Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee - Regulatory aspects of nanomaterials [SEC(2008) 2036]
Date: 2008-06-17
Institutions: European Commission
Subjects: EU law, chemical product, environmental protection, environmental risk prevention, nanotechnology, occupational health, occupational safety

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 17.6.2008 
COM(2008) 366 final 

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

REGULATORY ASPECTS OF NANOMATERIALS 

[SEC(2008) 2036] 

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   EN 

 
 
 
  
 
 
TABLE OF CONTENTS 

1. 

2. 

Introduction .................................................................................................................. 3 

Review of legislation applicable to nanomaterials....................................................... 3 

2.1. 

Chemicals..................................................................................................................... 4 

2.2.  Worker Protection ........................................................................................................ 5 

2.3. 

2.4. 

3. 

3.1. 

3.2. 

3.3. 

3.4. 

4. 

Products........................................................................................................................ 5 

Environmental protection............................................................................................. 7 

Implementation of legislation ...................................................................................... 8 

Improving the knowledge base .................................................................................... 8 

Improving the implementation of legislation............................................................... 9 

Information to users ................................................................................................... 10 

Market surveillance and intervention mechanisms .................................................... 11 

Conclusions ................................................................................................................ 11 

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

REGULATORY ASPECTS OF NANOMATERIALS 

(text with EEA relevance) 

INTRODUCTION 

1. 
In its Communication “Towards a European Strategy for Nanotechnology”,1 the Commission 
states  that  R&D  and  technological  progress  need  to  be  accompanied  by  scientific 
investigation  and  assessment  of  possible  health  or  environmental  risks  associated  with 
nanotechnology. The “Integrated, safe and responsible approach” has become the core of the 
EU policy for nanotechnology. The Communication “Nanosciences and nanotechnologies: an 
action plan for Europe 2005 – 2009”2, specified that all applications and use of nanosciences 
and nanotechnologies must comply with the high level of public health, safety, consumers and 
workers  protection,  and  environmental  protection  chosen  by 
the  Community.  The 
Commission  therefore  announced  a  regulatory  review  of  EU  legislation  in  relevant  sectors. 
The  present  Communication  reflects  this  commitment.  It  covers  nanomaterials  currently  in 
production and/or placed on the market. In the absence of generally accepted definitions, the 
term nanomaterials is used in this Communication to cover commonly used terminology such 
as  manufactured  (or  engineered)  nano-sized  and  nanostructured  nanomaterials.  The 
Communication  does  not  address  nanomaterials  or  nanoparticles  that  occur  naturally  or  are 
unintentionally produced, e.g. in combustion. 

2. 

REVIEW OF LEGISLATION APPLICABLE TO NANOMATERIALS  

Nanotechnologies  are  enabling  technologies,  with  a  high  potential  benefits  for  consumers, 
workers,  patients,  and  the  environment,  as  well  as  the  creation  of  jobs.  On  the  other  hand, 
nanotechnologies and nanomaterials may expose humans and the environment  to new risks, 
possibly involving quite different mechanisms of interference with the physiology of human 
and environmental species.  

The  regulatory  challenge  is  therefore  to  ensure  that  society  can  benefit  from  novel 
applications  of  nanotechnology,  whilst  a  high  level  of  protection  of  health,  safety  and  the 
environment is maintained. 

Legislation  relevant  for  health,  safety  and  environment  aspects  of  nanomaterials  can  be 
grouped  under  chemicals,  worker  protection,  products  and  environmental  protection, 
simultaneously  applicable.  Main  elements  in  relation  to  risks  associated  with  nanomaterials 
are described in the annexed Commission Staff Working Document.  

Overall, it can be concluded that current legislation covers to a large extent risks in relation to 
nanomaterials  and  that  risks  can  be  dealt  with  under  the  current  legislative  framework. 
However,  current  legislation  may  have  to  be  modified  in  the  light  of  new  information 
becoming available, for example as regards thresholds used in some legislation. 

1 
2 

COM(2004) 338 final of 12 5 2004, 
COM(2005) 243 final of 7 6 2005  

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Implementation of legislation and use of regulatory instruments created by legislation remains 
a particular challenge. Documents that support implementation, particularly in relation to risk 
assessment, adopted within the context of current legislation will have to be reviewed in order 
to ensure that they effectively address risks associated with nanomaterials and make best use 
of  the  information  becoming  available.  Similarly,  authorities  and  agencies  will  have  to  pay 
special  attention  to  risks  in  relation  to  nanomaterials  where  production  and  marketing  are 
subject to pre-market control. 

In  order  to  properly  develop,  modify  or  in  particular  to  implement  legislation, the scientific 
knowledge base needs to be improved. This Communication therefore pays attention both to 
legislation, implementation and bridging the knowledge gap.  

In this context, attention is also drawn to the Code of Conduct for responsible nanosciences 
and  nanotechnologies  research.3  This  Code  is  complementary  to  legislation  and  provides 
Member  States,  employers,  research  funders,  researchers  and  more  generally  all  individuals 
and  civil  society  organisations  involved  or  interested  in  nanosciences  and  nanotechnologies 
research with guidelines favouring a responsible and open approach to N&N research in the 
Community. 

Chemicals 

2.1. 
REACH4  provides  an  over-arching  legislation  applying  to  the  manufacture,  placing  on  the 
market and use of substances on their own, in preparations or in articles. REACH is based on 
the  principle  that  manufacturers,  importers  and  downstream  users  have  to  ensure  that  they 
manufacture, place on the market or use such substances that do not adversely affect human 
health or the environment. Its provisions are underpinned by the precautionary principle. 

There  are  no  provisions  in  REACH  referring  explicitly  to  nanomaterials.  However, 
nanomaterials are covered by the “substance” definition in REACH.  

Under  REACH,  manufacturers  and  importers  will  have  to  submit  a  registration  dossier  for 
substances  that  they  manufacture  or  import  at  or  above  1  tonne  per  year.  At  or  above  10 
tonnes/year, the registrant will be obliged to produce a chemical safety report. Furthermore, if 
deemed  necessary  for  the  evaluation  of  the  substance  the  European  Chemicals  Agency  can 
require  any  information  on  the  substance,  independent  of  the  minimum  information 
requirements of REACH 

When  an  existing  chemical  substance,  already  placed  on  the  market  as  bulk  substance,  is 
introduced on the market in a nanomaterial form (nanoform), the registration dossier will have 
to be updated to include specific properties of the nanoform of that substance. The additional 
information,  including  different  classification  and  labelling  of  the  nanoform  and  additional 
risk  management  measures,  will  need  to  be  included  in  the  registration  dossier.  The  risk 
management measures and operational conditions will have to be communicated to the supply 
chain.  

In  order  to  address  the  specific  properties,  hazards  and  risks  associated  with  nanomaterials, 
additional  testing  or  information  may  be  required.  To  determine  specific  hazards  associated 
with  nanomaterials,  current  test  guidelines  may  need  to  be  modified.  Until  specific  test 
guidelines  for  nanomaterials  exist,  testing  will  have  to  be  carried  out  according  to  already 
existing guidelines. 

3 
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C(2008) 424 final of 7 2 2008 
Regulation (EC) No 1907/2006; OJ L 396 of 30.12.2006 

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For substances of very high concern5, an authorisation will be required for their use and their 
placing  on  the  market.  The  restrictions  procedure  allows  to  take  measures  with  respect  to 
nanomaterials  where  there  is  a  risk  arising  from  the  manufacture,  use  or  placing  on  the 
market. Authorisation and restriction schemes apply regardless of quantities manufactured or 
placed on the market. 

The  Commission  will  carefully  monitor  the  implementation  of  REACH  with  respect  to 
nanomaterials. Based on information regarding production and marketing, or new knowledge, 
for  instance  regarding  toxicological  or  physical-chemical  properties,  current  provisions, 
including quantitative triggers and information requirements may have to be modified.  

Data  generated  under  REACH  will  serve  as  input  to  other  regulation,  such  as  worker 
protection, cosmetics and environmental protection. It complements product legislation (e.g. 
general product safety) to the extent that this does not cover environmental aspects. 

2.2.  Worker Protection 
Framework  Directive  89/391/EEC6  places  a  number  of  obligations  on  employers  to  take 
measures necessary for the safety and health protection of workers. It applies to all substances 
and  work  activities  including  manufacturing  and  use  of  chemicals  at  all  levels  of  the 
production process, regardless of the number of workers involved and quantities of materials 
produced or technologies used.  

This  Directive  fully  applies  to  nanomaterials.  Employers,  therefore,  must  carry  out  a  risk 
assessment and, where a risk is identified, take measures to eliminate this risk.  

The planning and introduction of new technologies must be subject to consultation with the 
workers  or  their  representatives,  as  regards  the  working  conditions  and  the  working 
environment in accordance with Articles 11 and 12 of the Framework Directive 89/391/EEC. 

The Directive foresees the possibility to adopt individual directives laying down more specific 
provisions  with  respect  to  particular  aspects  of  safety  and  health.  Relevant  directives  thus 
adopted relate to risks related to exposure to carcinogens or mutagens at work7, risks related 
to  chemical  agents  at  work8,  the  use  of  work  equipment  by  workers  at  work9,  the  use  of 
personal protective equipment at the workplace10 and safety and health protection of workers 
potentially at risk from explosive atmospheres.11 

As these Directives introduce minimum requirements, national authorities have the possibility 
to introduce more stringent rules. 

2.3. 

Products 

Product  legislation  lays  down  requirements  regarding  specific  products,  such  as  medicinal 
products, plant protection products (PPP), cosmetics, food and feed additives, etc. Consumer 
products  that  are  not  governed  by  specific  legislation  have  to  meet  the  requirements  of  the 

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Carcinogenic, mutagenic or toxic to reproduction (CMR), persistent, bioaccumulating and toxic (PBT) 
or very persistent and very bioaccumulating (vPvB) or substances giving rise to an equivalent level of 
concern. 
OJ L 183, 29.6.1989 
Directive 2004/37/EC of 29 4 2004; OJ L 158, 30.4.2004 
Directive 98/24/EC of 7 4 1998; OJ L 131, 5.5.1998 
Directive 89/655/EEC of 30 11 1989; OJ L 393, 30.12.1989 
Directive 89/656/EEC of 30 11 1989; OJ L 393, 30.12.1989  
Directive 1999/92/EC of 16 12 1999; OJ L 23, 28.1.2000 

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General Product Safety Directive.12 

Community  regulation  in  these  areas  contains  provisions  in  relation  to  health  and  safety  of 
consumers,  workers,  patients  and  users,  but  not  necessarily  in  relation  to  environmental 
protection. To the extent that nanomaterials contained in such products qualify as substances 
under  REACH,  they  are  subject  under  REACH  to  an  assessment  on  their  environmental 
impact.  

Virtually  all  product  legislation  imposes  a  risk  assessment  and  the  adoption  of  risk 
management measures. Nanomaterials are not excluded from this obligation. 

Where products are subject to a pre-market control or pre-market notification, e.g. medicinal 
products, novel foods, plant protection products, the assessment and management of risks in 
relation  to  nanomaterials  can  be  verified  by  authorities  (or  Notified  Bodies  under  the  New 
Approach) before placing on the market. Implementation of these procedures will lead either 
to implementing legislation (e.g. listing of new substances on a positive or a negative list) or 
to  binding  administrative  decisions  (e.g.  market  authorisations),  that  will  also  specify 
marketing conditions.  

Particularly relevant is the obligation to review, modify or cancel authorisations if there are 
indications that any of the relevant requirements are not longer satisfied, or if developments in 
scientific  and  technical  knowledge  require  such  action.  Similarly,  the  holder  of  an 
authorisation or certificate must immediately notify the relevant authority or body of all new 
information on risks.  

Where  products  can  be  placed  on  the  market  without  specific  pre-market  procedural 
requirements  (e.g.  cosmetics,  consumer  products  subject  to  the  general  product  safety 
directive,  various  products  regulated  under  the  New  Approach),  compliance  with  legal 
requirements must be verified at the level of market surveillance. This does not exclude the 
possibility to undertake action restricting the placing on the market, or requiring advice from 
the various EU Scientific Committees. At all times authorities can verify the risk assessment 
and risk management strategy at the premises of the manufacturer. 

In order to increase the level of protection, regulatory change has been proposed with respect 
to  cosmetic  products,  placed  on  the  market  without  pre-market  control.  The  requirements 
regarding  the  risk  assessment  will  be  clarified.  Further,  manufacturers  will  be  obliged  to 
indicate  whether  their  products  contain  nanomaterials  when  notifying  their  placing  on  the 
market and to set up a mechanism in order to monitor the health effects on cosmetic products 
placed on the market.13  

As  regards  medical  devices,  Commission  services  will  examine  the  possibility  to  make  the 
placing on the market of devices presenting risks associated with nanomaterials subject to a 
systematic pre-market intervention.  

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Directive 2001/95/EC; OJ L 11, 15.1.2002 
COM(2008)49 final 2008/0025 (COD); 5.2.2008 

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2.4. 

Environmental protection 

Environmental regulation relevant in this context relates in particular to integrated pollution 
prevention  and  control  (IPPC),  the  control  of  major  accident  hazards  involving  dangerous 
substances (Seveso II), the water framework directive and a number of waste directives.  
The IPPC Directive14 covers approximately 52,000 industrial installations across the EU and 
requires installations falling under its scope to operate in accordance with permits including 
emission  limit  values  based  on  the  application  of  best  available  techniques  (BAT).  In 
principle, the IPPC Directive could be used to control environmental impacts of nanomaterials 
and  nanomaterials  issues  at  IPPC  installations  through  the  inclusion  of  such  considerations 
into the Commission's BAT Reference Document (BREFs) process should the need arise.  
The  Seveso  II  Directive15  applies  to  establishments  where  named  dangerous  substances  (or 
substances  falling  within  certain  classification  categories)  are  present  above  specific 
quantities  (or  thresholds).  It  imposes  a  general  obligation  on  operators  to  take  all  measures 
necessary  to  prevent  major  accidents  and  to  limit  their  consequences  for  man  and  the 
environment. If certain nanomaterials are found to demonstrate a major accident hazard, they 
may be categorised, together with appropriate thresholds, in the context of the Directive. 
The  Water  Framework  Directive  (2000/60)16  sets  common  principles  and  an  overall 
framework  for  action  to  improve  the  aquatic  environment  and  to  progressively  reduce  the 
pollution from priority substances and phasing out emissions, discharges and losses of priority 
hazardous substances to water. A list of 33 priority substances has been established in 2001.17 
Nanomaterials could be included among the Priority Substances depending on their hazardous 
properties.  Environment  Quality  Standards  would  in  these  cases  be  proposed  by  the 
Commission.  For  groundwater18,  Member  States  will  have  to  establish  quality  standards  for 
pollutants representing a risk, in which case nanomaterials may also be included. 
Directive  2006/12/EC  on  waste19  sets  the  general  framework  and  imposes  an  obligation  on 
Member  States  to  ensure  that  waste  treatment  does  not  adversely  affect  health  and  the 
environment.  The  hazardous  waste  Directive20  defines  which  wastes  are  hazardous  and  lays 
down  stricter  provisions  regarding  such  waste.  Hazardous  waste  must  display  certain 
properties  set  out  in  an  Annex  to  the  Directive  and  feature  on  the  European  Waste  List  as 
hazardous.  Wastes  containing  nanomaterials  could  be  classified  as  hazardous,  if  the 
nanomaterial displays relevant properties which render the waste hazardous.  
Specific legislation has been adopted to deal with particular waste streams21 or specific waste 
treatment processes, such as incineration22 and landfill.23. Current EU waste legislation covers 
general  requirements  for  the  protection  of  health  and  the  environment  during  waste 
management.  It  also  includes  requirements  for  the  management  of  specific  waste  materials 

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Council  Directive  2008/1/EC  concerning  integrated  pollution  prevention  and  control;  OJ  L  24 
29.01.2008 
Directive  96/82  on  the  control  of  major-accident  hazards  involving  dangerous  substances;  OJ  L10  of 
14.1.1997 
Directive 2000/60/EC ,OJ L 327, 22.12.2000 
Decision No 2455/2001/EC, OJ L 331, 15.12.2001 
Directive 2006/118/EC; OJ L 372, 27.12.2006 
Directive 2006/12/EC; OJ L 114, 27 4 2006 
Directive 91/689/EEC; OJ L 377, 31.12.1991 
E.g.  electrical  and  electronic  equipment,  end  of  life  vehicles,  packaging  and  packaging  materials, 
batteries, titanium dioxide  
Directive 2001/80/EC; OJ L 309, 27.11.2001 
Directive 1999/31/EC; OJ L 182 , 16.07.1999 

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that may contain nanomaterials whilst not explicitly addressing the risks of nanomaterials. If 
the  need  for  more  specific  provisions  is  established,  appropriate  action  can  be  proposed  or 
implemented  under  the  current  legislative  framework.  Similarly,  action  can  be  taken  by 
Member States in implementing current provisions in the framework of national policies 

3. 

IMPLEMENTATION OF LEGISLATION  

Whilst the Community legislative framework generally covers nanomaterials, implementation 
of legislation needs further elaboration. Important elements are the test methods and the risk 
assessment  methods  that  serve  as  a  basis  for  implementing  legislation,  administrative 
decisions, manufacturer’s obligations or employer’s obligations. The scientific basis to fully 
understand all properties and risks of nanomaterials is not sufficiently available at this point in 
time.  
A number of reviews identifying “knowledge gaps” have been published24. The EU Scientific 
Committee on Emerging and Newly-Identified Health Risks (SCENIHR)25 and the Scientific 
Committee  for  Consumer  Products  (SCCP)26  have  pointed  to  the  need  to  improve  the 
knowledge  base,  in  particular  regarding  test  methods  and  risk  assessment  (hazards  and 
exposure) methods. In general, there is a consensus in Member States and at the international 
level  that  further  research  is  necessary.  An  indication  is  given  in  the  annexed  Commission 
Staff Working Document  

Where  the  full  extent  of  a  risk  is  unknown,  but  concerns  are  so  high  that  risk  management 
measures are considered necessary, as is currently the case for nanomaterials, measures must 
be based on the precautionary principle. 
As specified  in the  Commission Communication of 2 February 200027 on the Precautionary 
Principle,  recourse  to  the  precautionary  principle  does  not  necessarily  mean  adopting  final 
instruments designed to produce legal effects. A wide range of activities or measures can be 
used,  like  legally  binding  measures,  initiation  of  research  projects  or  recommendations. 
Measures  adopted  under  the  precautionary  principle  must  be  based  on  general  principles  of 
risk  management  and  must  therefore  inter  alia  be  proportionate,  non-discriminatory, 
consistent,  on  an  examination  of  benefits  and  costs  of  action  or  lack  of  action,  and  on  an 
examination of scientific developments. 

Against this background, Community action in relation to managing the risks in order to meet 
regulatory requirements should mainly focus on the following activities. 

3.1. 

Improving the knowledge base  

There  is  a  need  for  a  rapid  improvement  of  the  scientific  knowledge  basis  to  support  the 
regulatory work. Research activities are ongoing under the Research Framework Programmes 
and  in  the  Joint  Research  Centre,  as  well  as  in  EU  Member  States  and  internationally.  In 
particular,  research  is  needed  in  areas  underpinning  risk  assessments  and  risk  management 
like  

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E.g.  1st  Meeting  of  OECD's  Working  Party  on  Manufactured  Nanomaterials 
http://www.oecd.org/department/0,3355,en_2649_37015404_1_1_1_1_1,00.html 
updates 
modified Opinion (after public consultation) on The appropriateness of existing methodologies to assess 
the potential risks associated with engineered and adventitious products of nanotechnologies; 10 March 
2006;http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_003b.pdf 
http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_099.pdf 
Com(2000) 1 final 

(WPMN). 
subsequent 

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•  Data on toxic and eco-toxic effects as well as test methods to generate such data. 

•  Data  on  uses  and  exposures  throughout  the  lifecycle  of  nanomaterials  or  products 

containing nanomaterials, as well as exposure assessment approaches.  

•  Characterisation of nanomaterials, development of uniform standards and nomenclature, as 

well as analytical measurement techniques. 

•  For occupational health aspects, the effectiveness of a range of risk management measures 
including  process  enclosure,  ventilation,  personal  protective  equipment  like  respiratory 
protective equipment and gloves. 

The development of  standards  and test methods  requires close international collaboration to 
ensure  that  scientific  data  can  be  compared  globally  and  that  scientific  methods  used  for 
regulatory  purposes  are  harmonised.  A  main  forum  for  the  coordination  of  activities  at  the 
international  level  has  been  provided  by  the  OECD  Working  Party  on  Manufactured 
Nanomaterials.  Work  is  also  carried  out  in  the  framework  of  the  International  Organisation 
for Standardisation, ISO. 

A wide range of activities has been initiated to improve the knowledge base (see the annexed 
Commission Staff Working Document. and the Commission Communication “Nanosciences 
and  Nanotechnologies:  An  action  plan  for  Europe  2005-2009.  First  Implementation  Report 
2005-2007.28 

3.2. 

Improving the implementation of legislation 

Commission working groups, meetings of Competent Authorities and Agencies in charge of 
coordinating  the  implementation  of  regulation  will  have  to  examine  on  an  ongoing  basis 
whether and what type of further action is needed. These activities will mainly be reflected in 
documents that support implementation of existing legislation. 

Examples are the setting of thresholds, authorisation of substances and ingredients, qualifying 
waste  as  hazardous,  reinforcing  conformity  assessment  by  reclassification,  introducing 
restrictions  on  the  marketing  and  use  of  chemical  substances  and  preparations,  etc.  In  most 
cases, implementing legislation can be adopted through “Comitology” procedures. 
Work is also needed on documents for voluntary use, such as regulatory guidance29, European 
or international standards30, advice from Scientific Committees31 etc. Similarly, ethical issues 
have  to  be  dealt  with,  as  indicated  by  the  European  Group  on  Ethics  in  Science  and  New 
Technologies (EGE).32 

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COM(2007) 505 final ; http://ec.europa.eu/nanotechnology/pdf/comm_2007_0505_en.pdf 
E.g. Technical Guidance Document in support of Commission Directive 93/67/EEC on risk assessment 
for  new  notified  substances  and  Commission  regulation  1488/94  on  risk  assessment  for  existing 
substances; http://ecb.jrc.it/tgd 
E.g. EN ISO 14971:2000 Medical devices - Application of risk management to medical devices (ISO 
14971:2000) EN ISO 14971:2000/A1:2003 
E.g. Notes of guidance of the Scientific Committee for Consumer Products for the testing of cosmetics 
ingredients and their safety evaluation; 6th revision   
http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_03j.pdf  
http://ec.europa.eu/european_group_ethics/activities/docs/opinion_21_nano_en.pdf 

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Similarly,  input  is  required  from  the  relevant  Agencies  such  as  the  European  Medicines 
Agency33,  the  European  Food  Safety  Authority,  the  European  Chemicals  Agency  or  the 
European Agency for Safety and Health at Work (OSHA). 

The annexed Commission Staff Working Document indicates action already undertaken in a 
number of sectors. The need for further action relates in particular to the implementation of 
risk  assessment.  Relevant  Commission  working  groups  are  therefore  requested  to  give  a 
follow-up  to  the  opinions  of  the  European  Scientific  Committees  on  risk  assessment. 
Similarly,  the  European  Standards  Bodies  have  been  given  a  formal  mandate  to  verify 
existing  standards  on  whether  they  cover  in  an  appropriate  way  risks  in  relation  to 
nanomaterials.  

Particular  attention  will  have  to  be  given  to  those  products  that  are  not  subject  to  any  pre-
market verification. Concerted actions between authorities will have to be promoted to ensure 
optimal  market  surveillance.  A  dialogue  has  to  be  organised  with  stakeholders  in  specific 
sectors to ensure transparency on what is expected to meet regulatory requirements and how 
relevant information can be exchanged. 

At  international  level,  risks  in  relation  to  nanotechnologies  have  become  a  priority  for 
international collaboration in the field of cosmetics, pharmaceuticals, chemicals, food safety 
and medical devices 

Awaiting  the  adoption  of  more  specific  implementing  legislation,  standards  or  guidance, 
existing  documents  that  support  implementation  will  continue  to  be  used  on  a  case  by  case 
basis.  

3.3. 

Information to users  

There  are  no  provisions  in  Community  legislation  dealing  specifically  with  nanomaterials. 
However,  without  excluding  the  possibility  that  a  need  would  be  identified  for  specific 
labelling  requirements,  nanomaterials  have  to  comply  with  the  existing  provisions  of 
Community law addressing the labelling of products, warnings to consumers and users based 
on the properties of products, instructions for use, or any other information requirements. 

Also  relevant  are  the  provisions  in  REACH  with  obligations  of  data  dissemination  about 
environment, safety and health risks via Safety Data Sheets up and down the supply chain, to 
industrial  users  and  via  the  Internet  to  the  public  at  large.  Chemical  safety  reports  will  be 
produced for substances placed on the market in quantities at or above 10 tonnes34 and a data 
base  with  the  purpose  to  make  publicly  available  non  confidential  data  about  chemical 
substances will be kept by the European Chemicals Agency. 

Attention  is  also  drawn  to  provisions  in  Community  law  creating  a  right  of  access  to 
information  in  relation  to  programmes  mainly  implementing  legislation  on  environmental 
protection.  

The  obligation  to  provide  information  in  relation  to  the  use  of  nanomaterials  and  nano-
technologies  should  be  distinguished  from  manufacturers’  claims  regarding  the  presence  of 
particular  characteristics  associated  with  the  use  of  nanomaterials  and  nano  technologies. 

33 

34 

E.g.  EMEA  Reflection  paper  on  nanotechnology-based  medicinal  products  for  Human  Use, 
http://www.emea.europa.eu/pdfs/human/genetherapy/7976906en.pdf 
See also Article 14(4) and Annex III of the REACH Regulation (EC) No 1907/2006. 

EN 

10 

   EN 

 
                                                 
Community provisions on false or misleading advertising could be evoked if such claims are 
not justified.35  

3.4.  Market surveillance and intervention mechanisms 

Special attention will be given to the various instruments in Community legislation that oblige 
national  authorities  to  exchange  information  or  to  intervene  when  products  present  or  are 
likely to present a risk, even where they conform with legal requirements. Such instruments 
take  the  form  of  safeguard  clauses,  health  monitoring  measures,  food,  feed  and  pesticide 
to  standards,  precautionary  measures,  vigilance 
market  controls,  formal  objections 
procedures,  measures  based  on  new  evidence  or  re-assessment  of  existing  data,  mutual 
exchange  of  information,  alert/early  warning  systems,  etc.  At  all  stages,  authorities  can 
therefore  intervene  in  the  case  that  particular  risks  would  be  identified  with  respect  to 
products containing nanomaterials already on the market.  

4. 

CONCLUSIONS 

Current legislation covers in principle the potential health, safety and environmental risks in 
relation to nanomaterials. The protection of health, safety and the environment needs mostly 
to be enhanced by improving implementation of current legislation. The Commission and EU 
Agencies  will  therefore  in  the  first  place  review  current  documents  that  support 
implementation,  such  as  implementing  legislation,  standards  and  technical  guidance  with 
regard to their applicability and appropriateness to nanomaterials. 

Knowledge  on  essential  questions  such  as  characterisation  of  nanomaterials,  their  hazards, 
exposure, risk assessment and risk management should be improved. As knowledge becomes 
the critical factor for implementation and, eventually, legislation, targeted actions in a number 
of  areas  and  at  different  levels,  particularly  in  the  field  of  research  and  development,  were 
launched  as  a  matter  of  priority,  particularly  through  FP  6  and  7,  and  the  European 
Commission’s  Joint  Research  Centre.  Activities  are  coordinated  with  international  partners 
and stakeholders in the appropriate fora, such as the OECD and ISO. 

Commission  working  groups  in  charge  of  coordinating  implementation  of  legislation  are 
examining  on  an  ongoing  basis  whether  regulatory  change  on  specific  aspects  is  necessary, 
taking  into  account  the  continuously  generated  information  linked  with  the  identified 
knowledge  gaps.  They  will  take  into  consideration  work  that  has  been  carried  out  in  this 
respect at national and international level. 

Authorities and Agencies in charge of implementing legislation should continue to carefully 
monitor  the  market,  and  use  Community  market  intervention  mechanisms  in  case  risks  are 
identified for products already on the market. 

The Commission intends to report on progress in these areas 3 years after presentation of this 
Communication. 

35 

Directive  84/450/EEC  of  10  9  1984  relating  to  the  approximation  of  the  laws,  regulations  and 
administrative provisions of the Member States concerning misleading advertising  

EN 

11 

   EN