Commission staff working document accompanying document to the communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee - Regulatory aspects of nanomaterials - Summary of legislation in relation to health, safety and environment aspects of nanomaterials, regulatory research needs and related measures {COM(2008) 366 final}
Date: 2008-06-17
Institutions: European Commission
Subjects: chemical product, environmental law, environmental risk prevention, foodstuffs legislation, health legislation, labour law, nanotechnology, occupational health, occupational safety, research

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 17.6.2008 
SEC(2008) 2036 

COMMISSION STAFF WORKING DOCUMENT 

Accompanying document to the 

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

REGULATORY ASPECTS OF NANOMATERIALS 

Summary of legislation in relation to health, safety and environment aspects of 
nanomaterials, regulatory research needs and related measures 

{COM(2008) 366 final} 

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TABLE OF CONTENTS 

1. 

1.1. 

1.2. 

2. 

3. 

3.1. 

3.2. 

3.3. 

3.4. 

3.5. 

3.6. 

3.7. 

3.8. 

Chemicals..................................................................................................................... 5 

REACH ........................................................................................................................ 5 

Existing Regulation...................................................................................................... 8 

Worker Protection ...................................................................................................... 11 

Products...................................................................................................................... 12 

Plant Protection Products ........................................................................................... 12 

Biocides...................................................................................................................... 14 

New Approach Legislation ........................................................................................ 15 

Cosmetic Products...................................................................................................... 16 

Aerosol Dispensers..................................................................................................... 17 

Medicinal Products..................................................................................................... 18 

Cars ............................................................................................................................ 19 

Food Legislation......................................................................................................... 20 

3.8.1.  General Food Law...................................................................................................... 20 

3.8.2.  Novel Food................................................................................................................. 20 

3.8.3.  Food contact materials ............................................................................................... 22 

3.8.4.  Food additives ............................................................................................................ 23 

3.8.5.  Food supplements....................................................................................................... 24 

3.8.6.  Feed legislation .......................................................................................................... 25 

3.9. 

Consumer products not covered by specific regulation. ............................................ 27 

4. 

4.1. 

4.2. 

Environmental legislation .......................................................................................... 28 

Integrated Pollution Prevention and Control (IPPC) ................................................. 28 

Major-accidents, Seveso II Directive......................................................................... 29 

4.3.  Water .......................................................................................................................... 30 

4.4.  Waste.......................................................................................................................... 31 

4.5. 

4.6. 

4.7. 

Air quality .................................................................................................................. 33 

Soil ............................................................................................................................. 35 

Environmental liability............................................................................................... 35 

Research needed to support legislative work in the field of environment, health and safety .. 37 

1. 

2. 

3. 

4. 

Measurement methods, reference materials and materials characterisation, ............. 37 

Test methods for human health, safety and environment and reference materials .... 37 

Exposure information throughout the life cycle of nanomaterials............................. 37 

Risk assessment methods ........................................................................................... 38 

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5. 

6. 

Risk Management....................................................................................................... 38 

Networking and infrastructure aspects....................................................................... 38 

Addressing the knowledge gap ................................................................................................ 39 

1. 

1.1. 

1.2. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

International cooperation at the level of OECD......................................................... 39 

Testing Methods and Risk Assessment...................................................................... 39 

Information Sharing, Co-operation and Dissemination ............................................. 39 

Standardisation at the international and European level ............................................ 40 

Eu scientific committees with regard to risk assessment ........................................... 40 

The European Food Safety Authority ........................................................................ 42 

Ethical considerations with regard to nanomedecine................................................. 42 

Joint Research Centre of the European Commission................................................. 43 

Study on socio-economic factors ............................................................................... 43 

Sixth and Seventh Framework Programmes for Research and Technological 
Development .............................................................................................................. 44 

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Introduction 

This Commission staff working document provides a description of elements of selected EU 
legislation  that  seems  most  relevant  and  likely  to  apply  to  nanotechnologies  and 
nanomaterials.  It  served  as  a  basis  for  the  conclusions  presented  in  the  Commission 
Communication on Regulatory Aspects of Nanotechnologies. 

It  is  not  intended  to  provide  a  detailed  and  full  description  of  all  directives  and  regulations 
that  might  be  applicable,  but  to  highlight  some  main  features,  illustrating  how  provisions 
apply to nanomaterials. In further work based on the Commission’s Communication, it can be 
used in addition to detailed analyses of potential regulatory gaps have been or will be made 
available by various Member States.  

Consolidated versions of Directives or Regulations referred to in this document can be found 
through Eur–lex on http://eur-lex.europa.eu/en/index.htm 

This  document  also  indicates  research  needs  in  the  field  of  environment,  health  and  safety, 
referred to in the Commission Communication. 

Finally,  this  document  summarizes  main  action  undertaken  to  bridge  the  knowledge  gap  in 
relation to legislation and implementation, reference to which is made in the Communication. 

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Summary of elements of EU Regulation relevant for health, safety 
and environment aspects of nanomaterials 

1. 

CHEMICALS. 

As chemicals  regulation, and in particular REACH,  constitutes a cornerstone for  addressing 
health, safety and environmental risks in relation with nanomaterials, this overview starts with 
regulation on chemicals. REACH will repeal existing regulation at different points in time1, 
and  therefore  attention  is  still  drawn  to  the  current  provisions,  dealing  respectively  with  (i) 
classification/labelling,  notification/risk  assessment  of  new  substances  and  preparations,  (ii) 
information,  risk  assessment  and  management  of  existing  substances,  and  (iii)  market 
restrictions. 

REACH 

1.1. 
REACH2  introduces  fundamental  changes  to  the  current  regulatory  system,  inter  alia  by 
allocating  the  responsibility  for  the  safe  use  of  substances  to  manufacturers,  importers  and 
users  of  substances  instead  of  authorities,  by  widening  the  scope  for  registration  of 
substances, by introducing - for specific aspects of implementation - a centralised European 
system, which will contribute to ensuring consistency in implementation, by replacing a set of 
rules historically grown by one single regulatory system, etc.  

REACH  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 and to the placing on 
the  market  of  preparations.  REACH  also  complements  current  product  regulations  (e.g. 
cosmetics, general product safety). 

REACH does not cover explicitly nano materials. However, as REACH applies to substances 
on their own, in preparations or in articles, it covers areas in which nanomaterials are being 
used.  Furthermore,  REACH  provides  the  input  necessary  for  a  proper  implementation  of 
regulation in other areas.  

For the sake of this report, attention is drawn to the following elements: 

Registration. 

For  substances  produced  or  imported  in  quantities  of  one  tonne  or  more  per  year,  the 
manufacturers and importers must elaborate and submit a technical dossier and, for substances 
in  quantities  of  10  tonnes  or  more,  a  chemical  safety  report,  based  on  a  chemical  safety 
assessment.  

REACH contains detailed requirements as regards the composition of the Technical Dossier 
and  the  Chemical  Safety  Report.  Information  required  varies  according  to  the  tonnage 
manufactured  or  imported  per  year  per  manufacturer/importer  and  to  the  needs  of  the 
chemical safety assessment.  

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2 

Article 139, REACH 
Regulation  (EC)  No  1907/2006  of  the  European  Parliament  and  of  the  Council  of  18  December 
2006concerning  the  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals  (REACH), 
establishing  a  European  Chemicals  Agency,  amending  Directive  1999/45/EC  and  repealing  Council 
Regulation  (EEC)  No  793/93  and  Commission  Regulation  (EC)  No  1488/94  as  well  as  Council 
Directive  76/769/EEC  and  Commission  Directives  91/155/EEC,  93/67/EEC,  93/105/EC  and 
2000/21/EC, OJ L 396 of 30.12.2006 

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The  Technical  Dossier  and  the  Chemical  Safety  Report  must  be  submitted  to  the  European 
Chemicals Agency.  

Where substances that are already on the market as bulk substance, are produced or imported 
at the nano scale without modifications, they will, for registration purposes, not be considered 
as  different  from  the  bulk  material.  Manufacturers  and  importers  would  therefore  have  to 
cover the nano form in the same registration as the bulk substance. The following information 
about the nano form would be required in cases where properties or uses differ between the 
nano and the bulk: (1) the information about the properties and uses, (2) safety assessment for 
the  nano  form,  (3)  any  different  or  additional  classification  with  regard  to  hazardous 
properties of the nano form, and (4) any risk management measure and operational conditions 
required.  In  order  to  address  the  specific  hazards  associated  with  the  nanoform,  additional 
testing  or  information  may  be  required.  To  determine  specific  hazards  associated  with  the 
nanoform, current test guidelines may need to be modified. Until revised and/or specific test 
guidelines  for  nanomaterials  exist,  testing  will  have  to  be  carried  out  according  to  already 
existing guidelines. 

Substances in articles have to be registered if they are intended to be released from the article 
during normal and foreseeable conditions of use. Substances of very high concern are subject 
to a notification if they are present in the produced or imported article above a concentration 
of 0.1% (w/w).  

Downstream users (e.g. producers of paints, tyres) are required to consider the safety of the 
use  of  substances,  based  on  information  of  their  suppliers,  and  to  apply  appropriate  risk 
management measures. They must therefore communicate with the supplier of the substance, 
obtain the information needed through the data sheet, possibly communicate their “intended“ 
use to the supplier in order to have this qualified as intended use and included in an exposure 
scenario  ,  or  develop  his  own  safety  assessment.  Downstream  users  are  responsible  for 
assessing the risks from of substances if such use is not covered by the provided safety data 
sheet. 

Registrants  have  an  obligation  to  update  and  register  new  information  in  relation  to  issues 
such as changes in quantities produced or imported, new uses or new knowledge of risks to 
human  health  or  the  environment  of  which  they  may  be  reasonably  be  expected  to  have 
become aware. This may lead to changes in the safety data sheet or the chemical safety report, 
or  changes  in  the  classification  and  labelling.  Furthermore  (e.g.  with  higher  quantities  of 
production or import) more information may have to be submitted to the Agency to fulfil the 
REACH requirements.  

Evaluation. 

Evaluation  provides  a  means  for  the  authorities  to  require  registrants,  and  in  very  limited 
cases  downstream  users,  to  provide  further  information.  There  are  two  types  of  evaluation: 
dossier evaluation and substance evaluation. 

•  Dossier evaluation is conducted by the Agency to examine proposals for testing to ensure 
that  unnecessary  animal  tests  and  costs  are  avoided,  and  to  check  the  compliance  of  the 
registration dossier with the registration requirements.  

•  Substance evaluation is performed by Member States Competent Authorities when there is 
a reason to suspect that a substance presents a risk to human health or the environment.  

On  the  basis  of  the  evaluation,  the  European  Chemicals  Agency  can  require  further 
information, even information not required in Annexes VII to X of REACH. 

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Authorisation. 

For substances of very high concern included in Annex XIV of REACH, an authorisation at 
Community level is required for their use and their placing on the market. Substances subject 
to authorisation are  

•  CMRs (carcinogenic, mutagenic or toxic for reproduction) category 1 and 2 

•  PBTs  (persistent,  bioaccumulating  and  toxic)  and  vPvBs  (very  persistent  and  very 

bioaccumulating) 

•  substances with probable serious effects to humans or the environment which give rise to 
an equivalent level of concern as CMRs and PBTs/vPvBs. This is for instance the case for 
substances with endocrine disrupting properties. 

REACH  specifies  in  detail  the  conditions  in  which  a  substance  may  be  authorised,  in 
accordance with the regulatory Comitology procedure, based on criteria relating to the control 
of risks, (taking into account all discharges, emissions and losses, including risks from diffuse 
or  dispersive  uses),  risk  management  measures,  socio-economic  benefits,  availability  of 
alternatives  and  available  knowledge  on  risks  in  relation  to  alternatives.  The  European 
Chemicals  Agency  (Committee  for  Risk  Assessment  and  Committee  for  Socio-Economic 
Analysis)  is  requested  to  provide  an  opinion.  Authorisations  are  time-limited  and  can  be 
subject to conditions, such as monitoring arrangements. 

Specific provisions are foreseen dealing with the review of authorisations, for instance when 
the circumstances of the original authorisation have changed so as to affect the risk to human 
health or the environment, or the update of information. 

REACH also contains provisions regarding restrictions on the manufacturing, placing on 
the  market  and  use  of  certain  dangerous  substances,  preparations  and  articles.  When 
there  is  a  risk  to  human  health  or  the  environment  arising  from  the  manufacture,  use  or 
placing on the market of a substance, which needs to be addressed at Community-wide basis, 
restrictive  measures  shall  be  laid  down  by  the  Commission,  based  upon  an  opinion  of  the 
European  Chemicals  Agency  (Committee  for  Risk  Assessment  and  Committee  for  Socio-
Economic Analysis) and in agreement with Member States. This procedure can be initiated by 
the Commission or a Member State.  

REACH maintains the obligation to notify, for reasons of classification and labelling, to the 
European Chemicals Agency substances (on their own, in preparations or in articles) subject 
to  registration  and  substances  within  the  scope  of  Directive  67/548/EEC  which  qualify  as 
dangerous in terms of that directive . On the basis of registration and notification, the Agency 
will maintain a classification and labelling inventory.  

Particularly  relevant  are  the  provisions  contained  in  REACH  dealing  with  the  supply  of 
information: 

•  Regardless  of  quantities  produced,  suppliers  of  a  dangerous  substance  or  a  preparation 
must  provide  a  safety  data  sheet,  containing  the  data  required  by  REACH.  REACH 
introduces a “safety net” for cases where a safety data sheet would not be obligatory, but 
where  the  substance  is  subject  to  authorisation,  to  restrictions  or  where  information  is 
required to enable appropriate risk management measures to be identified and applied. 

•  Throughout  the  supply  chain,  suppliers  of  articles  containing  substances  subject  to 
authorisation in a concentration above 0.1% weight by weight must provide the recipient 
with  sufficient  information  available  to  allow  safe  use  of  the  article.  On  request,  such 
information must be given also to consumers. 

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•  Any  new  information  on  hazardous  properties,  regardless  of  the  uses  concerned  and  any 
other information that might call into question the appropriateness of the risk management 
measures identified in the safety data sheet must be passed on from any actor in the supply 
chain to the next actor or distributor. 

•  Workers  have  the  right  of  access  to  information  in  relation  to  substances  or  preparations 

that they use or may be exposed to. 

•  Regulation  No  1049/2001  on  access  to  documents  applies  to  documents  held  by  the 
European Chemicals Agency. Information kept by the European Chemicals Agency must 
be  made  available  over  the  Internet  to  the  public  at  large:  the  name  in  the  IUPAC 
Nomenclature of dangerous substances (within the meaning of Directive 67/548/EEC); if 
applicable, the name of the substance as given in EINECS; the classification and labelling 
of  the  substance;  physicochemical  data  concerning  the  substance  and  on  pathways  and 
environmental fate; the result of each toxicological and ecotoxicological study; any derived 
no-effect  levels  (DNEL)  or  predicted  no-effect  concentrations  (PNEC);  guidance  on  safe 
use;  analytical  methods  which  make  it  possible  to  detect  a  dangerous  substance  when 
discharged into the environment as well as to determine the direct exposure of humans.  

The Commission, in close co-operation with Member States, industry and other stakeholders, 
is  preparing  technical  guidance  documents  for  industry  and  authorities  to  facilitate  the 
implementation  of  the  REACH  regulation.  The  work  is  done  in  the  framework  of  so  called 
REACH  implementation  projects  (RIPs)  covering  the  main  processes  and  requirements  of 
REACH. RIP 3 relates to technical guidance for industry and RIP 4 to technical guidance for 
authorities.3 The guidance is published by the European Chemicals Agency. 

Overall, substances on the nano-scale, either as a substance, a preparation or contained in an 
article,  fall  under  the  scope  of  REACH  and  their  health  and  environment  properties  must 
accordingly  be  assessed.  All  REACH  provisions  apply  to  nanomaterials,  including  the 
mechanisms  put  in  place  by  REACH  that  allow  controlling  risks  (registration,  evaluation, 
authorisation, and restrictions).  

1.2. 

Existing Regulation. 

REACH progressively replaces a number of directives and regulations applicable hitherto to 
chemicals:  
Directive  67/548/EEC4  concerns  the  classification  and  labelling  of  chemical  substances 
according to their intrinsic dangerous properties. Any chemical that is (or is suspected to be) 
dangerous, must be classified and to be placed into one or several classes of danger defined by 
the  directive.  Classification  as  dangerous  requires  appropriate  labelling,  as  defined  by  the 
directive.5  

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More information on these projects is available at http://ecb.jrc.it/REACH/RIP_PROJECTS/ 
Council  Directive  67/548/EEC  of  27  June  1967  on  the  approximation  of  laws,  regulations  and 
administrative provisions relating to the classification, packaging and labelling of dangerous substances, 
OJ 196, 16.8.1967 
Classification and labelling will become subject to the UN Global Harmonised System. A proposal for a 
Regulation 
June  2007; 
http://ec.europa.eu/enterprise/reach/ghs_en.htm 

extent  was  presented  by 

the  Commission  on  27 

this 

to 

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Since  1981,  “new”  substances  have  to  be  notified  to  the  national  Competent  Authority6. 
Notification requires detailed information about e.g. production and uses, intrinsic properties, 
including  a  proposal  for  classification  and  labelling,  to  be  accepted  by  the  Competent 
Authority. The amount of information to be provided depends on quantities marketed.  

Since 1992, a competent authority receiving a notification of a “new” substance has to carry 
out  an  assessment  of  the  risks  to  human  health  and  the  environment7  in  accordance  with 
principles  that  have  been  laid  down  in  Directive  93/67/EEC8.  The  conclusions  of  the  risk 
assessment  may  provide  the  basis  for  subsequent  risk  management  decisions  that  have  an 
impact on production, handling, classification, labelling, marketing or use of the substance or 
include other protective measures.  

Notifiers  of  a  substance  are  obliged  to  provide  follow-up  information  regarding  quantities 
placed on the market, new knowledge on effects, new uses or changes in the composition.  

The Directive foresees a safeguard clause for cases where a substance constitutes a danger for 
man or the environment that may lead to measures applicable at Community level.  

A  “comitology”  procedure  is  foreseen  for  adaptation  to  technical  progress,  or  for  measures 
following a safeguard clause.  

Regulatory  guidance  has  been  elaborated  by  the  Commission  and  Competent  Authorities 
according  to  which  the  decisive  criterion  whether  a  nanomaterial  is  a  new  or  existing 
substance is the same as for all other substances, i.e. whether or not the substance is on the 
EINECS.9  The  authorities  also  decided  that  nanomaterials  having  specific  properties  may 
require a different classification and labelling compared to the bulk material. 
Detailed guidance has also been adopted on the risk assessment process.10 

By  virtue  of  Directive  1999/45,  similar  rules  apply  for  dangerous  preparations  as  regards 
classification, labelling and packaging11. 

In  addition,  both  Directives  require  producers  of  dangerous  chemicals  to  provide  industrial 
and  professional  users  with  health,  safety  and  environmental  information  and  advice  about 
their  products  in  the  form  of  safety  data  sheets.  Directive  91/155/EEC12,  as  amended  by 

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Council  Directive  79/831/EEC  of  18  September  1979  amending  for  the  sixth  time  Directive 
67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the 
classification, packaging and labelling of dangerous substances; OJ L 259 , 15/10/1 
Council Directive 92/32/EEC of 30 April 1992 amending for the seventh time Directive 67/548/EEC on 
the  approximation of  the  laws,  regulations and  administrative  provisions  relating  to  the  classification, 
packaging and labeling of dangerous substances; OJ L 154 , 05/06/1992 
Commission Directive 93/67/EEC of 20 July 1993 laying down the principles for assessment of risks to 
man and the environment of substances notified in accordance with Council Directive 67/548/EEC; OJ 
L 227 ,8.9.1993 
Competent  Authorities  for  the  Implementation  of  Directive  67/548  (New  Substances)  and  Council 
regulation 793/93/EEC (existing substances), Vienna, May 2006; http://ecb.jrc.it/DOCUMENTS/New-
Chemicals/Manual_of_decisions.pdf page 64 
http://ecb.jrc.it/tgd 
Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the 
approximation of the laws, regulations and administrative provisions of the Member States relating to 
the  classification,  packaging  and  labelling  of  dangerous  preparations;  OJ  L  200,  30.7.1999  ;  will  be 
replaced by the Global Harmonised System, see Directive 67/548 
Commission  Directive  91/155/EEC  of  5  March  1991  defining  and  laying  down  the  detailed 
arrangements  for 
in 
implementation of Article 10 of Directive 88/379/EEC; OJ L 76, 22.3.1991 

to  dangerous  preparations 

the  system  of  specific 

information  relating 

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Directives  93/112/EEC  and  Directive  2001/158/EC13,  sets  out  the  requirements  for  the 
information which should be included in a safety data sheet. The main purpose of safety data 
sheets is to enable employers to determine whether any hazardous chemicals are present in the 
workplace, and to assess whether there is any risk to the health and safety of workers and/or 
to the environment arising from their use.14 

Regulation (EEC) No 793/93 deals with the evaluation and control of the risks of “existing” 
substances.15  It  has  provisions  for  data  reporting,  priority  setting,  risk  assessment  and 
strategies for limiting the risks of existing substances.  
Manufacturers  or  importers  are  required  to  provide  specific  information  on  existing16 
substances produced or imported into the Community in excess of 10 tonnes per year. 

In  accordance  with  priorities  set  by  Commission  regulations,  the  risks  of  each  priority 
substance  are  assessed  by  a  Member  State.  If  the  conclusion  of  the  risk  assessment  is  that 
risks  are  not  adequately  managed,  the  regulation  requires  the  determination  of  a  strategy  to 
reduce those risks including control measures. 
Since 1994, 4 priority lists have been published with a total of 141 substances. 17 
Rules  for  risk  assessment  were  laid  down  in  Commission  Regulation  1488/9418  and  a  1996 
Technical Guidance Document (http://ecb.jrc.it/tgd/).  

When,  on  the  basis  of  the  evaluation  of  a  substance,  risk  reduction  measures  are  deemed 
necessary,  a  risk  reduction  strategy  is  developed.  The  recommended  measures  are  then 
implemented in the relevant Community and/or national frameworks. A Technical Guidance 
Document (TGD) and minimum requirements have been defined to support the development 
of  Risk  Reduction  Strategies  as  referred  to  in  Article  10(3)  of  Council  Regulation  (EEC) 
793/93.  The  document  outlines  possible  risk  reduction  measures,  implementing  instruments 
and criteria for selecting the most appropriate approach. 19 

The Existing Substances Regulation contains provisions for updating of reported information 
(that  also  apply  to  the  nano-form  of  existing  substances).  Manufacturers  and  importers  who 
have submitted information are required to update information. This concerns inter alia new 
uses  of  the  substance,  and  new  data  obtained  on  the  physico-chemical  properties, 
toxicological or ecotoxicological effects likely to be relevant to the evaluation of the potential 
risks presented by the substance.  

Manufacturers or importers of an existing substance, who acquire knowledge suggesting that 
the  substance  may  present  a  serious  risk  to  man  or  the  environment,  are  required  to  report 

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19 

Commission  Directive  2001/58/EC  of  27  July  2001  amending  for  the  second  time  Directive 
91/155/EEC defining and laying down the detailed arrangements for the system of specific information 
relating to dangerous preparations in implementation of Article 14 of European Parliament and Council 
Directive 1999/45/EC and relating to dangerous substances in implementation of Article 27 of Council 
Directive 67/548/EEC (safety data sheets); OJ L 212, 7.8.2001 
See also, hereunder, Directive 98/24/EC on the protection of the health and safety of workers from the 
risks related to chemical agents at work worker protection 
Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of 
existing substances; OJ L 84, 5.4.1993  
Substances  on  the  EU  market  before  18  September  1981,  reported  in  the  European  Inventory  of 
Existing Commercial Substances 
http://ecb.jrc.it/esis/esis.php 
Commission  Regulation  (EC)  No  1488/94  of  28  June  1994  laying  down  the  principles  for  the 
assessment  of  risks  to  man  and  the  environment  of  existing  substances  in  accordance  with  Council 
Regulation (EEC) No 793/93 (Text with EEA relevance); OJ L 161, 29.6.1994 
http://ec.europa.eu/environment/chemicals/exist_subst/pdf/tg_risk_reduction.pdf 

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such  information.  There  are  limitations  to  this  provision,  i.e.  it  applies  only  to  substances 
manufactured/imported  in  quantities  at  or  above  10  tonnes,  industry  and  use  categories  are 
quite  broad  and  may  not  “sufficiently”  catch  specific  new  applications  of  nanomaterials. 
Similarly,  the  effectiveness  may  be  limited  in  view  of  the  limited  information  generally 
available on nanomaterials. 
Finally,  Directive  76/769/EEC20  creates  a  harmonised  framework  by  which  the  use  of 
chemicals  are  banned,  or,  in  most  cases,  i.e.  restricted  for  particular  uses,  only.  If  need  be, 
restrictions on the marketing or use of nanomaterials could be introduced under this Directive.  

2. 

WORKER PROTECTION 

The  most  important  piece  of  legislation  in  the  area  of  health  and  safety  at  work  is  the 
Framework  Directive  89/391/EEC  "on 
to  encourage 
the 
improvements in the safety and health of workers"21, which fully applies to risks associated 
with nanoparticles.  

introduction  of  measures 

This  Directive  places  a  number  of  obligations  on  employers  to  take  measures  necessary  for 
the safety and health protection of workers. Employers must carry out a risk assessment and, 
where risks are identified, introduce measures to eliminate the risk. , When it is not possible to 
eliminate the risks then risks should be, minimised, preferably at the source. Prevention and 
protection  principles  are  listed  in  the  Directive.  The  planning  and  introduction  of  new 
technologies  must  be  subject  to  consultation  with  the  workers  or  their  representatives,  as 
regards the consequences of the choice of equipment, the working conditions and the working 
environment. The employer must be in possession of an assessment of the risks to safety and 
health  of  workers  at  work,  including  those  facing  groups  of  workers  exposed  to  particular 
risks.  The  Directive  furthermore  contains  various  provisions  regarding  worker  information 
and consultation and participation of workers in discussions on all questions relating to safety 
and health at work, and relevant training of workers. 

The  Framework  Directive  on  Health  and  Safety  foresees  the  possibility  to  adopt  individual 
directives  laying  down  more  specific  provisions  with  respect  to  particular  aspects  of  safety 
and  health.  "Daughter  directives"  which  are  relevant  to  risks  that  may  result  from  possible 
exposure to nanomaterials include:  

•  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)22 and  

•  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)23and 

20 

21 

22 
23 

Council  Directive  76/769/EEC  of  27  July  1976  on  the  approximation  of  the  laws,  regulations  and 
administrative  provisions  of  the  Member  States  relating  to  restrictions  on  the  marketing  and  use  of 
certain dangerous substances and preparations; OJ L 262, 27.9.1976 
Council  Directive  89/391/EEC  of  12  June  1989  on  the  introduction  of  measures  to  encourage 
improvements in the safety and health of workers at work; OJ L 183, 29.6.1989 
OJ L 158, 30.4.2004 
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 

EN 

11 

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•  Council Directive 89/655/EEC of 30 November 1989 concerning the minimum safety and 
health requirements for the use of work equipment by workers at work (second individual 
Directive)24 and 

•  Council  Directive  89/656/EEC  of  30  November  1989  on  the  minimum  health  and  safety 
requirements  for  the  use  of  personal  protective  equipment  at  the  workplace  (third 
individual Directive)25 and 

•  Directive  1999/92/EC  of  the  European  Parliament  and  of  the  Council  of  16  December 
1999 on minimum requirements for improving the safety and health protection of workers 
potentially at risk from explosive atmospheres (fifteenth individual Directive)26. 

The  Framework  Directive  and 
the  above-mentioned  daughter  Directives  present  a 
comprehensive package of legal requirements aiming at ensuring a high level of protection of 
workers health and safety. These requirements, whilst they do not make explicit mention of 
nanomaterials  and  nanotechnologies,  define  a  legislative  framework  that  applies  to  most 
occupational risks including those arising from the presence of nanomaterials. 

In  implementing  the  EU  occupational  safety  and  health  directives  the  Member  States  may 
introduce more strict requirements at national level. 

3. 

PRODUCTS 

Many groups of products are covered by specific Community legislation laying down product 
requirements for safety and health of workers, consumers and protection of the environment; 
e.g.  cosmetics,  pharmaceuticals,  cars  or  chemicals.  New  Approach  legislation  deals  with 
categories of risks applicable to product families, (e.g. medical devices, pressure equipment, 
personal  protective  equipment),  containing  sometimes  also  general  safety  requirements  (e.g. 
Low  Voltage  Directive).  Consumer  products  not  covered  by  specific  regulation  are  covered 
by the Directive on General Safety of Consumer Products. In many cases more than one piece 
of legislation applies to the same product.  

Where regulation contains requirements of a general nature, they will cover also risks related 
to nanotechnology, even if they have been adopted without specifically intending to address 
risks associated with nanomaterials and nanotechnologies.  

Legislation  will  determine  not  only  under  what  conditions  products  can  be  placed  on  the 
market,  but  also  establish  mechanisms  to  verify  compliance  with  regulatory  requirements, 
oblige manufacturers to monitor their products and authorities to intervene in case safety and 
health issues are at stake. 

Plant Protection Products 

3.1. 
Directive  91/414/EEC  concerning  the  placing  of  plant  protection  products  on  the  market27, 
lays  down  rules  and  procedures  for  approval  of  the  active  substances  at  EU-level  (i.e. 

24 

25 

26 

Council  Directive  89/655/EEC  of  30  November  1989  concerning  the  minimum  safety  and  health 
requirements  for  the  use  of  work  equipment  by  workers  at  work  (second  individual  Directive);  OJ  L 
393, 30.12.1989 
Council Directive 89/656/EEC of 30 November 1989 on the minimum health and safety requirements 
for  the  use  of  personal  protective  equipment  at  the  workplace  (third  individual  Directive);  OJ  L  393, 
30.12.1989 
Directive  1999/92/EC  of  the  European  Parliament  and  of  the  Council  of  16  December  1999  on 
minimum  requirements  for  improving  the  safety  and  health  protection  of  workers  potentially  at  risk 
from explosive atmospheres (fifteenth individual Directive); OJ L 23, 28.1.2000 

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inclusion in Annex I to Dir. 91/414/EEC) and for the authorisation at Member State level of 
plant protection products (PPPs) containing these substances. 

A PPP can only be authorized if it fulfils, among others, the following requirements: 

•  It is effective; 

•  It has no unacceptable effects on plants or plant products; 

•  It does not cause unnecessary suffering and pain to vertebrates to be controlled 

•  It  has  no  harmful  effect  on  human  or  animal  health  directly  or  indirectly  or  on 

groundwater; 

•  It has no unacceptable influence on the environment. 

Furthermore, it must be possible to determine by appropriate methods the nature and quantity 
of  its  active  substances  and  any  toxicologically  or  ecotoxicologically  significant  impurities 
and co-formulants, its residues which are of toxicological or environmental significance, and 
its physical and chemical properties deemed acceptable for the purpose of the appropriate use 
and storage of the product. 

Inclusion of an active substance in the Annex I to the Directive can only be granted when it is 
demonstrated that PPPs containing that active substance fulfil the following conditions: 

•  their  residues  do  not  have  any  harmful  effects  on  human  or  animal  health  or  on 

groundwater or any unacceptable influence on the environment; 

•  the use does not have any harmful effects on human or animal health or any unacceptable 

influence on the environment. 

One  essential  element  in  the  rules  and  procedures  laid  down  by  Directive  91/414/EEC  is 
harmonised  data  requirements,  i.e.  minimum  requirements  for  the  dossier  that  has  to  be 
submitted by an applicant in order to have an active substance authorised at EU level and a 
PPP containing the same substance marketed and used at Member State level. 

Data  requirements  are  specified  in  Annexes  II  (active  substance)  and  III  (PPP)  to  Directive 
91/414/EEC and are divided into six sections: 

•  Physical and chemical properties 

•  Analytical methods 

•  Toxicological and metabolism studies 

•  Residues in treated products, food and feed 

•  Fate and behaviour in the environment 

•  Ecotoxicology 

The dossier shall be in accordance with data requirements referred to in Annexes II and III 
and shall provide information to evaluate immediate or delayed risks for human, animal and 
environment, which can derive from the active substance proposed to be included in Annex I 
(i.e. to become an approved active ingredient in the EU) as well as from the plant protection 
product proposed for authorisation.  

27 

Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on 
the market; OJ L 230, 19.8.1991 

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Data  requirements  are  comprehensive  and  detailed.  Overall,  however,  the  applicant  must 
provide all the information necessary for evaluating the foreseeable risks, whether immediate 
or delayed, which the substance may entail for humans, animals and the environment. Where 
relevant,  authorities  can  always  require  additional  information  and  studies.  Consequently, 
under  this  rule,  also  information  regarding  the  use  of  nanotechnologies  and  nanomaterials 
could be requested if necessary.  

Authorizations  may  be  reviewed  at  any  time  on  the  basis  of  developments  in  scientific  and 
technical knowledge. 

The holders of authorizations are obliged to immediately notify the competent authority of all 
new  information  on  the  potentially  dangerous  effects  of  any  plant  protection  product,  or  of 
residues  of  an  active  substance  on  human  or  animal  health  or  on  groundwater,  or  their 
potentially dangerous effects on the environment.  

Where a Member State has valid reasons to consider  that a product  authorized constitutes a 
risk to human or animal health or the environment, it may provisionally restrict or prohibit the 
use and/or sale of that product on its territory. National measures will need to be confirmed at 
Community level. 

Nanomaterials could be used as co-formulants in plant protection products. Full composition 
of the plant protection product needs to be presented when  applying for authorisations. The 
proposal for  a Regulation amending Directive 91/414/EEC  (COM (2006)  388) foresees that 
certain  co-formulants  can  be  prohibited  in  case  of  concern  for  human,  animal  health  or  the 
environment.  

Based on the above, Directive 91/414/EEC does cover nanomaterials adequately in its current 
form.  However,  current  guidance  documents  (on  data  requirements,  risk  assessment  and 
decision  making)  could  need  to  be  amended  in  order  to  properly  address  risks  to 
nanomaterials. 

Biocides  

3.2. 
Directive 98/8/EC on Biocidal Products28 aims to harmonise the European market for biocidal 
products  and  their  active  substances.  At  the  same  time  it  aims  to  provide  a  high  level  of 
protection  for  humans,  animals  and  the  environment.  The  scope  of  the  Directive  covers  23 
different product types, varying from disinfectants to antifouling agents and rodenticides. 

The  Directive  follows  closely  Directive  91/414/EEC  on  placing  on  the  market  of  Plant 
Protection  Products.  It  lays  down  a  two  tier  approach:  active  substances  are  evaluated  at 
Community level (Annex I inclusion) whereas biocidal products are authorised or registered 
at national level. Risk assessment on active substances based on the dossier submitted by the 
industry  (applicant)  is  done  by  the  Rapporteur  Member  State.  Data  requirements  for  active 
substances and biocidal products are laid down in the Annexes of the Directive. It is important 
to note that there are no tonnage triggers for the data requirements. However, studies can be 
waived  in  case  there  are  sufficient  scientific  or  technical  justifications  provided  by  the 
applicant. 

The  final  decision  on  the  inclusion  of  an  active  substance  to  the  Directive  is  made  by  the 
Commission  via  a  regulatory  committee  procedure.  Member  States  can  then  authorise 
biocidal  products  containing  the  approved  active  substances,  provided  that  the  criteria  laid 
down in the Directive and in Annex VI (Common Principles) are fulfilled. 

28 

Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the 
placing of biocidal products on the market; OJ L 123, 24.4.1998 

EN 

14 

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The  Directive  also  establishes  rules  concerning  a  10-years  transitional  period  (until  May 
2010). During this period, all existing active substances need to be evaluated. 

The  definitions  of  a  biocidal  product  (Article  2(1)(a)  and  of  an  active  substance  (Article 
2(1)(d)  cover  also  nanomaterials  and  these  latter,  therefore,  fall  under  the  scope  of  the 
Directive if used for biocidal purposes. Data requirements are comprehensive and detailed. As 
no reference is made to any specific test guidelines, the requirements as such are applicable to 
nanomaterials as well. 

Nanomaterials can also be used as co-formulants in biocidal products. Full composition of the 
biocidal  product  needs  to  be  presented  when  applying  for  authorisation.  When  necessary, 
Competent Authorities can request additional data on 'substances of concern'. 

Based on the above, the Biocides Directive does cover nanomaterials adequately in its current 
form.  However,  current  technical  notes  for  guidance  (on  data  requirements,  risk  assessment 
and  decision  making)  would  need  to  be  amended  in  order  to  properly  address  risks  of 
nanomaterials. 

3.3. 

New Approach Legislation 

A number of products relevant for nanotechnology related risks are covered by the so-called 
New  Approach  on  Technical  Harmonisation  and  Standardisation29.  These  are  in  particular 
machinery, personal protective equipment, low-voltage, medical devices, etc. 

New Approach Directives deal with particular risks, defined in each Directive. As a general 
rule,  manufacturers  are  obliged  to  carry  out  an  assessment  of  the  risks  defined  in  each 
directive  and  to  adopt  a  risk  management  strategy.  This  implies  to  adopt  measures  to 
eliminate  risks,  or  to  reduce  risks  as  far  as  possible  (inherent  safe  design,  construction  and 
use), take the necessary protection measures in relation to risks that cannot be eliminated, and 
as a last resort, inform users of the residual risks due to any  shortcomings  of the protection 
measures  adopted,  and  advice  any  other  protective  measure  regarding  risks  that  cannot  be 
eliminated.  The  Directive  on  medical  devices  complements  these  rules  by  a  risk-benefit 
analysis. 

New  Approach  Directives  do  not  specify  the  technology  that  manufacturers  must  adopt  to 
meet  the  mandatory  regulatory  requirements.  Whilst  they  leave  in  this  way  flexibility  to 
manufacturers,  at  the  same  time  they  create  an  obligation  to  adapt  design  and  production 
processes in the light of the evolving technology and knowledge. Many Directives introduce 
concepts such as “the generally acknowledged state of art”, “the state of art” and “generally 
acknowledged rules of technology”. 

In order to assist manufacturers and authorities in complying with Directives, each Directive 
will have a body of supporting documents. 

•  Tailor-made  European  standards  can  be  developed  to  meet  the  Directives’  requirements, 

compliance with which provides a presumption of conformity.  

•  Stakeholders and authorities adopt guidance documents containing consensus based views 

on the interpretation of the Directives’ requirements 

•  In  many  cases,  also  the  Notified  Bodies  will  adopt  guidelines  in  order  to  achieve  a 
consistent  interpretation  of  requirements  and  to  achieve  equivalent  verification  of 
conformity assessment.  

29 

For a list of New Approach Directives and relevant harmonised standards, see   
http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist.html 

EN 

15 

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Under the New Approach, placing on the market is not subject to a prior market approval by 
public  authorities.  Various  methods  are  open  to  manufacturers  to  demonstrate  compliance 
with  the  Directive’s  requirements.  Depending  on  the  risks  involved  or  availability  of 
European standards, this will involve the intervention of a third party, the so-called Notified 
Body, designated and monitored by national authorities.  

The  risk  assessment  and  risk  management  approached  must  be  documented  in  a  technical 
dossier.  Any  change  to  the  design  or  construction  process  must  be  documented  and,  where 
third  party  intervention  is  required,  be  communicated  to  the  Notified  Body  who  approved 
originally the design and production process.  

New Approach Directives all contain intervention mechanisms, under which Member States 
can intervene on the market with regard to products likely to present a danger for man or the 
environment.  Similarly,  harmonised  standards  adopted  by  the  European  standards  bodies  in 
support of the directives can be challenged. The  Directives  on  medical  devices  also  contain 
provisions on health monitoring. 

New  Approach  Directives  have  mechanisms  to  introduce  regulatory  change  with  respect  to 
the definition of essential requirements, or, as the case may be, reclassification of products in 
order to submit them to more or less stringent conformity assessment procedures. 

Thus, the Medical Devices Experts Group has set up a working group on New and Emerging 
Technologies  in  Medical  Devices,  with  nanotechnology  as  first  priority.  Apart  from  the 
reclassification  of  devices,  the  group  also  recommended  the  development  of  regulatory 
guidance on the nature of the risks that should be taken into consideration, possible solutions 
to  manage  these  risks,  identification  of  appropriate  regulatory  pathways,  necessary  actions 
during  the  post-marketing  phase  and  mechanism  for  a  Voluntary  Reporting  Scheme. 
Furthermore,  the  Group  has  recommended  guidance  with  regard  to  the  conduct  of  clinical 
investigations with nanotechnology products 

Given  the  way  New  Approach  Directives  have  been  written,  they  allow  in  principle  risks 
associated with nanomaterials to be covered. More specific guidance can be made available, if 
need be, through European standards, or guidance documents adopted either by Commission 
working groups or the relevant Notified Bodies.  

Cosmetic Products 

3.4. 
Directive 76/768/EEC30 contains prescriptive elements through positive (substances that can 
be used) and negative lists (substances that can not be used) of ingredients, obligation for a 
manufacturer is to carry out a risk assessment. 

A  cosmetic  product  put  on  the  market  within  the  Community  must  not  cause  damage  to 
human health when applied under normal or reasonably foreseeable conditions of use, taking 
account, in particular, of the product's  presentation, its labelling, any instructions for its use 
and disposal as well as any other indication or information provided by the manufacturer or 
his  authorized  agent  or  by  any  other  person  responsible  for  placing  the  product  on  the 
Community market.  

The Directive contains detailed rules concerning substances that can not be used, or used only 
within certain limits and conditions, colouring agents, preservatives and UV filters. 

30 

Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States 
relating to cosmetic products;  OJ L 262, 27.9.1976 

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16 

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The use in cosmetic products of substances classified as carcinogenic, mutagenic or toxic for 
reproduction, of category 1, 2 and 3, under Annex I to Directive 67/548/EEC is prohibited. A 
substance  classified  in  category  3  may  be  used  in  cosmetics  only  if  the  substance  has  been 
evaluated by the Scientific Committee for Consumer Products and found acceptable for use in 
cosmetic products.  

The  manufacturer  must  have  available  an  assessment  of  the  safety  for  human  health  of  the 
finished product. To that end, he must take into consideration the general toxicological profile 
of  the  ingredients,  their  chemical  structure  and  their  level  of  exposure.  The  risk  assessment 
must take particular account of the special exposure characteristics of the areas on which the 
product will be applied or of the population for which it is intended. There must be inter alia a 
special assessment for cosmetic products intended for use on children under the age of three 
and for cosmetic products intended exclusively for use in external intimate hygiene.  

Also, the Cosmetics Directive contains a provision according to which a Member State may, 
awaiting measures at Community level, provisionally prohibit the marketing of a product in 
its  territory  or  subject  it  to  special  conditions  notes,  when  a  cosmetic  product  represents  a 
hazard to health.  

In  accordance  with  Comitology  procedures,  detailed  rules  can  be  laid  down  regarding  the 
composition  of  cosmetic  products:  substances  that  cannot  form  part  of  the  composition  of 
cosmetic  products  and  substances  the  use  of  which  is  subject  to  restrictions  and  conditions, 
substances; similarly, through Comitology procedures the lists can be adapted for colorants, 
preservatives and UV filters that can be used. The Commission, in agreement with Member 
States, can specify substances that cannot be part of the composition of cosmetics. 

On the basis of the obligation to carry out a risk assessment and the possibility to lay down 
through  implementing  legislation  detailed  conditions  of  use  for  certain  ingredients,  risks  in 
relation to nanomaterials and nanotechnologies can, therefore, in principle be dealt with in an 
appropriate way.  

However,  based  on  a  web  consultation,  the  Commission  has  proposed  a  revision  of  the 
Cosmetic Products Directive, which is directly relevant for products using nanomaterials.31 Its 
main elements are: 

•  clear minimum requirements for the cosmetics safety assessment  

•  a  system  of  administrative  cooperation  of  competent  authorities:  this  entails  a  system  of 
coordination  of  Member  States  in  the  assessment  of  products  and  their  supporting 
information, including rules for product withdrawal;  

•  an  obligation  of  industry  to  actively  report  serious  undesirable  effects  to  competent 
authorities  as part  of an early detection mechanism  for  risks  for  human  health  caused  by 
cosmetic products; and 

•  a  notification  requirement  which  provides  information  to  all  competent  authorities  of  the 

internal market through one single notification portal.  

Aerosol Dispensers 

3.5. 
According  to  the  aerosol  dispenser  directive32,  aerosol  dispensers  must  meet  a  number  of 
specific  requirements  before  they  can  be  placed  on  the  market.  Compliance  with  these 
requirements means that in principle the product is safe. 

31 

Proposal  for  a  regulation  of  the  European  Parliament  and  of  the  Council  on  cosmetic  products; 
COM(2008)49 final 2008/0025 (COD) 5.2.2008 

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However, the Directive itself accepts that it is possible that some aerosol dispensers placed on 
the  market  may  represent  a  hazard  to  safety  or  health,  even  though  they  comply  with  the 
requirements  of  the  Directive  and  of  the  Annex  thereto.  The  Directive  therefore  contains  a 
safeguard  procedure  allowing  Member  States  to  provisionally,  i.e.  subject  to  verification  at 
Community level, prohibit the sale of the dispenser or dispensers in their territory or subject it 
or them to special conditions. 

This Directive has been modified in April 2008 to introduce an obligation for manufacturers 
to  carry  out  a  hazard  analysis.33  Discussions  in  relation  to  health  and  safety  problems  with 
aerosols  placed  on  the  Community  market34  have  shown  that  risks  may  result  from  the 
physical  and  chemical  nature  of  nano-particles  in  conjunction  with  their  distribution  in  the 
form of an aerosol, i.e. within very small liquid droplets that can easily pass the human lung 
tissue.  Therefore,  the  revised  directive  specifies  that  where  appropriate,  this  analysis  shall 
include a consideration of the risks resulting from the inhalation of the spray ejected by the 
aerosol  dispenser  under  normal  and  reasonably  foreseeable  conditions  of  use,  taking  into 
account droplet size distribution in conjunction with physical and chemical properties of the 
contents.  The  manufacturer  must  then  design,  construct  and  test  the  dispenser,  and,  if 
applicable, draft special statements concerning its use, taking account of his analysis. 

3.6.  Medicinal Products 

The  European  regulatory  system  for  medicinal  products  offers  the  following  routes  for 
authorising medicinal products: 

•  a  “centralised”  procedure,  with  applications  made  directly  to  the  European  Medicines 
Agency, leading to the grant of a Community marketing authorisation by the Commission. 
Use of this procedure is compulsory for products listed in the Annex to Regulation (EC) 
No  726/2004,  and  optional  for  other  medicinal  products  under  conditions  laid  down  in 
Article 3 paragraph 2 of that Regulation; 

•  a “mutual recognition” procedure with applications submitted simultaneously in different 
Members States. One Member State is selected by the applicant as the reference Member 
State, other Member State(s) act as concerned Member State(s). Following the evaluation 
carried out by the reference Member State, the concerned Member State(s) have to approve 
the  assessment  report,  summary  of  product  characteristic,  labelling  and  package  leaflet 
proposed by the reference Member State. At the end of the procedure, a national marketing 
authorisation  is  issued  by  the  reference  Member  State  as  well  as  by  each  concerned 
Member State(s). 

•  a “decentralised” procedure based on the recognition by the concerned Member State(s) of 

a marketing authorisation already granted by another Member State; 

•  a  purely  national  authorisation  procedure  for  medicinal  products  to  be  marketed  in  only 

one Member State. 

Community procedures are based on a wide range of prescriptions laid down in implementing 
rules  and  guidance  documents.  No  specific  rules  are  foreseen  for  risks  related  with 
nanomaterials  or  nanotechnology.  Nevertheless;  the  EMEA  Committee  for  Medicinal 

32 

33 
34 

Council  Directive  75/324  of  20  May  1975  on  the  approximation  of  the  laws  of  the  Member  States 
relating  to  aerosol  dispensers,  OJ  L  147  of  9.6.1975,  as  last  amended  by  Commission  Directive 
2008/47/EC, OJ L 96, 9.4.2008 
http://ec.europa.eu/enterprise/pressure_equipment/aerosol_sector/index_en.html 
http://www.bfr.bund.de/cms5w/sixcms/detail.php/7842 

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Products for Human Use (CHMP) has produced a reflection paper on nanotechnology-based 
medicinal products for human use.  

As outlined in this reflection paper, the evaluation and prevention of potential hazards related 
to  the  use  of  any  given  'nanomedicinal'  product  is  already  foreseen  under  the  existing  EU 
pharmaceutical legislation. As for any medicinal product, the EU competent authorities will 
evaluate any application to place a nanomedicinal product on the market, utilising established 
principles  of  benefit/risk  analysis,  rather  than  solely  on  the  basis  of  the  technology  per  se. 
These considerations of principle equally apply in the field of veterinary medicinal products. . 

According to the CHMP, it is likely that many novel applications of nanotechnology will span 
the regulatory boundaries between medicinal products and medical devices. Under the current 
legislation, the mechanism of action is key to decide whether a product should be regulated as 
a  medicinal  product  or  a  medical  device  ((Directive  2001/83/EC,  as  amended,  Article  1,  2. 
Nanomedicinal  products,  however,  may  exhibit  a  complex  mechanism  of  action  combining 
mechanical,  chemical,  pharmacological  and  immunological  properties  and  combining 
diagnostic  and  therapeutic  functions.  Furthermore,  additional  specialised  expertise  may  be 
required  for  the  evaluation  of  the  quality,  safety,  efficacy  and  risk  management  of  such 
nanomedicinal products. 

For  the  CHMP,  it  is  likely  that  the  evaluation  of  products  of  such  novel  technology  will 
require  special  consideration.  The  accumulation  of  experience,  in  particular  from  informal 
discussion  in  Briefing  meetings,  Scientific  Advice  or  Marketing  Authorisation  applications 
evaluation procedures, will allow, on an ongoing basis, to assess the need for the development 
of  guidance  specific  to  nanomedicinal  products  or  for  the  update  of  existing  ones  to 
accommodate for the specific aspects of these products. 

In order to deal with the above issues, the EMEA has created the Innovation Task Force (ITF) 
to  ensure  EMEA-wide  coordination  of  scientific  and  regulatory  competence  in  the  field  of 
emerging therapies and technologies, including nanotechnologies, and to provide a forum for 
early dialogue with applicants on regulatory, scientific or other issues that may arise from the 
development.  In  the  absence  of  specific  guidance,  applicants  are  encouraged  to  contact  the 
EMEA from the early stages of the development of their products.35 

3.7. 

Cars 

Passenger  cars,  motorcycles  and  tractors  are  subject  to  the  EC  Whole  Vehicle  Type-
Approval (WVTA) system, which implies that these categories of vehicles must comply with 
the  relevant  EC  legislation  on  type-approval  in  order  to  be  placed  on  the  market.  Partial 
harmonisation  exists  for  the  remaining  vehicle  categories,  like  heavy-duty  commercial 
vehicles, buses and coaches. A new framework Directive36 adopted in 2007 makes EC WVTA 
mandatory for all the remaining categories of vehicles in stages from 2009 to 2014.  

Manufacturers must obtain a type approval for vehicles and their components, indicating that 
the type conforms to the technical requirements laid down in the EC legislation. On the basis 
of  the  type-approval  certificate,  the  manufacturer  will  issue  a  certificate  of  conformity  for 
each vehicle produced, i.e. a statement that the vehicle to be placed on the market, based on 
adequate  arrangements  for  ensuring  conformity  of  production,  conforms  to  the  relevant  EC 
type-approval.  

35 
36 

http://www.emea.eu.int/htms/human/itf/itfintro.htm 
Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing 
a  framework  for  the  approval  of  motor  vehicles  and  their  trailers,  and  of  systems,  components  and 
separate technical units intended for such vehicles; OJ L 263 of 9.10.2007 

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To  date,  about  100  specific  regulatory  acts  have  been  adopted.  They  prescribe  technical 
requirements to be met by the vehicles and components concerned in order to comply with a 
certain  safety  level  or  ensure  a  certain  environmental  performance,  but  in  principle  are  not 
design-restrictive  since  they  do  not  prescribe  a  certain  technology  or  material  to  be  used  in 
order  to  fulfil  those  requirements.  Accordingly,  they  do  not  cover  risks  related  to 
nanomaterials  or  nanotechnology.  Only  to  the  extent  that  other  regulations  apply  to 
components  or  materials  or  other  aspects,  risks  associated  with  nanomaterials  or 
nanotechnology  are  adequately  covered.  Such  aspects  would  however  not  be  subject  to 
approval by Member States under the WVTA. 

Consequently, the use of nanomaterials in articles such as paintings or tyres is to be assessed 
exclusively  under  REACH  and  its  provisions  on  substances  contained  in  articles  and 
downstream-users. 

3.8. 

Food Legislation 

3.8.1.  General Food Law 

Regulation  178/2002  laying  down  the  general  principles  and  requirements  of  food  law, 
establishing  the  European  Food  Safety  Authority  (EFSA)  and  laying  down  procedures  in 
matters of food safety37, applies horizontally to all foods and feed. Within the context of food 
law, also the general requirements for feed, including its production and use where that feed is 
intended for food-producing animals, are included.  

The General Food Law aims at ensuring a high level of protection of human life and health, 
taking  into  account  the  protection  of  animal  health  and  welfare,  plant  health  and  the 
environment.  The  Regulation  provides  for  e.g.  general  food  safety  requirements,  sets  the 
responsibility  of  safe  food  on  food  business  operators  and  defines  the  principles  of  risk 
analysis in relation to food. It also establishes the structures and mechanisms for the scientific 
and technical evaluations which are undertaken by EFSA as well as safeguard measures for 
emergency situations. 

Following  the  rules  on  access  to  documents,  applications  for  authorisation,  supplementary 
information  from  applicants  and  opinions  from  the  Authority,  excluding  confidential 
information, shall be made accessible to the public in accordance with Articles 38, 39 and 41 
of Regulation (EC) No 178/2002. 

More particularly relevant in relation to risks associated with nanomaterials are the following. 

3.8.2.  Novel Food 
Regulation 258/97 concerning novel foods and novel food ingredients38 regulates the placing 
on the market of foods and food ingredients which have not been used for 15 May 1997 for 
human  consumption  to  a  significant  degree  within  the  Community,  and  which  fall  under 
particular categories laid down in Article 1 paragraph 2 of Regulation, including e.g. 

•  foods  and  food  ingredients  with  a  new  or  intentionally  modified  primary  molecular 

structure;  

37 

38 

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying 
down  the  general  principles  and  requirements  of  food  law,  establishing  the  European  Food  Safety 
Authority and laying down procedures in matters of food safety, OJ L 31, 1.2.2002 
Regulation  (EC)  No  258/97  of  the  European  Parliament  and  of  the  Council  of  27  January  1997 
concerning novel foods and novel food ingredients, OJ L 43, 14.2.199 

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•  foods  and  food  ingredients  to  which  has  been  applied  a  production  process  not  currently 
used, where that process gives rise to significant changes in the composition or structure of 
the  foods  or  food  ingredients  which  affect  their  nutritional  value,  metabolism  or  level  of 
undesirable substances 

Foods  and  food  ingredients  falling  within  the  scope  of  this  Regulation  must  not  present  a 
danger  for  the  consumer,  mislead  the  consumer  and  differ  from  foods  or  food  ingredients 
which they are intended to replace to such an extent that their normal consumption would be 
nutritionally disadvantageous for the consumer. 

Food and food ingredients can only be placed on the market if they have been subject of an 
initial assessment arranged for by a Member State. The results of this initial assessment are 
distributed to the other Member States and the Commission. If  no objections are raised, the 
Member State to which the application was submitted, informs the applicant that he may place 
the  food  on  the  market.  If  objections  are  raised,  a  Commission's  decision  by  comitology 
procedure  is  required.  In  such  case  the  safety  assessment  is  often  duplicated  by  EFSA.  A 
simplified  procedure  (notification  to  the  Commission)  is  foreseen  for  foods  that  are 
substantially equivalent to already existing or authorised foods. 

Special  labelling  rules  are  foreseen.  Without  prejudice  to  other  requirements  of  Community 
law, information must be given in order to ensure that the final consumer is informed of  

•  Any  characteristic  of  the  food,  which  renders  a  novel  food  or  food  ingredient  no  longer 
equivalent  to  an  existing  food  or  ingredient.  In  this  case,  the  labelling  must  indicate  the 
characteristics  or  properties  modified,  together  with  the  method  by  which  that 
characteristic or property was obtained. 

•  The  presence  of  a  materials  which  is  not  present  in  an  existing  equivalent  foodstuff  and 

which may have implications for the health of certain sectors of the population 

•  The  presence  of  a  materials  which  is  not  present  in  an  existing  equivalent  foodstuff  and 

which gives rise to ethical concerns 

Detailed rules for implementing these requirements are to be adopted by the Commission in 
agreement with the Member States and proper information to the European Parliament. 

Where  as  a  result  of  new  information  or  a  reassessment  of  existing  information,  there  are 
detailed grounds for considering that the use of a food or a food ingredient complying with 
this  Regulation  endangers  human  health  or  the  environment,  Member  State  may  take 
restrictive  measures,  to  be  confirmed  or  withdrawn  subsequently  after  a  procedure  at 
Community level. 

In order to facilitate implementation of the Regulation, the Commission has published a series 
of recommendations on the scientific aspects and the presentation of information necessary to 
support applications for the placing on the market of novel foods and novel food ingredients 
and the preparation of initial assessment reports.39 

Consequently,  Regulation  258/97  allows  assessing  possible  risks  associated  with  the  use  of 
nanomaterials  and  nanotechnologies  (novel  food  ingredients)  and  nanotechnologies  (novel 

39 

Commission Recommendation of 29 July 1997 concerning the scientific aspects and the presentation of 
information  necessary  to  support  applications for  the placing on  the  market  of novel foods  and novel 
food ingredients and the preparation of initial assessment reports under Regulation (EC) No 258/97 of 
the European Parliament and of the Council; OJ L 253, 16.9.1997 

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technology  with  impact  on  food)  in  relation  with  food  and  food  ingredients.40  Similarly, 
provisions in relation to labelling allow to take, if need be, further risk management measures 
by setting conditions of use or by informing about the use of the food. 

3.8.3.  Food contact materials 

Regulation  (EC)  1935/2004  relating  to  materials  and  articles  intended  to  come  into  contact 
with food41 applies to materials and articles which are already in contact with food or which, 
are intended for food contact or which can be reasonably expected to come into contact with 
food. It covers also articles for contact with water intended for human consumption. 

As  a  basic  rule,  materials  and  articles  must  be  manufactured  in  compliance  with  good 
manufacturing practice so that, under their normal or  foreseeable  conditions  of  use, they  do 
not transfer their constituents to foodstuffs in quantities which could: 

•  endanger human health, 

•  bring about an unacceptable change in the composition of the food or 

•  a deterioration in the organoleptic characteristics of the food. 

The Regulation allows for the adoption of specific measures setting out specific requirements 
for  certain  materials  and  articles.42  These  groups  of  materials  and  articles  and,  where 
appropriate, combinations  thereof  as  well as recyled  materials  used  in  these  articles  may  be 
subject to specific measures that regulate issues such as: 

•  authorisation  of  substances  to  be  used,  including  specific  limits  on  their  migration  into 

food; 

•  purity criteria and specifications for such substances; 

•  special  conditions  of  use  for  these  substances  and/or  the  materials  and  articles  in  which 

they are used; 

•  the  basic  rules  necessary  for  checking  compliance:  sample  taking  and  the  methods  of 

analysis. 
If  need  be,  special  provisions  can  be  adopted  for  new  types  of  materials  and  articles 
designed  to  actively  maintain  or  improve  the  condition  of  the  food  (active  food  contact 
materials  and  articles)  or  designed  to  monitor  the  condition  of  the  food  (intelligent  food 
contact materials and articles). 

Prior  to  authorisation  for  their  use  in  food  contact  materials  substances  need  to  undergo  a 
safety  assessment  carried  out  by  EFSA.  EFSA  has  issued  guidelines  on  how  to  present  an 
application  for  evaluation  of  a  substance.  These  guidelines  would  need  to  be  adapted  to 
require  identifications  of  possible  compounds  present  in  “nano  form”.  The  risk  assessment 
would need to be adapted to take into account specific risk arising from the use of substances 
in “nano-form”, if any. 

40 

41 

42 

Under  the  novel  food  regime  only  the  food  produced  by  nanotechnology  is  assessed,  not 
nanotechnology as such 
Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on 
materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 
89/109/EEC,  OJ L 338, 13.11.2004  
For a list of specific directives on materials in contact with food, see 
http://ec.europa.eu/food/food/chemicalsafety/foodcontact/legisl_list_en.htm 

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The applicant or any business operator using the authorised substance or materials or articles 
containing  the  authorised  substance  shall  immediately  inform  the  Commission  of  any  new 
scientific or technical information, which might affect the safety assessment of the authorised 
substance  in  relation  to  human  health.  If  necessary,  the  Authority  shall  then  review  the 
assessment. 

When  a  Member  State,  as  a  result  of  new  information  or  a  reassessment  of  existing 
information has detailed grounds for concluding that the use of a material or article endangers 
human  health,  although  it  complies  with  the  relevant  specific  measures,  it  may  temporarily 
suspend or restrict application of the provisions in question within its territory.  

Consequently,  the  requirements  and  mechanisms  contained  in  Framework  Regulation  (EC) 
No  1935/2004  allow  risks  associated  with  nanomaterials  to  be  dealt  with  in  an  appropriate 
way.  

3.8.4.  Food additives 

Directive 89/107/EEC on food additives authorized for use in foodstuffs intended for human 
consumption43  covers  substances  added  to  food  for  a  “technological  purpose  in  the 
manufacture,  processing,  preparation,  treatment,  packaging,  transport  or  storage  of  such 
food". A food additive is not normally consumed as a food itself and not normally used as a 
characteristic ingredient of food; however, its intentional addition to food may result in it or 
its by-products becoming directly or indirectly a component of such food. 

The  only  substances  which  may  be  used  as  food  additives  are  those  included  in  the 
Community lists and then only under the conditions of use mentioned in those lists. 

Inclusion of additives on the Community lists occurs after an opinion of the European Food 
Safety  Authority  and  is  based  on  criteria  indicated  in  the  Directive.  Thus,  additives  can  be 
approved only provided that: 

•  they present no hazard to the health of the consumer at the level of use proposed, so far as 

can be judged on the scientific evidence available, 

•  there is a reasonable technological need and 

•  they do not mislead the consumer  

In order to assess the possible harmful effects, a food additive or derivatives thereof, will have 
been  subject  of  appropriate  toxicological  testing  and  evaluation,  which  must  also  take  into 
account,  for  example,  any  cumulative,  synergistic  or  potentiating  effect  of  its  use  and  the 
phenomenon of human intolerance to substances foreign to the body.  

All  food  additives  must  be  kept  under  continuous  observation  and  must  be  re-evaluated 
whenever necessary in the light of changing conditions of use and new scientific information. 
For  example  if  they  are  prepared  by  production  methods  or  starting  materials  significantly 
different from those included in the safety assessment they should be submitted for a further 
evaluation with emphasis on the new process or starting materials. Approval of food additives 
must take into account any acceptable daily intake, or equivalent assessment, established for 
the food additive and the probable daily intake of it from all sources.  

43 

Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member 
States concerning food additives authorized for use in foodstuffs intended for human consumption; OJ 
L 40, 11.2.1989 

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The Directives thus contains the necessary provisions to take into consideration the potential 
benefits and safety issues related to the use of nanomaterials or nanotechnologies.  

3.8.5.  Food supplements 

Directive  2002/46/EC  on  food  supplements  provides  with  a  definition  of  food  supplements, 
provides  for  appropriate  specific  rules  on  labelling,  presentation  and  advertising  of  these 
products and regulates their compositions in vitamins and minerals. 

Positive  lists  of  vitamins  and  minerals  and  of  their  sources  that  can  be  used  in  food 
supplements are given in the Annexes of the Directive. These sources have been evaluated for 
their safety and bioavailability. 

Prior to the authorisation and inclusion in the positive lists every vitamin and mineral and/or 
every  source  need  to  undergo  a  safety  assessment  carried  out  by  the  European  Food  Safety 
Authority  (EFSA).  EFSA  has  issued  guidelines  on  how  to  present  an  application  for 
evaluation of vitamins and minerals and of their sources. These guidelines could need to be 
adapted  to  require  identifications  of  possible  compounds  present  in  “nano  form”.  The  risk 
assessment would need to be adapted to take into account specific risk arising from the use of 
substances in “nano-form”, if any 

When  a  Member  State,  as  a  result  of  new  information  or  a  reassessment  of  existing 
information has detailed grounds for concluding that a product ,although it complies with the 
Directive, endangers human health, it may temporarily suspend or restrict application of the 
provisions  in  question  within  its  territory.  On  this  basis  the  Commission  may  consider  the 
necessary amendment to the Directive. 

Consequently,  the  requirements  and  mechanisms  contained  in  Framework  Directive 
2002/46/EC allow risks associated with the use of vitamins and minerals in "nano" forms to 
be dealt with in an appropriate way. 

However,  explicit  information  on  the  particle  form/production  process  of  vitamins  and 
minerals could be envisaged to be explicitly requested and scrutinised to in a future revision 
of Directive 2002/46/EC. 

Regulation  (EC)  1925/2006  on  the  addition  of  vitamins  and  minerals  and  of  certain  other 
substances  to  foods  lists  in  Annex  I  the  vitamins  and  minerals  that  may  be  added  and  in 
Annex  II  the  sources  of  vitamins  and  minerals  that  may  be  used  and  provides  for  certain 
restrictions regarding the foods to which vitamins and minerals may be added. Furthermore, it 
also  provides  the  basis  for  scrutinising  and,  where  necessary,  regulating  the  addition  of 
substances with nutritional or physiological effect, other than vitamins and minerals, to foods. 

Prior to the authorisation and inclusion in the positive lists every vitamin and mineral and/or 
every  source  need  to  undergo  a  safety  assessment  carried  out  by  the  European  Food  Safety 
Authority  (EFSA).  EFSA  has  issued  guidelines  on  how  to  present  an  application  for 
evaluation of vitamins and minerals and of their sources. These guidelines could need to be 
adapted  to  require  identifications  of  possible  compounds  present  in  “nano  form”.  The  risk 
assessment would need to be adapted to take into account specific risk arising from the use of 
substances in “nano-form”, if any. 

Furthermore,  the  Regulation  foresees  a  procedure  allowing,  under  certain  conditions,  to 
scrutinize and eventually restrict or forbid the use in foods of substances other than vitamins 
and minerals with a nutritional or physiological effect. 

This  procedure  can  be  followed  where  a  substance  other  than  vitamins  or  minerals,  or  an 
ingredient containing a substance other than vitamins or minerals, is added to foods or used in 

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the  manufacture  of  foods  under  conditions  that  would  result  in  the  ingestion  of  amounts  of 
this  substance  greatly  exceeding  those  reasonably  expected  to  be  ingested  under  normal 
conditions of consumption of a balanced and varied diet and/or would otherwise represent a 
potential risk to consumers. 

Therefore, it could be envisaged that a substance produced in "nano" form providing with an 
increased bioavailability, could be subject of this procedure. 

The  Regulation  contains  the  necessary  provisions  to  take  into  account  the  potential  safety 
issues  related  to  the  use  of  nanotechnologies.  However,  explicit  information  on  the  particle 
form/production  process  of  vitamins  and  minerals  could  be  envisaged  to  be  explicitly 
requested and scrutinised to in a future revision of Regulation (EC) 1925/2006. 

Dietetic  foods  are  regulated  by  Council  Directive  89/398/EEC  on  the  approximation  of  the 
laws  of  the  Member  States  relating  to  foodstuffs  intended  for  particular  nutritional  uses 
(framework Directive).  

Directive  89/398/EEC  foresees  the  adoption  of  specific  Commission  directives  for  different 
groups of foods for particular nutritional uses which are listed in its Annex. 

The  nutritional  substances  that  can  be  added  to  dietetic  foods  are  controlled  either  through 
positive  lists  included  in  the  specific  Commission  directives  or  by  Commission  Directive 
2001/15/EC. Directive 2001/15/EC includes a positive list of vitamins preparations, mineral 
substances, and nitrogen containing substances for use in foods for particular nutritional uses, 
except products infant formulae, follow-on formulae, processed cereal-based foods and other 
baby foods intended for infants and young children which have their own lists in the specific 
legislation.  

Prior  to  the  authorisation  and  inclusion  in  the  positive  lists  every  new  substance  need  to 
undergo  a  safety  assessment  carried  out  by  the  European  Food  Safety  Authority  (EFSA). 
EFSA  has  issued  guidelines  on  how  to  present  an  application  for  evaluation  of  these 
substances.  These  guidelines  could  need  to  be  updated  to  require  identifications  of  possible 
compounds in "nano form". 

Directive 89/398/EEC provides for the following: when a Member State, as a result of new 
information or a reassessment of existing information has detailed grounds for concluding that 
a  foodstuff  intended  for  particular  nutritional  use,  although  it  complies  with  the  Directive 
89/398/EEC  and/or  the  specific  directives,  endangers  human  health,  it  may  temporarily 
suspend or restrict application of the provisions in question within its territory. On this basis 
the Commission may consider the necessary amendment to the Directive(s). 

Directive  89/398/EEC  contains  the  necessary  provisions  to  take  into  account  the  potential 
safety  issues  related  to  the  use  of  nanotechnologies.  However,  explicit  information  on  the 
particle  form/production  process  of  the  substances  could  be  envisaged  in  the  revision  of 
Directive 89/398/EEC (ongoing). 

3.8.6.  Feed legislation 

As mentioned above, within the context of food law, also the general requirements for feed, 
including its production and use where that feed is intended for food-producing animals, are 
included. Specific requirements in relation to feedingstuffs have been laid down in a series of 
directives or regulations, such as  

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•  Directive 96/25/EC on feed materials, i.e. raw or processed materials intended for use as 
animal  feed  or  for  manufacturing  compound  feedingstuffs.44  The  Annex  to  Directive 
96/25/EC gives a non-exhaustive list of the feed materials that need to be identified on the 
label.  This  Annex  has  been  entirely  replaced  and  updated  to  technical  and  scientific 
progress by Commission Directive 98/67/EC 

•  Directive  79/373/EC  on  the  marketing  of  compound  feedingstuffs,  i.e.  mixtures  of  feed 
materials, which may contain additives for use as animal feed in the form of complete or 
complementary feedingstuffs.45 

Directives  96/25/EC  and  79/373/EC  contain  provisions  of  a  rather  general  nature.  Feed 
materials and feedingstuffs must be of sound, genuine and of merchantable quality. They must 
not represent any danger to animal or human health or to the environment and must not be put 
into  circulation  in  a  manner  that  is  liable  to  mislead.  Relevant  is  however  article  11  of 
Directive 96/25, according to which the Commission, in agreement with Member States, and 
with  information  of  the  European  Parliament,  can  draw  up  a  list  of  materials  whose 
circulation or use for animal nutrition purposes is restricted or prohibited in order to ensure 
their  compliance  with  these  generic  requirements.  On  this  basis,  any  risk  associated  with 
nanomaterials could be controlled. 

Directive 82/471/EEC concerning “bio-proteins” produced by certain technical processes e.g. 
fermentation,  lays  down  the  provisions  for  the  circulation  of  these  technological  products.46 
Risk  management  is  done  by  maintaining  a  positive  list  (e.g.  what  is  safe  is  on  the  list,  all 
other who are not evaluated are forbidden). 

Regulation  1831/2003  on  additives  for  use  in  animal  nutrition  establishes  more  detailed 
requirements.  Additives  can  only  be  placed  on  the  marker,  processed  or  used  as  a  feed 
additive  if  they  have  been  authorized,  conditions  for  use  have  been  respected  and  labelling 
and packaging requirement are being met.  

One of the conditions for authorisations is the absence of an adverse effect on animal health, 
human  health  or  the  environment.  Applications  for  authorisation  will  be  assessed  by  the 
European  Food  Safety  Authority,  on  the  basis  of  a  technical  documentation  that  contains, 
amongst others,  

•  a description of the method of production, manufacturing . and intended uses of the feed 
additive, of the method of analysis of the additive in feed according to its intended use and, 
where appropriate, of the method of analysis for the determination of the level of residues 
of the feed additive, or its metabolites, in food;  

•  a copy of the studies which have been carried out and any other material which is available 

to demonstrate that the feed additive satisfies the criteria.  

Specific guidelines have to be laid down for the authorisation of additives, if need be for each 
category of them defined in the regulation.  

44 

45 

46 

Council  Directive  96/25/EC  of  29  April  1996  on  the  circulation  and  use  of  feed  materials,  amending 
Directives 70/524/EEC, 7463/EEC, 82/471/ EEC and 93/74/EEC and repealing Directive 77/101/EEC; 
OJ L 125, 23.5.1996 
Council Directive 79/373/EEC of 2 April 1979 on the circulation of compound feedingstuffs; OJ L 86, 
6.4.1979 
Council  Directive  82/471/EEC  of 30  June 1982  concerning  certain products used  in animal  nutrition; 
OJ L 213, 21.7.1982 

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A  decision  on  authorisation  is  taken  by  the  European  Commission  under  the  regulatory 
committee  procedure  defined  by  Article  5  of  Council  Decision  1999/468,  which  includes,  a 
requirement  to  inform  the  European  Parliament.  Authorisations  can  impose  specific 
conditions  or  restrictions  in  relation  to  handling,  post  market  monitoring  and  use. 
Authorisations can be modified, suspended or withdrawn at any stage when the conditions for 
satisfying the Regulation are not no longer met.  

The  regulation  contains  a  clause  on  confidentiality  of  data  submitted  by  the  applicant. 
However, certain information cannot be confidential, such as physico-chemical and biological 
characteristics of the feed additive, the conclusions of the study results on effects of the feed 
additive  on  human  and  animal  health  and  on  the  environment,  the  conclusions  of  the  study 
results  on  effects  of  the  feed  additive  on  the  characteristics  of  animal  products  and  its 
nutritional  properties,  or  methods  for  detection  and  identification  of  the  feed  additive  and, 
where applicable, monitoring requirements and a summary of the results of the monitoring. 

Regulation 1831/2003 provides that EFSA shall apply the principles of Regulation (EC) No 
1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public 
access  to  European  Parliament,  Council  and  Commission  documents  when  handling 
applications  for  access  to  documents  held  by  the  Authority.  As  regards  data  that  can  be 
considered  as  confidential,  Member  States,  the  Commission  and  the  Authority  will 
nevertheless provide access where it is appropriate for such information to be made public in 
order to protect human health, animal health or the environment. 

Intervention  mechanisms  in  relation  to  feedingstuff  are  established  by  Regulation  178/2002 
laying down the general principles and requirements of food law, establishing the European 
Food  Safety  Authority  (EFSA)  and  laying  down  procedures  in  the  Regulation  882/2004/EC 
on official controls on matters of food safety and feeding Council Directive 95/53/EC .47 

Consumer products not covered by specific regulation. 

3.9. 
Directive 2001/95/EC on general product safety48 (GPSD) covers any product – including in 
the  context  of  providing  a  service  –  which  is  intended  for  consumers  or  likely,  under 
reasonably foreseeable conditions, to be used by consumers even if not intended for them, and 
is  supplied  or  made  available,  whether  for  consideration  on  or  not,  in  the  course  of  a 
commercial activity, and whether new, used or reconditioned. 

To  the  extent  that  regulatory  requirements  have  been  established  in  product-specific 
regulation,  these  latter  requirements  will  apply  (e.g.  for  medicinal  products,  cosmetics,  
chemicals…..), complemented by the requirements of the GPSD that are not covered by the 
product-specific regulation. 

According to the Directive, manufacturers can only place on the market “safe” products, i.e. 
products which under normal or foreseeable conditions of use, do not present any risk or only 
the  minimum  risks  compatible  with  the  product’s  use,  considered  to  be  acceptable  and 
consistent  with  a  high  level  protection  for  the  safety  and  health  of  persons,  taking  into 
consideration certain points such as the characteristics and presentation of the product. 

The assessment whether a  product  is  safe, is based on  a number  of factors, such as product 
legislation, standards, Commission recommendations, codes of good practice, state of the art 
and  reasonable  consumer  expectations.  Products  will  be  “deemed  safe”  when  they  comply 

47 

48 

Council  Directive  95/53/EC  of  25October  1995  fixing  the  principles  governing  the  organization  of 
official inspections in the field of animal nutrition ; OJ L 265, 8.11.1995 
Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general 
product safety; OJ L 11, 15.1.2002 

EN 

27 

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with  non  harmonised  national  regulatory  provisions49  and,  under  particular  conditions, 
European standards  

Attention  is  also  to  be  drawn  to  the  obligation  of  producers  to  provide  consumers  with  the 
relevant information to enable them to assess the risks inherent in a product where such risks 
are not immediately obvious without adequate warnings and to take precautions against those 
risks. 

The Directive creates an obligation for producers to monitor their products enabling them to 
be  informed  of  risks  which  products  might  pose  and  to  choose  “corrective”  action.  Where 
producers  know  or  ought  to  know  that  a  product  poses  risks  incompatible  with  the  general 
safety  requirements,  they  must  inform  so  the  national  competent  authorities,  and  cooperate 
with these latter. 

Within  the  scope  of  this  Directive,  obligations  placed  on  producers  are  very  wide,  obliging 
them “de facto” to carry out a risk assessment commensurate with the potential risks inherent 
to  products  and  to  technologies  employed.  In  this  respect,  there  is  no  exclusion  regarding 
nano-technologies or nano products.  

Where  producers  place  consumer  products  on  the  market  that  may  present  risks  associated 
with nanotechnologies,  they  must  take care of such risks. Where documents on the basis of 
which  products  are  “deemed  to  comply”  do  not  cover  nanotechnology  related  aspects,  the 
producer  will  remain  under  an  obligation  to  document  and  justify  the  use  of  technologies, 
components, etc. that may present nanotechnology related risks.  

The  mechanisms  foreseen  in  the  GPSD  allow  risks  in  relation  to  products  containing  or 
consisting of nanomaterials and nanotechnologies to be taken into account. In the absence of 
documents,  in  particular  European  standards,  assessment  will  take  place  on  a  case-by-case 
basis.  

4. 

ENVIRONMENTAL LEGISLATION 

Integrated Pollution Prevention and Control (IPPC)  

4.1. 
Council Directive 2008/1/EC concerning integrated pollution prevention and control50 sets a 
general  framework  for  integrated  pollution  prevention  and  control.  Particular  industrial 
activities  can  only  operate  if  the  operator  holds  a  permit  that  implements  certain  basic 
obligations in order to prevent, or where this is not practicable, to reduce emissions in the air, 
water  and  land,  including  measures  concerning  waste.  National  competent  authorities  can 
only give such a permit if, inter alia, all the appropriate preventive measures are taken against 
pollution,  no  significant  pollution  is  caused,  and  waste  production  is  avoided,  and  where 
waste is produced, it is recovered or disposed of while avoiding or reducing any impact on the 
environment.  

In their application for a permit, operators must provide a number of data, including the nature 
and quantities of foreseeable emissions from the installation in each environmental medium as 
well  as  the  identification  of  significant  effects  of  the  emissions  of  the  environment,  and  the 
technology and other techniques for preventing or reducing emissions from the installation.  

In  order  to  implement  its  provisions,  the  Directive  promotes  application  of  best  available 
techniques. In order to facilitate a consistent implementation of the Directive, the Commission 

49 
50 

In case of harmonisation, Community rules will be applied 
Council  Directive  2008/1/EC  of  15  January  2008  concerning  integrated  pollution  prevention  and 
control; OJ L 24, 29.1.2008 

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28 

   EN 

 
                                                 
has  produced  a  series  of  so-called  BAT  reference  (BREF)  documents,  which  constitute  the 
main guidance for implementation. 

The  IPPC  Directive  requires  that  permit  conditions  include  Emission  Limit  Values  (ELVs) 
based on BAT to control releases of polluting substances. The Directive does not specify what 
form  such  ELVs  must  take  –  conventionally  they  are  in  the  form  of  concentrations  (e.g. 
mg/m3),  but  in  principle  they  could  be  established  in  other  ways,  and  could,  therefore, 
conceivably be written specifically to address any concerns about releases of nanomaterials.  

Practical  IPPC  implementation  presently  tends  to  focus  mostly  on  conventional  pollutants 
(sulphur, nitrogen, dust, halogens, heavy metals, etc) emitted in conventional form, reflecting 
the  long-established  need  to  control  such  emissions  and  the  corresponding  expertise  of  the 
competent authorities concerned.  

Relying on implementation of the IPPC Directive as an effective regulatory tool in relation to 
nanomaterials would therefore require attention to be given to the assessment of the releases 
of  such  materials  from  IPPC  installations  (noting  that  some  such  releases  may  be  from 
industrial  installations  falling  outside  the  scope  of  the  IPPC  Directive),  their  impacts,  and 
control techniques that may be considered as BAT.  

The  capacity  of  competent  authorities  to  apply,  monitor  and  enforce  compliance  with 
emission limit values or other types of permit conditions relating to nanomaterials would also 
need to be established. 

4.2.  Major-accidents, Seveso II Directive 
Directive  96/82  on  the  control  of  major-accident  hazards  involving  dangerous  substances  51 
applies to establishments where dangerous substances are present above certain quantities (or 
thresholds) The dangerous substances are certain named substances or groups of substances, 
plus  all  dangerous  substances  and  preparations  that  are  classified  under  Directives 
67/548/EEC  or  Directive  1999/45/EC  as  very  toxic,  toxic,  oxidising,  explosive,  flammable, 
dangerous  for  the  environment  or  any  other  classification  in  combination  with  certain  risk 
phrases.  The  quantity  thresholds  vary  according  to  the  nature  and  degree  of  hazard  and  the 
level  of  controls  imposed.  For  example,  the  thresholds  for  toxic  substances  are  50  tons  and 
200 tons respectively.  

The  Directive  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. To this 
end,  operators  must  notify  their  activities  to  national  authorities.  They  must  draw  up  and 
implement  a  major-accident  prevention  policy  based  on  principles  defined  in  the  Directive. 
Operators  must  further  present,  and  regularly  review,  safety  reports  showing  that  the 
directive’s objectives on accident prevention are being met. Similarly, operators must draw up 
emergency  plans.  The  Directive  further  contains  a  number  of  provisions  in  relation  to 
provision of information, inspection, information on safety measures, land-use planning and 
“domino  effect”,  i.e.  an  obligation  for  authorities  to  identify  establishments  or  groups  of 
establishments where the likelihood and the possibility or consequences of a major accident 
may be increased because of the location and the proximity of such establishments, and to set 
up an exchange of information and cooperation on public information  

The major accident hazard potential of nanomaterials will depend primarily on the magnitude 
of  any  potential  effects  on  human  health  or  the  environment.  Due  to  the  atypical 

51 

Council  Directive  96/82/EC  of  9  December  1996  on  the  control  of  major-accident  hazards  involving 
dangerous substances; OJ L 10, 14.1.1997, as amended 

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29 

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physicochemical and unknown ecotoxicological properties of nanomaterials, it is possible that 
small quantities could have a significant impact on human health and the environment due to 
accidental  release.  If  in  the  future  certain  nanomaterials  are  found  to  demonstrate  a  major 
accident  hazard,  then  it  may  be  possible  to  categorise  these  materials,  together  with 
appropriate thresholds, in the context of the Seveso II Directive.  

4.3.  Water 

Directive 2000/60 of 23 October 2000 establishes a framework for Community action in the 
field of water policy52. As the provisions of this Directive are or progressively become fully 
operational, corresponding provisions in existing directives will be phased out.  

The  Directive  sets  common  principles  and  an  overall  framework  for  action  throughout  the 
Community,  aiming  to  improve  the  aquatic  environment  and  to  progressively  reduce  the 
emissions  of  hazardous  substances  to  water.  Directive  2000/60  presents  an  integrated 
approach,  closely  related  to  a  wide  variety  of  EU  law  relevant  for  the  quality  of  water, 
particularly as regards the control of emissions.  

Member States are obliged to identify individual rivers basins, and to establish programmes of 
measures  for  such  basins.  The  Directive  specifies  the  environmental  objectives  thus  to  be 
attained  for  surface  water,  ground  water  and  for  protected  areas.  Based  on  technical 
specifications  set  out  in  the  Directive,  Member  States  must  carry  out  for  each  basin  an 
analysis of its characteristics, a review of the impact of human activity of the status of surface 
and ground waters, and an economic analysis of water use. Programmes of measures and of 
quality assessments of water of are subject of regular review and monitoring. Discharges into 
surface  water  are  to  be  controlled  to  the  combined  approach  of  controlling  emission  and 
achieving quality objectives or quality standards.  

At Community level, the Directive foresees the adoption by the European Parliament and the 
Council  of  specific  measures  concerning  individual  (groups  of)  pollutants  presenting  a 
significant  risk  to  or  via  the  aquatic  environment,  based  on  priorities  proposed  by  the 
Commission.  

Priority substances will be subject of a series of measures, to be proposed by the Commission: 

•  the  progressive  reduction  of  discharges,  emissions  and  losses  of  the  substances,  and  the 

cessation or phasing out of discharges, emissions and losses.  

•  quality standards applicable in surface water, sediments or biota 

•  emission controls for point sources and environmental quality standards 

Priorities  are  based  on  a  risk  assessment  carried  out  under  chemicals  regulation,  the  plant 
protection products directive and the directive on biocidal products, or a targeted risk-based 
assessment focusing solely on aquatic ecotoxicology and on human toxicology via the aquatic 
environment.  
A list of 33 priority substances has been established in 2001.53  
Quality objectives were proposed at the end of 2006.54 As regards emission standards, a large 
number  of  standards  has  been  proposed,  or  is  available,  in  related  EU  legislation,  a  list  of 

52 

53 

Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a 
framework for Community action in the field of water policy OJ L 327, 22.12.2000 
Decision  2455/2001/EC  of  the  European  Parliament  and  of  the  Council  of  20  November  2001 
establishing  the  list  of  priority  substances  in  the  field  of  water  policy  and  amending  Directive 
2000/60/EC 15.12.2001; OJ L 331, 15.12.2001 

EN 

30 

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which is given in Annexes 5 and 6 of the Impact Assessment, accompanying the proposal for 
the Framework Water Directive55 

As regards groundwater, the Directive foresees the adoption by the European Parliament and 
the  Council  of  specific  measures  achieving  the  objective  of  good  groundwater  chemical 
status. Measures will include criteria for (a) assessing good groundwater chemical status, and 
(b)  the  identification  of  significant  and  sustained  upward  trends  and  for  the  definition  of 
starting points for trend reversals. Such measures were adopted on 12 December 200656 

Depending on their properties, nanomaterials could fall into categories of pollutants identified 
by  the  Directive  (Annex  VIII  and  list  of  Priority  Substances),  because  either  they  possess 
carcinogenic or mutagenic properties which may affect steriodogenic, thyroid, reproduction or 
other endocrine-related functions in or via the aquatic environment, or qualify as metals and 
their  compounds,  albeit  other  pollutant  categories  may  also  be  concerned  (e.g. 
bioaccumulative organic toxic substances).  

National  monitoring  programmes  to  evaluate  deterioration  risks  of  water  bodies  and  their 
actual chemical status and assessment of the efficiency of measures, monitoring will have to 
focus on a wide array of pollutants, including those arising from discharges of nanoproducts 
into the environment.  

Future  European  (Environment)  Quality  Standards  (EQS)  are  currently  proposed  by  the 
Commission related to priority substances in the context of a daughter directive expected to 
be  adopted  by  the  end  of  2008.  These  EQS  could  have  an  effect  on  the  way  emissions  of 
nanoparticles  will  be  tackled.  This  concerns  not  only  direct  emissions  to  the  water 
environment, but also particles that are absorbed onto suspended matters and/or deposited in 
sediments, this affecting filter-feeding and other biological organisms. A specific issue would 
be  to  investigate  how  the  presence  of  both  bulk  chemicals  and  their  nanoforms  would  be 
measured together to make up a concentration in media.  

In addition, Member States will have to establish groundwater quality standards for pollutants 
representing  a  risk  to  groundwater  (this  may  include  nanoparticles)  under  the  new 
Groundwater Directive developed under the WFD.  

4.4.  Waste 

Community  regulation  as  far  as  relevant  for  nanomaterials  and  nanotechnologies  can  be 
presented  under  the  general  framework  directives  on  waste  and  directives  on  specific  waste 
streams and specific waste treatment techniques. 
Directive 2006/12/EC on waste57 sets the general framework for waste policies. It provides 
the basic definitions for waste legislation and provides that Member States take the necessary 
measures to ensure that waste treatment does not adversely affect health and the environment. 
The  Directive  furthermore  sets  rules  regarding  the  setting  up  of  administrative  structures, 
planning,  implementation,  a  system  of  permits  for  installations  or  undertakings  treating, 
storing  recovering  or  disposing  waste  on  their  behalf  or  on  behalf  of  third  parties,  regular 

54 

55 
56 

57 

Proposal  for  a  Directive  of  the  European  Parliament  and  of  the  Council  on  environmental  quality 
standards  in  the  field  of  water  policy  and  amending  Directive  2000/60/EC  {COM(2006)  398  final} 
{SEC(2006) 947} 
http://ec.europa.eu/environment/water/water-dangersub/pdf/sec_2006_947_en.pdf, pp 51-59 
Directive 2006/118 EC on the protection of groundwater against pollution and deterioration; OJ L 372 
of 27 December 2006. 
Directive  2006/12/EC  of  the  European  Parliament  and  of  the  European  Council  of  5  April  2006  on 
waste; OJ L 114 of 27 4 2006 

EN 

31 

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inspections, etc. It also instructs Member States to adopt policies to encourage the prevention, 
recovery (including the reuse of waste, its recycling or use as a fuel) and sound disposal. 
Directive  91/689/EEC  on  hazardous  waste58  defines  which  wastes  are  hazardous  and  lays 
down  stricter  provisions  regarding  waste  that  is  to  be  considered  as  hazardous.  Hazardous 
waste must have one or more of the properties listed in Annex III to the Directive and feature 
on the European Waste List as hazardous. The list combining hazardous and non hazardous 
entries  was  established  by  Decision  2000/532/EC.  The  Directive  concerns  issues  such  as 
records  and  identification  of  waste,  prohibition  to  mix  different  categories  of  waste, 
separation  of  hazardous  waste,  permitting  of  facilities  treating  hazardous  waste,  packaging 
and  labelling,  the  establishment  of  national  plans  for  the  management  of  waste  and  public 
access to such plans, emergency measures and reporting to the Commission, Parliament and 
Council.  

The classification procedure and the specific R-numbers laid down in the Waste list Decision 
2000/532/EC refers to Directive 67/548/EEC on the classification, packaging and labelling of 
dangerous  substances  and  its  subsequent  amendments.  Both  Annex  III  to  the  Hazardous 
Waste  Directive  and  the  Waste  List  may  be  amended  through  the  regulatory  Comitology 
procedure, for example to add hazardous properties and/or to add wastes to the list.  

On this basis, wastes could be considered as hazardous if they contain relevant quantities of 
nanomaterials,  provided  these  materials  are  classified  as  dangerous  under  Directive 
67/548/EEC.  Relevant  information  allowing  qualifying  waste  as  hazardous  could  be  made 
better available in particular through the implementation of REACH. 

It  if  was  to  be  established  that  nanomaterials  cause  adverse  effects  on  the  environment  or 
human health that are also listed in Annex III the waste can be classified as hazardous. Even if 
it was to be concluded that a new criterion is needed, this can be accommodated by amending 
the list of hazardous properties. On that basis, Member States would have a basis to classify 
the nanomaterials becoming a waste as hazardous.  

Specific legislation has been adopted to deal with particular waste streams, such as end-of-
life  electrical  and  electronic  equipment59,  vehicles60,  packaging  and  packaging  materials61, 

58 
59 

60 

61 

Council Directive 91/689/EEC of 12 December 1991 on hazardous waste; OJ L 377 , 31/12/1991 
Directive  2002/95/EC  of  the  European  Parliament  and  of  the  Council  of  27  January  2003  on  the 
restriction of the use of certain hazardous substances in electrical and electronic equipment ; OJ L 37, 
13/02/2003 
Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of 
life vehicles; OJ L 269 , 21/10/2000 
Directive  94/62/EC  of  the  European  Parliament  and  the  Council  of  20  December  1994  on  packaging 
and packaging waste; OJ L 365, 31.12.1994 

EN 

32 

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batteries62, titanium dioxide63 and to deal with specific waste treatment processes, such as 
incineration64 and landfill.65 

None  of  these  Directives  address  specifically  nanomaterials  and  their  risks.  However, 
directives dealing with specific end-of-life products lay down (i) requirements in relation to 
the  collection,  recycling/re-use,  recovery  targets,  (ii)  as  minimum  mandatory  steps  for  the 
dismantling  of  the  end-of-life  products,  and  (iii)  restrict  or  prohibit  the  use  of  specific 
substances when alternatives are available. The latter relate mainly to heavy metals and some 
organic  substance.  The  dismantling  requirements  and  substance  restrictions  are  regularly 
reviewed  through  the  regulatory  committee  procedure.  It  is  possible  to  review  the  list  of 
exemptions  from  the  substance  bans  by  adding  new  exemptions  or  removing  the  existing 
ones, depending on the technical and scientific progress in the availability of substitutes. For 
packaging,  it  is  possible  to  allow  certain  packaging  types  to  exceed  the  maximum 
concentration values for heavy metals specified in the Directive.  

In  summary,  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 products that may contain nanomaterials whilst not including 
specific provisions addressing the risks of nanomaterials contained in these waste products. If 
the need for more specific provisions were established, the Commission could envisage taking 
appropriate action. Similarly, action can be taken by Member States in implementing current 
provisions in the framework of national policies. 

The classification of waste from nanomaterials as hazardous waste would trigger a particular 
set of provisions to reduce the environmental and health risks displayed by the materials at the 
risk phase. However, the central issue lies in the lack of understanding of the potential risks 
displayed  by  nanomaterials  at  the  waste  stage.  A  better  understanding  of  the  fate  of 
nanomaterials contained in articles throughout their lifecycle is needed. Currently there is not 
a  full  understanding  whether  nanoparticles  are  released  under  use  of  the  article,  or  if  they 
remain in the waste phase, and if so, in what form. The future implementation of the REACH 
Regulation should generate useful information. 

4.5. 

Air quality 

EU  legislation  on  air  quality,  comprises  the  framework  Directive  96/62/EC  on  ambient  air 
quality  assessment  and  management,66  and  the  following  daughter  Directives  1999/30/EC 
relating  to  limit  values  for  sulphur  dioxide,  nitrogen  dioxide  and  oxides  of  nitrogen, 

62 

63 

64 

65 
66 

Directive  2006/66/EC  of  the  European  Parliament  and  the  Council  of  6  September  2006  on  batteries 
and accumulators and waste batteries and accumulators and repealing Directive 91/157/EEC; OJ 
Council Directive 78/176/EEC of 20 February 1978 on waste from the titanium dioxide industry, OJ L 
54,  25.2.1978;  Council  Directive  82/883  of  3  December  1982  on  procedures  for  the  surveillance  and 
monitoring  of  environments  concerned  by  waste  from  the  titanium  dioxide  industry,  OJ  L  378  of 
31.12.1982, and Council Directive 92/112/EEC of 15 December 1992 on procedures for harmonizing 
the  programmes  for  the  reduction  and  eventual  elimination  of  pollution  caused  by  waste  from  the 
titanium dioxide industry; OJ L409 of 31 12 1992; under review in the context of the better regulation 
exercise 
Directive  2001/80/EC  of  the  European  Parliament  and  of  the  Council  of  23  October  2001  on  the 
limitation  of  emissions  of  certain  pollutants  into  the  air  from  large  combustion  plants;  OJ  L  309, 
27.11.2001 
Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste; OJ L 182 , 16/07/1999 
Council Directive 96/62/EC of 27 September 1996 on ambient air quality assessment and management; 
OJ L 296, 21.11.1996 

EN 

33 

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particulate matter and lead in ambient air67, Directive 2000/69/EC relating to limit values for 
benzene  and  carbon  monoxide  in  ambient  air,  Directive  68,  2002/3/EC  relating  to  ozone  in 
ambient  air69,  and  ambient  air70.  All  those  Directives,  except  Directive  2004/107/EC,  have 
been merged into a new Directive on ambient air and cleaner air for Europe71 which is due to 
enter into force in May 2008. 

Fuel  quality  is  regulated  through  Directive  98/70/EC  relating  to  the  quality  of  petrol  and 
diesel  fuels  and  amending  Directive  93/12/EC.  Directive  2005/33/EC  amending  Directive 
1999/32  as  regards  the  sulphur  content  of  marine  fuels  Emissions  of  air  pollutants  from 
mobile  sources  are  regulated  by  means  of  Directive  98/69/EC72  and  Regulation  (EC) 
715/200773  for  light-duty  vehicles,  Directive  2005/55/EC74  for  heavy-duty  vehicles,  and 
Directive 97/68/EC75 for non-road mobile machinery. 

Existing  EU  air  quality  legislation  does  not  contain  any  relevant  limit  values  and/or 
measurement  and  control  methods  suited  to  control  nanoparticles  in  ambient  air.  While 
embedded  in  the  particulate  matter  PM10  and  PM2.5,  the  metric  related  to  total  mass  is 
unsuitable  to  ultra-fine  particles.  Review  process  is  set  to  reconsider  the  objectives  and  the 
appropriate  PM  metric  by  2013.  Other  regulated  pollutants  such  as  heavy  metals  and  PAH 
may also exhibit quite different toxicity in combined exposure with the ultrafine particles. The 
legislation  on  Euro  5  (Regulation  (EC)  715/2007)  contains  provisions  to  set  limit  values  on 
the number count of particulate matter emissions. This has been motivated by concerns over 
the emissions of ultrafine particles (with a size of 100 nanometres or smaller) that are emitted 
by  diesel  engines.  The  proposal  on  new  Euro  VI  standards  for  heavy-duty  vehicles76  also 
contains such provisions. 

67 

68 

69 

70 

71 
72 

73 

74 

75 

76 

Council  Directive  1999/30/EC  of  22  April  1999  relating  to  limit  values  for  sulphur  dioxide,  nitrogen 
dioxide and oxides of nitrogen, particulate matter and lead in ambient air; OJ L 163, 29.6.1999. 
Directive 2000/69/EC of the European Parliament and of the Council of 16 November 2000 relating to 
limit values for benzene and carbon monoxide in ambient air; OJ L 313, 13.12.2000 
Directive  2002/3/EC  of  the  European  Parliament  and  of  the  Council  of  12  February  2002  relating  to 
ozone in ambient air; OJ L 67, 9.3.2002 
Directive 2004/107/EC of the European Parliament and of the Council of 15 December 2004 relating to 
arsenic,  cadmium,  mercury,  nickel  and  polycyclic  aromatic  hydrocarbons  in  ambient  air;  OJ  L  23, 
26.1.2005 
COM (2005) 447. 
Directive  98/69/EC  of  the  European  Parliament  and  of  the  Council  of  13  October  1998  relating  to 
measures  to  be  taken  against  air  pollution  by  emissions  from  motor  vehicles  and  amending  Council 
Directive 70/220/EEC. OJ L 350, 28.12.1998, p. 1–57  
Regulation (EC) No 715/2007 of the European Parliament and of the Council of 20 June 2007 on type 
approval  of  motor  vehicles  with  respect  to  emissions  from  light  passenger  and  commercial  vehicles 
(Euro 5 and Euro 6) and on access to vehicle repair and maintenance information; OJ L 171, 29.6.2007 
Directive  2005/55/EC  of  the  European  Parliament  and  of  the  Council  of  28  September  2005  on  the 
approximation  of  the  laws  of  the  Member  States  relating  to  the  measures  to  be  taken  against  the 
emission  of  gaseous  and  particulate  pollutants  from  compression-ignition  engines  for  use  in  vehicles, 
and  the  emission  of  gaseous  pollutants  from  positive-ignition  engines  fuelled  with  natural  gas  or 
liquefied petroleum gas for use in vehicles; OJ L 275, 20.10.2005 
Directive  97/68/EC  of  the  European  Parliament  and  of  the  Council  of  16  December  1997  on  the 
approximation of the laws of the Member States relating to measures against the emission of gaseous 
and  particulate  pollutants  from  internal  combustion  engines  to  be  installed  in  non-road  mobile 
machinery; OJ L 59, 27.2.1998 
Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  on  type-approval  of  motor 
vehicles  and  engines  with  respect  to  emissions  from  heavy  duty  vehicles  (Euro  VI)  and  on  access  to 
vehicle repair and maintenance information; COM(2007)851. 

EN 

34 

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4.6. 

Soil 

In  September  2006,  the  Commission  adopted  the  Thematic  Strategy  on  the  protection  of 
soil77, which includes a proposal for a Directive on soil protection78. This legislative proposal 
aims at establishing a framework for the protection of soil and the preservation of the capacity 
of  soil  to  perform  its  environmental,  economic  and  social  functions.  It  addresses,  inter  alia, 
the issues of the prevention of soil contamination and the management of contaminated sites.  

As regards the prevention of soil contamination, the proposal requires Member States "to take 
appropriate and proportionate measures to limit the intentional or unintentional introduction 
of dangerous substances on or in the soil, excluding those due to air deposition and those due 
to  a  natural  phenomenon  of  exceptional,  inevitable  and  irresistible  character,  in  order  to 
avoid accumulation that would hamper soil functions or give rise to significant risks to human 
health  or  the  environment."  For  the  purpose  of  this  Directive,  dangerous  substances  mean 
substances  or  preparations  classified  as  dangerous  within  the  meaning  of  Council  Directive 
67/548/EC79 and Directive 1999/45/EC80. 

The  first  reading  on  the  proposal  was  adopted  by  the  European  Parliament  in  November 
200681 

Environmental liability  

4.7. 
Directive  2004/35/EC82  establishes  a  framework  of  environmental  liability,  based  on  the 
"polluter-pays" principle, to prevent and remedy environmental damage. 

Under the terms of the Directive, environmental damage is defined as: 

•  direct  or  indirect  damage  to  the  aquatic  environment  covered  by  Directive  2000/60 

establishing a framework for Community action in the field of water policy ;  

•  direct or indirect damage to species and natural habitats identified by reference to Directive 
79/409 on the conservation of wild birds and Directive 92/43 on the conservation of natural 
habitats and of wild fauna and flora;  

•  direct  or  indirect  contamination  of  the  land  which  creates  a  significant  risk  to  human 

health.  

The  Directive  covers  environmental  damage  and  imminent  threat  of  damage  resulting  from 
occupational activities, where it is possible to establish a causal link between the damage and 
the activity in question.  

77 
78 
79 

80 

81 

82 

COM (2006) 231, 22.9.2006 
COM(2006) 232, 22.9.2006 
Council  Directive  67/548/EEC  of  27  June  1967  on  the  approximation  of  laws,  regulations  and 
administrative  provisions  relating  to  the  classification,  packaging  and  labelling  of  dangerous 
substances; OJ 196, 16.8.1967 
Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the 
approximation of the laws, regulations and administrative provisions of the Member States relating to 
the classification, packaging and labelling of dangerous preparations; OJ L 200, 30.7.1999  
European Parliament legislative resolution of 14 November 2007 on the proposal for a directive of the 
European  Parliament  and  of  the  Council  establishing  a  framework  for  the  protection  of  soil  and 
amending Directive 2004/35/EC (P6_TA(2007)0509). 
Directive  2004/35/EC  of  the  European  Parliament  and  of  the  Council  of  21  April  2004  on 
"environmental liability with regard to the prevention and remedying of environmental damage" ; OJ L 
143, 30.4.2004  

EN 

35 

   EN 

 
                                                 
The Directive distinguishes two complementary situations, each one governed by a different 
liability scheme: occupational activities specifically mentioned in Annex III to the Directive 
and any other occupational activities. 

The  first  liability  scheme  applies  to  the  dangerous  or  potentially  dangerous  occupational 
activities  listed  in  Annex  III  to  the  Directive.  These  include  activities  covered  by  Directive 
96/61  on  integrated  pollution  prevention  and  control  (IPPC),  activities  which  discharge 
polluting  substances  into  water  or  the  air,  installations  storing  or  producing  dangerous 
chemical  substances  (including  those  falling  under  Directive  96/82  on  the  control  of  major-
accident  hazards involving  dangerous  substances – Seveso II Directive), waste management 
activities (including landfills and incinerators) and activities concerning genetically modified 
organisms  and  micro-organisms.  Under  this  first  scheme,  the  operator  may  be  held 
responsible even if he is not at fault. There are, however, circumstances in which an operator 
may  not  be  required  to  bear  costs  under  the  Directive.  Of  particular  relevance  here  is  the 
circumstance  resulting  from  the  demonstration  by  the  operator  that  his  activity  was  not 
considered  likely  to  cause  environmental  damage  according  to  the  state  of  scientific  and 
technical  knowledge  at  the  time  when  the  activity  took  place.  It  should  be  noted,  however, 
that this exonerating circumstance is optional in that Member States are allowed – but are not 
required to – provide it in their national implementing legislation. 

The  second  liability  scheme  applies  to  all  occupational  activities  other  than  those  listed  in 
Annex III to the Directive, but only where there is damage, or imminent threat of damage, to 
protected species or natural habitats. In this case, the operator will be held liable only if he is 
at fault or negligent. 

Operators whose activity involves the use of nanotechnology and/or nanomaterials could be 
held liable under the Directive as and when the various conditions set out therein are met. 

The  operator  liable  under  the  Directive  must  bear  the  cost  of  the  necessary  preventive  or 
remedial measures. He will do so either directly or indirectly: 

•  In  the  first  case,  the  operator  pays  for  the  measures  he  takes  himself  or  he  entrusts  a 

specialised undertaking to take them on his behalf. 

•  In  the  second  situation,  where  a  competent  authority  has  acted,  itself  or  through  a 
specialised undertaking, in the place of the liable operator, that authority shall recover the 
costs it has incurred from the operator. 

Environmental damage may be remedied in different ways depending on the type of damage 
irrespective to chemicals or nanomaterials: 

•  for  damage  affecting  the  land,  the  Directive  requires  that  the  land  concerned  be 
decontaminated  until  there  is  no  longer  any  significant  risk  of  adverse  effect  on  human 
health;  

•  for damage affecting waters or protected species and natural habitats, and in addition to the 
removal  of  any  significant  risk  for  human  health,  the  Directive  aims  at  restoring  the 
environment  to  its  baseline  condition.  To  that  effect,  measures  to  restore,  rehabilitate  or 
replace  damaged  natural  resources  and/or  impaired  services,  or  to  provide  an  equivalent 
alternative to those resources or services should be taken. 

EN 

36 

   EN 

 
Research needed to support legislative work in the field of 
environment, health and safety 

1. 

MEASUREMENT  METHODS, 
CHARACTERISATION,  

REFERENCE  MATERIALS 

AND  MATERIALS 

•  Development  and  validation  of  reliable  methods  to  assess  relevant  properties 
(size,  shape,  surface  area  &  surface  chemistry),  particle  size  distribution  and 
physico-chemical and biological parameters of nanomaterials in various matrices 
and under various conditions. 

•  Reference  materials  and  certified 

the 
development,  validation  and  quality  assurance  of  these  characterisation  methods 
and exposure monitoring tests. 

reference  materials 

to  underpin 

•  Physicochemical  characterization  of  the  nanomaterials  (particle  size,  surface 
characteristics, substances on particle surface, particle charging, agglomeration & 
de-agglomeration  characteristics 
including  kinetics,  solubility,  formulation, 
explosion characteristics etc.). 

•  Research aiming to  support  the  development  of  a  uniform  nomenclature  system, 

for different types of nanomaterials.  

2. 

TEST METHODS FOR HUMAN HEALTH, SAFETY AND ENVIRONMENT AND REFERENCE 
MATERIALS 

•  Review, comparison and development of standard and validated test methods and 
test  schemes  for  nanomaterials.  Particular  attention  should  be  given  to  the 
development  of  non-animal  test  methods.  Comparison  of  in-vitro,  in-vivo  and  in 
silico test methods and models for materials.  

•  Review  of  existing  test  methods  and  where  appropriate  development  and 
validation  of  new  test  methods  to  detect  adverse  effects  from  nanomaterials  to 
human  health;  including  acute  and  chronic  toxicity  (oral,  inhalation,  dermal), 
toxicokinetics, CMR properties etc. 

•  Review  of  existing  test  methods  and  where  appropriate  development  and 
validation of new test methods to detect adverse effects from nanomaterials to the 
environment;  including  eco-toxicity  tests,  bioaccumulation,  persistence,  etc 
including bioavailability as well as their likely environmental/health impacts. 

3. 

EXPOSURE INFORMATION THROUGHOUT THE LIFE CYCLE OF NANOMATERIALS 

•  Uses and markets. Overview of potential sources of specific nanomaterials where 
environment 
of 
nanomaterials/nanoparticles predicted to be “high volume” or causing high exposure to 
humans or the environment. 

humans  may 

Identification 

exposed. 

be 

or 

•  Sampling,  measurement  and  monitoring  for  exposure  assessment  and  exposure 
mitigation  verification  linked  to  humans  and  various  environmental  species. 
Robust,  harmonised  and  reliable  sampling,  detection  and  monitoring  techniques 
for  nanomaterials  (also  for  routine  use  –  here:  in-situ,  on-line  &  at-line 

EN 

37 

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approaches). These should also be capable of distinguishing the background from 
the additionally manufactured nanomaterials. 

•  Identify  employment  sectors  in  which  nanomaterials  are  either  manufactured  or 
used  together  with  collecting  information  on  the  likely  number  of  persons  who 
work  with,  or  may  be  exposed,  to  them.  Also,  what  risk  management  measures 
have been identified as necessary and are they successful in practice in controlling 
any identified risks to workers health and safety 

4. 

RISK ASSESSMENT METHODS 

•  Review of existing methods for risk assessment and for life cycle analysis and, as 
appropriate,  application,  adjustment,  development  of  new  and  validation  of 
methods applicable to nanomaterials. 

•  Application,  adjustment,  development  of  new  and  validation  of  Life  Cycle 

Assessment.  

•  Environmental  fate  of  nanoparticles  (air,  water,  soil,  biota)  including  the 
application, adjustment and validation of existing models and as appropriate next 
to  the  eventual  development  and  validation  of  new  environmental  compartment 
and safety models.  

5. 

RISK MANAGEMENT  

•  For  worker  protection  purposes  -  determine  the  effectiveness  of  a  range  of  risk 
management measures including process enclosure, ventilation (general and local 
exhaust  ventilation,  filters  used  in  ventilation  systems  etc),  personal  protective 
equipment (PPE) including respiratory protective equipment (RPE) and gloves. 

6. 

NETWORKING AND INFRASTRUCTURE ASPECTS 

•  Networking of existing and establishment of new networks and infrastructures to 
ensure  a  cost-effective  and  time-efficient  examination  of  health,  safety,  and 
environmental aspects of nanomaterials throughout Europe and linking effectively 
with other international related activities.  

EN 

38 

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Addressing the knowledge gap 

A detailed account of various activities is given in the Communication from the Commission 
to  the  Council,  the  European  Parliament  and  the  Economic  and  Social  Committee: 
Nanosciences  and  Nanotechnologies:  An  action  plan  for  Europe  2005-2009.  First 
Implementation Report 2005-2007.83  

This  report  indicates  main  actions  addressing  the  knowledge  gap  directly  relevant  for 
addressing the knowledge gap on health, safety and the environment in relation to legislation 
and regulatory implementation.  

1. 

INTERNATIONAL COOPERATION AT THE LEVEL OF OECD 

The  OECD  Working  Party  on  Manufactured  Nanomaterials  (WPMN)  was 
established in 2006 under the Chemicals Committee. The objective of the WPMN is 
to  promote  international  co-operation  in  human  health  and  environmental  safety 
related  aspects  of  manufactured nanomaterials. The work is being implemented via 
specific projects dealing with research issues in the health and environment area, the 
setting  up  a  database,  development  of  test  methods,  test  guidelines,  and  risk 
assessment methods, and information exchange on voluntary schemes and regulatory 
approaches,  the  role  of  alternative  testing  methods,  and  exposure  measurement  and 
exposure  mitigation.  Some  aspects  of  the  OECD  work  are  closely  linked  with 
standardisation  activities,  and  the  International  Organisation  for  Standardisation 
(ISO) is taking part in the work. 

1.1. 

Testing Methods and Risk Assessment 

Existing  OECD  test  guidelines  (used  for  conventional  chemicals)  are  currently 
reviewed  with  respect  to  their  applicability  to  nanomaterials  as  part  of  the  WPMN 
work.  The  WPMN  has  also  set  up  a  sponsorship  programme,  under  which  certain 
selected nanomaterials will undergo testing. These two activities should lead to better 
understanding about the specific test requirements for nanomaterials, and the need to 
modify or develop new OECD test guidelines.  

Potential approaches for exposure measurement and detection of nanomaterials in the 
workplace  and  the  environment  are  currently  being  developed.  Methods  currently 
examined may extend to those assessing, amongst other things, compartmentalisation 
properties, monitoring, and measurement of exposure, fate and persistence.  

Risk assessment approaches are being reviewed and further developed based on new 
knowledge with a view to adjust these. This is supplemented by cooperation on the 
identification  of  alternative  test  methods  (e.g.  in  vitro  tests)  for  nanomaterials.  An 
important part of these activities involves sharing of assessment reports, case studies, 
and reviewing application of risk assessment methodologies. 

1.2. 

Information Sharing, Co-operation and Dissemination 

Clear and concise information relevant to the human health and environmental safety 
of  manufactured  nanomaterials  will  be  made  publicly  available..  An  inventory  and 
comparison  of  approaches  by  different  member  countries  will 
facilitate 
harmonisation  of  regulatory  practices  in  the  chemicals  regulatory  area.  Information 

83 

COM(2007) 505 final ; http://ec.europa.eu/nanotechnology/pdf/comm_2007_0505_en.pdf 

EN 

39 

   EN 

 
                                                 
on  current  or  planned  initiatives  on  risk  assessments,  voluntary  programmes  and 
regulation  will  be  shared.  Based  on  the  approaches  in  member  countries,  industry 
and other stakeholders, OECD will specific recommendations on research strategies 
for  the  short,  medium  and  longer  term,  and  identify  potential  opportunities  for 
collaboration.  An  OECD  Database  on  Human  Health  and  Environmental  Safety 
Research is under construction.  

2. 

STANDARDISATION AT THE INTERNATIONAL AND EUROPEAN LEVEL 

The  European  Committee  for  Standardization,  CEN,  has  started  standardisation 
work  on 
(ii)  metrology, 
measurement and characterization (including procedures for calibration), (iii) health, 
safety and environmental issues; and (iv) nanotechnology products and processes. 

terminology  and  nomenclature 

(i)  classification, 

Similarly,  the  International  Organisation  for  Standardisation,  ISO,  and  the 
International  Electrotechnical  Commission,  IEC,  have  created  Technical 
terminology  and 
Committees  on  nanotechnologies.  Work 
nomenclature; metrology and instrumentation, including specifications for reference 
materials;  test  methodologies;  modeling  and  simulation;  and  science-based  health, 
safety, and environmental practices. European input is ensured through CEN and the 
European Committee for Electrotechnical Standardization, CENELEC.  

is  scheduled  on 

As various aspects of standardization work may be relevant for the implementation 
of  regulation,  the  Commission  has,  in  accordance  with  Directive  98/34/EC  84 
addressed,  in  April  2007,  a  formal  standardization  mandate  to  the  European 
standards  bodies.  In  this  mandate,  the  Commission  invites  the  European  standards 
bodies in a first stage to: 

•  take  stock  of  current  standardisation  relevant 

to  nanotechnologies  and 
nanomaterials  (e.g.  medical  devices,  personal  protective  equipment,  etc.)  which 
may  need  a  revision  in  the  light  of  risks  associated  with  nanotechnologies  and 
nanomaterials; 

•  Identify the need for new standards; 

•  Identify  the  need  to  develop  standardisation  documents  other  than  standards  in 

relation to the above mentioned priority areas; 

A standardisation programme is expected early 2008.  

3. 

EU SCIENTIFIC COMMITTEES WITH REGARD TO RISK ASSESSMENT 

The  EU  Scientific  Committee  on  Emerging  and  Newly  Identified  health  Risks 
(SCENHIR)  has  produced  two  Opinions  in  relation  to  nanomaterials  risk 
assessment, respectively in March 200685, and in March 200786. In its first opinion, 

84 

85 

86 

EN 

Directive 98/34/EC, laying down a procedure for the provision of information in the field of technical 
standards and regulations; OJ L 204 , 21/07/1998  
Scientific  Committee  on  Emerging  and  newly  identified  risks;  modified  Opinion  (after  public 
consultation) on The appropriateness of existing methodologies to assess the potential risks associated 
with 
2006 
http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_003b.pdf  
SCENHIR,  Opinion,  approved  for  public  consultation,  on  the  appropriateness  of  the  risk  assessment 
methodology in accordance with the technical guidance documents for new and existing substances for 

nanotechnologies; 

10  March 

adventitious 

engineered 

products 

and 

of 

40 

   EN 

 
                                                 
SCENHIR  concluded  that  the  existing  toxicological  and  ecotoxicological  methods 
are  appropriate  to  assess  many  of  the  hazards  associated  with  the  products  and 
processes involving nanoparticles, but that they may not be sufficient to address all 
the hazards. The assays may need to be supplemented by additional tests, or replaced 
by  modified  tests,  as  it  cannot  be  assumed  that  current  scientific  knowledge  has 
elucidated  all  the  potential  adverse  effects  of  nanoparticles.  Specifically,  attention 
needs  to  be  given  to  the  mode  of  delivery  of  the  nanoparticle  to  the  test  system  to 
ensure that it reflects the relevant exposure scenarios.  

For exposure, SCENIHR also expressed that the use of mass concentration data alone 
to express dose is insufficient, and that the number concentration and/or surface area 
would  need  to  be  used  as  well.  Equipment  that  enables  routine  measurements  for 
exposure  to  free  nanoparticles  is  not  yet  available.  In  particular,  existing  methods 
used for environmental exposure assessment may not necessarily be appropriate for 
determining the environmental fate of nanomaterials. 

Consequently,  current  risk  assessment  procedures  may  require  modification  for 
nanoparticles  both  regarding  test  methods  for  hazard  identification  and  exposure 
assessment.  

The  SCENHIR  suggested  that  there  is  insufficient  knowledge  and  data  concerning 
nanoparticle  characterisation,  their  detection  and  measurement,  the  fate  (and 
especially the persistence) of nanoparticles in humans and in the environment, and all 
aspects of toxicology and environmental toxicology related to nanoparticles, to allow 
for satisfactory risk assessments for humans and ecosystems to be performed.  

In  its  second  opinion,  dealing  particularly  with  the  appropriateness  of  the  risk 
assessment  methodology  in  accordance  with  the  Technical  Guidance  Documents 
(“TGD”)  for  new  and  existing  (chemical)  substances  for  assessing  the  risks  of 
nanomaterials, the SCENHIR concluded that current methodologies described in the 
TGDs  are  likely  to  identify  certain  hazards,  but  that  modifications  are  required  for 
the  assessment  of  risks  to  human  health  and  the  environment.  Furthermore,  the 
opinion highlights needs to determine appropriateness of current test procedures for 
the  prediction  of  human  health  hazards  and  estimation  of  risks  for  all  types  of 
nanoparticles.87  In  particular, 
the  potential  of 
nanomaterials to reach new target organs in the body, when administered in similar 
ways  as  bulk  chemicals  (translocation).  This  observation  would  lead  to  additional 
requirements of test methods to demonstrate potential new hazards. 

the  SCENIHR  focussed  on 

In  December  2007,  the  Scientific  Committee  for  Consumer  Products  (SCCP) 
adopted  an  Opinion  on  safety  of  nanomaterials  in  cosmetic  products.88  For  labile 
particles, conventional risk assessment methodologies based on mass metrics may be 
adequate,  whereas  for  the  insoluble  particles  other  metrics,  such  as  the  number  of 
particles,  and  their  surface  area  as  well  as  their  distribution  are  also  required.  It  is 
crucial when assessing possible risks associated with nanoparticles to consider their 
uptake.  It  is  primarily  for  the  insoluble  particles  that  health  concerns  related  to 
possible  uptake  arise.  Should  they  become  systemically  available,  translocation/ 
transportation and eventual accumulation in secondary target organs may occur. The 

assessing the risks of nanomaterials. 
http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_004c.pdf 
http://ec.europa.eu/health/ph_risk/committees/04_sccp/sccp_opinions_en.htm 
http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_099.pdf 

87 
88 

EN 

41 

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Committee also identifies a number of knowledge gaps. More particularly as regards 
the ban on animal testing with respect to cosmetics,89 the Committee takes note that 
at  present  no  methodology  has  been  validated  for  nanomaterials.  Finally,  the 
Committee  states  that  review  of  the  safety  of  the  insoluble  nanomaterials  presently 
used in sunscreens is required. 

4. 

THE EUROPEAN FOOD SAFETY AUTHORITY 

The  European  Food  Safety  Authority  has  identified  the  risk  assessment  of 
nanoparticles as a priority action for its Advisory Forum and Scientific Committee.90 
It will be necessary to investigate how far guidance for evaluation of substances to be 
used in food or food contact materials has to be adapted to accommodate the use of 
nanomaterials  in  these  products.  In  June  2007,  the  Commission  has  therefore 
requested  EFSA  to  provide  an  initial  scientific  opinion  on  the  risks  arising  from 
nanomaterials and nanotechnologies in the food and feed area.  

5. 

ETHICAL CONSIDERATIONS WITH REGARD TO NANOMEDECINE 

Nanomedicine is still a 'new' technology and in an experimental phase (pre-clinical 
applications), involving a number of ethical issues that should be properly taken into 
account.  In  September  2005  the  European  Group  on  Ethics  in  Science  and  New 
Technologies (EGE) was requested to issue an opinion on ethics and nanomedicine. 
The Opinion was adopted on 17 January 2007.91 

The  EGE  underlines  the  vital  importance  of  addressing  concern  for  safety  with 
respect  to  nanomedical  developments  (and, in  fact,  nanotechnology  in  general)  and 
therefore  advocates  the  need  to  establish  measures  to  verify  the  safety  of 
nanomedical products and to ensure that nanomedical devices are properly assessed 
with  regard  to  public  health.  Attention  is  paid  to  public  participation  and 
transparency (including openness about uncertainties and knowledge gaps), essential 
for  public  trust  in  nanotechnology.  Additionally,  the  Group  underlines  the  need  for 
prospective technology assessment, including consideration of social effects (also in 
developing countries) and interdisciplinary research on the Ethical, Legal and Social 
Implications (ELSI) of nanomedicine, and enhanced information exchange, on issues 
such informed consent procedures with regard to safety. 

As  far  as  the  legal  implications  of  nanomedicine  are  concerned,  the  EGE  does  not 
propose any new regulatory structures specifically dealing with nanomedicine at this 
point,  and  argues  that  any  changes  should  be  made  within  existing  structures  (with 
focus on implementation of existing regulations). The Group proposes, however, that 
possible  regulatory  overlaps  should  be 
the 
implementation  of  existing  regulation  in  an  unambiguous  manner.  In  addition,  the 
EGE calls for comparative research on intellectual property rights and nanomedicine 
and  advocate  the  needs  to  look  further  into  the  balance  between  knowledge 
protection and information dissemination 

looked  at  carefully 

to  allow 

89 
90 
91 

Directive 2003/15/EC of 27 February 2003 (“7th Amendment”); OJ 66, 11.3.2003  
http://www.efsa.europa.eu/en/mboard/mb_meetings/mb_29th_meeting.html; 2007 management plan. 
http://ec.europa.eu/european_group_ethics/activities/docs/opinion_21_nano_en.pdf 

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6. 

JOINT RESEARCH CENTRE OF THE EUROPEAN COMMISSION 

The Joint Research Centre of the European Commission (JRC) is currently exploring 
the  needs  and  requirements  in  the  area  of  metrology  and  toxicology  related  to 
manufactured  nanomaterials.  Activities  are  focused  at  the  moment  on  the 
development of  

•  Reference  materials  to  increase  the  reliability  and  hence  the  confidence  in 
measurements  at  the  nanoscale  and  of  (engineered)  nanomaterials  in  order  to 
the  validation  and  comparison  of  existing  and  newly  proposed 
enable 
measurement methods, and the verification of the proficiency of test laboratories. 
The  JRC  cooperates  with  OECD,  CEN  and  ISO  on  such  topics  and  also  the 
characterisation  and 
tools  of 
nanomaterials. 

the  development  of  exposure  assessment 

•  validation  and  harmonisation  of  testing  methods  for  evaluating  the  potential 
toxicity  of  nanomaterials.  Manufactured  nanomaterials  are  characterised  and 
tested in vitro for their toxic potential; their uptake and intracellular distribution is 
tested by the means of radio-labelled nanoparticles.  

•  cell and molecular imaging systems in support to the development of non-animal 
methods in order to get a better insight into the mechanisms underlying different 
aspects of nanotoxicology,  

•  computer-based methods supporting the assessment of the distribution and fate of 
their  effects  on  human  health  and the  environment. 

nanoparticles  and 
nanomaterials 

Other  activities  include  a  feasibility  study  on  the  development  and  hosting  of  a 
database on the intrinsic properties of nanomaterials for the EU, or work by means of 
activated  nanomaterials  on  the  release  of  nanomaterials  from  advanced  consumer 
materials  under  wear  or  corrosive  conditions  and  the  development  and  testing  of 
sensor  and  detection  systems  corresponding  to  specific  requirements  for  various 
applications, such as in the area of environmental monitoring and security. 

7. 

STUDY ON SOCIO-ECONOMIC FACTORS 

The JRC is coordinating a study that will identify opportunities and risks for future 
developments in the European Union by examining the present and future market for 
nanotech products, the composition of the sectors and industries mainly affected, and 
the  competitiveness  of  the  European  industry  vis-à-vis  its  main  competitors.  These 
overall objectives of the Euronano study will be pursued along three main lines, i.e.  

•  a  brief  technical  description  on  main  groups  of  nanotechnologies  and  the  main 
technological advantages and an identification of applications of each technology 
and of the main application sectors 

•  Identifying appropriate indicators to provide for a comprehensive analysis of EU 
competitiveness 
in  nanotechnologies  and  marketable  nanomaterials/nano-
products; this includes an assessment of the availability, reliability and degree of 
accurateness of data sources for future more detailed sectoral study(ies) 

•  Analysing  the  competitiveness  of  the  European  industry  vis-à-vis  some  main 
competitors, the current status of R&D and the application of nanotechnology in 
products and processes; Identifying current and future centres/clusters of activities 

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related  to  nanotechnology;  Characterising  the  current  markets  for  nanotech 
products and processes and the already felt effects of this emerging technology on 
the sectors/industries mainly affected.  

This  study  will  find  a  follow-up  on  a  wider  and  more  permanent  basis  through  a 
support  action  under  FP7.  Under  this  action,  an  observatory  should  be  established, 
appropriate  methodology  developed,  data  collected  and  analysed  so  as  to  provide 
European  decision  makers  with  state-of-the-art  analyses  as  well  as  dynamic 
assessments  of  nanotechnology  development  and  use,  allowing  stakeholders  to 
understand levels of success and critical issues, and to take actions.  

8. 

SIXTH  AND  SEVENTH  FRAMEWORK  PROGRAMMES  FOR  RESEARCH  AND 
TECHNOLOGICAL DEVELOPMENT 

Funding  for  research  in  relation  to  nanotechnologies  has  been  steadily  increasing. 
Whilst for Framework Programme 6 (2002 – 2006) 1300 M€ was  earmarked to the 
theme  Nanosciences,  nanotechnologies,  materials  &  new  production  technologies 
(NMP), under Framework Programme 7 (2007 – 2013) 3400 M€ has been allocated. 
It  is  difficult  to  assess  what  share  will  eventually  be  available  for  nanotechnology. 
Not all funding available this theme will be made available for nanotechnologies, and 
inversely,  funding  for  nanotechnology  will  be  made  available  under  other  FP7 
themes, such as Health or nanoelectronics. Nevertheless, it is estimated that the share 
of overall spending on nanotechnology will more than double with respect to FP6. 

It  is  expected  that  past  research  activities  in  the  area  of  impact  assessment  of 
nanoparticles on the environment and health will continue and be reinforced within 
the FP7. In the first two years, the EC launched several topics in the area of health, 
safety and environmental impact of nanoparticles. There were 6 topics in the first call 
for research proposals (launched on 22 December 2006) and two more in the second 
call.  

Regulatory  priorities  identified  by  Commission  services  and  national  authorities  to 
be covered by the 7th Framework Programme relate to  

•  Nanomaterials/particles characterisation and nomenclature 

•  Hazard characterisation 

•  Exposure end effects assessment 

•  Environmental fate, transport and persistence 

•  Measurement, sampling and monitoring 

This  work  also  builds  upon  and  compliments  various  other  activities  by  several 
European  Technology  Platforms 
research 
programmes/activities. 

(ETPs)92,  COST  and  national 

92 

Information  on  Different  Activities  Related  to  Nanotechnologies  in  European  Technology  Platforms 
(ETPs), Version: 1 March 2006, European Commission. 

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