COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT Accompanying the document COMMISSION REGULATION (EU) 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) 475 final  COMMISSION STAFF WORKING DOCUMENT  EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT  Accompanying the document   COMMISSION REGULATION (EU) 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) 474 final}  
 
 
                                     ANNEX I 

Impact assessment on Possible amendments of Annexes to REACH for registration of nanomaterials   

Why? What is the problem being addressed? Maximum 11 lines 

A. Need for action 

As  any  other  chemicals,  nanomaterials  are  used  in  different  products,  addressed  by  various  legislation,  most 
importantly REACH. Jointly they should provide adequate information on their safe use. There is however a lack 
of clarity on how nanomaterials should be addressed and safety demonstrated in REACH registration dossiers. 
The information requirements depend on the total tonnage in which a substance (in all forms) is placed on the 
market.  The  information  to  demonstrate  safety  may  depend  on  the  form  of  a  substance,  and  although  the 
dossier structure allows it and ECHA encourages it, there is no explicit requirement in REACH to identify such 
different forms, undertake specific tests for different forms or to justify why the information provided is valid for all 
forms.  Based  on  an  evaluation  of  registration  dossiers  submitted  by  2010  for  substances  that  exist  also  in 
nanoforms,  the  Commission  identified  the  need  for  more  specific  requirements  on  how  nanoforms  should  be 
addressed  in  registration  dossiers.  In  case  of  inaction,  the  observed  insufficient  demonstration  of  safe  use  for 
nanoforms  might  continue,  resulting  in  increased  risk  for  health  and  environment  due  to  potentially  poor  risk 
management  and  safety  measures,  and  companies  wishing  to  register  nanoforms  will  face  uncertainties, 
resulting  in  ineffective  implementation  and  increased  costs,  affecting  innovation,  investment  decisions  and 
competitiveness.  

What is this initiative expected to achieve? Maximum 8 lines 

REACH aim 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.  In  line 
with the aim of the legislation, the objective of this initiative is to ensure clarity on how nanoforms of a substance 
are to be addressed and safety to be demonstrated in registration dossiers, thus allowing REACH to be fit for the 
purpose of dealing with nanomaterials. This will in turn enable REACH to play its part, as for other chemicals, in 
supporting availability of adequate information on safe use of nanomaterials.  

What is the value added of action at the EU level? Maximum 7 lines  

Regulation (EC) No 1907/2006 on REACH is an EU Regulation based on Article 114 TFEU. REACH sets out the 
registration  obligations  for  chemicals  that  are  placed  on  the  EU  market  and  provides  rules  for  their  free 
circulation,  including  the  manufacture  or  use  of  nanoforms  of  a  substance.  Legislative  initiatives  in  Member 
States pertaining to the placing on the market of substances, including their nanoforms, would be in breach of 
REACH. The possible modification of the provisions established in REACH can only be adopted at EU level.  

B. Solutions 

What  legislative  and  non-legislative  policy  options  have  been  considered?  Is  there  a  preferred 
choice or not? Why? Maximum 14 lines  
Further to the no-change scenario (option 1), several other options have been considered, each consisting of a 
set of specific measures, most of which could be evaluated individually. Option 2 would introduce changes to the 
information requirements of various REACH Annexes clarifying explicitly what the European Chemicals Agency 
(ECHA)  considered,  up  to  Board  of  Appeal  Decision  of  2  March  2017  on  titanium  dioxide,  to  be  the  implicit 
requirements  of  REACH.  Option  3  would  introduce  measures  of  soft  law  nature  to  provide  more  clarity  on  the 
registration  obligations  through  guidance  without  any  changes  to  REACH  Annexes.  Option  4  assumes  full 
implementation of option 2 and would introduce additional measures to demonstrate safe use in cases where the 
existing  information  requirements  in  REACH  are  not  tailored  for  nanoforms  of  a  substance  or  where  specific 
considerations  are  required  for  them.  Option  5  would  clarify  registration  obligations  and  reduce  certain 
information  requirements  based  on  the  explicit  assumption  that  the  information  in  a  registration  dossier  for  a 
substance is independent of its form. Option 6 assumes full implementation of options 2 and 4 and would require 
the generation of comprehensive information about any potential specific effects and extensive additional testing 
for  nanoforms  of  a  substance  with  the  objective  of  reducing  any  uncertainty.  The  preferred  option  is  a  mix  of 
measures  based  on  a  slightly  adapted  option  2  and  including  specific  measures  from  options  4  and  6  further 
chosen  to  maximize  effectiveness,  efficiency  and  coherence  of  the  action  taken.    During  discussion  with  the 
Member States in the REACH committee, some of the measures of this option were modified or extended.  

Who supports which option? Maximum 7 lines  
Respondents in the public consultation can be grouped into three main categories: 

1.  Industry representatives, trade associations and private companies supported option 5; 

1 

                                                            
 
 
2.  Government  authorities,  academic/research  institutions,  NGOs,  consumer  associations  and  individual 

citizens support option 6 followed by option 4;  

3.  'Others' (i.e. not having identified their affiliation) supported in equal shares options 6, 4 and 2. 

However, when considering the efficiency (i.e. the appropriate demonstration of safe use versus the associated 
costs) of the specific measures within the options, respondents ranked option 2 first, followed by option 4.  

C. Impacts of the preferred option 

What are the benefits of the preferred option (if any, otherwise main ones)? Maximum 12 lines                                       
The  proposed  changes  of  the  REACH  Annexes  for  the  registration  of  substances  with  nanoforms  that  are 
contained in the preferred option will lead to better knowledge about the potential effects of nanoforms on health 
and environment, and hence to more appropriate measures to prevent risks, which is the underlying rationale for 
the REACH Regulation for all chemicals. However, most of the health and environmental benefits are expected 
to materialise only with significant delays after implementation of the measures of the preferred option and are 
difficult to quantify. In terms of economic and social benefits, it  is expected that  legal clarity and certainty may 
positively  affect  companies'  investment  decisions  and  may  improve  the  consumer's  trust  in  the  safe  use  of 
substances with nanoforms.   

What are the costs of the preferred option (if any, otherwise main ones)? Maximum 12 lines                                       
The main costs of the preferred option are the additional compliance costs for companies registering substances 
with  nanoforms.  The  lack  of  clarity  of  the  current  REACH  requirements  for  nanomaterials  resulted  in  different 
interpretations  by  industry  and  ECHA  with  both  options  1  and  2  as  potentially  the  baseline,  and  costs  of  the 
preferred  option  can  be  compared  to  either  of  them.  Board  of  Appeal  Decision  of  2  March  2017  on  titanium 
dioxide clarified that the baseline should be considered closer to option 2, but not the option 2 in its entirety, as 
the  nanoform  characterisation  cannot  be  presently  requested  as  part  of  the  substance  identity  information. 
During  discussion  with  the  Member  States  in  the  REACH  committee,  the  Commission  modified  some  of  the 
provisions in its initial proposal, introducing explicit requirements for two relevant physico-chem parameters and 
mandatory  inhalation  rather  than  oral  acute  toxicity  testing.  Headline  information  on  cost  and  animal  use  is 
complemented in the report: the cost for the registration of one nanoform would increase by 32% compared to 
the  estimated  baseline.  The  cost  of  a  registration  dossier  (of  a  substance  with  a  bulk  form  and  4  nanoforms) 
would increase by 27%. The total cost of the preferred option, as modified, 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. These results are highly sensitive to several key assumptions in the underlying calculations leading to 
uncertainties of at least 50%. The preferred option increases some requirements on animal testing compared to 
the baseline. Significant negative impact on employment is not expected.  

How will businesses, SMEs and micro-enterprises be affected? Maximum 8 lines 

Companies  placing  on  the  market  nanomaterials  will  be  directly  affected  due  to  their  obligation  to  register 
substances  with  nanoforms  (both  EU  manufacturers  and  importers).  The  effects  will  be  additional  compliance 
costs  and  administrative  burden  for  such  businesses,  partly  compensated  by  a  clearer  legislative  environment 
for fulfilling their obligations. External studies performed for the European Commission in the preparation of the 
REACH Review 2013 estimated the total number of European nanomaterial manufacturers in the range of 200 
to  400.  Other  companies  from  various  downstream  sectors  that  use  nanomaterials  may  be  affected.  As  is  the 
case  for  REACH  in  general,  SMEs  would  be  more  affected  by  the  preferred  option  than  other  companies, 
because the cost increase is relatively higher for low tonnage registrations, where more SMEs are usually active.   

Will there be significant impacts on national budgets and administrations? Maximum 4 lines 
The initiative will not have any significant impact on national budgets and administrations. Since all the options 
aim to create more clarity for registrants of nanoforms of a substance, it is anticipated that the overall compliance 
and enforcement costs for public authorities will decrease.  

Will there be other significant impacts? Max 6 lines  
The  preferred  option  would  not  cause  any  other  significant  impacts.  The  changes  foreseen  in  the  preferred 
option would have non-significant impacts on the requirements under the CLP Regulation and under Annex II of 
REACH in relation to the communication of safety information in the supply chain via Safety Data Sheets for the 
registered nanoforms of substances. Other non-significant impacts, such as impacts on downstream users, cost 
and price competitiveness, international competitiveness or capacity to innovate are assessed in one appendix 
to the impact assessment. 

When will the policy be reviewed? Maximum 4 lines  

D. Follow up 

The  Commission  is  required  to  publish  every  five  years  a  general  report  on  the  operation  of  REACH  in 
accordance with its Article 117(4). The first REACH Review Report was published in February 2013. The second 

2 

 
 
 
 
review  was published  in  2018  and  the next  is due in 2022. Given that the measures foreseen in the preferred 
option are expected to start to deliver as of 2018, with full effect only sometime after 2018, the 2022 report will 
be the first occasion for their review. 

3