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Scientific Opinion on the safety of glycerol esters of gum rosin for the proposed uses as a food additive

机译:关于松香甘油酯作为食品添加剂的安全性的科学意见

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The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion evaluating the safety of glycerol esters of gum rosin (GEGR) for the proposed use as a stabilising and emulsifying food additive in certain beverages to a maximum level of 100 mg/l. The Joint FAO/WHO Expert Committee on Food Additives established a group ADI of 0–25 mg/kg bw/day for glycerol esters of wood rosin (GEWR) and GEGR and tentative specifications for GEGR pending the submission of additional data. GEGR are obtained by esterification of refined gum rosin and are described as a complex mixture of tri‐ and diglycerol esters of resin acids and a residual fraction of monoglycerol esters. Besides these esters, up to 4.2% free resin acids and up to 20.1% other non‐acidic saponifiable and unsaponifiable substances are present in GEGR. The percentages of resin acids derived from the three fractions upon saponification of GEGR are known. However, data on the identity and quantity of individual components in the three fractions of GEGR are absent and also data on the proportions of glycerol monoesters, (1,2)‐glycerol diesters, (1,3)‐glycerol diesters and glycerol triesters are not provided. In view of missing toxicity studies for GEGR, analytical data were submitted to demonstrate that GEGR are chemically equivalent to GEWR which have already been authorised as a food additive by Directive 95/2/EC. Overall, the Panel concluded that the chemical and toxicological characterisation of GEGR is not adequate. The Panel also did not have sufficient information to evaluate the chemical equivalence of GEGR and GEWR on the basis of which the toxicological data obtained with GEWR could be used for read across. Therefore, the Panel concluded that the available data are too limited to conclude on the safety of GEGR as a food additive at the proposed uses and use levels.
机译:食品中添加的食品添加剂和营养物来源小组提供了科学的见解,评估了在某些饮料中用作稳定和乳化食品添加剂的最大建议浓度为100 mg / l的松香甘油酯(GEGR)的安全性。粮农组织/世卫组织食品添加剂联合专家委员会为木松香(GEWR)和GEGR的甘油酯和GEGR制定了ADI(每日摄入量)0-25 mg / kg bw /天,有待进一步数据提交。 GEGR通过精制松香的酯化反应制得,被描述为树脂酸的甘油三酯和甘油二酯与残留的甘油单酯的复杂混合物。除这些酯外,GEGR中还存在高达4.2%的游离树脂酸和高达20.1%的其他非酸性可皂化和不可皂化物质。已知在将GEGR皂化后源自三个馏分的树脂酸的百分比。但是,缺少有关GEGR的三个馏分中各个成分的身份和数量的数据,也缺少关于甘油单酯,(1,2)-甘油二酯,(1,3)-甘油二酯和甘油三酯的比例的数据。不提供。鉴于缺少有关GEGR的毒性研究,因此提交了分析数据以证明GEGR在化学上与GEWR等效,后者已被95/2 / EC指令批准为食品添加剂。总体而言,小组得出结论,认为GEGR的化学和毒理学表征不足。专家小组也没有足够的信息来评估GEGR和GEWR的化学等效性,在此基础上可以将用GEWR获得的毒理学数据用于解读。因此,小组得出结论认为,现有数据太有限,无法就拟议用途和使用水平下的GEGR作为食品添加剂的安全性得出结论。

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    《EFSA Journal》 |2010年第7期|共31页
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