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. 2023 Aug 28;21(8):e08194. doi: 10.2903/j.efsa.2023.8194

Table F.1.

An approach for deriving HBGLVs for humans and food‐producing domesticated animals (adapted from EFSA Scientific Committee, 2012b)

  1. Obtain information/data on the relevant TP
  2. Identification of the critical effect: In this step it is assessed whether an effect should be considered as adverse and of relevance to humans.
  3. Identify NOAEL or LOAEL or BMDL
  4. Determine Tolerable Daily Intake (TDI)

TDI (mg/kg bw per day) = NOAEL or LOAEL or BMDL/UF1 × UF2 × UF3n × UF3n+1 × UF3n+2 etc.

UF1 = 10 (to account for interspecies variation)

UF2 = 10 (to account for intraspecies variation)

UF3n = 1–10 (to account for first data variation issue)

UF3n+1 = 2–10 (to account for further data variation issues when needed)

UF3n+2 = 2–10 (to account for further data variation issues when needed)

UF3n+ values are not applicable for good quality datasets

5) Derive the HBGLV, which considers chronic exposure, as follows:

HBGLV = TDI (mg/kg bw per day) × bw × AF/C

For humans:

bw = body weight [adults = 70 kg (aged above 18 years); toddlers = 12 kg (aged 1–3 years); infants = 5 kg (0–12 months)]

AF = allocation factor (see Section F.1.4)

C = daily drinking water consumption [default intake = 2 L adult (70 kg bw), 1 L children (12 kg bw), bottle‐fed infants 0.75 L (5 kg bw)]

For domesticated animals:

Bw = body weight (kg) depends on the category of domesticated animal (see Table F.2)

C = daily drinking water consumption (L) depend on the category of domesticated animal (see Table F.2)