ES Examples from RIP 3'21 3'51 by Andreas Ahrens kopol Finn Pedersen Depa Workshop on REACH Exposure

1
ES Examples from RIP 3.2-1 3.5-1 by
Andreas Ahrens (Ökopol)Finn Pedersen
(Depa)Workshop on REACH Exposure
ScenariosArona, 14.02.06
2
Outline of presentation

• ES framework and steps of ES development - based
  on RIP-3.2-1 scoping study
• Examples of exposure scenarios
• Lessons learned and work ahead

3
Two functions of the ES in REACH

• An element in the CSA/CSR based on which the
  exposure assessment and risk characterization for
  a substance (group of substances) is carried out.
• A mean for communicating operational conditions
  of use and risk management measures that are
  suitable to ensure adequate control of risk
  (integrated into the current SDS system).

4
The REACH approach

• REACH top-down approach
• Manufacturers and importers are responsible for
  documenting safe use throughout the lifecycle
• ES for downstream uses is main instrument in CSA
• Requires knowledge on downstream uses
• The challenge
• Formulators and industrial users know the details
• Most industry companies use preparations and not
  single substances
• A substance based system is expected to generate
  appropriate risk management for preparations

5
Development of an ES (top-down)
Tentative (or initial) ES

• Information available
• in house at M/I
• in data bases or by models
• at DU associations

Final ES
CSA
Refinement of ES 1

• Information to be
• collected from customers
• collected by DU organizations
• generated by new models
• generated by measurements

CSA
Refinement of ES 2

• Information to be
• generated for special cases

CSA
6
Steps to develop an ES (1) - example

• Example
• Standard ES for
• Industrial textile dying and finishing
• Textile wear and wash by consumers
• 1. Identification of uses, e.g.
• industrial textile dying and finishing
• consumer textile dying and finishing
• textile washing (consumer, professional)
• industrial paper making

7
Steps to develop an ES (2) - example

• 2. Description of manufacturing or use processes
  in
• standard terminology
• Life cycle stage, e.g.
• industrial use or consumer use of preparation
• service life of article
• Process, e.g.
• Bathing, dipping and washing in aqueous solutions
• Printing and coating
• Spraying
• charging/loading and unloading machinery
• wearing of textiles
• Broad function of substance
• Processing aid
• Substance manufactured into a matrix

8
Steps to develop an ES (2) - example

• Relevant routes of exposure
• Inhalation at workplace (e.g. dye powder)
• Skin contact workers and consumers
• Waste water (local and regional) and waste
• Waste air (only in certain cases)

9
Steps to develop an ES (2) - example

• Operational conditions driving release and
  exposure
• used amount per time (environment)
• frequency and duration of use (worker and
  consumer)
• broad function of substance (environment and
  consumer)
• type of textile article (consumer)
• used amount per textile (consumer)
• degree of adsorption or fixation to fabric
  (environment and consumer) by process management
  practice
• dustiness of dye powder (worker)
• Padding process (dipping) or exhaust process
  (bath) (environment and worker)
• receiving water volume

10
Steps to develop an ES (3) - example

• 3. Risk management measures (including efficacy)
• under control of single company, e.g
• Purchase of low dust grade dyes
• Local exhaust ventilation
• Gloves
• Good standard dyeing practice
• Dispose off spent baths as waste
• Pre-treatment of waste water
• outside control of single company
• Municipal sewage treatment
• Disposal of sewage sludge
• Treatment dyeing liquors and printing paste

11
Steps to develop an ES (4) - example

• 4. Development of a tentative Exposure Scenario
• Select a suitable name for the use/process
  addressed in the ES e.g.
• Industrial dyeing and finishing of textiles
• Prepare a short process description
• List the relevant operational conditions for
  which the ES is applicable, e.g.
• No spray application
• Temperature lt 180
• Locally available water surface water volume gt
  50,000 m3 per day
• List which RMMs should be in place and which
  efficacy is assumed
• List the determinants required for exposure
  estimates

12
Steps to develop an ES (5-7) - example

• 5. Assessment of exposure and risk, decision on
  iteration strategy, if needed
• Carry out exposure estimate and compare with DNEL
  or PNEC gt examples on spread sheets
• Decide how to proceed based on risk
  characterization
• Collect more information on use and exposure or
• tighten RMM or define a more narrow corridor for
  the operational conditions of use or
• refine the hazard assessment carry out
  additional testing no further support of use
• 6. Derive final Exposure Scenario
• 7. Integrate the ES into the Safety Data Sheet

13
Examples of simple Exposure Scenarios

• Bottom-up approach
• Consumer use of preparation (laundry detergent)
• Consumer use of article (textile)

14
7. Bottom up top down bottom up ..

• identified uses for which the ES is applicable
• operational conditions of manufacturing and use
  driving exposure
• risk management measures appropriate for safe use
  
• determinants for estimation of exposure in the CSA

SDS ES
SDS ...
SDS ...
Producer of substances
User of preparation
Preparation- maker 1
Preparation- maker 2
User of preparation
Producer of substances
15
Lessons learned (1)

• Developing ES under REACH (action by MFIU)
  requires a sector specific and/or a chain
  specific setting related to
• knowledge and skills of companies
• translation of branch specific technical language
  into REACH standard language and visa versa
• speciality and/or commodity market
• confidentiality requirements
• role of traders
• technical conditions to control release and
  exposure in large industries, small industries,
  professionals
• environmental conditions to absorb emissions

16
Lessons learned (2)

• Bottom-up mechanisms are needed
• The registrant usually does not have direct
  contact (customer relations) to companies/sectors
  where the industrial or professional use takes
  place.
• The ES should be based on typical conditions of
  use however these are known to the DU rather than
  M/I
• The conditions of use may vary, and the
  registrant may fail to set the right standard
  from the top-down perspective.
• A tentative ES worked out by DUs (and sent to
  suppliers) would prevent the need to integrate
  various ESs received from different suppliers
• Better practical possibilities to develop generic
  branch-specific ES at DU level

17
Lessons learned (3)

• Use the current SDS mechanisms with regard to
  preparations as a starting point for procedures
  to forward the information received with the
  substance-ES
• Identified use still a major issue for
  clarification
• A set (library) of standard titles would
  facilitate a common understanding on what
  identification of use means in practice.
• Clarify relationship between identified use and
  exposure scenario