7 Regulatory Perspective in Translating Science into Policy. . .
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Table 7.1
Summary data used in the derivation of the ARfD, as well as derived and current guidance levels, and Codex maximum level in the Standard
for live and raw bivalve molluscs (Codex Stan 292-2008)
LOAEL
(g/kg bw) Safety factor
Provisional
ARfD
Derived guidance level
(mg/kg Shellfish Meat)
Level implemented in some
countries in 2004 (mg/kg
Shellfish Meat)
Codex maximum level/
kg of mollusc flesh
Azaspiracid
0.4
10 (human data)
0.04
g/kg
0.024 (1)
0.16
Ä0.16 mg
2.4
g/adult
0.0096 (2)
0.0063 (3)
Brevetoxin
NA
NA
NA
NA
0.8 mg/kg SM as PbTx-2
Ä200 mouse units or
equivalent
Domoic acid
1,000
10 (human)
100
g/kg
60 mg/kg SM (1)
20 mg/kg SM
Ä20 mg domoic acid
6 mg/adult
24 mg/kg SM (2)
16 mg/kg SM(3)
Okadaic Acid
1
3 (human)
0.7
g/kg
0.2 mg/kg SM (1)
0.16 mg/kg SM
Ä0.16 mg of okadaic
equivalent
42
g/adult
0.08 mg/kg SM (2)
0.05 mg/kg SM (3)
Saxitoxin
2
3 (human)
0.33
g/kg
0.42 mg/kg SM (1)
0.8 mg/kg SM
Ä0.8 mg (2 HCL) of
saxitoxin equivalent
21
g/adult
0.17 mg/kg SM (2)
0.11 mg/kg SM (3)
In the Derived guidance level (mg/kg Shellfish Meat) column, (1), (2) and (3) level were derived based on the assumption of consumption of 100, 250, and
380 g molluscs per one meal, respectively