Handling of Exposure Scenarios for mixtures ESmodifier®

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

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 

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

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

} 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

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

{ 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

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

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)

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)

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)

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

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 

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

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 