Towards chemical sustainability Putting the EU Strategy into action - 2021 Review Meeting - Ecetoc
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2021 Review Meeting
Towards chemical sustainability
Putting the EU Strategy into action
14 April 2021
| 1
Overview of ECETOC activities
Introduction
Objectives of the event
Programme of the
day Keynote Prof. Annemarie van Wezel, UoA
‘Talking about the role of science in the context of
Panel
the Chemicals Strategy for Sustainability’
Persistent chemicals and water resources
protection
Reviews Assessing the human health and environmental
safety of polymers
Making best use of exposure science developments
Breakout What further could ECETOC do to support
the Chemicals Strategy for Sustainability
implementation?
Conclusion Plenary wrap-up and close
| 2 @ECETOC
Overview of ECETOC activities | 3
100+ scientific experts involved
2020 in numbers
2 Scoping meetings
4 Technical Reports
4 manuscripts in peer reviewed publications
3 Workshops
2 Workshop reports
2+ Online contributions to SETAC Dublin
3 Webinars on Science Communications #ScienceChats
1 App for the registration of nanomaterials #NanoApp
| 4
Contributions to ECHA, CARACAL and UNEP meetings
Discussion/debate seminars on
Persistence in the 21st Century (TBC)
2021 Outputs Manuscript from Expert Group on Special Thyroxine (T4) Task Force
State of the science of Manuscript #4
invertebrate endocrine disruption
in relation to EU regulation TR 133-3 on Polymers
(Case Studies)
TR on Exposure Based Workshop on Use of generic in
Adaptations (end April) vitro – in vivo extrapolation
(IVIVE) models
TR 139
Q1 Workshop on Omics thresholds
Persistent Chemicals and Water Q3 of non-adversity
Resources Protection
WR 37 on
Exposure Based Adaptations Literature Review on TRA
(February) Workers
TR 136 on Q2 Manuscript on TRA Consumers Q4
Derived No-Effect Level
(February)
Manuscript and TR from Task
TR 138 Guidance on dose- Force on Geospatial
setting in repeated-dose Approaches to increasing the
toxicity studies (March) ecological relevance of
chemical risk assessments
Special Thyroxine (T4) Task Force
Manuscript #2 (accepted for publication) Special Thyroxine (T4) Task Force
Manuscript #3
Manuscripts from Task Force on Moving
Persistence assessment into 21st century Discussion/debate seminars on
(submitted for review) Persistence in the 21st Century (TBC)
| 5
Objectives of today | 6
Putting the EU
Strategy into
action
Review Share
Discuss Plan
| 7
Keynote address Prof. Annemarie van Wezel Professor of Environmental Ecology Institute for Biodiversity and Ecosystem Dynamics University of Amsterdam | 8
Faculty of Science Science to help reaching a toxic-free environment Annemarie van Wezel
Faculty of Science
Growth in numbers and volumes of synthetic chemicals used
outpace other factors of global change
Bernhardt et al 2017 Front Ecol EnvironFaculty of Science
Global Understanding of Chemical Pollution
Over 350 000 chemicals and
mixtures registered for production
and use worldwide
Identities of many chemicals publicly
unknown, claimed as confidential
(over 50 000) or ambiguously
described (up to 70 000)
Wang et al 2020Faculty of Science
Current chemical legislation is not sufficiently protective
• Chemicals increasingly detected in EU
surface and drinking waters
• Chemical pollution affects biodiversity in EU
water bodies
• Over 50% of EU water bodies in poor
ecological condition
• Future societal developments result in
higher concentrations and diversity of
chemicals in the environment
• 90% of EU citizens worry about the impact
of chemicals on the environment
→ increasing pressure to make EU chemicals
regulation more stringent
msPAF‐EC50 highest share in relative explained deviance; Lemm et al Glob Change Biol ‘20Faculty of Science
As part of EUGD; Chemicals Strategy for Sustainability (CSS)
• Chemicals Strategy for
Sustainability (CSS, oct ‘20)
• First regional framework
addressing chemical pollution in a
holistic manner
• Covers complete life-cycle of a
chemical, including design and
remediation optionsFaculty of Science
Current (fragmented) EU registration/authorization frameworks
Van Wezel et al 2017Faculty of Science
One Substance – One Assessment?
Chemicals can be registered under multiple
frameworks
Chemicals not approved under one framework can be
allowed under others
Similar function of frameworks, but important
differences in risk assessment strategies → incoherent
assessments
PNEC values for 65 substances registered under
multiple frameworks can differ up to a factor of 5625,
a median difference of 3.6
Van Dijk et al 2021Faculty of Science
Comparing ecotoxicity
Comparing PNECs; biocides on average are the most hazardous group of
chemicals
Van Dijk et al 2021, J Environ ManFaculty of Science
Use of assessment factors
Applied on most sensitive endpoint, differ
between the frameworks
Little empirical evidence, debated if AFs
sufficiently cover extrapolations (acute to
chronic, lab to environment) and mixture
effects
→ additional uncertainties to
environmentally safe concentration
Van Dijk et al 2021Faculty of Science
Towards a successful move toa OS-OA
• Harmonise environmental protection goals and risk assessment strategies, no
exemptions for environmental risk assessments, regular re-evaluation
• Emission, use and production data publicly available and shared, before critical
PEC/PNEC ratio prioritize most essential uses/sectors
• Align criteria used to classify problematic substances (SVHC, CfS)
→ streamlining of RAs is not only key to achieve coherent and more transparent
outcomes but is also essential for functioning of the EU single market
Van Dijk et al 2021Faculty of Science
A toxic-free environment
CSS; where chemicals are produced and used in a way that maximises their contribution to
society including achieving the green and digital transition, while avoiding harm to the planet
and to current and future generations
→ crucial to define what
organisms, functions and
environmental effects are
to be protected
Van Dijk et al in press IAEMFaculty of Science
Optimism on achievability a toxic-free environment
Van Dijk et al in press IAEMFaculty of Science
Key research requirements
1) Inclusion of spatial (mobility) and temporal (persistency) variation
in the risk assessments, including future scenarios and improved
emission data
2) Recognise which compounds drive the toxicity of mixtures and
how these vary
3) Integrate solutions into the risk assessment process, ie improved
wastewater treatment, but also development of the sustainable
chemicals concept
4) Develop protocol for identifying safer (non)-chemical alternatives
5) Strengthen the science-policy interface
Van Dijk et al in pressFaculty of Science
Escher et al 2020Faculty of Science
Example target monitoring; Pesticide occurrence in sources for
drinking water
Data 2010-2014, The Netherlands,
63/408 pesticides and 6/52 metabolites
were prioritized.
Vast majority not detected or only in low
concentrations
In 67% of sources pesticides/metabolites
detected, in 31% of sources WFD water
quality standards exceeded
Sjerps et al 2019 ChemosphereFaculty of Science
Mobile and persistent pesticides more likely to be classified as
(high) priority pesticides
High priority: Pesticides or relevant metabolites present in drinking water
Priority: Pesticides or relevant metabolites present in drinking water sources >0.1 μg/L
Potential priority: Pesticides or relevant metabolites present drinking water sources > 0.1 < 0.1 μg/L
Low priority: Pesticides or relevant metabolites do not exceed 0.01 μg/L Sjerps et al 2019Faculty of Science
patRoon: Open-Source Software Platform for Environmental
Non-Target Studies
Helmus et al 21Faculty of Science
Risk based monitoring
• 108 source waters clustered on both
target as suspects
• Half relatively non-vulnerable
• 153/731 target chemicals detected
• 1,398/12,294 occurring HRMS
features match to 3,590 suspects
• Suspects prioritized for further
identity confirmation based on semi-
quantitative occurrence, frequencies
and info on toxicy
• Once confirmed and assessed as
relevant, the suspects could be added
to target monitoring
Sjerps et al 2021Faculty of Science
Source waters with higher number of chemicals
relate to high levels of infiltrated surface water
Sjerps et al 2021Faculty of Science
Computational material flow analysis for thousands of CECs in
European waters
• Europe-wide hydrology model E-Hype
• “Locator” values;
• REACH chemicals and pharmaceuticals -
Pop x GDP-PPP x WF
• Pesticides - agriculture land use, 7-day
application periods during the relevant
season
• STREAM-EU dynamic mass balance model
spatially and temporally resolved
• Substance properties
• Estimated emission for 621 pharmaceuticals, 408
pesticides and 4159 REACH registered organic
chemicals
• Comparison to monitoring data
Van Gils et al 2020Faculty of Science
Prediction per compound per basin
Van Gils et al 2020Faculty of Science
CMFA accuracy
Model outputs could be compared to measured
concentrations for 226 substance/basin combinations
Average error is effectively zero (-0.01), standard
deviation is 1.20.
In 65% of cases error is below one order of
magnitude, in 90% of cases the error is below two
orders of magnitude
Van Gils et al 2020Faculty of Science
Essentiality & benign-by-design
No available Equal/better functionality
Necessary for Less hazardous
technically and
health, safety or Less persistant/More
economically feasible
critical for societal durable
non-chemical
functioning Lower emissions
alternativesFaculty of Science
When is redesign suitable
Flerlage etalFaculty of Science
Computer aided approach
Flerlage etalFaculty of Science
Relevance and reliability criteria for water treatment removal
efficiencies
•9 relevance criteria and 51
reliability criteria
•Applied to 244 treatment
technology studies, 49 papers
fulfilled the relevance criteria
•Reliability criteria applied to
the 49 remaining papers.
•Findings clearly demonstrates
the need for a more uniform
approach.
Fischer et al 2019Faculty of Science
Treatment
R e m o v a l e f f ic ie n c y ( f r a c t io n )
-1 . 0
-0 . 5
0.0
0.5
1.0
S im p le
S o r p ti o n
S i z e e x c l u si o n
S o r p ti o n a n d si z e e x c l
Sjerps et al 2021Faculty of Science
Essential elements for a
Chemicals strategy for sustainability Thanks to
Funders (NWO, EU)
Co-authors
Legislation, chemical design & essentiality, technology YOU for listeningPanel discussion Annemarie van Wezel Professor of Environmental Ecology Institute for Biodiversity and Ecosystem Dynamics, University of Amsterdam Chantal Smulders General Manager Health Risk and Governance, Shell Chair of the Board, ECETOC Christel Musset Director of Hazard Assessment European Chemicals Agency (ECHA) Maurice Whelan Head of Unit Chemical Safety and Alternative Methods European Commission, Joint Research Centre (JRC) | 37
Review of ongoing ECETOC activities Persistent chemicals and water resources protection: Tiered approach to exposure and risk assessment Nathalie Vallotton, Dow Assessing the human health and environmental safety of polymers Mark Pemberton, Systox Ltd. Making best use of exposure science developments Tanya Dudzina, ExxonMobil | 38
Persistent
chemicals and
water resources
protection:
Tiered approach to
exposure and risk
Nathalie Vallotton, Dow
assessment
Disclaimer: the Task Force’s Technical Report is still in preparation.
Conclusions presented here should be considered preliminary and
| 39 subject to change [April 2021]Background Protecting ground- and drinking water resources is an important
common goal
A PMT/vPvM hazard-based concept within the REACH context has
been proposed to improve the protection of these resources
Available groundwater monitoring data showed:
• P/M criteria are not predictive of the occurrence of substances in
groundwater – questioning the proposed criteria
• Substances detected in drinking water(*) are not only REACH-
regulated substances – questioning the PMT-concept under REACH
This indicates the need for further adjustment of the concept
P/vP – Persistent/very Persistent
M/vM – Mobile/very Mobile
T – Toxic
(*)Arp, HP, Hale, S. 2018. Preliminary assessment of substances registered under REACH that could fulfil the proposed PMT/vPvM criteria, vol
1. Norwegian Geological Institute (NGI).
| 40Material & The ECETOC Task Force is elaborating on the following
relevant topics:
Methods
• Review of existing legislation
• Appropriateness of the proposed PMT-criteria
• Review of existing monitoring data
• Level of relevant metabolite concentrations
• Review of risk assessment approach
• ECETOC tiered approach
| 41Material & The ECETOC Task Force is elaborating on the following
relevant topics:
Methods
• Review of existing legislation
• Appropriateness of the proposed PMT-criteria
• Review of existing monitoring data
• Level of relevant metabolite concentrations
• Review of risk assessment approach
• ECETOC tiered approach
| 42Findings • Existing EU frameworks including REACH, already provide some
measures (prospective and reactive) to protect drinking water
resources. Opportunities were identified in improving the risk
assessment of man via environment.
• P & M properties do not seem to be appropriate predictors of
ground water/surface water contamination questioning the
proposed criteria
• The criteria for ‘T’ as in Annex XIII of REACH already fulfil the
protection goal to ensure a high level of human and environmental
safety
• The T criteria in the PMT concept focus on human health aspects
Disclaimer: the Task Force’s only in order to align with the protection goal of safe drinking water
Technical Report is still in for humans
preparation. Conclusions presented
here should be considered
preliminary and subject to change • The threshold for identification of metabolites should follow the
[April 2021] recommendations as set within the OECD 307 – 309 test guidelines
| 43Material & The ECETOC Task Force is elaborating on the following
relevant topics:
Methods
• Review of existing legislation
• Appropriateness of the proposed PMT-criteria
• Review of existing monitoring data
• Level of relevant metabolite concentrations
• Review of risk assessment approach
• ECETOC tiered approach
| 44Human health threshold approach
Overview of • Guideline values for water quality
frameworks
WHO Protection goal for humans health
• Quantitative risk assessment approaches for
man via the environment
Protection goal for humans health • Models: EUSES based models (e.g ECETOC TRA,
Quantitative risk assessment approaches for EPA CHESAR)
man via the environment FIFRA, REACH
• Models: SciGrow, PRZM-GW, FIRST FFDCA
Protection goal for groundwater
EU BPR
Protection goal for groundwater resources & PPP resources & man via environment
PPP • Quantitative risk assessment for
human health
• Quantitative risk assessment for the groundwater groundwater and “man via environment”
compartment • Property-based cut-off
• Property-based cut-off • Models: EUSES based models and FOCUS
• Models: FOCUS GW GW
WHO:World Health Organization; FIFRA: Pesticide registration: Federal Insecticide, Fungicide, and
Rodenticide Act; FFDCA: Federal Food, Drug and Cosmetic Act; REACH: Registration, Evaluation,
Authorisation and Restriction of Chemicals; PPP: Regulation (EC) No. 1107/2009 (EC, 2009 placing of
plant protection products on the markets); BRP: Biocidal Product Regulation (EU) 528/2012
| 45REACH Information required
Use and release patterns - exposure
exposure scenarios
assessment Physical-chemical properties
framework Abiotic and biotic degradation
Fig. 1
Routes of exposure
Drinking water is included in the exposure
assessment of man via environment
Sources of drinking water are
groundwater or surface water
Exposure in both compartment is
estimated
Fig. 2
Fig. 1: REACH guidance R.16 (previous version - version 2.1; Oct 2012) [Source: European Chemicals Agency, http://echa.europa.eu/]
| 46 Fig. 2: REACH guidance R.16 (current version - version 3.0; Feb 2016) [Source: European Chemicals Agency, http://echa.europa.eu/]REACH and PPP
Frameworks &
Route of exposure: indirect vs direct
Parametrisation
Application rate: estimate vs established dosing
Ground water : topsoil vs aquifer
Example of groundwater
Fig. 1
| 47 Fig. 1: REACH guidance R.16 (previous version - version 2.1; Oct 2012) [Source: European Chemicals Agency, http://echa.europa.eu/](B) Indirect exposure from
Case study (A) Pattern of exposure reflecting direct
application to soil 1000g/ha
release to the STP at 0.7 kg/d
Role of the exposure pathway on
groundwater exposure
Prediction of exposure [µg/L] with
selected degradation half-lives and
Koc values.
A. Direct dosing to soil
B. Emitted to Sewage treatment
plant (STP)
Identification of the source of drinking
water in the REACH framework.
C. Source with selected degradation
half-lives and Koc values for a
theoretical water soluble and low
volatility substance .
Blue - Surface water The transport of contaminants via bank filtration systems is addressed in
Green- Groundwater EUSES with a conservative approach and is not addressed in the higher
tier models.
| 48ECETOC Tier 0
Research gaps
Likelihood for exposure
1) Ionisable substances
• Develop appropriate
tools for mobility
assessment of ionisable
substances Assessment of partitioning: Substances
• Develop and validate new requiring specific assessments
models based on a better approaches (ionisable, UVCB)
mechanistic
understanding.
2) Develop screening
approaches by inclusion of
one or several leachability Screening for potential leaching
indices
| 49ECETOC tiered approach for assessment of drinking water safety: Tier 1, 2 and 3
exposure modelling
| 50Annual volumes, use patterns and emissions with routes of exposures are
Conclusion considered as the drivers for groundwater appearance of substances
Therefore, a risk-based (modelling) approach, using chemical properties
Tiered approach to combined with information on emissions and use pattern, provides a more
exposure and risk suitable alternative to identify potential substances of concern
assessment A tiered approach to characterising potential human exposure from contaminants
in drinking water has been developed by the Task Force
Research gaps have been identified:
• Partitioning assessment for substances with specific properties (e.g. ionisables)
or for soils with low organic carbon content
• Develop screening approaches by inclusion of one or several leachability indices.
• Improve comprehension of bank filtration processes with respect to transfer
of contaminants to and from water bodies
• Integrate this knowledge into environmental distribution models
ECO54: Developing a tiered modeling framework in support of risk assessment of
chemical substances associated with mobility concerns https://cefic-lri.org/projects/
| 51Assessing the
human health and
environmental
safety of polymers
Mark Pemberton, Systox Ltd.
| 52Task Force April 2018: Formation of the TaskForce
2018
timeline May 2019: Publication of ECETOCTechnical Report (TR)
2019
No. 133-1*
March 2020: Publication of TR No. 133-2**
2020
September 2021:
Planned publication of TR No. 133-3***
2021
* TR 133-1: The ECETOC Conceptual Framework for Polymer Risk Assessment(CF4Polymers)
**TR 133-2: Applicability of Analytical Tools, Methods and Models for Polymer Risk Assessment
*** TR 133-3: Case Studies Putting the TR 133-1 CF4Polymers and TR 133-2 in Practice
| 53Conceptual Framework for Polymer Risk Assessment
(CF4Polymers) [TR 133-1]
Objective: Develop a Conceptual Framework which:
– Addresses human health and environmental safety assessment of polymers
– Builds on existing knowledge and practices
– Addresses complexity of polymer chemistry, composition, lifecycles and associated
protection goals
– Outlines knowledge and data gaps
| 54CF4Polymers [TR 133-1] | 55
Test method applicability [TR 133-2]
▪ Diversity of polymers so no “one size fits all”
▪ Determine applicability on case-by-case basis
▪ Not all test methods are applicable to all polymers
▪ Not all methods developed for substances are necessary to ensure polymer safety
▪ Decision process:
1. Would the findings from this method add knowledge that would be relevant for risk assessment?
2. Is it physically / technically possible to perform the test following the formal, TG-conforming
protocol?
3. Can the testing protocol be adapted to enable testing of the given type of polymer?
| 56Grouping and PLC [TR 133-1 and 133-2]
Recommendation 1 of TR 133-1: Identify sets of structural and/or morphological descriptors as well as
physico-chemical and fate properties that are key parameters for different types of polymer products.
Further research is merited to identify which specific properties are the relevant key parameters for fit-
for-purpose polymer identification and grouping. Specific key parameters might generally be relevant
across different types of polymers, or they might be unique to specific types of polymer products.
Knowledge on such key parameters will also facilitate the identification of data needs during exposure
and hazard assessment.
Recommendation 4 of TR 133-2: Expand the knowledge base to (1) substantiate the PLC concept
and (2) to identify under which conditions the presence of specific structural alerts or physico-
chemical properties poses environmental or human health hazard concerns.
Particularly, there is only weak evidence that anionic or amphoteric and water absorbing
polymers might generally have a relevant hazard potential.
| 57▪ Address different components of polymer grouping and risk
assessment to put the CF4Polymers into practice
Case Studies
▪ Enhance the understanding on the applicability and/or technical
[TR 133-3] limitations of the corresponding tools, test methods, and models
▪ Seven case studies being developed:
– CS 1: Polyacrylates
– CS 2: Cationic polymers
– CS 3: Polyolefins
– CS 4: BADGE (Bisphenol-A diglycidylether) polymers (“polymers undergoing further
reaction”)
– CS 5: Polyetherols (“polymers undergoing further reaction”)
– CS 6: Surfactant polymers
– CS 7: Professional applications of polyurethane/polyurea (agricultural/ horticultural
and fragrance microencapsulations and in professional paints)
| 58▪ Case studies support CF4Polymers (TR No. 133-1)
▪ Confirm no “one size fits all” for
Case Studies ▪ Polymer hazard identification and risk assessment
[TR 133-3] ▪ Testing methods, where some tests may be:
– difficult or impossible to perform for some types of polymers
– may be relevant to key physico-chemical descriptors / hazard and risk
– irrelevant and be of little or no value
▪ Polymer identification for grouping purposes i.e.
– key structural descriptors / physico-chemical properties are specific to polymer type and not
generally applicable
▪ Confirm applicability of the three conceptual frameworks
for biodegradation / bioaccumulation & ecotoxicity testing
(presented in TR 133-2)
| 59▪ Provides important insight into grouping of polymers
▪ Proposes a structured approach to grouping supplemental to
Case Studies the CF4Polymers
[TR 133-3]
Polymers for
hazard similarity
Working towards
Graphic not to scale
grouping
Group level 1
Layer 1:
Chemical nature Group level 2
maintain hazard similarity
Establish, describe &
Group level 3
(final)
Maintain final group level
R
Layer 2:
Physico-chemical properties
Layer 3:
(Eco)toxicological properties
Hazard similarity achieved / maintained for polymers
Note that the grouping concept is intended to be flexible:
Certain steps steps may not be useful for all cases, and some cases may benefit from adding other aspects.
| 60Making best use of
exposure science
developments
Tanya Dudzina, ExxonMobil
| 61Overview EU CSS elements - where/how exposure science
developments may provide solutions
Mapping to ongoing ECETOC work
•Aggregate exposure TF
•Exposure Based Adaptations TF
•New Transformational Program
Summary & conclusions
•Delivering transparent, data-driven approaches
| 62EU CSS opens up opportunities
for exposure science
Actions
• banning the most harmful chemicals in consumer products - allowing their use only where essential
• account for the cocktail effect of chemicals when assessing risks from chemicals
• phasing out the use of per- and polyfluoroalkyl substances (PFAS) in the EU, unless their use is
essential
• boosting the investment and innovative capacity for production and use of chemicals that are safe
and sustainable by design, and throughout their life cycle
• promoting the EU’s resilience of supply and sustainability of critical chemicals
• establishing a simpler “one substance one assessment” process for the risk and hazard assessment of
chemicals
• playing a leading role globally by championing and promoting high standards and not exporting
chemicals banned in the EU
| 63ECETOC exposure projects
strategically address CSS objectives
“One substance one assessment”, “cocktail effect”
ECETOC TF on Mid-tier approaches to aggregate exposure
Screening aggregate exposure for 13 substances
– Develop methods to estimate reasonable worst- D5 – use in cosmetics not
included
D5 – use in cosmetics
included
case/more realistic aggregate
k=2
exposure across
k=3 k=2
Triethyl phosphate Triethyl phosphate
Triethyl phosphate Triethyl phosphate
Triethyl
k=4
phosphate
k=3 k=4
Triethyl phosphate
1,4-dichlorobenzene 1,4-dichlorobenzene 1,4-dichlorobenzene
different products/uses BPA Tributyl phosphate
Acrylonitrile 1,4-dichlorobenzene
BPA Tributyl phosphate
Acrylonitrile 1,4-dichlorobenzene
BPA Tributyl
Acrylonitrile 1,4-dichlorobenzene
BPA BPAphosphate BPA
1 1 Acrylonitrile 1 Acrylonitrile Acrylonitrile
1 Tributyl phosphate 1 Tributyl phosphate 1 Tributyl phosphate
– Address typical REACH widespread dispersive uses
DIDP DIDP DIDP 1-ethoxypropan-2-ol DIDP DIDP 1-ethoxypropan-2-ol DIDP 1-ethoxypropan-2-ol
(e.g. consumer articles, cleaning, coatings, DIY
0 DINP
1-ethoxypropan-2-ol
0 DINP
1-ethoxypropan-2-ol
06,6'-di-tert-butyl-2,2'-methylenedi-p-cresol
0 DINP
1-ethoxypropan-2-ol
06,6'-di-tert-butyl-2,2'-methylenedi-p-cresol 06,6'-di-tert-butyl-2,2'-methylenedi-p-cresol
products) 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol
DINP 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol DINP
Dim2 (18.1%)
Dim2 (18.1%)
Dim2 (18.1%)
Dim2 (20.7%)
Dim2 (20.7%)
Dim2 (20.7%)
DINP
Toluene Toluene Toluene
Toluene
Toluene -1 -1 Toluene -1
– Identify priorities & mechanisms for filling data
-1
DEHP
-1
DEHP MEK
-1
DEHP MEK MEK
gaps MEK
DEHP
-2 MEK
DEHP
-2 MEK -2
DEHP
-2 -2 -2
– Inform the need/scope of higher tier (probabilistic) Cluster boundaries
shifted
-3 -3 -3
assessments and/or mixture risk assessment
-3 -3 D5 -3
D5 D5 D5 D5 D5
-2 0 2 -2 -2 0 0 2 2 -2 -2 0 0 2 2 -2 0 2
Dim1 (42.2%) Dim1 (42.2%)
Dim1 (41.1%) Dim1 (42.2%)
Dim1 (41.1%) Dim1 (41.1%)
Cluster composition may
change if more realistic
| 64
assessment performedECETOC exposure projects
strategically address CSS objectives
“Championing and promoting high standards”, e.g. by avoiding unnecessary
animal testing Industrial Professional
PROC20 PROC20
PROC19
PROC18 PROC19
ECETOC TF on Exposure Based Adaptations PROC17 Elevated
PROC17
PROC16
PROC15
PROC18
PROC17
PROC16
PROC15
PROC14
PROC13 PROC14 TRA worker predicted exposure
Volatility
– Develop a science-based decision and documentation PROC12
PROC11
PROC10
PROC9
PROC13
PROC12
LowPROC11
fugacity
with and without
Use RMMs
PROC10 Industrial
PROC8b Elevated
framework for EBA of human health endpoints PROC8b
PROC8a
PROC7 Industrial
Medium Fugacity
PROC9
HighPROC8b
Professionalfugacity
Professional
PROC8a
PROC6
PROC20
PROC5 PROC7
PROC20
PROC19
PROC4 Elevated PROC6
Industrial Professional PROC19
– Determine exposure refinement boundaries for common
PROC20
PROC19
PROC3
PROC18
PROC4
Elevated
PROC17PROC3
Elevated
PROC17
PROC2 Elevated
PROC20
PROC19
PROC5
PROC4
PROC3
PROC18
PROC17
PROC18 PROC16 PROC2
REACH exposure models
PROC17 Elevated
PROC17
PROC16 PROC14
PROC2
PROC15
PROC1
10
-2 0 2
10 10 10 10
4 -2 0
PROC18
PROC17
10 PROC16
2
10 10
4
PROC1
10
-3
PROC16
PROC15
-2
10PROC14 10
-1
10
0
10
1
10
2
PROC15 PROC13 PROC15
PROC14
PROC13
PROC12 Inhalation exposure, mg/m3 PROC14
Volatility
Dermal exposure, mg/kg/day
PROC13
PROC12 PROC11
Volatility PROC13 PROC12 Use
– Propose revisions to REACH Annex XI to allow consistent and
PROC11
PROC10
PROC9
PROC10
Low PROC9
fugacity
PROC8b Elevated LEV
RMM
RMMs exposure reduction efficiencies assumed
PROC12
PROC11Industrial Professional
depends on PROC
Note
LowPROC11
Medium
inh & derm (for PROCs 7, 11,
fugacity
PROC10
17, 18 only) Fugacity
Use
Industrial
Industrial
PROC8b Elevated PROC10
PROC8b PROC9
robust EBA approaches
Medium Fugacity Ventilation 0.7 0.3 inh exposure only
Professional
PROC8b PROC8a RPE
PROC9 0.05 0.1 inh exposure only Professional
PROC8a High fugacity Duration (15 min-1PROC8b
HighPROC8bfugacity
PROC7 PROC7 hour) 0.2 0.2 inh & derm
PROC8a
Gloves PROC8a 0.05 0.1 dermal exposure only
PROC6 PROC6 PROC7 PROC7
PROC5 PROC5
PROC4 Elevated PROC6 PROC6
PROC4 Elevated
• Clarify vague terminology
PROC4 Industrial
PROC3 Elevated
PROC20PROC3
Professional PROC4
PROC3 Elevated
PROC5
PROC4
PROC5
PROC4
PROC2 Elevated PROC3 PROC3 PROC20
PROC19 PROC2 PROC2 PROC3
PROC2 Elevated PROC19
• Re-consider restrictions on “risk-based” EBA
PROC18PROC1
PROC17 Elevated -2 0 2 4 -2 0 2
PROC2
4
PROC1
PROC18
PROC2
PROC110
PROC17 10 10 10 10 10 10 10 10 PROC1 10
-3
10
-2
PROC17 10
-1
10
0
10
1 2
PROC16 Inhalation exposure, mg/m3 -2 0 2 4 -2 0 Dermal
2 exposure,
4 mg/kg/day -3 -2 -1 0 1 2
PROC15 10 10 10 10 10 10 PROC16
10 10 10 10 10 10 10 10
PROC15
– Set up the basis for “smarter” hazardVolatility
PROC14
PROC13
PROC12
data generation
Inhalation exposure, mg/m3 PROC14
PROC13
Dermal exposure, mg/kg/day
PROC11
framework where actual exposure, not tonnage, drive data
PROC10
PROC9
Low fugacity
LEV
RMM
RMMs exposure reduction efficiencies assumed
PROC12
PROC11Industrial Professional
depends on PROC
Note
inh & derm (for PROCs 7, 11, 17, 18 only)
Use
Industrial
PROC8b Elevated PROC10
Medium Fugacity
requirements PROC8b
PROC8a High fugacity
Ventilation
RPE
PROC9 0.05
PROC8b
Duration (15 min-1 hour)
0.7
0.2
0.3
0.1
0.2
inh exposure only
inh exposure only
inh & derm
Professional
PROC7 PROC8a 0.05
Gloves 0.1 dermal exposure only
PROC6
PROC5 PROC7
PROC4 Elevated PROC6
PROC4 PROC5
PROC3 Elevated PROC4
| 65 PROC3
PROC2 Elevated PROC3
PROC2ECETOC exposure projects
strategically address CSS objectives
“Essential uses”, “safe and sustainable by design”
Drafting an exposure pillar for the new Transformational Program on
Evolutionary CSAs
– Develop a framework that defines what hazard Proposed Risk Management scheme
based on Hazard AND Exposure
data is necessary for a substance used in
specific applications
– Describe mechanisms to determine how hazard
data can be obtained
– Envision an exposure categorization
system to guide consistent risk-based
decisions on use(s) of substances
| 66Key Exposure scientists are keen to contribute to successful roll out of EU CSS
Exposure-driven frameworks can enable transparent, objective risk-based
takeaways decisions on chemicals management
Exposure data gaps need to be filled (with appropriate mechanisms)
• To inform hazard assessment
• To verify safe use
• To enable alternatives assessment
| 67Group discussion:
What could ECETOC do to
further support the CSS
implementation?
| 68Q1: What would be the top 3 points of focus of ECETOC efforts
Breakout in the CSS context?
groups •
session: •
•
What could Q2: What uncertainties in the CSS framework could be
ECETOC do to assessed through ECETOC work?
further support the
•
CSS
implementation? •
•
Comments:
•
•
| 69For more information, please contact
info@ecetoc.org
or visit our website
www.ecetoc.orgYou can also read
