Documents scientifiques

Statement on the Safety Evaluation of Smoke Flavourings Primary Products: Interpretation of the Margin of Safety

Question nº: EFSA-Q-2009-00764
Adopté: 26 novembre 2009

Résumé (28 KB)

Opinion (54 KB)

EFSA asked its scientific Panel on Food Contact Material, Enzymes, Flavourings and Processing Aids (CEF) for a clarification of the margin of safety (MoS). The Panel has applied this approach for the safety evaluation of smoke flavourings. Because of their complex and incompletely characterised chemical nature and in view of the limited toxicological data available, the Panel considered it inappropriate to allocate an Acceptable Daily Intake (ADI) for these substances. Instead, the Panel calculated a margin of safety based on the No-Observed-Adverse-Effect Level (NOAEL) in a 90-day study and on dietary exposure calculated from use levels provided by the applicant (EFSA, 2009). The margin of safety is the ratio between the NOAEL of the critical effect in the pivotal animal study on the smoke flavouring and the anticipated dietary exposure of consumers to that smoke flavouring.

The initial toxicological dataset requested for the safety evaluation of smoke flavourings consisted of three in vitro genotoxicity tests and a subchronic 90-day feeding study. In those cases, where the overall evaluation of the genotoxicity studies in vivo did not raise concern and where the 90-day studies were of adequate quality by current standards, the Panel considered that, normally, an additional uncertainty factor of 3-fold in addition to the default uncertainty factor of 100, should be sufficient to cover the limited duration and statistical power of the pivotal study.

Whether a specific margin of safety for a particular smoke flavouring is sufficient, is highly dependent on the specific situation (e.g. composition, variability and stability, quality of the toxicological data) and default guidance cannot be given. The Panel notes that the determination of what margin of safety is acceptable may also depend on socio-political aspects to be considered by the risk managers.

The Panel wished to stress that the approach adopted in its safety evaluations is specific to the smoke flavouring Primary Products evaluated by the CEF Panel.

Publié: 8 janvier 2010