Following an EFSA request for clarification on the MoS approach used in the safety evaluation of smoke flavourings, a statement has been issued by the flavourings Panel that explains how the complex nature of these ingredients, and the limited toxicity data available, makes it inappropriate to allocate an acceptable daily intake. Instead, the Panel calculates a MoS that is the ratio between the No-Observed-Adverse-Effect Level from a 90-day study and the anticipated dietary exposure for consumers (estimated from use levels provided by the applicant). Providing no potential in vivo genotoxicity is identified (three in vitro genotoxicity assays are stipulated as a minimum dataset requirement for these flavourings), an additional 3-fold safety factor is applied to supplement the default uncertainty factor of 100. While offering this general guidance, the Panel stresses that each safety assessment must be considered on a case-by-case basis, depending for example on chemical composition, and quality of the available toxicological data.

[European Food Safety Authority’s Panel on Food Contact Material, Enzymes, Flavourings and Processing Aids (CEF). Statement on the safety evaluation of smoke flavourings Primary Products: Interpretation of the Margin of Safety. EFSA Journal 2010, 8(1):1325. Adopted on 26 November 2009. Available at on the internet.] {183963}

The above item was taken from the February 2010 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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