.  In  addition  to  on-going  scientific  and  technical  work  in  OECD-WPMN  and 
internationally,  several  large  scale  research  projects  are  on-going  on  the  health  and  safety 
assessments. They will contribute to further adjustment of the current methods as well as for 
the further development  of new approaches aiming  at  predictive, safe by design approaches 
for emerging nanotechnology products.  

iv. 

There  is  insufficient  guidance  over  the  substance  identification  for  substances  with 
nanoforms and the scope of the registration dossier 

From  a  generic  perspective,  REACH  is  simple:  each  substance  must  be  registered  in  a 
dedicated  registration  dossier  in  accordance  with  the  principle  of  'one  substance  –  one 
registration'. However, there are many variables  that influence naming and determination of 
sameness of substances. The co-regulators therefore decided to leave the decision on how to 
distinguish between substances to the manufacturers and importers supported by ECHA in the 
enquiry process62.  

Detailed guidance to help this decision making has been prepared and is available on ECHA's 
website. However, by the time the guidance was made, not enough was known to advise on 
substances  with  nanoforms  and  on  the  potential  additional  physico-chemical  properties  (see 
above) that could be used for the purpose. Later attempts to bring more specific guidance was 
made  with  RIPoN1.  Whilst  it  did  not  succeed  in  gathering  consensus  on  all  its 
recommendations,  it clarified that nanoforms  within  a dossier can be  addressed individually 
based  on  their  differences.  The  differentiation  would  be  triggered  by  the  difference  in  so-
called 'characterisers' in contrast to 'identifiers' that otherwise identify an individual substance 
and trigger a separate registration dossier. The final report of RIPoN1 was provided to ECHA, 
but  given  the  impossibility  to  gather  consensus,  it  has  not  been  translated  into  guidance 
available to firms.  

sizes, list of shapes and coatings. It also conditions the use by the absence of photo-catalytic activity of the 
material and restricts its use for sprayable applications, 
http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_136.pdf 

58 Six years of OECD work on the safety of manufactured nanomaterials, OECD, 2012 

http://www.oecd.org/chemicalsafety/nanosafety/Nano%20Brochure%20Sept%202012%20for%20Website%2
0%20(2).pdf 

59 OECD Council conclusion, 2013 
60 OECD Guidance on Sampling and Dosimetry, 2012 

http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=ENV/JM/MONO(2012)40&docLan
guage=En  

61 For further explanation on 'endpoints', refer to the Glossary. 
62 A process applicable for new firms entering the market helping the new firm to be associated with the correct 

registration dossier 

21 

 
 
                                                                                                                                                         
Accordingly, nanoforms can be seen as forms of a substance or as distinct substances. In the 
latter case, the question arises whether they are treated as “new” substances and whether they 
would be subject to immediate registration63. When more experience from the evaluation of 
registrations is available, ECHA will provide guidance on treating nanomaterials as forms of a 
substance or as distinct substances with the aim of enabling effective data sharing. The results 
of RIPoN1 suggest, however, that some flexibility will be needed. Whether nanoforms have 
been  addressed  in  one  or  several  registrations,  for  the  Commission  the  key  issue  remains 
whether  the  registration  provides  clear  information  on  the  safe  use  for  all  forms  of  the 
substance. 

Regardless  of  how  registrants  organise  their  dossiers,  it  is  expected  that  the  scope  of  the 
registration  is  clear;  it  should  be  clear  which  nanoforms  on  the  market  are  covered  by  the 
dossier. Any third party should also be in a position to verify whether a nanomaterial has in 
fact  been  registered,  and  relate  it  with  corresponding  demonstration  of  safety.  Experience 
indicates that this has proven difficult so far. 

v. 

There  is  uncertainty  on  how  to  deal  with  the  multiplicity  of  forms  in  the  chemical 
safety assessment (CSA)  

As  stated  in  the  Second  Regulatory  Review  on  Nanomaterials  (COM  (2012)  572),  the 
REACH approach to hazard assessment and risk characterisation, with its built-in flexibility, 
makes  it  overall  suitable  also  for  substances  with  nanoforms.  Within  the  registration 
information  requirements  of  the  REACH  Annexes  VII-X  and  in  the  Chemical  Safety 
Assessment that is to be conducted for the registration of substances at quantities of 10 tonnes 
or more per year, data for one form of a substance can be used to demonstrate the safety of 
another form (application of rules for grouping and read-across). 

This  requires  a  case-by-case  scientific  approach,  implying:  (i)  clarity  whether  and  which 
nanoforms  of  a  substance  are  covered  by  a  registration  and  that  these  nanoforms  should  be 
adequately characterised, with the user able to identify which operational conditions and risk 
management measures apply to them; (ii) information should be provided on which forms of a 
substance  have  been  tested,  with  the  test  conditions  adequately  documented,  and  (iii) 
conclusions of a chemical safety assessment should cover all forms in  a registration. Where 
data from one form of a substance are used in demonstration of the safe use of other forms, a 
scientific  justification  should  be  given  on  how,  applying  the  rules  for  grouping  and  read-
across, the data from a specific test or other information can be used for the other forms of the 
substance.  Similar  considerations  should  apply  to  exposure  scenarios  and  the  risk 
management measures.   

The assessment indicates that the curent general REACH provisions (although complemented 
by  ECHA  guidance)  have  often  not  lead  to  an  implementation  that  would  follow  such  an 
approach in a situation where multiple forms of a substance are included in the registration. 
Unclear scope of the registration but also unjustified assumptions in application of relevance 
of data on one form to another64 were frequent. As can be observed also from some concrete 
examples  provided55,56,57, these may lead to  situations  where  risk is  not  adequately assessed 
and consequently managed. 

63  Any  immediate  registration  requirement  for  a  specific  nanomaterial  to  be  treated  as  a  new  substance  could 
reasonably only apply from the moment that the interpretation of the REACH provisions was clear enough for 
registrants  to  exclude  the  interpretation  that  the  nanomaterial  is  a  form  of  an  existing  substance,  potentially 
assumed due to the identical chemical composition. 

64 For example at the general level expected between substances, see REACH, Annex XI, section 1.5. 

22 

 
 
                                                 
How will the problem evolve? 

2.4 
The  Nano  Support  project65  undertaken  by  the  Commission  suggested  that  almost  all  the 
reviewed  registration  dossiers  contained  insufficient  information  to  be  able  to  determine  if 
safe use of the materials placed on the market as nanoforms of a registered substance has been 
demonstrated.  ECHA  has  since  then  confirmed  these  observations  as  part  of  the  formal 
evaluation procedures pursuant to REACH and has faced appeals to some of the decisions that 
attempt to address issues identified above. 

It  is  thus  assumed  that  the  initiatives  undertaken  as  referred  to  in  section  2.2.3  Initiatives 
undertaken:  the  examination  of  testing  proposals  and  compliance  checks  by  ECHA,  the 
RIPoN  project,  the  definition  and  the  revised  definition  of  nanomaterials,  ECHA's 
nanomaterials working group, the CoRAP and the adjustment recommendations by the OECD 
WPMN – will at least not efficiently solve the way REACH addresses nanomaterials and will 
therefore not suffice to solve the problem in the short term.  

Based on existing evidence, the situation may develop as follows: 

2.4.1  Nanomaterials as nanoforms of phase-in substances 

Most nanomaterials have been registered so far as nanoforms of phase-in substances, meaning 
that they fall under the phase-in provisions (2010, 2013 and 2018 deadlines for registration). 
Since  there  is  not  enough  clarity  on  the  specific  REACH  information  requirements  for 
nanomaterials throughout the registration procedure, this means that the specificities in terms 
of how to handle them safely have most likely not been extensively described. 

Based on current information, it is probable that this will continue to be the case, so that the 
registrations  of  substances  with  nanoforms  in  2018  will  also  contain  multiple  nanoforms  of 
substances without sufficient information for all forms covered.  

2.4.2  Quality of the dossiers 

In addition to the legal means foreseen by REACH to ensure the compliance of the submitted 
dossiers with the registration requirements – examination of testing proposals and compliance 
check, ECHA has undertaken a series of support actions with the aim  to gradually bring the 
addressed  dossiers    into  compliance  according  to  ECHA's  interpretation  of  the  registration 
requirements66.  

Without further action, it is therefore reasonable to expect that, for the few current registration 
dossiers  with  often  well-known  nanomaterials  included,  the  situation  will  improve  over  the 
next couple of years based on the on-going work of ECHA Committees and several decisions 
of  the  Board  of  Appeal  on  nanomaterials  in  2016  and  2017  in  the  compliance  checks  and 
substance  evaluations.  The  latter,  annuling  a  number  of  decisions,  had  however  showed 
limitations of what can be achieved.   

However, some caveats are to be taken into account:  

 

Improvement  via  evaluation  processes  (compliance  check,  substance  evaluation)  is 
cumbersome,  expensive  (to  both  authorities  and  industry),  will  take  years  and 

65 Scientific technical support on assessment of nanomaterials in REACH registration dossiers and adequacy of 

available information, JRC, 12 March 2012.  
http://ec.europa.eu/environment/chemicals/nanotech/pdf/jrc_report.pdf   

66 Refer to Appendix VI for further information. 

23 

 
 
                                                 
conflicts with the obligation that the burden of proof is with industry if the pertinent 
information is only made available upon request from the authorities.  

 

 

It  is  likely  that  dossiers  that  are  not  directly  implicated  within  the  scope  of  these 
actions may not change, with the associated risks it may have on safety.  

There  continues  to  be  ground  for  concerns  that  the  root  cause  to  the  current 
problems, if unaddressed, will exacerbate due to the expected increasing number of 
dossiers and the growing number of companies involved. 

2.4.3 

Industry, SMEs and innovation 

Information  generated  for  the  registrations  provide  inspiration  for  the  innovative  use  of 
existing substances. As concluded by the REACH Review, REACH has had so far a positive 
impact on research into new substances. 

Nanomaterials  may  be  considered  complex  chemicals  due  to  the  potential  increased 
complexity of dossiers (e.g. with multiple forms under one dossier) and to the importance of 
the  relation  between  the  individual  nanoform  and  the  specific  use.  Such  relationship  often 
requires a tailored risk management response as well as good communication along the value 
chain for the adequate risk assessment and risk management.  

Consequently,  when  specifically  referred  to  substances  with  nanoforms,  it  can  be  assumed 
that  what  needs  to  be  included  and  how  safety  is  demonstrated  in  the  REACH  registration 
dossiers for substances  with nanoforms, may add to the compliance cost and affect industry 
investments and market decisions.  

The  REACH  review  studies  highlighted  that  REACH  compliance  costs  were  considerably 
higher  than  estimated.  Due  to  the  burdensome  processes  and  costs  of  information 
requirements, both nanotechnology and other companies, have shifted and may need to shift 
resources  from  R&D  to  REACH  compliance.  Accordingly,  along  with  other  constrains 
reported by nanotechnology companies, such as delays for the innovative products to market, 
high prices due to lack of investments in large scale processes, the way REACH registration 
deals with nanomaterials could form a challenge for the companies in the sector. 

SMEs  are  of  particular  concern.  Indeed,  smaller  firms  represent  a  significant  portion  of 
manufacturers,  importers  or  downstream  users  in  the  nanomaterials  sector.  Hence,  concerns 
remain  that  the  way  REACH  addresses  nanomaterials  may  discourage  SMEs  from  the 
nanotechnology sector to innovate.  

Based  on  current  knowledge,  the  situation  will  aggravate  over  time  as  it  is  anticipated  that 
more small firms will be subject to registration obligations when substances in volumes at one 
or more tonnes will have to be registered in June 2018.  

2.5 

Who is affected and how? 

Immediately  affected  is  industry  dealing  with  nanomaterials  with  an  obligation  to  register 
substances with nanoforms (both EU manufacturers and importers) that are manufactured or 
imported  over  one  tonne  per  year  per  manufacturer/importer.  The  effects  will  go  from  a 
possible  change  (positive  or  negative)  of  the  administrative  burden  and  a  clearer  legislative 
environment  for  fulfilling  the  obligations.  External  studies  performed  for  the  European 
Commission  in  the  context  of  the  REACH  Review  estimate  the  total  number  of  European 
nanomaterial  manufacturers  in  the  range  of  200  to  400.  The  numbers  of  importers  or 
downstream users were not assessed in the study.  

24 

 
 
All stakeholders involved in the implementation of REACH and working with nanomaterials 
will be affected. Among them, ECHA, competent authorities and enforcement authorities, will 
be affected when performing their dedicated tasks in accordance with REACH. 

By the provision of adequate information on safe use of registered substances with nanoforms 
there will also be positive effects on workers' health protection, on the environment and to a 
lesser extent on the health of the public at large. 

Lastly, clarifying REACH information requirements will eliminate regulatory uncertainty and 
confirm  the  effectiveness  of  the  regulatory  system  but  might  as  well  increase  compliance 
costs;  all  this  will  influence  investors’  views  on  Europe  as  a  site  for  innovation  and 
manufacturing. 

2.6 

The EU's right to act and justification  

The current initiative concerns clarification of the existing provisions established in REACH 
Annexes.  The  legislation  is  based  on  Article  114  TFEU.  According  to  the  principle  of 
subsidiarity established in Article 5 TFEU, the EU's right to act is justified based on the fact 
that  the  chemicals  market  is  an  important  part  of  the  internal  market  and  that  initiatives  in 
Member  States  would  be  in  breach  of  the  freedom  for  firms  to  manufacture  or  use 
nanomaterials  in  the  EU  market.  Any  modifications  to  REACH  including  its  annexes  can 
legally only be made at the EU level. If the EU does not take action there will be continued 
uncertainty for companies producing (and using) nanomaterials  about  their legal  obligations 
for registration and  continued lack of information about  those materials  which are the basis 
for  risk  assessment  and  safe  handling.  Actions  at  national  level  to  deal  with  the  described 
problems would have to be taken outside the REACH framework. They would by their nature 
entail  the  risk  of  distorting  and  fragmenting  the  internal  market.  In  addition,  there  are  no 
indications  that  special  national  or  regional  conditions  warrant  different  ways  and  levels  of 
protection. Based on these considerations, there is a clear added value of action to be taken at 
the EU level.  

3 

3.1 

OBJECTIVES – WHAT SHOULD BE ACHIEVED? 

General objective 

The aim of REACH, as provided for in its Article 1, 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  (mainly  to  reduce  animal  testing),  as  well  as  the  free 
circulation  of  substances  on  the  internal  market  while  enhancing  competitiveness  and 
innovation.  As  identified  in  section  2.2.1,  the  registration  dossiers  of  substances  with 
nanoforms currently do not document how the registrants ensure safe use of those forms. In 
line with the aim of the legislation, the general objective of this initiative is therefore to ensure 
that REACH is fit for the purpose of dealing with substances with nanoforms. 

Figure 3-1: The general objective and the problem: 

25 

 
 
 
 
3.2 

Specific objectives 

In  order  to  achieve  the  general  objective  and  to  address  the  two  main  consequences  of  the 
problem  as  identified  above  i.e.  the  uncertainty  on  how  to  comply  and  the  insufficient 
demonstration of safe use, the following specific objectives have been established: 

  Clarify the REACH information requirements for registrants on how substances with 

nanoforms must be registered pursuant to REACH; 

  Ensure adequate demonstration of safe use of nanoforms in registration dossiers.  

Figure 3-2: The specific objectives and the consequences of the problem: 

3.3 

Operational objectives 

Furthermore, the following operational objectives are to be accomplished: 

  Ensure  that  the  registration  dossiers  clearly  specify  that  they  cover  one  or  several 

nanoforms of a substance;  

  Make sure that the registration dossiers contain justifications for using data/test results 

from non nanoforms or between nanoforms;  

  Guarantee  that  the  registration  dossiers  identify  the  uses  of  and  the  related  exposure 

from nanoforms; 

  Increase  trust  of  downstream  users/consumers  in  nanomaterials  in  order  to  facilitate 

market uptake and innovation; 

  Speed up the process of achieving registration dossiers covering nanoforms that are of 

adequate quality. 

4 

POLICY OPTIONS 

At the start of the impact assessment process, the Commission identified five different options 
grouping a large number of specific measures for analysis and stakeholder consultation. These 
are  in  addition  to  the  'no  change  scenario'  as  described  in  chapter  2.4  above  on  how  the 
problem will evolve.  

In identifying some of the individual measures considered, the Commission was supported by 
the  Nano  Support  project  and  REACH  Review  studies,  as  well  as  contributions  from  EU 
Scientific Committees, OECD and ISO cooperation, expert networks and scientific literature 
on  nanotechnologies  and  nanomaterials.  Numerous  measures  were  proposed  based  on  a 
scientific assessment on the needed information to make a qualified assessment of the safe use 
of nanomaterials in addition to the information that the JRC – ECHA review team identified 

26 

 
 
 
in the concrete registration dossiers submitted up until December 2010. These were grouped 
under  options  2  and  4.  In  addtion  to  those,  the  Commission  has  identified  other  possible 
measures that have been grouped in options 3, 5 and 667.  

In  most  cases,  the  measures  could  be  individually  assessed  in  terms  of  effectiveness  and 
efficiency addressing the general objective.  

It is to be noted that the legal procedure this initiative is framed into does not allow to make 
changes to the enacting terms of REACH, but just to its Annexes; there is thus no possibility 
to  modify  the  tonnage  registration  thresholds,  explaining  why  the  possibility  to  lower  the 
threshold  for  substances  with  nanoforms  below  1  tonne  has  not  even  been  considered. 
Furthermore, there has been no evidence to indicate a need to change the tonnage thresholds 
structure  as  imposed  by  REACH  specifically  for  substances  with  nanoforms,  if  it  is  on  one 
hand understood that in most situations, nanomaterials will represent forms of the substance 
with  identical  chemical  composition  rather than  be considered  as substances by themselves, 
and on the other that REACH obligations pertain to the aggregated tonnage of all forms of the 
substance placed on the market by the economic operator.  

4.1 

Option 1: No change  

Option 1 is a continuation of the current situation under REACH assuming that there are no 
new  policy  actions  and  that  the  implementation  is  based  on  what  currently  is  known  i.e. 
including  the  guidance  update  from  April  and  May  2012,  the  use  of  the  Commission 
Recommendation  on  the  definition  of  Nanomaterial  and  the  updates  of  OECD  Test 
Guidelines.  The  assessment  of  this  option  makes  certain  assumptions  of  how  the  current 
situation may develop over time when dossiers are brought into compliance.  

Since  the  legal  text  allows  for  different  interpretations  of  the  REACH  registration 
requirements  vis-à-vis  substances  with  nanoforms,  the  no-change  scenario  is  set  where 
Industry's current stance to the level of compliance is effectively maintained. 

The figure below illustrates how the no-change scenario is expected to evolve along time in 
terms  of  demonstration  of  safe  use  as  ECHA  applies  tools  to  improve  compliance  and 
Member States conduct substance evaluations. 

67 For a complete list of the measures, refer to Appendix I. 

27 

 
 
                                                 
Figure 4-1: Evolution of the no-change scenario  

4.2 

Option 2: Clarifying the existing information requirements 

This option's aim is to clarify what companies are expected to do when registering nanoforms, 
by introducing changes to the description of certain information requirements in the REACH 
Annexes. The information requirements are in accordance with the registration obligations of 
REACH and the specific ECHA guidance, which takes into account CA/59/2008 Rev168 and 
the  scientific-technical  recommendations  from  RIPoN  2  and  3  reports  from  2011.  While 
ECHA's  guidance  still  needs  to  be  provided  in  some  cases  (the  appropriateness  of  some 
available  tests  to  substances  in  nanoform  is  still  under  discussion),  these  measures  would 
outline  necessities  for  an  accurate  information  base  to  allow  for  a  reasonable  hazard 
assessment.  

This option would therefore, according to ECHA,  not change any existing obligations as they 
are  understood  to  exist  and  these  measures  are/will  be  pursued  as  such  in  formal  ECHA 
evaluation, but it would provide companies with a clearer understanding on what information 
they  must  provide  in  the  registration  dossier69.  As  a  matter  of  fact,  when  asked  in  the 
framework of the Nano Support project, ECHA indicated that it considered that the measures 
listed in option 2 are derived from the general REACH requirements and are thus part of the 
baseline.  

68  Follow-up  to  the  6th  Meeting  of  the  REACH  Competent  Authorities  for  the  implementation  of  Regulation 

(EC) 1907/2006 (REACH), 15-16 December 2008 
http://ec.europa.eu/environment/archives/chemicals/reach/pdf/1A%20CARACAL%2015-
16%20DEC%2008.pdf 

69  For  example:  Measure  1:  Explicitly  require  registrants  to  describe  the  scope  of  the  registration  dossier;  for 

further details on the measures, refer to Appendix I.  

28 

 
 
 
 
                                                 
The  figure  below  illustrates  where  the  current  requirements  of  REACH  for  substances  with 
nanoforms are in terms of demonstration of safe use, according to ECHA, compared to option 
1.Figure 4-2: Requirements according to ECHA compared to the baseline: 

4.3 

Option 3: Soft law measures 

Option  3  pursues  the  same  goals  as  option  2  i.e.  providing  more  clarity  on  the  registration 
obligations for substances with nanoforms, but instead of amending the legal provisions in the 
REACH Annexes, this option would introduce measures of a non-legally binding nature. 

Within the operation of REACH, already a wealth of different soft law measures are applied; 
of  these,  the  following  would  also  be  applied  to  improve  the  clarity  of  obligations  for 
registrants of substances with nanoforms: 

  Development  of  further  specific  ECHA  Guidance;  presently  there  is  only  rather 
generic  guidance  on  nanomaterials  available  to  registrants  and  it  is  integrated  in  the 
general guidance on registration;  

  Enhanced  use  of  the  Directors  Contact  Group70  to  further  identify  possible  solutions 

for problems related to registration of substances with nanoforms;   

 

Initiatives  to  enhance  information  and  dissemination  at  EU  and  Member  State  level; 
the  overall  understanding  of  how  REACH  applies  to  substances  with  nanoforms  has 

70 In the run-up to the first registration dealdines in 2010, with a view to be able to address potential registration 
issues  prior  to  these  becoming  a  problem,  the  Commission  established  an  informal  group  formed  of  key 
players (Industry associations, ECHA and Commission) in order to screen and identify possible problems in 
the registration process. 

29 

 
 
 
 
                                                 
been shared between Member States and stakeholders that take part in the discussions 
in  CARACAL;  however,  based  on  the  empirical  evidence  on  how  companies  have 
complied, much more communication is necessary in view of raising awareness. 

The  core  difference  between  option  2  and  option  3  is  that  option  3  is  limited  to  the 
clarification  of  the  current  REACH  requirements  for  substances  with  nanoforms  through 
guidance,  whereas  option  2  imposes  these  clarified  requirements  by  amending  the  REACH 
Annexes. As such the potential of option 3 is limited by the outcome of the cases before the 
Board  of  Appeal  (and  possibly  subsequently  the  Court)  on  the  interpretation  of  the  current 
REACH  requirements  for  substances  with  nanoforms.  If  the  Board  of  Appeal  confirms 
ECHA's  interpretation,  then  option  3  and  option  2  would  impose  virtually  the  same 
requirements,  whereas  if  the  Board  of  Appeal  rules  (partly)  against  ECHA's  interpretation 
then some or most of the requirements under option 2 could not be demanded  under option 3. 
Based  on  the  Board  of  Appeal's  decision  of  2  March  2017,  it  is  clear  that  some  of  the 
requirements under option 2 cannot be requested under option 3.  

4.4 

Option  4:  Scientific-technical 
requirements 

recommendations 

tailoring 

information 

At  the  time  when  information  requirements  in  the  Annexes  to  REACH  were  drafted,  no 
consideration was given to nanomaterials and their specific properties. Thus this option's aim 
is,  beyond  the  mere  clarification  of  requirements  pursued  by  options  2  and  3,  to  achieve 
demonstration of safe use in cases where the existing information requirements in REACH are 
not tailored for substances with nanoforms or where specific considerations are required. The 
measures  this  option  proposes,  such  as  limitation  of  the  application  of  waivers71, 
consideration of the most appropriate route of exposure or limitations of the applicability of 
test methods72, are directly taken from the Nano Support project.  

The option is assuming full implementation of option 2.  

4.5 

Option 5: Reduced information requirements 

This  option  has  a  twofold  aim:  on  one  hand,  to  clarify  a  number  of  issues  regarding  how 
substances  with  nanoforms  should  be  addressed  when  being  registered;  on  the  other,  to 
alleviate  the  burden  on  companies,  by  reducing  certain  information  requirements  for 
nanoforms and by promoting the use of non-testing methods and exposure categorisation. 

This double aim would be addressed by two sets of measures:  

  First,  measures  providing  clarity  on  how  nanoforms  are  addressed  and  safety 
demonstrated  under  REACH  by  clarifying  relevant  provisions  and  specifying 
information  requirements  for  nanoforms73  with  the  aim  to  provide  for  specific 
solutions  that  increase  predictability  for  registrants  in  the  current  regulatory 
framework.  

71  For  example:  Measure  14  on  water  solubility-related  waivers;  for  a  further  detail  on  the  measures,  refer  to 

Appendix I. 

72  For  example:  Measure  13:  Require  non-bacterial  in-vitro  study;  measures  include  revised  or  additional 
endpoints  for  substances  with  nanoforms,  e.g.  in  low  tonnages;  most  relevant  route  of  exposure  for  acute 
toxicity and rep eated dose toxicity studies; and a non-bacterial gene mutation study (in vitro); in all REACH 
Annexes  exclusion  of  waiving  possibility  on  the  basis  of  insolubility  or  lack  of  short  term  toxicity,  and  a 
priority for test on soil and sediment organisms; for a further detail on the measures, refer to Appendix I.   
73 For example: Measure 21: Specify that the granulometry concept in 7.14 of Annex VII includes also shape 

and surface area of nanoforms; for a further detail on the measures, refer to Appendix I.   

30 

 
 
                                                 
  Second,  measures  reducing  certain  information  requirements  on  nanoforms  for  the 

purpose of the registration74 at 1 – 10 tonnes and 10 – 100 tonnes. 

4.6 

Option 6: Exhaustive information requirements 

Option 6 goes beyond options 2, 3 and 4 by putting additional emphasis on the generation and 
documentation  of  further  information.  The  objective  of  the  option  is  to  reduce  uncertainty, 
considering that knowledge is still under development regarding the influence of particle and 
nanomaterial-specific properties on risk75. 

The option would contain three types of measures: 

  More prescriptive rules as regards the organisation of the chemical safety assessment 
and  its  documentation  for  individual  nanoforms  and  the  influence  of  particle  and 
nanomaterial-specific properties;  

  Request  specific  information  (e.g.  toxicokinetics,  repeated  dose  toxicity  testing)  in  a 

targeted fashion and at lower tonnages; 

  Address  some  remaining  open  questions  regarding  the  scope  of  current  REACH 
provisions,  drafted  without  specific  consideration  to  nanomaterials  (e.g.  coverage  of 
new  substances  with  nanoforms  by  phase-in  provisions  in  Annex  III  of  REACH, 
substance identification in Annex IV,V). 

The option is assuming full implementation of options 2 and 4. 

4.7 

Interrelationship between options 

It is useful to keep in mind that options 2, 4 and 6 are sequentially staggered, with option 4 
adding further requirements to those contained in option 2 and option 6 adding again more to 
option 4.  
Options 2 and 3 aim to achieve the same result (subject to confirmation that the interpretation 
that  the  measues  in  option  2  are  already  in  line  with  the  current  REACH  requirements), 
though  option  2  does  so  through  legislative  adaptation  and  option  3  through  guidance  and 
other soft law measures.  
Option  1  captures  how  most  of  the  registrants  have  implemented  the  current  legislative 
requirements  –  subject  to possible updates as required by ECHA  compliance decisions, and 
option 5 reduces certain information requirements for nanoforms.  
The table and the figure below illustrate how the options are built and how they compare to 
one another and the REACH requirements according to ECHA: 
Table 4-1: Underlying logic of the policy options, additional to the no-change scenario 

2 

Clarifying the 
existing 
information 
requirements 

3 

Soft law 
measures 

4 

5 

6 

Scientific-
technical 
recommendations 
tailoring 

Reduced 
information 
requirements 

Exhaustive 
information 
requirements 

74 For example: Measure 28: No specific obligations for nanoforms in 10-100 tonnage band; for a further detail 

on the measures, refer to Appendix I. 

75 For example: Measure 40: Introduce rules to ensure mandatory separation between nanoforms identified and 
addressed  in  the  dossier  whenever  they  differ  in  coating,  shape,  crystalline  form  or  prescribed  classes  of 
particle size distribution; for a further detail on the measures, refer to Appendix I. 

31 

 
 
 
 
                                                 
information 
requirements 

On top of option 
2, additional 
measures aiming 
to ensure the 
demonstration of 
safe use by 
changing the 
Annexes to 
REACH, in cases 
where the existing 
requirements are 
not specific for 
substances with 
nanoforms or 
where specific 
considerations are 
required 

Measures 
proposed by the 
Nano Support 
project, and 
considered by 
ECHA as not 
currently required 
by REACH 

Clarification of 
existing 
information 
requirements and at 
the same time 
alleviating the 
burden on 
companies (and 
SMES in 
particular), by 
changing the 
Annexes to 
REACH 

On top of 
options 2 and 4, 
requesting 
additional 
information 
specific to 
nanomateirals 
(not required for 
substances in 
general) in order 
to further reduce 
the uncertainty 

Generation of 
additional 
information and 
its detailed 
documentation  

Increase clarity on 
information 
requirements for 
registrants while 
reducing 
information 
requirements for 
lower tonnages 

Underlying 
logic of the 
options 

Clarification of 
the existing 
information 
requirements 
(according to 
ECHA's 
interpretation), by 
changing the 
Annexes to 
REACH 

Clarification 
of the 
existing 
information 
requirements, 
by 
implementing 
soft law 
measures 
(but no 
changes to 
the REACH 
Annexes) 

Criteria 
for the 
measures 
therein 

Measures 
proposed by Nano 
Support project, 
and considered by 
ECHA as 
currently 
(implicitly) 
required by 
REACH (derived 
from general 
REACH 
Requirements) 

Further 
develop the 
ECHA 
Guidance, 
increase the 
involvement 
of Member 
States, 
ECHA and 
the 
Commission, 
raise 
awareness  

32 

 
 
Figure  4-3:  The  options  compared  to  current  practice  and  ECHA's  interpretation  of  the  current 

requirements 

4.8 

The Baseline 

Establishing  the  baseline  for  this  impact  assessment  as  required  by  the  guidelines  is  not 
straight forward. The current situation is set out as option 1 (current practice) in Figure 4-3. 
With time, assuming ECHA will fully implement compliance checks according to their own 
interpretation of current REACH requirements, the information generated under option 1 will 
eventually  increase  to  that  obtained  by  option  2.  However,  given  the  current  pace  of 
compliance checks by ECHA and the associated workload it is  doubtful that ECHA will be 
able  to  conduct  compliance  checks  for  all  substances  possibly  occuring  in  nanoforms. 
Furthermore, there are several compliance check decisions which through a Board of Appeal 
decisions further determine whether ECHA's interpretation of the current  legal requirements 
is  correct  or  not  (see  more  in  4.9.  Industry  appeals  to  ECHA  decisions  on  registration  of 
substances with nanoforms below). 

Similar  considerations  apply  to  option  3.  The  soft  law  option  will  explain  what  the 
information requirements are in ECHA's interpretation, but as registrants apply guidance in a 
more flexible manner than clear legal obligations, it is expected that the information generated 
under  option  3  will  eventually,  but  more  slowly  and  with  more  efforts  by  ECHA  to  ensure 
correct application of guidance, increase to that of option 2 (again subject to confirmation by 
the Board of Appeal that the measures in option 2 are already in line with the current REACH 
requirements). 

Therefore, for the purpose of this impact assessment, and without prejudice to the opinion of 
the  Board  of  Appeal  on  the  compliance  check  decisions,  it  has  been  assumed  that  ECHA's 

33 

 
 
 
interpretation  of  the  legal  requirements  is  correct  and  that  consequently,  the  information 
requirements  as  set  out  in  option  2  can  be  considered  as  the  baseline  for  what  should  be 
provided for the registration of nanoforms in REACH. However, should the Board of Appeal 
decide against ECHA in the pending cases, the baseline would be closer to option 1, i.e. what 
industry has provided so far and without additonal data generation.  
In the light of the dynamic character of the developments under options 1 and 3, for a precise 
calculation  of  costs  and  benefits  it  would  be  necessary  to  introduce  a  time  dependence  and 
appropriate  discounts  in  the  impact  assessment.  However,  given  the  uncertainties  of  this 
timeline and of the speed by which ECHA could be expected to require data generation using 
the  compliance  check  procedure,  this  impact  assessment  does  not  attempt  to  include  this 
additional  time  variable.  Instead,  for  simplicity  reasons,  the  impact  assessment  will  present 
the  costs  for  option  1  without  the  data  to  be  additionally  generated,  hence  only  looking  at 
current  practice,  and  for  options  2  and  3  considering  the  full  additional  data.  This  has  the 
following consequences: 

- 

costing  of  option  1  does  not  include  the  cost  (for  registrants  and  for  ECHA)  of 
bringing the information content of registration dossiers to the level defined by option 
2; 

-  options  2  and  3  will  have  the  same  cost  because  any  use  of  ECHA  administrative 
resources under option 3, and therefore also the likely higher effort and corresponding 
cost on ECHA of bringing the information content of registrations to the level defined 
by option 2, is not included in the costing model.    

For the purpose of this impact assessment, conceptually, a similar logic as for costs explained 
above, can be applied to capture the benefits of each option for the same snapshots of time as 
for costs. The benefits would be expected only to the extent the underlying data is available 
(i.e.  generated  when  required)  and  therefore  an  assumption  can  be  made  that  safe  use  is 
demonstrated  and applied. Option  1 can thus  not be  associated  with  the  benefits  that  would 
evolve  from  the  efforts  by  ECHA  and  competent  authorities  in  a  long  run  to  bring  the 
information content of registration dossiers to the desired level as defined by option 2. Thus, 
option 1 (under the current practice and without considering the developments in time) would 
not  generate  benefits.  On  the  other  hand,  the  benefits  of  option  3  can  be  considered 
comparable to  that of option 2, based on the assumption  that comparable underlying data is 
generated by the two options.  

4.9 

Industry  appeals  to  ECHA  decisions  on  registration  of  substances  with 
nanoforms 

As  indicated  above,  ECHA's  Board  of  Appeal76  is  presently  considering  several  industry 
appeals against ECHA compliance check decisions requesting nanoform specific information 
in  line  with  what  would  be  required  by  option  2.  While  each  case  is  specific,  industry's 
arguments as well as ECHA's rationale are of more general nature, so the Board's decisions 
are  expected  to  provide  the  Board's  general  views  on  information  currently  required  in  the 
registration  dossier,  thus  outlining  whether  ECHA's  or  industry's  interpretation  of  current 
REACH  requirements  for  the  registration  of  nanoforms  is  correct,  or  whether  the 
requirements  are  somewhere  in  between.  This  is  graphically  presented  in  the  figure  below, 
marking the space in which the no-change scenario might evolve, should ECHA's position not 
be favoured:  

76 It should be noted that the Board of Appeal's decision may not be the last resort for resolving this dispute, as 

further appeal may be lodged with the European Court of Justice. 

34 

 
 
                                                 
Figure 4-4: The no-change scenario and the decision by the Board of Appeal: 

*Taking into account the Board of Appeal's decision on the appeal A-011-2014 regarding the compliance 
check on titanium dioxide, it should be emphasised that the requirements under the 'no change' scenario 
will never fully evolve to the requirements under the 'ECHA scenario'.  

The  Board  of  Appeal's  decisions  will  not  affect  the  assessment  of  the  options  in  absolute 
terms  as  presented  in  this  report,  but  rather  the  relative  change  that  each  option  represents 
compared  to  the  baseline  (which  is  therefore  for  transparency  provided  in  relation  to  both 
options 1 and 2). 
The  Board  of  Appeal's  decision  of  2  March  2017  on  the  appeal  A-011-201450  annulled  the 
ECHA  compliance  check  decision  on  titanium  dioxide,  with  the  principal  argument  that, 
under  the  current  provisions  of  REACH  the  elements  that  are  listed  in  Annex  VI.2  are 
exhaustive so that the additional information on the characterisation of nanoforms requested 
by  ECHA  as  part  of  the  substance  identity  information  is  considered  as  new  information 
requirements  that  fall  under  the  exclusive  competence  of  the  EU  legislator  to  establish  by 
amending  the  REACH  Annexes.  In  addition,  the  Board  of  Appeal  confirmed  that  the 
registrant  has  the  liberty  to  define  the  registered  substance  broadly.  If  he  does  so,  then  the 
hazards of all the possible forms of the substance covered by that substance definition must be 
addressed by the toxicological  and  ecotoxicological  information provided in  the registration 
dossier.  

Consequently,  as  for  the  measures  and  scenarios  of  this  impact  assessment,  the  Board  of 
Appeal's decision implies that the option 2 'ECHA scenario' (e.g. in particular characterisation 
under  Annex  VI.2.  covered  by  measure  2  as  explicitly  addressed  by  Board  of  Appeal's 
decision) cannot be in its entirety considered as part of the baseline. Thus, it can be concluded 

35 

 
 
 
that the baseline (i.e. the 'no change' scenario) cannot fully bring the requirements to the level 
of requirements as set by option 2.   

The robustness of the approach in finding an adequate overall conclusion was assessed. While 
any  difference  in  the  interpretation  of  the  baseline  leads  to  different  evolution  of  the  no-
change scenario and would therefore also affect the relative impact of the implementation of 
the options compared to the no-change scenario, an approach using the total impact (e.g. total 
implementation  cost)  and  the  assessment  of  the  impact  of  individual  measures  allows  the 
comparison between the options and avoids excessive sensitivity to the evolution of the no-
change  scenario.  This  argument  does  not  apply  to  option  3,  that  would  for  example  remain 
bound  by  any  potential  legal  constraint  identified  and  that  would  in  turn  modify  the 
assessment accordingly, including the estimation of costs and uses of animals. As the Board 
of Appeal Decision confirmed the lack of competences of ECHA to request under the current 
provisions  of  REACH  nanoform-specific  information  to  be  submitted  as  part  of  the  Annex 
VI.2,  option  3  in  itself  cannot  resolve  all  of  the  issues  discussed  under  section  2.2  The 
problem  requiring  action  and  its  drivers.  Thus,  there  is  need  for  further  action  beyond  soft 
law measures. 

5 

ANALYSIS OF IMPACTS 

This section introduces first a summary of the main findings of the Public Consultation and 
then develops a qualitative (and quantitative, where possible) analysis of the economic, social 
and environmental impacts of each of the options.   

Quantified  costs  for  each  option  will  be  presented  based  on  data  models  utilising  certain 
assumptions. It is important to note that quantitative estimates on costs from different studies 
vary  due  to  different  methodologies,  assumptions  and  interpretations  of  the  options,  but  are 
adequate  to  support  qualitative  grading  and  indicative  of  the  magnitude  of  the  impacts.  In 
particular, the estimates are often built on the basis of assumptions and interpretations of the 
different measures.  

As  is  often  the  case  for  health  and  environmental  issues,  as  well  as  for  innovation  and 
competitiveness, it is impossible to establish a meaningful direct causal link between a single 
measure and the associated, often long term, benefit it may bring to society. This is not unique 
to  the  present  impact  assessment.  In  absence  of  better  alternatives  and  for  simplicity,  it  is 
generally assumed that correct risk management of nanomaterials will lead to health benefits 
similar to managing risks for bulk substances. For the same reason the benefits assessment as 
well as the assessment on innovation and competitiveness will be mainly qualitative.  

5.1 

Public Consultation 

The  results  of  the  Public  Consultation  are  presented  in  detail  throughout  the  analysis  of  the 
impacts and in Appendix V.  

Overall, when asked about their preferences for the options as a whole, a majority of the 142 
respondents preferred option 5, closely followed by option 6; and then options 2 and 4, while 
option 3 had the lowest  preference. Respondents can be grouped into three main categories, 
according to their preferences: industrial and trade associations and private companies, which 
preferred  clearly  option  5;  government  authorities,  academic/research  institutions,  NGOs, 
consumer associations and individual citizens, which preferred option 6 followed by option 4; 

36 

 
 
and 'others',77 for which the preference is more or less equally shared between options 6, 4 and 
2. 

When  asked  about  the  cost,  the  efficiency  and  the  safety  of  each  measure  contained  in  the 
options,  option  2  received  the  highest  ranking  for  both  efficiency  and  safety,  option  5  the 
highest ranking for cost and the lowest for safety, and option 6 the lowest ranking for cost but 
only the third highest for safety. Option 4 ranked second, both for safety and efficiency and 
fourth for cost. Given the staggered interrelationship between options 2, 4 and 6, the outcome 
in terms of ranking of the three options for costs is coherent, while the ranking for safety is 
somewhat  surprising.  In  response  to  a  separate  question  regarding  the  efficiency  of  the 
options as a whole, option 4 received high appreciation by the majority of the respondents. 

5.2 

Economic impacts 

5.2.1  Conduct of business 

5.2.1.1  General considerations 

Companies placing on the market substances with nanoforms (manufacturers and importers) 
would  be  directly  affected  by  the  measures  under  this  proposal  (downstream  users  of  such 
substances  will  be  indirectly  impacted).  A  large  part  of  how  the  conduct  of  business  is 
affected by each of the options relies on the analysis of the testing costs and the administrative 
burden on registrants (understood as the costs linked to the information obligations placed on 
businesses,  including  the  need  to  undertake  tests).  This  section  is  mainly  focused  on  the 
compliance  costs  for  registrants  (i.e.  companies  placing  substances  with  nanoforms  on  the 
market).  
Two supporting studies by BiPRO78 and Matrix79 have been conducted to support this impact 
assessment. Based on the information available from the two studies and the understanding of 
the possible applications of the different measures, the Commission services have made their 
own calculations80.  

Other  impacts  on  the  conduct  of  business,  including  that  for  SMEs  and  how  the 
clarity/certainty  of  the  regulatory  requirements  are  going  to  be  affected  by  each  of  the 
measures, are also explained, mostly in a qualitative manner.  

It should be noted that the costs for business have been assessed from the perspective of cost 
incurred from registration requirements, while some of the information may be available from 

77 The category 'Others' groups all the respondents who did not identify themselves within any of the previous 

categories. 

78 BiPRO (2013) “Examination and assessment of consequences for industry, consumers, human health and the 
environment  of  possible  options  for  changing  the  REACH  requirements  for  nanomaterials”,  Final  Report, 
prepared for the European Commission, Joint Research Centre, Institute for Health and Consumer Protection. 
79 A study to support the Impact Assessment of relevant regulatory options for nanomaterials in the framework 

of REACH, Matrix, 31 March 2014  
http://ec.europa.eu/DocsRoom/documents/5826/attachments/1/translations/en/renditions/native 

80 The differences with the figures from the Matrix and the BiPRO studies reflect different interpretations of the 
measures, different assumptions and subsequent changes in the understanding of how the specific measures of 
each option would operate in practice (the cost calculations themselves led to refinements on assumptions, as 
did further discussion with experts and stakeholders). Clearly, changes in the assumptions of when and how 
many times a specific activity (e.g. test) will be required per company or substance for a specific measure will 
change the estimates of the costs of that specific measure and the option it is grouped under. Over the impact 
assessment  process,  the  understanding  improved  considerably  of  how  REACH  and  the  specific  measures 
would operate in practice and of when a measure would lead to cost-incurring behavioural change. 

37 

 
 
                                                 
normal business operation (e.g. characterisation/reproducible product and functionality, safety 
information  for  investment)  or  from  compliance  with  other  legislation  (e.g.  sector  specific 
legislation such as for Cosmetic Products).  

5.2.1.2  Costs calculations 

The cost calculations and related underlying assumptions are presented in detail in Appendix 
XIII.  

In  the  tables  below,  the  cost  of  registering  a  nanoform  (or  in  grand  total,  all  nanoforms 
estimated  to  be  registered)  is  presented,  as  a  function  of  the  tonnage  band  to  which  the 
nanoform  is  associated,  and  the  impact  of  the  measures  considerd  to  be  applied  under  each 
option81.  

In  accordance  with  the  baseline  narrative  developed  under  section  4.8  The  Baseline, 
presentation  of  costs  under  option  1  do  not  include  compliance  costs  according  to  ECHA's 
interpretation of the current REACH requirements. 

The total costs and not the incremental cost as compared to the baseline are presented in all 
the  following  tables.  Some  relative  figures  are  however  provided  in  the  accompanying  text 
assessing individual options under section 5.2.1 Conduct of business.  

Most  assumptions  and  estimations  come  within  a  certain  range  (e.g.  minimum/maximum 
costs).  Therefore,  in  most  calculations  a  'typical'  value  is  used  while  individual  ranges  are 
used as specific examples to discuss the sensitivity of the results.  

The resulting tables are presented below:  

Costs of registration per nanoform 

For the calculations  in  table 4-1, it has been assumed that it is  possible  to  apply  alternative 
methods to fulfil an information requirement (e.g. read-across between substances, grouping, 
QSAR, etc.) also for different forms of the same substance and to justify relevance of data on 
one form for the other or identify the worst form. Although currently the documented82 use of 
such methods for nanoforms is limited, it is expected to increase with the development of the 
knowledge base. In the absence of better information, it is assumed that this leads to the same 
percentage of reduction for testing needs, as has been observed for conventional substances83.  
Within  option  1,  the  costs  are  presented  in  two  ways:  one  (1a)  indicating  the  cost  for  one 
information  dataset  for  substance  regardless  of  the  number  of  forms,  and  the  other  (1b) 
indicating the cost per nanoform/set of nanoforms calculated by dividing the first cost figure 
by an estimated average number of nanoforms or sets of nanoforms for a substance at a given 
tonnage band.  

81 There is a potential impact of the changes on the registration of other forms of the substance with nanoforms. 
Most of it is neutral (as the bulk form would be already registered) or reduces cost (application of read-across 
or worst case approach from nanoform to bulk). Such impacts were not quantified. Measure 41 may however 
lead to increased cost and use of animal and is thus addressed separately. See Appendix XIII for more details.  
82  One  may  argue  that  in  cases  where  a  single  dataset  is  used  for  a  number  of  (nano)forms,  an  implicit 
assumption on its relevance for each of those (nano)forms is made, with test material in another form serving 
either  as  an  analogue  or  applying  a  worst  case  approach;  as  such  claims  are  not  explicitly  documented  and 
justified, this cannot be validated. See  JRC: http://publications.jrc.ec.europa.eu/repository/handle/JRC106386 

83 See Appendix XIII for the table of applied percentages for each information requirement. 

38 

 
 
 
 
                                                 
 
Table  5-1:  Costs  of  options  per  nanoform  and  per  tonnage  band  (use  of  alternative  information 
considered possible, typical cost) (in thousand Euro): 

1a 

1 b 

Estimated 
baselinee 

2 

3 

4 
(including 
2) 

5 

6 
(including 2 
and 4) 

772 

538 

183 

49 

77 

77 

37 

12 

1049 

1157 

1049 

1256 

770 

814 

770 

334 

359 

334 

91 

116 

91 

939 

471 

137 

458 

375 

40 

12 

2256 

1736 

869 

466d 

>1000 tonnes 

100-1000 tonnes 

10-100 tonnes 

1-10 tonnesc 

Weighted Average 
a  Costs  per  substance  regardless  of  the  number  of  forms  –  one  test  performed  per  substance  per  information 

358 

47 

516 

565 

516 

642 

212 

1254 

requirement  

b  To  calculate  and  present  the  cost  per  nanoform  or  set  of  nanoforms,  the  costs  for  conducting  all  tests 
according to the measures constituting option 1 are divided by an estimated average number of nanoforms or 
sets of nanoforms for a substance at a given tonnage band 

c  Weighted average: depending on applicable conditions of Annex III to REACH, the implications differ between 

registrants in the 1-10 tonnage band; more details in Appendix XIII 

d  Indirect impact of measure 41 on registration of bulk forms may bring an estimated additional cost of 10 K 
EUR  per  nanoform  of  substance  otherwise  benefiting  from  Annex  III  exemption.  Relative  additional 
contribution 2%. More details in Appendix XIII 

e  Estimated  baseline  consequent  to  Board  of  Appeal  Decision  2  March  2017(see  discussion  in  section  4.9). 

Option 2 cannot be considered baseline in its entirety.  

Grand Total costs 

Multiplying  the  figures  in  table  4-1  by  the  estimated  total  number  of  nanoforms  or  sets  of 
nanoforms  and  the  number  of  substances  with  nanoforms  per  tonnage  band  provides  an 
estimation of the total costs.  

Table  5-2:  Registration  costs  –  Grand  total  per  tonnage  band  (use  of  alternative  information 
considered possible, typical cost) (in million Euro): 

1a 

Estimated 
baselined 

2 

3 

4 
(including 
2) 

5 

6 
(including 2 
and 4) 

36 

43 

9 

10 

482 

426 

84 

73 

532 

450 

90 

93 

482 

426 

84 

73 

578 

519 

118 

110 

211 

207 

10 

10 

1038 

960 

217 

373c 

>1000 tonnes 

100-1000 tonnes 

10-100 tonnes 

1-10 tonnesb  

97 

1065 

1165 

1065 

1325 

437 

Total 
a Note that in this grand total cost table only one number is used to represent option 1; it assumes that, whether 
sufficient for risk assessment or not, at most one test is performed per substance per information requirement, 
regardless of the number of nanoforms that the registration of that substance includes 

b Weighted average: depending on applicable conditions of Annex III to REACH, the implications differ between 

2588c 

registrants in the 1-10 tonnage band; more details in Appendix XIII 

39 

 
 
 
 
 
c  Indirect  impact  of  measure  41  on  registration  of  bulk  forms  may  bring  an  estimated  additional  cost  of  6  M 

EUR. Relative additional contribution 1.6%. More details in Appendix XIII 

d  Estimated  baseline  consequent  to  Board  of  Appeal  Decision  2  March  2017(see  discussion  in  section  4.9). 

Option 2 cannot be considered baseline in its entirety.  

Additional  scenarios  are  provided  under  Appendix  XIII  for  costs  of  nanoform  registration 
without  alternative  information  available,  costs  per  registration  dossier  and  costs  per 
company. 

Interpretation, uncertainties and sensitivity analysis 

Assessment  of  individual  options  is  provided  in  the  following  chapters,  but  some  broad 
features of tables 5-1 and 5-2  should be highlighted: 

  Higher costs for nanoforms to be registered under higher tonnages reflect more 

extensive information requirements as set out in REACH ; 

  Total costs rather than cost incremental to the baseline are presented; 
  As explained in section 4.8, option 1 estimates present cost reflecting information 

found in many REACH dossiers of substances with nanoforms at present;  

  As explained in section 4.8, option 3 will in time lead to costs as in the baseline – (see 
discussion in section 4.9 on the Board of Appeal decision in the case A-011-2014). 

It should be emphasised that the costs presented above, in particular the Grand Total costs, are 
highly sensitive to several key assumptions, namely the number of substances with nanoforms 
subject to registration, the number of nanoforms within a substance, the extent to which use of 
alternative  methods  for  providing  information  (read-across,  ability  to  apply  worst  case 
approach etc.) can be applied between the substances and the nanoforms, testings costs, etc. 
As evident from Appendix XVI, where different scenarios are examined, the uncertainties of 
the average cost is likely to be in the order of at least +/- 50%.  

Individual  materials  may  present  specific  challenges  when  tested  and  the  cost  difference 
between them can correspondingly be significantly larger, within one order of magnitude of 
the  average  cost.  The  actual  number  of  registrants  sharing  the  costs  of  the  information 
requirements for an individual nanoform will also influence proportionally the actual cost per 
registrant. 

In  the  Grand  Total,  costs  are  directly  related  to  the  assumed  number  of  nanoforms,  i.e.  the 
higher the number of forms, the higher the grand total cost. As the information related to the 
number  of  nanoforms  covering  nanomaterials  on  the  market  is  highly  uncertain,  the 
assumptions are associated with significant uncertainty.  

5.2.1.3  Option 1  

As explained in section 2.4 How will the problem evolve?, it is reasonable to expect that the 
situation  will  improve  over  the  next  years  and  the  issues  stemming  from  the  differences  in 
understanding how REACH addresses substances with nanoforms at present will diminish due 
to  the  mechanisms  foreseen  in  REACH,  such  as  compliance  checks  by  ECHA,  continuous 
development  of  guidance,  and  the  learning  process  within  industry.  However,  the  process 
would be cumbersome, take time and uncertainties for companies (on how to comply with the 
REACH  registration  requirements)  would  remain  in  the  short  to  medium  term.  Many  more 
companies will get involved by 2018 (1-100 tonnes) and as new nanomaterials make it to the 
market, many of the same issues will persist. 

40 

 
 
 
When  preparing  this  initiative,  it  has  also  been  shown  that  there  exist  clear  discrepancies 
between  the  involved  parties  on  what  REACH  entails  when  it  comes  to  nanomaterials.  As 
recalled  above,  there  is  indeed  a  certain  grey  area  with  regard  to  the  interpretation  of  the 
current  information  requirements  as  applicable  to  substances  with  nanoforms,  and  thus 
different interpretation of the evolving baseline scenario. This leads to legal uncertainties that 
will not be resolved (or at least not quickly and not for all operators) with this option.  

The  assessment  of  this  option  makes  the  assumption  that  there  will  not  be  significant 
improvements in the short term of the information provided, and this is reflected in the cost 
estimation of the option in table 5-2. 

5.2.1.4  Option 2 

Public Consultation: 94% of respondents from industry report that costs of compliance would 
"significantly increase" under this option, whereas other stakeholders do not expect an impact.  

Analysis  

According to ECHA's interpretation, this option does not change any existing obligations, but 
explicitly  explains  what  information  companies  must  provide.  Under  this  interpretation, 
option 2 would constitute the baseline.  

Compliance cost  (including administrative burden): The weighted average cost  of providing 
information for a nanoform or set of nanoforms in accordance with option 2 is estimated to be 
565 K EUR (depending on the tonnage band ranging from 116 to 1,157 K EUR - the higher 
the tonnage band, the bigger the cost). The most costly measures within this option are related 
to  the  characterisation  of  the  nanoform  (measure  2)  and  providing  information  on 
characterisation  of  test  samples  as  a  consequence  of  the  insertion  of  clarifications  in  the 
REACH Annexes I and VI to X according to the OECD requirements (measure 4)  84. These 
measures  weigh  more  strongly  in  the  low  1-10  t  tonnage  band  (a  2.4  fold  relative  increase) 
and less at higher tonnages (1.5 fold increase for >1000t). 

The Board of Appeal's decision on 2 March 2017 in the case A-011-2014 (see discussion in 
section 4.9) indicates option 2 in its entirety cannot be considered as baseline. It is estimated 
that  the  difference  (per  nanoform)  is  in  the  order  of  25K  to  108  K  EUR  (the  higher  the 
tonnage  band,  the  bigger  the  cost).  In  the  grand  total,  the  cost  of  this  measure  amounts  to 
approximately 100 M EUR (or 9.4% of the estimated baseline).  

When  comparing  to  option  1,  the  major  cost  increase  comes  from  testing  that  might  be 
required  for  individual  nanoforms  or  sets  of  nanoforms  and  is  therefore  proportional  to  the 
number  of  nanofoms  registered  under  one  substance.  Regardless  of  whether  the  registrants 
had not assessed different forms covered in the registration, or had perhaps just not included 
documentation of such assessment in the dossier, option 2 would cause additional costs that 
might be substantial compared to what they have incurred until now. In the medium/long term 
as  ECHA  progresses  with  evaluation,  registrants  are  forced  to  upgrade  the  dossiers,  the 
difference  would  eventually  diminish,  however,  option  2  would  still  incur  at  least  a  total 
additional  cost  of  100  M  EUR  (as  compared  to  the  estimated  baseline),  with  high  relative 
increase in the lowest tonnage band. 

84 Measure 2: Explicitly require registrants to provide more detailed characterisation of nanoforms; Measure 4: 
Require detailed description of the test material/sample preparation; for further details on the measures, refer 
to Appendix I. 

41 

 
 
                                                 
Regulation  clarity/certainty:  The  option  is  expected  to  increase  clarity  and  hence  reduce 
regulatory uncertainties, which would permit firms to better plan business activities entailing 
the  use  of  nanomaterials.  Also,  the  increased  knowledge  base  regarding  the  properties  of 
nanomaterials  is  likely to reduce costs in  the long  run, also  via increased trust  for investors 
that  there  are  no  hidden  liabilities  and  general  demand  side  trust  in  the  safety  of 
nanomaterials. 

5.2.1.5  Option 3 

Public  Consultation:  For  a  large  number  of  the  respondents,  option  3  would  either  increase 
the costs of compliance (44%), or have no impact on it (39%).  

Analysis  

Compliance  cost  (including  administrative  burden):  Non-binding  measures  could  have  an 
impact  on  costs,  e.g.  specific  guidance  leading  to  different  interpretations  of  the  legislation 
can increase or decrease compliance costs. However, any cost changes will by definition not 
stem  from  a  change  of  the  obligations,  but  could  stem  from  e.g.  administrative  cost  of 
organising data differently or different testing costs. The compliance cost as well as the ability 
to address the problem in its entirety depends on the interpretation of the current information 
obligations. Pursuing the same objective as option 2, soft measures are effectively limited to 
those  that  might  be  pursued  as  current  compliance.  Assuming  ECHA's  interpretation  is 
correct, it is thus expected that the costs for this option would be similar to those of option 2. 
It  is  worth  noting however that the costs might  potentially occur at  different  points in  time, 
since compliance costs triggered by option 2 would occur immediately after implementation 
and that those triggered by soft law recommendations would likely take some time to occur. If 
interpretation of compliance is different (see discussion in section 4.9 on the Board of Appeal 
decision) and since the Board of Appeal ruled (partly) against ECHA's interpretation in terms 
that  some  of  the  requirements  under  option  2  cannot  be  considered  as  current  REACH 
requirements) then the total cost of this option would differ, i.e. being lower that the total cost 
of option 2. 

Regulation  clarity/certainty:  Since  the  measures  contained  in  this  option  aim  at  providing 
explanations about what the obligations for companies are or where more information can be 
found, this option would increase clarity and reduce uncertainty for companies. The degree of 
clarity/certainty provided by changes solely in the guidance would, however, be weaker than 
that provided by changes in the legal text itself.   

5.2.1.6  Option 4 

Public Consultation: Option 4 is ranked fourth in terms of cost burden.  

Analysis  

Compliance cost (including administrative burden): A condition for option 4 to work properly 
is that the registrants provide correct data in accordance with option 2. With option 4, a few 
new  tests  are  introduced  or  would  be  made  compulsory  for  registrants  at  lower  production 
levels than hitherto. The weighted average total cost of option 4 is estimated to be 642 K EUR 
(137  K  EUR  for  1-10t  –  1,256K  EUR  for  >1000t).  The  weighted  average  cost  of  the 
additional  measures  of  option  4  compared  to  option  2  is  77  K  EUR  (14%  increase),  with 
higher  impact  on  lower  tonnage  bands  (18%  and  33%  for  1-10t  and  10-100t,  respectively). 
The most costly measure within this option relates to the prioritisation of testing on soil and 
sediments  (measure  17,  which  requires  data  generation  at  lower  tonnages  than  for 
conventional  substances,  thus  having  a  maximum  impact  in  the  10-100  tonnes  registration 

42 

 
 
band) and additional justification further to water solubility for test waiving (measure 14). If 
compared to option 1, the cost increase is substantially higher (i.e. 14 fold). 

this  option 

Regulation  clarity/certainty:  While  option  2  addresses  the  clarity  in  relation  to  legal 
requirements, 
the  scientific 
recommendation  compiled  by  the  JRC  in  the  Nano  support  project.  These  should  provide 
more certainty in the effectiveness in the regulatory requirements for this specific subgroup of 
chemicals. 

includes  additional  requirements  based  on 

5.2.1.7  Option 5 

Public  Consultation:  This  is  the  best  ranked  option  in  terms  of  cost  (for  40%  of  the 
respondents this option would have no impact on the costs of compliance).  

Analysis  

Compliance cost (including administrative burden): The aim of this option being to reduce the 
cost of compliance, its implementation would indeed have a weighted average cost of 212 K 
EUR and entail savings of 62% for companies compared to option 2. Savings are in particular 
high  for  lower  tonnages  (92%  and  90%  for  1-10t  and  10-100t,  respectively).  The  estimated 
savings per nanoform, assuming they being registered together with a bulk form carrying the 
entire cost, has been estimated to range between -104 K EUR for the lower tonnage band to -
699 K EUR for the upper one compared to option 2. In case of option 1 being the baseline, 
implementing option 5 would not cause any additional cost in lower tonnage bands but would 
cost 298 K EUR and 380 K EUR for 100-1000t and >1000t respectively.  

There are two main reasons for such significantly lower cost:  

  The  specific  requirements  for  a  nanoform  or  set  of  nanoforms  in  terms  of  scope 
and  characterisation  under  option  5  do  not  exist  or  are  less  demanding  than  the 
ones under option 2 (e.g. measure 18 versus measures 2 and 385). 

  The option would exempt the registrants from providing any ecotoxicological and 
environmental  fate  information  for  the  nanoform  or  set  of  nanoforms  and  in 
addition  assumes  provision  of  information  by  alternative  means  rather  than  by 
testing86.  

This  cost  reduction  does  not  affect  the  information  supplied  for  the  bulk  or  another  (non-
nano) form of a substance in the dossier.  In general this option would not oblige data to be 
generated for the registered nanoform or set of nanoforms. 

Regulation clarity/certainty: The option does provide further clarity to the registrants who will 
face  easier  tasks  in  fulfilling  their  requirements,  imply  savings  and  permit  better  planning. 
Essentially,  the  proposed  option  would  reduce  the  standard  information  requirements  for 

85 Measure 2: Explicitly require registrants to provide more detailed characterisation of nanoforms; Measure 3: 
Require that nanoforms are explicitly addressed in the endpoint sections; forms should be clearly addressed in 
study  summaries;  and  Measure  18:  Describe  whether  and  which  different  nanoforms  are  covered  in  the 
chemical  safety  assessment,  including  a  statement  when  and  how  information  on  one  form  is  used  to 
demonstrate safety of other forms; for further details on the measures, refer to Appendix I. 

86  Measure  5:  Require  scientific  justifications  for  grouping  /  read  across  /  QSAR  and  other  non-testing 
approaches  for  different  forms;  Measure  24:  Specify  that  the  use  of  non-testing  methods  (e.g.  read-across, 
grouping, categorisation etc. methods) is a priority for nanoforms; and  Measure 33: Create presumption that 
non-testing  methods  are  valid  for  nanoforms  in  all  endpoints;  for  further  details  on  the  measures,  refer  to 
Appendix I. 

43 

 
 
                                                 
nanoforms  of  a  substance  and  change  the  legal  situation  for  substances  with  nanoforms 
produced in quantities below 100 tonnes per  year per company to a situation comparable to 
what was applicable to existing chemicals before REACH was adopted.  

5.2.1.8  Option 6 

Public Consultation: Option 6 was the worst ranked option in terms of impacts on costs (4 of 
the  measures  are  particularly  qualified  as  affecting  or  significantly  affecting  the  costs  of 
compliance87).  Indeed,  almost  90%  of  the  respondents  indicated  cost  increases,  and  half 
expected a "significant increase".  

Analysis.  

Compliance cost (including administrative burden): Option 6 would add further obligations to 
those  established  under  options  4  and  2.  It  would  add  administrative  requirements,  e.g. 
presenting separate information for nanoforms of a substance that differ among themselves in 
terms  of  specific  characteristics  (coating,  shape,  form  etc.).  The  option  implies  an  average 
weighted  cost  increase  by  121%  compared  to  option  2.  The  total  cost  of  this  option  is 
estimated to be 1,254 K EUR (466 K EUR for 1-10t and 2,256 K EUR for >1000t). Compared 
to option 1, the cost increase is 27 fold. There is also an estimated indirect additional cost of 
10 K EUR per nanoform from measure 41 through registration of the bulk form of substances 
in  1-10t  tonnage  band,  leading  to  (small  in  comparison  to  the  impact  of  other  measures) 
estimated total additional indirect costs of 5.8 million EUR (1.5% of the total cost in the 1-10t 
tonnage  band,  0.2%  in  total).  The  highest  costs  come  from  the  measures  that  effectively 
increase the number of nanoforms to be addressed (measures 41 and 4988 addressing REACH 
Annexes III, IV and V) and those which reduce the availability of information via alternative 
means  (measure  46).  Further  costs  are  incurred  by  requesting  additional  physico-chemical 
requirements from measure 44 and the toxicokinetic study from measure 51. However, it is to 
be  noted  that  with  better  toxicokinetic  information  available,  it  can  be  reasonably  assumed 
that at least some more tests can be waived (in particular in the higher tonnage bands) based 
on  justifications  referring  to  the  toxicokinetic  data  or  as  the  information  is  provided  via 
alternative means; this means that despite more requirements being added, the general testing 
requirements  (both  new  and  existing  testing)  may  be  reduced  so  that  the  overall  impact  is 
lower than expected. 

Regulation  clarity/certainty:  This  option  adds  additional  requirements.  Because  it  is 
prescriptive and detailed, it supports the objective of providing clarity for the registration.   

5.2.2 

Impact on SMEs 

5.2.2.1  Option 2 

The costs for complying with  option  2 are considerable, even more so in the lower tonnage 
bands (see above - the relative impact of the measures for the 1-10 t tonnage band is 1.6 times 
the  one  for  >  1000t)  where  it  is  expected  that  more  SMEs  are  active.  However,  the 

87 Refer to the Appendix V for more detail about these. 
88 Measure 41: Information requirements for substances covered by Annex III (b) must also apply to nanoforms; 
Measure  44:  For  nanoforms,  require  additional  physico-chemical  characterisation  along  the  particle's  fate 
when particle properties impacts on hazard; Measure 46: For nanoforms, explicitly limit the potential for use 
of  non-testing  approaches  for  hazard  and  exposure  where  science  is  not  consolidated,  but  encourage  its 
parallel  application  and  documentation;  Measure  49:  Specify  that  list  of  substances  in  Annexes  IV  and  V 
does not cover nanoforms of these substances; and Measure 51: Perform toxicokinetic screening; for further 
details on the measures, refer to Appendix I. 

44 

 
 
                                                 
information  gained  through  these  measures  is  essential  for  demonstrating  safe  use  of  the 
nanoforms  of the substance.  In fact  enhanced clarity  is  assumed to  make it easier and more 
efficient also for small firms that are not lead-registrants to apprehend precisely and up-front 
what  obligations  REACH  puts  on  them.  However,  the  increase  in  the  compliance  cost  may 
create a barrier for some SMEs and force them to exit the nanomaterial market. 

5.2.2.2  Option 3 

SMEs are the businesses least able to access information and the most likely to misunderstand 
how REACH works. As such, they stand to gain the most from soft law measures aiming at 
providing more clarity on the registration obligations. Other considerations apply as for part 
of option 2. 

5.2.2.3  Option 4 

The measures and their associated costs have proven to follow relatively closely the existing 
cost  development  between  the  different  tonnages  with  the  exemption  for  the  tonnages  10  – 
100 tonnes due to the expensive soil and sediment test that would be additionally required in 
that  tonnage  range.  Assuming  that  SMEs  have  a  higher  relative  representation  in  the  lower 
production  volumes,  it  is  important  to  assess  if  the  lower  volumes  are  harder  hit  than  the 
higher volumes. As shown in table 4-2, and comparing to option 2 this would be the case for 
the volumes 10-100 tonnes (mainly due to measure 17), but not that much for the volumes 1-
10 tonnes, where it is expected more SMEs are active.  

5.2.2.4  Option 5 

Like for other company sizes, the short term savings on compliance cost will benefit SMEs. 
However, the continuous lack of relevant information on safety might impede the commercial 
success of the SME in the medium to long term.  

5.2.2.5  Option 6 

The impacts on the viability of SMEs explained under option 4 move in the same directions 
for this option, but their magnitude is much stronger. In particular for the lowest tonnage band 
(1-10 tonnes) the resulting cost increase, as compared to option 2, could be a challenge. SMEs 
involved in the manufacturing or importing of nanomaterials could see their viability severely 
affected.  

5.2.2.6  General discussion on impacts on SMEs 

The  requirements  for  registration  and  generation  of  information  under  REACH  are  strictly 
company-neutral and related solely89 to the tonnage of the substance placed on the market by 
a company. However, in particular through the tiered tonnage thresholds, REACH is already 
providing  some  relief  for  SMEs,  for  all  chemicals,  as  a  higher  proportion  of  SMEs  is 
registering  low(er)  tonnage  substances  under  the  less  onerous  standard  information 
requirements  for  the  lower  tonnage  bands.  Furthermore,  SMEs  benefit  from  significantly 
reduced registration fees and dedicated implementation support by ECHA90.  

89 There are a number of specific provisions (e.g. exclusion under Annex IV,V, polymers, intermediates) but they 

are all explicitly captured by the legal text. See Appendix XIV and REACH regulation for more details.  

90 Including dedicated events and webinars, webpages, helpdesk, SME ambassador, implementation support such 
as recent development of list of low tonnage chemicals likely to fulfil conditions under Annex III of REACH 
etc.  

45 

 
 
                                                 
Any  further  adaptations  (i.e.  waivers  for  subgroups  of  chemicals)  are  based  on  scientific 
justification (generally available or demonstrated by registrants) and clear demonstration that 
such  an  adaptation  does  not  impede  the  ability  to  safely  manage  the  substance,  but  these 
cannot be dependent on the size of the registering company.  

Measures  addressing  nanoforms,  in  all  options  apart  from  option  5,  follow  this  same  logic. 
SMEs seem to be proportionally affected more by the options, compared to the situation for 
conventional chemicals. That is principally because the nanoforms need to be characterised, a 
basic  requirement  to  properly  identify  them,  and  thus  defining  the  scope  of  the  registration 
dossier,  and  subsequently  enable  better  functioning  of  REACH91.  At  low  tonnages, 
characterisation  contributes,  in  relative  terms,  a  higher  proportion  to  the  total  costs  (i.e. 
characterisation  + 
lower.  The  same 
'disproportionate'  effect  is  observed  already  in  present  REACH  implementation  e.g.  for 
properly identifying a UVCB substance registered at low tonnage. The same argument applies 
to some of the related measures under options 2 and 4. Option 6 causes additional burdens for 
SMEs, but this has been clearly identified.  

testing  requirements  are 

testing),  given 

that 

Option 5 includes several measures that attempt to mitigate impacts on SMEs also by further 
reduction of information requirements for lower tonnages via a generic waiver, applying to all 
nanoforms, of ensuring nanoform-relevant information and relying on data on whichever form 
of  the  substance  that  is  available.  A  case  by  case  assessment  may  in  many  cases  eliminate 
need  for  further  testing  as  relevant  information  for  nanoforms  may  be  available  through 
alternative means (e.g. read across, worst-case approach), but a generic waiver applicable to 
all  nanoforms  of  all  low  tonnage  substances  cannot  be  scientifically  justified  and  thus 
represent a deviation from the REACH approach presented above. 

5.2.3 

Innovation and research 

Drivers for innovation and research are manifold and not always equally well understood. In 
this particular case, it should be borne in mind that the measures all are to be introduced in 
context of already existing REACH registration obligations so isolated effects of the different 
options are even more difficult to identify. Overall the discussions have identified two general 
positions, those who argue that extra health and safety requirements adds compliance cost to 
companies that otherwise would have been spent on developing new products (the findings of 
the  REACH  review  indicate  that  there  has  been  indeed  a  shift  of  resources  from  R&D  to 
compliance); and those who argue the opposite way claiming that research and innovation is 
(also)  fuelled  by  legislative  requirements  and  that  compliance  information  is  not  passive 
knowledge but also an asset that can help further development. 

The  ‘de-regulation’  argument  as  voiced  by  some  companies  being  part  of  the  consultation 
assumes  that  regulation  simply  increases  costs  and  erodes  competitiveness  and  existing  or 
future  innovation;  several  answers  of  decision  makers  in  companies  showed  that  “data 
generation  as  such  does  not  necessarily  lead  to  conception  of  new  ideas  and  innovative 
activity”.  Fulfilling  the  requirements  of  the  REACH  Regulation  requires  scarce  company 
resources  otherwise  needed  for  other  purposes,  e.g.  goal-oriented  research  and  development 
activities  and/or  gaining  better  position  in  the  global  markets.  This  is  confirmed  in  a  study 

91 In fact, the registrant is always registering the substance (with nanoforms) with other registrants of the same 
substance,  also  when  he  registers  at  different  tonnages.  Data  sharing  reduces  total  costs  for  testing  and  the 
number of animals required. However, failure to characterise nanoforms by all registrants would not allow the 
joint submission to function as desired.  

46 

 
 
                                                 
monitoring the impacts of REACH on innovation, competitiveness and SMEs92, where results 
show  that  about  half  of  the  companies  have  had  to  reallocate  R&D  staff  to  compliance 
activity. 

The  ‘pro-regulation’  argument  builds  e.g.  on  information  gathered  by  the  introduction  of 
additional  requirements  in  the  options,  addressing  human  health  hazards  and  environmental 
fate and hazards may also help spark innovation  as has been demonstrated by the effects of 
information generated thus far for the first registration dossiers. As soon as companies have 
performed the additional tests required, they gain additional information, on particular hazards 
and  risks  of  these  nanoforms,  and  also  on  relations  between  their  characteristics  and  risks. 
Having  this  information  early  helps  focus  innovation  to  the  more  successful  final  solutions 
(i.e.  ‘safety  by  design’)  and  helps  secure  investment.  It  may  also  induce  further  innovation, 
e.g.  on  alternatives  with  less  hazards  and  risks.  This  does  not  apply  only  to  the  company's 
own  development  -  harvesting  the  joined  increased  knowledge  opens  new  innovation 
potential. 
The impact assessment prepared in the run-up to REACH93 forecasted no substantial changes 
related  to  REACH  with  regards  to  R&D  investments  by  firms  in  the  chemical  sector. 
Similarly,  the  more  recent  CSES  interim  evaluation94  mentions  that  there  have  been  no 
significant effects in terms of innovation activities, which could however arise in the future. 
According  to  the  preliminary  findings  in  the  same  study  cited  above,  in  spite  of  forcing 
reallocation of resources to compliance for a significant share of companies, REACH has also 
increased  activity  in  R&D  for  26%  of  all  companies.  Indeed,  an  increase  in  knowledge  of 
chemical  substances  and  awareness  of  needs  of  upstream  and  downstream  actors  in  value 
chains was reported by a significant share of respondents to a questionnaire, and about a fifth 
of  respondents  indicated  that  they  had  launched  new  products  or  services  as  a  result  of 
knowledge gained through the compliance process. Costs due to the registration process have 
resulted in withdrawal of substances for 30% of the respondents; however, among these, half 
have  increased  their  R&D  activity  to  identify  alternative  substances  to  use,  and  between  25 
and  33%  have  changed  their  manufacturing  processes  in  order  to  avoid  the  use  of  those 
substances.  The  REACH  Review  concluded  that  information  generated  for  the  registrations 
provide inspiration for the innovative use of existing substances and that REACH has had a 
positive impact  on research into new substances.  The survey of nanomaterial  manufacturers 
and importers (ca. 15%  with  actual experience implementing REACH) highlighted REACH 
and CLP, alongside other reasons such as value chain readiness problems and lack of capital, 
to have negatively influenced time-to-market of nanomaterials, which might indicate shifts of 
resource  allocations  and  loss  of  the  momentum  in  gaining  market  shares  for  innovative 
applications95.  The  BiPRO  study  mentions  that  impacts  on  innovation  from  requirements 
related  to  substances  with  nanoforms  could  also  arise  in  different  directions,  with  increased 

92  Monitoring  the  Impacts  of  REACH  on  Innovation,  Competitiveness  and  SMEs,  CSES/RPA/Okopol,  
http://ec.europa.eu/DocsRoom/documents/14581/attachments/1/translations/en/renditions/native&usg=AFQjC
NH4hu-0KJUtY0QyMvRSptk6jZnmow&sig2=xs3I5pBS91RMrXfBuNjvlw  

93 REACH – Further work on impact assessment. A case study approach, Final report, KPMG, July 2005 
   http://ec.europa.eu/enterprise/sectors/chemicals/files/reach/kpmg_final_report_en.pdf   
94  Interim  Evaluation:  Impact  of  the  REACH  Regulation  on  the  innovativeness  of  the  EU  chemical  industry, 

Final Report and Annexes, Centre for Strategy & Evaluation Services (CSES), 14 June 2012  
http://ec.europa.eu/enterprise/sectors/chemicals/documents/reach/review2012/innovation_en.htm 

95 Study on REACH contribution to the development of emerging technologies, October 2012 
    http://ec.europa.eu/enterprise/sectors/chemicals/documents/reach/review2012/emerging_technologies_en.htm  

47 

 
 
                                                 
knowledge as a possible driver of positive future impacts. Again, limitations in available data 
allow only a qualitative analysis. 

Several measures aiming at improved clarity, especially in options 2 and 5, would allow better 
tailoring of the nanoform specific measures on the key aspects of hazard, exposure and risk 
assessment  in  REACH.  Further  measures  reducing  obligations  for  nanoforms,  such  as  in 
option 5, might sometimes facilitate access to market for innovative SMEs; on the other hand, 
the reduced knowledge base or scientifically supported safety information could even impede 
innovation and market access.  

Options  implying  an  increase  of  requirements,  such  as  options  4  and  6  (and  depending  on 
where  the  baseline  is,  also  option  2),  would  entail  both  positive  and  negative  impacts  on 
innovation. On one hand, an increase in fixed costs could hamper innovation, as compliance 
costs  would  take  away  resources  that  could  otherwise  be  devoted  to  R&D  activities.  This 
negative  effect  would  be  even  stronger  if  costs  would  reduce  the  financial  viability  of  a 
number  of  SMEs  working  with  nanotechnologies.  On  the  other  hand,  testing  requirements 
would in the medium and long term increase the knowledge base in the sector with regard to 
the characteristics of nanomaterials, possibly facilitating their employment in new avenues for 
innovation  in  nanotechnologies.  Please  refer  to  Appendix  XI  for  a  table  summarising  an 
assessment performed by Matrix on the capacity to innovate under the different options. 

To  facilitate  innovative  SMEs  developing  nanomaterials  would  contribute  to  the  long-term 
competitiveness  and  employment  in  Europe.  However,  given  several  indicators  of  drivers 
pulling in different directions and the general absence of data, a conclusive assessment of the 
effects of any of the options’ impact on innovation cannot be made. 

5.2.4  Competitiveness, trade and investment flows 

The  effects  on  the  competitiveness  of  EU  firms  operating  with  nanomaterials  could  be 
twofold.  On one hand, increments in  costs would potentially harm the ability to  compete in 
international markets. On the other, regulatory certainty, improvements in the knowledge and 
exchange of information could instead bolster competitiveness.  

In the context of this assessment building on an established regulatory framework, EU based 
companies using nanoforms in the production of articles may be in disadvantage as compared 
to  importers  and  non-EU  companies,  since  these  are  not  subject  to  the  REACH  registration 
obligation  when  the  nanomaterial  is  integrated  within  an  article  (unless  Article  7(2)  of 
REACH96 applies). EU based firms manufacturing nanomaterials will also be affected when 
competing with third country companies outside the EU territory. This is so because REACH 
is  also  applicable to  the manufacture of products  exported out  of the EU territory. With the 
exception  of  Australia97,  the  EU’s  main  trading  partners  tackle  nanomaterials  through  their 
existing chemicals legislation. Unlike in the EU, this most often means that new substances 
are  subject  to  (limited)  notification  requirements  prior  to  their  placing  on  the  market  while 
existing substances are subject  to  measures only  when the authorities have gathered enough 
evidence  to  introduce  measures.  For  example,  the  US-EPA  has  interpreted  that  some 

96  If  a  substance  is  identified  as  being  of  very  high  concern,  obligations  apply  as  to  the  identification  of  its 

presence in products, including imported ones. 

97 Australia has introduced specific rules on the use of nanomaterials in cosmetics. 

48 

 
 
 
                                                 
nanomaterials represent  ‘new uses’ triggering in  some cases further testing requirements for 
companies98. 

Given  the  general  absence  of  data  to  underpin  a  quantitative  conclusive  assessment  of  the 
effects  of either of the options’ impact  on competitiveness,  trade and investment  flows, this 
analysis is based upon the qualitative assessment provided by Matrix99. Accordingly, options 
2 and 3 are likely to impact negatively in the short term in the cost of production and possibly 
affect  manufacturers  or  downstream  users  of  substances  with  nanoforms;  however,  the 
options would at the same time decrease the cost of capital in the long  term due to reduced 
uncertainties and would increase the market shares of companies due to a higher confidence 
in the products containing their nanomaterials. By reason of a probable increment of the costs 
of  production  with  regard  to  options  2  and  3,  the  negative  impacts  on  competitiveness  of 
option 4, and even more that of option 6, are likely to outweigh the increase in the confidence 
of the products containing nanomaterials. Finally, option 5 would, disregarding the negative 
impact  of  reduced  confidence  in  products  themselves,  help  decrease  the  cost  of  production, 
allowing  the  entry  into  the  market  of  new  operators,  which  would  result  in  stronger 
competition and hence would presumably result in a reduction of prices of the final products; 
this would eventually allow improving the international competitiveness of EU firms. 

5.3 

Health impacts 

5.3.1 

Introduction 

It  is  a  challenge  to  estimate  the  health  impacts  associated  with  chemicals  in  general:  their 
intrinsic properties are not a priori known for such an analysis (that is the purpose of testing 
under REACH); nor are they easily translated into dose-response functions, not least because 
exposure depends on the way in which they are used. Given this it is even more difficult to 
monetise the benefits. 

The most direct health and safety impact affect the workers handling nanomaterials. Control 
of risks and exposures is dependent on the level of information available.  

Most  of  the  health  benefits  are  expected  to  take  place  with  significant  delays  after 
implementation  of  appropriate  measures.  This  is  also  because  enhanced  protection  of 
workers’  safety  will  not  automatically  occur  as  a  consequence  of  the  measures  taken  with 
regard to the REACH registration requirements, but will only be achieved if appropriate risk 
reduction  measures  are  implemented  based  on  the  information  contained  in  the  registration 
dossiers, which in turn can lead to additional costs. 

There is a priori a lower risk for potential danger for the final consumer, in comparison with 
workers,  because  workers  will  experience  higher  levels  of  exposure  during  manufacturing 
processes involving nanomaterials. Health impacts are, therefore, likely to be smaller than in 
relation to occupational health. 
More than 99% of the calculated health benefits of REACH refer to avoided cancer deaths100. 
However, for nanomaterials it may be relevant to refer to costs from other diseases, especially 

98 See http://www.epa.gov/oppt/nano/ for general approach, and 

https://www.federalregister.gov/articles/2015/02/02/2015-01721/significant-new-use-rules-on-certain-
chemical-substances for an individual example of decision on premanufacture notice P-13-573 including 
carbon nanotubes, as restrictions are set on use prior to the submission and analysis of specific tox and ecotox 
information.  

99 Please refer to Annex XI for a table summarising the impacts on competiveness based on qualitative analysis. 
100 Assessment of the Impacts of the New Chemicals Policy on Occupational Health, RPA, June 2003 

49 

 
 
                                                 
 
irritation,  oxidative  stress  and  genotoxicity.  In  any  case,  the  majority  of  health  benefits 
expected  to  be  delivered  by  the  measures  discussed  in  the  impact  assessment  will  occur 
between 2022 and 2042, due to  the latency  of health risks and the consecutive extension of 
life years lost. 

Two studies have recently been conducted and a third one is currently ongoing, which are not 
directly  linked  to  nanomaterials  or  the  assessed  options,  but  rather  to  the  assessment  of 
benefits of better information on chemicals and the environmental legislation in general:  

  A  recent  report  by  RPA  and  CSES  on  the  potential  extension  of  the  registration 
requirements  for  substances  manufactured  or  imported  between  1  and  10  tonnes  per 
year101 assesses the costs and the benefits of different options for the modification of 
the  information  requirements  for  substances  registered  in  the  1-10t  band.  The  study 
assesses the benefits, expressed in terms of damage costs avoided, on the basis of the 
avoidance of one incidence of ‘disease’ per year per substance identified with a human 
health  classification  and  improvement  in  1  km  of  waterbody  for  every  substance 
identified  with  a  classification  for  aquatic  toxicity.  The  study  concludes  that  the 
baseline  scenario  provides  €10.02  benefits  for  every  €1.00  of  cost  and  that  by 
increasing  the  information  requirements,  there  is  a  roughly  proportionate  increase  in 
benefit in terms of damage costs avoided. Note that the assessment of the baseline cost 
was  made  for  bulk  substances  and  concerns  only  the  information  requirements 
relevant for 1 – 10 tonnes per year, with similar assumptions regarding cost per bulk 
substance as done in the analysis above for the nanoform or set of nanoforms. 

through  economic,  environmental  and  health  benefits,  according 

  Another  study  compared  the  costs  and  benefits  of  environmental  regulation  in  the 
UK102. According to this study, the cost benefit of environmental regulation in the UK 
has  increased,  with  every  £1  spent  on  compliance  and  enforcement  returning  £3  to 
society 
to 
government  research.  The  environment  ministry  quantified  the  costs  and  benefits  of 
428  of  its  regulations  affecting  UK  businesses,  just  over  half  of  which were  derived 
from  EU  or  international  legislation.  The  total  estimated  direct  cost  to  business 
between 2012 and 2021 will be £6bn, of which 86% is related to compliance and 14% 
to  administrative  burden.  The  estimated  direct  benefit  to  business  is  £2bn  a  year, 
giving  an  estimated  net  cost  of  £4bn.  But  the  wider  benefit  of  regulation  to  parties 
other  than  business  is  about  £10bn  a  year.  Chemicals  legislation,  almost  exclusively 
based on EU regulation, provided the best cost benefit ratio of almost 1 to 20. 

  The DG GROW study referred to in section 5.2.3 Innovation and research shows that 
around 53% of companies have improved their risk management procedures because 
of REACH, with  personal  protection equipment and new safety instruction indicated 
with  more  frequency.  When  distinguishing  by  the  role  of  the  company  within  the 
supply  chain,  51%  of  manufacturers  and  70%  of  formulators  changed  their  risk 
management  measures;  these  shares  decrease  going  down  the  supply  chain  but  still 
remain  relatively  high  (from  48%  for  distributors  to  27%  for  suppliers  of  articles). 

http://ec.europa.eu/environment/chemicals/reach/pdf/background/envhlthimpact.pdf  

101  Technical  assistance  related  to  the  review  of  REACH  with  regard  to  the  extension  of  the  registration 
tonnes  per  year 

for  substances  manufactured  or 

imported  between  1  and  10 

requirements 
(ENV.A.3/SER/2013/0057r) 

102  The  costs  and  benefits  of  Defra's  regulations,  2015  https://www.gov.uk/government/publications/the-costs-

and-benefits-of-defra-s-regulations  

50 

 
 
                                                                                                                                                         
This  is  an  important  finding  and  certainly  constitutes  a  positive  economic  effect: 
various studies  have concluded that expenditure on occupational  safety and health is 
an  investment  that  “pays  off”  and  calculated  the  Return  on  Prevention  (ROP)  to  be 
2.2103 or the Benefit-Cost Ratio to be between 1.04 and 2.70104.  

In  summary,  while  there  are  many  indications  that  health  benefits  are  to  be  expected  as  a 
result  of  better  information  availability  for  registered  substances  with  nanoforms,  it  has  not 
been  possible  to  quantify  all  the  potential  benefits  that  are  expected  to  occur  as  a  result  of 
introducing the various options examined in this impact assessment. The analysis that follows 
is thus based mainly on a qualitative assessment of each of the options.  

5.3.2  Option 1 

Public  Consultation:  It  can  be  deduced  from  the  overwhelming  majority  of  respondents 
indicating a need for change and the majority (51%) supporting the measures under option 2 
(which are also part of options 4 and 6) leading to increased information on potential health 
hazard of nanoforms, that 'no change' does not score high in relation to safety. 

Analysis: Even if it is expected that, depending on the outcome of the pending appeal cases 
concerning  the  ECHA  compliance  check  decisions  (see  2.2.3  Initiatives  undertaken),  over 
time  the  availability  of  information  for  substances  with  nanoforms  will  improve  via  the 
control  mechanisms  foreseen  in  REACH  (i.e.  moving  towards  a  similar  situation  as  under 
option  2  in  the  medium/long  term),  option  1  may  entail  risks  for  the  health  of  workers  and 
consumers in  the short/medium term,  leading to  potential long term  impacts  (see discussion 
on cancer above). 

5.3.3  Option 2 

Public Consultation: In the public consultation, the majority of respondents (51%) considered 
the implementation of measures under option 2 (which are also contained in options 4 and 6) 
in their preferred option. Its measures also rank first in relation to the contribution to safety. 

Analysis: Enhanced clarity can improve the effectiveness of current information requirements 
to  generate  relevant  information  leading  to  adequate  risk  management,  delivering  health 
benefits. This is the case, for instance, from the additional information about the nature of the 
nanoform being tested, established under measure 2, or the requirement that the nanoform is 
specifically  addressed  (measure  3),  but  especially  from  the  requirement  of  identification  of 
uses and exposure assessment for the nanoform (measure 9). 

Overall, this option would entail positive impacts on occupational health safety.  

5.3.4  Option 3 
Public Consultation: In public consultation, this option ranked 4th in the safety category.  

Analysis: Depending on the legal interpretation of present information requirements, the “soft 
law”  approach  would  have  similar  health  effects  than  those  for  option  2,  although  slightly 
lower,  and  with  longer  delays,  similar  to  what  has  been  described  for  option  1.  This  is 
expected to be so because, compared to option 2, guidance and the other accompanying soft 

103  Calculating  the  international  return  on  prevention  for  companies.  Costs  and  benefits  of  investments  on 

occupational safety and health. DGUV. 2013 
http://publikationen.dguv.de/dguv/pdf/10002/23_05_report_2013-en--web-doppelseite.pdf  
104 Socio-economic costs of accidents at work and work-related ill health, DG EMPL, EC, 2011 

http://ec.europa.eu/social/BlobServlet?docId=7416&langId=en  

51 

 
 
                                                 
law measures contained in option 3 are not as binding as formal requirements in the legal text, 
and  therefore  companies  may  not  be  as  inclined  to  adapt  their  registration  practices  to 
nanomaterials  specificities.  Moreover,  the  ECHA  evaluation  process  is  assumed  not  to  be 
sufficient on its own to ensure an immediate implementation by companies. 

5.3.5  Option 4 

Public  Consultation:  More  than  40%  of  the  respondents  considered  implementation  of 
measures  under  option  4  (i.e.  measures  listed  under  options  2  and  4  combined)  in  their 
preferred option. Its measures rank second in relation to the contribution to safety. 

Analysis:  This  option  entails  an  important  increase  in  requirements  beyond  option  2. 
Measures requiring data on dustiness (measure 10), route of exposure (measure 11) and non-
bacterial  in  vitro  gene  mutation  study  (measure  13)  could  potentially  entail  significant 
improvements in occupational safety, especially in terms of prevention of lung cancer, as they 
would increase information on exposure to hazardous substances. Those health impacts would 
affect  workers  in  the  chemical  sector  but  also  those  in  downstream  sectors  using 
nanomaterials. Benefits would also indirectly affect employers, as they are legally responsible 
for workplace safety and have to conduct risk assessments for their workers, as specified by 
the European Framework Directive 89/391/EC.  

5.3.6  Option 5 

Public Consultation: this option ranked last in the safety category.  

Analysis: This option could potentially entail a higher risk of disease for workers due to the 
fact that less information for risk assessment will be available. The considerations developed 
for option 4 in terms of reduction of risk, in particular in relation to lung cancer, are reversed 
here. While there is no clarity with regard to actual risks in relation to nanoformcompared to 
bulk  chemical,  this  option  could  allow  potential  dangers  to  materialise.  For  instance,  the 
omission of mutagenicity and acute toxicity tests in lower tonnages could result in missing the 
identification of adverse health impacts (e.g. cancer) and possibility of accidental death from 
acute exposure. 

5.3.7  Option 6 

Public  Consultation:  this  option  ranked  third  in  relation  to  the  contribution  to  safety,  after 
options 2 and 4. 

Analysis:  As  a  consequence  of  its  increased  information  requirements,  option  6  further 
reinforces  the  prevention  of  occupational  diseases.  Additional  requirements  related  to 
toxicokinetics  (measure  51),  physico-chemical  characterisation  (measure  44)  and  separate 
documentation  for  each  nanoform  (measure  45)  can  enhance  the  informational  benefits  of 
testing. Establishing inhalation as the appropriate route of exposure in repeated dose toxicity 
study unless such exposure can be excluded (measure 50) can help  protect  from  cancer and 
respiratory diseases. 

5.4 

Environmental impacts 

5.4.1 

Introduction 

The UK study mentioned above in section 5.3  Health impacts, also points to environmental 
benefits  arising  from  the  cost  spent  on  environment  legislation.  A  study  conducted  by  a 

52 

 
 
consultant105 identified several ways in which REACH can reduce the discharge of chemicals 
into the environment, which is confirmed by the provisional results from the study on impacts 
of  REACH  on  innovation,  competitiveness  and  SMEs  (see  section  5.2.3  Innovation  and 
research), according to which around 39% of companies have improved their management of 
environmental emissions and waste due to REACH.  

The impacts on the environment are however hard to quantify. This is mainly due to the lack 
of meaningful reference systems, i.e. ecosystems that are small enough to be useful while not 
being too simplistic to transfer the results to more commonplace, larger ecosystems. One way 
to  assess  the  benefits  of  measures  (and  regulation  in  general)  is  to  evaluate  the  ability  to 
identify  (and  where  necessary  to  manage)  chemicals  that  are  hazardous  to  the  environment: 
aquatic  toxicity  and  persistence,  bioaccumulation  and  toxicity  (PBT)  are  the  most  common 
indicators  that  have  been  picked  also  in  the  ESTAT  REACH  Baseline  study106  and  recent 
RPA and CSES study107.  

Nanoforms  should  be  considered  as  any  other  forms  of  chemical.  Possible  impacts  range 
from:  probably  insignificant  dissolution  or  immediate  agglomeration  and  precipitation,  to 
persistence in ecosystems and organisms with genetic and morphologic consequences as well 
as  potentially  different  susceptibilities  depending  on  species.  There  is  already  evidence  of 
specific  nanomaterials  in  the  environment  and  their  impact108  and  SCENIHR  recently 
delivered  an  opinion  which  included  an  assessment  of  the  environmental  impact  of  one 
specific  substance  with  nanoforms  (nanosilver)109.  More  comprehensive  work  has  recently 
been concluded110, however it is considered that extrapolation from the scarce information on 
the  few  specific  nanomaterials  available  at  present  is  more  appropriate  than  drawing 
conclusions  from  the  environmental  impacts  of  chemicals  in  general.  The  analysis  is, 
however, limited to a qualitative discussion. 

As regards the public consultation, the ranking on safety did not differentiate between health 
and environmental impacts and the conclusions summarised in the chapter on health above are 
not  repeated.  It  should  be  noted  that  apart  from  the  two  more  general  measures  related  to 
environment (option 4, measure 14 on water solubility, option 6, measure 44 on consideration 
of  modification  of  hazard  along  the  life  cycle),  environmental  measures  scored  marginally 
lower in importance to safety than those related to health.  

5.4.2  Option 1 

In  analogy  to  consideration  on  health  impacts  and  depending  on  the  outcome  of  the  appeal 
11/2014 (see 3.2 Specific objectives), over time the availability of information for substances 
with nanoforms is expected to improve via the control mechanisms foreseen in REACH (i.e. 
moving towards a similar situation as under option 2 in the medium/long term), option 1 may 

105  DHI  (2005):  “The  impact  of  REACH  on  the  environment  and  human  health”,  ENV.C.3/SER/2004/0042r, 

report to DG Environment 

106 For latest see "The REACH Basline Study, 5 years update" 

http://ec.europa.eu/eurostat/documents/3888793/5851097/KS-RA-12-019-EN.PDF 

107 See reference in 5.3.1. 
108  See  for  example  "  Environmental  and  health  effects  of  nanomaterials  in  nanotextiles  and  façade  coatings", 

March 2011 http://www.ncbi.nlm.nih.gov/pubmed/21397331  

109 See  "Opinion on Nanosilver: safety,  health and environmental effects and role in antimicrobial resistance", 

SCENIHR, 2014; http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_039.pdf  

110 See for example NanoFATE project under FP7 http://www.nanofate.eu  

53 

 
 
                                                 
 
entail risks for the environment in the short/medium term with potential long term impacts in 
case of persistent nanoforms. 

5.4.3  Option 2 

Specification  under  this  option  improves  the  information  derived  from  tests  or  alternative 
methods  such  as  read-across,  which  will  enable  positive  impacts  in  terms  on  environmental 
protection. This is the case, for instance, for measure 3 (and related measure 7) requiring that 
environmental endpoints are addressed specifically for nanoforms. More precise information 
related  to  nanoforms  will  generate  more  accurate  information  that  can  lead  to  a  better 
functioning of the Regulation on Classification, Labelling and Packaging of Chemicals, which 
is  the  key  legislation  used  to  trigger  action  in  downstream  environment  legislation  on  e.g. 
waste and water.  

5.4.4  Option 3 

The “soft law” approach would have similar effects than those for option 2, although slightly 
lower and with delay, similar to what has been described for option 1, and depending on the 
legal  interpretation  of  the  current  REACH  requirements.  It  is  reasonable  to  assume  that 
compared to option 2, some adverse impacts on the environment may occur as they will not 
be  addressed  immediately.  Some  companies  will  not  follow  guidance  or  voluntarily  follow 
best  practices  identified  by  others  and  not  all  registration  dossiers  will  be  subject  to  ECHA 
evaluation. 

5.4.5  Option 4 

Similarly  as  for  health  impacts,  requirements  under  option  4  provide  further  concrete 
measures in addition to also implemented option 2 clarification measures to adequately assess 
hazard  to  the  environment  and  thus  limit  any  potential  risk.  Measure  15  (specification  that 
long  term  testing  should  not  be  waived  based  on  lack  of  short  term  toxicity)  contributes  to 
preserve  wildlife,  measure  17  (requiring  that  testing  on  soil  and  sediment  organisms  is 
conducted already for low tonnages) and measure 16 (preventing the waiving of algae testing 
based on insolubility) help preventing harm for cases where nanoforms might end up in the 
aquatic environment, while measure 13 (requiring non-bacterial in vitro gene mutation study), 
provides information regarding toxicity to mammalian wildlife and agricultural animals.  

5.4.6  Option 5 

The  reduced  information  required  pertinent  to  nanoforms  of  a  substance  might  generally 
increase  the  risk  to  the  environment,  in  particular  due  to  measure  32,  which  excludes  an 
obligation  to  provide  any  ecotoxicological  or  environmental  fate  information  specifc  to  the 
nanoform or set of nanoforms.  

5.4.7  Option 6 

This  option  provides  limited  additional  protection  to  the  environment,  in  comparison  with 
option  4.  Measures  42  and  44  increase  test  relevance  as  they  augment  knowledge  on 
nanoform fate and transformation through the life-cycle, while measures 39, 40 and 45 help 
protecting environmental harm through imposing separate documentation for each nanoform.  

5.5 

Animal testing 

The table 5-1 below includes a rough estimation of the cumulative number of animals used for 
the testing of one nanofom or set of nanoforms, using assumptions on the average animal use 

54 

 
 
per test from a report made by the JRC111 and the same assumptions as in section 6.2 on the 
generation of information via alternative means. One can observe that the main impact stems 
from measures under option 2. The impact of additional measures under option 4 is marginal 
while under option 6 they are more significant. As expected, animal use is lower in option 5 
as the obligation to have information relevant to the nanoforms or set of nanoforms is waived 
by several measures. 

Table  5-3:  Animal  use  per  option  per  nanoform  (or  set  of  nanoforms),  use  of  alternative  methods 
considered possible, with default assumptions (see Appendix XIII): 

1 

1a 

Estimated 
baselined 

2 

3 

4 
(includin
g  2) 

5 

6 
(including 
2 and 4) 

>1000 tonnes 

100-1000 tonnes 

10-100 tonnes 

1-10 tonnesb  

118 

1178 

1178 

1178 

1178 

1182 

154 

1076 

1076 

1076 

1076 

1081 

97 

2 

80 

485 

9 

613 

485 

485 

485 

9 

9 

9 

496 

16 

613 

613 

613 

619 

301 

1288 

600 

577 

97 

2 

2463 

2195 

835 

128c 

Weighted Average 
a The column represents animal use for bulk form registration, which can be directly compared with the other 

estimates under REACH 

b  For  the  1-10  tonnage  band  animal  testing  is  required  only  for  phase-in  substances  that  fulfil  the  Annex  III 
conditions;  therefore,  for  most  substances  no  information  requirements  beyond  physico-chemical  properties 
are requested, apart from option 6 (due to measure 41) 

c  Indirect impact of measure 41: 8 additional animals. See Appendix XIII for details 
d  Estimated baseline consequent to Board of Appeal Decision 2 March 2017(see discussion in section 4.9).  

Table 5-4: Total estimated animal use per option (in thousands): 

1a 

Estimated 
baselined 

2 

3 

4  
(including 
2) 

5 

6 (including 2 
and 4) 

54 

85 

24 

2 

542 

595 

121 

7 

542 

542 

595 

595 

121 

121 

7 

7 

544 

598 

124 

12 

276 

319 

24 

2 

165 

1266 

1266 

1266 

1278 

621 

1133 

1214 

209 

102c 

2658c 

>1000 tonnes 

100-1000 tonnes 

10-100 tonnes 

1-10 tonnesb 

Total 

111 Numbers are primarily used from the JRC report: 

http://publications.jrc.ec.europa.eu/repository/bitstream/JRC29111/EUR%2021405%20EN.pdf. 

55 

 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
 
a  Only one number is used to represent option 1, assuming that, whether sufficient for risk assessment or not, at 
most one test is performed per substance per information requirement, regardless of the number of nanoforms 
the registration of that substance includes 

b  Weighted average 
c  Estimated  indirect  impact  of  Measure  41:  4387  animals  (4.3%  of  use  in  1-10t  tonnage  band,  0.1%  of  total 

estimated use). See Appendix XIII for details 

d  Estimated baseline consequent to Board of Appeal Decision 2 March 2017(see discussion in section 4.9). 

5.6 

Classification and Labelling (CLP) 

Depending on the changes to be made in the Annexes of the REACH Regulation (in particular 
Annex VI), the changes would affect not only the registration requirements as analysed above, 
but also the requirements under the CLP Regulation and Annex II of REACH in relation to 
the communication in the supply chain via Safety Data Sheets for the registered substances or 
certain nanoforms thereof. As expected by the main objectives of REACH, the changes would 
have  a  ‘domino  effect’  with  impacts  on  the  implementation  of  the  CLP  Regulation  (and 
subsequent  regulation  relying  on  CLP),  communication  in  the  supply  chain  via  Safety  Data 
Sheets in general and even in view of companies operating with substances with nanoforms in 
volumes  of  less  than  1  tonne  per  year,  as  well  as  to  the  chemical  safety  assessment  by 
downstream users. This is because the provisions of the CLP Regulation require the notifiers 
of  hazardous  substances  to  the  C&L  Inventory  to  notify  to  ECHA  the  information  on  the 
identity  of  the  substance  as  required  under  sections  2.1  to  2.3.4.  of  Annex  VI  to  REACH, 
based on the available information and taking into account different classification for different 
forms. There are no requirements to generate information, but it is expected that any available 
information (that will become available as a consequence of the implementation of the options 
examined in this impact assessment) is acted upon also under CLP.  

For the purpose of this impact assessment, none of these impacts are explicitly entered under 
cost,  as  they  are  considered  'business  as  usual',  i.e.  standard  implementation  of  the  CLP 
Regulation which relates to any increase in available information and is not nanomaterial or 
REACH Annexes modification specific.  

5.7 

Summary of the impacts 

5.7.1  Option 1 

With  more  companies  and  more  specialised  substances  with  nanoforms  being  subject  to 
REACH registration in the coming years, maintaining the status quo is expected to give rise 
to  further problems similar to  those already identified in  the submitted registration dossiers. 
Mitigating factors are ECHA’s and the Member States’ evaluation processes (note that legal 
interpretation of some important aspects of present information requirements or the ability to 
request  certain  information  under  REACH  are  presently  under  appeal)  and  the  general 
learning process in the private sector on what REACH entails.  

Overall it is expected that the no-action scenario will maintain uncertainties among companies 
which  could  reduce  the  appetite  in  innovating  in  the  nanomaterial  sector.  Coupled  with 
question marks about whether REACH provides an adequate answer to the safety assessment 
needed for nanoforms this option may not only lead to a suboptimal protection level but may 
also  be  bad  for  business,  both  at  the  micro  economic  level  and  viewed  from  a  broader 
perspective on the ability to embrace new technologies and products. The public consultation 
also established very neatly that the current system is not clear, hence almost all actors agree 
on the need to do something. 

56 

 
 
 
5.7.2  Option 2 

Under this option firms  must register nanoforms and are expected to incur significant costs. 
The biggest cost in this option is associated with the 'characterisation' of the nanoforms and 
the  characterisation  of  test  samples  used  to  fulfil  information  requirements  for  nanoforms. 
However, as explained in earlier parts of this impact assessment, without this information it is 
not  possible  to  determine  what  is  covered  by  the  registration  dossier,  nor  determine  the 
relevance  of  the  test  results  that  have  been  used  to  claim  the  safe  use  of  the  registered 
substance  with  nanoforms.  It  is  important  to  stress  that  the  measures  under  option  2  are 
already  considered  as  present  compliance  requirements  by  ECHA  as  an  indispensable 
requirement  in  order  to  deliver  the  'case-by-case'  assessment  broadly  recommended  by 
science.  Based  on  the  outcome  of  the  appeal  case  on  ECHA’s  compliance  check  decisions 
(see 2.2.3 Initiatives undertaken and 4.9 Industry appeals to ECHA decisions on registration 
of  substances  with  nanoforms),  some  of  the  costs  may  thus  be  incurred  also  under  option 1 
through a lengthy and resource-intensive process of ECHA requesting additional information 
from registrants. A key benefit of option 2 is to shorten this process, make it more effective 
and providing upfront clarity to registrants on what needs to be included in the dossiers when 
assessing  nanoforms  of  a  substance.  Although  SMEs  may  be  disproportionately  affected  as 
compared  to  larger  companies,  this  option  requires  essential  information  for  demonstrating 
safe use.  

The clearest benefits compared to option 1 would come from the enhanced clarity in terms of 
which  information  is  required  for  the  registration  of  nanoforms  and  the  correspondingly 
better, targeted and quicker information to protect human health and the environment. It could 
also help reduce the uncertainty amongst downstream users where information suggests some 
reluctance  to  accept  nanomaterials  where  they  can  be  avoided.  Most  importantly,  the 
overarching  aim  of  REACH  registration  of  demonstrating  safe  use  will  be  helped  by  the 
introduction of these measures. 

Generating  relevant  information  on  nanoforms  or  sets  of  nanoforms  may  at  present,  as  for 
substances in general, still require significant use of animals, even when assumptions on use 
of alternative information (QSAR, read-across, grouping) are made.  

Overall,  it  can  therefore  be  concluded  that  the  introduction  of  the  measures  in  option  2 
represent  a  good  trade-off  between  the  costs  and  the  potential  benefits.  It  has  been  marked 
with  the  highest  efficiency  and  safety  score  in  the  public  consultation  with  a  majority  of 
respondents (51%) supporting the measures in their preferred option. Furthermore, the option 
is coherent with the tiered information requirements foreseen in REACH (i.e. the higher the 
volume for which a substance is registered, the more information has to be provided). 

5.7.3  Option 3 

REACH is already today supported by thousands of pages of guidance ranging from general 
ECHA  guidance  that  has  gone  through  a  rigorous  approval  process  involving  all  the 
stakeholders of relevance to the particular guidance to FAQs that can address very particular 
technical needs where doubt may arise. 

Since  April  2012,  the  ECHA  guidance  has  already  been  complemented  with  appendices 
containing specific guidance of relevance to registration of nanoforms of substances, with the 
last update in May 2017. The foundation for this guidance was the comprehensive RIPoN that 
was  initiated  by  the  Commission  in  collaboration  with  ECHA  in  2009,  as  well  as  further 
research work and implementation experience. 

57 

 
 
This  impact  assessment, largely backed by the views expressed by most  stakeholders in  the 
public consultation, supports the conclusion that, while better guidance always should remain 
a goal as such, only relying on these non-legislative initiatives may not deliver the objectives 
this project aims to achieve or, would only deliver with a certain delay. This being said, there 
will  be  a  need  for  reviewing  the  existing  guidance  where  it  is  relevant  in  function  of  the 
changes that may be introduced following this initiative. As has been the case before, this will 
be  done  in  an  inclusive  manner  to  ensure  broad  consensus.  This  secondary  introduction  of 
revised  guidance once REACH has been modified will obviously have beneficial effects  on 
all the objectives. In terms of animal use and depending on the legal interpretation for current 
requirements (see discussion for option 1 and 2 above) this option would be in the range of 
option 2. The option is coherent with the tiered information requirements foreseen in REACH.  

5.7.4  Option 4 

The measures in this option would introduce additional obligations over and above option 2 
and  what  today  is  possible  to  request  pursuant  to  REACH  in  a  normal  registration  dossier 
except  for  cases  where  a  substance  has  been  selected  for  substance  evaluation  where 
additional data can be requested. 

The  measures  are  based  on  scientific  recommendations  on  what  is  relevant  to  pay  special 
attention to as regards nanomaterials, in addition to the information that is already asked for in 
REACH.  Most  measures  were  already  identified  by  the  RIPoN  as  scientific/technical 
recommendations  and  later  brought  forward  as  proposals  for  measures  under  the  Nano 
support project.  

In REACH providing data for several endpoints can be waived based on 'water solubility'. As 
water solubility has been identified as an inappropriate basis for waiving for many nanoforms, 
the  consequence  in  this  option  is  that  all  current  waivers  building  on  that  information  may 
also not be appropriate and cannot automatically be used for nanoforms. This option will thus 
require that registrants generate more information than today either by developing additional 
justification why the already existing data is relevant and adequate, or performing the test. 

Furthermore  there  are  measures  that  will  require  additional  tests  in  lower  volume  bands  for 
nanoforms  compared  with  option  2.  This  has  cost  implications  that  have  a  relative  higher 
weight for lower volume registration dossiers, and as such impacts SMEs more strongly. At 
the same time these measures are addressing some of the key loopholes of the present hazard 
assessment  when  it  comes  to  particulate  nanoforms  and  thus  also  where  some  of  the  most 
important  health  /  environment  benefits  can  be  achieved.  In  the  public  consultation,  this 
option  was  ranked  second  in  terms  of  safety  as  well  as  efficiency.  Separately,  the  option 
received  high  appreciation  by  the  majority  of  the  respondents  to  a  separate  question  with 
regard to its efficiency as a whole. Some increase in animal use is expected, however with the 
purpose of ensuring that all tests (including animal  tests) contribute with genuinely  relevant 
information for the safety assessment of nanoforms of a substance. 

It is arguable whether the option is coherent with the tiered information requirements foreseen 
in REACH as some of the measures require tests currently only foreseen at higher tonnages 
already for lower tonnages, e.g. where a given tests foreseen at lower tonnages cannot be used 
for nanoforms.  

5.7.5  Option 5 

This  option  has  been  designed  predominantly  with  a  view  to  make  it  less  costly  to  register 
substances with nanoforms, spur innovation and be of help to SMEs. This option contains two 

58 

 
 
sets  of  measures;  measures  aiming  to  provide  clarity  for  registrants  and  measures  reducing 
information requirements and thus compliance burden.  

On  the  cost  side  asking  for  substantially  less  information  for  nanoforms  reduces  the 
registration  cost  for  companies  and  will  reduce  the  number  of  animals  needed  for  testing. 
However, this may have an adverse impact on the demand side due to concerns of accepting a 
higher  risk  for  nanomaterials,  where  already  today  there  is  information  pointing  to  the 
avoidance of nanomaterials by European downstream users. 

The  option  might  increase  the  risks  to  human  health  and  environment,  as  in  particular  the 
second  set  of  measures  exempts  nanoforms  of  substances  from  requirements  applicable  to 
other chemicals, even beyond what can be supported scientifically, so any hazards specific to 
nanoforms will remain undetected. This will most likely lead to more public debate about the 
safety of nanomaterials and further pressures at national level in some Member States to take 
action. In the public consultation, while option 5 scored first in terms of cost, it ranked last in 
terms of safety and third in terms of efficiency. 

It is arguable whether the option is coherent with the tiered information requirements foreseen 
in  REACH,  as  some  of  the  measures  lower  the  requirements  for  nanoforms  of  substances 
registered in a given tonnage band compared to bulk substances without sound justification.  

5.7.6  Option 6 

In addition to the content of options 2 and 4 (for most measures), this option pushes further 
the separation between nanoforms and other forms of the substance in the registration dossier, 
which has impacts on the operation of the registration process under REACH. 

On  the  cost  side,  the  option  will  lead  to  significant  compliance  costs.  The  additional  cost 
stems from significantly increased administrative cost in establishing the dossier in a way that 
effectively means that one dossier is a collection of two or more parallel dossiers. Additional 
costs  are  due  to  the  need  to  generate  more  data  by  conducting  also  some  specific  tests  on 
nanoforms which are not required for substances in general.  

On the benefit side, the option will provide significantly more information for the protection 
of  human  health  and  the  environment  (note  that  much  of  the  benefit  is  due  to  the 
implementation of all measures under options 2 and 4, which are also included in option 6) 
and thereby further reduce any doubt as to the completeness with which the conclusion of safe 
use has been made.  

Due  to  the  measure’s  comprehensive  and  prescriptive  nature  ruling  out  room  for  adaptation 
and  thus  adding  substantial  additional  cost  on  firms,  the  efficiency  of  the  option,  with  the 
exception  of  the  three  measures  41  (reducing  the  exemption  possibilities  for  phase-in 
substances  provided  by  Annex  III),  combined  measures  42/44112  (requiring  consideration  of 
modifications  of  the  nanoforms  during  use)  and  51  (requiring  a  toxicokinetic  screening),  is 
considered low which was identified also by the respondents in the public consultation. 

112 Measures 42 and 44 are considered complementary: M42 outlines documentation of considerations where 
transformation might occur (also for downstream users), while M44 includes cost of physico-chemical 
characterisation of potentially transformed nanoforms. While both are costed, in the text reference is made 
only to measure 42. 

59 

 
 
                                                 
The additional measures under this option increase animal use significantly, in particular due 
to the identification of additional nanoforms requiring assessment and the reduced ability to 
rely on alternative information.  

It is arguable whether the option is coherent with the tiered information requirements foreseen 
in REACH, as some of the measures require tests currently only foreseen at higher tonnages 
already for lower tonnages. 

5.7.7 

Schematic summary 

The following figure illustrates in a schematic way the main impacts of the options: 

Figure 5-1: The main impacts of the options: 

6 

6.1 

COMPARING THE OPTIONS 

Qualitative comparison 

The graph below illustrates how demonstration of safe use for nanoforms of substances would 
be achieved timewise by each of the options. 

60 

 
 
 
Figure 6-1: Demonstration of safe use by the different options: 

*Taking into account the Board of Appeal's decision on the appeal A-011-2014 regarding the compliance 
check on titanium dioxide.  

As  discussed  in  section  4.9,  on  the  basis  of  the  Board  of  Appeal's  decision  in  case  A-011-
2014, option 2 cannot be considered as covered in its entirety by existing REACH information 
requirements. However, the Board of Appeal concludes in its decision in  case the registrant 
defines  the  registered  substance  broadly,  the  hazards  of  all  possible  forms  of  the  substance 
covered  by  the  substance  definition  must  be  addressed  by  that  relevant  toxicological  and 
ecotoxicological information. As already indicated before it is noteworthy that: 

  Option 1 would eventually reach a similar level of demonstration of safe use (but still 

somewhat lower) as option 2, and this would take considerable time;  

  Option 2 would achieve the level set rather quickly after its implementation; 

  Option 3 would achieve the same level as option 1, with a somewhat shorter delay; 

  Options 4 and 6 would go beyond that level rather quickly after their implementation; 

  Option  5  would  result  rather  quickly  after  its  implementation  in  a  higher  level  of 

demonstration of safe use than option 1, but lower than the rest of the options.  

Table  6-1  below  summarises  schematically  the  results  of  the  analyses  in  qualitative  terms. 
The scores indicate whether the impacts are positive or negative compared to option 1. 

Table 6-1: Qualitative summary of the main impacts of the options, per category: 

1. Economic impacts 

1.1 Conduct of business 

  Compliance costs (including administrative burden) 

  SMEs 

  Regulation clarity/certainty 

2 

- 
- 
++ 

3 

- 
- 
+ 

4 

-- 
-- 
++ 

5 

+ 
+ 
+ 

6 

--- 
--- 
++ 

61 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1.2 Innovation and research 

 

Investment in R&D 

  Knowledge 

1.3 Competitiveness, trade and investment flows 

2. Health impacts 

3. Environmental impacts 

4. Animal testing 

2 

0 
++ 
0/- 
++ 
++ 
-- 

3 

0 
+ 
0 
+ 
+ 
-- 

4 

0 
++ 
- 
+++ 
++ 
-- 

5 

0 
- 
+ 
-- 
- 
+ 

6 

0/- 
+++ 
-- 
+++ 
++ 
--- 

Key to the scores applied as compared to the no-change (current practice) scenario: 

--- …   - 
0 
+ … +++ 
N/A 

decreasingly negative / undesirable 
Neutral 
increasingly positive / desirable 
not applicable 

In  conclusion,  all  options  except  option  5  would  provide,  in  different  degrees,  higher 
protection of health and the environment than option 1 - in decreasing order: 6, 4, 2 and 3 -, 
but  with  an  inverse  effect  on  the  conduct  of  business.  Option  5  is  the  only  option  that, 
although having negative effects on human health and the environment, would have positive 
impacts on compliance costs and on SMEs; indeed, although the impacts on SMEs differ for 
each of the options, none of them includes specific mitigation measures, except for option 5 
which provides for a reduction of the requirements for the lowest tonnage registrations where 
more SMEs are active.  Advantages for smaller size companies are already embedded in  the 
general  tiered  information  requirements  of  REACH,  which  establishes  different  level  of 
obligations depending on the tonnage level the substance is registered in, as well as in the fee 
structure that provides for lower registration fees for SMEs.   

6.2 

The choice of the preferred option 

This impact assessment has led to a better understanding of the specific measures contained in 
the  different  options  and  of  the  practical  implications  that  implementing  them  would  have, 
based on repeated discussions with stakeholders, ECHA experts and Member States. Instead 
of  a  simple  choice  between  the  options  as  such,  it  has  therefore  been  considered  more 
appropriate  to  choose  a  combination  from  the  underlying  specific  measures  of  different 
options.  

The choice has thus been made taking into account how each of the  measures addresses the 
causes of the problem (their effectiveness) and how much they cost (their efficiency). Some 
measures  have  been  left  out  as  they  would  not  address  (sufficiently)  the  causes  of  the 
problem, they would be too costly or they are already  covered (partially or totally) by other 
measures.  Furthermore, in order to increase their effectiveness  and their efficiency, some of 
the  measures  have  been  slightly  modified  in  the  preferred  option  compared  to  what  was 
proposed  initially.  These  modifications  have  been  considered  in  the  assessment  of  the 
preferred  option  as  set  out  in  Appendix  XII.  Schematically,  the  approach  to  choose  the 
measures within the preferred option can be illustrated as follows:  

62 

 
 
 
 
 
 
 
 
Figure 6-2: The 3-step decision process to choose the measures within the preferred option: 

Combining the observations from the qualitative comparison in 6.1 above and the conclusion 
of  the  Matrix  study113  that,  based  on  a  multi  criteria  analysis,  option  2  scored  significantly 
higher than any other option, and that there were a number of measures contained within each 
of the other options that deserve attention, it follows that the preferred option needs to be built 
on option 2 by adding specific measures from the other options.  

Considering the scientific and economic evidence at hand, the commitments already made by 
the Commission and the increased pressures from Member States to take action to address the 
concerns associated with the safety of nanomaterials balanced against the interest of ensuring 
a competitive chemicals sector with scope for innovation and growth, the preferred option is 
consequently  a  combination  of  different  measures.  In  the  initial  Commission  proposal,  to 
which most of the information in the report refers to as ‘the preferred option’, these are: all 
measures of option 2, plus six measures of option 4 (measures 10,12,13,14,16,17) and three 
measures from option 6 (measures 41, 42 and 51). The reasoning behind the choice of each of 
the measures is explained in detail in Appendix XII; the summary of the justification for the 
inclusion of the measures within the preferred option is as follows:   

  The preferred option is based on all measures from option 2, with some modifications 

as explained above. 

  The six measures from option 4 have been retained in the preferred option due to their 
appropriateness  in  addressing  the  specific  nature  of  nanoforms  of  a  substance  and 

113 See Appendix X. 

63 

 
 
 
                                                 
considering  their  efficiency;  measures  16  and  17  have  been  modified  in  order  to 
optimise the way they address nanoforms, but without placing an excessive burden on 
companies,  in  particular  those  registering  at  lower  tonnages,  where  also  SMEs  are 
more strongly represented.  

  The  three  measures  from  option  6  have  been  chosen  for  the  clearly  identified  cost 
effectiveness  in  addressing  the  objectives;  measure  41  would  close  the  potential 
loophole  for  nanoforms  of  phase-in  substances  while  maintaining  the  prioritisation 
aspect of Annex III; measure 42 would ensure transparency and increased confidence 
in  the  safety  assessment  along  more  complex  value  chains  of  substances  with 
nanoforms;  measure  51  would  provide  data  on  toxicokinetics  of  nanoforms  for  the 
chemicals  safety  assessment  (only  registrations  above  10  tonnes  per  year),  while 
modification  ensures  that  any  need  for  additional  testing  would  be  scrutinised  via 
testing proposal examination. 

Based on the discussion in  the REACH  committee and some  further concerns  expressed by 
the Member States  on the detail  of the selection of measures, the Commission modified the 
initial  proposal,  following the same overarching  objectives  and the 3-step process  described 
above.  For  detail,  see  table  of  changes  in  Section  9.15.3  in  Appendix  XV.  Beside  several 
changes to the drafting for increased clarity but non-measureable changes in impacts on cost 
or animal  use, the  final Commission proposal as  voted in  the REACH committee includes 
also the following measures: 

  Dissolution rate and dispersion stability are considered as principal physico-chemical 

parameters of nanoforms and are as such explicity expected for all registered 
nanoforms (extended measure 2).  

  For low volume registrations, testing of acute toxicity of nanoforms via inhalation 
route rather than the default oral route (measure 11) has been promoted from the 
recommendation to mandatory requirement.  

Impacts  on  SMEs  have  been  considered  in  selecting  the  measures  in  the  preferred  option. 
Some  of  the  possible  additional  measures  were  fully  excluded,  some  others  modified,  to 
minimise  adverse  impacts.  Some  measures  or  elements  of  them  (in  particular  in  option  5) 
were explored to further minimise impact on SMEs. 

The figure below shows how the preferred option compares to the other options in terms of 
demonstration of safe use for nanomaterials. 

64 

 
 
Figure 6-3: The preferred option compared to the other options: 

6.3 

The costs of the preferred option 

The  assessed  costs  of  the  measures  within  the  preferred  option  (both  the  initial  and  final 
Commission proposal) are reflected in the tables below114, compared to the costs for options 1 
to 6:  

114  Following  the  submission  of  draft  report  to  the  Regulatory  Scrutiny  board  and  the  REACH 
committee in October 2017, a minor calculation error has been identified in the calculation of 
the preferred option, In addition, the assumption on number of toxicokinetic studies that are 
triggered  in  addition  to  the  available  information  as  well  as  the  newly  adopted  subchronic 
inhalation  toxicity  testing  guidelines  TG  412  and  TG413  (with  included  consideration  of 
biokinetics), if performed, has been conservatively reset to 50% of all nanoforms registered in 
volumes  >10  tonnes.  The  numbers  on  cost  and  animal  use  are  therefore  deviating  slightly 
from the tables provided at the time for the preferred option, with ca.3% in cost estimation, 
but do not qualitatively change the assessment. 

65 

 
 
 
 
 
 
                                                 
Table  6-3:  Costs  of  options  per  nanoform,  with  the  preferred  option  (per  tonnage  band,  use  of 
alternative information methods possible) (in thousand Euro): 

1a 

1b 

Estimated 
baselinee 

2 

3 

4 (incl. 2) 

5 

6 (incl. 4) 

Preferred 
Final 
proposal 
(Apr 
2018) 

Preferred 
Initial 
proposal 
(Oct 
2017, 
corrected
*) 

>1000 tonnes 

100-1000 tonnes 

10-100 tonnes 
1-10 tonnes (Full 
Annex VII) 
1-10 tonnes (Only 
Phys-chem) 

1-10 tonnesa 

772 

538 

183 

78 

37 

49 

77 

77 

37 

20 

9 

12 

1049 

1157 

1049 

1256 

458 

2256 

1265 

1294 

770 

334 

162 

62 

91 

814 

359 

187 

87 

116 

770 

334 

162 

62 

91 

939 

471 

249 

91 

137 

375 

1736 

40 

20 

9 

12 

869 

466 

466 

932 

444 

240 

164 

649 

961 

480 

278 

195 

680 

466d 

132d 

161d 

358 

47 

516 

565 

516 

642 

212 

1254 

Weighted Average 
a The column represents the cost for a substance with one (bulk) form, which can be directly compared with the 
majority of REACH registration cost assessments for substances, as the usual assumption in those calculations 
is that one test is performed per substance per information requirement 

b The costs of 1a are divided by an estimated average number of nanoforms or sets of nanoforms for a substance 
c Weighted average 
d Indirect impact of measure 41 on registration of bulk form may bring an estimated additional cost of 10 K EUR 
per  nanoform  of  substance  otherwise  benefiting  from  Annex  III  exemption.  Relative  additional  contribution 
2.2% (option 6) and 8% (preferred option). More details in Appendix XIII 

e  Estimated  baseline  consequent  to  Board  of  Appeal  Decision  2  March  2017(see  discussion  in  section  4.9). 

Option 2 cannot be considered baseline in its entirety.  

Table  6-4:  Grand  total  costs,  with  the  preferred  option  (per  tonnage  band,  use  of  alternative 
information methods possible) (in million Euro): 

1a 

Estimated 
baselinec 

2 

3 

4 (incl. 2) 

5 

6 (incl. 4) 

>1000 tonnes 

100-1000 tonnes 

10-100 tonnes 

1-10 tonnes (Full 
Annex VII) 
1-10 tonnes (Only 
Phys-chem) 

36 

43 

9 

5 

5 

482 

426 

84 

38 

35 

532 

450 

90 

44 

49 

66 

482 

426 

84 

38 

35 

578 

519 

118 

58 

52 

211 

207 

10 

5 

5 

1038 

960 

217 

109 

264b 

Preferred 
Initial 
proposal 
(Oct 2017, 
corrected*) 

Preferred 

Final 

proposal 
(Apr 2018) 

582 

515 

111 

56 

75b 

595 

531 

120 

65 

91b 

 
 
 
 
 
 
1-10 tonnesa 

Total  

10 

73 

93 

73 

110 

10 

373 

131 

156 

107 

1065 

1165 

1065 

1325 

437 

2588 

1339 

1402 

a Note that only one number is used to represent option 1; it assumes that, whether sufficient for risk assessment 
or not, at most one test is performed per substance per information requirement, regardless of the number of 
nanoforms the registration of that substance includes 

b  Indirect  impact  of  measure  41  on  registration  of  bulk  form  may  bring  an  estimated  additional  cost  of  5.8M 
Euro  for  substances  otherwise  benefiting  from  Annex  III  exemption.  Relative  additional  contribution  2.2% 
(option 6) and 8% (preferred option). More details in Appendix XIII 

c  Estimated  baseline  consequent  to  Board  of  Appeal  Decision  2  March  2017(see  discussion  in  section  4.9). 

Option 2 cannot be considered baseline in its entirety.  

Table  6-5:  Registration  costs  for  a  substance  with  one  nanoform/set  per  company  and  per  tonnage 
band (use of alternative information considered possible, typical cost) (in thousand Euro): 

1a 

Estimated 
baselined 

2 

3 

4 (incl. 2) 

5 

6 (incl. 4) 

>1000 tonnes 

100-1000 tonnes 

10-100 tonnes 
1-10 tonnes (Full 
Annex VII) 
1-10 tonnes (Only 
Phys-chem) 

1-10 tonnesb 

110 

179 

102 

43 

20 

27 

150 

257 

165 

271 

186 

199 

90 

35 

51 

104 

48 

64 

150 

257 

186 

90 

35 

51 

179 

313 

262 

138 

51 

76 

65 

125 

22 

11 

5 

7 

322 

579 

483 

259 

259c 

259 

96 

144 

159 

144 

185 

53 

386 

Weighted Average 
a The column represents the cost for a bulk form, which can be directly compared with the majority of REACH 
cost  assessments  for  substances,  as  the  usual  assumption  in  those  calculations  is  that  at  most  one  test  is 
performed per substance 
b Weighted average: depending on applicable conditions of Annex III to REACH, the implications differ between 
registrants in the 1-10 tonnage band. More details above 
c  Following  assumption  on  registration  of  nanoform  only,  no  additional  indirect  cost  of  measure  41  through 
registration of bulk form 
d  Estimated  baseline  consequent  to  Board  of  Appeal  Decision  2  March  2017(see  discussion  in  section  4.9). 

Option 2 cannot be considered baseline in its entirety.  

Additional  scenarios  are  provided  in  Appendix XIII,  for  costs  per  nanoform  under  different 
assumptions  (depending  on  whether  alternatives  to  testing  exist  or  not  and  on  different 
assumptions on the cost of testing) and for the Grand Total costs under different assumptions 
on the existence of alternatives and on the number of nanoforms). 

67 

Preferred 

Final 

proposal 
(Apr 2018) 

Preferred 
Initial 
proposal 
(Oct 2017, 
corrected*
) 

181 

311 

246 

133 

74c 

91 

185 

320 

267 

154 

89c 

108 

189 

201 

 
 
 
 
 
 
The  more  comprehensive  description  of  impact  of  the  changes  between  the  initial  and  final 
Commission proposal, also on animal use, is provided in the Section 9.15.3 of Appendix XV.  

6.4 

Conclusion 

Based  on  the  above  evidence  and  analysis,  a  comparison  of  the  options  in  terms  of 
effectiveness, efficiency and coherence can be summarised in the following table 6-6:  

Table 6-6: Qualitative comparison of options in terms of effectiveness, efficiency and coherence: 

EFFECTIVENESS115 

EFFICIENCY 

COHERENCE 

Clarify the 
legislative 
obligations 
acting on 
companies 

Ensure 
adequate 
demonstrat
ion of safe 
use 

In terms of striking a 
balance between 
appropriate 
demonstration of safe 
use and the associated 
costs 

With REACH  - make 
REACH fit for 
nanomaterials as for 
other chemicals 

Option 1 

Option 2 

Option 3 

Option 4 

Option 5 

Option 6 

Preferred option 

0 

++ 

+ 

++ 

+ 

++ 

++ 

0 

+ 

+ 

++ 

-- 

++ 

++ 

0 

+ 

+ 

- 

- 

-- 

+ 

0 

+ 

+ 

- 

-- 

-- 

+ 

Magnitude  of  impact  as  compared  with  the  baseline  scenario  (the  baseline  is  indicated  as  0):  ++  strongly 
positive; + positive; – – strongly negative; – negative; ≈ marginal/neutral 

Option  1  scores  neutrally  under  the  assumption  that  industry  continues  applying  its  current 
interpretation of the REACH registration requirements and no particular actions by ECHA or 
Member States are taken to require additional data.  

Option  2  scores  positively  against  all  of  the  objectives.  It  is  indeed  a  package  of  measures 
that shows a good ratio between what it demands and what it delivers in return. 

Option 3 may deliver within the limits of the current legal obligations, but would not be as 
efficient as option 2, as it entails similar costs while the degree of clarity/certainty provided 
by the changes in the guidance would not be the same than that provided by changes in the 
legal text and it would take longer to implement.  

Option 4 fares better in terms of effectiveness, but this comes at a cost that is not negligible. 
However,  some  individual  measures  display  a  good  ratio  between  what  they  cost  and  what 
they deliver. For example, the substitution of mutagenicity test on bacteria by a test that works 

115 As regards the fulfilment of the Specific objectives stated in 3.2.  

68 

 
 
 
 
                                                 
better for nanomaterials (measure 13) will deliver more reliable information on mutagenicity 
for nanoforms, while the costs are proportionate.   

Option  5 induces  savings but  fails on demonstrating safe use and results  in  reduced human 
health and environmental protection. However, it contains measures that score high in terms 
of  effectiveness  on  providing  clarity  on  the  information  requirements  for  nanoforms  of  a 
substance and with lower costs especially for SMEs. 

Option  6  would  bring  incremental  improvements  to  the  level  of  protection  compared  to 
options 2 and 4, but these improvements are, in  general and in particular at lower tonnages, 
outweighed  by  the  considerable  extra  costs  imposed  on  firms,  not  least  SMEs.  However,  it 
contains some individual measures that also display a good ratio between what they cost and 
what they deliver (for example measures 41, 42 and 51). 

The preferred option (initial Commission proposal) 

As evident from the above analysis, the preferred option is much more effective than options 
1,  3  and  5,  and  it  is  more  effective  than  option  2,  as  on  top  of  clarifying  the  registration 
requirements, it adds specific considerations for substances with nanoforms. Its effectiveness 
is slightly higher than that of option 4, due to the generation of additional information specific 
to nanomaterials, and comparable to that of option 6. In terms of efficiency, considering that 
quantification and monetisation of benefits was not possible and bearing in mind the general 
objective of the initiative to ensure adequate demonstration of safe use for nanomaterials, in 
order  to  identify  the  most  efficient  policy  option,  the  trade-offs  between  benefits  and  costs 
were assessed based on the cost-effectiveness of the most effective options. The effectiveness 
of options 1, 3 and 5 was considered insufficient to attain the objectives of the initiative, thus 
their  cost-effectiveness  is  not  further  assessed.  The  cost  of  the  preferred  option  is  slightly 
higher than the cost of option 2 (15%), however as mentioned above, option 2 is less effective 
in terms of ensuring adequate demonstration of safe use. The cost of the preferred option is 
effectively the same as option 4 whereas its effectiveness is higher than that of option 4. Thus, 
the preferred option is more cost-effective than option 4. The cost of the preferred option is 
half that of option 6, whereas their effectiveness is comparable. Thus, the preferred option is 
more  cost-effective  than  option  6.  Based  on  this  analysis,  it  can  be  concluded  that  the 
preferred  option  is  the  most  cost-effective  option  that  would  attain  the  objective  of  the 
initiative to ensure adequate demonstration of safe use for nanomaterials.  

It is to be noted that, compared to option 1, the cost increase of the preferred option would be 
significant (almost 14-fold). However, based on the decision of the Board of Appeal in case 
A-011-2014 (see discussion in section 4.9), it is not appropriate to compare the cost to option 
1,  even  if  that  could  be  construed  from  many  of  the  REACH  dossiers  as  the  level  of 
information  presently  provided,  but  rather  to  what  can  be  considered  as  the  baseline.  The 
average  costs  increase  of  registering  a  substance  with  one  nanoform  per  company  and  per 
tonnage band compared to this estimated baseline is 26%. However, the cost increase in the 
low tonnage band is significant (79%).  

The total additional cost of the preferred option as compared to the baseline is approximately    
274 million EUR.  

Three  measures  in  the  preferred  option  stand  out  as  being  mainly  responsible  for  the  cost 
increase  compared  to  option  2:  measure  41  addressing  the  exemption  system  introduced  by 
REACH Annex III (essentially exempting any health and safety assessment below 10 tonnes 
unless  a  substance  has  already  been  identified  as  a  CMR  substance),  measure  13  (i.e. 
requiring  higher  tonnage  genotoxicity  testing  at  lower  tonnage  due  to  the  scientific 

69 

 
 
unsuitability of the test method foreseen), and measure 51 with the requirement to perform a 
toxicokinetic screening. The first two, in particular, affect costs for the lower tonnages where 
most SMEs are expected to be active.  

Measure 41 aims at generating an equal amount of information for non-classified substances 
with  nanoforms  in  volumes below 10 tonnes. The existing exemption in REACH Annex III 
for  non-classified  substances  was  introduced  to  ease  the  burden  for  firms  producing 
substances with a longstanding well-recorded knowledge base in relatively modest volumes. 
Accepting  that  nanoforms  (even  newly  generated  and  potentially  without  any  recorded 
knowledge  base)  may  be  registered  together  with  'phase-in'  bulk  form  of  a  substance  rather 
than being registered as new substances makes it not compatible with such an understanding. 
Eliminating the waiver in Annex III for substances with nanoforms completely (measure 41 as 
foreseen  originally  under  option  6)  would  subject  ‘existing’  nanoforms  of  substances 
(including those which  may have been with  unchanged nanoforms on the market  for a long 
time already) to the same requirements as new nanoforms as they would have to provide the 
full data package. A modified measure 41 as included in the preferred option is thus nuanced 
and would apply only to priority substances with nanoforms (see Appendix XII for details).  

Measure  13  is  justified,  as  the  genotoxicity  test  currently  foreseen  at  low  tonnages  is 
scientifically  unsuitable  for  many  nanoforms.  In  order  to  acquire  for  nanoforms  the  same 
knowledge  as  for  general  substances,  another  test  must  thus  be  used  –  the  best  option  for 
nanoforms being a test currently foreseen for the next higher tonnage band. 

Measure  51  on  toxicokinetic  screening  could  be  justified  for  nanoforms  of  a  substance 
because  due  to  their  small  size  they  may  translocate  to  other  parts  of  the  human  body  than 
bigger particles. By knowing where the specific types of particles translocate in organisms the 
measure offers in return enhanced access to reliable use of alternative and non-test methods 
for a range of other end-point tests (however, this would be limited mostly to those foreseen 
in the higher tonnage bands). It should be noted that additional toxicokinetic tests may often 
not be needed – relevant information may be generated when some tests e.g. 28-day repeated 
dose  toxicity  testing  are  perfomed.  Applying  the  measure  would  however  ensure  that  this 
information  is  always  available  for  nanoforms  of  a  substance.  It  is  estimated  that  the 
additional stand-alone cost for a toxicokinetics study, when one is still required, is more than 
offset  in  the  higher  tonnage  registration  band  by  the  increased  ability  to  reduce  the  cost  of 
other testing and the increased application of alternatives such as read-across, that often times 
presupposes in particular toxicokinetic information. 

The total cost (Grand total) of the preferred option would be about 1.3 billion EUR, i.e. 174 
million  EUR  in  addition  to  the  costs  for  option  2  (which  itself  creates  costs  of  1.17  billion 
EUR)  and  1.2  billion  EUR  in  addition  to  option  1  (which  itself  creates  costs  of  97  million 
EUR).  Based  on  the  decision  of  the  Board  of  Appeal  of  ECHA  in  case  A-011-2014  (see 
discussion in section 4.9), which sets the baseline between Option 1 and 2, the additional cost 
of  the  preferred  option  as  compared  to  the  baseline  is  approximately  274  million  EUR 
(increase of 26%).  

As  already  mentioned,  it  is  not  possible  to  make  a  comparably  accurate  calculation  on  the 
benefits  side.  Two  benchmarks  can  be  established  for  the  purpose  of  comparison  of  the 
overall costs and benefits of the options:   

  The  2003  Extended  Impact  Assessment  of  REACH  estimated  health  benefit  for  all 
chemicals over 30 years from its entry into force to be 50 billion EUR. The proposed 

70 

 
 
 
changes of the REACH Annexes for registration of substances with nanoforms would 
allow to fully achieve the benefit potential for these substances, which can, however, 
not be quantified.  

  The estimated costs should be considered in the context of the size of the nanomaterial 
market.    As  noted  in  1.2  Uses  of  nanomaterials  and  size  of  the  market,  the  global 
nanomaterial market value is estimated to be of roughly 20 billion EUR, which, for the 
EU  would  mean  ca.  4  billion  EUR  if  one  assumes  that  the  share  of  sales  of 
nanomaterials is comparable to the share of sales of chemicals in the EU compared to 
global  sales  (i.e.  ca  20%).  Considering  the  value  of  the  products  into  which  the 
nanomaterials  are incorporated, the estimation  goes up to  2 trillion  EUR globally by 
2015, i.e. 400 billion in the EU. 

The  preferred  option  would  also  be  the  most  coherent  one  with  REACH,  since  it  applies 
within  the  margins  of  the  mandate  and  the  scope  of  the  legislation  and  ensures  that  the 
legislation is fit for nanomaterials as for any other chemical. 

As  regards  the  use  of  animals  (see  full  Table  in  the  Section  9.15.3  of  Appendix  XV),  the 
preferred  option  is  almost  neutral  (it  is  estimated  that  it  uses  620  (612  +  8  due  to  indirect 
impact on registration of bulk by measure 41) instead of 614 animals per nanoform or set of 
nanoforms),  in  total  11,500(12,000-4,528  due  to  indirect  impact  on  registration  of  bulk  by 
measure 41) animals less than option 2. This is mainly due to the estimated positive impact of 
the  measure  regarding  toxicokinetics.  The  use  in  lowest  tonnages  is  marginally  higher  (16 
instead of 9 animals). 

Overall, the preferred option is the best ranked one among all assessed options. 

The preferred option (final Commission proposal) 

The qualitative analysis of the preferred option presented in the previous chapter remains. For 
detailed  assessment  and  impact  on  cost  and  animal  use  of  the  changes  made  in  the  final 
Commission proposal  please refer to Appendix XV.  

Each of these changes aims at increasing the relevance of available information on nanoforms 
and is expected to bring benefit in the quality as well as effectiveness of safety assessment. It 
is however not possible to quantify this benefit.  

The  average  cost  per  nanoform  is  estimated  to  be  increased  by  EUR  31K,  with  a  total 
additional cost estimate EUR 63M, a 4.5% increase as compared to the original Commission 
proposal.  The  highest  relative  increase  (~20%)  as  compared  to  the  original  proposal  is 
estimated  for  low  tonnage  registrants.  The  total  cost  for  the  registration  of  all  nanoforms 
assumed to be on the market is estimated at 1.4 billion EUR, i.e. 337 million EUR in addition 
to the estimated baseline. Regarding the scenario of registration of bulk with 4 nanoforms, the 
cost of registration compared to baseline would increase by 27%.  

In terms of animal use, on average an additional 8 animals per nanoform – 597 in total - are 
expected  to  be  used  under  the  final  Commission  proposal,  leading  to  the  estimated  total 
additional  use  of  16  thousand  animals  (1.232  million,  or  +1.3%  compared  to  original 
Commission  proposal).  This  estimate  is  still  within  estimates  for  animal  use  under  the 
baseline  scenario,  as  additional  animal  testing  is  offset  in  the  calculation  by  the  increased 
ability to read-across, based on better and available non-animal supporting data. 

71 

 
 
 
7 

MONITORING AND EVALUATION 

For  monitoring  and  evaluation,  the  existing  provisions  pursuant  to  REACH,  apply,  namely: 
Title  VI  on  Evaluation,  Article  117  on  Reporting  and  Title  XIV  on  Enforcement.  Based  on 
these already existing review mechanisms ECHA in the first place and then the Commission 
will  be  able  to  regularly  follow  the  effectiveness  and  effects  of  the  changes.  These  will  be 
reported every five  years, and every three  years as regards the status of implementation and 
use of non-animal methods and testing strategies. 

A  standing  ECHA  expert  group  on  nanomaterials  will  continuously  monitor  technical 
implementation and the impact the adaptations will have. On a policy level, CARACAL and 
as necessary its dedicated subgroup CASG Nano will follow the uptake of revised provisions 
by  the  industry  and  the  perception  of  the  wider  stakeholder  base,  in  particular  the  Member 
States  and  NGOs.  This  group  would  also  help  to  maximize  the  impact  of  these  REACH 
adaptations  in  pursuing  objectives  on  transparency  on  nanomaterials,  by  facilitating 
dissemination of public nanomaterial-related registration information.  

A simple indicator of whether the changes are performing adequately will be the number of 
registrations of substances with nanoforms, number of nanoforms documented in the dossiers 
and  associated  consequences  (e.g.  nanoform  specific  documentation  of  safe  use, 
classification), where appropriate. Another indicator will be the the quality of the information 
provided.  The  reporting  by  Member  States  on  the  operation  of  the  Regulation  on  their 
respective territories and on the enforcement, according to Article 117 will also be important.  

Under Article 138, REACH registration requirements are also subject to a review by 1 June 
2019, including registration requirements for nanomaterials. 

8 

GLOSSARY 

Agglomerate:  a  collection  of  weakly  bound  particles  or  aggregates  where  the  resulting 
external surface area is similar to the sum of the surface areas of the individual components. 

Aggregate: a particle comprising of strongly bound or fused particles. 
Characterisation:  substance  characterisation  is  an  analytical  process  through  which  the 
chemical identity and composition of a substance may be demonstrated. Every manufacturer 
or  importer  intending  to  undertake  a  registration  dossier  must  characterise  their  substances 
fully.  The  nature  of  a  given  substance  will  determine  which  analytical  tests  are  appropriate 
and clearly, technical expertise is essential at this stage. 

Chemical  Safety  Assessment  CSA:  the  chemical  safety  assessment  is  carried  out  to 
demonstrate that the risks from the exposure to a substance, during its manufacture and use, 
are  controlled  when  specific  operational  conditions  and  risk  management  measures  are 
applied.  

Chemical  Safety  Report  CSR:  the  chemical  safety  report  documents  the  chemical  safety 
assessment undertaken as part of the REACH registration process, and is the key source from 
which  the  registrant  provides  information  to  all  users  of  chemicals  through  the  exposure 
scenarios.  

Classification,  labelling  and  packaging  CLP:  CLP  of  substances  and  mixtures  is  the 
Regulation  on  classification,  labelling  and  packaging  of  substances  and  mixtures.  Its  main 
objectives are to facilitate international trade in chemicals and to maintain the existing level of 
protection of human health and environment.  

72 

 
 
CMR: A substance classified in the hazard classes cancenogenicity, germ cell mutageneticity 
or reproductive toxicity. 

ECHA:  the  European  Chemicals  Agency  (ECHA),  located  in  Helsinki,  is  the  driving  force 
among regulatory authorities in implementing the EU's ground-breaking chemicals legislation 
for  the  benefit  of  human  health  and  the  environment  as  well  as  for  innovation  and 
competitiveness.  ECHA  helps  companies  to  comply  with  the  legislation,  advances  the  safe 
use of chemicals, provides information on chemicals and addresses chemicals of concern. 

EMA: European Medicines Agency (EMA) 

Endpoint:  a  biological  endpoint  is  a  direct  marker  of  disease  progression  -  e.g.  disease 
symptoms  or  death  -  used  to  describe  a  health  effect  (or  a  probability  of  that  health  effect) 
resulting from exposure to a chemical. 

Exposure  to  a  particular  chemical  may  lead  to  a  series  of  endpoints.  The  most  sensitive 
endpoint (critical endpoint) is the one that occurs at the lowest exposure level. 

The derivation of a tolerable daily intake (TDI) or an acceptable daily intake (ADI) is based 
on the NOAEL (no observed adverse effect level) of the most sensitive endpoint and will also 
ensure protection against all other adverse effects. 

EFSA: European Food Safety Authority (EFSA) 

Form:  generally  the  term  'form'  can  be  understood  to  identify  the  state  of  a  substance  e.g. 
granular, lamellar, sheets, but is usually (and in this document) applied more widely to allow 
differentiation  when  one  or  more  intrinsic  physico-chemical  properties  (i.e.  characterisers) 
differ.  Form  would  therefore  include  bulk(solid)  in  different  crystalline  forms,  different 
powders etc. A form fulfiling the nano-definition is called nanoform (see below).  

Identification:  Unambiguous  substance  identification  is  a  pre-requisite  to  most  of  the 
REACH  processes.  Actors  in  the  supply  chain  must  have  sufficient  information  on  the 
identity  of  their  substance.  The  following  information  on  the  manufactured  or  imported 
substance shall be included in the dossier in order to unambiguously identify the substance: 

  Substance  name  and  related  identifiers,  molecular  and  structural  formulae,  if 

applicable; 

 

Information on the composition and purity of the substance; 

  Spectral data and analytical information to verify the identity and composition of the 

substance; 

  Clear and concise description of the analytical methods. 

Measure: each of the proposed actions that compose the options included within this impact 
assessment. 

Nanomaterial:  a  natural,  incidental  or  manufactured  material  containing  particles,  in  an 
unbound state or  as  an aggregate or as an  agglomerate  and where, for 50 % or more of the 
particles in the number size distribution, one or more external dimensions is in the size range 
1 nm-100 nm. In specific cases and where warranted by concerns for the environment, health, 
safety or competitiveness the number size distribution threshold of 50 % may be replaced by a 

73 

 
 
threshold  between  1  and  50  %.  By  way  of  derogation,  some  specific  materials  are  always 
nanomaterials  (graphene  flakes,  single  wall  carbon  nanotubes,  fullerenes),  based  on 
Commission Recommendation No 2011/696. 

Nanoform:  a  form  of  a  substance  that  falls  within  the  scope  of  the  definition  of  a 
nanomaterial  (see  above).  There  is  a  defined  minimum  list  of  characterisers  that  enable 
characterisation  of  (and  differentiation  between)  nanoforms.  Substance  may  be  in  many 
forms,  include  multiple  nanoforms.  As  different  nanoforms  may  exhibit  very  similar 
behaviour  –  a  proposition  that  needs  to  be  adequately  justified  –  such  sets  of  similar 
nanoforms  can  be  approached  jointly  using  same  documentation  requirements.  Within  this 
assessment,  the  term  nanoform  is  often  used  to  describe  individual  entities  for  which 
documentation  requirements  are  considered  in  the  different  options.  Such  entities  may  be 
nanoforms,  but  may  also  be  sets  of  similar  nanoforms,  providing  that  the  range  of 
characterisers for each set is well described, that the same information requirements datasets 
apply,  and  it  can  be  assumed  that  if  data  generation  is  required  at  most  one  test  would  be 
required for the set.  

Non-phase-in  substances:  all  substances  that  do  not  fulfil  any  of  the  criteria  for  phase-in 
substances  are  considered  as  non-phase-in  substances.  Normally,  non-phase-in  substances 
have  not  been  manufactured,  placed  on  the  market  or  used  in  the  EU  before  1  June  2008, 
unless they were notified under Directive 67/548/EEC. 

Potential manufacturers and importers of non-phase-in substances have to submit an inquiry 
to ECHA and subsequently register the substance in accordance with REACH before they can 
manufacture or import the substance.  

Options:  in  the  framework  of  this  exercise,  it  refers  to  possible  amendments  of  REACH 
Annexes  that  will  enable  to  ensure  further  clarity  on  how  substances  with  nanoforms  are 
addressed and safety of nanoforms demonstrated in registration dossiers. 

Particle: minute piece of matter with defined physical boundaries. 

Phase-in substances: substances which were already manufactured or placed on the market 
before  REACH's  entry  into  force.  In  accordance  with  REACH  (Article  3(20)),  phase-in 
substances must fulfil at least one of the following criteria: 

  Substances  listed  in  the  European  Inventory  of  Existing  Commercial  Chemical 

Substances (EINECS); 

  Substances that have been manufactured in the EU (including the countries that joined 
on 1 January 2007) but have not been placed on the EU market after 1 June 1992; 

  Substances that qualify as "no-longer polymer". 

Three distinct registration deadlines have been defined for these substances. 

QSAR  models:  Quantitative  structure–activity  relationship  models  (QSAR  models)  are 
regression  or  classification  models  used  in  the  chemical  and  biological  sciences  and 
engineering. 

Read-across approach: “Read-across” is a technique of filling data gaps. To “read-across” is 
to apply data from a tested chemical for a particular property or effect (cancer, reproductive 
toxicity, etc.) to a similar untested chemical. The read-across technique is often applied within 
groups  of  similar  chemicals  assembled  for  assessment  using  either  analogue  approach 
(grouping  based  on  a  very  limited  number  of  chemicals)  or  category  approach  (grouping 

74 

 
 
based  on  a  larger  number  of  chemicals).  In  an  analogue/category  approach,  not  every 
chemical needs to be tested for every endpoint. REACH Annex XI, Section 1.5. sets out the 
requirements for the application of this strategy. 

Set of similar nanoforms: See nanoform above 

SCCS: Scientific Committee on Consumer Safety (SCCS) 

SCENIHR:  The  Scientific  Committee  on  Emerging  and  Newly  Identified  Health  Risks 
(SCENIHR) is one of three independent non-food scientific committees which give scientific 
advice on consumer safety, public health and the environment. It was set up by the European 
Commission  to  consider  in  particular  emerging  issues  arising  from  new  technologies.  The 
Committee provides opinions on emerging or newly identified health and environmental risks 
and on broad,  complex or multidisciplinary issues requiring a comprehensive assessment  of 
risks to consumer safety or public health and related issues not covered by other Community 
risk assessment bodies.  

For 
http://ec.europa.eu/health/scientific_committees/emerging/index_en.htm 

information 

further 

the 

on 

SCENIHR 

see: 

75 

 
 
9 

9.1 

APPENDIXES 

APPENDIX I: Detail of the measures 

9.1.1  Overview of the measures in option 2 

#  Measure 

What the measure aims to achieve 

1  Explicitly  require  registrants  to  describe  the 

scope of the registration dossier 

2  Explicitly require registrants to provide more 

detailed characterisation of nanoforms 

3  Require 

that  nanoforms  are  explicitly 

addressed in the endpoint sections 

4  Require  detailed  description  of 
material/sample preparation 

the 

test 

5  Require scientific justifications for grouping / 
read-across  /  QSAR  and  other  non-testing 
approaches for different forms 

76 

Without  exact  knowledge  about  what  is 
covered  by  a  registration  dossier  neither 
compliance  check  nor  enforcement 
is 
possible.  Accuracy  is  particular  important 
when  several  nanoforms  are  in  a  single 
dossier.  A  clarification  of  Annex  VI.2  is 
anticipated. 

Even  small  difference  between  nanoforms 
can  have  significant  effects  on  properties. 
For  that  reason  detailed  characterisation  is 
necessary. Also to enable data sharing this is 
a crucial point. Clarifications of Annex VI.2  
and  physico-chemical  properties  (Section  7 
of Annexes VII-X) are anticipated. 

Due  to  the  current  need  for  a  case-by-case 
assessment and the variety of properties the 
relevance  of  data  provided  for  each  end-
point  needs  to  be  made  for  each  nanoform. 
Does  not  automatically  necessitate  data 
generation as justified read across to existing 
data  may  be  possible.  Clarifications  are 
required in Annexes I and XII, VI – X. 

Testing  nanoforms  requires  an  accurate 
description  of  the  material,  its  dose  in  the 
test  system  and  how  the  sample  has  been 
prepared.  This  is  an  OECD  recognised 
requirement.  Also  to  enable  data  sharing  or 
read  across 
is  a  crucial  point. 
Clarifications are required in  Annexes  I, VI 
– X. 

this 

not 

The  rules  of  using  non-testing  approaches 
are  set  out  in  Annex  XI.  However,  it  is 
currently 
same 
considerations  must  apply  when  results  are 
used  between  different  forms  within  a 
dossier. Clarifications are required in Annex 
XI but also Annex I and Annexes VI-X. 

clear 

that 

the 

 
 
6  Require 

considerations 

most 
appropriate/relevant  metric  with  preferable 
presentation in several metrics 

of 

7  Require  that  bioaccumulation  is  addressed 

specifically for the nanoform 

8 

Specify that  absorption/desorption  behaviour 
of  nanoforms  should  not  be  assessed  based 
on Kd values derived from Koc and Kow 

To guide the registrant (or downstream user) 
to give due regard to the best metric for each 
situation  while  ensuring  that  data  can  be 
compared.  Clarifications  are  needed 
in 
Annex I, XII. 

to 

Specific  case  of  measure  3,  explicitly 
acknowledging 
bioaccumulation 
that 
potential  of  a  nanoform  could  be  different 
compared 
form.  Often 
the  bulk 
assessment  for  those  forms  is  waived  on 
basis  of  predictors 
such  as  partition 
coefficient  Kow  that  do  not  generally  work 
well  for  nanomaterials.  Clarifications  are 
needed in Annex VII – X. 

as 

For nanomaterials, a number of deficiencies 
have  been  found  in  the  implementation  of 
methods  to  determine  several  indicators 
partitioning 
water-octanol 
such 
coefficient Kow. In addition, the complexity 
of their interpretation (dispersed particles do 
not  partition 
reduces 
significantly  their  predictive  powers  for 
other  properties  related 
the 
environment 
bioavailability. 
the 
Adaptations  using  such  indicators  should 
therefore  be  applied  with  caution  and 
alternative  information  should  be  sought. 
Clarifications are needed in Annex VII – X. 

in  equilibrium) 

to  fate 

and 

in 

9  Require  identification  of  uses  and  exposure 

assessment of the nanoforms 

9.1.2  Overview of the measures in option 3 

Development of further ECHA guidance 

77 

Linked 
to  measure  3.  Properties  of 
nanoforms  often  enable  specific  uses  or 
variation/improvement  in  the  use  of  the 
substance  that  should  be  appreciated  in  the 
dossier,  while  their  state  of  agglomeration, 
surface 
functionalization  or  application 
within  a  matrix  may  significantly  influence 
behaviour.  Clarifications  are  needed 
in 
Annex I.  

Guidance  development  is  a  continuous  task 
of ECHA. Specific guidance for registration 
includes 
is  already  available 
concrete 
for  
nanomaterials. 

that  also 
recommendations 

 
 
Enhanced use of the Directors Contact Group 

The Directors Contact Group was set up by 
the  Commission  in  the  run  up  to  the  first 
registration  deadline  and  was  used  as  an 
informal  forum  discussing  and  anticipating 
potential problems faced by firms. 

Initiatives 
enhance 
dissemination at EU and Member State level 

information 

to 

and 

ECHA,  Competent  Authorities  of  Member 
States  and  industry  confederations  all  play 
dissemination 
an 
information  on  what  is  expected  by  firms 
subject to REACH obligations.  

important 

role 

in 

9.1.3  Overview of the measures in option 4 

#  Measure 

10 

Include information on dustiness 

11  Require  acute  toxicity  data  for  the  most 

relevant route of exposure 

12  Change  ‘particles’  to  ‘(nano)particles’  for 
repeated dose toxicity studies (inhalation) 

13  Require non-bacterial in vitro gene mutation 

study 

78 

Generally  considered  a  very 
relevant 
parameter in particular in the manufacturing 
occupational  safety  context  of  any  granular 
materials and could therefore be particularly 
relevant where nanoforms of a substance are 
manufactured  and  handled  as  dry  powders 
with  inhalation  potential.  Clarifications  in 
Annex VII are needed. 

This 
the 
is  already  a  requirement  for 
substances  above  10  tons.  Below,  an  oral 
route  is  required  as  default  while  its  results 
may  not  be  relevant  when  e.g.  inhalation  is 
the most relevant route (which might be the 
case  for  many  nanoforms).  Clarifications  in 
Annex VII are needed. 

Measure  addresses  several  considerations 
that 
to  specificities  of  nanoforms 
due 
include  justification  for  not  considering 
inhalation  as  the  most  relevant  route  of 
exposure and extension of evaluation of the 
exposed  animals.  Clarifications  in  Annex 
VIII - X are needed. 

is  not  appropriate 

Bacterial  testing  is  a  first  step  in  tiered 
mutagenicity testing. Unfortunately bacterial 
testing 
for  many 
nanomaterials  and  may  give  false  negative 
tests  (i.e.  a  prediction  of  no  adverse  effect 
where this is not the case) thereby failing to 
trigger  higher 
tier  studies.  For  some 
nanoforms  the  current  test  in  Annex  VII 

 
 
 
14  Consider  water  solubility  in  relation  to  test 

waiving 

15  Specify that long term testing should not be 

waived based on lack of short term toxicity 

must  be  replaced  by  test(s)  with  ability  to 
in 
address  mutagenicity  of  substances 
nanoform.  Clarifications  in  Annex  VII  are 
needed. 

to 

and 

dispersion 

additional 
Due 
mechanisms  of  uptake,  the  insoluble  nature 
of  some  nanoforms  does  not  automatically 
bioavailable. 
they 
imply 
Clarifications 
in  Annex  VII  –  X  are 
appropriate  where  tests  are  waived  due  to 
low solubility in water. 

not 

are 

At present, long term testing may be waived 
in  few  specific  situations  if  there  is  no 
evidence  of  toxicity  in  the  short  term.  For 
nanomaterials  in  particular,  there  is  very 
little evidence that short term toxicity might 
predict  long  term  effects,  also  as  lower 
concentrations  delivering  same  dose  over 
longer  exposure  as  applied  in  long  term 
testing  often  imply  different  bioavailability 
due  to  modified  state  of  aggregation  / 
agglomeration.  

16  Specify  that  algae  testing  should  not  be 

waived based on insolubility 

Specific case of more general measure 14 as 
same consideration applies.  

17  Require  that  testing  on  soil  and  sediment 

organisms is prioritised 

however  may 

These  environmental  compartments  are 
considered important sinks for substances in 
nanoform. REACH applies a tiered approach 
requiring  an  assessment  for  lower  tonnages 
based  on  an  equilibrium  partitioning  trigger 
for 
that 
not  work 
Prioritisation  may 
nanomaterials. 
be 
addressed 
different  modifications: 
by 
requirement for testing of nanoforms already 
at  lower  tonnages  or  only  modification  of 
the  trigger.  Clarifications  in  Annex  IX  are 
needed. 

9.1.4  Overview of the measures in option 5 

#  Measure 

18  Describe  whether  and  which  different 
nanoforms are covered in the chemical safety 
assessment,  including  a  statement  when  and 

the  need 

Clarifies 
to  describe  how 
substances with  nanoforms  are addressed in 
REACH  Chemical  Safety  Assessment, 

79 

 
 
 
 
how  information  on  one  form  is  used  to 
demonstrate safety of other forms 

including 
information  about  non-testing 
methods, e.g. read-acrosss between different 
nanoforms.  Clarifications 
needed 
especially for Annex I. 

are 

19  Specify that nanoform specific information is 
required  only  when  an  insoluble  or  poorly 
soluble  nanoform  put  on  the  market  is 
classified hazardous/ dangerous 

20  Specify 

that  a  coated  nanomaterial 

is 
considered  as  a  special  mixture  e.g.  in 
classification  and  labelling  as  accepted  e.g. 
alloys  

21  Specify  that  the  granulometry  concept  in 
7.14  of  Annex  VII  includes  also  shape  and 
surface area of nanomaterials 

when 

nanoform 

specific 
Clarifies 
information  is  required  for  the  hazard  and 
risk  assessment  in  REACH.  Clarifications 
are needed especially for Annexes I, VI-XII. 

Change  current  practices  for  forms  of 
substances  with  coated  nanoparticles,  with 
an  example  from  the  registration  of  alloys 
and  surface  treated  substances  in  REACH. 
Clarifications  are  needed  especially  for 
Annexes I, VI-XII. 

the 

Clarifies 
information 
scope 
requirement  on  granulometry  as  also 
described in ECHA guidance. Clarifications 
are needed for Annex VII. 

of 

22  Specify  that  the  information  on  dustiness  is 
required  for  nanoforms  only  where  relevant 
for the worker safety assessment 

Clarifies  that  the  need  for  information  on 
dustiness  relates  only  to  worker  safety. 
Clarifications are needed for Annex VII. 

23  Specify  that  waiving  of  endpoint  specific 
for  classified 
information 
requirements 
insoluble  or  poorly  soluble  nanoforms 
applies as for any other forms and also when 
nanoforms  do  not  significantly  differ  from 
each other in specific endpoints 

24  Specify  that  the  use  of  non-testing  methods 
(e.g.    read-across,  grouping,  categorisation 
etc. methods) is a priority for nanoforms  

25  Specify and require explicitly that waiving of 
testing  on  the  basis  of  exposure  conditions 
and categories applies also for nanoforms, in 
particular  when  nanoforms  are  completely 
reacted  (cured),  incorporated  or  embedded 
into a completely cured matrix or permanent 
solid  polymer  forms,  or  otherwise  used  in 

80 

Determines that nanoforms are as any other 
forms of a substance, some toxic, some not, 
and  waivers  in  REACH  apply  also  to 
nanoforms 
necessary 
flexibilities  in  testing  and  cost  savings. 
Clarifications are needed for Annexes I, VI-
XII. 

allowing 

the 

Reiterates  that  the  Commission  strategy  for 
non-testing  methods  as  a  priority  applies 
also  to  substances  with  nanoforms  in  line 
with  in  recital  40  and  Articles  13  and  25, 
reducing  thus  animal  testing  and  testing 
costs. Clarifications are needed for Annexes 
I, VI-XII. 

that  exposure  conditions  and 
Clarifies 
categories,  apply  as  waivers  and  should  be 
used to reduce animal testing and the overall 
costs  of  REACH  compliance.  Clarifications 
are needed for Annexes I, VI-XII. 

 
 
closed systems or controlled conditions 

26  Specify that absorption/desorption behaviour 
of  nanoforms  can  be  based  on  biological 
surface  adsorption  index,  affinity  coefficient 
or other relevant parameters 

27  No  specific  obligations  for  nanoforms  in  1-

10 tonnage band 

that 

assessment 

Clarifies 
of 
the 
absorption/desorption  behaviour  in  REACH 
may  take  place  via  other  parameters  than 
octanol-water  partition  coefficient  which 
may  not  always  apply  for  nanomaterials. 
Clarification is needed for Annex VIII. 

tonnage  and  allows 

This  measure  does  not  require  nanoform 
specific  information  of  the  substance  at  the 
lowest 
the 
companies to allocate resources to upscaling 
of innovative applications and gaining better 
market  shares.  Clarification  is  needed  for 
Annex VII. 

thus 

28  No specific obligations for nanoforms in 10-

100 tonnage band 

This  measure  does  not  require  nanoform 
specific  information  of  the  substance  at  10-
100 tonnage and allows  thus  the companies 
to  allocate 
to  upscaling  of 
innovative  applications  and  gaining  better 
market  shares.  Clarification  is  needed  for 
Annex VIII. 

resources 

29  No nanomaterial specific obligations for 2nd 
exposure  route  at  10-100  tonnage  band  for 
acute toxicity 

30  Specify that information generated according 
to  existing 
test 
methods  is  sufficient  for  the  purposes  of 
hazard  assessment  of  nanomaterials  under 
REACH 

test  guidelines  and/or 

31  A  nanoform  consisting  of  aggregates  is 
considered  same  as  bulk  form  and  the  same 
endpoint  information  for  (eco)toxicological 
and environmental fate apply  

81 

This  measure  assumes  that  the  oral  acute 
toxicity represents well the dermal exposure 
(usual 2nd route) rendering additional dermal 
testing  redundant.  This  prevents  animal 
testing 
companies. 
Clarification is needed for Annex VIII. 

burden 

and 

to 

Clarifies  that  existing  test  guidelines  apply 
for  the  hazard  assessment  of  nanoforms  in 
REACH  recognising  thus  the  earlier  GLP 
compliant 
cover 
nanoforms  even  when 
these  were  not 
considered.  Clarifications  are  needed  for 
Annexes I, VI-XII. 

assessments 

safety 

It  is  assumed  that  the  primary  particles  are 
bound in aggregates so strongly that there is 
minimum  chance 
they  could  be 
that 
released.  Aggregates  should  be  considered 
(or  constituent 
as 
studies. 
particles) 
Clarifications are needed for Annexes I, VI-
XII. 

indivisible  particles 

(eco)toxicological 

in 

 
 
32  No  specific  obligations  for  nanoforms  to 
provide  ecotoxicological  and  environmental 
fate information 

33  Create presumption that non-testing methods 
are  valid  to  apply  for  nanomaterials  in  all 
endpoints 

34  Amend 

the 

information 
granulometry 
requirements  in  Annex  VII  (1-10  tonnage 
band)  for  nanomaterials  in  line  with  Annex 
II,  Section  9.1.a  of  REACH  on  Safety  Data 
Sheet  and  respective  ECHA  Guidance  on 
Compilation of Safety Data Sheets  

35  Specify  explicitly  that  coating  agents  of 
nanoforms  are  registered  separately  in  line 
with practices already accepted for e.g. alloys   

36  Reduce  the  set  of  combined  methods  for 
nanomaterial  determination  (Nanomaterial 
definition,  EU/2011/696)  to  only  one  (e.g. 
DLS)  

37  For 

the  purposes  of  REACH,  consider 
aggregates  as  constituent  particle  (primary 
the  nanomaterial  definition 
particle) 
(EU/2011/696)  

in 

This  measure  considers  pragmatically  base 
and 
considerations 
environmental  fate  on  substance  level  data. 
Clarifications are needed for Annexes I, VI-
XII. 

ecotoxicology 

of 

This  measure  aims  to  spur  innovation  with 
application  of  non-testing  methods,  tools 
and  instruments  for  hazards  assessment  and 
minimising 
safety 
assessment.  Clarifications  are  needed  for 
Annexes I, VI-XII. 

efforts  under 

the 

This  measure  streamlines  Annex  II  and  VII 
information  on  granulometry.  Clarification 
is needed for Annex VII. 

Changes current practise so that registration 
of the  coating  agent  is in  a separate dossier 
while  risk  assessment  in  the  registration 
dossier  of  the  substance  will  take  into 
account  the  way  how  the  coating  agent  is 
bound  to  nanoparticle  of  the  registered 
nanoform.  This  is  analogical  to  the  risk 
assessment  of  the  substances  bonded  in  the 
alloys.  Clarifications 
for 
Annexes I, VI-XII. 

are  needed 

This  measure  strives  for  more  pragmatic 
identification  of  nanoforms  and  potential 
reduction  of  associated  costs. 
Industry 
should  have  one  standardized  method  in 
particular  for  the  so  called  unintentional 
nanomaterials.  Clarifications  are  needed  for 
ECHA guidance on this matter. 

The  measure  assumes  that  the  primary 
particles are bound in aggregates so strongly 
that  there  is  minimum  chance  that  they 
could  be  released.  Aggregates  should  be 
considered  as 
(or 
constituent  particles)  in  hazard  assessment 
(see  measure  31).  Clarifications  are  needed 
for ECHA guidance on this matter. 

indivisible  particles 

38  Omit mutagenicity and acute toxicity tests in  This  measure  minimises  the  information 

82 

 
 
tonnages;  no  skin 

lower 
irritation,  skin 
corrosion or in vivo eye irritation information 
required for 10-100 t/y if the assessments in 
1-10 t/y has been negative 

for 

skin 

irritation 

requirements 
and 
corrosion  as  well  as  eye  irritation  and 
considers  substance  level  information  on 
mutagenicity and acute toxicity adequate for 
nanoforms  of  a  substance.  These  reduce 
tonnage 
regulatory  burden  of 
manufacturers  and  importers  of  nanoforms 
in  general.  Clarifications  are  needed  for 
Annexes I, VI-VIII. 

lower 

9.1.5  Overview of the measures in option 6 

#  Measure 

What the measure aims to achieve 

39  Apply clear rules on when nanoforms can be 
in  one  dossier  or  in  separate  ones  based  on 
possibility for data sharing 

40 

to 

rules 

Introduce 
ensure  mandatory 
separation between nanoforms identified and 
addressed  in  the  dossier  whenever  they 
differ  in  coating,  shape,  crystalline  form  or 
prescribed 
size 
distribution 

particle 

classes 

of 

41 

Information  requirements  for  substances 
covered by Annex III (b) must also apply to 

83 

Rules are expected to improve level playing 
field,  more  effective  enquiry,  registration 
and evaluation process. While it may restrict 
flexibility  and  increase  administrative  cost 
(registration  fee),  it  is  not  expected  to 
increase testing requirements (read-across is 
possible  between 
forms  or  between 
substances)  and  may  in  some  cases  reduce 
them  (separation  in  different  substances 
leads  to  registration  of  substances  with 
lower tonnages).  

Measure  is  expected  to  be  implemented  via 
ECHA  guidance,  regularly  updated  with 
progress and experience.  

An  extension  of  the  measures  1  and  2 
(Option 2) by providing further clarification 
regarding  administrative  organisation  of  the 
dossier  with  multiple  forms.  Expected  to 
transparency, 
provide 
easier 
level 
evaluation 
implementation, 
playing  field.  Mandatory  separation  is  not 
expected  to  increase  testing  requirements 
(read-across between separated nanoforms is 
possible,  or  implied  grouping  before  such 
separation 
requirement  would  not  be 
compliant)  but  may  increase  administrative 
cost for industry.  

and 

Measure  is  expected  to  be  implemented  via 
ECHA  guidance,  regularly  updated  with 
progress and experience. 

Annex  III  exemption  to  the  requirement  to 
document 
and 
ecotoxicological  hazard  is  applicable  to 

toxicological 

basic 

 
 
nanoforms 

42 

For  nanoforms,  require  all  information  on 
potential  alterations  of  hazard  due 
to 
the 
conditions 
operational 
exposure situation is considered  

upstream 

tonnage 

phase-in 

lowest 
substances. 
Allowing  exemption  to  be  applied  to  new 
nanoforms  that  happen  to  share  substance 
identity  (but  not  necessarily  hazardous 
properties)  with  the  legacy  bulk  or  nano 
phase-in material may be seen as a loophole 
that  creates  unfair  advantage  to  the  legacy 
materials.  

Modification is required in Annex III. 

to  acknowledge 

It has been demonstrated that due to particle 
nature  that  most  nanoforms  share,  their 
properties  and  transformation  such  as  state 
of  aggregation/agglomeration  may  strongly 
depend  on  the  local  environment  as  well  as 
the history of the material in a life cycle. An 
explicit  provision 
that 
operational  conditions  can  affect  the  actual 
status 
e.g. 
nanoform 
otherwise 
agglomeration),  which 
implicit 
already  be  considered  as  an 
requirement,  may 
to 
lead 
in  practice 
additional  administrative  costs  related  to 
documentation  but  should  enable  a  higher 
degree  of  confidence  for  specific  value 
chains. 

(through 
can 

of 

Clarification required in Annex I and XII.  

43 

require 

For  nanoforms, 
available 
information  on  the  use  is  considered,  even 
when  the  use  would  not  be  covered  by  the 
registration 

all 

84 

When  so  much  attention  is  put  into  the 
adequate  delimitation  between  different 
nanoforms  (see  measures  1-3  of  Option  2, 
39-40 of Option 6), there is potential for the 
abuse  or  the  mismanagement  of  the  safety 
taking  a  very 
assessment  approach  by 
narrow  view  as  to  the  relevance  of  the 
available 
discarding 
warning signals  from  information  generated 
on  different  yet  similar  (nano)forms  or 
unrecognized  uses 
the  particular 
nanoform.  

information 

e.g. 

for 

to 

and 

encourage 
aims 
This  measure 
consideration of innovation dimension in the 
dossier  preparation 
in  particular 
minimize  the  potential  abuse  of  rejecting 
available relevant information due to lack of 
adequate  handle  on  the  value  chain.  This 
will also facilitate proper SDS entry of 'uses 
advised against' where relevant.  

 
 
44 

For  nanoforms,  require  additional  physic-
chemical characterisation along the particle's 
fate  when  particle  properties  impacts  on 
hazard 

45 

Physico-chemical, 
CSA  documented 
nanoform 

(eco)toxicological  and 
for  each 

separately 

46 

For nanoforms, explicitly limit the potential 
for use of non-testing approaches for hazard 
is  not 
and  exposure  where 
consolidated,  but  encourage 
its  parallel 
application and documentation 

science 

Clarification in Annex I and XII is required. 

Following  similar  argument  as  for 
the 
measure  42,  here  related  to  the  actual 
properties  of  the  nanoform  through  its  life 
in  different  value 
cycle  (and  possibly 
chains).  Operational  conditions  modify 
physico-chemical properties that will in turn 
influence the actual hazard.  

Information  should  facilitate  application  of 
adaptation possibilities e.g. read-across.  

Clarification in Annex I and XII is required. 

While 
in  principle  not  providing  any 
difference  in  content,  such  administratively 
different  approach  to  dossier  preparation 
may 
in  many  cases  provide  additional 
transparency in dealing with substances with 
nanoforms. No extra testing can be implied. 
Additional  cost  is  difficult  to  ascertain; 
while  volume  of  the  dossier  is  expected  to 
increase,  the  work  required  may  not,  as  the 
elaborations  for  grouping  etc.  are  replaced 
by  more  straightforward  copy/paste  of 
information between different forms. 

Clarification required in Annex I, VI-XII but 
in  particular  via  ECHA  guidance  also  on 
IUCLID. 

There  is  still  uncertainty  as  regards  the  use 
for 
of 
individual  non-testing  methods 
to 
nanomaterials.  This  measure  aims 
facilitate 
the 
the  responsible  work  by 
registrants,  pointing in  specific situations to 
the  generation  of  information  without  the 
delay that may occur as the attempt to apply 
a  non-testing  method  is  eventually  rejected 
by the evaluator and the test is required.  

The  measure  also  still  encourages  that  the 
adaptation approach is tried and documented 
in order to facilitate faster development and 
validation of non-testing methods. 

To  be  implemented  via  (regularly  updated) 
ECHA guidance. 

47  Require  adapted  DNEL  setting  based  on 
different  routes  through  the  value  chain  / 

See  argumentation  under  measures  42  and 
transparent  and 
44; 

this  may  provide 

85 

 
 
specific uses 

48  Add  to  the  SDS  information  relevant  to 

Nano registries in Member States  

49 

Specify that list of substances in Annexes IV 
and  V  does  not  cover  nanoforms  of  these 
substances 

50  Choose inhalation as the appropriate route of 
exposure  in  repeated  dose  toxicity  study 
unless such exposure can be excluded. 

51 

Perform toxicokinetic screening 

86 

potentially  more  cost-effective  route 
to 
document  safety  of  individual  value  chains 
with higher degree of confidence.  

While  the  aim  of  REACH  remains  a  more 
general  demonstration  of  safety  of  a 
substance and not just an individual process, 
it may require work via individual chains to 
generate  enough  understanding  before  the 
for  substances  with 
aim 
nanoforms.  

is  achieved 

SDS  is  an  effective  tool  developed  for 
international use that can serve to effectively 
cross any impediments to the internal market 
by exchange of the necessary information. It 
is  expected to  help  users of SDS  as well as 
the MS authorities compiling the inventories 
that will benefit from consistent information. 

An  alternative  is  a  parallel  documentation 
(e.g.  EU  registry  currently  still  being 
assessed for impacts). 

Modification in Annex II is required. 

without 

Lists  of  substances  in  both  Annexes  were 
designed 
of 
potentially  new  nanoforms  being  developed 
with the same substance identity, benefiting 
perhaps inappropriately from the exemption.  

consideration 

Modification to Annexes IV,V. 

Experts  suggest  that  in  a  lot  of  cases,  the 
oral route may not be the most relevant route 
of exposure to nanomaterials. To provide the 
most relevant information with a single test, 
another  route  (e.g. 
inhalation)  may  be 
warranted.  The  limited  knowledge  on  the 
uses  may  however  make  the  argument  for 
relevance  difficult.  The  measure  may  serve 
to ensure generation of the most appropriate 
information not just for the present but  also 
for the foreseeable future.  

Modification in Annex VIII is required. 

Toxicokinetics  –  an  understanding  of  how 
materials are distributed between the organs 
in  the  body  -  is  one  of  the  most  important 
determining  whether 
information 

in 

 
 
52 

For nanoforms, request 28 day repeated dose 
toxicity in Annex VII 

additional  mechanisms  of  toxicity  may  be 
expected, and whether it may be possible to 
apply  grouping  between  the  nanoforms  or 
with  the  bulk  counterpart  for  a  variety  of 
endpoints.  

Clarifications in Annex VIII are needed. 

is 

For  the  lowest  tonnage,  only  acute  toxicity 
required.  Some 
currently 
testing 
information  on  nanomaterials  and 
their 
mode of action, but in particular the absence 
of 
that  we  have  with 
conventional chemicals, suggests that testing 
for  an  indication  of  'chronic'  toxicity  at 
lower 
indicative  of 
potential hazard and should be explored.  

levels  seem  more 

the  experience 

Modification in Annex VII is required. 

87 

 
 
 
 
9.2 

APPENDIX II: Monitoring and evaluation  

Concept 

Referring to 

Relevant 
Article 
in 
the  REACH 
Regulation 

Enforcement and Information 

Enforcement: 
Tasks  of  the 
Member 
States 

Enforcement: 
Penalties  for 
non-
compliance 

Art. 126 

Information: 
Reporting 

Art. 117 

Art. 125 

Member States shall maintain a system of official controls and 
other activities as appropriate to the circumstances. 

Member  States  shall  lay  down  the  provisions  on  penalties 
applicable for infringement of the provisions of this Regulation 
and  shall  take  all  measures  necessary  to  ensure  that  they  are 
implemented.  The  penalties  provided  for  must  be  effective, 
proportionate and dissuasive.  

the 
Every  five  years  Member  States  shall  submit 
Commission  a  report  on  the  operation  of  this  Regulation  in 
their  respective  territories,  including  sections  on  evaluation 
and enforcement.  

to 

Enforcement: 
Report 

Art. 127 

This report shall include the results of the official inspections, 
the  monitoring  carried  out,  the  penalties  provided  for  and  the 
other measures. 

Evaluation 

Evaluation: 
Dossier 
evaluation 

Evaluation: 
Substance 
evaluation 

Evaluation: 
Intermediates 

Art.  40,  41, 
42 

Examination  of  testing  proposals,  Compliance  check  of 
registrations 

Art.  44,  45, 
46, 47, 48 

for  substance  evaluation,  Competent  authority, 
Criteria 
Requests  for  further  information  and  check  of  information 
submitted 

Art. 49 

Further information on on-site isolated intermediates 

88 

 
 
 
9.3 

APPENDIX III: Ex-post assessment of 2010 registration dossiers 

We  quote  below  the  main  conclusions  of  the  JRC  Nano  Support  report.  To  consult  the  full 
report, 
2012  
JRC, 
support 
http://ec.europa.eu/environment/chemicals/nanotech/pdf/jrc_report.pdf 

12  March 

to:  Nano 

project, 

please 

refer 

The  current  REACH  regulation,  including  information  requirements,  does  not  contain  any 
specific  provisions  related  to  substances  with  nanoforms.  Additionally,  the  current  REACH 
guidance is not tuned to address the properties of nanomaterials. In this respect, it should be 
noted that a REACH Competent Authority document (CA/59/2008 rev1) has clarified that the 
REACH  provisions  apply  to  nanomaterials  and  that  registrants  should  attempt  to  apply  the 
existing guidance in their registrations. An additional complicating factor for registrants was 
the fact that there was no adopted EC Recommendation on the definition of nanomaterial at 
the  time  of  the  first  registration  deadline  (December  2010).  Moreover  the  REACH 
Implementation Projects (RIP-oNs), addressing how the REACH guidance could be updated, 
were not finalised by the time. 

a) Identification of dossiers addressing substances with nanoforms: 

According  to  the  dossiers  analysed  in  the  report,  registrants  generally  did  not  provide  the 
constituent/primary particle size distribution needed to explicitly verify whether nanoform(s) 
is/are addressed by a given dossier. This is not unexpected as constituent/primary particle size 
distribution is not a REACH standard information requirement. On the other hand, given other 
information found in various places of the (…) [analysed] dossiers and expert judgment, it is 
believed  that  the  25  dossiers  address  (or  with  very  high  probability  address)  nanomaterials 
and/or nanoforms. 

b) Analysing and assessing the information reported on ‘nano’ in those dossiers: 

The  information  on  identification/characterisation  of  the  substances  addressed  by  a  given 
dossier was of varying level  of detail.  Some  (…) explicitly mentioned that  a nanoform  was 
covered by the registration. In those dossiers a nanoform was described in a generic way. 

Regarding  information  on  other  parameters  relevant  for  identifying  or  characterising 
nanoforms/nanomaterials, it was found that about half of the dossiers reported information (in 
various  places  of  the  dossiers)  indicating  that  the  registered  substance  could  be  surface 
treated,  but  specific  information  (including  analytical  data)  on  the  type  and  extent  of  such 
treatments was only indicated in one dossier. 

Information on particle size (distribution) was given under the ‘granulometry’ endpoint and in 
some  cases  in  the  Substance  Identity  section  (IUCLID  section  1).  The  quality  of  the 
information on this endpoint varied among the different dossiers, but a number of issues with 
significant  impacts  on  the  assessment  of  nanomaterials  were  identified.  First,  the  methods 
used were in several cases not appropriate for the measurement of particle size distributions of 
nanomaterials (e.g. the method does not detect particles in the 1- 100 nm range). Second, the 
results  from  several  methods  do  not  distinguish  between  primary  particles,  aggregates,  and 
agglomerates,  and  registrants  did  not  clearly  and  consistently  make  a  distinction  between 
these. Thirdly, members of a joint  submission did not  provide their own granulometry data. 
For joint submissions, normally one set of particle size data were given in the lead dossier. As 
particle  size  (distribution)  depends  on  the  manufacturing  process,  and  is  logically  not 
amenable  to  read-across,  the  project  suggests  that  members  of  a  joint  submission  should 
submit  their  own  individual  granulometry  data.  It  should  be  noted  that  under  the  current 
REACH  regulation,  submission  of  granulometry  data  individually  by  members  of  a  joint 

89 

 
 
submission  would  require  an  ‘opt  out’  for  this  endpoint,  which  has  some  consequences  in 
relation to fees and the possibility for prioritisation of the dossier for compliance check. 

About  half  of  the  dossiers  provided  some  additional  information  on  other  possible 
characterisers  such  as  density  and  surface  area.  However,  typically  the  description  of  the 
method used to obtain the reported data was not included. 

The  ambiguity  in  relation  to  the  scope  and  identification/characterisation  of  nanoforms 
addressed  by  the  registrations  generally  cascaded  through  the  dossiers.  A  few  dossiers  did 
distinguish between ‘bulk’ and ‘nano’. Though the purpose was to explicitly address different 
forms,  this  was  done  in  varying  level  of  detail  between  dossiers,  as  well  for  information 
(CSRs  and  endpoints)  within  those  dossiers  and  did  not  go  to  a  level  beyond  considering 
‘nano’  as  one  form,  i.e.  differences  in  characteristics  between  nanoforms  of  the  same 
substance were not addressed. 

Further,  it  was  found  that  test  data  provided  for  physico-chemical,  human  health  and 
environmental endpoints generally did  not  describe the test material  in  great  detail.  Further, 
description  of  sample  preparation,  which  is  an  important  aspect  known  to  influence  the 
outcome  of  a  given  study,  was  varying  and  sometimes  lacking.  On  a  positive  note  it  seems 
that  this  situation  is  improving  for  recent  (eco-)toxicological  studies  of  nanomaterials, 
probably supported by the fact that scientific journals continuously raise their requirements in 
this respect. 

It is the outcome of this assessment that, in order to address the above mentioned ambiguities, 
it is essential to outline in a transparent manner what is registered in terms of nanoforms and 
how these are addressed in terms of information requirements and assessment. 

The information that needs to be generated should be focussed on demonstrating safety of the 
different  forms  that  are  manufactured,  imported  and  used  on  the  EU  market.  To  facilitate 
generation of specific information  there is  a strong need for developing  nontesting methods 
and  for  creating  stakeholder  consensus  on  the  use  of  non-testing  data.  An  important 
prerequisite for this is a clear understanding of the characteristics of the nanoforms within the 
relevant  registration  dossiers.  In  any  case,  it  is  important  that  a  transparent  scientific 
discussion is made by the registrant when using such methods for nanoforms/nanomaterials. 

90 

 
 
 
9.4 

APPENDIX IV: Ex-post assessment of the REACH impacts to companies 

Large variations exist in the registrations costs of substances with nanoforms. The compliance 
costs are largely taken out of R&D resources in smaller companies, even if it should be noted 
that  these  costs  are  not  fixed  costs,  hence  after  the  registration  has  successfully  been  done 
only marginal costs will be incurred e.g. to keep the data up to date.  

In  cases  where  companies  are  unable  to  transfer  the  compliance  cost  to  the  product  price  - 
typically seen as a problem for SMEs - it may affect their competitiveness. This was one of 
the reasons why REACH changed the requirements for non-phase-in substances only to apply 
from  1  tonnes  instead  of  the  previous  10  kg.  In  addition,  REACH  offers  a  possibility  for 
companies  to  apply  for  up  to  a  five  year  registration  exemption  for  Process  and  Product 
Oriented  Research  and  Development.  In  2012  there  were  only  4  SME  companies  out  of 
overall  105  applications  suggesting  that  this  segment  of  companies  may  need  extra  help  in 
this regard. 

The nanotechnology  companies were asked about  potential changes to  legislation. Although 
only 15% of those that responded had any experience with REACH, they considered, mainly 
due to administrative burden and time-to-market, the possible modifications of “Considering 
all nanomaterials as new substances”, “Chemical Safety Report with exposure assessment for 
all  registered  nanomaterials”  and  “Notification  requirement  for  all  nanomaterials  placed  on 
the market on their own, preparations or in articles” mainly negative for the enhancement of 
competitiveness  and  innovation,  while  “Simplified  registration  also  for  nanomaterials 
manufactured  or  imported  in  quantities  of  less  than  one  tonne”  a  third  of  manufacturers 
considered the effect negative and a fourth indicated no effect.   

REACH contribution to the development of emerging technologies 

The  regulatory  uncertainties  (e.g.  leading  to  additional  testing  costs  and  authorisation)  and 
lack  of  capital  were  considered  the  main  challenges  in  bringing  nanomaterials  to  market  in 
Europe.  The  main  REACH  and  CLP  impacts  on  products  of  emerging  technologies  were 
considered  to  be  administrative  burden  and  information  requirements,  as  well  as  negative 
effect to time-to-market and marginal cost structure. 

A set of six recommendations on key policy options put forward by the consultant were: 

 

 

 

 

I Reduce uncertainties related to regulatory aspects (e.g. testing costs, authorisation); 

II Streamline information/testing requirements between sectoral legislations; 

III  Substances  produced  by  emerging  technologies  should  not  be  treated  more 
stringently than any other substances (or forms of substance); 

IV Strengthen the integration of REACH provisions into the Research & Development 
& Innovation processes; 

  V Enhance market uptake of safer chemicals; 

  VI  Ensure  affordable  means  for  financing  REACH  compliance  in  Research  & 

Development & Innovation process. 

91 

 
 
9.5 

APPENDIX V: Summary of the Public Consultation 

9.5.1  Context 

The  Public  Consultation  exercise  was  a  targeted  process  that  sought  to  gather  stakeholder 
views  relating  to  the  Problem  Definition,  the  Baseline  scenario  and  the  five  additional 
substantive options under consideration. The consultation ended on 13 September 2013. The 
results  are  not  binding  for  the  Commission's  decision,  but  can  affect  the  decision-making 
process, as they give an idea of what the perception of the European society is. 

Given  the  current  limited  number  of  registrations  of  substances  with  nanoforms  under 
REACH, it was unlikely that respondents would be able to do more than make an estimation 
of cost, efficiency and impact, as it relates to the measures and options under consideration. 
That having been said, it appears to be the case that respondents were able to  give nuanced 
and  considered  responses  and  that  as  a  result,  the  survey  presents  a  detailed  assessment  of 
each  option  and  the  specific  measures  within  them.  Note:  term  nanomaterial  (and  not 
nanoform) is used below, in consistency with the terminology applied at the time. 

9.5.2 

Typology of respondent 

A total of 142 questionnaires were submitted:  

  A  majority  of  respondents  were  representing  an  organisation  (82%),  the  rest  being 

individuals;  

  Belgium116,  Germany  and  UK  were  the  Member  States  where  most  responding 

organisations are located; 

  86% of the respondents considered that the current requirements for the registration of 

nanomaterials as unclear or very unclear. 

Graph 9.5-1: Profile of the respondents 

116 Most probably due to the fact that EU-wide associations and NGOs are located in Belgium 

92 

 
 
 
                                                 
Organisations  belonged to half of  all Member States.  In terms of  geographic spread, a little 
over a quarter of the respondents were based in Belgium (most probably due to the location of 
organizations (NGOs, trade associations) representing interests of stakeholders in  more than 
one  or  all  MSs),  with  Germany  being  the  second  highest,  the  United  Kingdom  the  third 
highest, Italy fourth and France fifth.  

Graph 9.5-2: Nationality of the respondents 

The  organizational  profile  suggests  that  industrial/trade  associations  were  the  largest  group, 
followed by private companies. NGOs made up one in ten respondents, with ten respondents 
stating  themselves  to  be  an  environmental  NGO.  Government  authorities  made  up  15%  of 
respondents,  with  the  remainder  made  up  of  consumer  associations,  academic  bodies  and 
other. 

9.5.3  Main observations 

9.5.3.1  Rankings 

Respondents were asked a series of questions regarding the potential impact of the measures 
contained in each of the options on overall cost (increase or reduce the cost of compliance), 
efficiency  (higher  or  lower  overall  efficiency  of  the  regulatory  process  for  nanomaterials 
within REACH in terms of striking the balance between appropriate demonstration of safe use 
and  the  cost  to  achieve  it)  and  safety  (increase  or  reduce  the  demonstration  of  safe  use  of 
nanomaterials).  The  table  9.1  below  compares  the  overall  summary  results  for  each  of  the 
options when the assessment was done for each of the measures within the options.  

Table 9.5-1: Ranking of Policy Options by Individual Measure 

COST 

EFFICIENCY 

SAFETY 

Option 2 

Third 

Option 3 

Second 

First 

Fifth 

First 

Fourth 

Option 4 

Fourth 

Second 

Second 

Option 5 

First 

Third 

Fifth 

93 

 
 
 
 
Option 6 

Fifth 

Fourth 

Third 

It  needs  to  be  stressed  that  respondents  were  not  explicitly  asked  to  rank  options,  but  the 
summary table 9-1 provides interesting comparative insight. Notable points include option 2 
receiving  the  highest  ranking  for  both  efficiency  and  safety,  option  5  receiving  both  the 
highest ranking for cost and the lowest for safety, and option 6 receiving the lowest ranking 
for  cost  but  only  third  highest  for  safety.  Option  4  ranked  second  both  for  safety  and 
efficiency and fourth for cost. Given the staggered interrelationship between options 2, 4 and 
6, the outcome in terms of ranking the three options for costs is coherent, while the ranking 
for safety is somewhat surprising.  

Table 9.5-2: Overall ranking of Policy Options  

OVERALL 

Option 2 

Fourth 

Option 3 

Fifth 

Option 4 

First 

Option 5 

Third 

Option 6 

Second 

Based  on  a  separate  question  regarding  the  efficiency  of  the  options  as  a  whole,  option  4 
received high appreciation by the majority of the respondents.   

9.5.3.2  Preferences 

When asked about their preferences, results are slightly different: respondents as a whole opt 
clearly for option 5, and then 6; options 2 and 4 are the next favoured ones, being option 3 the 
last preference.  

Considering  that  options  6  and  4  include  measures  of  options  4  and  2  respectively, 
respondents as a whole have as a majority promoted measures under option 2 (51%), followed 
by measures included under option 4 (41%).   

Graph 9.5-3: Options preferences 

94 

 
 
 
When  narrowing  down  by  type  of  respondent  (eight  different  types),  the  results  diverge  as 
follows: 

Graph 9.5-4: Options preferences by typology of respondent 

By analysing the results, some common tendencies are noticed: 

Graph 9.5-5: Options preferences by category 

95 

 
 
 
 
80

70

60

50

40

30

20

10

0

6

5

4

3

2

1

Individual citizens,
Government authorities,
Academic/research
institutions, NGOs,
Consumer associations

Industrial or trade
associations and Private
companies

Other

Overall,  respondents  can  be  grouped  into  three  main  categories,  according  to  their 
preferences: 

 

 

Industrial  and trade associations and Private companies, which opt clearly for option 
5; 

Individual  citizens,  Government  authorities,  Academic/research  institutions,  NGOs, 
Consumer associations opt for option 6 followed by option 4; 

  Others117 for which the preference is more or less equally shared between options 6, 4 

and 2. 

9.5.4 

Specific observations 

We report here some specific observations that derive from the breakdown of the results per 
category (except for Option 3). 

9.5.4.1  Option 2 

Three  measures  outstand  particularly  among  the  9  proposed  ones  that  integrate  this  option 
with regards the negative impact they can have on costs; they refer to bioaccumulation, uses 
and exposure and endpoints specificities of nanomaterials. 118 

117 The category 'Others' groups all the respondents  who did not identify themselves within any of the previous 

categories. 

118  The  three  following  measures  are  considered  as  having  a  negative  impact  on  costs  for  more  than  70%  of 
respondents:  g)  Require  that  bioaccumulation  is  addressed  specifically  for  the  nanoform  (77%);  i)  Require 
identification  of  uses  and  exposure  assessment  of  the  nanoform  (76%);  and  c)  Require  that  nanoforms  are 
explicitly  addressed  in  the  endpoint  sections  (72%).  For  more  detail  about  the  Public  Consultation,  refer  to 
Appendix V  

96 

 
 
 
                                                 
Graph 9.5-6: Option 2 - Costs 

40
35
30
25
20
15
10
5
0

Don't know

++

+

0

-

--

Key to the scores applied as compared to the baseline scenario: 
Positive impact  
No impact  
Negative impact  

+ … ++ 
0 
-- …   - 

When analysed by stakeholder category industrial  associations  as  well as private companies 
believe that this option would increase the cost of compliance (94% in both cases), whereas 
for the rest of stakeholders the option would not have any impact on the costs. 

9.5.4.2  Option 4 

A  vast  majority  of  respondents  to  the  public  consultation  (almost  80%)  agree  that  costs  of 
compliance  with  REACH  regulation  would  increase  under  option  4.  Industrial  associations 
and  companies  see  this  option  as  particularly  harmful  for  costs  (9  out  of  10  respondents 
consider that this option will increase costs, more than half of them believe that it will do so 
significantly).  As  for  option  2,  3  of  the  9  proposed  measures  are  especially  negatively 
perceived.119 

Graph 9.5-7: Option 4 - Costs 

40
35
30
25
20
15
10
5
0

Don't know

++

+

0

-

--

119 The three following measures are considered as having a negative impact on costs for approximately 80% of 
respondents:  Measure  17:  Require  that  testing  on  soil  and  sediment  organisms  is  prioritised  (83%);  Measure 
16: Specify that algae testing should not be waived based on insolubility (81%); and Measure 13: Require non-
bacterial in vitro gene mutation study (77%). For more detail about the Public Consultation, refer to Appendix V 

97 

 
 
 
 
 
                                                 
In contrast, this option is considered as contributing to the safe use of nanomaterials (in 63% 
of respondents). There is here a clear difference of perception between industry and the rest of 
stakeholders: two thirds of the respondents from  industry consider this option as not having 
any  impact  on  safety,  whereas  among  academic  institutions,  consumer  associations, 
government authorities, NGOs and individual citizens, almost all the answers recognize that it 
increases or significantly increases safety. The remark for safety extends to the perception of 
how this option impacts on efficiency.  

Graph 9.5-8: Option 4 - Safety 

40
35
30
25
20
15
10
5
0

Don't know

--

-

0

+

++

Special  mention  is  to  be  made  to  the  measure  requiring  the  inclusion  of  information  on 
dustiness120,  which  is  considered  as  having  the  most  impact  on  safety  (for  91%  of  the 
respondents) and as providing the highest increase in efficiency (74%). 

9.5.4.3  Option 5 

For a large number of the respondents (40%), option 5 would have no impact on the costs of 
compliance.  

The  perception  that  this  option  will  not  have  any  impact  on  costs  is  especially  true  among 
industrial  associations  (58%).  Moreover,  an  important  percentage  of  these  believe  that  the 
option will even help to reduce the costs of compliance (36% for Industrial associations and 
53% for Companies). 

120  Reminder:  Measure  10:  Include  information  on  dustiness;  for  a  further  detail  on  the  measures,  refer  to 
Appendix I 

98 

 
 
 
                                                 
Graph 9.5-9: Option 5 - Costs 

40
35
30
25
20
15
10
5
0

Don't know

++

+

0

-

--

Three measures out  of the 21 that  are contained in  this option stand out  for stakeholders  as 
impacting  most  positively  on  the  cost  of  compliance,  and  these  refer  to  the  reduction  of 
methods  for  nanomaterial  combination,  the  consideration  of  aggregates  as  constituent 
particles and the omission of mutagenicity and acute toxicity tests for lower tonnages.121 

However, the option is ranked as the lowest in terms of safety. 

9.5.4.4  Option 6 

Graph 9.5-10: Option 6 – Costs  

40
35
30
25
20
15
10
5
0

Don't know

++

+

0

-

--

This option comes on a second place in the overall assessment of options by the public. 

The  observations  are  similar  to  those  already  stated  for  option  4:  high  reluctancy  from 
industrial associations and private companies, good acceptance from the rest of stakeholders 
regarding its impacts on safety and efficiency. 

121  Reminder:  Measure  36:  Reduce  the  set  of  combined  methods  for  determination  whether  a  material  is  a 
nanomaterial (Nanomaterial definition, EU/2011/696) to only one (e.g. DLS); Measure 37: For the purposes of 
REACH,  consider  aggregates  as  constituent  particle  (primary  particle)  in  the  nanomaterial  definition 
(EU/2011/696);  and  Measure  38:  Omit  mutagenicity  and  acute  toxicity  tests  in  lower  tonnages.  No  skin 
irritation, skin corrosion or in vivo eye irritation information required for 10-100 t/y if the assessments in 1-10 t/y 
has been negative; for a further detail on the measures, refer to Appendix I. 

99 

 
 
 
 
                                                 
9.5.5 

Assessment of the measures 

9.5.5.1  Option 2: relation of answers per measure 

Specific Measures 

a)  Explicitly  require  registrants  to  describe  the  scope  of 
the registration dossier 
b)  Explicitly  require  registrants  to  provide  more  detailed 
characterisation of nanomaterials/nanoforms 
c)  Require  that  nanoforms  are  explicitly  addressed  in  the 
endpoint sections 
d)  Require  detailed  description  of  the  test  material  / 
sample and sample preparation 
e)  Require  scientific  justifications  for  grouping  /  read-
across  /  QSAR  and  other  non-testing  approaches  for 
different forms 
f)  Require  considerations  of  most  appropriate  /  relevant 
metric with preferable presentation in several metrics 
g)  Require  that  bioaccumulation  is  addressed  specifically 
for the nanoform 
h)  Specify 
that  absorption/desorption  behaviour  of 
nanomaterials should  not be assessed based on Kd  values 
derived from Koc and Kow 
i) Require identification of uses and exposure assessment 
of the nanoform 

Impact on 
Cost122 
35% 

Impact on 
Efficiency 
54% 

Impact on 
Safety 
49% 

67% 

72% 

60% 

52% 

57% 

77% 

52% 

55% 

50% 

52% 

48% 

42% 

45% 

40% 

57% 

57% 

54% 

52% 

49% 

58% 

51% 

76% 

64% 

71% 

9.5.5.2  Option 3: perception of the impact on safety according to companies 

Business Respondents by Company Size 
Large: >250 

Don't know 
Have no impact on the safe use of nanomaterials 
Increase the safe use of nanomaterials 

Medium: <250 
Don't know 
Increase the safe use of nanomaterials 
Significantly increase the safe use of nanomaterials 

Micro: <10 

Have no impact on the safe use of nanomaterials 
Increase the safe use of nanomaterials 

Small: <50 

Have no impact on the safe use of nanomaterials 
Significantly reduces the safe use of nanomatrials 

Grand Total 

Total 

23 
4 
11 
8 
5 
1 
3 
1 
2 
1 
1 
4 
3 
1 
34 

9.5.5.3 Option 4: relation of answers per measure 

Specific measures 

a) Include information on dustiness 
b) Require acute toxicity data for the most relevant route 
of exposure 
c)  Change  ‘particles’  to  ‘(nano)  particles’  for  repeated 
dose toxicity studies (inhalation) 
d) Require non-bacterial in vitro gene mutation study  

Impact on 
Cost 
70%  
72%  

Impact on 
Safety 
91% 
68% 

Impact on 
Efficiency 
74%  
50%  

71%  

77% 

54%  

75% 

46%  

63% 

122 The higher the rating, the more the measure is considered as having negative impact on cost of compliance 

100 

 
 
                                                 
e) Consider water solubility in relation to test waiving 
f)  Specify  that  long  term  testing  should  not  be  waived 
based on lack of short term toxicity 
g) Specify  that algae testing should not be  waived based 
on insolubility 
h) Require that testing on soil and sediment organisms is 
prioritised  
i)  Require  consideration  of  most  appropriate  /  relevant 
metric with preferable presentation in several metrics 

35%  
72%  

81% 

83% 

65%  

9.5.5.3  Option 5: relation of answers per measure 

52%  
59%  

56%  

53%  

60%  

58%  
43%  

46%  

46%  

47%  

Specific measures 

Impact on 
Cost123 

Impact on 
Efficiency 

Impact on 
Safety 

a)  Describe  whether  and  which  different  nanoforms  are 
covered  in  the  chemical  safety  assessment,  including  a 
statement  when and how information on one  form is used 
to demonstrate safety of other forms  

b)  Specify  that  nanoform  specific  information  is  required 
only when an insoluble or poorly soluble nanoform put on 
the market is classified hazardous/ dangerous  

c)    Specify  that  a  coated  nanomaterial  is  considered  as  a 
special  mixture  e.g.  in  classification  and  labelling  as 
accepted e.g. alloys 

11% 

62% 

20% 

34% 

53% 

36% 

23% 

30% 

38% 

d) Specify that the granulometry concept in 7.14 of Annex 
VII includes also shape and surface area of nanomaterials  

7% 

44% 

29% 

e) Specify that the information on dustiness is required for 
nanoforms  only  where  relevant  for  the  worker  safety 
assessment - 

f)  Specify  that  waiving  of  endpoint  specific  information 
requirements  for  classified  insoluble  or  poorly  soluble 
nanoforms  applies  as  for  any  other  forms  and  also  when 
nanoforms  do  not  significantly  differ  from  each  other  in 
specific endpoints  

g)  Specify  that  the  use  of  non-testing  methods  (e.g.  read-
across, grouping, categorisation etc. methods) is a priority 
for nanoforms - 

h) Specify and require explicitly that waiving of testing on 
the basis of exposure conditions and categories applies also 
in  particular  when  nanoforms  are 
for  nanoforms, 
completely reacted (cured), incorporated or embedded into 
a  completely  cured  matrix  or  permanent  solid  polymer 
forms,  or  otherwise  used  in  closed  systems  or  controlled 
conditions  

21% 

47% 

38% 

32% 

30% 

40% 

31% 

44% 

41% 

34% 

39% 

32% 

123 The higher the rating, the less the option is considered as having negative impact on cost of compliance 

101 

 
 
                                                 
i)  Specify 
that  absorption/desorption  behaviour  of 
nanoforms  can  be  based  on  biological  surface  adsorption 
index, affinity coefficient or other relevant parameters  

17% 

17% 

32% 

j)  No  specific  obligations  for  nanoforms  in  1-10  tonnage 
band -single choice reply- (compulsory) 

24% 

19% 

50% 

k)  No  specific  obligations  for  nanoforms  in  10-100 
tonnage band  

25% 

14% 

51% 

l)  No  nanomaterial  specific  obligations  for  2nd  exposure 
route at 10-100 tonnage band for acute toxicity  

24% 

14% 

39% 

that 

information  generated  according  to 
m)  Specify 
existing test guidelines and/or test methods is sufficient for 
the purposes of hazard assessment of nanomaterials under 
REACH  

n) A nanoform consisting of aggregates is considered same 
as  bulk  form  and  the  same  endpoint  information  for 
(eco)toxicological and environmental fate apply  

30% 

32% 

39% 

45% 

44% 

42% 

o)  No  specific  obligations  for  nanoforms  to  provide 
ecotoxicological and environmental fate information  

27% 

21% 

48% 

p)  Create  presumption  that  non-testing  methods  are  valid 
for nanomaterials in all endpoints  

34% 

20% 

64% 

q)  Amend  the  granulometry  information  requirements  in 
Annex  VII  (1-10  tonnage  band)  for  nanomaterials  in  line 
with  Annex  II,  Section  9.1.a  of  REACH  on  Safety  Data 
Sheet  and  respective  ECHA  Guidance  on  Compilation  of 
Safety Data Sheets  

r)  Specify  explicitly  that  coating  agents  of  nanoforms  are 
registered separately in line with practices already accepted 
for e.g. alloys  

s)  Reduce  the  set  of  combined  methods  for  nanomaterial 
determination  (Nanomaterial  definition,  EU/2011/696)  to 
only one (e.g. DLS) - 

t)  For  the  purposes  of  REACH,  consider  aggregates  as 
constituent  particle  (primary  particle)  in  the  nanomaterial 
definition (EU/2011/696)  

u)  Omit  mutagenicity  and  acute  toxicity  tests  in  lower 
tonnages.  No  skin irritation, skin corrosion or in  vivo eye 
irritation  information  required  for  10-100  t/y  if  the 
assessments in 1-10 t/y has been negative  

9.5.5.4  Option 6: relation of answers per measure 

Specific measures 

102 

11% 

33% 

31% 

17% 

25% 

33% 

53% 

22% 

47% 

47% 

45% 

40% 

69% 

46% 

44% 

Cost - 
'greatest 
increase in 
cost 

Efficiency - 
'greatest 
increase in 

Safety - 
'highest 
increase in 

 
 
burden' 

efficiency' 

safety' 

a)  Apply  clear  rules  on  when  nanoforms  can  be  in  one 
dossier  or  in  separate  ones  based  on  possibility  for  data 
sharing 

49% 

49% 

49% 

b.) Introduce rules to ensure mandatory separation between 
nanoforms 
the  dossier 
whenever they differ in coating, shape, crystalline form or 
prescribed classes of particle size distribution  

identified  and  addressed 

in 

64% 

42% 

55% 

c)  Information  requirements  for  substances  covered  by 
Annex III (b) must also apply to nanoforms  

69% 

39% 

61% 

d)  For  nanoforms,  require  all  information  on  potential 
alterations  of  hazard  due 
to  operational  conditions 
upstream the exposure situation is considered  

e) For nanoforms, require all available information on the 
use is considered, even when the use would not be covered 
by the registration  

f)    For  nanoforms,  require  additional  physic-chemical 
characterisation  along  the  particle's  fate  when  particle 
properties impacts on hazard  

69% 

40% 

62% 

85% 

39% 

48% 

53% 

42% 

76% 

g)  Phys-chem,  (eco)tox  and  CSA  documented  separately 
for each nanoform  

80% 

42% 

51% 

h)  For  nanoforms,  explicitly  limit  the  potential  for  use  of 
non-testing  approaches  for  hazard  and  exposure  where 
science  is  not  consolidated,  but  encourage  its  parallel 
application and documentation  

75% 

38% 

49% 

i) Require adapted DNEL setting based on different routes 
through the value chain / specific uses - 

62% 

38% 

56% 

j) Add to the SDS information relevant to Nano registries 
in Member States  

63% 

40% 

46% 

k) Specify that list of substances in Annexes IV and V does 
not cover nanoforms of these substances  

73% 

42% 

44% 

l) Choose inhalation as the appropriate route of exposure in 
repeated  dose  toxicity  study  unless  such  exposure  can  be 
excluded.  

61% 

42% 

67% 

m) Perform toxicokinetic screening  

n) For nanoforms, request 28 day repeated dose toxicity in 
Annex VII  

82% 

87% 

47% 

40% 

63% 

65% 

9.5.5.5  Perception  of  the  options  in  terms  of:  Cost,  Safety  and  Efficiency,  per  category  of 

respondent (number of received responses) 

Option 2 

COST (question #21.j) 

SAFETY (question #22.j) 

EFFICIENCY (question #23.j) 

103 

 
 
-- 

- 

0 

+ 

Academic/research 
institution 
Consumer 
association 
Government 
authority 
Industrial or trade 
association 
NGO 

Other 

0 

0 

1 

1 

1 

6 

23 

10 

0 

1 

2 

6 

Private company 

19 

13 

Individual citizen 

5 

6 

49 

45 

2 

0 

8 

1 

7 

6 

0 

14 

38 

0 

0 

0 

0 

1 

0 

0 

0 

1 

++  Don't 
know 
1 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

2 

2 

0 

1 

2 

1 

9 

++  + 

0 

- 

2 

0 

3 

1 

8 

9 

0 

17 

40 

2 

1 

12 

0 

0 

0 

13 

20 

1 

3 

1 

1 

15 

16 

8 

0 

55 

38 

0 

0 

0 

0 

0 

0 

0 

0 

0 

--  Don't 
know 
0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

2 

2 

0 

1 

3 

1 

9 

++  + 

0 

- 

2 

0 

4 

1 

8 

6 

0 

14 

35 

2 

1 

12 

5 

1 

6 

4 

7 

0 

0 

0 

19 

0 

0 

0 

0 

0 

9 

1 

1 

11 

12 

2 

2 

38 

32 

25 

--  Don't 
know 
0 

0 

0 

0 

0 

0 

0 

1 

0 

1 

0 

1 

2 

0 

1 

6 

1 

11 

Total 

Option 3 

Academic/research 
institution 
Consumer 
association 
Government 
authority 
Industrial or trade 
association 
NGO 

Other 

Private company 

Individual citizen 

Total 

Option 4 

Academic/research 
institution 
Consumer 
association 
Government 
authority 
Industrial or trade 
association 
NGO 

Other 

Private company 

Individual citizen 

Total 

Option 5 

Academic/research 
institution 
Consumer 
association 
Government 
authority 
Industrial or trade 
association 
NGO 

Other 

Private company 

Individual citizen 

Total 

COST (question #24.d) 

SAFETY (question #25.d) 

EFFICIENCY (question #26.d) 

-- 

- 

0 

+ 

0 

0 

0 

0 

0 

3 

11 

14 

0 

0 

3 

2 

1 

5 

21 

3 

16 

47 

3 

1 

10 

6 

9 

6 

3 

18 

56 

0 

0 

0 

2 

0 

2 

2 

1 

7 

++  Don't 
know 
1 

0 

0 

0 

0 

0 

0 

1 

0 

1 

0 

4 

3 

0 

1 

4 

2 

15 

++  + 

0 

- 

0 

0 

0 

0 

0 

0 

1 

3 

4 

1 

0 

11 

1 

1 

5 

14 

19 

1 

6 

12 

7 

52 

7 

3 

15 

12 

63 

2 

0 

1 

1 

2 

4 

0 

2 

12 

--  Don't 
know 
0 

0 

0 

0 

0 

0 

0 

1 

0 

1 

0 

0 

0 

0 

0 

1 

3 

4 

++  + 

0 

- 

--  Don't 
know 
0 

0 

0 

0 

0 

5 

1 

1 

9 

0 

3 

2 

0 

1 

7 

2 

1 

0 

8 

9 

1 

6 

7 

4 

1 

1 

4 

19 

0 

1 

13 

6 

2 

0 

1 

6 

3 

5 

5 

1 

36 

45 

23 

16 

15 

0 

0 

1 

0 

1 

0 

1 

4 

7 

COST (question #27.j) 

SAFETY (question #28.j) 

EFFICIENCY (question #29.j) 

-- 

- 

0 

+ 

0 

0 

1 

1 

1 

7 

19 

14 

0 

2 

18 

5 

45 

9 

6 

14 

16 

68 

2 

0 

7 

1 

1 

5 

0 

4 

20 

0 

0 

0 

0 

0 

0 

0 

0 

0 

++  Don't 
know 
1 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

2 

2 

0 

1 

2 

1 

9 

++  + 

0 

- 

2 

1 

5 

1 

7 

6 

1 

19 

42 

2 

0 

11 

0 

0 

0 

10 

23 

1 

8 

1 

0 

11 

19 

5 

1 

48 

44 

0 

0 

0 

0 

1 

0 

0 

0 

1 

--  Don't 
know 
0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

1 

2 

0 

0 

3 

1 

7 

++  + 

0 

- 

2 

1 

2 

4 

8 

6 

0 

15 

38 

1 

0 

12 

4 

0 

1 

6 

8 

1 

0 

1 

9 

0 

4 

6 

0 

0 

0 

0 

17 

2 

2 

14 

2 

32 

21 

37 

--  Don't 
know 
0 

0 

0 

0 

1 

0 

0 

4 

0 

5 

0 

2 

1 

0 

1 

4 

1 

9 

COST (question #30.v) 

SAFETY (question #31.v) 

EFFICIENCY (question #32.v) 

-- 

- 

0 

+ 

3 

0 

1 

0 

0 

5 

21 

10 

3 

10 

12 

6 

0 

2 

9 

4 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

1 

3 

0 

6 

0 

3 

11 

24 

++  Don't 
know 
1 

0 

0 

1 

3 

1 

1 

7 

0 

0 

7 

2 

0 

1 

3 

3 

56 

30 

13 

17 

--  Don't 
know 
0 

2 

1 

10 

1 

7 

7 

1 

14 

43 

0 

1 

1 

0 

1 

2 

2 

7 

++  + 

0 

- 

0 

0 

0 

3 

1 

0 

3 

4 

1 

0 

1 

22 

0 

2 

1 

0 

1 

9 

1 

0 

17 

10 

3 

3 

0 

0 

6 

1 

1 

4 

2 

1 

11 

46 

25 

15 

--  Don't 
know 
0 

2 

1 

7 

1 

7 

7 

0 

13 

38 

0 

2 

0 

0 

1 

2 

2 

7 

++  + 

0 

- 

0 

0 

0 

0 

2 

0 

0 

4 

6 

1 

0 

1 

3 

0 

0 

0 

0 

0 

29 

1 

2 

10 

17 

2 

0 

1 

0 

5 

2 

0 

4 

4 

4 

17 

49 

20 

104 

 
 
 
 
 
 
Option 6 

COST (question #33.o) 

SAFETY (question #34.o) 

EFFICIENCY (question #35.o) 

-- 

- 

0 

+ 

Academic/research 
institution 
Consumer 
association 
Government 
authority 
Industrial or trade 
association 
NGO 

Other 

Private company 

Individual citizen 

Total 

1 

0 

1 

30 

1 

3 

27 

4 

67 

0 

1 

12 

3 

8 

6 

5 

15 

50 

2 

0 

2 

1 

1 

3 

0 

6 

15 

0 

0 

0 

0 

0 

1 

0 

0 

1 

++  Don't 
know 
1 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

2 

2 

0 

1 

2 

1 

9 

++  + 

0 

- 

2 

1 

10 

3 

8 

7 

0 

18 

49 

2 

0 

6 

5 

0 

5 

0 

0 

0 

26 

1 

1 

11 

16 

6 

1 

35 

45 

0 

0 

0 

0 

1 

0 

0 

0 

1 

--  Don't 
know 
0 

0 

0 

0 

0 

0 

0 

1 

0 

1 

0 

1 

2 

0 

1 

6 

1 

11 

++  + 

0 

- 

2 

1 

10 

3 

8 

7 

0 

18 

49 

2 

0 

6 

5 

0 

5 

0 

0 

0 

26 

1 

1 

11 

16 

6 

1 

35 

45 

0 

0 

0 

0 

1 

0 

0 

0 

1 

--  Don't 
know 
0 

0 

0 

0 

0 

0 

0 

1 

0 

1 

0 

1 

2 

0 

1 

6 

1 

11 

105 

 
 
 
 
9.6 

APPENDIX  VI:  Undertaken  actions  to  ensure  the  quality  of  the  registration 
dossiers  

The  safe  use  of  all  substances  under  REACH,  including  substances  with  nanoforms,  starts 
with  compliant  high  quality  registration  dossiers.  There  are  further  tools  provided  under 
REACH to address deficiencies:  

i.  Request for complementing information 

Sometimes, the lack of explicit provisions under REACH for substances with nanoforms may 
be  dispelled  by  the  application  of  Article  36  that  enables  ECHA  and  Member  States 
Competent Authorities to request complementing information in the dossier by other available 
information.  This  procedure  has  already  been  used  by  ECHA,  requesting  clarity  on  the 
physico-chemical  properties  of  the  registered  substances  with  suspected  nanoforms,  a 
precondition for adequate chemical safety assessment. 

ii.  Evaluation 

Examination of testing proposal Highest tier testing under REACH requires pre-submission of 
a testing proposal that is examined by ECHA, which verifies whether it adequately covers the 
endpoint for the substance (in all its forms) and that may result in acceptance, amendment or 
rejection of the proposed tests.  Such examination ensures that at  least  in  highest  tier testing 
any  specificity  required  for  nanoforms  covered  by  the  registration,  even  when  potentially 
omitted by the registrant, is accounted for, provided that the scope of the dossier as regards 
their coverage is transparent to ECHA. 

Compliance  check  In  compliance  check,  ECHA  determines  whether  or  not  the  information 
submitted  in  the  selected  subset  of  registration  dossiers  is  in  compliance  with  standard  (i.e. 
minimum)  requirements  of  REACH.  Such  checks  are  able  to  address  substance  identity, 
information  gaps,  but  also  inappropriate  use  of  adaptation  possibilities  such  as  waivers, 
weight of evidence or read-across that may represent challenges when applied to substances 
with  nanoforms.  Only  a  limited  percentage  of  dossiers  is  however  annually  subject  to  this 
resource intensive scrutiny124.  

CoRAP Where 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  further 
measures  are  introduced,  ECHA,  in  cooperation  with  the  Member  States,  can  add  the 
substance to the Community Rolling Action Plan (CoRAP). This enables the substance to be 
evaluated under substance evaluation, where the potential request to the registrants to generate 
the  necessary  information  is  not  restricted  to  the  standard  information  requirements  of 
Annexes VII-X under REACH. 

124 Compliance check strategy is multifaceted and complex: high percentage of dossiers may be investigated in a 
targeted fashion (only selected endpoints) and individual chemical families of known substances with nanoforms 
may be selected for particular scrutiny. Legal obligation is however limited to 5% of the dossiers annually. For a 
good  overview  of  the  activity  see  the  ECHA  Report  Evaluation  under  REACH:  Progress  report  2017  that 
includes also a 10-year review.  

106 

 
 
                                                 
Dossiers with substances with nanoforms have been selected for both dossier evaluation and 
substance evaluation125.  

iii.  Other tools 

In addition to these legal tools, ECHA has taken steps to support registrants' efforts to provide 
quality  dossiers  with  substances  with  nanoforms  also  via  other  means,  such  as  the  standing 
Working  Group  on  nanomaterials  that  discusses  open  sci-technical  questions  in  relation  to 
nanomaterials  under  REACH,  and  the  Group  Assessing  Already  Registered  Nanomaterials 
(GAARN),  established  with  a  view  to  discuss  and  learn  best  practices.  It  is  hoped  that  the 
participating  firms,  in  liaison  with  their  umbrella  organisations  involved  in  the  general 
discussions, will help other firms to update their dossiers and that future dossiers will build on 
current best practise experiences. The same applies of course for the continuous commitment 
of ECHA to improve guidance and apply its communication strategies to raise awareness. 

125 By March 2018, 4 lead dossiers for substances with nanoforms have been subject to compliance check, while 
seven substances with nanoforms have been put on CoRAP or already in substance evaluation.  

107 

 
 
                                                 
9.7 

APPENDIX VII: 2013 BiPRO report: costs and benefits for industry of option 4  

9.7.1  Costs of the measures 

According to the 2013 BiPRO report, the total costs for implementing the measures which are 
foreseen in this option amount to between €11 million and €73 million as a cumulative effort 
for all concerned companies for a time period until 2022.  

These cost calculations were made in 2012, predominantly based on previous figures used by 
the industry in 2011126. The industry estimated that between 500 – 2.000 nanomaterials would 
be  subject  to  registration  pursuant  to  REACH.  These  figures  have  not  been  validated,  but 
based on the first two registration rounds the number of nanomaterials seems to be high. This 
can partly be explained by some assumptions about substance ID that were being discussed by 
the time the CEFIC study  was  commissioned, but  since then have been (partially) clarified, 
leading to many nanomaterials now being regarded as forms of the very same substance. 

The split of total costs on single measures shows big differences between options with high or 
medium efforts, and hence high or medium costs, and options with no or very little additional 
costs.  
Overview of the measures costs in Policy Option 4127 

#  Measure 

10 

Include information on dustiness 

Human health hazards 

Additional 
costs (€ 1.000) 

210 - 640 

11  Require acute toxicity data for the most relevant route of exposure 

1.280 – 9.400 

12  Change  ‘particles’  to  ‘(nano)particles’  for  repeated  dose  toxicity 

0 

studies (inhalation) 

13  Require non-bacterial in vitro gene mutation study 

2.000 – 9.600 

Environmental fate & hazards 

14  Consider water solubility in relation to test waiving 

5.090 – 29.540 

15  Specify  that  long  term  testing  should  not  be  waived  based  on  lack  of 

1.800 – 15.270 

short term toxicity 

16  Specify that algae testing should not be waived based on insolubility 

0 

17  Require that testing on soil and sediment organisms is prioritised 

770 – 7.660 

126  Impact  Assessment  of  the  REACH  Implementation  Project  on  Substance  ID  for  Nanomaterials,  RPA  on 

behalf of CEFIC, March 2012 

127  Measure  21  has  been  withdrawn  from  the  calculations,  as  it  is  not  one  of  the  measures  finally  included  in 

Option 4 

108 

 
 
                                                 
Resulting additional costs for industry 

11.200 
72.200 

– 

The assessed costs take into consideration an extensive grouping and read-across approach, as 
specified in the provisions of the REACH Regulation. Without this approach, the final costs 
would increase up to €100 million and €600 million. 

9.7.2 

Benefits of the measures 

According to the same 2013 BiPRO report, the quantification of total benefits of the measures 
in  monetary  terms  is  hampered  by  considerable  uncertainties.  The  dimensions  of  additional 
costs can be compared to expected revenues of concerned companies in that period of about 
€40  billion.  The  revenues  are  assumed  and  extrapolated  on  the  basis  of  the  current  global 
turnover  for  nanomaterials  (worth  €20  billion  per  year)  and  the  current  share  of  European 
chemicals  market  to  the  global  chemicals  market.  Related  to  health  benefits,  an  average  of 
€165 million (with a range between €83 million and €248 million) for cumulative savings for 
a period until 2042 could be calculated. It needs to be mentioned that, due to latency effects, 
most of the health benefits are expected to occur with significant delays after implementation 
of  the  measures.  It  needs  to  be  further  mentioned  that  health  benefits  do  not  automatically 
occur as a consequence of the measures but will be achieved only if appropriate risk reduction 
measures  are  taken,  which  in  turn  could  lead  to  additional  costs.  It  is  estimated  that  the 
increase of health benefits per substance in  average will amount to about 20% of the health 
benefits per substance to be obtained as the total potential of REACH. This share is based on 
a  judgment  of  a  plausibility  range  between  10%  and  30%,  estimated  during  a  set  of  expert 
interviews. 

Besides the quantifiable benefits, additional added value is expected through implementation 
of the proposed measures. This concerns in particular the reduction in uncertainty regarding 
potentially adverse effects on the environment and the increased ability to react promptly and 
appropriately  in  cases  where  risks  are  suspected  or  identified.  Furthermore,  increased 
knowledge  is  likely  to  stimulate  innovation  processes  within  companies  searching  for  new 
and  better  solutions.  Nanoforms  identified  as  being  hazardous  to  human  health  and/or  the 
environment can be subject to substitution activities within the concerned companies. It will 
consequently help to improve the image of companies in the public view and provide options 
for  concerned  companies  to  communicate  that  non-hazardous  nanoforms  are  used  in  the 
manufacturing  process.  The  conclusion  is  that  these  non-quantifiable  effects  should  not  be 
neglected.  

109 

 
 
9.8 

APPENDIX  VIII:  Nanoforms,  sets  of  nanoforms  and  the  importance  of 
characterisation 

The diagram describes the main terms used in the document, describing the relation between 
the substance, registration, nanoform and set of nanoforms used in the main text also as the 
unit in calculating impacts.  

In a simple picture of one registrant registering a substance, the diagram represents the scope 
of the registration by outlining the different forms the registrant is putting on the market. The 
information in the dossier is expected to cover (eco)tox information of all forms. While forms 
are all the same substance, they differ in different ways that may affect hazard or risk of the 
form. To ensure that the relevant hazard information in the dossier (e.g. toxicology testing) is 
associated  with  the  use,  risk  and  risk  management  of  the  material  on  the  market,  the  forms 
themselves  need  to  be  described  so  they  can  serve  as  'assessment  entities',  linking  the 
information.  

Description  is  done  by  the  use  of  characterisers  –  quantifiable  properties  that  can  be 
attributed to each nanoform, such as particle size or shape. As shown in the picture, a set of 
nanoforms can be unambiguously described by providing ranges for the characterisers; all 
nanoforms  that  fall  within  the  ranges  belong  to  the  set.  Ranges  are  not  prescribed;  the 
registrant is expected to define them in a way that any information requirement in a dossier 
can be effectively fulfilled for a complete set by a single piece of information.  

There may be several non-overlapping sets in the single dossier – they are defined separately 
as it is expected that the corresponding hazard or risk information may differ between them. 
This makes the set a best possible unit for the assessment of impacts.  

It is clear however that the difference in the properties between forms/sets may be only on a 
very specific information requirement and that for many if not most information requirements, 
the information  may be  shared between them or  even with  information  for other substances 
(grouping). In the same manner, a 'worst case' form may often (but not necessarily always) be 
identified in advance of testing, reducing a necessary dataset required to cover all registered 
forms.  

110 

 
 
Graph 9.8-1: The nanoform/set registration 

This  picture  applies  to  individual  registration  of  a  substance,  but  can  as  well  apply  to  joint 
registrations and multiple registrants.  

The difference is that in joint dossiers, the nanoform or set of nanoforms is used as the basis 
for the information requirements within a joint submission. In the adjoint individual dossiers, 
the sets are only used to describe the scope of the individual registration dossier, to indicate 
uses-per form, and to enable the link with the relevant  information requirements in the joint 
dossier.  

Hence  not  all  forms/sets  from  joint  registration  are  necessarily  included  in  every  individual 
registration,  In contrast,  the sets  in  the joint  dossier are  expected to  cover all the individual 
forms/sets of the registrations in the joint submission. 

111 

 
 
 
9.9 

APPENDIX IX: Assessment of non-significant impacts 

9.9.1 

Functioning of internal market and competition 

9.9.1.1  General comments 

Given the nature of all the options i.e. committee changes to some technical provisions of an 
already established internal market based Regulation, neither of the measures as such lead to 
any  principal  changes  of  the  functioning  of  the  internal  market.  However,  in  light  of  the 
current regulatory uncertainty there is a risk that some Member States may introduce national 
based measures to counteract political pressures which may have significant negative internal 
market effects. This has not yet happened, but closely related to this area it is noteworthy that 
three EU Member States have enacted or at least notified their intentions to introduce specific 
reporting obligations for nanomaterials. 

9.9.1.2  Option 2 

Analysis. In principle, the clarification involved in this option may foster an increment in the 
circulation  of  goods,  due  to  increased  confidence  across  borders  with  regards  to  product 
characteristics  and  safety.  There  are  no  concrete  data  at  the  moment  validating  this 
hypothesis.  

Competition could decrease if some firms are driven out of the market. However, if reduced 
uncertainty  over  the  registration  process  leads  to  more  registrations  then  it  would  increase. 
Overall,  for  an  option  aimed  specifically  at  reducing  uncertainty,  the  impacts  should  be 
marginally positive.  

9.9.1.3  Option 3 

Analysis.  We  do  not  anticipate  significant  impacts  on  the  viability  of  SMEs  and  hence  on 
market structure under option 3. On the other hand, there could be positive effects in terms of 
easier circulation of goods in presence of greater clarity, if the latter results from “soft law” 
measures.  

9.9.1.4  Option 4 

Analysis. The effect on consumer confidence and hence on the circulation of goods described 
above in reference to option 2 would be potentially stronger under option 4, especially due to 
its greater focus on a thorougher (data basis for) chemical safety assessment.  

On the other hand, the possible effects on businesses and in particular on SMEs, in particular 
for substances with nanoforms subject to Annex VIII or VII as a result of increased upfront 
(registration)  costs  for  using  nanomaterials,  could  also  change  the  competitive  landscape  in 
several sectors, leading to greater market concentration in the manufacturing and importing of 
nanomaterials. Higher market concentration could also entail higher prices downstream in the 
supply chain. - 
9.9.1.5  Option 5 

Analysis.  Almost  half  of  the  respondents  (large  majority  when  industry  is  excluded)  to  the 
public  consultation  express  the  belief  that  safety  in  the  use  of  nanomaterials  could  be 
undermined.  Uncertainties  could  in  turn  undermine  the  circulation  of  goods  due  to  possible 
higher uncertainties with regards to safety. Market concentration is unlikely to be affected; in 
fact, existing fragmentation in many EU sectors could even rise if lower costs boost market 
access. 

112 

 
 
9.9.1.6  Option 6 

Analysis. The further increment in requirement established under option 6 could enhance the 
magnitude of the effects mentioned under option 4 in terms of market concentration (mainly 
due to possible exit of SMEs which are negatively affected by this option), and hence prices 
charged to downstream users.  

9.9.2 

Impacts on consumers 

Analysis. The costs involved for the different options are fixed, meaning that, once a firm has 
to  engage  in  costly  activities  determined  under  an  option,  increasing  further  its  level  of 
production using the same substances does not involve any additional cost. This implies that 
changes in the fixed cost are less likely to lead to changes in the profit-maximising sale price 
faced by consumers.  

On  the  other  hand,  increases  in  market  concentration  that  may  arise  under  option  4,  and 
especially under option 6 (because of the possible exit from the market of some firms), could 
lead to higher prices. Limitations in data and high variability in the markets affected prevent 
the drawing of clear-cut conclusions. 

As well as prices, the other impacts on consumer relate to information and protection. At this 
stage we do not have enough information to establish ex ante, for each option, to which extent 
consumers  are  likely  to  receive  and  benefit  from  information  specifically  referred  to 
nanomaterials. More, differentiated information leads to increased security and reassurance to 
immediate customers and to the public directly or indirectly in contact with the relevant types 
of nanoforms. This contributes to a better informed and more differentiated opinion, attitude 
and level of awareness of customers and consumer protection organisations, showing that not 
all  nanomaterials  per  se  are  dangerous  or  problematic.  Products  with  nanomaterials  having 
been  tested  and  proved  to  be  non-problematic  will  gain  a  higher  and  sustainable  degree  of 
public acceptance. This also increases the trust in industry and authorities. 

Finally,  availability  of  different  substances  to  buyers  of  intermediate  goods  could  also  be 
affected.  We  note  that  the  previous  KPMG  impact  assessment  on  REACH  reports  that  case 
study analysis provides no indication of future significant impacts in terms of availability of 
substances. While we cannot provide further evidence in that respect, we argue that increased 
information  on  nanomaterials  arising  from  options  establishing  stronger  test  requirements 
could increase knowledge base and future product development. 

The effects of the options on health and safety are discussed in more detail among the social 
impacts. 

9.9.3 

Public authorities 

The  role  of  public  authorities  is  to  assess  compliance  and  to  pursue  the  objectives  of  the 
legislation.  By  doing  so,  public  authorities  incur  costs.  Since  we  do  not  have  information 
related  to  these,  we  provide  below  a  qualitative  reasoning.  However,  as  the  options  aim  to 
create  more  clarity  on  what  to  be  expected  it  is  anticipated  that  the  overall  compliance  and 
enforcement  costs  for  public  authorities  will  go  down.  It  is  even  possible  in  cases  of  more 
vigorous  testing  that  it  will  off-set  needs  for  substance  evaluation  which  further  will 
significantly cut cost for the competent authorities. 

9.9.4 

Employment and labour markets 

The  development  of  nanotechnology  is  increasingly  associated  with  job  creation,  as 
mentioned  in  the  problem  definition  section.  Modification  in  regulatory  requirements 

113 

 
 
regarding  nanomaterials  may  ease  or  hamper  job  creation,  in  firms  specialised  in 
nanotechnologies  and  in  the  other  businesses  operating  with  nanoforms.  Data  on  the 
workforce involved in testing are very limited, and it is impossible to quantify likely effects. 
We provide here a qualitative evaluation of the mechanisms behind effects in labour market. 

Among  previous  studies,  the  CSES  interim  evaluation  reports  a  downward  trend  in 
employment in the chemical sectors that is not, in principle, associated to REACH, but rather 
to a long-term relocation trend of activities outside Europe, mainly into Asia, and increases in 
productivities leading to less need for workers. On the other hand, REACH also leads to the 
creation  of  specialised  units  within  firms  devoted  to  regulatory  requirements.  Specific 
requirements for substances with nanoforms are likely to show similar effects. 

The  assumption  used  here  is  that  increases  in  the  details  regarding  nanoforms  would  create 
demand for professional services  related to  registration and testing.  This  would be the most 
direct  effect.  The  extent  of  the  positive  impacts  of  this  increase  in  demand  on  employment 
and salaries depend on several factors, including  the landscape in specific sectors and in the 
overall economy. 

The  magnitude  of  salary  growth  depends  on  whether  there  is  a  “reserve”  of  unemployed 
people  with  required  professional  characteristics,  in  which  case  salary  rates  would  remain 
largely unaffected, or if on the contrary there is scarcity of available workers, in which case 
firms  will  need  to  compete  to  attract  them.  Situations  in  EU  labour  markets  widely  vary 
across  countries  and  regions,  and  we  anticipate  that,  in  presence  of  high  unemployment, 
effects  will  mainly  involve  increase  in  employment  rather  than  in  salaries;  vice-versa  in 
contexts with low unemployment. 

Labour  demand  would  increase  even  more  if  increases  in  buyers’  confidence  determine  an 
expansion in the markets for goods produced using nanomaterials.  

On the other hand, if some of SMEs involved in the supply of nanomaterials close down as a 
result of higher costs, this would shift downward the labour demand in the sectors affected, 
with negative impacts on employments and salary rates. 

Given the context of all the measures that are technical changes to an existing Regulation is it 
not possible to extrapolate meaningful job figures at EU level. All the options will entail the 
characteristics  described  above  but  none  of  them  stands  out  based  on  the  information 
currently available. It is therefore assumed that the overall impact on employment and labour 
markets is negible for all the options. 

9.9.5 

Standards and rights related to job quality 

9.9.5.1  Introduction 

The job quality dimension mainly involves safety in relation to the manipulation of substances 
containing  nanomaterials.  The  2003  Commission  Staff  Working  Paper  presented  the 
“Extended  Impact  Assessment” of REACH128 mentions  that “it is impossible to  identify the 
benefits that will arise from REACH” (p.25). It is even harder to establish and quantify health 
benefits for workers from modifications accounting for the specificities of nanomaterials.  A 
document  by  the  European  Trade  Union  Institute129  underlines  that  nanoparticles  pose 

128 COM (2003) 644 Final 
129 Ponce del Castillo, A.M. (2013): “Nanomaterials and workplace health & safety. What are the issues for the 

workers?” European Trade Union Institute. 

114 

 
 
                                                 
potential dangers additional to the ones already recognised in current REACH regulation with 
regards  to  chemical  substances.  Inhalation  is  the  main  route  to  exposure  to  nanoparticles, 
which can deposit in the respiratory tract and also be transported to other organs, as they can 
easily enter the blood stream. Ingestion and absorption through skin are other potential entry 
routes, from which nanoparticles can enter the blood stream. Therefore nanomaterials could in 
principle  exacerbate  the  occupational  dangers  inherent  in  the  manipulation  of  chemical 
substances. 

9.9.5.2  Option 2 

Analysis. Increases in the details regarding nanoforms, defined under option 2, would create 
limited  additional  demand  for  professional  services  related  to  registration  and  testing.  This 
would be the most direct effect. However, the number of jobs created would be fairly limited 
as  there  would  be  little  or  no  additional  expenditure  compared  to  what  is  expected  already 
now.  

The  potentially  strongest  effect  would  come  from  an  increase  in  productions  related  to 
increased confidence in the properties of nanomaterials.   

On the other hand, if some of SMEs involved in the supply of nanomaterials close down as a 
result of higher costs, this would reduce labour demand. 

9.9.5.3  Option 3 

Analysis. The soft-law approach could in principle entail some limited health impact. A full-
fledged  analysis  cannot  be  developed  without  knowing  ex  ante  which  types  of  measures 
would  be  developed.  However,  as  the  requirements  to  be  clarified  equals  those  that  are 
applicable  in  option  2  some  of  the  same  benefits  may  be  seen  but  due  to  the  non-binding 
nature  the  soft-law  approach  may  not  be  as  effective  in  delivering  exactly  because  the  core 
technical provisions will continue to be unspecific to nanoforms.  

9.9.5.4  Option 4 

Analysis.  This  option  entails  an  increase  in  requirements  with  respect  to  the  baseline.  The 
measures requiring data on dustiness (measure 10), route of exposure (measure 11) and non-
bacterial  in  vitro  gene  mutation  study  (measure  13)  could  potentially  entail  significant 
improvements  on  occupational  safety,  especially  in  terms  of  prevention  of  lung  cancer, 
ameliorating the informational asymmetries suffered in this case by workers, who may ignore 
the extent of exposure to hazardous substances.130 Those health impacts would affect workers 
in  the  chemical  sector  but  also  those  in  downstream  sectors  using  nanomaterials.  Benefits 
would also indirectly affect employers, as they are legally responsible for workplace safety, as 
specified by the European Framework Directive 89/391/EC.  

Under  this  option,  potential  risks  related  to  lung  cancer  and  other  serious  conditions, 
especially  in  relation  to  respiratory  diseases,  would  be  ameliorated.  As  is  the  case  with 
previous  evaluation  exercises  conducted  for  nanomaterials,  and  also  with  regards  to  the 
evaluation of REACH in general, it is difficult to establish to what extent occupational risk of 
a given condition is reduced under a specific regulatory option.  

130 Measure 10: Inclusion of information on dustiness; Measure 11: Requirement of acute toxicity data for the 
most relevant route of exposure; Measure 13: Requirement of non-bacterial in vitro gene mutation study; for 
a further detail on the measures, refer to Appendix I 

115 

 
 
                                                 
9.9.5.5  Option 5 

Analysis. The reduced requirements for nanoforms under this option could potentially entail a 
higher risk of disease for workers. However, previous considerations in terms of reduction of 
risk, in particular in relation to lung cancer, are reversed. Exactly because there is no clarity 
with  regards  to  actual  risks  in  relation  to  nanoforms  of  substances,  this  option  could  allow 
potential dangers to materialise. For instance, the omission of mutagenicity and acute toxicity 
tests  in  lower  tonnages  could  result  in  missing  the  identification  of  adverse  health  impacts 
(e.g. cancer) and (to a lesser extent) possibility of accidental death from acute exposure.  

9.9.5.6  Option 6 

Analysis.  Option  6  further  reinforces  the  prevention  of  disease  established  under  option  4. 
Additional  requirements  in  terms  of  physico-chemical  characterisation  (measure  44)  and 
separate  documentation  for  each  nanoform  (measure  45)  can  enhance  the  informational 
benefits of testing, and establishing inhalation as the appropriate route of exposure in repeated 
dose  toxicity  study  unless  such  exposure  can  be  excluded  (measure  50)  can  help  protecting 
from cancer and other respiratory diseases.131  

131  Measure  44:  For  nanoforms,  require  additional  physic-chemical  characterisation  along  the  particle's  fate 
when  particle  properties  impacts  on  hazard;  Measure  45:  Phys-chem,  (eco)  tox  and  CSA  documented 
separately  for  each  nanoform;  and  Measure  50:  Choose  inhalation  as  the  appropriate  route  of  exposure  in 
repeated dose toxicity  study  unless such exposure can be excluded;  for a  further detail  on  measure, refer to 
Appendix I 

116 

 
 
  
                                                 
9.10 

APPENDIX X: Summary of the Matrix Study 

This  Research  Study  has  been  undertaken  to  support  the  proposed  forthcoming  Impact 
Assessment  on  the  REACH  Regulation  as  it  relates  to  Nanomaterials  (NM),  where  the 
objective of the policy  initiative is  “to  ensure  further  clarity on how NM are addressed and 
safety demonstrated in registration dossiers”.  

The Research Study includes an assessment of future options to address NM under REACH 
while  taking  into  account,  on  the  one  hand,  the  competitiveness  of  the  European  chemicals 
and  NM  sector,  innovation  and  employment,  including  SME-specific  impacts,  and  on  the 
other hand, human health and the environment and impacts from the use of NM. 

9.10.1  Methodology 

The Research Study was undertaken over a ten-month period starting from January 2013, with 
the following research methods being utilised: 

  secondary evidence review;  
  semi structured interview programme;  
 
testing cost capture and analysis;  
 
impact assessment; and 
  options comparison informed by the assessment of multiple criteria.   

In addition the Research Team worked closely with colleagues from the Commission on the 
development of the formal Public Consultation Exercise and have used the findings to inform 
the  study.  The  Research  Study  additionally  drew  upon  a  number  of  prior  studies,  with  the 
‘Bipro/JRC’  2012  Final  Report,  prepared  for  the  European  Commission,  Joint  Research 
Centre,  Institute  for  Health  and  Consumer  Protection  providing  comparative  references  and 
assumptions. 

9.10.2  Problem Definition 

The  Problem  Definition  was  developed  primarily  by  reference  to  the  Commission’s  Draft 
Road  Map  (Appendix  One)  alongside  primary  evidence  from  stakeholder  interviews  with 
industry, environmental, trades union and scientific bodies, the output from the Formal Public 
Consultation  Exercise,  as  well  as  a  secondary  evidence  review.  Following  Commission 
Impact Assessment Guidelines the Problem Definition has been outlined as follows: 

The nature and scale of problem – The principal problem is there is currently sub-
optimal  regulation  of  NM  within  REACH.  This  problem  is  considered  by  a  broad 
range  of  stakeholders  to  be  linked  to  the  current  perceived  lack  of  clarity  regarding 
informational requirements for NM within REACH. The consequence is that dossiers 
that are submitted for NM do not provide sufficient evidence to ensure protection of 
human  health  and  the  environment  and  the  free  movement  of  substances  on  the 
or 
internal  market  while 
alternatively/additionally  that  dossiers  for  NM  are  not  being  submitted  to  ECHA  for 
assessment. 

competitiveness 

innovation, 

enhancing 

and 

Stakeholders  most  affected  by  it  –  Producers  of  NM  are  immediately  impacted  by 
current issues regarding clarity of requirements, which in turn will impact on a range 
of  stakeholders  across  the  supply  chain  from  the  production  of  NM  into  the  product 
lifecycle for goods and products that contain NM, impacting as it does on consumers, 
workers  and  the  wider  environment.  Stakeholders  suggest  that  there  may  be 

117 

 
 
 
 
 
disproportional  impact  for SME, micro  enterprises  and start-ups, which  maybe more 
likely  than  larger  enterprises  to  respond  to  current  regulatory  imprecision  by 
withdrawing from the market or being dissuaded from entering the market.  

Drivers  or  underlying  causes  of  the  problem  –  The  immediate  drivers  of  the 
problem  relate  to  the  absence  of  sufficient  specific  provisions  for  NM  within  the 
annexes  of  REACH.  Results  for  the  Commission’s  Formal  Public  Consultation 
Exercise found that in relation to the overall view of the current registration provisions 
and  information  requirements  for  the  registration  of  NM,  68%  considered  it  to  be 
“unclear” and a further 18% “very unclear”. 

Problem  Development  and  the  impact  of  existing  policies  at  Community  or 
Member  State  level  –  A  functional  starting  point  for  the  problem  can  be  identified 
from  the  establishment  of  REACH,  the  setting  of  the  definition  of  NM  by  the 
Commission  and then the issuing of ECHA Guidance. One of the main  responses at 
Member  State  level  has  been  the  introduction  of  national  registers  of  NM,  although 
this has limited connection to the issue of the requirements for NM within REACH or 
the associated guidance provided by ECHA. 

Assumptions,  Risks  and  Uncertainties  –  Key  assumptions  relate  to  estimating  the 
potential  impact  of  any  changes  to  the  annexes  of  REACH  on  NM.  There  are  risks 
relating to balancing potential regulatory benefits with increased costs for business and 
other stakeholders. Uncertainties pertain to the evolving evidence base on NM safety 
testing. 

Justification  for  Community  level  action  –  The  principle  of  chemical  regulation 
being  a  Community-level  responsibility  is  well  established.  Although  there  is  scope 
for  MS  to  support  the  guidance  process,  there  remains  an  evident  need  for  central 
coordination.  

9.10.3  Options Development and Refinement 

The European Commission provided options for change to the Research Team.  

Baseline – The baseline option incorporates the European Commission’s definition of 
NM  and  is  supported  by  the  most  recent  ECHA  guidance  on  the  interpretation  of 
REACH requirements for NM. 

Option  2  –  Would  introduce  “changes  to  certain  Annex  provisions  clarifying  what 
companies  are  expected  to  do  in  accordance  with  the  registration  obligations  of 
REACH  and  the  specific  guidance  which  takes  into  account  CA/59/2008  and  the 
RIPoN  2  and  3  reports  from  2011”.  The  measures  would  require  more  precise 
descriptions  of  the  scope  of  the  dossier,  clarification  of  requirements  for  nanoform-
specific  information  in  endpoint  sections,  and  clarification  of  how  data  is  to  be 
reported. 

Option 3 – Is based on “soft law” and would include one or more of the following:  

  Communication; 
  Resolution; and 
  Other Measures. 

Option  4  –  is  built  upon  the  requirements  specified  in  Option  2  with  further 
requirements  focussed on additional testing, clarifications and elaborations to  further 
describe the potential impact of the NM. 

118 

 
 
Option  5  –  is  based  upon  tailored  information  requirements  in  a  dossier  for  NM 
placed  on  the  market,  a  reduction  in  certain  testing  requirements,  clarification  of 
regulatory provisions and the ability to maximise the use of non-testing methods and 
exposure categorisation, and in doing so maintain openness to flexible solutions.132 

Option 6 – includes the full implementation of Option 2 and 4 and the inclusion of a 
number  of  additional  requirements.  Option  6  gives  additional  emphasis  to  the 
generation of targeted information with the objective of further reducing uncertainty in 
an area where knowledge is still under development regarding the influence of particle 
and nanomaterial-specific properties on risk.  

In terms of the overall integrity of individual options, it is difficult on an a priori basis to find 
the  grounds  to  exclude  individual  measures  within  any  of  the  options  or  to  include  further 
measures.  What  is  certain  is  that,  having  established  the  costs  and  potential  benefits  of 
individual  measures,  there  will  need  to  be  a  level  of  scrutiny  as  to  whether  particular  tests 
within each option are cost  beneficial.  This  could lead to further restructuring of options or 
the partial or full merging of one or more options. 

9.10.4  Cost Analysis 

The  data  capture  element  of  the  Stakeholder  Engagement  Programme  constituted  a  core 
element  within  the  broader  Research  Programme  and  provides  up-to-date  estimates  of  the 
prospective  cost  of  testing  (where  tests  and  such  information  are  available  from  GLP-
compliant laboratories currently offering NM testing to private clients as a service) as relevant 
to each of the Options considered within the study.  

The  methodology  for  the  cost  assessment  included  determining  relevant  tests,  designing  a 
Data  Capture  Tool,  sourcing  of  laboratories  and  finally  collating  data  returned  from 
laboratories into a form for use in the Cost Data Assessment.  

The  presentation  of  the  cost  data  divides  into  two  broad  elements.  The  first  provides  an 
overview of potential costs on a per form/dossier basis, providing a maximum and minimum 
scenario for additional characterisation costs that might arise.  

The second element draws on these estimates to develop an updated set of aggregate estimates 
of  cost  developed  utilising  the  assumptions  that  underpinned  the  last  commissioned 
JRC/Bipro  study  on  the  regulation  of  NM  under  REACH.  In  table  9.3  the  costs  have  been 
extrapolated to provide estimates of the respective costs under each of the substantive options 
under consideration (costs for each option being additional to the Baseline position). 

132 European Commission Impact Assessment of the possible amendment of REACH Annexes for nanomaterials 

Preliminary options and measures 

119 

 
 
 
 
                                                 
Table 9.10-1: Aggregate Cost Summaries based upon BIPRO assumptions 

Baseline 

Option 
Two 

Option 
Three 

Option 
Four 

Option 
Five 

Option Six 

(183)* 

30.75 

n/a 

15,200 

n/a 

n/a 

104.4 

-136.4 

270.25 

22,100 

2,800 

240,000 

Additional 
Testing Costs €M) 
Additional 
Administrative 
Costs (€) 

(*baseline costs i.e. ‘additional testing costs’ to be added to this baseline aggregate cost.) 

It  is  important  to  stress  that  these  costs  could  increase  or  decrease  depending  on  the  actual 
number of forms as well as the degree/level of read across that may be applicable. 

9.10.5 

Impact Analysis 

Assessment of impact has been the least developed area of research into the regulation of NM 
and the Research Team were only able to make limited progress in assessing how each of the 
options  under  consideration  may  impact  within  the  health  and  social,  economic,  and 
environmental domains.  Assessment was principally qualitative, being based upon secondary 
review and expert input from toxicologists with health and environmental expertise. 

  Option  2  was  viewed  to  have  a  potentially  positive  impact  on  human  health  and 
environmental  safety,  with  a  broadly  neutral  impact  on  economic  or  environmental 
issues. 

  Option 3 not being linked to any substantive clarification or extension of requirements 

had the same limitations in terms of impact as the Baseline (no change). 

  Option 4 extends the scope of REACH as well as providing additional requirements, 
with  the  potential  to  identify  the  highest  consequence  health  and  environmental 
impacts.  

  Option 5 could have positive impacts on employment, but increased risk of failing to 

identify and mitigate health and environmental risk.    

  Option 6 involved a potential doubling of costs over the baseline position with only a 
limited number of measures that could be viewed to have the highest potential impact 
on improved human health and environmental safety. 

9.10.6 

Impact on SMEs 

Whilst improved clarity was considered to be advantageous to SMEs, micro enterprises and 
start  ups,  there  was  significant  concern  that  an  increase  in  the  regulatory  cost  burden,  and 
most  particularly  Option  6  and  to  a  lesser  extent  Option  4,  could  negatively  impact  on  the 
ability of European small businesses to compete in the NM market. 

9.10.7  Options Comparison 

The  final  chapter  of  this  study  involves  a  comparison  of  each  of  the  six  options  under 
consideration, bringing together assessments of effectiveness, efficiency and coherence, these 
being  the  assessment  criteria  set  out  in  the  European  Commission’s  Impact  Assessment 
Guidelines. Scoring for each aspect was ranked from minus 5 (least positive) to plus 5 (most 
positive), with a zero being a neutral (no impact) rating. Scores represent the total for a range 
of measures used to assess each summary measure. 

120 

 
 
 
 
 
The  multi  criteria  assessment  presents  Option  2  to  be  significantly  higher  scoring  than  any 
other  option.  This  stands  in  contrast  to  the  summary  response  of  stakeholders  in  the  Public 
Consultation  Exercise  where  Options  5  and  6  were  the  most  popular,  but  is  in  line  with 
stakeholder assessments  of each Option when assessed on a measure-by-measure basis. The 
no  change  and  soft  law  options  received  negative  scores,  which  is  likely  to  be  in  part  a 
reflection  of  stakeholder  evidence  that  was  negatively  impacted  by  perceptions  as  to  the 
current application of REACH for NM as opposed to the ideal or complete application of all 
the measures that constitute each of these options. 

Table 9.10-2: Summary Option Assessment 

Summary 
Impact 
Measure 
Effectiveness 

Efficiency 
Coherence 
Total 
Assessment 
Score 
Ranking 

Option 
One 

Option 
Two 

Option 
Three 

Option 
Four 

Option 
Five 

Option 
Six 

-1.4 

-0.8 
-2.4 
-4.6 

1.6 

0.4 
3.0 
5.0 

-1.0 

1.75 

0.55 

1.65 

-0.8 
-2.4 
-4.2 

-1.0 
2.2 
2.95 

1.4 
0.2 
2.15 

-2.6 
2.0 
1.05 

6th 

1st 

5th 

2nd 

3rd 

4th 

9.10.8  Conclusions  

This Research Study provides a range of new evidence and analysis to support the European 
Commission’s Impact Assessment process. The core findings of the study are that: 

  A significant majority of stakeholders believe REACH to be the appropriate means to 

regulate NM. 

  Equally  the  majority  of  stakeholders  believe  that  NM  require  particular  provisions 
within REACH in order for the wider aims of REACH to be deliverable for NM. 

  Stakeholders  also  agree  that  the  current  provisions  within  REACH  require  further 

development if the full benefits of REACH are to be obtained for NM. 

  The multi criteria assessment presents Option 2 to be significantly higher scoring than 

any other option.  

  There are a number of measures contained within each of the Options with high cost 
benefit, which suggests further review of the composition of existing options would be 
appropriate. 

121 

 
 
 
 
9.11 

APPENDIX XI: Matrix report: impacts on competitiveness 

9.11.1  Option 2 

Cost and price competitiveness  

Positive  

Negative 

Cost of compliance 

Cost of capital 

Possible  savings  in  the 
long term 

Likely 
slightly 
term. 

to 
in 

increase 
the  short 

May  decrease  in  the 
long 
to 
term 
reduced uncertainties 

due 

Cost  of  production,  distribution, 
after-sales services  

Cost  of  production 
may  increase  slightly 
in the short term. 

Price of outputs (directly not through 
the cost, e.g. price controls)  

Exit  of  some  SMEs  could  lead  to  increase  in 
prices. Unlikely to have a major impact. 

International competitiveness 

Positive 

Negative 

Market shares (single market)  

Market shares (external markets)  

Revealed comparative advantages 

Possible increase due to 
higher  confidence 
in 
EU products containing 
Possible 
NM. 
of 
replacement 
dangerous  NM,  to  the 
advantage  of  producers 
of substitute products. 

Possible increase due to 
higher  confidence 
in 
EU products containing 
NM 

Possible increase due to 
higher  confidence 
in 
EU products containing 
NM 

Possible  exit  from  the 
market  of  producers  or 
users  of  NM  found  to 
be dangerous.  

of 

Possible  exit  from  the 
market 
EU 
producers  or  users  of 
NM 
be 
dangerous. 

found 

to 

Capacity to innovate 

Positive 

Negative 

Capacity  to  produce  and  bring  R&D 
to the market  

by 
Stimulated 
generation 
of 
information  base  on 
NM 

Slight  increase  in  cost 
of  compliance  could 
reduce 
resources 
devoted to R&D. 

122 

 
 
 
 
 
Capacity for product innovation  

Same as above 

Same as above 

Capacity 
innovation 
for  process 
(including  distribution,  marketing 
and after-sales services) 

Unlikely to be affected 

Access to risk capital 

9.11.2  Option 4 

In  the  long  run  fewer 
may 
uncertainties 
to 
increase 
capital 

access 

Cost and price competitiveness  

Positive  

Negative 

Cost of compliance 

Cost of capital 

Possible  savings  in  the 
from 
long 
term 
risk 
improvement 
management 
and 
enhanced knowledge of 
NM. 

in 

May  decrease  in  the 
to 
term 
long 
reduced uncertainties. 

due 

increase, 
to 
Likely 
especially  in  the  short 
term. 

May  increase  if  cost 
the 
increases 
financial  viability  of 
SME uncertain. 

render 

Cost  of  production,  distribution, 
after-sales services  

Price of outputs (directly not through 
the cost, e.g. price controls) 

of 

production 
Cost 
likely 
increase, 
especially  in  the  short 
term. 

to 

Exit  of  some  SMEs 
could  lead  to  increase 
in prices of NM (due to 
market 
higher 
concentration) 
that 
would  be  reflected  in  a 
price 
for 
increase 
downstream users. 

International competitiveness 

Positive 

Negative 

Market shares (single market)  

Possible increase due to 
higher  confidence 
in 
EU products containing 
Possible 
NM. 
replacement 
of 
dangerous  NM,  to  the 

Possible  exit  from  the 
market  due  to  higher 
costs.  Possible  exit  if 
are 
some 
NM 
prohibited  on 
safety 
grounds. 

123 

 
 
 
 
 
Market shares (external markets)  

advantage  of  producers 
of substitute products. 

Possible increase due to 
higher  confidence 
in 
EU products containing 
NM 

Possible  exit  of  firms 
unable 
to  cope  with 
increase  in  fixed  costs. 
Possible  exit  from  the 
market  of  EU  firms  if 
some  NM  are  found  to 
be  dangerous 
the 
short term – in the long 
term,  prohibitions  are 
likely  to  align  in  other 
markets. 

in 

Revealed comparative advantages 

Possible increase due to 
in 
higher  confidence 
EU products containing 
NM. 

Possible  disadvantage, 
especially  in  the  short 
term,  due 
to  higher 
costs for EU firms. 

Capacity to innovate 

Positive 

Negative 

Capacity  to  produce  and  bring  R&D 
to the market  

by 
Stimulated 
of 
generation 
information  base  on 
NM 

in  cost  of 
Increase 
could 
compliance 
resources 
reduce 
devoted 
R&D. 
to 
Possible  exit  from  the 
market  of  some  SMEs 
operating 
in 
nanotechnologies. 

Capacity for product innovation  

Same as above 

Same as above 

Capacity 
innovation 
for  process 
(including  distribution,  marketing 
and after-sales services) 

Higher 
compliance 
costs could force SMEs 
to reduce investment in 
process innovation. 

Access to risk capital 

9.11.3  Option 5 

In  the  long  run  fewer 
uncertainties 
may 
actually increase access 
to capital 

Uncertainty in financial 
viability  could  worsen 
the 
risk  profile  of 
SMEs. 

Cost and price competitiveness  

Positive  

Negative 

Cost of compliance 

Cost 
relation to NM. 

decrease 

in 

Possible 
savings 
increased 

long-term 
due 
to 
knowledge 

124 

 
 
 
of  NM  are  limited  if 
informational 
requirements 
reduced.  

are 

 Limited  effect.  May 
increase  in  the  long 
term  if  reductions  in 
informational 
requirements  preserve 
uncertainties. 

Cost of capital 

Cost  of  production,  distribution, 
after-sales services  

Price of outputs (directly not through 
the cost, e.g. price controls) 

Enhanced viability may 
facilitate 
to 
capital. 

access 

to 

decrease, 
Likely 
especially  in  the  short 
term. 

Entry  of  new  SMEs 
could  result  in  stronger 
competition 
and 
output 
in 
decrease 
prices,  in  relation  to 
NM and to products for 
which  NM  are  used  as 
input  down  the  supply 
chain. 

International competitiveness 

Positive 

Negative 

Possible  decrease  (in 
comparison  with 
the 
counterfactual  option 
lower 
1) 
EU 
confidence 
products 
containing 
NM. 

due 

in 

to 

Possible  decrease  (in 
comparison  with 
the 
counterfactual  option 
lower 
1) 
EU 
confidence 
containing 
products 
NM. 

due 

in 

to 

Market shares (single market)  

Market shares (external markets)  

Possible increase in the 
combined  output  of 
or 
producers 
NM 
importers,  and  in  the 
output  of  firms  using 
NM 
production 
input. 

as 

cost 

Possible increase due to 
lower 
of 
production  for  EU  NM 
producers 
and 
importers.  

125 

 
 
 
 
Revealed comparative advantages 

Cost decrease. 

Possible  decrease  (in 
the 
comparison  with 
counterfactual  option 
lower 
1) 
EU 
confidence 
products 
containing 
NM. 

due 

to 

in 

Capacity to innovate 

Positive 

Negative 

Capacity  to  produce  and  bring  R&D 
to the market  

Reduction  in  cost  of 
could 
compliance 
resources 
enhance 
devoted 
R&D. 
to 
Prevention  of  possible 
exit from the market of 
some  SMEs  operating 
in nanotechnologies. 

Reduction in 
information 
requirements would 
entail less creation of 
new information 
regarding NM, that 
would otherwise be 
useful for innovation 
activities. 

Capacity for product innovation  

Same as above 

Same as above 

Capacity 
innovation 
for  process 
(including  distribution,  marketing 
and after-sales services) 

Lower 
costs  would 
firms,  and  SMEs 
particular, 
more 
in 
innovation. 

compliance 
allow 
in 
invest 
process 

to 

Access to risk capital 

in 

the 
Improvement 
risk  profile  of  SMEs 
due  to  lower  costs  of 
compliance. 

the 

long 

run, 
In 
uncertainties  in  safety 
could  increase  the  risk 
with 
associated 
activities  entailing  the 
use  of  NM,  and  hence 
worsen the risk profile, 
in particular for SMEs. 

9.11.4  Option 6 

Cost and price competitiveness  

Positive  

Negative 

Cost of compliance 

Likely 
increase 
to 
.substantially,  especially 
in the short term. 

Possible  savings  in  the 
from 
term 
long 
risk 
improvement 
management 
and 
enhanced knowledge of 
NM. 

in 

126 

 
 
 
 
Cost of capital 

May  decrease  in  the 
to 
term 
long 
reduced uncertainties. 

due 

Cost  of  production,  distribution, 
after-sales services  

Price of outputs (directly not through 
the cost, e.g. price controls) 

increase 

render 
viability 

if  cost 
May 
the 
increases 
financial 
of 
SME  uncertain,  thereby 
worsening the risk profile 
of those firms.. 

of 

Cost 
production 
involving  NM  as  inputs 
increase 
likely 
to 
significantly, 
especially 
in the short term. 

as 

Exit  of  some  SMEs  as 
well 
cost-shifting 
could  lead  to  increase  in 
prices  of  NM  (due  to 
higher 
market 
concentration) that would 
be  reflected  in  a  price 
increase  for  downstream 
users. 

International competitiveness 

Positive 

Negative 

Market shares (single market)  

Possible increase due to 
in 
higher  confidence 
EU products containing 
Possible 
NM. 
replacement 
of 
dangerous  NM,  to  the 
advantage  of  producers 
of substitute products. 

Higher  possibility  (with 
respect to option 4 and to 
all  other  options)  of  exit 
from  the  market  due  to 
higher costs. Possible exit 
are 
some  NM 
if 
prohibited 
safety 
grounds. 

on 

Market shares (external markets)  

Possible increase due to 
higher  confidence 
in 
EU products containing 
NM 

Possible  exit  of  firms 
unable 
to  cope  with 
increase  in  fixed  costs. 
the 
Possible  exit  from 
market  of  EU  firms  if 
some NM are found to be 
dangerous  in  the  short 
term  –  in  the  long  term, 
prohibitions  are  likely  to 
align in other markets. 

Revealed comparative advantages 

Possible increase due to 
higher  confidence 
in 
EU products containing 
NM. 

disadvantage, 
Likely 
especially 
the  short 
in 
term,  due  to  higher  costs 
for EU firms. 

127 

 
 
 
 
Capacity to innovate 

Positive 

Negative 

Capacity  to  produce  and  bring  R&D 
to the market  

by 
Stimulated 
generation 
of 
information  base  on 
NM 

cost 

devoted 

Increase 
of 
in 
compliance  could  reduce 
to 
resources 
R&D.  Possible  exit  from 
the market of some SMEs 
operating 
in 
nanotechnologies. 

Capacity for product innovation  

Same as above 

Same as above 

innovation 
for  process 
Capacity 
(including  distribution,  marketing 
and after-sales services) 

Access to risk capital 

Higher  compliance  costs 
to 
could 
reduce 
in 
process innovation. 

force  SMEs 
investment 

Uncertainty  in  financial 
viability could worsen the 
risk profile of SMEs. 

In  the  long  run  fewer 
uncertainties 
may 
actually increase access 
to capital 

128 

 
 
 
 
 
 
 
9.12 

APPENDIX XII: Measures included in the preferred option (initial Commission 
proposal) 

9.12.1  The 3-step decision process towards the preferred option 

The 3-step decision process follows on from an initial assessment of the effectiveness of the 
measures, thus considering how each of the measures addresses the causes of the problem, as 
indicated  in  2.2.1  The  problem  and  its  consequences:  (i)  Nanomaterials  definition,  (ii) 
Physico-chemical properties, (iii) Applicability of tests methods, (iv) Substance identification 
and  (v)  Description  of  the  CSA  and  multiplicity  of  forms.  The  subsequent  3-step  process 
applies as follows: 

1.  Effectiveness:  based  on  the  criterion  that  the  preferred  option  needs  to  ensure  that 
nanomaterials are properly addressed and safety demonstrated, those measures which 
impose  reduction  of  the  current  requirements  have  been  discarded  (this  concerns 
thirteen out of the twenty-one measures of option 5). 

2.  Efficiency:  eleven  measures  from  option  6  and  two  measures  from  option  4  were 
considered  as  too  costly  compared  to  the  information  they  would  provide  and  were 
discarded; furthermore it was considered that one measure of option 2, two of option 4 
and two of option 6 were too costly but could be adapted in order to render them less 
burdensome  while  keeping  their  effectiveness;  the  one  option  from  option  2  and  the 
two  from  option  6  have  been  modified  accordingly,  as  explained  in  9.12.2  Detail  of 
the measures. 

3.  Overlap:  the  eight  remaining  measures  from  option  5  have  been  discarded  as  they 
were  already  covered  by  other  retained  measures;  the  resulting  preferred  option 
contains eighteen measures, some of them adapted as explained below. 

129 

 
 
 
9.12.2  Detail of the final measures within the preferred option 

Option  Measure 

Detail 

Modification 

2 

1 

2 

require 

to 
Explicitly 
describe the scope of the registration 
dossier 

registrants 

require 

Explicitly 
provide 
characterisation of nanoforms 

more 

registrants 

to 
detailed 

None 

Further  clarification  is  provided 
by explicitly including a number 
of 
physico-
chemical  properties  under  new 
information' 
endpoint 

nano-relevant 

'Other 

130 

 
 
 
3 

4 

5 

6 

7 

8 

9 

10 

12 

13 

14 

16 

4 

only for high tonnage substances 
(Annexes  IX  and  X),  subject  to 
testing proposal. 

None 

that 

nanoforms 

Require 
are 
explicitly  addressed  in  the  endpoint 
sections.  Forms  should  be  clearly 
addressed in study summaries. 

Require  detailed  description  of  the 
test material/sample preparation 

None 

Require  scientific  justifications  for 
grouping  /  read-across  /  QSAR  and 
other  non-testing  approaches  for 
different forms 

Require  considerations  of  most 
appropriate/relevant  metric  with 
preferable  presentation  in  several 
metrics 

None 

None 

Require 
addressed 
nanoforms 

that  bioaccumulation 

specifically 

for 

is 
the 

Effectively  taken  by  measure  3, 
also  1  and  5.  No  additional 
obligation  at  lower  tonnages  is 
considered. 

that  absorption/desorption 
Specify 
behaviour  of  nanoforms  should  not 
be  assessed  based  on  Kd  values 
derived from Koc and Kow 

None 

Require  identification  of  uses  and 
exposure 
the 
assessment 
nanoforms 

of 

None 

Include information on dustiness 

None 

‘particles’ 

to 
Change 
‘(nano)particles’  for  repeated  dose 
toxicity studies (inhalation) 

None 

Require  non-bacterial  in  vitro  gene 
mutation study 

None 

Consider  water  solubility  in  relation 
to test waiving 

None 

Specify that algae testing should not  Wording  is  ‘solubility  alone’; 
consequently,  solubility  can  be 

131 

 
 
be waived based on insolubility 

used  as  an  argument  but  in 
context 

relation 

No  modification  of  existing 
obligations 
to 
(in 
tonnage) is  considered.  Wording 
in waiver is however modified to 
ensure  proper 
is 
provided. 

justification 

Instead  of  blanket  application  to 
all nanoforms, modified to apply 
priority/insoluble 
to 
only 
nanoforms 

Same 

Instead  of  blanket  requirement 
for  the  test,  wording  requires  to 
the  difference 
address  only 
(some 
information  may  be 
available).  The  requirement  is 
also  subject  to  testing  proposal 
so  that  ECHA  and  MSCA  can 
review  the  need  prior  to  actual 
testing, which involves animals. 

17 

Require  that  testing  on  soil  and 
sediment organisms is prioritised 

6 

41 

requirements 

Information 
for 
substances covered by Annex III (b) 
must also apply to nanoforms 

42 

require 

nanoforms, 

For 
all 
information  on  potential  alterations 
of  hazard  due 
to  operational 
conditions  upstream  the  exposure 
situation is considered  

51 

Perform toxicokinetic screening 

132 

 
 
 
9.13 

APPENDIX XIII: Analytical models used in preparing the impact assessment – 
Costing methodology 

9.13.1  Main assumptions 

In summary: 

  Generation of information: when a nanoform of a substance is placed on the market, 

the REACH registration dossier is expected to include relevant information.  

  Separate  and  single  dossiers:  information  on  a  nanoform  may  be  provided  in  a 
separate  dossier  (in  case  the  nanoform  is  considered  a  separate  substance)  or  within 
one dossier together with other forms of the substance. The estimation of the cost in 
either  approach  is  effectively  the  same,  as  substantial  needs  to  characterise  the 
material and generate relevant safety data, when not already available, do not depend 
on the administrative procedure chosen and it can be assumed that the same effort will 
be applied to justify the relevance of existing or specifically generated data.  

  Unit cost: the "nanoform or set133 of nanoforms" is the basic element of the model 
for  which  the  'unit  cost'  is  calculated.  It  is  assumed  that  data  for  this  basic  element, 
when  covered  by  the  registration,  is  either  generated  (via  specific  testing  per 
information requirement) or filled by existing data for other substances or forms of the 
same substance for the specific nanoform or set of nanoforms and this is justified (e.g. 
read-across  and  grouping).  Test  costs  were  compiled  via  a  survey,  and  assumptions 
were made regarding the possibilities for read-across for each individual test, leading 
to 'normalised testing cost' per information requirement.  

  Assumptions: cost calculations require a number of assumptions, some of which are 
difficult  to  verify;  for  example,  the  ability  to  read-across  between  nanoforms  of  the 
same substance or between substances or to identify a 'worst case' (i.e. the form of a 
substance that is likely to have the most severe outcome in a given test) will always be 
case-specific.  

  Cost  at  nanoform  or  set  of  nanoforms  level:  summation  over  all  the  relevant 
information  requirements,  accounting  for  the  impact  of  measures  taken  under  the 
individual option, leads to cost for the nanoform or set of nanoforms when registered 
for a specific tonnage band. 

  Cost at option level: multiplying the cost at nanoform (or set of nanoform) level with 
the assumed number of nanoforms or sets of nanoforms registered within the tonnage 
bands enables calculation of the total cost per option and tonnage band.  

The graph below schematically depicts the different steps in the calculation: 

133  A  set  would  cover  different  nanoforms  that  are,  however,  sufficiently  similar  to  be  covered  by  the  same 

toxicological and ecotoxicological information (see 9.8 Appendix VIII)). 

133 

 
 
                                                 
Figure 9.13-1: The steps in the calculation: 

Step  1:  the  cost  per  nanoform  or  set  of  nanoforms  for  each  information  requirement  is 
calculated,  taking  into  account  possible  read-across/grouping,  and  cost  of  fulfilling 
information requirements for each tonnage level;  

Step 2: the costs for the individual measures at each tonnage level are calculated;  

Step  3:  the  costs  of  information  requirements  as  foreseen  including  impact  of  each  of  the 
measures under each option are summed together to obtain the total cost per nanoform, 
at each tonnage level and for each option.  

All resulting costs are provided in the tables below in absolute terms. It has to be noted (as 
mentioned  in  section  2.2.3  Initiatives  undertaken,  also  4.8  The  Baseline  and  4.9  Industry 
appeals to ECHA decisions on registration of substances with nanoforms) that industry may 
not share ECHA's interpretation that measures listed in option 2 of this impact assessment are 
current obligations that are derived from the general REACH requirements. The relative costs 
of options 4, 5 and 6 may be calculated by subtracting the respective total cost of either option 
1 or option 2 from these.  

For  option  3,  it  can  be  assumed  that  the  costs  would  be  eventually  similar  to  option  2, 
supposing that option 2 is confirmed as the baseline and that the measures in option 3 would 
aim to come as close as possible to option 2 (see description of option 3 in section 4.3 Option 
3: Soft law measures and discussion in section 2.2.3 Initiatives undertaken). 

9.13.2  General methodology and discussion in detail 

The very basic concept in understanding the model is the 'unit' to which all is related. As the 
main costing aspect are costs of tests and documentation, the basic element of the model for 
which the 'unit cost' is calculated, is a nanoform or set of nanoforms as explained in Appendix 
VIII. For such a unit it should be possible to identify (with justification) relevant datasets in 
the  existing  substance  registration  documentation,  and  if  they  cannot  be  identified,  further 
tests  (and  therefore  associated  costs)  are  required.  It  is  further  assumed  that  for  a  single 
nanoform or set of nanoforms only one test per information requirements is sufficient. 

The unit cost thus obtained can be used to directly compare impacts of the different options. 
The total cost can be calculated by the multiplication of unit cost with a number of nanoforms 

134 

 
 
 
or  sets  of  nanoforms  that  are  expected  to  be  registered.  This  number  is  however  associated 
with significant uncertainty as it is associated with the research and development as well as 
market uptake. All assumptions are listed and discussed in a subchapter below.  

Calculation134 is performed in several steps: 

  Testing  costs  are  mainly  provided  from  the  Matrix  study.  For  many  tests  a 
minimum/maximum  cost  interval  could  be  assigned  but  calculations  apply  an 
average  cost.  There  is  no  information  or  experience  to  indicate  the 
appropriateness  of  the  assumption  regarding  the  average  cost.  However,  it  is 
likely that at least for some if not many challenges in implementation of the test 
on  a  nanoform  may  increase  costs  rather  than  reduce  them.  In  some  specifc 
results  an  interval  is  used  to  discuss  sensitivity  of  the  calculation.  Specific 
attention  is  given  to  characterisation  of  nanoforms  as  an  expected  main 
contributor to the cost: including also information provided by CEFIC, the cost 
into  an  average  cost  of 
of  several  applied  methods  was  combined 
characterisation of nanoform or set of nanoforms and a default characterisation 
of the sample was added to any test cost. 

  Basic  unit  costs  are  calculated  for  each  tonnage  interval,  based  on  the 
respective  REACH  information  requirements  as  applied  to  the  individual  unit 
(nanoform  or  set  of  nanoforms).  Assumptions  are  made  in  terms  of  average 
applicability  of  waivers  and  the  ability  to  use  alternative  ways  to  fil  the 
information  requirement  instead  of  testing  (read-across,  weight  of  evidence 
etc.). The latter is throughout the model applied as the 'normalised testing cost', 
i.e. the full test cost  is  reduced in  proportion135 to  the assumed availability of 
waivers or 'alternative means' for the particular information requirement, but in 
the same proportion a justification cost is added (as it is necessary to explain in 
the registration dossier e.g. why a waiver applies or an alternative method can 
be used).  

  Assumptions  related  to  such  a  proportion  under  'normalised  testing  cost'  is 
arguably  the  most  critical  aspect  of  the  model.  In  the  absence  of  more  robust 
data,  the  model  assumes  that  the  statistics  derived  for  chemicals  in  general 
regarding  application  of  non-testing  methods  (e.g.  read  across  between 
substances)  for  individual  endpoints136  can  be  applied  also  to  the  nanoforms, 
including  in  relation  to  the  use  of  information  from  the  bulk  or  another  form 
(also  nanoform)  of  the  same  substance.  As  such  application  remains  to  be 
justified on a case-by-case basis, these statistical factors are highly speculative 
in either direction: in the first instance, information to be potentially useful in 
the non-testing method should already exist as vast majority of nanoforms are 

134 Raw input data and equations are available in the attached XLS spreadsheet which was used to calculate all 

the results (including sensitivity analysis) presented in the impact assessment. 

135 With proportion 0%, the 'normalised testing cost' is the full testing cost, while with proportion 100%, this cost 
would include only cost caused by the justification why testing is not necessary. With 50%, this cost is half the 
testing cost plus half cost of justification.  

136 ECHA reporting under REACH Article 117(3) on the use of alternative methods. The proportion includes e.g. 
48% for in vivo skin irritation or 64% for repeated dose toxicity testing, 13% for short term sudy on Daphnia. 
Where such information is not available default factors were used (e.g. 0% in phys-chem characterisation or 
33% for other).  

135 

 
 
                                                 
expected  to  belong  to  substances  also  containing  non-nano  forms,  many 
registered  already.  On  the  one  hand,  as  none  of  the  methods  are  explicitly 
validated for nanomaterials137, one may argue that such argument cannot even 
be made at this time (i.e. the proportion is 0%), while on the other hand, current 
application in the registration dossiers as well as demonstrations in the ECHA 
Nano  Materials  Working  Group  for  selected  substances  with  nanoforms  have 
shown that very often "the worst case" can be argued138 that alleviates the need 
to perform more than one tests for an information requirement for many if not 
all forms of the substance, even when there are a number of "nanoforms or sets 
of  nanoforms"  (i.e.  proportion  95%  in  case  of  10  nanoforms  of  the  same 
substance  and  assuming  that  no  information  is  available,  otherwise  100%). 
Sensitivity to different assumptions is explored in Appendix XVI. 

  Option  1  is  a  special  case  as  a  single  test  is  considered  adequate  for  the 
substance regardless of the forms covered by the registration. To calculate the 
cost  per  nanoform  or  set  of  nanoforms,  the  basic  cost  (i.e.  cost  for  one  form 
without  any  nano-consideration  such  as  characterisation)  is  divided  by  an 
estimated average number of 'nanoforms’ or ‘sets of nanoforms' for a substance 
at a given tonnage band. This conservatively assumes that information for bulk 
substance  is  not  yet  available  as  otherwise  the  cost  to  register  additional 
nanoforms under option 1 assumptions would be zero. 

 

  For  each  measure  under  the  different  options  (with  the  exception  of  option  5 
where all measures are assessed jointly), the impact of the measure is calculated 
– sometimes the impact is expressed as administrative cost, sometimes as extra 
testing  either  due  to  explicit  requirements  (characterisation),  and  sometime 
implicitly through the expected reduced ability to apply an otherwise available 
waiver.  Few  specific  measures  under  option  5  and  option  6  also  have  the 
specific effect of increasing/reducing the ability to apply an alternative way to 
fill an information requirement.  
In option 6, some measures (addressing Annexes IV and V) do not change the 
cost  but  effectively  increase  the  number  of  nanoforms.  To  enable  direct 
comparison of the 'unit costs' while not disregarding this impact, the unit cost 
for the option was increased in proportion to the estimated increase in number 
of nanoforms.  
It  is  anticipated  that  any  changes  to  the  registering  regime  of  nanoforms  will 
have  impact  also  on  the  registration  of  other  (bulk)  form  of  a  substance. 
Impacts are expected to span from neutral (most bulk forms of substances with 
nanoforms  are  expected  to  be  already  registered)  to  reduced  cost  (testing 
strategies  may  optimize/reduce  also  testing  on  bulk  via  read  across  and 
application  of  worst  case  approach),  but  also  in  increased  cost  at  least  in  the 

 

137  It  should  be  noted,  though,  that  validation  of  the  test  method  is  always  restricted  in  scope:  showing 
applicability  for  a  specific  chemical  (or  nanoform)  may  not  prove  that  the  applicability  domain  may  be 
extended  to  all  chemicals  (or  nanoforms  of  any  substance),  regardless  of  their  chemistry  or  the  specifics 
(coating, shape, size).  

138  This  is  a  well  established  approach  in  the  testing  of  chemicals.  In  case  when  within  two  or  more  forms,  a 
single form can be identified in advance, due to shape, size etc., for which the most pronounced effect can be 
expected for s specific information requirement (e.g. most adverse toxic effect), such form may be chosen for 
testing as 'the worst case'. This information is then used to interpret the information requirement for all other 
forms. 

136 

 
 
                                                 
cases  where  measure  may  have  an  impact  on  registration  obligation.  Positive 
impacts are not being quantified and the measures are by large strictly restricted 
in scope of their impact to nanoforms. Measure 41 (modification of conditions 
of Annex III of REACH, prioritising substances in low tonnage interval for full 
testing or phys-chem only) however cannot be fully restricted in scope, so the 
indirect  impact  to  registering  bulk  form  of  the  low-tonnage  registration  of 
substance  with  nanoforms  is  quantified  and  presented  in  addition,  assuming 
that  no  (eco)tox  information  on  the  bulk  for  of  the  substance  affected  by  the 
change is available and needs to be generated in full.  

  For  each  of  the  options,  the  cost  of  fulfilling  information  requirements  is 
compiled with the impact of different measures to get the total cost for a single 
nanoform  or set  of nanoforms  registered in  a specific tonnage interval.  While 
the impact of the measures is assessed to the maximum extent as 'additional' to 
the situation without the measure being implemented, this is  difficult  in cases 
where  the  measure  was  set  to  clarify  and  not  essentialy  change  the  existing 
requirement  or  when  the  measures  are  partially  overlapping.  The  impact  of 
individual measures is therefore of more ilustrative nature, but great effort was 
invested in  avoidance of any double  counting to  ensure that the total  cost per 
option is as representative as possible. 

  Based  on  further  assumptions  on  the  total  number  of  nanoforms  or  sets  of 
nanoforms and the average number of companies registering the individual set 
(note  that  the  information  under  Annex  VI  should  be  supplied  individually), 
two ‘totals’ are provided: the cost per company and the 'grand total' cost, again 
for  each  of  the  options  and  the  tonnage  interval.  The  number  of  nanoforms 
considered  within  a  specific  tonnage  thresholds  was  set  by  the  assumptions 
provided  in  different  reports,  the  survey  of  existing  dossiers  under  Nano 
support  and  discussion  in  the  subgroup  of  CARACAL139.  In  addition,  a  ratio 
between  all  nanoforms  in  the  1-10  tonnes  interval  and  those  that  would  be 
affected by Annex III was also assumed on the basis of existing information on 
the classification of substances.  

The calculation as presented above requires a few caveats for proper interpretation.  

  The  information  under  option  1  applies  to  'average  chemicals'  as  information 
was, as far as possible, pinned to the available data (mostly ECHA report under 
Article  117(3)).  For  nanoforms,  some  assumptions  (e.g.  likelihood  of 
conclusion  that  inhalation  is  the  most  appropriate  route  of  exposure, 
insolubility, complexity  to  perform  test) probably  systematically diverge from 
the  average  for  all  chemicals  and  to  the  extent  reasonable,  this  was  explicitly 
accounted  for  in  the  evaluation  of  the  options.  The  most  important  impact  is 

139 A number of nanoforms that would potentially be included in the registration dossiers e.g. by 2018, 2020 or 
2030 is difficult to establish for a number of reasons. While the number of substances containing nanoforms 
has  been  identified  in  a  range  of  ca  200  (2nd  regulatory  review)  to  500-2000  nanomaterials  (CEFIC),  it  has 
been stressed that the number of substances with nanoforms with significant market presence at the moment is 
probably less than 20. The high CEFIC estimate of 2000 is associated primarily with organic pigments with 
narrow specific use that are not expected to result in variety of forms as more general-purpose nanomaterials 
such as silica or carbon nanotubes. Associating an 'average' number of "nanoforms or sets" (4-10 dependent on 
tonnage) to individual substance in such an already divergent set therefore adds further uncertainty.  

137 

 
 
                                                 
visible in option 2, where by far the highest cost is incurred by the requirement 
set  under  OECD  test  guidelines  to  characterise  test  samples.  Similar 
requirements  apply to  all complex chemicals, not just nanomaterials, but  such 
requirements are not included in the option 1 cost.  

  Costs as presented cannot be directly translated to the cost of e.g. a grade or an 
individual  material  as  still  several  materials  may  be  described  by  a  single 
'nanoform’ or ‘set of nanoforms'.  

  As  already  mentioned  above:  the  total  data  to  be  generated  for  the  specific 
information requirement is expected to be reduced via a ‘worst-case argument’, 
grouping/read-across  and  in  particular  read-across  between  forms  of  the  same 
substance.  The  arguments  are  however  always  case/form  specific  and  any 
statistical approach, as the one taken in this model, is speculative.  

  Characterisation  cost  attempts  to  include  in  an  informed  manner  all  the  costs 
that would be expected by the individual registrants  under Annex VI, making 
assumptions  on  the  average  number  of  registrants  as  well  as  individual 
nanoforms  so  as  to  be  able  to  normalise  the  cost  back  to  the  individual 
nanoforms/set.  It  is  expected  that  each  registrant  would  incur  some  basic 
characterisation  costs  to  understand  the  scope  of  his  dossier  and  accordingly 
develop appropriate sets (i.e. define ranges of required characterisers) and 'sort' 
the  sets.  Only  some  representative 
its  nanoforms  accordingly  within 
measurement  information  for  the  set  is  eventually  required  –  as  now, 
documentation does not need to be provided for individual grades.  

9.13.3 

Input tables 

Table 9.13-1: Estimated average number of nanoforms or sets of nanoforms per substance registered 
in the specific tonnage bands 

Tonnage band 

NF/sets per substance 

> 1000  
100 - 1000 
10 – 100 
1 - 10 

10 
7 
5 
4* 

* This estimate is used also when considering indirect impact of measure 41 

Table  9.13-2:  Ratio  between  substances  registered  in  different  tonnage  bands  (based  on  ECHA's 
registration statistics and estimation for 2018 registration) 

Tonnage band 
> 1000  
100 – 1000 
10 – 100 
1 – 10 

Substances registered per 
tonnage band (ratio of total) 
0,12 
0,21 
0,13 
0,53 

138 

 
 
Table 9.13-3: Estimated number of nanoforms or sets of nanoforms to be registered per tonnage band 
(the ratio of substances with nanoforms is expected to follow the ratio between 'normal' substances in 
various tonnage bands) 

Tonnage band 

Number of NF/sets 

Typ 

Min 

Max 

> 1000  

100 – 1000 

10 – 100 

1 – 10 Full 

1 - 10 AIII applied* 

1 - 10 AIII not appl. 

Total 

(# substances) 

460 

553 

250 

800 

566 

234 

230 

277 

125 

400 

283 

117 

2063 

375 

1032 

187,5 

920 

1106 

500 

1600 

1133 

467 

4126 

750 

*  Ratio  based  on  assumption  regarding  phase-in  chemicals  that  could  not  benefit  from  reduced  information 

requirement due to conditions (ca. 73% hazard* 40% dispersive use = 29.2%) 

Table 9.13-4: Average number of companies in SIEF registering in specific tonnage band (assumed to 
apply to number of companies registering nanoforms in that specific tonnage band) 

Tonnage 
band 

Companies per 
SIEF 

> 1000  
100 - 1000 
10 – 100 
1 - 10 

7 
3 
1,8 
1,8 

Table  9.13-5:  Testing  costs  (based  on  Matrix  Study  and  further  internal  communication  with 
developers  and  applicants  of  the  tests)  and  ratio  of  applied  alternative  information  to  derive 
normalised testing cost (based on Article 117(3) ECHA report and default internal assumptions where 
data not available) 

REACH Information requirements as 
specified in Annex VI - X (IUCLID 
codes)  

Minimum 
Cost 

Maximum 
Cost 

Probability for 
alternative 
Opt 2-4* 

Toxico 
kinetic 
factor**  

v 011   - Spectral data 

v 012   - Analytical characterization 
v 014   - Development of analytical 
method 

150 

6450 

Bespoke  Bespoke 

Bespoke  Bespoke 

v 5.02   - Melting point 

v 5.04   - Relative density 

v 5.05   - Vapour pressure 

v 5.06   - Surface tension  

v 5.07   - Water solubility  

v 5.08   - Partition coefficient   

v 5.09   - Flash-point   

850 
750 
3780 
1900 
4930 
5490 
950 

100 
750 
3780 
1900 
4930 
3890 
950 

139 

0% 

0% 

0% 

33% 

33% 

33% 

33% 

33% 

33% 

33% 

100% 

100% 

100% 

100% 

100% 

100% 

100% 

100% 

100% 

100% 

 
 
 
v 5.10   - Flammability  

v 5.11   - Explosive properties   

v 5.12   - Self-ignition temperature  

v 5.13   - Oxidising properties  

v 5.14   - Granulometry  

vii 5.18  - Stability in organic solvents  

vii 5.19  - Dissociation constant  

vii 5.20  - Viscosity  
v 6.1      - In vitro skin 
irritation/corrosion 
vi 6.1.1   - In vivo skin 
irritation/corrosion 
v 6.2      - In vitro eye 
irritation/corrosion 
vi 6.2.1   - In vivo eye 
irritation/corrosion 

v 6.3      - Skin sensitisation (LLNA)  

v 6.4.1   - In vitro gene mutation 
study (Ames test) 

1190 
750 
1620 
750 
990 
4930 
1260 
1630 

3233 

1190 
3800 
2840 
3800 
3480 
4930 
5630 
1630 

3233 

1575 

1575 

2320 

2320 

1573 

4320 

1573 

4320 

3377 

4775 

vi 6.4.2   - In vitro cytogenicity study 
in mammalian cells (CA)  

17517 

21550 

vi 6.4.2   - In vitro cytogenicity study 
in mammalian cells (MNT)  

14742 

20200 

vi 6.4.3   - In vitro gene mut. study in 
mammal. cells (MLA) 

16440 

22400 

vi 6.4.3   - In vitro gene mut. study in 
mammal. cells (HPRT) 

19093 

21400 

vii 6.4     - Mouse micronucleus assay  

16294 

20400 

viii 6.4.4  - Furtherin vivo mutagen. 
study: micronucleus or UDS test 
(16850-34500) ; worst case: Consider 
TGR as preferred and most 
expensive option for in vivo GT 

COMET ASSAY 
vi 6.5.1   - Acute toxicity, oral route 
(rats)   

120000 
6500 

120000 
34200 

1680 

1680 

vi 6.5.2   - Acute toxicity, inhalation 
route (rats) 
vi 6.5.3   - Acute toxicity, dermal 
route (rats)   

8000 

8000 

2380 

2380 

vi 6.6.1a  - Short-term repetead dose 
toxicity: 28 days, oral (rats) 

48000 

48000 

140 

33% 

33% 

33% 

33% 

0% 

33% 

33% 

33% 

100% 

100% 

100% 

100% 

100% 

100% 

100% 

100% 

30% 

100% 

48% 

100% 

29% 

100% 

45% 

54% 

100% 

100% 

56% 

105% 

56% 

110% 

56% 

105% 

56% 

105% 

56% 

59% 

105% 

105% 

59% 

59% 

105% 

105% 

49% 

105% 

49% 

105% 

49% 

105% 

64% 

105% 

 
 
vi 6.6.1b   - Short-term repetead dose 
tox.: 28 days, inhalation (rats) 

50000 

50000 

64% 

105% 

vii 6.6.1c   - Further short-term 
repetead dose tox.: 28 days, dermal 
(rabbit) 

vii 6.6.1d   - Further short-term 
repetead dose tox.: 28 days, 
inhalation 

49615 

49615 

50000 

50000 

vii 6.6.2a    - Sub-chronic repetead 
dose tox. study: 90 days, oral (rats) 

101075 

101075 

Sub-chronic repeatad dose tox. 
study: 90 days, inhalation (rats)  

108000 

108000 

64% 

105% 

64% 

105% 

64% 

105% 

64% 

105% 

viii 6.6.3   - Long-term repetead dose 
tox. study (longer than 12 month) 

331180 

331180 

64% 

105% 

vi 6.7.1    - Screening for 
reproduction/developmental tox. 
(rats)  

vi 6.7.2   - Developmental toxicity 
study (rats), oral gavage   

vi 6.7.2   - Developmental toxicity 
study (rabbits), oral gavage   

vii 6.7.3   - Two-generation 
reproduction tox. study, oral gavage/ 
(371095 euro)replaced by EOGRTS ( 
vi 6.8.1    - Assessment of 
toxicokinetic behaviour (no data 
generation) 

viii 6.8.2   - Further studies on 
toxicity of particular concern  
viii 6.9     - Carcinogenicity study 
(rats)  

69590 

69590 

86735 

86735 

146450 

146450 

750000 

750000 

1300 

1300 

800000 

800000 

815890 

815890 

v 7.1.1    - Short-term acute toxicity 
study on daphnia  

v 7.1.2    - Growth inhibition study on 
algae  

4348 

5421 

5057 

5057 

v 7.1.3    - Short-term acute toxicity 
study on fish 

5339 

6072 

v 7.1.4    - Activated sludge repiration 
inhibition testing  

3327 

5978 

vii 7.1.5   - Long-term toxicity study 
on daphnia, 21 days   

22595 

22595 

vii 7.1.6   - Long-term toxicity study 

17232 

17232 

141 

67% 

105% 

68% 

105% 

68% 

105% 

67% 

105% 

0% 

100% 

33% 

105% 

62% 

105% 

13% 

100% 

13% 

100% 

60% 

100% 

13% 

100% 

13% 

78% 

100% 

100% 

 
 
on fish  

vii 7.1.6.1   - Fish early-life stage 
(FELS) toxicity test  

vii 7.1.6.2   - Fish short-term tox. test 
on embryo & sac-fry stages 

vii 7.1.6.3   - Fish, juvenile growth 
test  

vi 7.2.1.1   - Ready biodegradability  

vii 7.2.1.2   - Simul. test. on ultimate 
degrad. in surface water  

vii 7.2.1.3   - Soil simulation testing 
(for subst. adsorbing to soil)Simul. 
test. on ultimate degrad. in surface 
water  

vii 7.2.1.4   - Sediment simulat. test. 
(for subst. asorb. to sedim.)  

31646 

31646 

14853 

14853 

21309 

24299 

5809 

5809 

6974 

53731 

60% 

100% 

60% 

100% 

60% 

0% 

100% 

100% 

33% 

100% 

70207 

70207 

33% 

100% 

77612 

77612 

33% 

100% 

viii 7.2.1.5   - Further studies on 
confirmatory biodegradation rates  

72180 

72180 

vi 7.2.2.1    - Abiotic degradation: 
Hydrolysis as a function of pH 

6381 

24711 

vii 7.2.3    - Identification of 
degradation products  

vi 7.2.3    - Adsorption/desorption 
screening study (HPLC method)    

4500 

9500 

4816 

5328 

vii 7.3.2   - Bioconcentration in  (one) 
aquatic species, preferably fish 

49800 

76565 

vii 7.3.3   - Further studies on 
adsorption/desorption  

37844 

42627 

viii 7.3.4   - Further environmental 
fate and behaviour studies - Aerobic 
transformation in soil 

Transformation in aquatic sediment 

Mineralisation in surface water 

vii 7.4.1    - Short-term toxicity 
testing on earthworms   

vii 7.4.2   - Effects on soil micro-
organisms  

43693 

44807 

26860 
19680 

68010 
28400 

6186 

6186 

11459 

11459 

vii 7.4.3   - Short-term toxicity testing 
on plants  

13934 

13934 

viii 7.4.4   - Long-term toxicity testing 
on earthworms 

12273 

12273 

142 

33% 

100% 

0% 

100% 

66% 

100% 

0% 

100% 

87% 

100% 

0% 

100% 

33% 

33% 

33% 

100% 

100% 

100% 

33% 

100% 

33% 

100% 

33% 

100% 

33% 

100% 

 
 
viii 7.4.4   - Long-term toxicity testing 
on soil invertebrates 

viii 7.4.6   - Long-term toxicity testing 
on plants 

viii 7.5     - Long-term toxicity testing 
on sediment organisms 

viii 7.6     - Long-term or 
reproductive toxicity to birds:  

- Metabolism study, OECD 417 

Tox of particular concern (estimate) 

Dustiness 
Dissolution rate in water as well as in 
relevant biological and 
environmental media 

Dispersion stability 

10928 

10928 

33% 

100% 

18922 

18922 

33% 

100% 

22052 

22052 

33% 

100% 

120880 

120880 

50000 
100000 
2000 

50000 
200000 
3000 

74% 

20% 

33% 

0% 

100% 

100% 

100% 

100% 

32000 
8000*** 
10000***  20000 

0% 

0% 

100% 

100% 

*  Probability  to  apply  'alternatives'  instead  of  testing,  expressed  in  percentage.  Listed  values  are  used  under 
option 1, option 2, option 4 and the preferred option. For option 5 the value is assumed to be increased (by 
1.4)  due  to  measure  33  "default  presumption  of  validity  of  non-testing  methods  in  all  endpoints"  while 
decreased  (multiplied  by  0.6)  for  option  6  due  to  measure  46  "…limit  the  potential  for  use  of  non-testing 
approaches for hazard and exposure where science is not consolidated".  

**  For  some  information  requirements  the  possibility  to  use  alternative  methods  is  expected  to  benefit  from 
availability of toxicokinetic information (as required by measure 51 under option 6 and the preferred option). 
This has been translated into a 'boost' to application of alternatives under selected information requirements 
(by 5%).  

*** TG for dissolution rate is still in development, exact standardised media not yet defined. Cost is based on 
input by industry (internal communication with Eurometaux) on the TD 29 (Transformation dissolution test on 
metals  and  metal  compounds)  with  cost  per  material/media  range  from  2000  for  24 h  test-8500  for  28 day 
test).  Cost  for  the  recently  adopted  OECD  TG  318  Dispersion  stability  of  Nanomaterials  in  Simulated 
Environmental Media has been estimated at 10000 Euro (high end) by the developing OECD party (internal 
communication);  the  higher  estimate  links  to  the  fact  that  further  development  currently  ongoing  in  OECD 
may include additional biologically relevant media, leading to higher cost.  A conservative estimate is made 
that no possibility of use of information between the different nanoforms is possible for these two endpoints.  

The cost of justification when alternative methods for providing information are used (read-
across, grouping) has been estimated as 300 EUR. While such cost may be considered low in 
particular  for  more  complex  information  requirements,  it  should  be  reflected  that  a  similar 
argument  (e.g.  ion  toxicity)  would  then  normally  be  recycled  in  more  than  one  information 
requirement while costed each time. 

9.13.4  Characterisation costs 

Upon the Matrix calculations and the discussions with CEFIC, the characterisation costs are 
based on the following:  

  Principal methods 

Table 9.13-6: Principal methods costs (minimum and maximum) 

Minimum 
Cost 

Maximum 
Cost 

143 

 
 
  
Principal methods with costs where available 

Agglomeration/aggregation 

Water Solubility/ Dispersibility 

Crystalline phase 

Crystallite size 

Representative Electron Microscopy (TEM) picture(s) 

Particle size distribution – dry and in relevant media 

Specific surface area 

Zeta potential (surface charge) 

Surface chemistry, where appropriate 

Pour density 

Porosity 

Octanol-water partition coefficient 

  Basics  

100 
4930 
100 
200 
200 
100 
100 
100 
200 
100 
100 
5490 

100 
4930 
100 
200 
200 
3480 
140 
100 
200 
750 
100 
5490 

Table 9.13-7: Basics based on the cost of identified methods and associated cost calculation 

Characterisation per test* 

Characterisation cost Annex VI  (per form) for each 
registrant 

Minimum 
Cost 

Maximum 
Cost 

2000 

24000 

9000 

15000 

* For some (simple) tests a standard 3.000 EUR cost was used, while for the majority the assumption is that two 
sample  characterisations  are  required,  i.e.  once  as  received  in  a  test  facility  and  once  as  tested.  The  wide 
interval  between  minimum  and  maximum  (set  as  2  x  12.000  EUR)  costs  is  due  to  the  fact  that  while  it  is 
possible  that  a  full  set  of  characterisation  methods  is  always  applied  (twice),  it  is  likely  that  a  lot  of 
characterisation data will  be 'recycled'  and that the tests are accompanied by  a minimum set that validates 
continued representativeness of the characterisation performed before and as necessary its specific delivery in 
the test medium. 

Annex  VI  characterisation  cost  per  nanoform  or  set  of  nanoforms  depends  on  the  tonnage 
band and number of companies and is calculated as:  

CharC = CostPerForm* # of companies in SIEF– CostGranulometry 

Granulometry cost (incurred jointly as presented for the nanoforms or set of nanoforms in the 
joint dossier) is deducted as it is reasonably expected that the generation of characterisation 
information by the registrants covered this information requirement.  

  Spectral information 

Requirement  to  document  nanoforms  or  sets  of  nanoforms  also  leads  to  additional  costs  to 
obtain  (simple)  spectral  information  under  Annex  VI  per  registrant  (estimated  at  150-
6450EUR) and is calculated in a similar way: 

SIDC = CostPerForm* # of companies in SIEF 

144 

 
 
  
  
 
  
  Specifics of the preferred option 

For the preferred option, it is explicitly considered that more precise characterisation (beyond 
basic size, shape, surface area and surface) may be required and is estimated to be in the range 
2-8KEUR plus 3KEUR as basic phys-chem characterisation during such test. 

  Measure 44 

Measure 44 requires characterisation along the path; an estimation of range of additional 10-
20K multiplied by the number of grades per tonnage band is employed. 

9.13.5  Adaptations, tiered approaches and administrative costs 

  Adaptation 

Column 2 adaptation to standard information requirements offers the possibility of waiving of 
the  test  requirement  or  lead  to  performance  of  another  test.  The  table  below  indicates  how 
frequent the adaptation is implemented (0-test is waived; 1-test is performed) 

Table 9.13-8: Adaptation  

9.3.2 Cross membranes vs phys-chem (KoW and else) in 
bioaccum  

9.2.2 Abiotic  degradation (solub) 

9.3.1,9.3.3 Low adorption potential vs physchem 

9.1.1, 9.1.3 long term rater than short trigered  

9.2.1.2 Water simulation – solubility 

9.5.1 Sediment org 

9.1.1,9.1.2,9.1.5  algae and daphnia -solubility 

9.1.3, 9.1.6 Fish-solubility 

9.1.4 Sludge-solubility 

8.6.1,8.6.2 Inhallation subchronic tox 

8.6.2 Subchronic waivers -Short term no tox 90d 

 8.6.3 Very long term testing 

8.6.4 Tox of particular concern (triggered in Annex X) 

8.9.1 Carcinogenicity^  

9.2.1.3-4 Simulation (unlikely exposure) 

9.6.1 Birds^ 

M50 - increased prob. inhallation testing 

8.6.1 90d instead of 28d triggered 

Toxicity of particular concern (triggered  in 28d or 90d)  

8.7.1,8.7.3 Reproductive toxicity 

8.7.2 Developmental toxicity 

9.1.6 Long term fish  

145 

1 

0,5 

0,5 

0,2 

0,5 

0,5 

0,5 

0,94 

0,6 

0,18 

0,75 

0,01 

0,01 

0,8 

0,9 

0,85 

0,75 

0,85 

1 

0,9 

0,8 

1 

0,02 

0,02 

0,0086 

0,086 

0,85 

0,5 

0,0048 

0,048 

0,95 

0,030 

0,18 

0,2 

0,015 

0,647 

0,841556 

0,57 

 
 
 
  
  
  
  
  
  
*  Values  were  mostly  derived  from  2015  ECHA  117(3)  report.  Values  for  nanoforms  are  based  on  internal 

assumptions based on most general common features (e.g. insolubility). 

^  For  carcinogenicity  and  toxicity  to  birds,  the  statistics  derived  from  the  (mainly  old)  testing  registered  high 
tonnage substance was not transferred directly to nanoforms as considered unrealistic, view supported by the 
very low number of such additional testing triggered by REACH. Lower percentage was used. 

  Genotoxicity 

Estimating  genotoxicity  testing  costs  is  rather  difficult  due  to  the  tiered  nature  of  the 
information  requirement.  The  2014  RPA  study  shows  that  due  to  the  small  percentage  of 
actual CMRs, testing is driven mainly by exclusion of 'false positives'. The calculation applies 
same  assumptions  as  2014  RPA  study  as  for  normal  chemicals  further  in  vitro  testing  is 
triggered in 28% of cases, while the results of Annex VIII in vitro test will on average trigger 
in vivo TGR testing (assumed as worst case- in many situations much cheaper Comet assay 
may  be  appropriate  as  seen  also  in  current  implementation  under  REACH)  in  65%  of  the 
cases and MNT testing in 73%. Same statistical information on false positives was adapted to 
assess  triggering  of  in  vivo  testing  in  absence  of  reliable  AMES  results  (52%  and  73%  for 
TGR and MNT testing, respectively).  

  Some other basics: 

-  Assuming 100 EUR for an hour of work, extra documentation cost was associated 
with additional hours that could in turn be dependent on the comprehensiveness of 
the dossier i.e. proportional to the tonnage band  

Table 9.13-9: Administrative costs 

Measure  Administrative cost (hours)* 

M01 

M03 

4 

10 (for 1-10t, and multipliers) 

M09^ 

2 

M18 

M40 

M42 

M43 

1 (per test in tonnage band) 

2 

8 (for each registration) 

16 

M44^ 

2 (for each grade) 

M45 

M47 

M48 

8 (for 1-10t, and multipliers) 

3 (for each grade, and multipliers) 

5 (for 1-10t, and multipliers) 

* Hours are multiplied based on the tonnage band (e.g. 0.8 for 1-10t unhazardous phase-in and 1.2 
respectively  for  each  higher  tonnage  band)  and  by  number  of  registrants  in  SIEF  or  number  of 
grades as appropriate. 

^ Indicates that further costs beyond working hours are considered. 

-  Measure  6  (required  consideration  of  metrics)  was  assumed  to  be  linked  to  5% 

increase of all tests 

146 

 
 
 
- 

Inclusion  of  nanoform  specific  consideration  when  performing  inhalation  testing 
(impact assigned in measures 11 and 12 and Option 5) was estimated to increase 
the cost of the test by the factor 1.6. 

-  Measure 9 (information on exposure and use), beyond admin cost also extra cost 
per nanoform or set of nanoforms was estimated at 2 K EUR multiplied by number 
of companies in SIEF 

-  Measure  39  (new  data  entry)  estimated  by  4250-5250  EUR  for  1-10t  (full)  with 
weights  0.8 and 1.2 for 1-10t  (phase in) and each jump to higher tonnage bands, 
respectively. The split is estimated in 10% of the cases. 

-  PBT assessment: assumptions were used from the 2014 RPA study, with 250EUR 
for screening and 1KEUR for PBT assessment, with further assessment triggered 
in 2% of the cases, while emission characterisation is triggered in 0.4%.  

-  Measure 41: Estimating indirect costs on registering bulk form for substances per 
nanoform is made by estimation of total cost of (eco)tox information requirements 
under Annex VII, divided by an average number of nanoforms in the tonnage band 
(i.e. 4). Total indirect cost is then calculate in the same manner as other impacts, 
by multiplying with the number of nanoforms 'affected', i.e. 566 nanoforms under 
the typical assumption. When estimating testing cost for bulk form, an additional 
assumption is made that read-across is always possible, at an estimated proportion 
derived principally from ECHA 117(3) report (see table 9-9 Testing Costs above). 
While Measure 41 is  considered modified in  the preferred option, triggering less 
full (eco)tox data generation (see Appendix XII above, ratio is 0.8 compared to all 
nanoforms  captured  by  option  6)  estimated  impact  is  considered  the  same 
(conservative estimate – each of the 4 forms may trigger the requirement).  

9.13.6  Additional costs scenarios 

9.13.6.1 Costs per nanoform without alternative information available 

The assumptions concerning the possibility to use alternative methods significantly impact the 
costs  of  the  different  options,  as  shown  in  the  table  below,  which  provides  cost  estimations 
when  it  is  considered  that  no  alternative  information  could  be  used  and  no  worst  case 
approach  could  be  followed.  As  expected,  the  costs  are  substantially  higher  than  with 
alternative information available. 

Table 9.13-10: Costs of options per nanoform and per tonnage band (use of alternative information 
not considered possible, typical cost) (in thousand Euro): 

1a 

1b 

2 

3 

5 

4 
(includin
g 2) 

6 
(includin
g 2 and 
4) 

>1000 tonnes 

100-1000 tonnes 

10-100 tonnes 

1686 

1246 

348 

169 

178 

70 

2312 

2312 

2490 

1078 

3277 

1720 

1720 

1935 

898 

2561 

640 

640 

830 

73 

1189 

147 

 
 
 
 
1-10 tonnesc  

67 

17 

157 

157 

193 

17 

639d 

Weighted Average 
a  Costs  per  substance  regardless  of  the  number  of  forms  –  one  test  performed  per  substance  per  information 

778 

100 

1115 

1115 

1249 

496 

1809 

requirement  

b To calculate and present the cost per nanoform or set of nanoforms, the costs for conducting all tests according 
to  the  measures  constituting  option  1  are  divided  by  an  estimated  average  number  of  nanoforms  or  sets  of 
nanoforms for a substance at a given tonnage band 

c Weighted average: depending on applicable conditions of Annex III to REACH, the implications differ between 

registrants in the 1-10 tonnage band; see assumption details above  

d Estimated indirect cost of Measure 41 through registration of bulk form, per nanoform: 10,000 Euro (1.5%); 

see assumption details above 

9.13.6.2 Costs per registration dossier 

As explained already, in reality registration is not made per nanoform but per substance. The 
costs  of  each  registration  dossier  are  case-specific  and  are  highly  influenced,  among  other 
things, by the number of nanoforms to be addressed in the registration dossier140.  

The table 9-12 below presents  the additional costs  of a registration dossier (with one single 
registrant)  for  one  bulk  form  and  4  nanoforms/sets,  assuming  that  the  information  on  bulk 
form is complete and already included in the dossier.  

As  the  dossier  is  now  expected  to  include  not  one  but  5  forms  that  are  assumed  to  require 
separate assessment,  the costs of including the 4 nanoforms in the dossier lead to  increased 
costs  compared  to  'bulk  only'  for  all  options,  except  option  1  (as  it  assumes  by  default  that 
already  existing  information  on  bulk  is  adequate,  so  the  additional  cost  is  zero).  For  the  4 
nanoforms,  default  assumptions  regarding  the  possibility  to  use  alternative  methods  for 
generating information are applied.  

Table 9.13-11: Additional costs to bulk per option for a registration dossier of 4 nanoforms, assuming 
bulk information is already available in the dossier (in thousand Euro):  

1a 

2 

3 

5 

4 
(includi
ng 2) 

6 
(includi
ng 2 
and 4) 

0 

0 

0 

0 

4350 

4350 

4746 

1831 

8745 

3170 

3170 

3669 

1499 

6857 

1403 

1403 

1850 

159 

3444 

714 

714 

962 

78 

1831 

>1000 tonnes 

100-1000 tonnes 

10-100 tonnes 

1-10 tonnes (Full Annex VII) 

1-10 tonnes (Only Phys-chem)b 
a  Costs  per  substance  regardless  of  the  number  of  forms  –  one  test  performed  per  substance  per  information 

0 

315 

315 

332 

37 

1831c 

requirement  

140  Please  refer  to  Appendix  XIII  (9.13.7  Additional  illustrative  cases)  for  examples  on  how  the  costs  may 

develop depending on different scenarios. 

148 

 
 
 
                                                 
b For the 1-10 tonnage band tox/ecotox testing is required only for phase-in substances that fulfil the Annex III 
conditions;  therefore,  for  most  substances  no  information  requirements  beyond  physico-chemical  properties 
are requested, apart from option 6 (due to measure 41) 

c Estimated additional indirect cost of Measure 41 through registration of bulk form: 41.000 Euro (+2%); see 

assumption details above 

Costs are extremely sensitive to the ability to identify relevant information prior to resort to 
additional testing. As in this prototype example it is already assumed that the full dataset on 
the  bulk  form  of  the  same  substance  is  already  available,  it  is  very  likely/expected  that  the 
default assumptions are overly conservative. Assuming that for every endpoint 'the worst case' 
form  can  be  identified  (which  is  then  the  only  one  to  be  tested),  and  that  in  half  of  the 
situations the bulk form is the worst case so data is already available (see also note c in table 
below), the estimation for additional registration cost for the 4 extra nanoforms would be as 
set out in the table below. 

Table 9.13-12: Additional costs to bulk per option for a registration dossier of 4 nanoforms, assuming 
bulk information is  already  available in  the  dossier and  assuming that  worst  case  approach can  be 
fully applied and such data (i.e. from bulk) available in 50% of the cases (in thousand Euro). 

1a 

2 

3 

5 

4 
(includi
ng 2) 

6 
(includi
ng 2 
and 4) 

0 

0 

0 

0 

1554 

1554 

1652 

669 

2238 

1195 

1195 

1312 

549 

1747 

509 

251 

509 

251 

616 

316 

79 

36 

868 

492 

>1000 tonnes 

100-1000 tonnes 

10-100 tonnes 

1-10 tonnes (Full Annex VII) 

1-10 tonnes (Only Phys-chem)b 
a  Costs  per  substance  regardless  of  the  number  of  forms  –  one  test  performed  per  substance  per  information 

0 

136 

136 

145 

19 

492c 

requirement  

b For the 1-10 tonnage band tox/ecotox testing is required only for phase-in substances that fulfil the Annex III 
conditions;  therefore,  for  most  substances  no  information  requirements  beyond  physico-chemical  properties 
are requested, apart from option 6 (due to measure 41) 

c Estimated additional indirect cost of measure 41 through registration of bulk form: 41.000 Euro (+8.3%); see 

assumption details above 

Costs include characterisation of 4 nanoforms, additional one test per information requirement 
in  half  of  the  cases  and  justifications  documenting  relevance  of  the  existing  or  newly 
generated information to all 4 nanoforms. 

9.13.7  Additional costs scenarios including the preferred option 

9.13.7.1 Registration cost per company (registrant), per nanoform 

Table  9.13-13:  Costs  per  company,  with  the  preferred  option  (per  tonnage  band,  use  of  alternative 
information methods possible) (in thousand Euro): 

1 a 

1  

2 

3 

4 
(including 
2) 

5 

6 
(including 
2 and 4) 

Preferred 
(Mix) 

149 

 
 
 
 
>1000 
tonnes 
100-1000 
tonnes 
10-100 
tonnes 

1-10 tonnes 

110 

179 

102 

27 

11 

26 

20 

7 

165 

165 

271 

271 

199 

199 

64 

64 

179 

313 

262 

76 

65 

125 

22 

7 

322 

579 

483 

259b 

176 

300 

229 

89c 

96 

Weighted 
Average 
a The column represents the cost for a substance with one (bulk) form, which can be directly compared with the 
majority of REACH registration cost assessments for substances, as the usual assumption in those calculations 
is that one test is performed per substance per information requirement 

182 

159 

159 

185 

386 

53 

14 

b Estimated additional indirect cost of Measure 41 through registration of bulk form, per company with present 

obligation in phys-chem only: 6.000 Euro (+2.1%); see assumption details above 

c Estimated additional indirect cost of Measure 41 through registration of bulk form, per company with present 

obligation in phys-chem only: 6.000 Euro (+6.7%); see assumption details above 

9.13.7.2 Preferred option - sensitivity to assumptions 

As  mentioned  above,  the  costs  are  highly  sensitive  to  assumptions  concerning  key  cost 
elements  and  these  uncertainties  equally  apply  to  the  cost  calculations  for  the  preferred 
option. The two following tables provide some sensitivity analysis for the preferred option141.  

The table below illustrates different  ranges of costs of registration per nanoform, depending 
on  whether  alternatives  to  testing  exist  or  not  and  on  different  assumptions  on  the  cost  of 
testing. 

Table 9.13-14: Costs per nanoform for the preferred option under different assumptions (in thousand 
Euro): 

No 
alternative, 
typical test 
cost 

Default 
alternatives, 
typical test 
cost 

High 
alternative 
assumption, 
typical test 
cost  

Default 
alternative 
assumption, 
low testing 
cost 

Default 
alternative 
assumption, 
high testing 
cost 

>1000 tonnes 

100-1000 tonnes 

2515 

1924 

1234 

901 

633 

464 

989 

712 

1479 

1090 

202 

413 

756 

377 

10-100 tonnes 
1-10 tonnes (Full Annex 
VII) 
1-10 tonnes (Only Phys-
chem)b 
1-10 tonnesa 
Weighted Average 
a Weighted average 
b Estimated additional indirect cost of Measure 41 through registration of bulk form, per nanoform: 10,000 Euro 

1261 

235 

103 

163 

240 

184 

128 

104 

159 

121 

628 

319 

493 

307 

152 

197 

764 

62 

74 

540 

286 

(+5.5%; +7.8%; +16.1%; +9.6%; +6.6% respectively); see assumption details above 

The  table  below  shows  how  the  figures  for  the  Grand  Total  costs  vary  in  function  of 
assumptions on the existence of alternatives and on the number of nanoforms. 

141 Please refer to Annex XVI for sensitivity analysis addressing these uncertainties. 

150 

 
 
 
                                                 
Table 9.13-15: Grand total registration costs for the preferred option under different assumptions (in 
million Euro): 

High 
alternative 
assumption, 
minimum 
number of 
nanoforms 

Default 
alternative 
assumption, 
minimum  
number of 
nanoforms 

Default 
alternative 
assumption, 
typical 
number of 
nanoforms 

Default 
alternative 
assumption, 
maximum 
number of 
nanoforms 

Default 
alternative 
assumption, 
inverted 
assumption 
on 
substances/ 
tonnages 
based on FR 
notification 
resultsb 

>1000 tonnes 

100-1000 tonnes 

146 

128 

284 

249 

568 

498 

1135 

997 

1481 

757 

165 

25 

52 

103 

206 

18 

12 

27 

55 

10-100 tonnes 
1-10 tonnes (Full Annex 
VII) 
1-10 tonnes (Only P-chem)c 
1-10 tonnesa 
Totald 
a Weighted average 
b  See  section  9.16.2  in  Appendix  XVI  for  details  on  the  assumptions  based  on  results  from  FR  nanomaterial 
notification scheme 
c Estimated additional indirect cost of Measure 41 through registration of bulk form, grand total: (2.92 M Euro, 
5.83M Euro, 11.7 M Euro for minimum, typical and high number of nanoforms, respectively) and 2.34M Euro 
under FR registry assumption. In relative terms, the additional contribution is (+16.2%; +8.1%; +8%; +8%; 
+19.5% respectively); see assumption details above 

1297 

2593 

648 

329 

110 

145 

127 

255 

36 

73 

64 

30 

53 

12 

51 

2468 

d Estimated additional indirect cost of Measure 41 through registration of bulk form, per nanoform: 5.83M Euro 
and  2.34M  Euro  under  FR  registry  assumption  (+0.8%;  +0.4%%;  +0.4%;  +0.4%;  0.1%  respectively);  see 
assumption details above 

9.13.8  Additional illustrative cases 

The tables below illustrate different scenarios for calculating the cost of a registration dossier 
of  a  substance  depending  on  the  number  of  nanoforms  /  set  of  nanoforms  that  need  to  be 
addressed and whether or not alternative information is considered possible. For convenience, 
Table 5-1 presented already in section 5.2.1.2 Costs calculations of the main text and the table 
from  section 9.13.6  Additional costs scenarios above are reproduced  as  starting information 
for the estimation of costs for a few illustrative cases later in the text. 

Table 9.13-16: Registration costs of options per nanoform and per tonnage band (use of alternative 
information considered possible, typical cost) (in thousand Euro): 

1* 

1** 

2 

3 

4 
(including 2) 

5 

6 
(including 
2 and 4) 

>1000 tonnes 

100-1000 tonnes 

10-100 tonnes 

772 

538 

183 

77 

77 

37 

1157 

1157 

1256 

458 

2256 

814 

359 

814 

359 

939 

375 

1736 

471 

40 

869 

151 

 
 
 
 
 
1-10 tonnes (full) 

1-10 tonnes (Annex 
III) 

1-10 tonnes (w.av.) 

78 

37 

49 

Weighted Average 

358 

20 

9 

12 

47 

187 

87 

116 

565 

187 

87 

116 

565 

249 

20 

466 

91 

9 

466*** 

137 

12 

466 

642 

212 

1254 

* Costs per substance with one form (bulk) - one test performed per substance per information requirement. The 
column  represents  cost  for  bulk  form,  which  can  be  directly  compared  with  the  majority  of  REACH  cost 
assessments  for  substances,  as  the  usual  assumption  in  those  calculations  is  that  one  test  is  performed  per 
substance per information requirement  

**To calculate and present the cost per nanoform or set of similar nanoforms, the costs for conducting all tests 
according to the measures constituting Option 1 is divided by an estimated average number of nanoforms or 
sets of nanoforms for a substance at a given tonnage band 

***  Indirect  impact  of  measure  41  on  registration  of  bulk  form  may  bring  estimated  additional  cost  of  10,000 
Euro  per  nanoform  of  substance  otherwise  benefiting  from  Annex  III  exemption.  Relative  additional 
contribution: +2%; more details on assumptions above 

In  case  that  no  alternative  information  can  be  used  when  registering  a  substance  with 
nanoform(s) and a full set of tests is required, the costs are substantially higher:  

Table 9.13-17: Registration costs of options per nanoform and per tonnage band (use of alternative 
information not considered possible, typical cost) (in thousand Euro): 

1* 

1** 

2 

3 

4 
(including 2) 

5 

6 
(including 
2 and 4) 

1686 

1246 

348 

120 

45 

67 

169 

178 

70 

30 

11 

17 

2312 

2312 

2490 

1078 

3277 

1720 

1720 

1935 

898 

2561 

640 

280 

106 

157 

640 

280 

106 

157 

830 

391 

111 

193 

73 

30 

11 

17 

1189 

639 

639* 

639 

778 

100 

1115 

1115 

1249 

496 

1809 

>1000 tonnes 

100-1000 tonnes 

10-100 tonnes 

1-10 tonnes (full) 

1-10 tonnes (Annex 
III) 

1-10 tonnes (w.av.) 

Weighted Average 

For * and **, see footnotes of table 9-17 above 

***  Indirect  impact  of  measure  41  on  registration  of  bulk  form  may  bring  estimated  additional  cost  of  10,000 
Euro  per  nanoform  of  substance  otherwise  benefiting  from  Annex  III  exemption.  Relative  additional 
contribution: +1.5%; more details on assumptions above 

The difference between option 1 and e.g. option 2 in the above tables comes primarily from 
the  assumption  that  under  option  1,  the  testing  cost  is  divided  between  all  forms  of  the 
substance registered (e.g. for tonnages >1000 tonnes it is assumed that there are 10 nanoforms 
or sets per substance, see 9.13.3 above). But as can be observed from the difference between 
1* and 2, there are additional costs caused by some measures under option 2, the main drivers 

152 

 
 
 
being characterisation costs for identification of nanoforms and when testing nanoforms. The 
two  tables  below  include  additional  rows  that  indicate  the  difference  in  cost  and  impact  of 
individual  options  on  low  tonnage  dossiers,  depending  on  the  applicability  of  conditions  of 
Annex III of REACH. It is evident that the relative impacts are largest for options that include 
measures  requiring  generation  of  tox/ecotox  data  also  for  the  substances  that  are  generally 
required to document only physico-chemical hazards. 

Several illustrative cases estimating cost of specific registration dossiers (registration fee not 
included)  are  presented  below.  For  completeness,  the  proposed  preferred  option  is  also 
included.  The  tables  are  followed  by  comments  that  explain  how  the  unit  cost  "per 
nanoform/set" from the first table can be used to estimate the cost for an individual case. 

9.13.8.1 Registration  of  substance  with  bulk  form  and  one  nanoform/set  (default 

assumptions), one registrant (in thousand Euros) 

Table 9.13-18: Registration of bulk form and one nanoform (default assumptions). 

1 

2 

3 

4 
(including 
2) 

5 

6 
(including 2 
and 4) 

Preferred 

>1000 tonnes 

100-1000 tonnes 

772 

538 

1860 

1331 

1860 

1331 

1959 

1456 

1230 

913 

2959 

2253 

1937 

1418 

534 

183 

534 

10-100 tonnes 
1-10 tonnes (Full 
Annex VII) 
1-10 tonnes (Only 
157a 
116 
Phys-chem) 
a Indirect impact of measure 41 on registration of bulk form may bring estimated additional cost of 22,900 Euro 
per substance per company otherwise benefiting from Annex III exemption. Relative additional contribution in 
option 6 is +4.6% and for the preferred option 14.6%; more details on assumptions above 

495a 

257 

587 

305 

257 

319 

536 

116 

120 

98 

46 

78 

37 

1044 

223 

645 

If one disregards the costs for bulk (e.g. interested only in the additional cost for an existing 
dossier where  bulk  and 1 nanoform/set  are registered but  at  present  the dossier documented 
only  bulk),  the  costs  in  options  2,  4,  6  and  preferred  are  effectively  the  costs  per  nanoform 
under  default  assumptions  (see  above  table),  together  with  the  impact  of  measure  41  when 
applied.  

9.13.8.2 Registration  of  substance  with  bulk  from  and  one  nanoform/set  (existing  data  can 
however not be applied, complete testing battery  needed for the nanoform/set), one 
registrant (in thousand Euro) 

Table 9.13-19: Registration of bulk form and one nanoform (existing data cannot be applied). 

1* 

2 

3 

4 
(including 
2) 

5 

6 
(including 2 
and 4) 

Preferred 

>1000 tonnes 

100-1000 tonnes 

10-100 tonnes 
1-10 tonnes (Full 
Annex VII) 
1-10 tonnes (Only 
Phys-chem) 

1686 

1246 

348 

120 

45 

3929 

2944 

980 

392 

142 

3929 

2944 

980 

392 

142 

153 

4107 

3159 

1170 

503 

147 

2765 

2143 

421 

151 

56 

4893 

3785 

1529 

751 

675a 

4132 

3147 

1095 

488 

220a 

 
 
 
 
*For illustration purposes, here the cost for the bulk is also presented without application of any adaptation; full 
test battery is assumed 

a Indirect impact of measure 41 on registration of bulk form may bring estimated additional cost of 22,900 Euro 
per substance per company otherwise benefiting from Annex III exemption. Relative additional contribution in 
option 6 is +3.4% and for the preferred option 10.4%; more details on assumptions above 

As  no  existing  information  (either  for  this  or  another  substance)  can  be  justified  as  being 
relevant for the nanoform/set, the cost in addition to the cost for bulk is  effectively the cost 
per nanoforms of the table above, together with the impact of measure 41 when applied.  

An analogue approach is taken to estimate cost for a dossier with multiple nanoforms – such 
prototype dossier cost estimation is presented already in the main text under section 5.2.1.2: 

9.13.8.3 Registration of substance with 4 nanoform/sets (default assumptions), one registrant 

(in thousand Euro) 

Table 9.13-20: Registration of substance with 4 nanoforms (default assumptions, 1 registrant) 

1* 

2 

3 

4 
(including 
2) 

5 

6 
(including 2 
and 4) 

Preferredb 

>1000 tonnes 

100-1000 tonnes 

10-100 tonnes 
1-10 tonnes (Full 
Annex VII) 
1-10 tonnes (Only 
Phys-chem) 

1686 

1246 

348 

120 

45 

4350 

3170 

1403 

714 

315 

4350 

3170 

1403 

714 

315 

4746 

3669 

1850 

962 

332 

1831 

1499 

159 

78 

37 

8745 

6857 

3444 

1831 

1831a 

4659 

3517 

1618 

908 

479a 

* For illustration purposes, the cost is presented without application of any adaptation; one full test battery is 

assumed 

a Indirect impact of measure 41 on registration of bulk form may bring estimated additional cost of 22,900 Euro 
per substance per company otherwise benefiting from Annex III exemption. Relative additional contribution in 
option 6 is +1.2% and for the preferred option 4.8%; more details on assumptions above 

b Estimation for initial Commission proposal, uncorrected.  

The  cost  is  effectively  4  times  the  cost  indicated  in  table  above  'cost  per  nanoforms  under 
default  assumptions'  –  options  1  and  partly  5  reflect  the  fact  that  nano-specificity  is  not 
required, and their costs reflect testing for 1 form only. Indirect impact of measure 41 should 
also be considered, with similar relative contributions. 

9.13.8.4 Registration of substance with 4 nanoform/sets 

 Assumed that worst case approach is applicable (only 1 data set needed), and that in 50% of 
the cases bulk form, for which data is already available, represents worst case. One registrant 
(in thousand Euro) 

Table 9.13-21: Registration of substance with 4 nanoforms (worst case approach) 

1* 

2 

3 

4 
(including 
2) 

5 

6 
(including 
2 and 4) 

Preferredb 

>1000 tonnes 

1686 

1557 

1557 

1655 

669 

2242 

1763 

154 

 
 
 
 
100-1000 tonnes 

10-100 tonnes 
1-10 tonnes (Full 
Annex VII) 
1-10 tonnes (Only 
P-chem) 

1246 

348 

120 

45 

1197 

511 

253 

138 

1197 

511 

253 

138 

1315 

618 

317 

147 

549 

79 

36 

19 

1750 

870 

494 

494a 

1392 

641 

308 

182a 

* See footnote at table above  
a Indirect impact of measure 41 on registration of bulk form may bring estimated additional cost of 22,900 Euro 
per substance per company otherwise benefiting from Annex III exemption. Relative additional contribution in 
option 6 is +4.6% and for the preferred option 12.6%; more details on assumptions above 

b Estimation for initial Commission proposal, uncorrected.  

While under option 1 the estimation of cost does not differ e.g. from the case c) above, as only 
1  dataset  is  considered  adequate,  the  cost  of  the  other  options  include  characterisation  and 
justification costs, and in 50% of cases generation of data for one test material (worst case). 
This  demonstrates  how  strongly  the  assumption  on  the  availability  of  alternative  to  testing 
affects the result. 

155 

 
 
9.14 

APPENDIX XIV: REACH in brief 

9.14.1  REACH 

REACH  entered  into  force  on  1  June  2007.  The  concepts  of  phase-in  and  non  phase-in 
substances are introduced in order to distinguish between substances manufactured or placed 
on the market before and after REACH's entry into force142. 

REACH  introduced  a  harmonised  set  of  rules  for  the  management  of  chemicals  in  the  EU 
with the two key most striking changes to the past system being 1) the reversal of the burden 
of proof i.e. under REACH producers must demonstrate safety before producing or placing on 
the market and 2) identical requirements to new and old substances. The latter was introduced 
to tackle the huge volume of legacy substances, for which little knowledge was available, as 
well as to stimulate innovation due to much less stringent rules for new substances. Several 
instruments, e.g. exemptions for research and tiered information requirements, should further 
foster innovation.  

REACH establishes procedures for collecting and assessing information on the properties and 
hazards of substances.  Manufacturers and importers need to register their substances in order 
to  access  the  EU  market.  The  European  Chemicals  Agency  (ECHA)    is  the  responsible 
organization for the reception and evaluation of individual registrations for their compliance, 
whereas  the  EU  Member  States  evaluate  selected  substances  to  clarify  concerns  for  human 
health or for the environment. Authorities and ECHA's scientific committees assess whether 
the risks of hazardous substances can be adequatly managed. Authorities can ban hazardous 
substances if their risks are unmanageable. They can also propose to restrict a use or make it 
subject to a prior authorisation. 

142 For further details on phase-in and non phase-in substances, refer to the Glossary  

156 

 
 
 
                                                 
9.14.2  The Registration process 

This Impact Assessment exercice relates to the Registration process. Registration is one of the 
REACH  Regulation's  core  mechanisms  delivering  on  the  reversed  burden  of  proof.  The 
registration  obligation  seeks  to  address  the  concerns  pre-REACH143  regarding  the  lack  of 
information  for  99%  of  the  volume  of  chemicals  on  the  market  in  the  EU.  In  general,  it 
requires  companies  to  register  all  substances  manufactured  or  imported  in  quantities  of  one 
tonne  or  more  per  year  per  manufacturer/importer.  Failure  to  register  would  result  in  a 
manufacturer  or  importer  being  unable  to  legally  manufacture  or/and  import  or  place  their 
substance on the EU internal market. 

REACH sets three distinct registration deadlines: 

1.  30 November 2010: substances manufactured or imported at 1.000 tonnes or more per 
year144, carcinogenic, mutagenic or toxic to reproduction substances above 1 tonne per 
year,  and  substances  dangerous  to  aquatic  organisms  or  the  environment  above  100 
tonnes per year; 

2.  31 May 2013: substances manufactured or imported at 100-1.000145 tonnes per year; 
3.  31 May 2018: substances manufactured or imported at 1-100146 tonnes per year. 

A registration dossier should  demonstrate that the risks through the lifecycle of a substance 
are controlled. The amount of information  required for registration is depending on tonnage 
and  it  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 per year per legal entity. 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. 

Different  forms  of a substance can be  considered within a single  registration.  Generally the 
term  'form'  can  be  understood  to  identify  the  state  of  a  substance  e.g.  granular,  lamellar, 
sheets,  but  is  usually  (and  in  this  document)  applied  more  widely  to  allow  differentiation 
when  one  or  more  intrinsic  physico-chemical  properties  (i.e.  characterisers)  differ.  Form 
would  therefore  include  bulk(solid)  in  different  crystalline  forms,  different  powders  etc. 
Forms  may  differ  based  on  the  differences  in  the  values  of  these  characterisers.  A  form 
fulfiling  the  nano-definition  is  called  nanoform.  There  is  a  defined  minimum  list  of 
characterisers  of  a  nanoform,  included  by  the  proposal  as  new  information  requirement  in 
Section 2.4. of the Annex VI of REACH, that enable characterisation of (and differentiation 
between)  nanoforms.  The  list  includes:  particle  size  distribution,  description  of  surface 
functionalisation  or  treatment,  particle  shape,  aspect  ratio  and  other  morphological 
characterisation,  and  surface  area.  Substance  may  be  in  many  forms,  include  multiple 

143 White Paper for the Strategy for a future Chemicals Policy, Commission of the European Communities, 27 

February 2001: http://eur-lex.europa.eu/LexUriServ/site/en/com/2001/com2001_0088en01.pdf  

144  Referred  to  in  REACH  Annex  X:  Standard  information  requirements  for  substances  manufactured  or 

imported in quantities of 1.000 tonnes or more 

145  Referred  to  in  REACH  Annex  IX:  Standard  information  requirements  for  substances  manufactured  or 

imported in quantities of 100 tonnes or more 

146  Referred  to  in  REACH  Annexes  VIII  and  VII:  Standard  information  requirements  for  substances 

manufactured or imported in quantities of 10 tonnes or more and 1 tonne or more, respectively 

157 

 
 
                                                 
nanoforms. For example, depending on the difference in particle number size distribution or  
particle shape, the same substance may exist in several different nanoforms. A particular form 
may  change  during 
state  of 
aggregation/agglomeration  is  most  frequently  encountered.  As  different  nanoforms  may 
exhibit very similar behaviour – a proposition that needs to be adequately justified – identified 
sets  of  similar  nanoforms  may  be  approached  jointly  using  same  documentation 
requirements.  

for  nanoforms, 

the  change 

life  cycle; 

its 

in 

158 

 
 
9.15 

APPENDIX XV: Procedural information  

9.15.1  Procedural issues and consultation of interested parties 

The IA has been undertaken by DG ENV in co-responsibility with DG GROW.  

Preparatory work for the IA started immediately upon adoption of the Nano Communication 
in  October  2012.  An  IASG  was  then  established.  Its  inaugural  meeting  took  place  on  16 
January  2013  with  the  participation  of  SG,  MARKT  (now  part  of  GROW),  JRC,  RTD, 
SANTE and TRADE. 

A  public  consultation  was  carried  out  for  12  weeks  (from  21  June  to  13  September  2013), 
which  resulted  in  inputs  from  142  respondents.  The  Commission’s  minimum  standards  for 
consultation  have  been  met.  The  consultation  focused  on  the  options  assessed  in  this  report 
with a view to get feedback to the proposed detailed measures in each option. The inputs of 
the  consultation  are  reflected  in  the  analytical  part  of  this  Impact  Assessment.  The  results 
highlighted the fact that currently there is a problem in the way REACH obligations address 
and  safety  is  demonstrated  for  nanoforms  of  a  substance  in  the  registration  dossiers147.  The 
majority  of  industry  and  private  companies  preferred  reduced  information  requirements  and 
thus  lower  associated  cost,  while  governments,  academic/research  institutions,  NGOs  and 
consumer organisations favoured more extended requirements. Please refer to Appendix V for 
a summary of the results of the public consultation.  

In addition to the public internet consultation, three meetings with the Competent Authorities 
for  the  implementation  of  REACH  as  well  as  stakeholders  have  been  held  in  2013-14 
(CASGNano on 15 April and 24 October 2013 and on 12 May 2014) with a view to discuss 
progress of the work and to gather data and information to improve the evidence base.  

Additional information necessary to assess the policy options has been gathered through two 
studies prepared by external consultants  -  BiPRO148 (covering certain measures in options 2 
and  4  of  this  impact  assessment)  and  Matrix  (covering  all  measures  included  in  this  impact 
assessment). 

9.15.2  Consultation of the Regulatory Scrutiny Board 

The  Impact  Assessment  Report  was  examined  by  the  Regulatory  Scrutiny  Board  on  3 
February  2016.  The  Board  gave  a  negative  opinion  to  the  report  due  to  a  number  of 
shortcomings that required improvement.  

The following table briefly  explains how the  Board's  recommendations have led to  changes 
compared to the earlier draft. 

147 86% of the respondents answered that the requirements of REACH for nanomaterials within the registration 

process are unclear or very unclear. 

148 Examination and assessment of consequences for industry, consumers, human health and the environment  of 

possible options for changing the REACH requirements for nanomaterials, BiPRO, 14 January 2013 
http://ec.europa.eu/environment/chemicals/nanotech/pdf/Final_Report.pdf  

159 

 
 
 
 
                                                 
Table 9.15-1: Response to Regulatory Scrutiny Board recommendations 

Main  recommendations  for  improvement  from  the 
Board 

Implementation  of  the  recommendations  into  the 
revised IA Report 

Procedure and presentation  

a.  The consistency between this initiative and the 
one on transparency of nanomaterials should 
be fully ensured in the presentation of the 
policy context, the overarching problems, the 
policy objectives and the baseline scenario. 
If merging the two IA reports into one is not 
possible, coherence should be ensured by 
applying a common 'chapeau' for both reports, 
which would clarify the links to the other 
report and make the report self-standing 

b. 

c.  Avoid technical language to make the report 
more accessible to the non-expert reader 

d.  Presentation to be improved 

e.  Report to be shortened 

1.  Clarify the broader context 

a.  Outline upfront the global issues relating to 

nanomaterials 

Complete redrafting of section 1 with the insertion of 
a  common  chapeau  in  both  reports  Creation  of  a 
separate  section  1.6  on  the  IA  on  transparency 
measures.  The  context,  the  common  overarching 
problems and objectives and differences between the 
issues addressed in the two impact assessments were 
highlighted in a common ‘chapeau’  for both reports. 
Where  relevant,  references  to  possible  synergies, 
links,  and  differences 
impact 
assessment  on  REACH  Annexes  were  added  in  the 
remainder of this impact assessment report 

the  parallel 

to 

Technical  language  avoided  as  far  as  possible. 
Insertion of illustrative figures in several parts of the 
report to better convey the messages. 

The  presentation  has  been  modified  in  order  to 
improve the readability.  

Explanations on the calculations moved to Appendix 
XIII. 

The  explanation  of  the  global  issues  is  included  in 
section  1,  under  the  common  chapeau  which  also 
applies 
for 
report  on 
nanomaterials. 

transparency 

the 

for 

b.  Clarify what scientific evidence is available on 
characteristics of nanomaterials, including their 
potential health and environmental 
implications 

c.  Systemic description of how information on 

nanomaterials is generated and acted upon and 
where the shortcomings are 

d.  Existing policy framework and how it relates 
to the initiative on transparency measures 

e.  Clarify the sequencing and link with the 

revision of the definition of nanomaterials, the 
outcome of the ECHA Board of Appeal and the 
CLP 

General  overview 
the  common 
is  provided 
chapeau  including  chapter  1.3  that  outlines  some  of 
the characteristics and related scientific evidence. 

in 

Substances  with  nanoforms  (i.e.  nanomaterials)  are 
chemicals  as  any  other;  information  is  generated 
according  to  REACH  requirements,  explained  in 
more  detail 
in  Annex  XIV.  Shortcomings  are 
addressed  by  further  clarification  in  the  problem 
definition section.  

Creation  of  a  new  section  1.6  specific  to  the 
transparency  measures  report  where  the  differences 
between the two initiatives are explained. 

Clarification of the presumable impact of the revision 
of  the  nanomaterial  definition  on  section  2.2.3. 
Impact of the Board of Appeal decision is addressed 
by  further  narrative  in  section  4.9.  Relation  of 
REACH  and  CLP  is  clarified  in  the  chapeau,  while 

160 

 
 
more  details  on  the  impact  of  CLP  have  been 
included in subsection 5.6. 

2.  Improve the problem definition and develop a robust baseline scenario 

a.  Specify the particular problem(s) this initiative 

aims to address 

"Lack  of  clarity"  replaced  by  "Nanoforms  of 
substances  not  properly  addressed  and  safety 
demonstrated by REACH" throughout the text. 

The  problems  this  initiative  aims  to  address  are 
included 
the  explanations  are 
underpinned by a graphical illustration. 

section  2; 

in 

b. 

Illustrate, with examples, why the nanoform 
has substantially different characteristics than 
other forms of the same chemical, and when or 
where it may pose a different risk for health 
and the environment 

c.  Clarify what proportion of nanomaterials on 

the market would be covered by the 
amendment of REACH annexes given the one 
tonne threshold 

d.  As part of the baseline scenario, clarify what 

information can be obtained within the existing 
REACH requirements and how the outcome of 
the ECHA Board of Appeal will affect it 

Under  section  2.3  "underlying  causes  of 
the 
problem",  several  nanoform  characterisers  are  listed 
with  specific  references  showing  how  reviews  (each 
comprising a large  number of scientific articles  with 
compiled scientific evidence) brought conclusions on 
(nano)material 
related 
properties 
classification/risk  management  dependent  on  the 
characterisers. 

and 

Inclusion  of  a  new  section  2.2.2  on  the  size  of  the 
market. 

Insertion  in  section  4.1  of  a  figure  illustrating  the 
evolution in the no-change scenario. 

Creation  of  a  specific  section  4.8  explaining  the 
baseline. 

Insertion  of  a  figure  and  a  narrative  in  section  5.7.7 
illustrating  how  the  no-change  scenario  would  be 
affected by the Board of Appeal's opinions. 

e.  Explain how the situation would evolve in 

terms of market size for nanomaterials, as well 
as health and environmental implications, 
assuming a no-policy change scenario 

Health  and  environment  implications  of  no-change 
scenario  are  addressed  in  the  text.  The  relation 
between the size of market and the problem is, to the 
extent possible, captured in section 2.2.2. 

3.  Clarify the policy options 

a.  Clarify the content of policy options and 

simplify their presentation and explain the 
underlying logic in combining the different 
measures into policy options 

b.  Explain why the lowering of the threshold for 
nanomaterials (i.e. below one tonne) was 
discarded as an option 

Clarifications  included  in  the  description  of  the 
options of the purposes and content of each of them. 

Insertion  of  a  figure  illustrating  the  differences 
between 
the  current  REACH 
requirements  according  to  ECHA's  interpretation 
(section 4.2). 

the  options  and 

Insertion of a graphical illustration of the differences 
between the options in section 4.7.  

Clarification  added  in  the  introduction  of  section  4 
explaining  that  modification  of  thresholds  is  not 
within the legal limitations of this exercise because it 
could  not  be  achieved  through  modification  of  the 
REACH  Annexes  but  would  require  modifying  the 

161 

 
 
4.  Improve the analysis of impacts 

a.  Better demonstrate the cost-effectiveness of the 

different measures, in particular when 
comparing costs in relation to the total market 
value of the nanomaterials 

enacting terms of the Regulation. 

the  effectiveness  and 

The  description  of 
the 
efficiency of each of the measures has been enhanced 
in  section  6  and  a  table  has  been  included  in 
Appendix  I  showing  how  each  of  the  measures 
addresses the underlying causes of the problem.  

Cost-effectiveness  of  different  options  can  be 
compared  between  each  other  (see  section  6).  Large 
uncertainties  in  estimates  of  total  size  of  the  market 
impacted  by  proper  functioning  of  REACH  for 
nanomaterials,  together  with  complex  correlation 
with  assumptions  (e.g.  number  of  nanoforms,  in 
which tonnage bands, role of 'old nanomaterials' with 
already existing data in present market valuation etc.) 
would  however  make  comparison  in  absolute  terms 
highly speculative and potentially misleading, so it is 
not attempted.  

Proportionality 
general,  and 
effectiveness of REACH is a better marker.  

in  comparison 
then 

in 
to  chemicals 
to  general  cost-

relation 

b.  Better explain differences between options 2 

and 3 

c.  Further elaborate on the impacts on SMEs and 

any mitigation measures envisaged 

d.  Better explain the choice of the preferred 

option 

Clarifications  in  the  narrative  and  graphs  have  been 
provided to illustrate the differences between options 
2 and 3. 

Creation of a specific section on SMEs in section 5.2 
Economic impacts where all the comments on SMEs 
are gathered. 

Inclusion  of  a  qualitative  appreciation  of  how 
REACH addresses SMEs (6.1).  

Further  clarification  how  options  are  constructed 
from  individual  measures  that  were  individually 
assessed  for effectiveness and efficiency (incl. cost). 
Insertion  of  a  graphical  illustration  of  how  the 
preferred  option  is  built  and  how  it  compares  to  the 
other options in section 6.2. 

5.  Clarify monitoring and evaluation arrangements  

a.  Present the key indicators that will be used to 
measure the success of the chosen policy-mix 

Insertion of clarifications in section 7. 

The  revised  Impact  Assessment  Report  was  resubmitted  with  the  above  mentioned 
modifications  and,  on  14  September  2016,  the  Regulatory  Scrutiny  Board  provided  its 
positive  opinion,  with  a  number  of  recommendations  for  improvement,  which  have  been 
addressed on the following manner:   

Main  recommendations  for  improvement  from  the 
Board 

Implementation  of  the  recommendations  into  the 
final IA Report 

The  description  of  the  individual  options  has  been 
further improved in chapter 4, with clarifications and 

162 

 
 
 
1.  Further clarify the policy options. The report 
should better explain the underlying logic of 
the policy options. It should show on the basis 
of which criteria the various policy measures 
have been screened and selected to be included 
into the policy options. In this context, the 
relevance of option 3 needs to be clarified 
(option 3 is identical to option 2 if the Board of 
Appeal confirms ECHA's interpretation while 
option 3 is not viable in case of rejection of this 
interpretation, see page 24 of the report). 
Moreover, the choice of policy measures to be 
included in the preferred option needs to be 
better explained. 

2.  Improve the analysis of impacts. The report 
should better demonstrate how the policy 
options compare with regard to their cost-
effectiveness, i.e. explain how, in the absence 
of quantitative benefit estimates and the 
presence of uncertain cost estimates, the trade-
off between benefits and costs was made in 
order to identify the most efficient policy 
option. Moreover, the baseline should be used 
in a consistent way throughout the report and 
its tables. 

insertions along the text, fine tuning of the graphs and 
inclusion of an explanatory table in section 4.7.  

The  particularities  of  option  3  have  been  better 
explained  in  the  description  of  the  option  part 
(chapter  4)  and on  the  assessment  of  the  impacts,  in 
terms  of  compliance  costs,  certainty,  health  impacts 
and environmental impacts (chapter 5). 

The  choice  of 
the  policy  measures  has  been 
elaborated  by  explaining  a  3-step  decision  process 
leading  to  the  preferred  option,  emphasising  the 
importance of the effectiveness and the efficiency of 
each  of 
the  measures;  explanations  have  been 
underpinned  by  illustrative  tables  and  graphs  in 
chapter 6 and Appendix XII.  

The  report  now  explicitly  explains  how  the  policy 
options  compare  in  terms  of  their  cost-effectiveness 
(chapter  6).  The  inclusion  of  the  explanations  about 
the  3-step  process  allows 
the 
appropriateness of the  measures  within the preferred 
option. 

strengthening 

It has been ensured that the baseline is addressed in a 
consistent  way  throughout  the  report  and  that  the 
uncertainties  related  to  the  decision  of  the  Board  of 
Appeal,  which  may  have  an  effect  on  the  baseline, 
are clearly underlined and highlighted. 

3.  Consistency with the impact assessment on 
'transparency measures for nanomaterials 
on the market' 

Consistency  with  the  other  impact  assessment  has 
been  maintained by introducing the same  changes to 
the common chapter (chapter 1). 

9.15.3  Update of the information following the discussions and partial modification of the 

Commission proposal in the REACH Committee 

The  Impact  Assessment  Report  has  been  finalized  addressing  the  Recommendations  of  the 
Regulatory Scrutiny Board (see 9.15.2 above), passing the inter-service consultation along the 
Commission proposal in October 2017.  

Based  on  the  discussions  with  the  Member  states  in  the  Committee  under  the  Regulation 
1907/2006  (the  REACH  Committee),  the  Commission  modified  several  elements  of  its 
proposal  that  was  eventually  voted  upon  and  unanimously  approved  in  the  REACH 
Committee  on  26  April  2018.  There  were  numerous  changes  to  the  legal  text  in  several 
Annexes of the proposal. Most changes are improving the clarity of the text but do not affect 
the  scope  or  content  of  the  provisions,  nor  would  they  change  the  estimated  impact.  
Nevertheless,  some  changes  may  increase  the  costs  and  the  benefits.  The  impact  of  these 
changes,  as  well  as  some  relevant  legislative  developments  during  that  time,  have  been 
assessed and discussed with the Member States prior to the vote. The assessment is presented 
below together with reference to some relevant developments. This assessment supersedes the 
information provided in the main text and the sensitivity analysis in Annex XVI but doesn’t 
change the outcome of the performed assessment. The individual changes are presented in the 

163 

 
 
 
table  below.  The  main  changes  and  the  estimated  impacts  on  costs  have  also  already  been 
included in the main tables in Section 6. The changes include also the revisit of an assumption 
and eliminate minor calculation errors identified during the review114.  

The table with estimated animal use for all options as well as the initial and final Commission 
proposals  is  also  attached  for  transparency.  The  sensitivity  analysis,  of  which  none  of  the 
outcomes is qualitatively altered by the changes, is not repeated. 

Relevant complementary information 

Subject 

Content, reference in the main text 

Statistical 
implementation 

information  regarding  REACH 

Initiatives undertaken (Chapter 2.2.3) 

Number  of  registration  dossiers  explicitly 
indicating  nanomaterials 
is  a  constantly 
moving  target.  In  March  2018,  the  total 
substances  with 
number  of 
nanoforms was 21, compared to 13 in August 
2015. (Chapter 2.2.1, p.14). 

registered 

In  addition  to  the  2013  ECHA  Guidance 
updates  mentioned  in  the  text  (p.17),  ECHA 
in  May  2017  updated  the  Appendices  to 
Guidance  on  Information  Requirements  and 
Chemical  Safety  Assessment  (IR  &  CSA), 
together  with 
the  further  Appendix  on 
Grouping  and  Read-across  for  nanoforms, 
and  published  the  Practical  guide  "How  to 
prepare 
that  cover 
nanoforms: best practices”.  

registration  dossiers 

the 
In  February  2017,  ECHA  updated 
the 
including  also 
mandate  of  NMWG, 
Product 
Biocidal 
implementation 
Regulation  and  renamed  the  working  group 
into  "Nanomaterials  Expert  Group  (NMEG) 
(p.17) 

of 

ECHA 

evaluation 

ECHA Board of Appeal Decisions on appeals 
against 
decisions 
addressing nanomaterials listed in footnote 50 
(p.18)  have  been  complemented  by  further 
two decisions on appeals A-014-2015 and A-
0015-2015,  addressing  substance  evaluation 
of  silicon  dioxide.  BoA  decisions  partially 
annulled  the  substance  evaluation  decision, 
supporting  some  but  not  all  of  the  requested 
testing,  with  the  principal  arguments  that  a) 
concern was not demonstrated for all types of 

164 

 
 
 
 
 
the 

request  was 

silica;  b) 
in  parts 
disproportionate  and  c)  there  was  lack  of 
clarity  in  the  use  of  the  term  'SAS  form'. 
Unlike  the  BoA  decision  A-11-2014  already 
referred  to  in  the  main  text,  these  decisions 
did not further influence the baseline applied 
as described in the Chapter 4.8. 

(TGs) 

Further  adjustments  of 
the  OECD  Test 
currently  being 
are 
Guidelines 
discussed  by  the  OECD  Working  Party  on 
Manufactured  Nanomaterials 
(WPMN). 
Three test guidelines that specifically address 
nanomaterials  have  been  published  by  the 
OECD, two new TGs specifically addressing 
nanomaterials  are  under  development  in  the 
OECD  Test  Guidelines  Programme  (TGP), 
and  two  have  been  proposed  to  the  TGP  for 
development149.  Furthermore,  several 
test 
guidelines  are  developed  in  the  WPMN. 
guidance 
Additionally, 
documents have also been proposed as a way 
of  addressing 
testing  of 
nanomaterials.  The  last  state  of  development 
in  March  2018,  including  information  on 
costs  where  available,  has  been  taken  into 
account  during 
the 
the  REACH 
Commission  proposal 
Committee.  

several  OECD 

finalization  of 

the  regulatory 

the 

in 

Terminology: set of similar nanoforms 

in 

The  concept  of  set  of  nanoforms  has  been 
the  REACH 
extensively  discussed 
Committee  and  eventually  kept 
the 
in 
proposal.  While  the  concept  (and  associated 
impacts evaluated in this report) has remained 
as  in  the  original  proposal,  the  term  ‘set  of 
similar  nanoforms’  is  now  consistently  used 
instead. 

As  part  of  the  discussion,  the  following 
clarification  has  been  presented 
the 
REACH  Committee  on  the  nanoforms  and 

to 

149  Published:  TG318  (Dispersion  stability  of  nanomaterials  in  Simulated  Environmental  Media),  TG412  and 
TG413  on  subchronic  inhalation  toxicity.  In  preparation:  TG  on  particle  size  and  size  distribution  of 
Manufactured Nanomaterials, TG on the Determination of (Volume) Specific Surface Area (V)SSA of 
Manufactured 
on 
http://www.oecd.org/science/nanosafety/. 

Nanomaterials. 

programme 

WPMN 

also 

See 

of 

165 

 
 
 
                                                 
  
sets of nanoforms:  

an 

stands 

symbols 

represent 

a 
below 
The 
hypothetical  substance  that  exists  in  a 
number  of  different  nanoforms  (potential 
bulk  forms  are  not  presented).  Each 
symbol 
individual 
for 
nanoform,  and  its  colour,  size  and  shape 
depict  characterisation  of  the  nanoform: 
size indicates different particle sizes (e.g. 
average  particle  size  10 nm,  50 nm  and 
95 nm),  shape  of  the  symbol  indicates 
shape (e.g. spheres, rods, stars), while the 
colour  indicates  application  of  different 
surface  coating  (uncoated  blue,  and  red 
and  yellow  depicting  coating  with 
chemical groups A and B). For simplicity 
let's assume all rods are long but only the 
thickest are rigid. Each nanoform can be 
represented by the characteriser troika in 
square  brackets  e.g.  [50nm,rod,coating 
B].  

27 different combinations are possible. Of 
these,  there  is  no  present  interest  in 
placing on the market uncoated little stars 
and spheres, so 25 have to be covered by 
registration.  

the 

invented 

Based  on 
information 
available,  stars  and  spheres  are  applied 
for  the  same  uses  while  rods  may  differ. 
Modelling  and  tests  indicate  that  size 
does not play a role, apart in the case of 
large  (rigid)  rods.  While  coating  A  does 
not  seem  to  affect  any  hazard  or  fate 
properties, coating B seems to influence it 
strongly.  Stars  are  expected  to  behave 
like  spheres  but  this  is  to  be  further 
confirmed.  One  way  to  consider  the  sets 
would  be  [square  brackets  represent 
characterisation,  which  is  provided  in 
ranges]: 

166 

 
 
 
Changes to the proposal in Annexes VII-X 
(information requirements) 

regarding 

Changes 
physico-chemical 
requirements  (Modification  of  application  of 
measures 2 and 3)  

  Set  1  :  [5-100nm,  spheres  or  stars, 

uncoated or coating A] 

  Set  2  :  [5-100nm,  spheres  or  stars, 

coating B] 

  Set  3  :  [5-50nm,  rods,  uncoated  or 

coating A] 

  Set 4 : [5-50nm, rods, coating B] 
  Set  5  :  [5-100nm,  rods,  uncoated  or 

coatings A or B] 

These  assessed  impacts  relate  to  information 
provided  in  Chapter  6  and  Annexes  XII  and 
XIII. 

The  Member  States  have  received 
this 
information  in  a  separate  Explanatory  note 
that  accompanied  the  changed  proposal  for 
the discussion and vote in the meeting of the 
REACH committee in April 2018.  

The  Commission  proposal  now 
includes 
explicit  reference  to  two  physico-chemical 
properties  (dissolution  rate  and  dispersion 
stability), to be considered as part of existing 
water  solubility  and  octanol-water  partition 
coefficient  (Kow)  information  requirements 
under Annex VII of REACH.  

Dissolution rate 

The  dissolution  rate  with  its  recognised 
importance for the preparation of tests and for 
the  interpretation  of  test  results,  plays  a 
pivotal  role  in  the  safety  assessment  and  the 
justification for read across between different 
forms. For nanoforms, the characterisation of 
the  proposal 
the  dissolution  rate 
explicitly  included  under  Point  5.2.3  of 
Annex  I  on  Chemical  Safety  Assessment. 
Testing  of  the  "dissolution  rate  in  water  as 
and 
relevant 
well 
biological 
environmental  media" 
for  nanoforms 
becoming  a  mandatory  consideration  under 
the Point 7.7. on Water Solubility.  

as 

in 

in 

is 

is 

A  Test  Guideline  for  the  dissolution  rate  is 
still  under  development  and 
the  exact 
standardised  media  are  not  yet  defined.  The 
Commission  estimate  for  the  cost  of  the  test 

167 

 
 
 
per  nanoform,  considering  all  the  listed 
media,  is  EUR  8-32K150.  In  a  conservative 
approach  (assuming  there  is  no  potential  for 
read  across  between  the  nanoforms/sets),  the 
total  additional  cost  for  all  nanoforms  is 
estimated in the order of EUR 16.5-66M.  

As  this  information  is  a  key  element  of 
intelligent testing strategies and the chemical 
safety  assessment,  the  registrants  may  have 
already generated such information to support 
these needs. These  costs could  also  be offset 
by  the  increased  efficiency  of  the  employed 
testing strategies, in particular when it comes 
to  higher  tier  testing.  However,  no  robust 
quantitative  assumption  can  be  made  on  the 
net  impact  so  full  cost,  for  each  nanoform, 
was used in the estimates.  

The  additional  burden  is  estimated  at  an 
average  of  EUR  20K  for  the  set  of  tests.  On 
average, this represents around 3% of the cost 
of  registration  of  one  nanoform151,  but  a 
relative increase of 10.9% for the low volume 
registrants. 

Dispersion 
behaviour) 

stability 

(agglomeration 

Dispersion  stability  is  included  with  the 
proposal  as  a  mandatory  consideration  under 
Annex  VII  whenever  octanol  water  partition 
coefficient  (Kow)  is  not  applicable.  This  is 
assumed to be true in 90% of the cases.  It is 
also  recognised152  as  one  of  the  crucial 
physico-chemical properties of the nanoform, 
its  bioavailability,  kinetics, 
influencing 
transformation 
the 
fate.  As 
dissolution  rate,  the  information  is  a  key 
element  of  intelligent  testing  strategies  and 
the chemical  safety  assessment  and the same 
consideration  would  apply  as  for  the  net 
impact  of  the  requirement  but,  again,  no 

and 

for 

150 In the assessment of impact,  the cost of the water solubility measurement, estimated at EUR 5.5K could be 
deducted because it is in principle expected to be provided by the same test. The cost is based on input 
by  industry  (internal  communication  with  Eurometaux)  on  the  OECD  TD  29  "Transformation 
dissolution test on metals and metal compounds" with cost per material/media range from 2 000 for the 
24h  test  to  the  8  500  for  28-day  test  that  already  includes  consideration  of  sample  preparation  and 
improved filtration techniques, but was complemented to consider multiple media covered.  

151 Respectively to the probable baseline as estimated in the impact assessment report.  
152 Agglomeration behaviour is part of the information that relates to the dispersion stability.  

168 

 
 
                                                 
robust  quantitative  assumption  can  be  made 
on the net impact.  

at  EUR  10K 

The cost  for the recently adopted OECD TG 
318 (Dispersion stability of Nanomaterials in 
Simulated  Environmental  Media)  has  been 
estimated 
(conservative 
estimate)  by  the  competent  authority  leading 
the  development  of  the  OECD  guideline153. 
Considering  that  in  the  future  additional 
biologically  relevant  simulated  media  are 
expected  to  be  included  in  the  Guidance 
Document (assuming the similar cost of EUR 
10K), 
the 
additional  cost  per  nanoform  of  including 
dispersion  stability  under  the  Point  7.8. 
Octanol  water  partition  coefficient  to  be  in 
the  order  of  EUR  4.1K-13.1K154  or  5.0%  of 
the baseline cost in the Annex VII where the 
relative  impact  is  highest,  leading  to  an 
additional total cost of EUR 8.4-26.9 million.  

the  Commission 

estimates 

Further  information  on  physicochemical 
properties (Measure 44*) 

the 

The Commission modified its initial proposal 
regarding 
the  need  for  consideration  of 
additional  physico-chemical  properties  of 
nanoforms,  moving 
information 
requirements  from  Annex  IX  to  Annex  VIII. 
Due  to  the  other  changes  (inclusion  of 
dissolution  rate,  dispersion  stability),  it  is 
difficult to estimate what could cost of further 
information  be  while  avoiding  any  double 
the 
counting.  Conservatively 
possibility  of  double  counting  and  keeping 
the  initial  estimate  of  the  measure  (average 
EUR  8K  per  nanoform),  the  change  would 
increase  in  relative  terms  cost  per  nanoform 
under  Annex  VIII  by  1.8%,  and  1.2% 
compared 
to  an  average.  The  change 
contributes  EUR  2M  or  0.15%  to  the  total 
cost.  

ignoring 

153 Internal communication. 
154 When applied, it is assumed that the testing of Kow at the cost of EUR 5.49K, currently assumed in the impact 
assessment,  would not be performed, and that Kow  is  not applicable for 90% of nanoforms, triggering 
consideration of dispersion stability testing.  

169 

 
 
 
                                                 
Changes  regarding 
toxicity  via 
(Measure 11) 

the 

testing  of  acute 
the  most  appropriate  route 

As  above,  summary 
explanatory note to the Member states: 

is  based  on 

the 

The  proposal  modifies  the  default  route  for 
acute toxicity testing of nanoforms in  Annex 
VII from the oral route (standard requirement 
for  substances) 
inhalation  route, 
because  this  route  has  been  considered  to  be 
more  relevant  for  nanoforms.  This  change 
indirectly  considers  animal  welfare  concern: 
when  necessary  to  use  animals,  maximum 
relevance of the test should be pursued.  

the 

to 

In the original Commission proposal, the text 
of  the  Annex  was  just  encouraging  such 
testing,  so  the  measure  was  not  explicitly 
recognized  as 
the 
preferred option. The main text of this report 
is  therefore  not  consistent  anymore  with  the 
proposal in this regard. 

implemented  under 

Performing  the  inhalation  instead  of  the  oral 
test  under  Annex  VII  is  expected  to  bring 
additional costs and animal use: 

the 

Firstly, 
test  costs  are  higher  by 
approximately  EUR  6.3K  per  nanoform. 
Secondly,  as  the  requirement  differs  from 
standard  requirements  for  substances,  the 
possibilities  for  read  across  from  bulk  or 
other substances will be  reduced.  This  factor 
is currently set at 49% i.e. roughly half of the 
are  presently 
information 
fulfilled  using 
avoids 
performing  the  test.  Assuming  the  reduction 
of  this  percentage  to  20%  (e.g.  80%  of  all 
nanoforms registered would require the test), 
the additional cost per nanoform in the lowest 
tonnage  range  is  roughly  estimated  at  EUR 
9.5K155.  

requirements 

adaptation 

that 

As  generally  more  animals  are  used  in  the 
inhalation  test  than  in  the  oral  one  (the 
assumption in the impact assessment report is 
40 vs 15 for the respective tests), the increase 
in the additional use of animals per nanoform, 

155  Characterisation  of  the  testing  material  is  also  included  in  the  estimation  whenever  the  test  is  triggered. 
Estimation  includes  the  difference  in  triggering  as  well  as  the  differences  between  the  tests  in  use  of 
animals. 

170 

 
 
 
 
                                                 
considering  also 
that  most  but  not  all 
nanoforms  will  be  tested,  is  estimated  to  be 
24.  

is 

impact  of 

the  change 

For the registration at the higher tonnages, the 
change in provisions does not have any effect 
route  must  always  be 
as 
the  second 
considered.  The 
the 
total 
requirement  therefore  only  relates  to  the 
lowest  tonnage  rate.  When  full  Annex  VII 
submission 
is 
required, 
resulting  in  increase  of  EUR  6.5M  (0,5%  of 
average  total  cost  or  3.8%  of  cost  for  full 
Annex VII registrants), with an additional use 
of 16500 animals. With a worst-case estimate 
that  all  Annex  VII  registrations  would  be 
subject  to  this  provision,  this  would  lead  to 
EUR  7.6  million  and  an  additional  use  of 
19200  animals156.  For  consistency  with  data 
for  the  other  options,  tables  below  however 
include the former assumption.  

this 

Triggers of long term testing on daphnia and 
fish  (Points  9.1.1  and  9.1.3)  now  explicitly 
include the triggering for low-dissolution rate 
nanoforms.  However,  the  current  assessment 
information  requirement  already 
for 
estimates that long term testing of nanoforms 
would be triggered in 90% of the cases based 
already  on  the  existing  trigger.  It  is  hard  to 
justify  further  increase  in  the  assumption. 
While the change will contribute to triggering 
that is better informed and targeted, the initial 
estimates do not need to change. 

As  indicated  individually  above,  each  of  the 
changes in the proposal aims at increasing the 
information  on 
relevance  of  available 
nanoforms.  It  is  however  not  possible  to 
quantify 
the  significantly 
improved relevance of the basic toxicological 

the  benefit  of 

Changes regarding the wording of Column 2 
information 
in 
the 
requirements, 
to 
perform 
(Measures 
14,16,17) 

ecotoxicological 
indicating 
term 

adaptations 

testing 

long 

Summary of the impact and assessment of the 
benefits of the changes to the proposal 

156 Scenario that all low tonnage nanoforms (800) may be considered for the testing, rather than only the subset 
not benefiting from Annex III prioritisation as taken in the present IA estimations in the report. This is 
based  on  present  statistics  on  very  low  number  of  dossiers  including  only  physico-chemical 
information, and the ongoing discussion in the application of phase-in status. As the baseline animal use 
per nanoform for low volume registration is13; additional 24 represent 60% of the estimated use at this 
tonnage  level.  But  in  total,  the  additional  19200  animals  represent  roughly  1,3%  increase  in  the 
estimated use of animals. 

171 

 
 
 
 
                                                 
information. 

As  regards  the  cost,  the  average  cost  per 
nanoform  is  estimated  to  be  increased  by 
EUR  31K,  with  a 
total  additional  cost 
estimate  EUR  63M,  or  4.5%  increase  as 
compared to original proposal. Regarding the 
scenario  of  registration  of  bulk  with  4 
nanoforms,  the cost  of registration compared 
to baseline would increase by 27%.  

In  terms  of  animal  use,  on  average  an 
additional  8  animals  per  nanoform  are 
expected to be used, with total additional use 
of  16  thousand  animals  (+1.3%  compared  to 
original  proposal).  This  estimate 
is  still 
within  estimates 
for  animal  use  under 
baseline scenario, as additional animal testing 
is  offset  in  the  calculation  by  the  increased 
ability  to  read-across,  based  on  better  and 
available non-animal supporting data.  

Final tables on estimated animal use 

Table 9.15-1: Animal use per option per nanoform (or set of nanoforms), use of alternative methods 
considered  possible,  with  default  assumptions  (see  Appendix  XIII).  Complements  Table  5-3  and 
discussion under Chapter 6.4 in the main text: 

Estimated 
baseline 

2 

3 

4 (incl. 2) 

5 

6 (incl. 4) 

Preferred-
initial 
proposal 
(Oct 2017, 
corrected*) 

Final 
proposal 
(Apr 
2018) 

1178 
1076 
485 
9 
613 

1178 
1076 
485 
9 
613 

1178 
1076 
485 
9 
613 

1182 
1081 
496 
16 
619 

552 
548 
97 
2 
283 

2395 
2166 
817 
128 
1263 

1120 
1024 
488 
16 
589 

1120 

1024 

488 

37 

597 

Animal Use per form 
>1000 tonnes 
100-1000 tonnes 
10-100 tonnes 
1-10 tonnes (w.av.) 
Weighed Average 

Table 9.15-2: Total estimated animal use per option (in thousands). Complements Table 5-4 and 
discussion under Chapter 6.4 in the main text: 

Animal Use Total 
(thousands) 
>1000 tonnes 

Estimated 
baseline 

2 

3 

4 (incl. 2) 

5 

6 (incl. 4) 

Preferred 
(Oct 2017, 
corrected*) 

Final 
proposal 
(Apr 
2018) 

542 

542 

542 

544 

254 

1102 

515 

515 

172 

 
 
 
 
100-1000 tonnes 
10-100 tonnes 
1-10 tonnes (w.av.) 
Total 

595 
121 
7 
1266 

595 
121 
7 
1266 

595 
121 
7 
1266 

598 
124 
12 
1278 

303 
24 
2 
583 

1198 
204 
102 
2606 

566 
122 
13 
1216 

566 

122 

29 

1232 

173 

 
 
 
 
9.16 

APPENDIX XVI: Sensitivity analysis 

This appendix elaborates a sensitivity analysis that allows establishing high, low and realistic 
scenarios  which  put  into  context  the  cost  figures  presented  in  the  main  text.  The  sensitivity 
analysis has been calculated for the cost per nanoform, for the grand total and for the cost per 
company.  

9.16.1  Cost per nanoform 

In Appendix XIII, illustrative cases presented the importance of case-specific parameter, such 
as number of forms per substance, to the estimation of cost of a registration dossier. Appendix 
XIII also outlines the way to calculate dossier cost based on the unit cost table 9-9 and shows 
that the main driver of dossier costs is the availability of data that can be applied as alternative 
to testing of individual nanoforms/sets of nanoforms: 

  High  cost  scenario:  alternatives  are  not  available,  full  testing  cost  applies.  Presented 

e.g. in Table 9-18 of Appendix XIII. 

While such a situation can probably not be excluded for some individual nanoforms, it 
is in many cases unrealistic to expect that alternatives would not be available for any 
nanoform/set  of nanoforms  as this would contradict existing information  on selected 
nanomaterials (see e.g. discussions of ECHA Nanomaterial Working Group) 

  Default:  the  'default  assumptions'  (e.g.  Table  9-17  of  Appendix  XIII),  based  on  the 
information on application of alternative methods for substances already registered, as 
this is the most robust data available.  

  Low  cost  scenario:  specific  situations  have  been  outlined  in  the  illustrative  cases  in 
Appendix XIII: it is probable, due to economic as well as regulatory pressures (animal 
testing as a last resort) to assume that all existing data, in particular available data on 
the  same  substance  (but  another  form)  will  be  exploited  to  the  maximum  before 
commissioning any testing. For the vast majority of substances with nanoforms with 
known bulk form (i.e. excluding carbon nanotubes etc.), data on bulk form is already 
available. As identified  also  in  the  Impact  assessment on the transparency measures, 
many  nanomaterials  (though  presently  not  registered  as  substances  with  nanoforms) 
are  commodity  materials,  often  with  limited  number  of  nanoforms  with  already 
available toxicity data.  

In  short,  a  significantly  lower  proportion  of  testing  than  under  default  assumption  is 
also  a  realistic  assumption.  For  simplicity,  cost  is  approximated  by  assuming  that 
testing  (Annex  VII-X  only,  for  Annex  VI  full  costs  apply)  is  required  in  the  same 
proportion as the number of substances with nanoforms vs number of nanoforms, i.e. 
18%.  In  other  cases,  only  justification  is  sufficient.  For  option  1,  where  a  single 
dataset is applied to different nanoforms, the default assumption is applied also for the 
low cost scenario.  

174 

 
 
Table 9.16-1: Sensitivity analysis with regard to the proportion of available use of alternative information (high/default/no alternative). Cost per nanoform, in 
thousand Euro) 

1 

2 

3 

4  
(including 2) 

5 

6 
(including 2 and 
4) 

Preferred (Mix)c 

>1000 tonnes 

77/77/169 

575/1157/2312 

575/1157/2312 

609/1256/2490 

225/458/1078 

796/2256/3277 

633/1234/2515 

100-1000 tonnes 

77/77/178 

409/814/1720 

409/814/1720 

450/939/1935 

185/375/898 

591/1736/2561 

464/901/1924 

10-100 tonnes 
1-10 tonnes (Full Annex 
VII) 
1-10 tonnes (Only Phys-
chem) 
1-10 tonnesa 

37/37/70 

168/359/640 

168/359/640 

205/471/830 

23/40/73 

286/869/1189 

202/413/756 

20/20/30 

84/187/280 

84/187/280 

107/249/391 

10/20/30 

163/466/639 

103/235/377 

9/9/11 

47/87/106 

47/87/106 

49/91/111 

12/12/17 

58/116/157 

58/116/157 

66/137/193 

5/9/11 

7/12/17 

163/466/639 b 

62/128/184 b 

163/466/639 

74/159/240 

Weighed Average 

47/47/100 

281/565/1115 

281/565/1115 

307/642/1249 

105/212/496 

434/1254/1809 

319/628/1261 

a Weighted average 
b Indirect impact of measure 41 on registration of bulk form per nanoform (10K EUR) is not included in the sensitivity analysis in the table; contributions are identified in the 
tables in Appendix XIII. Maximum relative additional contribution is 16.1% for  the preferred option, when using assumption for high use of alternative information. Even 
maximum contribution is several times lower compared to the uncertainty regarding this single assumption. 

c Estimation for initial Commission proposal, uncorrected.  

175 

 
 
 
The other main drivers for the cost per nanoform are the assumptions on the cost of testing. 
To evaluate the maximum potential impact on individual registrations of the assumptions on 
test costs, the impact of applying a low and high cost estimate instead of an average one has 
been evaluated in the costing per nanoforms in a scenario when full testing is required. Ratios 
between the results were calculated. The impact shows a maximum increase of 34% for a new 
substance under 1-10t under option 2, with an average increase of 20% for all options 2, 4 and 
6 under a high testing cost assumption, and a corresponding 20% decrease under low testing 
cost  assumption  (this  result  is  as  expected,  as  typical  cost  is  set  as  an  average  between  the 
two).  

9.16.2  Grand total costs 

The  main  driver  of  the  grand  total  costs  is  the  number  of  nanoforms  or  set  of  nanoforms 
which  will  need  to  be  registered,  as  the  total  is  directly  proportionate  to  this  number.  The 
assumption  on  the  number  of  forms  (and  the  ratio  of  nanoforms  registered  in  respective 
registration  tonnages)  is  highly  speculative,  but  has  been  compared  against  data  or  similar 
estimations developed under other studies or activities157: 

Based on the general survey of available information (see summary of main studies below), it 
had to be concluded that no hard data is available. Assumptions have therefore been made that  
0.5%  /  1%  /  2%  of  all  substances  (in  individual  tonnage  bands)  have  nanoforms  which  are 
expected  to  be  registered.  The  ratio  of  nanoforms  per  substances  (10/7/5/4  for  highest  to 
lowest  tonnage  band,  respectively)  is  then  applied.  Such  choice  leads  in  the  default 
assumption  to  a total  of 2063  nanoforms,  a  number  that  can  be  roughly  associated  with  the 
limited  data  available.  It  also  corresponds  to  the  number  of  substances  (375)  known  or 
expected to have nanoforms at present or in the near future. The sensitivity range presented 
above  leads  to  1032/2063/4126  nanoforms  respectively,  with  corresponding  number  of 
substances 188/375/750.  

As  the  grand  total  cost  is  directly  proportionate  to  the  number  of  nanoforms,  applying  the 
sensitivity range leads to costs from one half to 2 times the grand total costs presented in the 
main text.  

9.16.2.1 Existing REACH registrations 

REACH registrations, which allow the voluntary indication that nanoforms are covered by a 
registration  since  2010,  are  not  a  reliable  source:  by  March  2018,  only  21  substance 
registrations had indicated nanoform as any of the forms of the substance registered. For the 
majority, no estimations of actual numbers of nanoforms can be made at present but it can be 
expected, based on the different compositions reported, to be well below the average number 
of  10  different  nanoforms/sets  of  nanoforms  assumed  in  this  impact  assessment  for  high 
tonnage substances. 

9.16.2.2 French registry 
The  French  nanoregistry  report158  identified  in  2014  319  notified  substances.  Comparison 
with ECHA's REACH database indicates that 60% are already registered, with an  additional 

157  Please  refer  to  table  'Estimated  number  of  nanoforms  or  sets  of  nanoforms'  under  9.13.3  Input  tables  and 
summary  of  main  assumptions  for  a  detail  of  the  assumptions  which  have  been  used  for  this  impact 
assessment. 

158 Rapport d'étude 2014 des élements issus des déclarations des substances à l'état nanoparticulaire, Ministère de 
https://www.ecologique-
et 

l'Ecologie, 
durable 
solidaire.gouv.fr/sites/default/files/2014-11%20-%20Rapport%20R-nano%202014.pdf 

du  Développement 

l'Energie, 

p.23  

de 

. Since 2015 further notifications have been provided that however do not qualitatively change the assessment 

based on 2014 data. See R-nano.fr. 

176 

 
 
 
                                                 
5%  expected  by  2018  with  certainty,  while  35%  are  outside  REACH's  scope  or  notified  at 
present  below  1  tonne.  Again  there  is  no  clear  link  to  nanoforms,  but  ca.  210  substances 
(corresponding to the 65% mentioned above) is within the interval of the assumption made.  

The French registry however indicates that the ratio between the number of substances with 
nanoforms in different tonnages might be rather inverted to the one observed from chemicals 
in general. The sensitivity analysis can address that by a new ratio proposed which would put 
ca.  60%  of  substances  in  higher  tonnages,  and  40%  in  lower.  In  the  absence  of  other 
knowledge, these can be distributed equally (30% in >1.000t, 30% 100-1.000t, 20% 10-100t, 
20%  1-10t).  Using  the  same  ratios  forms/substance  and  aim  at  number  of  substances  at 
minimum to be roughly the number of reported substances that are already or are expected to 
be registered by 2018, the following alternative table 9-25 results: 

Table  9.16-2:  Number  of  nanoforms/sets  of  nanoforms  expected  to  be  registered  (based  on  FR 
registry): 

Tonnage band 

> 1000  

100 – 1000 

10 – 100 

1 – 10 Full 

1 - 10 Annex III applied 

1 - 10 Annex III not appl. 

Total 

(# substances) 

Number of NF/sets 

Min 
600 

420 

200 

160 

113 

47 

1380 

200 

Max 
2400 

1680 

800 

640 

453 

187 

5520 

800 

Typ 
1200 

840 

400 

320 

227 

93 

2760 

400 

The 210 substances reported from the French registry roughly fit with the the lower estimate. 

Using  the  default  assumptions  for  the  cost  per  nanoforms,  but  applying  the  numbers  from 
Table  9-25  the  grand  total  e.g.  increases  by  90%  for  the  preferred  option,  with  a  2.6  times 
increase in registrations >1000t.  

9.16.2.3 Canadian nanomaterial survey 2015 

Canada has identified 206 substances with anticipated nanoforms for mandatory reporting of 
substance  identity/composition,  volumes  and  uses  of  nanoforms.  Considering  that  some 
substances  are  excluded  due  to  the  fact  they  have  been  included  under  new  substances 
assessment, the number fits within the interval used.  

9.16.2.4 US list of substances that could have nanoforms 

The US EPA has solicited information on likely chemicals that could be nanoscale materials. 
The Nanoscale Materials Stewardship Program (NMSP) report159 identified 2.328 chemicals 
with differing CAS numbers, based on 3 sources (Nanowerk, PEN and NMSP). Many of these 
overlap or could be considered as forms of same substances and the report (p.18) concludes: 
"Combining all three datasets, EPA identified over 200 existing chemicals that are produced 
at  the  nanoscale  for  commercial  and  R&D  purposes,  of  which  91  are  likely  to  be 
manufactured for commercial purposes". The numbers are difficult to compare to the number 

159  Chemical  Substances  When  Manufactured  or  Processed  as  Nanoscale  Materials:  TSCA  Reporting  and 
Recordkeeping  Requirements,  US  EPA,  2015,  https://www.epa.gov/reviewing-new-chemicals-under-toxic-
substances-control-act-tsca/control-nanoscale-materials-under 

177 

 
 
 
 
                                                 
of substances or nanoforms used in this IA and cannot be used directly but on the other hand 
do not undermine the assumptions made.  

9.16.2.5 BiPRO/Oeko report  

This report of 2012 under the Nano support project led by JRC used 500-2.000 as the actual 
number  of  forms  to  be  assessed.  This  interval  overlaps  with  the  lower  range  of  the  interval 
used in this assessment.  

9.16.2.6 RPA/CEFIC 2012 

The most frequently quoted numbers regarding nanomaterials are 500-2.000 which originate 
from  the  2012  RPA/CEFIC  study.  The  objective  of  the  study  was  to  estimate  impact  of 
changes to Substance ID rules to the number of substances and is indirectly applicable as the 
number of 'new' substances can be related to the number of forms, elevated to substances in 
their own right due to modified rules. The  study based the interval on estimation by several 
VCI  experts. With a number of caveats  (the main  ones regarding the implementation  of the 
nano-definition),  the  500-2.000  in  the  study  indeed  determines  the  number  of  potential 
chemical  substances  with  nanoforms  to  be  registered  under  REACH,  on  top  of  which  two 
assumptions  were  made  regarding  the  number  of  nanoforms  that  could  become  substances 
under  modified  rules:  a)  1  nanoform  per  substance  (size  as  identifier)  or  b)  2-5  (coating  as 
identifier, low/high estimate).  

These  assumptions  lead  to  500-2.000  substances  with  nanoforms  and  1.000-16.000 
nanoforms,  respectively.  The  latter  high-end  estimate  was  used  as  part  of  the  sensitivity 
analysis  and  in  the  analysis  triggered  significant  implications  to  the  ratio  between  tonnages 
registered  (the  study  assessed  the  substance  identity  changes  that  would  trigger  separate 
registration).  The  numbers  are  difficult  to  compare  with  the  'nanoform/set  of  nanoforms' 
convention  used  in  this  impact  assessment  as  that  might  include  both  size  and  coating  as 
relevant  characterizers,  while  on  the  other  hand  allows  for  ranges  to  be  combined  within  a 
single set. Comparison may also put in question the average ratio of the number of form-per 
substance  (10/7/5/4)  applied,  as  they  are  at  the  high  end  of  the  CEFIC  approach.  This  was 
further  confirmed  in  the  bilateral  discussions  with  CEFIC  –  the  higher  end  of  the  range  of 
2.000  was  principally  based  on  the  high  number  of  organic  pigments  with  nanoforms;  for 
which  experts  could  not,  in  spite  of  high  tonnage,  identify  high  numbers  of  nanoforms  per 
substance. Rather the opposite – it was indicated that many (48%, see RPA/CEFIC p.46) fall 
under  the  study's  'Scenario  1'  that  indicates  little  effort  beside  'ticking  the  nano  box',  as  the 
relevant  form  of  this  'conventional  substance'  is  already  registered  and  presented  in  the 
dossiers.  As  regards  the  high  end  assessment  with  5  coatings  leading  to  5  nanoforms,  the 
association  of  the  organic  pigments  industry  consistently  claimed  that  practically  for  all 
organic  pigments  with  nanoforms,  despite  potential  differences  in  chemical  identity  of 
coatings, a single dataset per substance will be adequate as coatings serve the same function 
and therefore bring very similar physico-chemical surface properties. Under the assumptions 
of the impact assessment, such an approach is well within a single set concept.  In any case, 
these substances (one half of 2.000) are therefore very unlikely to correspond to the average 
10 nanoforms per substance. It should also be noted that under RPA/CEFIC assumptions, only 
10%  of  forms  (high  estimate,  likely  estimate  5%)  are  actually  expected  to  come  from  new 
chemicals, while 95% are 'legacy materials'.  

9.16.3  Cost for the registrant 

A single company may produce and register 1 or many nanoforms (or substances).. Sensitivity 
analysis may however be applied to the number of companies registering the same nanoforms. 

178 

 
 
 
As  indicated  in  the  main  text,  the  costs  of  addressing  information  requirements  in  Annexes 
VII-X of REACH are shared between them. 

The  situation  is  complex  as  registrants  of  the  same  nanoforms  may  register  at  different 
tonnage  levels  or  opt  out  for  individual  information  requirements,  making  their  shares 
variable.  To  better  address  these  variations  in  cost  calculations,  a  Monte  Carlo  approach  is 
required, as  applied in  some studies160. As such, a methodology is  not  applied in  the model 
used in this impact assessment, the sensitivity analysis can only estimate difference in costs 
when  the  number  of  registrants  of  the  substances  with  nanoforms  varies  within  the  tonnage 
band. The lower estimate is that a registrant is registering the nanoform of a substance alone, 
which leads to the highest cost per company. The higher estimate can be set by doubling the 
average  number  of  registrants  in  a  SIEF161  as  observed  for  already  submitted  registrations, 
used under default assumption – even more registrants is possible, but increasingly unlikely. 
The analysis confirms what can be deduced directly by observing the magnitudes of different 
contributions  to  the  total  cost:  with  increasing  tonnage,  the  contribution  of  characterisation 
costs  under  Annex  VI  becomes  less  and  less  important  in  comparison  to  the  testing  costs 
under Annexes VII-X of REACH, making the total cost almost inversely proportionate to the 
number of companies in the SIEF. A single registrant in the highest tonnage band may incur 6 
times the costs compared to the average situation (and correspondingly 3, 1.7 and 1.5 times in 
the respective lower tonnages), while doubling the numbers of registrants in  a SIEF divides 
the cost in half.  

9.16.4  Alternative Methodology for cost calculation 

As explained in  section 5.2.1.2 the main text  and in  more detail  in  Appendix XIII, the  core 
methodological  approach  is  the  attribution  of  unit  cost  per  nanoform.  Another  way  is  to 
calculate costs and use of animals for one registration dossier of a substance with nanoforms 
in  each  tonnage  band.  The  calculation  of  the  costs  and  use  of  animals  for  one  registration 
dossier of a substance with nanoforms takes place in a following manner: 

1.  The costs and use of animals for the testing of the conventional form of a substance 
with nanoforms is presented in Option 1, while the absolute costs and use of animals 
after additional nanoform specific measures requested Options 2-6 and in the Preferred 
Option (in line with the draft legal proposal) are presented under Options 2-6 and the 
Preferred Option. As the endpoint specific testing costs from the Matrix study used in 
the  impact  assessment  relate  to  minimum  and  maximum  costs  for  conventional 
substances and are expected to be lower than for nanomaterials on average, the highest 
prices  instead  of  the  average  ones  are  used  for  endpoint  specific  testing  costs  (see 
Appendix XIII).  

2.  The  decision  from  the  Board  of  Appeal  of  2  March  2017  provided  clarity  about  the 
current requirements in REACH. Consequently, neither Option 1 nor Option 2 are the 
baseline,  but  it  is  situated  in  between  Options  1  and  2.  Accordingly,  the  soft  law 
measures in Option 3 of a non-legally-binding nature related to the REACH provisions 
for nanoforms of substances are at the same level as in the baseline in this alternative 
methodology. Where requested in measures related to Annex VI in Options 2, 4, 6 and 
in the Preferred Option each registrant in a SIEF is requested to report characterisation 
data on its different nanoforms to ECHA and the average cost of characterisation (12 
000 €/nanoform) is multiplied in each tonnage band by the number of registrants in a 
SIEF and by the number of different nanoforms; 

160  See  for  example  recent  RPA  study  on  impact  of  modification  of  information  requirements  for  1-10t, 

http://ec.europa.eu/environment/chemicals/reach/pdf/1-10t%20P2%201-10t.pdf   

161 Reminder from Appendix XIII: >1000: 7; 100-1000: 3; 10-100: 1,8; 1-10: 1.8 

179 

 
 
 
                                                 
3.  The  measure  41  in  Option  6  and  in  the  Preferred  Option  requires  a  full  Annex  VII 
dossier with (eco)toxicological information for 100% (Option 6) and 80% (Preferred 
Option) instead of 29,2% (Option 1). So additional costs and animal uses of the testing 
of  both  substance  and  nanoform  at  1-10  tpa  tonnage  on  top  physicochemical 
information have been included under Option 6 and Preferred Option; and  

4.  Otherwise, the lead registrant of a SIEF of a substance with nanoforms is reporting in 
the  Joint  Submission  any  relevant  nanoform  specific  information  requested  in 
measures  related  to  Annex  VII-X  in  line  with  practices  in  REACH  e.g.  for  positive 
triggers for additional testing and applying the worst case approach also in testing of 
nanoforms.  The  costs  and  animal  uses  are  calculated  for  Scenario  1  and  Scenario  2: 
The former represents  a situation without alternative methods for nanoforms  and the 
latter  one  where  alternative  methods  will  be  available  for  nanoforms  as  for 
conventional substances today.     

The  costs  and  use  of  animals  in  one  registration  dossier  of  a  substance  with  nanoforms  is 
multiplied by the total number of substances with nanoforms to be registered (CEFIC 2012) to 
obtain a Grand Total Costs and Grand Total Use of Animals. The division of the costs and use 
of animals by the average number of companies in SIEF in  each tonnage band provides the 
company specific costs. 

It should be noted that the final "Preferred mix" results of the alternative methodology do not 
include  reassessment  due  to  the  changes  made  in  the  Commission  proposal  in  the  REACH 
committee  and  are  thus  not  directly  comparable  to  the  estimates  for  the  final  Commission 
proposal.  

The results in different scenarios are as follows: 

Table 9.16-3: Total costs of one registration dossier of substances with nanoforms 

180 

Scenario 1 No alternative methods for Nanoforms (1000 €, high price)1Baseline234 (including 2)56 (including 2 and 4)Preferred Mix>1000 tonnes75687237408724080121050994267100-1000 tonnes6547322808732316010643940329310-100 tonnes26830210813021308274174412981-10 tonnes, Full Annex VII1241275381276551249676671-10 tonnes, Annex VII PC363721237216367374491-10 tonnes (w.av.)62643076434462804513Weighted average299        299          1.358      335       1.524          442       2.117           1.664         Scenario 2 Alternative methods for Nanoforms (1000 €, high price)1Baseline234 (including 2)56 (including 2 and 4)Preferred Mix>1000 tonnes75685426738542838121035172913100-1000 tonnes6547151800715196710642441200310-100 tonnes26829777129789327411968631-10 tonnes, Full Annex VII1241274181274761246604701-10 tonnes, Annex VII PC363718637191365943341-10 tonnes (w.av.)62642546427462613374Weighted average299        299          945         329       1.028          442       1.432           1.094          
 
 
 
 
 
 
Table 9.16-4: Grand total costs of registration dossiers of 500 substances with nanoforms 

Table 9.16-5: Total costs of one registration dossier of substances with nanoforms per company 

181 

Scenario 1 No alternative methods for Nanoforms (MEURs high price)1Baseline234 (including 2)56 (including 2 and 4)Preferred Mix>1000 tonnes46532295325074313262100-1000 tonnes69772967733311241534710-100 tonnes182072208718116871-10 tonnes, Full Annex VII10104210511075521-10 tonnes, Annex VII PC77407417139851-10 tonnes (w.av.)8841844812075TOTAL 1501686791687622211058832Scenario 2 Alternative methods for Nanoforms (MEURs, high price)1Baseline234 (including 2)56 (including 2 and 4)Preferred Mix>1000 tonnes46521645217474216179100-1000 tonnes69751907520711225721110-100 tonnes18205120601880581-10 tonnes, Full Annex VII10103310371051371-10 tonnes, Annex VII PC77357367112631-10 tonnes (w.av.)883483689455TOTAL 150164473164514221716547Scenario 1 No alternative methods for Nanoforms (1000 €, high price)1Baseline234 (including 2)56 (including 2 and 4)Preferred Mix>1000 tonnes108        125          534         125       583            173       728             610            100-1000 tonnes218        244          936         244       1.053          355       1.313           1.098         10-100 tonnes149        168          601         168       727            152       969             721            1-10 tonnes, Full Annex VII69         71           299         71         364            69         537             370            1-10 tonnes, Annex VII PC20         21           118         21         120            20         409             249            1-10 tonnes (w.av.)34351703519134447285Weighted average97108434108492135733554Scenario 2 Alternative methods for Nanoforms (1000 €, high price)1Baseline234 (including 2)56 (including 2 and 4)Preferred Mix>1000 tonnes108        122          382         122       405            173       502             416            100-1000 tonnes218        238          600         238       656            355       814             668            10-100 tonnes149        165          428         165       496            152       664             480            1-10 tonnes, Full Annex VII69         71           232         71         265            69         367             261            1-10 tonnes, Annex VII PC20         21           103         21         106            20         330             186            1-10 tonnes (w.av.)34351413515234341208Weighted average97106305106335135503366 
 
 
 
 
 
 
 
With the estimated number of animal use: 

Table 9.16-6: Total use of animals per one registration dossier of substances with nanoforms 

Table 9.16-7: Grand total use of animals in registration dossiers of 500 substances with nanoforms 

182 

Scenario 1 No alternative methods for Nanoforms1Baseline234 (including 2)56 (including 2 and 4)Preferred Mix>1000 tonnes940940365610724116144650664239100-1000 tonnes93893836551070411314445062400110-100 tonnes2692699792691261269177412171-10 tonnes, Full Annex VII515110851227515481881-10 tonnes, Annex VII PC0000001711021-10 tonnes (w.av.)151531156615281127Weighted average357       357           1.366    401       1.575           526       2.074           1.593        Scenario 2 Alternative methods for Nanoforms 1Baseline234 (including 2)56 (including 2 and 4)Preferred Mix>1000 tonnes94094019239582147144626241933100-1000 tonnes9389381922956214414442621185310-100 tonnes26926955726969226910135661-10 tonnes, Full Annex VII51518551161513931061-10 tonnes, Annex VII PC000000136571-10 tonnes (w.av.)15152515471521171Weighted average357       357           728       363       832             526       1.122           741           Scenario 1 No alt.methods for Nanoforms (1000)1Baseline234 (including 2)56 (including 2 and 4)Preferred Mix>1000 tonnes58582246625289311260100-1000 tonnes999938511343315253342110-100 tonnes181865188418118811-10 tonnes, Full Annex VII448418443151-10 tonnes, Annex VII PC00000032191-10 tonnes (w.av.)1121513518TOTAL 1781786832007872631037797Scenario 2 Alt. methods for Nanoforms (1000)1Baseline234 (including 2)56 (including 2 and 4)Preferred Mix>1000 tonnes58581185913289161119100-1000 tonnes999920210122615227619510-100 tonnes18183718461868381-10 tonnes, Full Annex VII44741343181-10 tonnes, Annex VII PC00000026111-10 tonnes (w.av.)1121412710TOTAL 178178364181416263561371 
 
 
 
 
Table 9.16-8: Total use of animals in one registration dossier of substances with nanoforms per 
company 

9.16.5  Sensitivity analysis –  summary 

Due to the unknown distribution of the probabilities between the different assumptions, it is 
inappropriate  to  combine  them  in  a  way  that  would  range  from  using  always  the  lowest  to 
always the highest assumptions, as this would result in a giant interval of cost figures. Some 
qualitative summary is however possible: 

 

It  is  shown  that  the  estimates  are  very  sensitive  to  the  underlying  assumptions;  the 
uncertainties of the average cost is likely to be in the order of at least 50%, with the 
understanding that the differences in cost for specific substances with nanoforms are 
likely to vary within one order of magnitude. 

  The impact of the application of different assumptions under the sensitivity analysis is 
visible in particular between the tonnages, as proportions of individual contributions to 
the cost differ (e.g. testing cost vs characterisation); on the other hand, the comparison 
between options is rather robust. The uncertainties are not by themselves reducing the 
ability  to  analyse  the  impacts  of  individual  measures  and  thus  making  an  informed 
choice between the options.  

  The grand total cost is directly proportionate to the assumed number of nanoforms and 
numbers of substances with nanoforms. That number is however proportionate also to 
the  presence  of  these  nanomaterials  in  the  market  and  therefore  to  the  associated 
potential benefits (in terms of economic value as well as getting things right in relation 
to health and environmental protection). 

  The results of the cost calculations from the methodology described in Appendix XIII 
and  the  alternative  methodology  used  in  section  9.16.4  of  this  Appendix  can  be 
compared  for  the  Grand  Total  Costs,  i.e.  between  Table  6-4  from  the  main  text 
(section  6.3  The  costs  of  the  preferred  option)  and  Table  9.16-4  in  section  9.16.4. 
Alternative  Methodology  for  cost  calculation  of  this  Appendix.  Such  a  comparison 

183 

Scenario 1 No alternative methods for Nanoforms 1Baseline234 (including 2)56 (including 2 and 4)Preferred Mix>1000 tonnes134       134           522       153       588             207       724             606           100-1000 tonnes313       313           1.218    357       1.371           481       1.687           1.334        10-100 tonnes150       150           544       150       700             150       986             676           1-10 tonnes, Full Annex VII28        28            60         28        126             28         304             105           1-10 tonnes, Annex VII PC-       -           -        -       -              -        95               57             1-10 tonnes (w.av.)8817837815671Weighted average107107403118474151659483Scenario 2 Alternative methods for Nanoforms 1Baseline234 (including 2)56 (including 2 and 4)Preferred Mix>1000 tonnes134       134           275       137       307             207       375             276           100-1000 tonnes313       313           641       319       715             481       874             618           10-100 tonnes150       150           310       150       384             150       563             315           1-10 tonnes, Full Annex VII28        28            47         28        89               28         219             59             1-10 tonnes, Annex VII PC-       -           -        -       -              -        76               32             1-10 tonnes (w.av.)8814826811740Weighted average107107217108253151368227 
 
 
 
 
shows that the costs of registration in Table 6-4 are roughly 3.2 times higher than in 
9.16-4.  This  is  mainly  due  to  the  assumption  of  possibility  to  apply  the  worst  case 
approach.  When  a  similar  assumption  is  applied  in  the  main  methodology162,  total 
costs  for  the  preferred  option  are  estimated  at  736  million  EURO,  to  be  compared 
against the 547 million Euro in the Table 9.16-4.  

162 The assumption can be approximated in the main methodology as follows: a) the same number of nanoform 
per substance is assumed (Nf = 10/7/5/4 respectively, see Table 9.13-1). b) It is assumed that 1 full dataset is 
required (i.e. cost per nanoform with no alternative possible). c) For (Nf-1) nanoforms, a full read-across is 
assumed  (i.e.  effectively  only  characterisation  costs  of  Annex  VI  +  justification  costs  remain.  Note  that 
characterisation is calculated for all registrants of the nanoform). d) Costs under b) and c) are added. e) Such 
cost  is  multiplied  by  number  of  substances  (500),  assuming  same  ratios  between  the  tonnage  bands  (Table 
9.13-2), and summed across all tonnage bands.  

184