REACH: Chemical Safety Report RIP 3'2

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REACH Chemical Safety Report (RIP 3.2)
Dr. Erwin Annys Sr. Advisor Product Innovation
Policy WERCS 2007 EU User group Napoli 31/05/07
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Annex I

• A chemical safety assessment consists of
• Evaluation human health hazard
• Evaluation physicochemical hazard impact on
  human health
• Evaluation environmental hazard
• PBT en vPvB evaluation

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Annex I

• If this ends up in a classification according to
  directive 67/548/EEG or 1999/45/EG or as PBT or
  vPvB
• Exposure assessment
• Risk characterisation

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Human health hazard assessment

• Objectives
• Classification and labelling according to
  67/548/EEC
• Determine the levels not to be exceeded upon
  exposure by man
• Derived no effect level DNEL
•  Treshold concentration 

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Human health hazard assessment

• Following effects are evaluated
• Toxicocinetics, metabolism and distribution
• Acute effects (toxicity, irritation and
  corrosion)
• Sensibilisation
• Toxicity repetitive administration
• CMR-effects

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Human health hazard assessment

• The evaluation consists of four steps
• Step 1 Evaluation of other information than on
  man
• Step 2 Evaluation of information on man
• Step 3 Classification and labelling
• Step 4 Derive DNEL and treshold concentration

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Human health hazard assessment

• Step 1 Evaluation of other information than on
  man
• Identification of hazard based on all available
  non human information
• Determine quantitative relationship between dose
  (concentration) and respons (effect)

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Human health hazard assessment

• If not possible then semi quantitative or
  qualitative
• Describe all information (preferentially tabular)
  (LD50, NO(A)EL, LO(A)EL)
• If different studies available, use the one
  raising the highest concern

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Registration
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Registration
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Human health hazard assessment

• Step 2 Evaluation of information on man
• If nothing available, mention this explicitky

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Human health hazard assessment

• Step 3 Classification and labelling
• Directive 67/548/EEC, a comparison with the
  criteria of CMR substances category 1 or 2 must
  be evaluated
• If not sufficient information to determine the
  endpoint, the registrant has to motivate this

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Human health hazard assessment

• Step 4 Derive DNEL and treshold concentration
• Based
• On results in step 1 - 3
• Expected exposure routes
• Time, frequency
• More than one value may be necessary
• Take care of relevant human populations
• Workers
• Consumers
• Indirect exposure via environment

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Human health hazard assessment

• Upon determination of DNEL treshold
  concentration consider following factors
• The uncertainty, result of variability
  experiments and interspecies variations
• The nature and severity of the effect
• The sensitivity of the human population
  consideredde

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Physicochemical hazard assessment

• Objectives
• Classification and labelling according to
  67/548/EEC
• Potential effects to human
• Explosivity
• Flammability
• Oxydising potential

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Registration
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Environmental hazard assessment

• Objectives
• Classification and labelling according to
  67/548/EEC
• Determine predicted no-effect concentration -
  PNEC

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Registration
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Registration
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Environmental hazard assessment

• Consider potential effects on the environment
• Aquatic compartment (including sediment)
• Terrestrial compartiment
• Atmospheric compartiments
• Possible effects via food chain accumulation
• Potential effects on microbiological activity of
  sewage treatment

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Environmental hazard assessment

• The hazard assessment comprises three steps
• Step 1 Evaluation of information
• Step 2 Classification and labelling
• Step 3 Derivation Predicted No-Effect
  Concentration (PNEC)

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Environmental hazard assessment

• Step 1 Evaluation of information
• The avaluation shall comprise
• Hazard identification based on all available
  information
• Determine quantitative relationship between dose
  (concentration) and respons (effect)
• If not possible then semi quantitative or
  qualitative

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Environmental hazard assessment

• All information shall be briefly commented, if
  possible in table form mentioning relevant test
  results (LC50 or NOEC) and test conditions (test
  duration, route of administration)
• If different studies available, use the one
  raising the highest concern

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Environmental hazard assessment

• Step 2 Classification and labelling
• Directive 67/548/EEC
• If not sufficient information to determine the
  endpoint, the registrant has to motivate this

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Environmental hazard assessment

• Step 3 Derivation Predicted No-Effect
  Concentration (PNEC)
• Based on the available informationthe PNEC for
  each environmental sphere shall be established.
  de PNEC voor elk milieucompartiment bepaald. The
  PNEC may be calculated by applying an appropriate
  assessment factor to the effect values (such as
  LC50 or NOEC).
• If it is not possible to derive the PNEC, then
  this shall be clearly stated and fully justified

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PBT and vPvB assessment

• The PBT and vPvB assessment is based on all
  information entered in the technical dossier. If
  the dossier only contains information on the
  endpoints requested for annex V and VI, then the
  registrant has to consider whether additional
  information has to be generated to make the PBT
  vPvB assessment possible

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PBT and vPvB assessment

• The PBT and vPvB assessment comprises two steps
• Step 1 Comparison with the criteria
• Step 2 Emission characterisation

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PBT and vPvB assessment

• Step 1 Comparison with the criteria
• Compare with the criteria described in annex XII
  

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PBT and vPvB assessment

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PBT and vPvB assessment
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PBT and vPvB assessment
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PBT and vPvB assessment

• Step 2 Emission characterisation
• If the substance fulfils the an emission
  characterisation shall be conducted comprising
  the relevant parts of the exposure assessment as
  described in Section 5. In particular it shall
  contain an estimation of the quantities of the
  substance released to the different environmental
  compartments during all activities carried out by
  the M/I and all identified uses, and an
  identification of the likely routes by which the
  humans and the environment are exposed to the
  substance

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Exposure assessment

• Objective
• Quantitative or qualitative estimation of
  dose/concentration of substance to which humans
  and environment are or may be exposed. The
  assessment has two steps
• Step 1 generation of exposure scenarios
• Step 2 exposure estimation

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Exposure assessment

• Step 1 generation of exposure scenarios
• Iterative
• For each identified use
• An exposure scenario gives the operating
  conditions and the risk management measures for
  production and use of the substance in all parts
  of the chain and covering the whole life cycle

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Exposure assessment

• Production processes
• The processes for the identified uses of the
  substances
• The applied risk management measures by the
  producer
• The risk management measures to reduce or avoid
  exposure of humans and environment to the
  substance during use, waste, disposal and
  recycling

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Exposure assessment

• Step 2 exposure estimation
• The exposure is estimated for each exposure
  scenario and contains three
• Estimation of the emission
• Assessment of chemical fate and pathways
• Estimation of exposure levels

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Exposure assessment

• Emission in all relevant phases of the life cycle
  are estimated taking into consideration the risk
  management measures
• The characterisation of of possible
  transformation, degradation or reaction products
  and an estimation of the distribution and fate
  shall be done
• An estimation of the exposure levels for all
  populations
• Workers, consumers, indirect exposure
• By each relevant exposure route
• Inhalation, oral, dermal and combinations
• Considering
• Frequencies, duration

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Risk characterisation

• The risk characterisation will be done for each
  exposure scenario
• Looking at the risks for all human populations
  and the environmental compartments

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Risk characterisation

• The risk characterisation consists of
• A comparison of the exposure of each human
  population known to be likely to be exposed with
  the appropriate DNEL and treshold conc
• A comparison of the predicted environmental
  concentrations in each environmental sphere with
  the PNECs
• An estimation of the likelihood and severity of
  an event occurring due to the physicochemical
  properties of the substance

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Risk characterisation

• For any exposure scenario the risk to humans and
  the environment can be considered to be
  adequately controlled, throughout the lifecycle
  of the substance that results from manufacture or
  identified uses if
• The exposure levels do not exceed the appropriate
  DNEL, treshold concentration and PNEC
• The likelihood and severity of an event occurring
  due to the physicochemical properties of the
  substance is negligible

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Thanks for your attention