Consultant experience on the development of Exposure Scenarios

1. Consultant experience on the development of Exposure Scenarios 2nd Workshop on REACH Exposure Scenarios (Human Health) – Industry, ECHA and Authority Perspectives Hans Marquart 2nd Workshop on REACH Exposure Scenarios (Human Health)

2. The issues as seen by a consultant

3. Process - Cooperation: ES needs CSA • No Exposure Scenario without a Chemical Safety Assessment

4. Use identification misunderstood Exposure Scenario unclear

5. Process – Cooperation • Offer  agreement • Division of work • Hazard – Exposure (Risk?) • Human health – Environment • CSA – CSR – Exposure Scenarios for SDS • Scope of work • Tier 1 only • Followed by Tier 2 • Consortium – One client (consortium in background) • Technical committee – Steering committee Content Money Time

6. Process smooth or not? By the way: Here are the new DNELs! Start: Mid 2009 Dec 2010 Jan 2010

7. Crucial information on exposure

8. Challenges – science? Yes, this really is gasoline! • Strange use descriptors • ES = Use of a fuel  PROC 19 (hand mixing)??? • Calculate with high percentage in product • Unrealistic duration of exposure in calculations • Tier 2 assessments? • Lower percentage • Changes in classification • And suddenly we had to do an exposure assessment …. • Sensitisation • How realistic are DNELs? • Can safe use ever be shown? • Is qualitative assessment sufficient? • Physical hazards • Guidance not highly practical Selma, go home, your 15 minutes are over! Sensitive? Na I use protective gloves! Just check some local details!

9. Deadlines! • Early birds • Sufficient time • Realistic scenarios • High quality dossiers • Late requests • Extra pressure • Limited quality • Priority / money? • Update needed after 2010 • Quantities in exposure scenarios • Allocation not yet decided • Make CSA based on preliminary findings • Re-do exposure assessments and chapter 10 ….. and again

10. Preferences Manufacture Formulation Industrial use * 2 Professional use * 2 Consumer use Manufacture Formulation Uses high percentages Uses low percentages Manufacture Formulation * 2 Industrial use * 8 Professional use * 6 Consumer use * 4

11. Preferences - 2

12. Tools 2010: manual – slow – one-by-one – error prone 2013: part automated – faster – bulk – reduced possibilities for error 2018: automated – lightning fast – all-at-once – failsafe?

13. Coping with difficulties

14. From ES to eSDS - lessons learnt • CSRs differ in quality – enormous range! • No safe use • RMM are insufficient, e.g. no gloves for corrosive substance • Inconsistency in RMM • Inadequate description of RMM • But: eSDS should be consistent with CSR • CSR could contain different level of detail • Registrants preferences • Tools/data used • Format used • Solutions: • Stuck to ‘standard company format’ • Vary level of detail according to CSR

15. From ES to eSDS: Practical advice

16. Integrate eSDS generation and distribution • Several IT-systems have an eSDS module • Standard phrases  easy translation • Non-standard phrases  internal standardisation • Implement internal standard phrases in your system • Entering ES in system: not just typing • Expertise required • Check: are users of the substance sufficiently protected? • Errors need to be corrected • Discrepancies resolved • Distribution on paper or electronically • E.g. e-mail

17. eSDS - what downstream user may expect • The SDS with Exposure Scenarios may: • Have a different format, e.g. • Excel table • Word format • Automated, e.g. SAP or Atrion/IHS • Contain only your, or all possible uses • 1 ES: about 2-3 pages • Some substances have up to 50 ES • Be of different quality • Due to the CSR quality • Due to a lack of knowledge of the eSDS creator • Describe the OC and RMM in a very different level of detail • Depending on the type of exposure assessment • Due to the use of standard phrases or not

18. ES in risk communication: will it work? • Experience: many eSDS not understandable • Standard REACH language ≠ user language • Conditions are too stringent • Professional rolling for up to 15 minutes? • Large flexibility in conditions  stringent RMM • Splitting ES for large and small users? • Do the ES reach the work floor? • New, better OC and RMM? • Does the user take account? • Will risks be lower?? Selma, go home, your 15 minutes are over!

19. How the client sees the consultant

20. The end – Thanks!