The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) of EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 3-(1-((3,5-dimethylisoxazol-4-yl)methyl)-1H-pyrazol-4-yl)-1-(3-hydroxybenzyl)imidazolidine-2,4-dione [FL-no: 16.127], in the Flavouring Group Evaluation 400 (FGE.400), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intended to be used as a flavour modifier in specific categories of food. There is no safety concern with respect to genotoxicity. A 90-day dietary administration study in rats showed no adverse effects for doses up to 100 mg/kg body weight (bw) per day, providing an adequate margin of safety. Developmental toxicity was not observed in a study with rats at dose levels up to 1,000 mg/kg bw per day. The Panel concluded that [FL-no: 16.127] is not expected to be of safety concern at the estimated levels of intake. This conclusion applies only to the use of the substance as a flavour modifier and when used at levels up to those specified for various foods in different food categories.
EFSA Publication (2016). EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2016. Scientific opinion on Flavouring Group Evaluation 400 (FGE.400): 3-(1- ((3,5-dimethylisoxazol-4-yl)methyl)-1H-pyrazol-4-yl)-1-(3-hydroxybenzyl)imidazolidine-2,4-dione. Europen Food Safety Authority. the EFSA Journal, No. 4334, Vol.. 14(7) https://doi.org/10.2903/j.efsa.2016.4334