1. Handling of Exposure Scenarios for mixtures ESmodifier®

2. Focus group: Formulators of end-use products
Own use
Customers use
ESmodifier

3. Formulators are challenged by REACH
Background for development of ESmodifier®
Hundreds of substances
1000
Thousands of products
Use 1
Use 2
Use 3
Use 4
100
#Substances
#Products
#Products×Uses
ESmodifier 

4. Own ES for substance(s)
Principle
Data from Supplier
(Registrant)
- Substance data
- Classification
- DNEL/PNEC
- Exposure Scenarios
Own data
Own uses
Own conditions
Customer uses
Customer conditions
Composition data
ESmodifier®
Own ES for substance(s)
ES for own mixtures

5. } Principle Data from Supplier (Registrant) - Substance data
- Classification
- DNEL/PNEC
- Exposure Scenarios }

6. } Principle Data from Supplier (Registrant) - Substance data
- Classification
- DNEL/PNEC
- Exposure Scenarios }
Headline data SU
CES(E): ERC, Determinants
CES(H): PROC, Determinants SU
CES(E): ERC, Determinants
CES(H): PROC, Determinants SU
CES(E): ERC, Determinants
CES(H): PROC, Determinants SU
CES(E): ERC, Determinants
CES(H): PROC, Determinants
CES(E): ERC, Determinants
CES(H): PROC, Determinants

7. Own ES for substance(s)
Principle
Data from Supplier
(Registrant)
- Substance data
- Classification
- DNEL/PNEC
- Exposure Scenarios
Own data
Own uses
Own conditions
Customer uses
Customer conditions
Composition data
ESmodifier®
Own ES for substance(s)
ES for own mixtures

8. { Principle Own data Own uses Own conditions Customer uses
Customer conditions
Composition data {
Headline data SU
CUS(E): ERC, Determinants
CUS(H): PROC, Determinants SU
CUS(E): ERC, Determinants
CUS(H): PROC, Determinants SU
CUS(E): ERC, Determinants
CUS(H): PROC, Determinants SU
CUS(E): ERC, Determinants
CUS(H): PROC, Determinants
CUS(E): ERC, Determinants
CUS(H): PROC, Determinants

9. { Principle Own data Own uses Own conditions Customer uses
Customer conditions
Composition data {

10. Principle – Mixtures step 1
Data substance 1
- Classification
- DNEL inhalation
- DNEL dermal
- PNEC (environment)
- Exposure Scenarios
Own data
Own uses
Own conditions
Customers uses
Customers conditions
Composition data
Data substance 2
- Classification
- DNEL inhalation
- DNEL dermal
- PNEC (environment)
- Exposure Scenarios
ESmodifier®
Check/adjust
Data substance 3
- Classification
- DNEL inhalation
- DNEL dermal
- PNEC (environment)
- Exposure Scenarios
(check if own uses or customers uses are (can be) covered by the Exposure
Scenarios recieved from supplier)

11. Principle – Mixtures step 2
Data substance 1
- Classification
- DNEL inhalation
- DNEL dermal
- PNEC (environment)
- Exposure Scenarios
Own data
Own uses
Own conditions
Customers uses
Customers conditions
Composition data
Data substance 2
- Classification
- DNEL inhalation
- DNEL dermal
- PNEC (environment)
- Exposure Scenarios
ESmodifier®
DPD+
Data substance 3
- Classification
- DNEL inhalation
- DNEL dermal
- PNEC (environment)
- Exposure Scenarios
(Uses the classification of the component substances together with their percentages, to determine the risk determining substance per exposure route)

12. Principle – Mixtures step 3
Data substance 1
- Classification
- DNEL inhalation
- DNEL dermal
- PNEC (environment)
- Exposure Scenarios
Own data
Own uses
Own conditions
Customers uses
Customers conditions
Composition data
Data substance 2
- Classification
- DNEL inhalation
- DNEL dermal
- PNEC (environment)
- Exposure Scenarios
ESmodifier®
Exposure/risk estimation
Data substance 3
- Classification
- DNEL inhalation
- DNEL dermal
- PNEC (environment)
- Exposure Scenarios
(Calculates exposure with a model like ECETOC TRA using own or customers conditions with data from the risk determining substances)

13. Principle – Mixtures step 4
Data substance 1
- Classification
- DNEL inhalation
- DNEL dermal
- PNEC (environment)
- Exposure Scenarios
Own data
Own uses
Own conditions
Customers uses
Customers conditions
Composition data
Data substance 2
- Classification
- DNEL inhalation
- DNEL dermal
- PNEC (environment)
- Exposure Scenarios
ESmodifier®
Data substance 3
- Classification
- DNEL inhalation
- DNEL dermal
- PNEC (environment)
- Exposure Scenarios
ES for own mixtures

14. Background ESmodifier®
Excel prototype (2010)
Paid by Danish EPA
Limitation to number of substances/products which can be handled As
Formulators need to handled a large number of uses, products and substances
Build-in limitations in Excel
New version developed => handling of a large number of products, substances and uses
Development paid by Danish EPA and DHI
Esmodifier 

15. Facts (1) Stand-alone tool Language: English
Can scale ES according to suppler specifications
”Simple equations”
Table lookup
Use of exposure tools
Check compliance with ES
Prepare harmonised ES for substances
Prepare consolidated ES for products
Support the development of DU-CSR
Esmodifier

16. Facts (2) SQL-database + user interfase programmed in Csharp
Exposure tools “imbedded” in ESmodifier ®
Interface to CHESAR and ERM :
CHESAR: CSR module to IUCLID – developed by ECHA (future version)
Import and export of substance, product data via XML
We are awaiting a final xml-format for ES
Esmodifier 