2nd Exposure scenario workshop

1
European Commission
Enterprise and Industry Directorate-General

• 2nd Exposure scenario workshop
• Break-out session 1
• REACH requirements related to exposure scenarios
  for consumer use and waste stage
• Elina Karhu DG ENTR
• Stresa, 9 June 2006

2

• Obligations related to consumer uses
• Manufactures / importers of substances
• Downstream users of substances
• Obligations related to waste stage
• Consumer exposure assessment
• Communication in the supply chain
• (Further development needs) (Suggest to delete)

3
Obligations of manufacturers/importers of
substances related to consumer uses

• A Manufacture or importer of a substance has to
• identify operational conditions (OCs) and risk
  management measures (RMMs) needed to control the
  risks related to consumer uses (consumers and the
  environment)
• demonstrate by an exposure assessment and risk
  characterisation that risks are controlled when
  those OCs and RMMs are applied
• document the consumer exposure scenario(s)
  ( recommended OCs and RMMs) and
  exposure assessment as a part of the CSR
• communicate down the supply chain the exposure
  scenario as an annex of a SDS (NB consumers do
  not receive SDS)

4
The role of the downstream users related to
consumer uses

• Downstream users (e.g. producer incorporating a
  substance in a consumer article)
• Have a possibility
• To inform his supplier of his use to get his used
  covered by the M/Is CSR
• NB the DU needs to provide sufficient information
  
• Needs to
• check that his use is covered by the ES
  communicated to him as annex to a SDS and
• implement at least as effective RMMs and
  operational conditions recommended in the ES
• OR
• prepare his own CSR and notify it to the Agency
• Implement the relevant RMMs

5
Exposure assessment Level of detail

• Level of detail is defined by the need to
• identify risk management measures and operational
  conditions needed to control the risk
• demonstrate that the risks are controlled

6
Exposure assessment Steps

• Identify the consumer uses
• Generate information on the use conditions
  determining the exposure (i.e. the determinants
  of exposure)
• Screen the uses to identify where there is a need
  for more detailed exposure assessment
• Conduct more detailed exposure assessment where
  needed
• Document the Exposure Scenario leading to
  conclusion that risks are adequately controlled

Iteration
7
Exposure assessmentinformation needs

• Consumer uses
• the short titles / identifier for uses
• Use conditions/determinants of exposure ( ES)
• frequency / duration
• amount applied
• factors determining the release from the matrix
• risk management measures
• product integrated
• measures applied by consumers
• Supply chain communication
• Ways to deal with confidential business
  information

8
Communication in the supply chain

• M/I of a substance needs information on the uses
  and use conditions to fulfill his registration
  obligations under REACH
• A DU of a substance producing consumer products
  benefits from submitting the information on his
  use and on the use conditions during the
  service-life of his products
• to fulfill his DU obligations under REACH
• to facilitate him to meet his obligations under
  the GPSD
• NB A DU may further detail the assessment he
  recieves
• Ways to deal with confidential business
  information
• Further development of means and tools to
  facilitate the communication RIP 3.2 and 3.5

9
Obligations of manufacturers/importers of
substances related to the waste stage

• When exposue scenairos are required also the
  waste stage has to be addressed
• Waste ES not to be communicated to the waste
  operators gt End of the supply chain is broken
• ES mainly needed in order for the M/I to ensure
  that the overall release of the substance will
  not cause any risks and to recommend DU how to
  dispose of waste containing the substance
• RIP 3.2-2 task to suggest general ESs for a
  number of standard waste operations

10
Conclusions

• Exposure scenario is a key output of the
  assessment
• REACH requires the manufacturers / importers of
  substances to
• generate information on intrinsic properties of
  substances and exposures (health and environment)
  resulting from consumer uses and waste stage(s)
• assess the risks
• identify and communicate risk management measures
  and operational conditions needed to manage risks
• Main (new) guidance and tool needs are related to
  these Manufacturer / Importer obligations
• how to identify consumer uses and waste stage(s)
• how to screen on the basis of available
  information consumer uses and waste stages
  requiring more detailed assessment
• RMMs and their efficiency
• support for supply-chain communication