How nanomaterials are covered by REACH

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How nanomaterials are covered by REACH

• ETUI-REHS, HESA Dpt./ FNV
• 3rd Seminar on workers protection chemicals
• Amsterdam, 21-22 January 2008
• Henrik Laursen
• DG Environment, European Commission

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Setting the scene

• Breakthrough in science - ability to control
  matter at the atomic level ( 1-100 nm)?
• Materials with new properties due to the small
  size (but some with same chemical formula)?
• Production and marketing of products containing
  nanomaterials rapidly increasing
• Huge benefits, but uncertainties about health,
  safety and environment aspects.

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The EU Approach safe, integrated and
responsible

• Commission Communications
• Towards a European Strategy for Nanotechnology
  (May 2004)
• Nanotechnology Action Plan for Europe 2005-2009
  (June 2005)?
• Action Plan Implementation Report 2005-2007
• (September 2007)?

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Four groups of actions in the Action Plan

• Research, Development and Innovation
• Public Concern, Safety, Health and Environment
  Protection
• International Cooperation
• Coherent Approach at European Level

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Main actions in EHS chapter in the EU Action Plan

• Regulatory aspects
• inventory of existing legislation
• 2. Improve knowledge base
• - definitions, measurements, toxicological and
  eco-toxicological test methods, exposures, risk
  assessment

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Legislation relevant for nanomaterials
-horizontal and sector related

• Legislation by DG Environment, Enterprise, SANCO
  and Employment
• Industrial chemicals (new and existing ? REACH)?
• Pharmaceuticals, Pesticides, Biocides
• Medical devices, Cosmetics, Food and Food
  packaging
• Worker protection
• Air, Water, IPPC, Seveso, Waste
• Environment Liability, Product liability, Product
  safety

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Conclusions regarding existing EU Directives and
Regulations

• Environmental and health risks of nanomaterials
  are
• in principle covered by EU regulatory frameworks
• Implementation of the legal frameworks remains
  difficult
• due to
• Scientific knowledge gaps
• Fast evolving market for products, moving
  target
• Does not exclude regulatory changes in light of
  new
• evidence or results of RD
• COM services view, not official COM view

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Identifying knowledge gaps from an EH
perspective

• Nomenclature, definitions, standards
• Data on human health and environmental effects
• and test methods to generate data
• Data on exposures throughout the lifecycle,
• exposure assessment methods
• Measurement, characterisation and analytical tools

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EU Chemicals Legislation
Publication proposal REACH regulation
REACH in force
Dangerous Substances Directive 1999/45/EEC
Notification new substances 92/32/EEC 7e
Amendment
White Paper
65. . . .70. . . .75. . . .80. . . .85. . . .90.
. . .95. . . .00. . . . 05 . . .
EINECS list
Risk assessment 93/67/EEC (new substances)? Reg
793/93 (existing subst.)?
Hazard assessment 67/548/EEC Classification,
Packaging Labelling dangerous substances
Restrictions of marketing and use of
certain chemicals / preparations 76/769/EEC
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EU wg recommendationson existing chemicals
legislation

• 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 EINECS.
• Specific properties may require a different
  classification and labelling compared to the bulk
  material.
• For the longer term, review the applicability of
  testing methods and risk assessment methods at
  international level (e.g. within the OECD
  chemicals programme) with active input from
  industry and contributions from the EU.
• Invite industry to provide a number of dossiers
  on different representative nanomaterials, to
  show available data, how risk assessment is being
  performed and risks are controlled.

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What is REACH?

• Regulation on the Registration, Evaluation,
  Authorisation and Restrictions of CHemicals
• REACH is based on the Principle that
• It is for manufacturers, importers and
  downstream users to ensure that they manufacture,
  place on the market or use such substances that
  do not adversely affect human health or the
  environment. Its provisions are underpinned by
  the precautionary principle.

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REACH - key elements

• Registration of substances 1 tonne/yr
• Increased information and communication
  throughout the supply chain
• Evaluation of some substances
• Authorisation only for substances of very high
  concern
• Restrictions - the safety net (Community wide
  action)?
• Agency to efficiently manage system

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REACH and Nanomaterials

• REACH requirements apply to nanomaterials but
  does not contain specific provisions for
  nanomaterials.
• On the basis of knowledge development
• Guidance for implementation, e.g. on safety
  assessment, may need to incorporate specific
  elements related to nanomaterials
• Review REACH, at a later stage as appropriate,
  with regard to adequacy to address and manage the
  safety of nanomaterials (incl. information
  requirements, assessments and management by
  industries)?

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REACH and Nanomaterials

• Registration of substances in the nanoform
• as phase-in substance (e.g. nanogold)?
• as a non-phase in substance (e.g. fullerenes)?
• Chemicals Safety Assessment
• Nanomaterials may have specific properties
• specific hazards (incl. classification and
  labelling)?
• specific risks
• specific risk management (exposure scenarios)?
• Communicate in Safety Data Sheets

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SCENIHR opinion on risk assessment of chemicals

• Based on the methods in the EU TGD on risk
  assessment
• likely identify the hazards associated to
  nanoparticles
• nanoparticle formulations are not per se more
  toxic than formulations based on bulk substances
  gt case-by-case
• appropriate metrics needed (number concentration
  and surface area to complement mass
  concentration)?
• physico-chemical characteristics may change, e.g.
  agglomeration, dissociation, adsorption
• The Scientific Committee on Emerging and Newly
  Identified Health Risks
• EU Technical Guidance Documents

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SCENIHR opinion on risk assessment of chemicals

• Based on the methods in the EU TGD on risk
  assessment
• the applicability of environmental exposure
  methods for assessment of nanoparticles should be
  evaluated
• there is a lack of standardised methods for the
  testing of properties of nanoparticles
• no clear guidance can be given on the methods to
  assess the effects of nanoparticles in
  environmental compartments
• consideration should be given to possible
  translocation away from the portal of entry and
  passage across membranes may occur (e.g. across
  the blood-brain barrier)?

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Mandate for SCENIHR

• The update should be done in a step-wise manner
  taking into account the upcoming risk assessment
  demands related to specific nanomaterials and the
  evolving scientific information from various
  sources, including results from scientific
  research projects and activities of the European
  Technology Platforms related to the safety of
  nanomaterials.
• Deliverables
• Recommendations on improvements of
• existing test methods and/or need for new ones,
• exposure assessment
• risk assessment in general
• further prioritised needs for short, medium and
  long-term research based on a knowledge gap
  closure analysis
• Identification of
• direct or indirect health risks with regard to
  current and foreseeable applications of
  nanomaterials based on information related to
  volume of production in different sectors.

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OECD Working Party on Safety of Nanomaterials

• Established under the Chemicals Committee in
• September 2006. A work programme 2006-2008
• has been endorsed as well as 8 projects
• Database on environment and health effects
• Research strategy on EHS and international
  co-ordination
• Safety testing of a set of nanomaterials
• Test guidelines
• Voluntary schemes
• Risk assessment
• The Role of Alternative Methods in Nano
  Toxicology
• Exposure Measurement and Exposure Mitigation

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We need to work togetherEU Commission and
Member StatesWith industry, academia and all
stakeholdersOECDInternationalThanks for your
attention!