Transcript REACH Nanomaterials

Nano-Safety:
Some Future Perspectives
Conference on Nano-Safety
22-24 April, Slovenia, Ljubljana
Bjorn G. Hansen
dHoU Chemicals, DG ENV, European Commission
Chair, OECD Working Party on Manufactured Nanomaterials
Contents
1.
2.
3.
4.
5.
Introduction
Problems are not new – the solutions are
OECD WPMN – what’s next
EU Legislation – what’s next
Conclusions
1. Introduction
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If given the choice, everyone would chose to
live in a pristine environment
Our standard of living is dependent on our
human activities, but all human activity results in
some level of pollution
So environment and health policy is all about
finding the balance between these two factors
2. Problems are not new – the
solutions are

Environment and Health policies are (generally) based
on science, but science and policy do not (generally)
develop in perfect co-ordination

2 example from the “chemicals area” where policy
needs outran scientific knowledge: endocrine
disruptors and REACH

Many more: C&L (Dir 67/548), RA (Reg 793/93)
2. Problems are not new – the
solutions are


The case of endocrine disruptors: Policy concern
for the long term effects of exposures to
endocrine disruptors triggered significant
research activities and a re-assessment of current
chemicals policies
Results:
Validated OECD Test Methods
 Re-assurance that (generally) current regulatory
systems can identify endocrine disruptors
 Further research

2. Problems are not new – the
solutions are


So, up to recently, policy drove (regulatory)
scientific research and awaited the outcome.
However,

Commission given 4 years to develop legislative
criteria for identifying PPPs as EDs
and so the pressure is on (again)!
2. Problems are not new – the
solutions are

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The case of REACH: Policy concern (among
others) for un-tested substances triggered a
system for generating sufficient information to
assess all chemicals manufactured or imported
into the EU
Results: Legislative

Legislative frame developed, but science needs to fill
(part of) this frame, e.g., category approaches
(including QSAR), exposure scenrios, DNELs, …..
2. Problems are not new – the
solutions are


So (chemicals) policy drives (regulatory) scientific
research to enable implementation.
However,
To utilise fully the potential of “alternative”
information, much more research is needed
 For many substances (petroleum substances, metals,
waste streams, ….), details need to be sorted out
(what should be tested, how to test, how to measure,
what to measure, …….)

and so the pressure is (still) on!
2. Problems are not new – the
solutions are
Lessons learned:
 Problems are not new
 The solutions are new
 The way to get solutions is not new
Questions are:
 If and when policy will require action (regulatory
or voluntary)
 How far have we reached in finding scientific
solutions
3. OECD WPMN – what’s next

Thanks to Jim Willis (U.S. E.P.A. and first
WPMN Chair) and the OECD Secretariat
Nanosafety Team for getting us as far as we
are today!!!!

OECD WPMN is about co-operating on the
(regulatory) science, developing common
(regulatory) scientific understanding, using
the well established “learning by doing”
approach
3. OECD WPMN – what’s next
SG 5: Co-operation on Voluntary Schemes and Regulatory
Programmes
SG 6: Co-operation on Risk Assessment
SG 3: Testing a Representative
Set of Manufactured
Nanomaterials
SG 8: Exposure Measurement
and Exposure Mitigation
SG 4: Manufactured
Nanomaterials and Test
Guidelines
SG 7: The Role of Alternative
Methods in Nanotoxicology
SG 1/2: Database and Research Strategy(ies) on Human Health and
Environmental Safety Research
3. OECD WPMN – what’s next
SG 5: Co-operation on Voluntary Schemes and Regulatory
Programmes
SG 6: Co-operation on Risk Assessment
Sub-groups who’s work provides a platform for coordinated (or not conflicting) authority action
(regulatory or voluntary), but where different
approaches are currently applied for chemicals in
general in OECD countries
3. OECD WPMN – what’s next
Sub-groups who’s work provides the fundament for coordinated (or not conflicting) authority/industry action
(regulatory or voluntary)
SG 3: Testing a Representative
Set of Manufactured
Nanomaterials
SG 4: Manufactured
Nanomaterials and Test
Guidelines
SG 8: Exposure Measurement
and Exposure Mitigation
3. OECD WPMN – what’s next
Will finish Stage 1 exploratory
testing between 2010 and 2011
SG 3: Testing a Representative
Set of Manufactured
Nanomaterials
SG 4: Manufactured
Nanomaterials and Test
Guidelines
Will finish evaluation of changes
needed between 2010 and 2011
Will finish phase 1 (occupational)
in the medium term
SG 8: Exposure Measurement
and Exposure Mitigation
4. EU Legislation – what’s next

Current legislation covers in principle the
relevant risks relating to nanomaterials.

In action, European Parliament have
followed this line in the recent co-decision
process for Novel Foods and Cosmetics
legislation, but nano-safety specific
requirements have been introduced
4. EU Legislation – REACH

REACH is based on the principle that M/I
and DUs have to ensure that they
manufacture, place on the market or use
such substances that do not adversely affect
human health or the environment.

REACH requirements apply to
nanomaterials, even though there are no
specific provisions for nanomaterials.
4. EU Legislation – REACH
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Definitions:
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Nanomaterial
Substance at the nanoscale
Nano form vs. bulk form
Scope includes also e.g. agglomerates and
aggregates below/at micro size
4. EU Legislation – REACH
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Registration of substances manufactured/
imported in volumes of 1 tonne or more per year
Chemicals Safety Report required at volumes of 10
tonne or more per year
Tonnage triggers apply to the total volume
Safety has to be ensured for the substance in
whatever size or form and for manufacturing and
all identified uses.
A registration has to include all relevant
information on the nanomaterial.
4. EU Legislation – CLaP

Nanomaterials having specific properties may require a
different classification and labelling compared to the bulk
material, also when the nanoform is derived from a bulk
substance

Following CLP:
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
the information shall relate to forms or physical states in which the
substance is placed on market / used;
tests shall be carried out on the substance in the form(s) or physical
state(s) in which it is placed on the market and used.
4. EU Legislation – what’s next?
We need to work on Substance Identification
Substance identification of nanomaterials takes place
on the basis of:
-
-
‘traditional’ parameters, i.e. name of the substance,
information re molecular and structural formula,
composition of the subst
refinement based on specific parameters characterizing the
nanomaterial
properties of the substance allowing for meaningful
sharing of data
Build on OECD WPMN work!
4. EU Legislation – what’s next?
We need to work on Chemical Safety Assessment

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Guidance on Information requirements and Chemical
Safety Assessment (IR-CSA TGD) is available from ECHA;
The guidance does not yet address specific characteristics
of nanomaterials;
The same assessment principles apply, but guidance needs
further work for use on nanomaterials.
SCENIHR opinion provides critical analysis
Build on OECD WPMN work!
4. EU Legislation – what’s next?
We need to work on Test Guidelines

In order to address the specific properties, hazards and
risks associated with nanomaterials, additional testing or
information may be required.

To determine specific hazards associated with
nanomaterials, current test guidelines may need to be
modified. Until specific test guidelines for nanomaterials
exist, testing will have to be carried out according to
already existing guidelines.
Build on OECD WPMN work!
4. EU Legislation – what’s next?
EP Resolution (up for adoption/rejection today):
3. Does not agree, before an appropriate evaluation
of current Community legislation, and in the
absence of any nano-specific provisions therein,
with the Commission's conclusions that a) current
legislation covers in principle the relevant risks
relating to nanomaterials, and b) that the
protection of health, safety and the environment
needs mostly be enhanced by improving
implementation of current legislation, when due to
the lack of appropriate data and methods to assess
the risks relating to nanomaterials it is effectively
unable to address their risks;
4. EU Legislation – what’s next?
EP Resolution (up for adoption/rejection today):
3. Does not agree, before an appropriate evaluation
of current Community legislation, and in the
absence of any nano-specific provisions therein,
with the Commission's conclusions that a) current
legislation covers in principle the relevant risks
relating to nanomaterials, and b) that the
protection of health, safety and the environment
needs mostly be enhanced by improving
implementation of current legislation, when due to
the lack of appropriate data and methods to assess
the risks relating to nanomaterials it is effectively
unable to address their risks;
5. Conclusions
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The European Parliament is of the view that the time
for policy action (regulatory) has come
The Commission will carefully examine the
suggestions made by the European Parliament
The OECD WPMN is central to inform this discussion
in a (internationally) coherent way
Many scientific gaps still exist and need to be
addressed, but this will take time
The situation of having policy needs which can not
(yet) be answered by science is not new
If the policy needs increase, then further stepping up
of efforts on the (regulatory) science basis will prove
the more essential