OSH testing and information
requirements
for biopersistent particles and fibres
Dr. Rolf Packroff
Scientific Director of the Division
„Hazardous substances and biological agents"
BAuA – Federal Institute for Occupational Safety
and Health, Dortmund (Germany)
8th EU/US Joint Conference on Health and Safety at Work
Fort Worth, Texas, 17 – 19 September 2015
EU regulatory framework
for chemical safety
Classification
Labelling
Packaging
Registration
Evaluation
Authorisation of
CHemicals
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information
about
hazards
information
about
Bild: ECHA
Dr. Rolf Packroff
OSH testing and information requirements for biopersistent particles and fibres
8th EU-US Joint Conference on Health and Safety at Work, Fort Worth, 2015
risk
Risk and safety communication in the
chemicals´supply chain
OSH regulation
CLP / REACH
risk
management
producer /
importer
employer
eSDS
control measures
exposure
scenario
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effectiveness check
Dr. Rolf Packroff
OSH testing and information requirements for biopersistent particles and fibres
8th EU-US Joint Conference on Health and Safety at Work, Fort Worth, 2015
EU definition for nanomaterials
(proposal of 2011)
"Nanomaterial"
means a natural, incidental or manufactured material containing
particles, in an unbound state or as an aggregate or as an
agglomerate
and
where, for 50 % or more of the particles in the number size
distribution, one or more external dimensions is in the size range
1 nm - 100 nm.
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Dr. Rolf Packroff
OSH testing and information requirements for biopersistent particles and fibres
8th EU-US Joint Conference on Health and Safety at Work, Fort Worth, 2015
For OSH the EU definition of nanomaterials ...
carcinogenic potency
fibre diameter (µm)
... is not helpful for a legal
discrimination of known health risks
from inhalation of bio-persistent
particles or fibres
(better use existing definitions for
respirable particles and WHO fibres)
... offers only a limited legal security
for industry and authorities due to a
lack of standardized methods and
high costs for identification of
nanomaterials
Pott, F - ASP 8/77
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Dr. Rolf Packroff
OSH testing and information requirements for biopersistent particles and fibres
8th EU-US Joint Conference on Health and Safety at Work, Fort Worth, 2015
EU regulations for chemicals,
which use the definition of nanomaterials
• Cosmetics: Label information about nanomaterials
(since 2013, regulation (EC) no. 1223/2009 on cosmetic products)
• Biocides: Requirements for a specific risk assessment of
nanoscaled active substances and for label information about
nanoscaled ingredients
(since 2013, regulation (EC) no. 528/2012 concerning the making
available on the market and the use of biocidal products)
• Food additives: Labelling requirements for manufactured
nanomaterials as ingredients in pre-packaged foods
(since 2015, regulation (EC) no. 1169/2011 on the provision of food
information to consumers)
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Dr. Rolf Packroff
OSH testing and information requirements for biopersistent particles and fibres
8th EU-US Joint Conference on Health and Safety at Work, Fort Worth, 2015
Nanomaterials and REACH
Guidance of the German CA for
characterisation of nanomaterials (2012):
A nanoscaled morphology generally does
not modify a substance to another
substance.
The nanoscaled form has to be registered
together with the bulk material, if their
quantity from production or import exceeds
1 ton per year.
http://www.reach-clp-biozid-helpdesk.de/de/Downloads/Kurzinfo/Kurzinfo%20Characterisierung%20Nanomaterialien.pdf
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Dr. Rolf Packroff
OSH testing and information requirements for biopersistent particles and fibres
8th EU-US Joint Conference on Health and Safety at Work, Fort Worth, 2015
REACH is lacking in information and testing
requirements for coherent workers protection, which
...
… obliges producers and importers for an exposure and risk
assessment of biopersistent substances, which have a relevant
potential for release of respirable particles, despite not being classified
as hazardous acc. to the CLP regulation,
… generates useful information on dustiness of a material during
relevant activities for downstream users,
… decribes tests to determine bio-persistence of released particles for
deduction of toxicological reference values (DNEL / DMEL) and to
derive exposure scenarios for a safe use along the supply chain.
… enables a targeted identification of materials, which release respirable
and biopersistent fibres of high concern for human health.
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Dr. Rolf Packroff
OSH testing and information requirements for biopersistent particles and fibres
8th EU-US Joint Conference on Health and Safety at Work, Fort Worth, 2015
Testing stategy for particle-related health risks
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Dr. Rolf Packroff
OSH testing and information requirements for biopersistent particles and fibres
8th EU-US Joint Conference on Health and Safety at Work, Fort Worth, 2015
Dustiness Testing
Dustiness Testing
• adequate methods?
• 2 EU standards (EN)
• 2 + 1 add. national standards (DIN)
• have to be adopted to NM
• results depend on type of handling
(process category)
• enforceable methods?
• acceptable costs
• broadly applicable
• communication?
• type of information (dustiness class)
• in (M)SDS
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Projects (with BAuA participation)
CarboSafe 2008 - 2012
CarboLifeCycle 2010 - 2014
nanoIndex (EU) 2013 - 2016
NANoREG (EU) 2013 - 2017
Dr. Rolf Packroff
OSH testing and information requirements for biopersistent particles and fibres
8th EU-US Joint Conference on Health and Safety at Work, Fort Worth, 2015
Granular Particles
DNEL: Derived no-effect level
BAuA project F 2336
(10/2013 – 10/2016),
contracted to Fraunhofer ITEM (Hannover):
Method for the identification of granular
biopersistent dusts at workplaces
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Dr. Rolf Packroff
OSH testing and information requirements for biopersistent particles and fibres
8th EU-US Joint Conference on Health and Safety at Work, Fort Worth, 2015
NANoREG 2013 – 2018
Default DNEL for GBP from
long-term inhalation study
(„nano-in-vivo“) on CeO2?
Fibres
0.01 f/ml (German acceptance level) ???
•
•
•
•
short term test by inhalation
short term test by intratracheal instillation
appropriate intra-peritoneal test
suitable long term inhalation test
Criteria to distinguish
between rigid and
non-rigid fibres?
BAuA project: Development of
an enforceable test method
for determination of the
rigidity
of
respirable
biopersistent fibres
started, 2015 - 2016
DMEL: Derived maximum exposure level
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Dr. Rolf Packroff
OSH testing and information requirements for biopersistent particles and fibres
8th EU-US Joint Conference on Health and Safety at Work, Fort Worth, 2015
Research vs. Regulation
Health and Safety Research
• antenna function for new risks
• verification of hypotheses
• good expert manning
• development of new methods
Regulation
• practicable
• enforceable
• risk-related
• coherent
• limited expert manning
• established methods
Do we need
a nano
definition in
OSH
regulation?
Maynard's comment in Nature proposes that a
"‘one size fits all' definition of nanomaterials
will fail to capture what is important for
addressing risk," and suggests that regulators
use "a list of nine or ten attributes (including
size and surface area) for which certain values
trigger action“
Andrew D. Maynard, Nature, 475, 31 (2011)
http://www.nanotech-now.com/columns/?article=572
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Dr. Rolf Packroff
OSH testing and information requirements for biopersistent particles and fibres
8th EU-US Joint Conference on Health and Safety at Work, Fort Worth, 2015
Requirements for a targeted research
on health risks and safety of advanced materials
inter- /
transdisciplinary
• enable long-term
basic research
• balance continuity
and project founding
• allow gathering and
exchange of
experiences
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• interdisciplanary risk characterisation
• consultation of social partners and
regulators
• collaboration of safety research with
materials scientists and start-ups
adequate
manning
and funds
early
warning
system
(antenna)
Dr. Rolf Packroff
OSH testing and information requirements for biopersistent particles and fibres
8th EU-US Joint Conference on Health and Safety at Work, Fort Worth, 2015
• detection of risks at
an early stage
• generate scientific
evidence
• hold pace with
innovation
• enable sciencebased risk
communication
Thank you
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Dr. Rolf Packroff
OSH testing and information requirements for biopersistent particles and fibres
8th EU-US Joint Conference on Health and Safety at Work, Fort Worth, 2015