Human

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Human Environmental Risk Assessment An
introduction to HERA an A.I.S.E and CEFIC
initiative on focused risk assessment for
household cleaning chemicals John Solbé Chair
of the HERA Members Forum and Management Team
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• The need
• The EU comprehensive risk assessment programme on
  Priority List substances is delivering very
  slowly.
• One danger for industry was the administratively
  convenient solution of chemicals management on
  the basis of hazard assessment only.
• The White Paper Strategy for a future Chemicals
  Policy puts an onus on industry
• Exposure estimates.should be obligatory for
  manufacturers and downstream users
• HERA anticipates
  this need.

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• Problems
• We have few publicly available risk assessments
  on detergent ingredients.
• We need a process for collecting and reviewing
  the required data.
• We need to identify significant gaps in hazard
  and exposure data.
• The existing risk assessment procedures contain
  default values set at highly conservative levels.
• We need streamlined but scientifically sound
  processes.
• Public confidence in chemicals needs to be
  improved - transparency in our work will help
• HERA set out to address these problems.

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• Outline
• Hazard and risk
• Historical perspective, including industry
  work, risk assessment for new and existing
  chemicals, priority and working lists of
  chemicals
• Origins of HERA
• HERA partnerships, objectives, focus
• HERA principles and programme
• Relationships with other initiatives the
  White Paper
• Organisation of HERA

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• Hazard and Risk
• What is the hazard of a substance?
• Some, or all, of its intrinsically harmful
  properties, including
• toxicity and ecotoxicity
• carcinogenicity, mutagenicity.
• flammability, corrosivity.
• irritancy, sensitisation potential etc etc
• Note that these arent necessarily included in
  HERA assessments.

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• Hazard and Risk
• What is the hazard of a substance?
• ..and properties which are not in themselves
  harmful but may increase the hazard of other
  properties, including
• persistence
• bioaccumulation potential.

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• Hazard and Risk
• What is hazard assessment used for?
• Classification, eg under the Classification,
  Packaging Labelling Directive 67/548/EEC.
• Examples of classifications
• very toxic to aquatic life
• carcinogenic
• toxic to honey bees
• irritant
• reproductive toxicant

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Hazard and Risk What is hazard assessment
used for? Identification of hazard by use of
symbols and safety phrases Some symbols, used
with warning labels Such symbols guide
users, and emergency services in the event of
accidents.
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Hazard and Risk What is risk? Risk is an
expression of the probability, the possibility or
the likelihood that hazardous properties,
combined with exposure, will cause harmful
effects. Therefore risk assessment involves an
estimate of probability or chance, based on the
co-incidence of a hazard and some kind of
exposure to that hazard.
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Hazard and Risk How is risk expressed? (a)
pictorially, statistically
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Hazard and Risk How is risk expressed? (b)
by risk diagrams
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Hazard and Risk How is risk expressed? (c)
by commonly understood reference points
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Hazard and Risk How is risk expressed? (d)
by comparing PEC and PNEC, or Margins of Safety
Situation (scenario) A
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Hazard and Risk How is risk expressed? (d)
Comparing PEC and PNEC
Lack of safety margin shows that a significant
risk exists in this prediction.
Situation (scenario) B
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Hazard and Risk How is risk expressed? (d)
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Hazard and Risk What happens when a significant
risk is predicted?
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Hazard and Risk separating the constituent parts
Exposure concerns all these areas Occupational,
Consumer, Environmental
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• Examples of exposure
• to skin
• to eye
• from diet
• to terrestrial environment
• to surface waters
• to the atmosphere

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Hazard is intrinsic it is independent of
usage, environment, quantity marketed etc
X
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• Examples of hazard
• dangerous to the environment
• corrosive
• highly flammable
• irritant
• harmful
• toxic

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Putting together exposure and hazard to evaluate
risk
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Graded risks white negligible black
severe grey intermediate The thickness of the
lines indicates the magnitude of the hazard or
likelihood of exposure.
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Historical perspective of legislation involving
hazard risk assessment relevant to the
detergents industry
Detergents
73/404/EEC detergents 73/405/EEC anionics
86/94/EEC detergents
82/242/EEC nonionics 82/243/EEC anionics
revision
60. . . .65. . . .70. . . .75. . . .80. . . .85.
. . .90. . . .95. . . .00
Risk assessment 93/67EEC (new subst) Reg 793/93
(existing subst)
Risk assessment included in 76/464/EEC(Dangerous
Subst)
General Chemicals
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Historical perspective of work on hazard and risk
assessment relevant to the detergents industry - ?
AIS/CESIO assembly of toxicity biodegradation
data for surfactants
Limelette III assessment of LAS, AE, AES, soap in
NL
89 90 91 92 93 94 95 96
97 98 99 00 01
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Historical perspective of work on hazard and risk
assessment relevant to the detergents industry -
??
89 90 91 92 93 94 95 96
97 98 99 00 01
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Historical perspective of work on hazard and risk
assessment relevant to the detergents industry -
???a
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Historical perspective of work on hazard and risk
assessment relevant to the detergents industry -
???b
ECETOC Technical Reports
Monitoring modelling for aquatic risk assessment
QSARs in environmental fate effect assessment
Value of aquatic ecosystem studies
Role of bioaccumulation in aquatic risk assessment
89 90 91 92 93 94 95 96
97 98 99 00 01
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Historical perspective - Priority Lists for risk
assessment of existing chemicals (number of
substances in brackets)
Fourth Priority List ( 30 )
Third Priority List ( 32 )
Second Priority List ( 36 )
S 140
First Priority List ( 42 )
89 90 91 92 93 94 95 96
97 98 99 00 01
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Historical perspective of work on hazard and risk
assessment relevant to the detergents industry -
?V Origins of HERA
A.I.S.E and CEFIC initiative on focused risk
assessment
CED XXXI Annual Meeting
Phases 1A and 1B and drafting of methodology by
Task Forces and Substance Teams administrative
communication arrangements developed
Founding meeting - September
89 90 91 92 93 94 95 96
97 98 99 00 01
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HERA Some detail..

• A European new joint initiative between
• A.I.S.E (International Soap, Detergent and
  Maintenance Products Association)
• and
• CEFIC (European Chemical Industry Council),
  suppliers of the raw materials

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HERA Partnership

• Producers
• and
• Downstream users
• of chemicals in household cleaning products.

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HERA Objectives

• To show with real examples that HERA risk
  assessment concepts can provide relevant safety
  information on ingredients used in detergent and
  cleaning products, to Authorities and to the
  public in a fast, effective and transparent way
• To contribute in a useful and practical way to
  the risk-based approach in EU chemicals
  legislation
• To serve as a pilot for possible application in
  other product sectors and /or geographical areas.

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HERA Risk Assessment Concept

• Focus on ingredients of household detergents
  and cleaning products and identify
• potential environmental effects
• potential effects on human health
• Focus on consumer phase
• known and probable uses and discharges
• of detergent and cleaning products
• ..a form of focused, targeted risk assessment

hazard
exposure
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HERA F O C U S
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HERA Principles

• Partnership chemicals/products manufacturers
• Open dialogue with stakeholders
• Transparency
• Data
• Procedures
• Sound science at all steps
• Risk (hazard probable exposure) based
  priorities
• Tiered approach
• No preconception of outcome of risk assessment
• Risk management to be considered where needed

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HERA Phased Work Programme
Phase 1

• Develop methodology for HERA risk assessments
• Objective rapid efficient, but still good,
  sound science

• Work on example substances
• Objective establish feasibility with industry
  partners, Authorities and all interested parties

Phase 2
Apply to a wider range of substances
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• Phase 1
• Scientific and regulatory stakeholder input
• 1A Establish methodology and write guidance
  manual, using three substances as examples
• alkylsulphates surfactant family,
• an optical brightener,
• a zeolite
• Additional stakeholder input
• 1B Evaluate and refine methodology on another
  15-20 substances, using Substance Teams
• Broad stakeholder input

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• Phase 2
• Use methodology on relevant A.I.S.E.
  Ingredients, again using Substance Teams
  (supported, as before, by advice from Task
  Forces).

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HERAs relationship with other chemical
initiatives
Voluntary initiative complementary to others
ICCA, ACA, EU Existing Chemicals current
programme and USA HPV program
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HERAs relationship with the EC White Paper
Strategy for a future Chemicals Policy, and other
international chemical programmes

• HERA looks compatible with the aspirations of
  such programmes, in terms of
• industry taking responsibility,
• focus (flexibility) driven by exposure,
• information to downstream users,
• grouping of substances,
• international integration and
• meeting the challenge of coping with existing
  substances.

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HERA Administration
HERA Sponsors
HERA SteeringCommittee
Communications Committee
Management Team
Secretariat
Environmental ExpertsTask Force
Human Health ExpertsTask Force
SubstanceTeams
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HERA Substance Teams

• multi-disciplinary
• expert knowledge
• one team per substance
• advised by Task Force members when needed
• assemble and approve hazard and exposure
  data-sets
• prepare and approve draft risk assessment reports

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HERA Databases

• data on substances
• confidential in individual details
• managed within AISE offices
• record of decisions with justification
• managed within AISE offices

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HERA Further presentations at CED XXXI
HERA Sponsors
HERA SteeringCommittee
Communications Committee
Management Team
Secretariat
Environmental ExpertsTask Force
Human Health ExpertsTask Force
SubstanceTeams
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HERA Summary

• We have focused our work on risk assessments for
  human health and the environment of the
  ingredients of household cleaning and detergent
  products.
• We have developed a collaborative team structure
  with responsibilities assigned to experts in risk
  assessment and communication, and to production
  and formulation. International communication and
  co-ordination are integral to the team.

HERA Focused RAhc S Focused RA1-n
Comprehensive RA
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HERA Summary

• We have established a methodology using a small
  number of substances and have incorporated
  advances in risk assessment thinking to help
  create an efficient, science-based process. Some
  advances have already been taken up at EU
  authority level.
• We have designated Substance Teams to use this
  process to complete assessments of the most
  important ingredients used in household cleaning
  and detergent products.

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• HERA is on its way!
• 
  Thanks for listening.