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 82 Tier overview for module Concentrations.

Name	EC 2018 Acute Tier I	EC 2018 Chronic - Tier I	EC 2018 Acute Tier II	EC 2018 Chronic Tier II	EFSA 2012 Acute Pessimistic	EFSA 2012 Chronic Pessimistic	EFSA 2022 Acute Tier I	EFSA 2022 Chronic Tier I	EFSA 2022 Acute Tier II	EFSA 2022 Chronic Tier II	EFSA 2023 Acute Prospective Tier II	EFSA 2023 Chronic Prospective Tier II
Filter samples exceeding the concentration limits	false	false	false	false	false	false	false	false	false	false	true	true
Use substance conversion rules	true	true	true	true			true	true	true	true	true	true
Substance conversion method	UseMostToxic	UseMostToxic	DrawRandom	DrawRandom			UseMostToxic	UseMostToxic	DrawRandom	DrawRandom	DrawRandom	DrawRandom
Retain all allocated substances after active substance allocation	true	true	true	true			true	true	true	true	true	true
Account for substance authorisations in substance conversions	false	false	true	true			false	false	true	true	true	true
Fix duplicate substance allocation inconsistencies	false	false	false	false			false	false	false	false	false	false
Use extrapolation rules	true	true	true	true			false	false	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	true	true
Water concentration value (µg/kg)	0.1	0.1	0.05	0.05			0.1	0.1	0.05	0.05	0.05	0.05
Restrict water imputation to the five most toxic substances	true	true	true	true			true	true	true	true	true	true
Restrict water imputation to authorised uses	false	false	false	false			false	false	false	false	false	false
Restrict water imputation to approved substances	false	false	false	false			true	true	true	true	true	true
Concentration limit filter exceedance factor											2	2
Include focal commodity concentrations											true	true
Focal commodity concentrations replacement method											ReplaceSubstances	ReplaceSubstances
Focal commodity substance occurrence percentage											20	20
Adjustment factor for the focal food/substance concentration											1	1
Use deterministic substance conversions for focal commodity											true	true

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

Table 83 Tier definition for Retrospective dietary CRA (EC 2018) - Acute / Tier I.

Name	Setting
Filter samples exceeding the concentration limits	false
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	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 I

Table 84 Tier definition for Retrospective dietary CRA (EC 2018) - Chronic / Tier I.

Name	Setting
Filter samples exceeding the concentration limits	false
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	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 85 Tier definition for Retrospective dietary CRA (EC 2018) - Acute / Tier II.

Name	Setting
Filter samples exceeding the concentration limits	false
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	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 II

Table 86 Tier definition for Retrospective dietary CRA (EC 2018) - Chronic / Tier II.

Name	Setting
Filter samples exceeding the concentration limits	false
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	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 2012) - Acute / Pessimistic

Acute probabilistic exposure assessment using the pessimistic model settings according to the EFSA Guidance 2012. Only processing factors > 1 are applied. For unit variability, the Beta distribution is applied.

Table 87 Tier definition for Retrospective dietary CRA (EFSA 2012) - Acute / Pessimistic.

Name	Setting
Filter samples exceeding the concentration limits	false

Retrospective dietary CRA (EFSA 2012) - Chronic / Pessimistic

Chronic probabilistic exposure assessment using the pessimistic model settings according to the EFSA Guidance 2012. Only processing factors > 1 are applied.

Table 88 Tier definition for Retrospective dietary CRA (EFSA 2012) - Chronic / Pessimistic.

Name	Setting
Filter samples exceeding the concentration limits	false

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

Table 89 Tier definition for Retrospective dietary CRA (EFSA 2022) - Acute / Tier I.

Name	Setting
Filter samples exceeding the concentration limits	false
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 I

Table 90 Tier definition for Retrospective dietary CRA (EFSA 2022) - Chronic / Tier I.

Name	Setting
Filter samples exceeding the concentration limits	false
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 91 Tier definition for Retrospective dietary CRA (EFSA 2022) - Acute / Tier II.

Name	Setting
Filter samples exceeding the concentration limits	false
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 II

Table 92 Tier definition for Retrospective dietary CRA (EFSA 2022) - Chronic / Tier II.

Name	Setting
Filter samples exceeding the concentration limits	false
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

Prospective dietary CRA (EFSA 2023) - Acute / Tier II

Table 93 Tier definition for Prospective dietary CRA (EFSA 2023) - Acute / Tier II.

Name	Setting
Filter samples exceeding the concentration limits	true
Concentration limit filter exceedance factor	2
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
Include focal commodity concentrations	true
Focal commodity concentrations replacement method	ReplaceSubstances
Focal commodity substance occurrence percentage	20
Adjustment factor for the focal food/substance concentration	1
Use deterministic substance conversions for focal commodity	true

Prospective dietary CRA (EFSA 2023) - Chronic / Tier II

Table 94 Tier definition for Prospective dietary CRA (EFSA 2023) - Chronic / Tier II.

Name	Setting
Filter samples exceeding the concentration limits	true
Concentration limit filter exceedance factor	2
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
Include focal commodity concentrations	true
Focal commodity concentrations replacement method	ReplaceSubstances
Focal commodity substance occurrence percentage	20
Adjustment factor for the focal food/substance concentration	1
Use deterministic substance conversions for focal commodity	true