Human & Environmental Risk Assessment
Human Health Risk Assessment under HERA:
Challenges and Solutions
Christeine Lally
Co-Chair of the HERA Human Health Task Force
HERA at CED XXXI C.Lally
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Human Health Task Force
C. Poelloth, C. Arregui, J. Backmann – AISE Secretariat
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G. Holland (Unilever) *
C. Lally (P&G) *
F. Bartnik (Henkel)
J. Boyd (Colgate)
G. Helmlinger (P&G)
S. Kirkwood (McBride)
( * = co-chairs )
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W. Aulmann (Cognis)
O. Grundler (BASF)
S. Jacobi (Degussa)
R. Kreiling (Clariant)
M. Maier (ZEODET)
P. Martin (Rhodia)
H. Messinger (Cognis)
J.R. Plautz (Ciba)
G. Veenstra (Shell)
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Human Health Task Force
 The GOAL
propose a Methodology for a Human Health Risk
Assessment (hazard + exposure)
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test the Methodology with 3 initial chemicals – alkyl
sulphates, a zeolite, an optical brightener (Phase IA)
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seek peer consultation from scientific stakeholders
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refine Methodology -“Framework Document”
deploy Methodology to Phase IB (15-20) and refine
further (lessons learned!)
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Human Health Task Force
 The Process
 focus on a tiered approach to both hazard and
exposure assessment
focus on chemicals used primarily in AISE products –
hazard profiles and potential exposure for humans
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focus on consumer use of these products (i.e. not
professional use or workplace exposure)
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focus on intended use but also consider other
foreseeable uses and accidental use
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focus on endpoints of concern for the consumer from
the exposures expected from AISE products
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 Human Health Conclusions
Specific for European Usage
HERA Human Health Risk Assessment
based on EU Technical Guidance Document
for New and Existing substances
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The HERA methodology follows a tiered approach:
Consider possible uses of chemicals in household
detergent and cleaning products
Consider consumer activity during cleaning tasks review also foreseeable other uses of products
Consider hazards which are relevant for known
product uses and exposures (e.g. is dermal contact
likely? could ingestion occur inadvertently?)
Consider also serious adverse effects (e.g. cancer,
reproductive toxicity) and review relevance for
consumer exposure through product use
Determine whether the consumer is at risk? (is the
Margin of Exposure adequate for consumer safety?)
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What do consumers do
with products ?
?
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USE & EXPOSURE
Identify
which product category (laundry compact, fabric
conditioner, toilet cleaner….)
product concentration (% in product, range)
type of application (powder, tablet, spray,
wipe….) and how is product used
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Formulator companies asked to provide (in
confidence):
 Use levels of Phase 1A and 1B ingredients in their
products
 List of product categories where ingredients are
currently used
 Published or in-house data on consumer habits and
practices for product categories (at least provide
‘recommended use’)
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CATEGORY
Grams/Task
(grams/use)
Use Frequency
(Fill in LEFT or RIGHT column)
# Tasks per
week
Duration of
Task
(minutes)
Other uses of
product
Geography where data
apply & Data source
(A) # Tasks / day
(B) # Days / week
LAUNDRY REGULAR
Powder
Liquid
LAUNDRY COMPACT
Powder
Liquid
Tablet
Gel
FABRIC CONDITIONERS
Liquid Regular
Liquid Concentrate
Others (SPECIFY)
LAUNDRY ADDITIVE
G. Helmlinger, version.3.1 – 25/02/2000
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USE & EXPOSURE
 HERA provides simple multiplicative mathematical models
– based on exposure equations in EU TGD and in ECETOC
Technical Reports
 HERA uses real data (formulators) or, if unavailable, it
uses ‘reasonable’ defaults
 HERA uses a conservative ‘worst case’ scenario in first
step (tiered approach)
 HERA checks exposure estimate for ‘realism’
 HERA considers need for more refined exposure estimate
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EXPOSURE
Identify where ingredient used
Product category and form (e.g. gel, tablet…)
Concentration range of ingredient in product
Consumer Contact with product
Use scenarios (recommended, foreseeable uses, accidents)
Relevant exposure routes
Indirect Exposures (via the Environment)
Estimate Exposure using Simple Models
Apply H&P data, defaults, models
Use measured data where available
Consumer
Exposure
Combine Exposure Estimates
Use additive approach to give consumer ‘dose’
Include indirect exposure estimates from Environment TF
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HAZARD
Producer companies asked to:
collect available toxicology data on ingredient – IUCLID,
SIDS, IPCS, in-house company data etc.
validate data based on current standards - but do not
discard older data; consider human experience
consider toxicological endpoints most relevant for use endpoints of interest largely driven by predicted exposure;
identify no-effect-levels and possible data gaps
And Formulator companies asked to provide:
product safety data where available and useful
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HAZARD
Collect toxicological data on ingredient
Validate the data required
Criteria for reliability
Identify critical endpoints of concern and data
gaps
Consider bridging data, QSAR and product safety data
Consumer
“Hazard”
Summarise relevant data (robust summaries)
focused on relevant exposures and endpoints
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EXPOSURE
HAZARD
Identify where ingredient used Collect toxicological data on
Product category and form (e.g. gel, tablet…)
ingredient
Concentration range of ingredient in product
Consumer Contact with product Validate the data required
Use scenarios (recommended, foreseeable
uses, accidents)
Relevant exposure routes
Indirect Exposures (via the Environment)
Criteria for reliability
Estimate Exposure using
Simple Models
Identify critical endpoints of
concern and data gaps
Apply H&P data, defaults, models
Use measured data where available
Consider bridging data, QSAR and product
safety data
Combine Exposure Estimates
Summarise data (robust
summaries) focused on relevant
exposures and endpoints
Use additive approach to give consumer ‘dose’
Include indirect exposure estimates from
Environment TF
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Is the consumer at risk…?
 compare relevant hazard(s) with foreseeable
exposure(s) for consumer
 ratio of “no effect level” and “exposure”  MOS
or “margin of safety” [NOAEL/Exposure = MOS].
 consider whether MOS is adequate to protect the
consumer – follow guidance in Technical Reports from
ECETOC and in EU TGD
 how good is the answer ? (Uncertainty….)
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Is the consumer at risk…?
If MOS is unacceptable……..
 review exposure estimates
 review hazard dataset
 consider product safety data
 use human experience data
 get more data…. (exposure, hazard…)
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Expert judgement
Transparency in arguments & decisions !
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 Thank You !
 Gracias !
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