Statement on the Re-evaluation of 3,7-dimethylocta-1,5,7-trien-3-ol [FL-no: 02.146] based on additional data on a supporting substance | European Food Safety Authority Pasar al contenido principal

Statement on the Re-evaluation of 3,7-dimethylocta-1,5,7-trien-3-ol [FL-no: 02.146] based on additional data on a supporting substance

Metadata

Panel members at the time of adoption

Ulla Beckman Sundh, Mona-Lise Binderup, Leon Brimer, Laurence Castle, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Catherine Leclercq, Jean Claude Lhuguenot, Wim Mennes, Maria Rosaria Milana, Iona Pratt, Kettil Svensson, Fidel Toldra and Detlef Wölfle

Abstract

In 2010 the CEF Panel concluded in its Opinion FGE.18Rev2 that for the substance 3,7-dimethylocta-1,5,7-trien-3-ol [FL-no: 02.146], no appropriate NOAEL was available in order to establish a margin of safety, and additional data were requested (90 days study or ADME). 3,7-Dimethylocta-1,5,7-trien-3-ol [FL-no: 02.146] is allocated to subgroup 3 of FGE.18. In 2012, EFSA received new data on linalool [FL-no: 02.013], a supporting substance in FGE.18Rev2 (subgroup 2). However, the CEF Panel concluded that linalool [FL-no: 02.013] is not sufficiently structurally related to 3,7-dimethylocta-1,5,7-trien-3-ol [FL-no: 02.146] for the re-evaluation of [FL-no: 02.146]. Accordingly, a 90-day study on 3,7-dimethylocta-1,5,7-trien-3-ol [FL-no: 02.146] or on a sufficiently structurally related substance has to be provided in order to establish an appropriate NOAEL.