. 2024 Aug 1;22(8):e8897. doi: 10.2903/j.efsa.2024.8897

TABLE 6.

Reference points for impurities potentially present in shellac (E 904).

Impurity HBGV/RP	Basis/reference
Lead (Pb)/ 0.5 μg/kg bw per day (BMDL₀₁)	The reference point is based on a study demonstrating perturbation of intellectual development in children with the critical response size of 1 point reduction in IQ (Schwartz, 1994). The EFSA CONTAM Panel mentioned that a 1 point reduction in IQ is related to a 4.5% increase in the risk of failure to graduate from high school and that a 1 point reduction in IQ in children can be associated with a decrease of later productivity of about 2%. A risk cannot be excluded if the exposure exceeds the BMDL₀₁ (MOE lower than 1) EFSA CONTAM Panel (2010)
Chloroform/15 μg/kg bw per day (TDI)	A TDI of 15 μg/kg bw per day is established based on the non‐carcinogenic endpoint hepatotoxicity (WHO, 2004, 2022). Chloroform is classified as Carc Cat 2 (suspected to be carcinogenic) by the European Chemical Agency. Data from a chronic rat study (Jorgenson et al., 1985), in which carcinogenic endpoints have been evaluated were used to perform a Benchmark dose analysis by the panel (Annex F) The resulting BMD confidence interval ranged from 42 to 67 mg/kg bw per day. In the case of chloroform, with a non‐genotoxic mode of action (non‐genotoxic carcinogen), an MOE of > 1000 would be considered appropriate. Therefore, an exposure of chloroform < 42 μg/kg bw per day would not raise concern. Compared to this exposure the TDI for chloroform for the non‐carcinogenic endpoint hepatotoxicity of 15 μg/kg bw per day would be lower and should be used for the risk assessment of chloroform

Impurity HBGV/RP

Basis/reference

Lead (Pb)/ 0.5 μg/kg bw per day (BMDL₀₁)

The reference point is based on a study demonstrating perturbation of intellectual development in children with the critical response size of 1 point reduction in IQ (Schwartz, 1994). The EFSA CONTAM Panel mentioned that a 1 point reduction in IQ is related to a 4.5% increase in the risk of failure to graduate from high school and that a 1 point reduction in IQ in children can be associated with a decrease of later productivity of about 2%. A risk cannot be excluded if the exposure exceeds the BMDL₀₁ (MOE lower than 1)

EFSA CONTAM Panel (2010)

Chloroform/15 μg/kg bw per day (TDI)

A TDI of 15 μg/kg bw per day is established based on the non‐carcinogenic endpoint hepatotoxicity (WHO, 2004, 2022). Chloroform is classified as Carc Cat 2 (suspected to be carcinogenic) by the European Chemical Agency. Data from a chronic rat study (Jorgenson et al., 1985), in which carcinogenic endpoints have been evaluated were used to perform a Benchmark dose analysis by the panel (Annex F) The resulting BMD confidence interval ranged from 42 to 67 mg/kg bw per day. In the case of chloroform, with a non‐genotoxic mode of action (non‐genotoxic carcinogen), an MOE of > 1000 would be considered appropriate. Therefore, an exposure of chloroform < 42 μg/kg bw per day would not raise concern. Compared to this exposure the TDI for chloroform for the non‐carcinogenic endpoint hepatotoxicity of 15 μg/kg bw per day would be lower and should be used for the risk assessment of chloroform