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对瓜尔胶(E 412)作为食品添加剂的重新评估。

Re-evaluation of guar gum (E 412) as a food additive.

作者信息

Mortensen Alicja, Aguilar Fernando, Crebelli Riccardo, Di Domenico Alessandro, Frutos Maria Jose, Galtier Pierre, Gott David, Gundert-Remy Ursula, Lambré Claude, Leblanc Jean-Charles, Lindtner Oliver, Moldeus Peter, Mosesso Pasquale, Oskarsson Agneta, Parent-Massin Dominique, Stankovic Ivan, Waalkens-Berendsen Ine, Woutersen Rudolf Antonius, Wright Matthew, Younes Maged, Brimer Leon, Peters Paul, Wiesner Jacqueline, Christodoulidou Anna, Lodi Federica, Tard Alexandra, Dusemund Birgit

出版信息

EFSA J. 2017 Feb 24;15(2):e04669. doi: 10.2903/j.efsa.2017.4669. eCollection 2017 Feb.

Abstract

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of guar gum (E 412) as a food additive. In the EU, guar gum was evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1970, 1974 and 1975, who allocated an acceptable daily intake (ADI) 'not specified'. Guar gum has been also evaluated by the Scientific Committee for Food (SCF) in 1977 who endorsed the ADI 'not specified' allocated by JECFA. Following the conceptual framework for the risk assessment of certain food additives re-evaluated under Commission Regulation (EU) No 257/2010, the Panel considered that adequate exposure and toxicity data were available. Guar gum is practically undigested, not absorbed intact, but significantly fermented by enteric bacteria in humans. No adverse effects were reported in subchronic and carcinogenicity studies at the highest dose tested; no concern with respect to the genotoxicity. Oral intake of guar gum was well tolerated in adults. The Panel concluded that there is no need for a numerical ADI for guar gum (E 412), and there is no safety concern for the general population at the refined exposure assessment of guar gum (E 412) as a food additive. The Panel considered that for uses of guar gum in foods intended for infants and young children the occurrence of abdominal discomfort should be monitored and if this effect is observed doses should be identified as a basis for further risk assessment. The Panel considered that no adequate specific studies addressing the safety of use of guar gum (E 412) in food categories 13.1.5.1 and 13.1.5.2 were available. Therefore, the Panel concluded that the available data do not allow an adequate assessment of the safety of guar gum (E 412) in infants and young children consuming these foods for special medical purposes.

摘要

食品添加剂及添加到食品中的营养源(ANS)小组提供了一份科学意见,重新评估瓜尔胶(E 412)作为食品添加剂的安全性。在欧盟,食品添加剂联合专家委员会(JECFA)于1970年、1974年和1975年对瓜尔胶进行了评估,其指定的每日允许摄入量(ADI)为“未规定”。食品科学委员会(SCF)于1977年也对瓜尔胶进行了评估,认可了JECFA指定的“未规定”的ADI。根据欧盟委员会第257/2010号法规重新评估的某些食品添加剂风险评估概念框架,该小组认为已有足够的暴露量和毒性数据。瓜尔胶实际上未被消化,不会完整吸收,但会在人体中被肠道细菌大量发酵。在亚慢性和致癌性研究中,在测试的最高剂量下均未报告不良反应;在遗传毒性方面也无问题。成年人口服瓜尔胶耐受性良好。该小组得出结论,无需为瓜尔胶(E 412)设定数值ADI,并且在将瓜尔胶(E 412)作为食品添加剂进行精细暴露评估时,一般人群不存在安全问题。该小组认为,对于瓜尔胶在婴幼儿食品中的使用,应监测腹部不适的发生情况,如果观察到这种影响,应确定剂量作为进一步风险评估的基础。该小组认为,没有充分的具体研究涉及瓜尔胶(E 412)在第13.1.5.1和13.1.5.2食品类别中的使用安全性。因此,该小组得出结论,现有数据不足以充分评估瓜尔胶(E 412)在食用这些特殊医疗用途食品的婴幼儿中的安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e0fc/7010168/33b3b726dcf3/EFS2-15-e04669-g001.jpg

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