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首页> 美国卫生研究院文献>EFSA Journal >Scientific Opinion on Flavouring Group Evaluation 57 Revision 1 (FGE.57Rev1): consideration of isopulegone and three flavouring substances evaluated by JECFA (55th meeting)
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Scientific Opinion on Flavouring Group Evaluation 57 Revision 1 (FGE.57Rev1): consideration of isopulegone and three flavouring substances evaluated by JECFA (55th meeting)

机译：关于调味剂组评估的科学意见57修订版1（FGE.57Rev1）：审议JECFA评估的异戊烯酮和三种调味剂物质（第55次会议）

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The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint / Expert Committee on Food Additives ( ), and to decide whether further evaluation is necessary, as laid down in Commission Regulation ( ) No 1565/2000. The present consideration concerns a group of four flavouring substances consisting of isopulegone and three other substances evaluated by at the 55th meeting. This revision is made due to additional toxicity data available for (1 ,2 ,5 )‐isopulegol [FL‐no: 02.067]. The substances were evaluated through a stepwise approach that integrates information on structure–activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. ‐Mentha‐1,4(8)‐dien‐3‐one [ ‐no: 07.127] is no longer supported by the flavour industry and was not evaluated. In agreement with , the Panel evaluated the candidate substances in this Flavouring Group Evaluation ( ) via the B‐side of the Procedure. Based on a no observed adverse effect level ( ) from a 90‐day oral toxicity study on [ ‐no: 02.067], adequate margins of safety for the three candidate substances could be calculated. Therefore, the Panel agrees with the conclusion, ‘No safety concern at estimated levels of intake as flavouring substances’ based on the maximised survey‐derived daily intake ( ) approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered and found adequate. For the three substances evaluated in this , use levels have become available and the modified theoretical added maximum daily intakes ( s) were estimated. For [ ‐no: 02.067 and 07.067], the exceeds the toxicological threshold of concern for their structural classes and need more refined exposure assessment to finalise the evaluation.
机译：食品接触材料，酶，调味剂和加工助剂小组被要求审议自2000年以来食品添加剂联合/专家委员会（）评估的调味物质评估，并决定是否有必要进一步评估，如委员会规定第（1565/2000）条。目前考虑的是一组由第四十五次会议评估的，由异普勒酮和其他三种物质组成的四种调味物质。进行本修订是由于可利用（1，2，5）-异胡薄荷醇的其他毒性数据[FL-no：02.067]。通过逐步方法对这些物质进行了评估，该方法综合了结构与活性之间的关系，当前使用量，所关注的毒理学阈值以及有关代谢和毒性的可用数据。 ‐Mentha‐1,4（8）‐dien‐3‐one [‐no：07.127]不再受香料行业支持，也未进行评估。与达成共识的是，专家组通过程序的B面对本调味组评估（）中的候选物质进行了评估。根据对[‐no：02.067]进行的90天口服毒性研究得出的未观察到的不良反应水平（），可以计算出三种候选物质的足够的安全限度。因此，专家组同意基于最大化的调查得出的每日摄入量（）方法得出的结论“在调味品的估计摄入量上没有安全隐患”。除了对这些调味物质的安全性进行评估外，还考虑了商业材料的规格，并认为这些规格是适当的。对于在此评估的三种物质，已经可以使用，并估算了改良的理论增加的最大每日摄入量。对于[‐no：02.067和07.067]，其结构类别超出了关注的毒理学阈值，需要更精细的暴露评估才能最终确定评估。

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