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

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.