COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE Second Regulatory Review on Nanomaterials
Date: 2012-10-03
Institutions: European Commission
Subjects: environmental risk prevention, labelling, nanotechnology, occupational health, packaging, safety standard, technical standard

EUROPEAN 
COMMISSION 

Brussels, 3.10.2012  
COM(2012) 572 final 

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL 
COMMITTEE 

Second Regulatory Review on Nanomaterials 

(Text with EEA relevance) 

{SWD(2012) 288 final} 

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   EN 

 
 
 
  
 
COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL 
COMMITTEE 

Second Regulatory Review on Nanomaterials 

(Text with EEA relevance) 

1. 

INTRODUCTION 

This  Communication  constitutes  the  follow-up  to  the  2008  Commission  Communication  on 
regulatory aspects of nanomaterials1. 

It  assesses  the  adequacy  and  implementation  of  EU  legislation  for  nanomaterials,  indicates 
follow-up actions and responds to issues raised by the European Parliament2, the Council3 and 
the European Economic and Social Committee4. 

It is accompanied by a Commission Staff Working Paper (SWP) on Nanomaterial Types and 
Uses, including Safety Aspects5 which responds to the European Parliament’s concern that the 
Commission’s approach to nanomaterials is jeopardised by the lack of information on the use 
and on the safety of nanomaterials that are already on the market. The SWP provides detailed 
information  on  the  definition  of  nanomaterials,  nanomaterial  markets,  uses,  benefits,  health 
and safety aspects, risk assessment, and information and databases on nanomaterials. Its main 
conclusions are reflected in sections 3 and 4. 

2. 

DEFINITION OF NANOMATERIALS 

The  2011  Commission  Recommendation  on  the  definition  of  nanomaterials6  defines 
‘nanomaterial’ as “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 
threshold between 1 and 50 %. […]” 

The  definition  is  intended  to  be  used  by  Member  States,  European  Union  agencies  and 
companies. The Commission will use it in EU legislation and instruments of implementation 
where  appropriate.  Where  other  definitions  are  used  in  EU  legislation,  provisions  will  be 
adapted  in  order  to  ensure  a  consistent  approach,  although  sector  specific  solutions  may 

1 
2 
3 
4 
5 
6 

COM (2008) 366, 17.6.2008 
Resolution European Parliament on Regulatory Aspects of Nanomaterials (2008/2208(INI), 24.4.2009 
Conclusions on “improving environmental policy instruments” of 20 December 2010 
Opinion European Economic and Social Committee; INT/456 of 25.2.2009, Nanomaterials 
SWD(2012) 288 final 
Commission Recommendation 2011/696/EU, OJ L 275, 20.10.2011 

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remain necessary. The Commission will review this definition in 2014. 

3. 

BENEFITS OF NANOMATERIALS AND THEIR CONTRIBUTION TO GROWTH AND JOBS; 
INNOVATION AND COMPETITIVENESS 

The  total  annual  quantity  of  nanomaterials  on  the  market  at  the  global  level  is  estimated  at 
around  11  million  tonnes,  with  a  market  value  of  roughly  20bn  € 7.  Carbon  black  and 
amorphous  silica  represent  by  far  the  largest  volume  of  nanomaterials  currently  on  the 
market8. Together with a few other nanomaterials, they have been on the market for decades 
and are used in a wide variety of applications. 

The  group  of  materials  currently  attracting  most  attention  are  nano-titanium  dioxide,  nano-
zinc  oxide,  fullerenes,  carbon  nanotubes  and  nanosilver.  Those  materials  are  marketed  in 
clearly  smaller  quantities  than  the  traditional  nanomaterials,  but  the  use  of  some  of  these 
materials is increasing fast. 

Other  new  nanomaterials  and  new  uses  are  being  developed  rapidly.  Many  are  used  in 
innovative  applications  such  as  catalysts,  electronics,  solar  panels,  batteries  and  biomedical 
applications including diagnostics and tumour therapies. 

The  benefits  of  nanomaterials  range  from  saving  lives,  breakthroughs  enabling  new 
applications  or  reducing  the  environmental  impacts  to  improving  the  function  of  everyday 
commodity products. 

Products underpinned by nanotechnology are forecast to grow from a volume of 200 bn € in 
2009  to  2  trn  €  by  2015. 9  These  applications  will  be  essential  for  the  competitiveness  of  a 
wide area of EU products in the global market. There are also many newly founded SMEs and 
spin-off  companies  in  this  high  technology  area.  Currently,  the  direct  employment  in 
nanotechnology  is  estimated  at  300  000  to  400  000  jobs  in  the  EU,  with  an  increasing 
tendency.10 

Nanotechnology has been identified as a key enabling technology (KET) providing the basis 
for further innovation and new products.11 In its Communication ‘A European strategy for 
Key Enabling Technologies – A bridge to growth and jobs’12 the Commission has outlined a 
single strategy for KETs, including nanotechnology, built upon three pillars: technological 
research, product demonstration and competitive manufacturing activities. 

The  applicable  legislation  must  ensure  a  high  level  of  health,  safety  and  environmental 
protection.  At  the  same  time,  it  should  permit  access  to  innovative  products  and  promote 
innovation and competitiveness. The regulatory environment affects time to market, marginal 
cost structure and allocation of resources,  especially for SMEs. It also creates new business 
opportunities and contributes to consumer and investor confidence in the technology. 

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9 

10 
11 
12 

SWP, p. 10. 
Carbon  black  accounts  for  around  85%  of  total  nanomaterials  on  the  market  in  terms  of  tonnage, 
synthetic amorphous silica accounts for another 12%.  
http://www.forfas.ie/media/forfas310810-nanotech_commercialisation_framework_2010-2014.pdf, 
referring  to  Lux  Research.  Those  figures  refer  to  the  value  of  products  into  which  nanomaterials  are 
incorporated (as opposed to the value of nanomaterials marketed). 
http://ec.europa.eu/enterprise/sectors/ict/files/kets/hlg_report_final_en.pdf, p. 13. 
http://ec.europa.eu/enterprise/sectors/ict/key_technologies/kets_high_level_group_en.htm 
http://ec.europa.eu/enterprise/sectors/ict/files/kets/act_en.pdf 

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International collaboration in particular with our trade partners can stimulate the development 
and commercialization of nanotechnology-enabled applications and industries. 

In addition to cooperation such as in the OECD or at UN-level, the Commission has started a 
regular dialogue with the United States in the context of the Transatlantic Economic Council 
(TEC), with a view to avoiding unnecessary divergences. 

4. 

SAFETY ASPECTS 

4.1. 

Nanomaterials in the workplace, in consumer products and in the environment  

Natural and incidental man-made nanoparticles are ubiquitous in the human environment and 
their presence and behaviour is generally known and understood. However, limited data exist 
on  manufactured  nanoparticles  in  the  workplace  and  the  environment.  There  are  major 
technical challenges to monitor their  presence,  including  those pertaining to their small size 
and  low  concentration  levels  and  to  distinguishing  particles  of  manufactured  nanomaterials 
from natural or incidental nanoparticles. Detecting nanomaterials in complex matrices such as 
cosmetics,  food,  waste,  soil,  water  or  sludge  is  even  more  challenging.  While  some 
monitoring methods exist, these often remain to be validated, which hampers comparability of 
data. 

4.2. 

Safety, risk assessment, and risk/benefit assessment 

Since  2004,  the  Scientific  Committee  on  Emerging  and  Newly  Identified  Health  Risks 
(SCENIHR) and the Scientific Committee on Consumer Safety (SCCS), the European Food 
Safety Authority (EFSA) and the European Medicines Agency (EMA) have been working on 
the risk assessment of nanomaterials. 

In 2009, SCENIHR concluded that “while risk assessment methodologies for the evaluation 
of potential risks of substances and conventional materials to man and the environment are 
widely  used  and  are  generally  applicable  to  nanomaterials,  specific  aspects  related  to 
nanomaterials  still  require  further  development.  This  will  remain  so  until  there  is  sufficient 
scientific  information  available  to  characterise  the  harmful  effects  of  nanomaterials  on 
humans and the environment.” 

It  further  asserted  that  “health  and  environmental  hazards  have  been  demonstrated  for  a 
variety of manufactured nanomaterials. The identified hazards indicate potential toxic effects 
of  nanomaterials  for  man  and  the  environment.  However,  it  should  be  noted  that  not  all 
nanomaterials induce toxic effects. Some manufactured nanomaterials have already been in 
use for a long time (e.g., carbon black, TiO2) showing low toxicity. Therefore, the hypothesis 
that  smaller  means  more  reactive,  and  thus  more  toxic,  cannot  be  substantiated  by  the 
published data. In this respect nanomaterials are similar to normal chemicals/substances in 
that some may be toxic and some may not. As there is not yet a generally applicable paradigm 
for  nanomaterial  hazard  identification,  a  case-by-case  approach  for  the  risk  assessment  of 
nanomaterials is still warranted.”13 

13 

http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_023.pdf, p. 52 and p. 56. 

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EFSA  in  its  2011  scientific  opinion14  confirmed  that  the  risk  assessment  paradigm  used  for 
the evaluation of standard food products is also appropriate for nanomaterial applications in 
the  food  and  feed  chain  and  the  need  for  a  case  by  case  approach.  Such  a  case-by-case 
approach  is  in  place  through  the  pre-market  approval  system  in  food  and  feed  legislation 
(such as novel foods, food additives, feed additives, plastic food contact materials). A similar 
approach was adopted by the EMA for medicinal products.15 

Despite  certain  limitations  as  mentioned  by  the  Scientific  Committees  and  Agencies,  in 
particular the need for a case-by-case scientific approach when assessing differences between 
bulk  and  various  nanoforms  of  the  same  chemical  substance,  it  is  possible  to  perform  risk 
assessments of nanomaterials today. 

Several  risk  assessments  and  risk/benefit  assessments  have  been  completed  and  various 
products  in  different  sectors  have  been  authorised  (such  as  20  medicines  and  three  food 
contact  materials16).  The  SCCS  has  assessed  and  approved  the  safety  of  one  nanomaterial 
used  as  a  UV  filter  and  is  completing  the  assessment  of  three  other  nanomaterials.  Other 
substances will be assessed as the case arises (e.g. UV filters, food and feed ingredients). 

Harmonization  and  standardization  of  measurement  and  test  methods  in  support  of  risk 
assessment  of  nanomaterials  is  being  promoted  through  the  OECD  and  by  a  Commission 
Mandate to the European Standards Organisations.17 

A  study  launched  by  the  Commission  in  2011  on  occupational  risks  of  nanomaterials,  and 
other  relevant  research,  including  on  the  fate  of  nanomaterials  in  the  environment  and  in 
waste, will provide more insight for further legislative guidance and risk assessment work. 

Research concerning safety and the development of reliable test methods will also remain a 
key priority under the EU Framework Programmes and for the Commission's Joint Research 
Centre. 

5. 

REACH AND CLP 

Pursuant to REACH18, chemical substances imported or manufactured in the EU must in most 
cases  be  registered  with  ECHA,  demonstrating  their  safe  use.  The  registration  dossier  or 
substance may be subject to evaluation. Depending on its characteristics, any substance may 

14 

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18 

Scientific  opinion  on  "Guidance  on  the  risk  assessment  of  the  application  of  nanoscience  and 
nanotechnologies in the food and feed chain” (2011), 9(5):2140. 

http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_0

00345.jsp&mid=WC0b01ac05800baed9  
Namely silicon dioxide, carbon black and titanium nitride. Silicon dioxide has also been authorised as 
food additive. 
M/461 EN of 2.2.2010 
Regulation  (EC)  No  1907/2006  of  18  December  2006  concerning  the  Registration,  Evaluation, 
Authorisation  and  Restriction  of  Chemicals  (REACH).  OJ  L  136,  29.5.2007,  p.3.  Unofficial 
consolidated version see: 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2006R1907:20110505:en:PDF  

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be subject to authorisation or restrictions. REACH applies equally to substances for which all 
or some forms are nanomaterials.19 

The CLP Regulation20 provides an obligation to notify to ECHA substances in the forms as 
placed  on  the  market,  including  nanomaterials,  which  meet  the  criteria  for  classification  as 
hazardous, independent of their tonnage. 

The European Parliament called on the Commission to evaluate the need to review REACH 
concerning  simplified  registration  for  nanomaterials  manufactured  or  imported  below  one 
tonne, consideration of all nanomaterials as new substances, and a chemical safety report with 
exposure assessment for all registered nanomaterials. 

5.1. 

Coverage of nanomaterials in REACH registrations and CLP notifications 

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. 
However,  the  registrant  must  ensure  the  safety  of  all  included  forms  and  provide  adequate 
information to address the different forms in the registrations, 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 substance, 
including  all  forms.  There  is  no  prescription  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 from 
ECHA encourages it. 

In  close  collaboration  with  ECHA,  the  Commission  has  assessed  how  nanomaterials  have 
been  addressed  in  REACH  registrations  and  CLP  notifications.  As  of  February  2012,  7 
substance registrations and 18 CLP notifications had selected "nanomaterial" as the form of 
the substance in  voluntary fields. A further assessment identified additional substances with 
nanoforms.21 

Many registrations for substances known to have nanomaterial forms do not mention clearly 
which forms are covered or how information relates to the nanoform. Only little information 
is specifically addressing safe use of the specific nanomaterials supposed to be covered by the 
registration  dossiers.  These  findings  can  partly  be  explained  by  the  absence  of  detailed 
guidance  to  registrants  on  registration  for  nanomaterials  and  the  general  wording  of  the 
REACH annexes. 

The Commission Recommendation on a definition of nanomaterial will clarify terminology, 
but  will  in  itself  not  provide  the  necessary  clarity  to  the  registrants  on  how  to  address 
nanomaterials in REACH registrations. 

The  Commission  will  therefore,  based  on  available  information  on  technical  progress, 
including  the  REACH  Implementation  Projects  on  Nanomaterials  and  experience  with  the 
current  registrations,  in  the  upcoming  REACH  review  assess  relevant  regulatory  options,  in 

19 

20 

21 

For an explanation of terminology see 
http://ec.europa.eu/enterprise/sectors/chemicals/files/reach/nanomaterials_en.pdf  
Regulation  (EC)  No  1272/2008  of  16  December  2008  on  classification,  labelling  and  packaging  of 
substances and mixtures, OJ L353, 31.12.2008 
For details see SWP, chapter 5.2 and appendix 3. 

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particular possible amendments of REACH annexes, to ensure clarity on how nanomaterials 
are addressed and safety demonstrated in registrations. 

5.2. 

Substance identification and registration timelines 

Many  substances  exist  as  bulk  and  nanoforms.  The  nanoforms  can  be  seen  as  forms  of  the 
same 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 
registration.22 

When more experience from the evaluation of registrations is available, ECHA will provide 
guidance on treating nanomaterials as forms of a bulk substance or as distinct substances with 
the aim of enabling effective data sharing. The results of the REACH Implementation Project 
on  Nanomaterials  on  Substance  Identification  (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. 

5.3. 

Chemical safety assessment  

RIPoN  on  Information  Requirements  (RIPoN2)  and  the  RIPoN  on  Chemical  Safety 
Assessment  (RIPoN3)23  address  –  inter  alia  -  the  question  whether  the  existing  REACH 
requirements and the relevant guidance are appropriate to assess nanomaterials. They contain 
a number of specific proposals. 

RIPoN 2 concluded that, with a few caveats, the guidance at the time of the project and the 
information  requirements  were  considered  applicable  for  the  assessment  of  nanomaterials. 
RIPoN3  concluded  that  known  exposure  assessment  methods  were  generally  applicable  but 
may still experience methodological challenges. 

The  REACH  approach  to  hazard  assessment  and  risk  characterisation,  with  its  built-in 
flexibility, makes it overall suitable for nanomaterials. The key remaining question is to what 
extent data for one form of a substance can be used to demonstrate the safety of another form, 
due  to  still  developing  understanding  of  e.g.  drivers  of  toxicity.  In  a  case-by-case  scientific 
approach: 

• 

• 

• 

22 

23 

Clarity  is  required  whether  and  which  nanoforms  of  a  substance  are  covered  by  a 
registration.  These  nanoforms  should  be  adequately  characterised,  and  the  user 
should  be  able  to  identify  which  operational  conditions  and  risk  management 
measures apply to them. 

Information  should  be  provided  on  which  forms  of  a  substance  have  been  tested, 
with the test conditions adequately documented. 

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 

Any  immediate  registration  requirement  for  nanomaterials  treated  as  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. 
http://ec.europa.eu/environment/chemicals/nanotech/index.htm#ripon 

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grouping and read-across24, the data from a specific test or other information can be 
used for the other forms of the substance. Similar considerations apply to exposure 
scenarios and the risk management measures. 

ECHA has updated guidance to take into account the final RIPoN Reports. ECHA has set up a 
Group  Assessing  Already  Registered  Nanomaterials  (GAARN),  who  considers  in  co-
operation  with  the  Commission,  Member  States  experts  and  stakeholders,  a  few  key 
nanomaterial  registrations.  The  purpose  is  to  identify  best  practices  for  assessment  and 
reporting of nanomaterials in REACH registrations and to develop recommendations on how 
to  fill  potential  information  gaps.  In  addition,  ECHA  has  set  up  a  Nanomaterials  Working 
Group  to  give  advice  on  scientific  and  technical  issues  in  relation  to  nanomaterials  under 
REACH. 

5.4. 

Extension of REACH obligations to small volume nanomaterials 

Most nanomaterials which are subject to a scientific debate are manufactured or imported in 
volumes  of  1  tonne  per  year  or  more.  Small  volume  nanomaterials  are  mostly  used  in 
technical applications such as catalysts or in applications where the nanomaterials are bound 
in  a  matrix  or  enclosed  in  equipment.  Consumer  and  environmental  exposure  to  those 
nanomaterials is likely to be limited. 

In  line  with  SCENIHR’s  conclusion  that  nanomaterials  are  similar  to  normal  substances  in 
that some may be toxic and some may not, the Commission does not consider appropriate at 
present  to  change  the  rules  for  when  a  chemicals  safety  assessment  is  required.  As  regards 
registration  thresholds  and  timelines  for  registration  based  on  volume,  the  Commission 
considers REACH appropriate, subject to actions outlined in chapter 7. 

6. 

HEALTH, SAFETY AND ENVIRONMENT PROTECTION IN EU LEGISLATION 

The Parliament called on the Commission to evaluate the need to review a number of areas of 
legislation, including air, water, waste, industrial emissions and worker protection legislation. 

• 

As  regards  safety  and  health  at  work,  the  ongoing  work  can  be  summarized  as 
follows: 

In  addition  to  the  study  on  nanomaterials  in  the  workplace25,  a  Nano  subgroup  of  the 
Chemicals working party set up under the Advisory Committee on Safety and Health at Work 
is  working  on  a  draft  opinion  on  risk  assessment  and  management  of  nanomaterials  at  the 
workplace, to be subsequently endorsed by the Advisory Committee. A final assessment on a 
review of occupational health and safety legislation will be made by 2014 in the light of these 
activities and respective conclusions. 

• 

24 
25 

As regards consumer product safety legislation, work is under way on adapting the 
relevant  legislation  in  order  to  transpose  the  horizontal  definition  and  to  introduce 
specific  provisions  on  nanomaterials;  on  updating  the  relevant  risk  assessment 
processes; on strengthening market surveillance; and on improving information and 
labelling requirements: 

REACH, Annex XI, section 1.5 
See section 4.2 

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The  Commission  is  committed  to  implement  the  definition  of  nanomaterials  in  consumer 
product safety legislation, when appropriate. Specific provisions on nanomaterials have been 
introduced for biocides, cosmetics, food additives, food labelling and materials in contact with 
foodstuff. 

At  the  same  time,  the  Commission  undertook  a  detailed  analysis  of  how  consumer  product 
legislation is being implemented with reference to nanomaterials. The main challenge remains 
the implementation of a proper risk assessment, also in those areas where legislative change 
has been implemented. 

Therefore,  for  instance,  EFSA  has  at  the  request  of  the  Commission  adopted  a  guidance 
document26  clarifying  the  data  to  be  provided  when  submitting  an  application  dossier  for  a 
nanomaterial to be incorporated in food and feed. 

Similarly,  guidance  has  recently  been  developed  by  the  Scientific  Committee  on  Consumer 
Safety for cosmetic products. 

The  Commission  takes  the  view  that  current  legislation  on  medicinal  products  allows  an 
appropriate risk/benefit analysis and risk management of nanomaterials. 

For  legislation  on  medical  devices,  actions  under  consideration  include  a  labelling 
requirement  in  a  proposal  foreseen  for  2012.  In  addition,  the  Commission  is  considering  to 
reclassify devices containing free nanomaterials under Class III, making them subject to the 
most severe conformity assessment procedure(s). 

The Commission considers that New Approach and in general consumer product legislation 
allow nano-specific issues to be taken into consideration. 

Market surveillance is a key element in effective consumer protection, and the Commission is 
facilitating  a  joint  surveillance  pilot  project  with  various  Member  States  on  the  presence  of 
nanomaterials in cosmetic products. 

A  main  issue  in  the  debate  on  nanomaterials  is  consumer  information  and  labelling  of 
nanomaterials.  Nano-ingredient  labelling  has  been  introduced  in  products  of  relevance  to 
consumers, notably food and cosmetics. 

Similar provisions can be envisaged for other regulatory schemes where ingredient labelling 
already exists, allowing consumers to make an informed choice. 

• 

As  regards  environmental  legislation,  the  evaluation27  of  this  legislation  identified 
and  assessed  environmental  exposure  pathways  for  nanomaterials  relevant  to  each 
piece  of  legislation,  the  level  of  control  afforded  over  possible  releases  of 
nanomaterials and the associated risks. 

The  evaluation  showed  that  all  environmental  legislation  reviewed  could  be  considered  to 
address nanomaterials in principle. Nevertheless, this might pose challenges and has not been 
tested in practice. Principal triggers of pollutant identification are hazard classification under 

26 

27 

Scientific  opinion  on  "Guidance  on  the  risk  assessment  of  the  application  of  nanoscience  and 
nanotechnologies in the food and feed chain (2011)”, 9(5):2140. 
http://ec.europa.eu/environment/chemicals/nanotech  

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CLP  and  exposure  information.  There  is  still  a  considerable  lack  of  data  on  exposure  to 
nanomaterials  via  the  environment.  Consequently,  no  specific  provisions  for  nanomaterials 
have  yet  been  established  in  EU  environmental  legislation,  triggering  measures  to  control 
such  pollutants  through  monitoring,  separate  treatment  or  environmental  quality  standards. 
This  applies  also  to  the  risk  management  responses  explicitly  identified  by  the  European 
Parliament: new environmental quality standards, revision of emission limit values, a separate 
entry  for  nanomaterials  in  the  list  of  waste  and  the  revision  of  waste  acceptance  criteria  in 
landfills. As risk characterisation may depend on particle size or surface functionalization, it 
is  anticipated  that  setting  the  precise  scope,  dose  metrics  and  value  of  any  thresholds 
employed under environmental legislation, if necessary, would be more challenging than for 
conventional pollutants. REACH should generate relevant data in this respect. 

Even  when  it  is  possible  to  show  the  presence  of  specific  nanoparticles  in  environmental 
media or waste, it would be technically difficult to separate or eliminate them. Therefore 'end-
of-pipe'  measures  would  not  be  effective  to  prevent  potential  negative  impacts  on  the 
environment or health, nor would they allow addressing any emerging recycling challenges or 
need for remediation in a cost-effective manner. 

Although the Commission does not exclude specific provisions in downstream environmental 
legislation,  potential  risks  are  normally  best  addressed  "upstream"  by  REACH  and  product 
legislation.  Any  CLP  classification  of  a  nanomaterial  will  automatically  unlock  some 
operative provisions across a range of environmental legislation that serve to control releases 
of hazardous substances into the environment. 

The  Commission  is  also  taking  steps  to  ensure  that  remaining  implementation  gaps  of  the 
legislation  are  addressed.  For  example,  revisions  of  the  selection  process  for  priority 
substances  under  the  water  legislation  and  the  relevant  BREF28  documents  under  industrial 
emissions legislation, incorporating various nanomaterial aspects, are already being pursued. 

Developing  capacity  to  monitor  and  model  nanomaterials,  e.g.  in  the  environment  is 
necessary.  This  will  facilitate  the  evaluation  of  the  efficiency  of  different  tools  of  the 
environmental  legislation  and  inform  appropriate  risk  management  strategies.  Where 
necessary, this will be supported by targeted implementing environmental legislation. 

7. 

NEED FOR BETTER ACCESSIBLE INFORMATION 

Transparency  of  information  on  nanomaterials  and  products  containing  nanomaterials  is 
essential. This has been recognised by the Parliament which has called on the Commission to 
evaluate  the  need  for  notification  requirements  for  all  nanomaterials,  including  in  mixtures 
and  articles,  and  the  Council,  which  invited  the  Commission  to  evaluate  the  need  for  the 
further development of a harmonized database for nanomaterials, while considering potential 
impacts. 

Current  knowledge  about  nanomaterials  does  not  suggest  risks  which  would  require 
information about all products in which nanomaterials are used. Experience so far shows that, 
if risks were to be identified, they could be handled with the existing tools such as the General 

28 

BREFs - Best available technique REFerence Documents define Best Available Technique (BAT) for 
individual industrial sectors under the Industrial Emission Directive 

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Product Safety Directive29 and its RAPEX system30, or more specific instruments under EU 
product legislation. 

Currently  available  information  (such  as  the  information  presented  in  the  attached  Staff 
Working  Paper  and  the  information  generated  by  existing  legislative  tools  such  as  REACH 
and the Cosmetics Regulation) is considered a good basis for policy making. 

As  a  first  step,  the  Commission  will  create  a  web  platform  with  references  to  all  relevant 
information sources, including registries on a national or sector level, where they exist. A first 
version mainly based on links to available information will be put on line as soon as possible. 
The  Commission  will  assist  in  the  elaboration  of  harmonised  data  formats,  to  improve 
exchange of information. In parallel, the Commission will be launching an impact assessment 
to  identify  and  develop  the  most  adequate  means  to  increase  transparency  and  ensure 
regulatory  oversight,  including  an  in-depth  analysis  of  the  data  gathering  needs  for  such 
purpose.  This  analysis  will  include  those  nanomaterials  currently  falling  outside  existing 
notification, registration or authorisation schemes. 

8. 

CONCLUSIONS 

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

The definition of nanomaterials will be integrated in EU legislation, where appropriate. The 
Commission  is  currently  working  on  detection,  measurement  and  monitoring  methods  for 
nanomaterials and their validation to ensure the proper implementation of the definition. 

Important  challenges  relate  primarily  to  establishing  validated  methods  and  instrumentation 
for  detection,  characterization,  and  analysis,  completing  information  on  hazards  of 
nanomaterials and developing methods to assess exposure to nanomaterials. 

Overall the Commission remains convinced that REACH sets the best possible framework for 
the  risk  management  of  nanomaterials  when  they  occur  as  substances  or  mixtures  but  more 
specific  requirements  for  nanomaterials  within  the  framework  have  proven  necessary.  The 
Commission envisages modifications in some of the REACH Annexes and encourages ECHA 
to further develop guidance for registrations after 2013. 

The Commission will carefully follow developments, and report back to the Parliament, the 
Council and the European Economic and Social Committee within 3 years. 

29 
30 

Directive 2001/95/EC OJ L 11, 15.1.2002. 
http://ec.europa.eu/consumers/safety/rapex/index_en.htm 

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Action 

Content 

Timeline 

ANNEX 

Nanomaterial 
Definition 

Implementation of definition 
into 
Union 
European 
legislation and use in Union 
Agencies 

Done  for  biocides;  adaptation  of  the 
definition for cosmetics is in progress

on 

Report 
measurement 
possible update of Q&A 

existing 
methods, 

2012 

Proposal  for  a  first  set  of 
detection,  measurement  and 
monitoring methods 

2014 

Review of definition 

2014 

REACH and CLP 

Possible 
REACH Annexes 

amendment 

of 

Planning  and  Timelines  will  be 
addressed in REACH Review 

and 

CASG(Nano) – Subgroup of 
CLP 
REACH 
Competent 
Authorities 
(CARACAL),  advising  the 
Commission  on  regulatory 
issues  relating  to  REACH 
and CLP 

Evaluation 
registration 
concerning nanomaterials 

of  REACH 
dossiers 

assessment 

of 
ECHA 
in  REACH 
nanomaterials 
registration 
CLP 
and 
notification dossiers 

Set up in 2008 

Nanomaterials  prioritised  by  ECHA 
for  compliance  check;  substance 
evaluation 
the 
according 
“CoRAP”  list  (currently  including 
silicon dioxide (NL 2012), silver (NL 
2013) and titanium dioxide (F 2014)) 

to 

Done  (see  Appendix  3  of  Staff 
Working Paper) 

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covering 

Part  1  (identification  of  registration 
nanomaterials, 
dossiers 
scientific  assessment  and  proposals 
to address shortcomings) – done and 
on 
available 
http://ec.europa.eu/environment/che
micals/nanotech/pdf/jrc_report.pdf, 
(assessment  of  potential 
part  2 
environmental 
and 
economic 
consequences 
technical 
the 
of 
proposals  made  in  Task  I)  expected 
in October 2013 

Set up in 2012, end of work foreseen 
in 2013 

Set up in 2012 

Nano  Support  Project  (JRC 
in cooperation with ECHA) 

(Group 

on 
GAARN 
Assessing 
Already 
Registered Nanomaterials) – 
Informal  group 
to  assess 
three  selected  registration 
dossiers on nanomaterials 

Nanomaterial 
ECHA 
Working 
– 
Group 
Permanent  Group  to  advise 
ECHA  on  scientific  and 
technical  aspects  relating  to 
nanomaterials 

ECHA Guidance Update for 
Registration 

Done,  further  updates  possible  after 
the end of the next registration round 

Update  of 
facilitate 
structured 
NM 

to 
IUCLID 
submission 
of 
information  on 

Initial  solutions  provided  already  in 
2010  (IUCLID  5.2)  and  recently  in 
2012  (IUCLID  5.4);  further  relevant 
updates  expected  after  the  REACH 
2013 deadline 

Cosmetics 

Assessment  of 
substances 

individual 

ETH-50: concluded; 

titanium 
zinc 
HAA299: foreseen for 2012 

dioxide, 

oxide, 

Joint  market  surveillance 
pilot 
on 
project 
nanomaterials in cosmetics 

2013 

Medicines 

Authorisation  of  individual 
medicines 

20  medicines  authorised  so  far, 
further assessments as the case arises 

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Food 

Mandatory 
nano-ingredients 
introduced 
in 
Regulation  

labelling 

for 
food 
in 
labelling 

Labelling  applicable  from  December 
2014 

Definition of "engineered 
nanomaterial" in labelling 
Regulation 

Definition 
to 
Commission Recommendation 

updated 

be 

to 

Pre-market approval under 
Novel Food Regulation for 
food under nano form 

To  be  addressed  in  the  Novel  Food 
Proposal foreseen for 2013 

Requirement for risk 
assessment for food 
additives and food contact 
materials  

For  additives  and 
food  contact 
materials risk assessment as the case 
arises 
(with  authorisation  where 
appropriate)  

Food 
materials 

contact 

Authorisation  of  individual 
food contact materials 

nanomaterials 

Two 
authorised; 
further assessments as the case arises 

Worker 
Legislation 

Protection 

Study  on  occupational  risks 
of nanomaterials 

2013 

Final  assessment  on  review 
of  occupational  health  and 
safety legislation 

2014 

OECD Working Party 
on 
Manufactured 
Nanomaterials 

Mandate  M/461 
CEN 

to 

Eight  subgroups,  including 
one on safety testing of a set 
representative 
of 
manufactured  nanomaterials 
which  should  provide  data 
on 13 selected nanomaterials

Development of methods for 
nanomaterial 
characterisation, 
sampling, 
measurement  and  exposure 
simulation 

Current  Programme  started  in  2009, 
with  work  towards  completion  of 
Phase1 well progressed 

Work  started  in  2010,  will  take 
several more years 

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Research, 
and 
Development 
Innovation  activities 
under Horizon 2020 

Nano-ingredient 
labelling 

Information 
Nanomaterials 

on 

Final  calls  under  7th  Framework 
Programme  for  Research  to  bridge 
gap towards Horizon 2020 

Implemented  in  the  Cosmetics  and 
Biocides Regulations 

(Annexed  Staff  Working 

Done 
Document) 

2013 

2013 

for 

proposal 

the 
establishing 

The 
Regulation 
Horizon2020 
(COM(2011)809)  identifies 
Nanotechnologies  as  one  of 
the 
six  Key  Enabling 
Technologies  (KETs)  under 
the 
Industrial  Leadership 
the  safe 
pillar.  Ensuring 
development and application 
of  nanotechnologies  is  one 
of the main lines of activity. 

Information 
on 
Nanomaterial  Types  and 
Safety 
Uses, 
including 
of 
Aspects 
available 
as 
well  as  information  sources, 
databases, etc.) 

(overview 
information 

Web-platform 

on 

nanomaterials 
Study 
falling  outside  the  scope  of 
existing 
or 
requirements 
registration 
for  getting 
and  options 
information 

notification 

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