Human

1
Human Environmental Risk Assessment Human
Health Risk Assessment under HERA Challenges and
Solutions Christeine Lally Co-Chair of the HERA
Human Health Task Force
2
Human Health Task Force
C. Poelloth, C. Arregui, J. Backmann AISE
Secretariat

• G. Holland (Unilever)
• C. Lally (PG)
• F. Bartnik (Henkel)
• J. Boyd (Colgate)
• G. Helmlinger (PG)
• S. Kirkwood (McBride)
• ( co-chairs )

• 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)

3
Human Health Task Force

• The GOAL
• propose a Methodology for a Human Health Risk
  Assessment (hazard exposure)
• test the Methodology with 3 initial chemicals
  alkyl sulphates, a zeolite, an optical brightener
  (Phase IA)
• seek peer consultation from scientific
  stakeholders
• refine Methodology -Framework Document
• deploy Methodology to Phase IB (15-20) and
  refine further (lessons learned!)

4
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
• focus on consumer use of these products (i.e.
  not professional use or workplace exposure)
• focus on intended use but also consider other
  foreseeable uses and accidental use
• focus on endpoints of concern for the consumer
  from the exposures expected from AISE products

5

• Human Health Conclusions
• Specific for European Usage

HERA Human Health Risk Assessment based on EU
Technical Guidance Document for New and Existing
substances
6

• 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?)

7
What do consumers do with products ?
?
8

• 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

9

• 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)

10
(No Transcript)
11

• 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

12
Consumer Exposure
13

• 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

14
Consumer Hazard
15
(No Transcript)
16

• 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.)

17

• 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)
• Expert judgement
• Transparency in arguments decisions !

18

• Thank You !
• Gracias !