BENZOE TONKINENSIS

Comments:

Given the no-observed-adverse-effect level (NOAEL) of 500 mg/kg body weight (bw) per day for Benzoe tonkinensis identified in a 90-day oral toxicity study in rats and the previously established ADIs for the major components of Benzoe tonkinensis (benzoic acid, benzyl benzoate and vanillin), the Committee confirmed the conclusion from the seventy-fourth meeting that Benzoe tonkinensis would not be of safety concern at current estimated dietary exposures, provided that it complies with the specifications prepared at the current meeting, when used as a flavouring agent and in accordance with good manufacturing practice.

Meeting:

79

Specs Code:

R

Report: 

Specification: 

Comments:

The Committee concluded that the available data were inadequate to establish an acceptable daily intake (ADI) because of the variability in composition of Benzoe tonkinensis and the inadequate characterization of the material tested. The margin of exposure between the conservative dietary exposure estimate of 0.2 mg/kg body weight per day and the NOAEL of 500 mg/kg body weight per day identified in a 90-day oral toxicity study in rats is 2500. Given this margin of exposure as well as the nature of the hepatic effects observed at doses above the NOAEL and the negative genotoxicity results, the Committee concluded that Benzoe tonkinensis would not pose a health concern at current estimated dietary exposures, provided that it complies with the tentative specifications prepared at the current meeting, when used as a flavouring agent and in accordance with good manufacturing practice. The Committee also noted that exposure to benzoic acid and benzyl benzoate from the use of Benzoe tonkinensis is well below the upper limit of the group ADI (0–5 mg/kg body weight) for benzyl derivatives, and exposure to vanillin is also well below the upper limit of its ADI (0–10 mg/kg body weight). The Committee further noted that benzoic acid, one of the major components of Benzoe tonkinensis, is used as a preservative, but that Benzoe tonkinensis has not been assessed for this use.

Meeting:

74

Specs Code:

N, T

Report: 

Tox Monograph: 

Specification: