Experience

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Experience Conclusions from testing the Draft
cTGD

• Dr. Christine Stevens D.A.B.T.
• Dow Corning

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Characterization according to market risk
properties

• Substance volatile siloxane
• Classification and Labelling F N (R11, R50)
• Use identification
• Polymers Intermediates
• Used in personal care
• Off-site chemical intermediate
• Automotive

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Environmental Emission Estimation

• Method Exposure Tools
• ECETOC TRA
• EUSES (European Union System for Evaluation of
  Substances)
• cTGD Part A Questionnaire
• AISE exemplification based on detailed
  discussions with a customer to obtain their
  estimation of potential losses
• Output from AISE exemplification compared with
  EUSES output
• At all stages where more accurate information was
  available, EUSES defaults were overwritten
• Conducted for personal/domestic chemical
  intermediate use

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Environmental Emission Estimation
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Prediction of Regional Concentrations
PECRegional

• Regional background reflects all EU inputs from
  all sources
• Regional background obtained by dividing total
  tonnage by 10 (10 theoretical regions)
• However this may be amended if all the production
  use occur in a single region
• Quantities emitted to the various compartments
  depends on the phys/chem properties of the
  material. This is calculated by EUSES
  automatically
• The Regional Background is also added when
  calculating Local Emissions

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Prediction of Regional Concentrations
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Prediction of Local Concentrations (PECLocal)

• Local concentrations are calculated using the
  local production or processing tonnages, combined
  with EUSES defaults for emission fractions
  released to the environment number of emission
  days per year (the infamous A B tables)
• These are highly conservative defaults should
  be overwritten if site specific data is
  available
• Recognising this, ECB intends that in future
  re-iterations of the model, e.g. the EUSES
  Spreadsheet version, the AB tables will be
  replaced by specific information
• To improve the output of the model very detailed
  information is required.

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Prediction of Local Concentrations
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Risk Characterization Ratios (RCRs)
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Key Experience and conclusions

• Draft cTGD part A questionnaire is too detailed
  for many DU.
• Likely that will need two levels of detail for
  the questionnaire for customers with without
  expertise
• Good quality feedback on the questionnaire is
  essential, but, more detail required to avoid
  generating over cautious RA
• Questionnaire does not address re-use of waste
  (on DU site) or cleaning of vessels process
  lines, or maintenance

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Key Experience and conclusions

• Use descriptors in TGD EUSES do not correspond
• Descriptor for technical function has limited
  value is difficult to assign What happens if
  product serves more than one technical function?
  e.g.
• Adhesion Promoter
• Curing Agent
• Sizing Agent
• Also may encounter confidentiality problems as
  customers do not want to reveal exact function of
  an ingredient in a formulation
• Problem that procedures vary from one customer to
  another (even if doing same basic process), such
  that exposures will differ. Must therefore base
  it on worst-case or sub-divide into e.g. two
  levels of environmental protection.

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Key Experience and conclusions (re environment)

• ECETOC TRA Phase 1 not adequate for Tier 1
  Environmental assessment too simplistic
  automatically requires a Tier 2 assessment
• Tier 2 Tool EUSES (European Union System for
  Evaluation of Substances)
• Developed to support Existing Substance RAs
• Based on Industry Use Categories (IC/UC) and A
  B Emission Tables
• Complex requires expert user
• Large amount of detailed information required to
  avoid the application of highly conservative
  defaults
• Initial input data may generate RCRs gt 1.0 for
  some compartments

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Key Experience and conclusions

• EUSES is a good tool but require a high level of
  expertise unlikely that all but the large DUs
  have this. Therefore subdivide customers
• Work with key customers to develop use-specific
  ES
• Translate into generic form to send to other less
  skill-rich DU
• Process has only evaluated a single substance,
  will be much more complex for preparations
• It is not clear how useful these tools or the
  Phase II developments will be to assess
  environmental exposure of Preparations

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Additional tools

• EU TGD Spreadsheet Version
• Simpler to use than EUSES
• Not reliant on A B Tables (ECB to drop these as
  no substantiation for some emission values)
  specific emission data can be inputted
• Enables impact of changes in input data to output
  data to be seen at once
• But errors exist in the spreadsheet code, which
  still need rectifying

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Improvements to Existing Tools

• ECETOC TRA Phase II objective is to
• Generate a user-friendly tool
• Based on EU TGD Spreadsheet Version, with the
  proviso
• Inconsistencies with EUSES are corrected
• Will be able to calculate safe emission levels
• Enable Tier 1 assessment based on minimal data
  input
• Enable higher Tier assessment based on more
  detailed data input
• Identifies the Target Compartment of concern
  calculates the quantity of material which can be
  used without exceeding RCR of 1
• Provides a Customer Scaling Tool for the customer
  to conduct his/her own compliance check for
  specific site conditions
• Should also include option to calculate partial
  vapour pressures for complex mixtures/preps