Single value risks settings

Calculation settings

Table 198 Calculation settings for module Single value risks.
Name Description

Multiple substances analysis

Specifies whether the assessment involves multiple substances.

Express results in terms of reference substance equivalents (cumulative)

Specifies whether the assessment involves multiple substances and results should be cumulated over all substances.

Risk type

The type of exposure considered in the assessment; acute (short term) or chronic (long-term).

Risk metric type

Report risks in terms of hazard index (HI = 1/MOE) or margin of exposure.

Single value risk calculation method

Calculate single value from exposures and hazard or from an individual risks distribution.

Percentage for percentile

Percentage for percentile (default 0.1 for MOE or 99.9 for HI).

Use inverse distribution to calculate percentile

Calculate percentile via the complementary percentage of the inverse distribution (default: no). Description: E.g., P0.1 of MOE distribution is calculated via P99.9 of 1/MOE distribution. Note: This option is provided because percentile calculation in small data sets is asymmetric in both tails.

Apply adjustment factors to the specified MOE percentile

Specify adjustment factors, e.g. based on expert knowledge elicitation, to a specified MOE percentile (default 0.1%). If the selected risk metric is HI, the adjustment factors should still be specified for the complementary percentile of MOE (e.g. P0.1 of MOE if P99.9 of HI is selected).

Adjustment type related to exposure

Specify the factor and/or distribution of the adjustment factor for the MOE percentile. Default is no adjustment. Alternatives are a fixed factor or an uncertainty distribution. If distributions are selected, default values are set based on EFSA cumulative risk reports 2020.

Parameter A (Fixed factor, mean Lognormal or Log Student-t, or shape parameter Beta or Gamma)

This parameter can be: 1) the fixed adjustment factor; 2) for Lognormal or LogStudent_t, the mean of the underlying normal distribution; 3) For Beta or Gamma. the shape parameter.

Parameter B (standard deviation Lognormal or Log Student-t or second shape parameter Beta or rate parameter Gamma)

This parameter can be: 1) for Lognormal or LogStudent_t, the standard deviation of the underlying normal distribution; 2) For Beta, the second shape parameter; 3) for Gamma, the rate parameter.

Parameter C (Lower bound Beta, offset Gamma or Lognormal or degrees of freedom Logstudent-t)

This parameter can be: 1) for Beta, the lower bound value; 2) for Gamma or Lognormal, the offset; 3) for LogStudent-t, the degrees of freedom.

Parameter D (Upper bound Beta or offset Log Student-t)

This parameter can be: 1) for Beta, the upper bound value; 2) for Log Student-t, the offset.

Adjustment type related to hazard

Specify the factor and/or distribution of the adjustment factor for the MOE percentile. Default is no adjustment. Alternatives are a fixed factor or an uncertainty distribution. If distributions are selected, default values are set based on EFSA cumulative risk reports 2020.

Parameter A (Fixed factor, mean Lognormal or Log Student-t, or shape parameter Beta or Gamma)

This parameter can be: 1) the fixed adjustment factor; 2) for Lognormal or LogStudent_t, the mean of the underlying normal distribution; 3) For Beta or Gamma. the shape parameter.

Parameter B (standard deviation Lognormal or Log Student-t or second shape parameter Beta or rate parameter Gamma)

This parameter can be: 1) for Lognormal or LogStudent_t, the standard deviation of the underlying normal distribution; 2) For Beta, the second shape parameter; 3) for Gamma, the rate parameter.

Parameter C (Lower bound Beta, offset Gamma or Lognormal or degrees of freedom Logstudent-t)

This parameter can be: 1) for Beta, the lower bound value; 2) for Gamma or Lognormal, the offset; 3) for LogStudent-t, the degrees of freedom.

Parameter D (Upper bound Beta or offset Log Student-t)

This parameter can be: 1) for Beta, the upper bound value; 2) for Log Student-t, the offset.

Restrict the adjustment to the non-focal (background) exposure contributions

When exposures are calculated by combining focal food/substance concentrations with background concentrations, it may be appropriate to have separate adjustment for the foreground and background. A pragmatic solution agreed with EFSA is to estimate the contribution (c) of the focal exposure in the tail above the selected percentile. Note that the focal exposure may add over several active substances if the focal substance refers to multiple active substances (e.g. dithiocarbamates). If this option is selected, the adjustment factors are multiplied by (1-c), representing no adjustment for the focal part.