Concentrations tiers

In addition to the possibility for users to work with their own choices for all settings, MCRA implements Tier 1 and 2 from the European Commission working document SANTE-2015-10216 rev. 7 (2018) on risk management aspects related to the assessment of cumulative exposure.

Overview

Table 74 Tier overview for module Concentrations.
Name	EC 2018 Acute - Tier I	EC 2018 Acute - Tier II	EC 2018 Chronic - Tier I	EC 2018 Chronic - Tier II	EFSA 2022 Acute Tier I	EFSA 2022 Acute Tier II	EFSA 2022 Chronic Tier I	EFSA 2022 Chronic Tier II
Substance conversion method	UseMostToxic	DrawRandom	UseMostToxic	DrawRandom	UseMostToxic	DrawRandom	UseMostToxic	DrawRandom
Retain all allocated substances after active substance allocation	true	true	true	true	true	true	true	true
Account for substance authorisations in substance conversions	false	true	false	true	false	true	false	true
Fix duplicate substance allocation inconsistencies	false	false	false	false	false	false	false	false
Use extrapolation rules	true	true	true	true	false	false	false	false
Threshold for extrapolation	10	10	10	10
Restrict extrapolations to equal MRLs	true	true	true	true
Restrict extrapolations to authorised uses	true	true	true	true
Impute water concentrations	true	true	true	true	true	true	true	true
Water concentration value (µg/kg)	0.1	0.05	0.1	0.05	0.1	0.05	0.1	0.05
Restrict water imputation to the five most toxic substances	true	true	true	true	true	true	true	true
Restrict water imputation to authorised uses	false	false	false	false	false	false	false	false
Restrict water imputation to approved substances	false	false	false	false	true	true	true	true
Use substance conversion rules					true	true	true	true

Retrospective dietary CRA (EC 2018) - Acute / Tier I

Table 75 Tier definition for Retrospective dietary CRA (EC 2018) - Acute / Tier I.
Name	Setting
Substance conversion method	UseMostToxic
Retain all allocated substances after active substance allocation	true
Account for substance authorisations in substance conversions	false
Fix duplicate substance allocation inconsistencies	false
Use extrapolation rules	true
Threshold for extrapolation	10
Restrict extrapolations to equal MRLs	true
Restrict extrapolations to authorised uses	true
Impute water concentrations	true
Water concentration value (µg/kg)	0.1
Restrict water imputation to the five most toxic substances	true
Restrict water imputation to authorised uses	false
Restrict water imputation to approved substances	false

Retrospective dietary CRA (EC 2018) - Acute / Tier II

Table 76 Tier definition for Retrospective dietary CRA (EC 2018) - Acute / Tier II.
Name	Setting
Substance conversion method	DrawRandom
Retain all allocated substances after active substance allocation	true
Account for substance authorisations in substance conversions	true
Fix duplicate substance allocation inconsistencies	false
Use extrapolation rules	true
Threshold for extrapolation	10
Restrict extrapolations to equal MRLs	true
Restrict extrapolations to authorised uses	true
Impute water concentrations	true
Water concentration value (µg/kg)	0.05
Restrict water imputation to the five most toxic substances	true
Restrict water imputation to authorised uses	false
Restrict water imputation to approved substances	false

Retrospective dietary CRA (EC 2018) - Chronic / Tier I

Table 77 Tier definition for Retrospective dietary CRA (EC 2018) - Chronic / Tier I.
Name	Setting
Substance conversion method	UseMostToxic
Retain all allocated substances after active substance allocation	true
Account for substance authorisations in substance conversions	false
Fix duplicate substance allocation inconsistencies	false
Use extrapolation rules	true
Threshold for extrapolation	10
Restrict extrapolations to equal MRLs	true
Restrict extrapolations to authorised uses	true
Impute water concentrations	true
Water concentration value (µg/kg)	0.1
Restrict water imputation to the five most toxic substances	true
Restrict water imputation to authorised uses	false
Restrict water imputation to approved substances	false

Retrospective dietary CRA (EC 2018) - Chronic / Tier II

Table 78 Tier definition for Retrospective dietary CRA (EC 2018) - Chronic / Tier II.
Name	Setting
Substance conversion method	DrawRandom
Retain all allocated substances after active substance allocation	true
Account for substance authorisations in substance conversions	true
Fix duplicate substance allocation inconsistencies	false
Use extrapolation rules	true
Threshold for extrapolation	10
Restrict extrapolations to equal MRLs	true
Restrict extrapolations to authorised uses	true
Impute water concentrations	true
Water concentration value (µg/kg)	0.05
Restrict water imputation to the five most toxic substances	true
Restrict water imputation to authorised uses	false
Restrict water imputation to approved substances	false

Retrospective dietary CRA (EFSA 2022) - Acute / Tier I

Table 79 Tier definition for Retrospective dietary CRA (EFSA 2022) - Acute / Tier I.
Name	Setting
Use substance conversion rules	true
Substance conversion method	UseMostToxic
Retain all allocated substances after active substance allocation	true
Account for substance authorisations in substance conversions	false
Fix duplicate substance allocation inconsistencies	false
Use extrapolation rules	false
Impute water concentrations	true
Water concentration value (µg/kg)	0.1
Restrict water imputation to the five most toxic substances	true
Restrict water imputation to authorised uses	false
Restrict water imputation to approved substances	true

Retrospective dietary CRA (EFSA 2022) - Acute / Tier II

Table 80 Tier definition for Retrospective dietary CRA (EFSA 2022) - Acute / Tier II.
Name	Setting
Use substance conversion rules	true
Substance conversion method	DrawRandom
Retain all allocated substances after active substance allocation	true
Account for substance authorisations in substance conversions	true
Fix duplicate substance allocation inconsistencies	false
Use extrapolation rules	false
Impute water concentrations	true
Water concentration value (µg/kg)	0.05
Restrict water imputation to the five most toxic substances	true
Restrict water imputation to authorised uses	false
Restrict water imputation to approved substances	true

Retrospective dietary CRA (EFSA 2022) - Chronic / Tier I

Table 81 Tier definition for Retrospective dietary CRA (EFSA 2022) - Chronic / Tier I.
Name	Setting
Use substance conversion rules	true
Substance conversion method	UseMostToxic
Retain all allocated substances after active substance allocation	true
Account for substance authorisations in substance conversions	false
Fix duplicate substance allocation inconsistencies	false
Use extrapolation rules	false
Impute water concentrations	true
Water concentration value (µg/kg)	0.1
Restrict water imputation to the five most toxic substances	true
Restrict water imputation to authorised uses	false
Restrict water imputation to approved substances	true

Retrospective dietary CRA (EFSA 2022) - Chronic / Tier II

Table 82 Tier definition for Retrospective dietary CRA (EFSA 2022) - Chronic / Tier II.
Name	Setting
Use substance conversion rules	true
Substance conversion method	DrawRandom
Retain all allocated substances after active substance allocation	true
Account for substance authorisations in substance conversions	true
Fix duplicate substance allocation inconsistencies	false
Use extrapolation rules	false
Impute water concentrations	true
Water concentration value (µg/kg)	0.05
Restrict water imputation to the five most toxic substances	true
Restrict water imputation to authorised uses	false
Restrict water imputation to approved substances	true