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Scientific opinion on the extension of the authorisation of use of the food additive steviol glycosides (E 960a-d) and the modification of the acceptable daily intake (ADI) for steviol.关于食品添加剂甜菊糖苷(E 960a - d)使用授权的延长以及甜菊醇每日允许摄入量(ADI)修订的科学意见。
EFSA J. 2024 Nov 4;22(11):e9045. doi: 10.2903/j.efsa.2024.9045. eCollection 2024 Nov.
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Safety evaluation of the food additive steviol glycosides, predominantly Rebaudioside M, produced by fermentation using VRM.使用VRM发酵生产的食品添加剂甜菊糖苷(主要为莱鲍迪苷M)的安全性评估。
EFSA J. 2023 Dec 20;21(12):e8387. doi: 10.2903/j.efsa.2023.8387. eCollection 2023 Dec.
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EFSA J. 2022 Feb 9;20(2):e07066. doi: 10.2903/j.efsa.2022.7066. eCollection 2022 Feb.
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EFSA J. 2019 Mar 13;17(3):e05626. doi: 10.2903/j.efsa.2019.5626. eCollection 2019 Mar.
5
Safety of a proposed amendment of the specifications for steviol glycosides (E 960) as a food additive: to expand the list of steviol glycosides to all those identified in the leaves of .作为食品添加剂的甜菊糖苷(E 960)规格拟议修订案的安全性:将甜菊糖苷清单扩展至在甜叶菊叶片中鉴定出的所有甜菊糖苷。
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Extension of use of lycopene (E 160d) to certain meat preparations, meat products and fruit and vegetable preparations.将番茄红素(E 160d)的使用范围扩展至某些肉类制品、肉制品以及水果和蔬菜制品。
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Exposure assessment of annatto colouring principles bixin and norbixin (E 160b) when used as food additives.胭脂树橙色素成分降红木素和去甲降红木素(E 160b)用作食品添加剂时的暴露评估。
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Re-evaluation of phosphoric acid-phosphates - di-, tri- and polyphosphates (E 338-341, E 343, E 450-452) as food additives and the safety of proposed extension of use.作为食品添加剂的磷酸 - 磷酸盐(二磷酸盐、三磷酸盐和多磷酸盐,E 338 - 341、E 343、E 450 - 452)的重新评估以及拟议的使用范围扩展的安全性。
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Safety of the proposed amendment of the specifications of the food additive E960c(i) or E960c(ii).食品添加剂E960c(i)或E960c(ii)规格拟议修订案的安全性。
EFSA J. 2025 May 14;23(5):e9396. doi: 10.2903/j.efsa.2025.9396. eCollection 2025 May.

本文引用的文献

1
Safety evaluation of the food additive steviol glycosides, predominantly Rebaudioside M, produced by fermentation using VRM.使用VRM发酵生产的食品添加剂甜菊糖苷(主要为莱鲍迪苷M)的安全性评估。
EFSA J. 2023 Dec 20;21(12):e8387. doi: 10.2903/j.efsa.2023.8387. eCollection 2023 Dec.
2
Safety of the proposed amendment of the specifications for enzymatically produced steviol glycosides (E 960c): Rebaudioside D produced via enzymatic bioconversion of purified stevia leaf extract.酶法生产甜菊糖苷(E 960c)规格拟议修订案的安全性:通过纯化甜叶菊叶提取物的酶促生物转化生产的莱鲍迪苷D。
EFSA J. 2022 May 16;20(5):e07291. doi: 10.2903/j.efsa.2022.7291. eCollection 2022 May.
3
Safety evaluation of glucosylated steviol glycosides as a food additive in different food categories.不同食品类别中作为食品添加剂的糖基化甜菊糖苷的安全性评估。
EFSA J. 2022 Feb 9;20(2):e07066. doi: 10.2903/j.efsa.2022.7066. eCollection 2022 Feb.
4
Safety evaluation of steviol glycoside preparations, including rebaudioside AM, obtained by enzymatic bioconversion of highly purified stevioside and/or rebaudioside A stevia leaf extracts.甜菊糖苷制剂的安全性评估,包括通过对高纯度甜菊糖苷和/或甜叶菊叶提取物莱鲍迪苷A进行酶促生物转化而获得的莱鲍迪苷AM。
EFSA J. 2021 Aug 3;19(8):e06691. doi: 10.2903/j.efsa.2021.6691. eCollection 2021 Aug.
5
Safety of a proposed amendment of the specifications for steviol glycosides (E 960) as a food additive: to expand the list of steviol glycosides to all those identified in the leaves of .作为食品添加剂的甜菊糖苷(E 960)规格拟议修订案的安全性:将甜菊糖苷清单扩展至在甜叶菊叶片中鉴定出的所有甜菊糖苷。
EFSA J. 2020 Apr 29;18(4):e06106. doi: 10.2903/j.efsa.2020.6106. eCollection 2020 Apr.
6
Metabolic fate in adult and pediatric population of steviol glycosides produced from stevia leaf extract by different production technologies.不同生产工艺从甜菊叶中提取的甜菊糖苷在成年和儿科人群中的代谢情况。
Regul Toxicol Pharmacol. 2020 Oct;116:104727. doi: 10.1016/j.yrtph.2020.104727. Epub 2020 Jul 31.
7
Safety of the proposed amendment of the specifications for steviol glycosides (E 960) as a food additive: Rebaudioside M produced via enzyme-catalysed bioconversion of purified stevia leaf extract.将甜菊糖苷(E 960)作为食品添加剂的规格拟议修订案的安全性:通过纯化甜叶菊叶提取物的酶催化生物转化生产的莱鲍迪苷M。
EFSA J. 2019 Oct 28;17(10):e05867. doi: 10.2903/j.efsa.2019.5867. eCollection 2019 Oct.
8
Safety of the proposed amendment of the specifications of the food additive steviol glycosides (E 960).拟议修订食品添加剂甜菊糖苷(E 960)规格的安全性。
EFSA J. 2018 Mar 28;16(3):e05236. doi: 10.2903/j.efsa.2018.5236. eCollection 2018 Mar.
9
Chemical-specific adjustment factors (inter-species toxicokinetics) to establish the ADI for steviol glycosides.用于确定甜菊糖苷每日允许摄入量的化学物质特异性调整因子(种间毒物动力学)
Regul Toxicol Pharmacol. 2016 Aug;79:91-102. doi: 10.1016/j.yrtph.2016.05.017. Epub 2016 May 13.
10
Steviol glycosides in purified stevia leaf extract sharing the same metabolic fate.纯化甜叶菊叶提取物中的甜菊糖苷具有相同的代谢命运。
Regul Toxicol Pharmacol. 2016 Jun;77:125-33. doi: 10.1016/j.yrtph.2016.02.015. Epub 2016 Feb 27.

关于食品添加剂甜菊糖苷(E 960a - d)使用授权的延长以及甜菊醇每日允许摄入量(ADI)修订的科学意见。

Scientific opinion on the extension of the authorisation of use of the food additive steviol glycosides (E 960a-d) and the modification of the acceptable daily intake (ADI) for steviol.

作者信息

Castle Laurence, Andreassen Monica, Aquilina Gabriele, Bastos Maria Lourdes, Boon Polly, Fallico Biagio, FitzGerald Reginald, Frutos Fernandez Maria Jose, Grasl-Kraupp Bettina, Gundert-Remy Ursula, Gürtler Rainer, Houdeau Eric, Kurek Marcin, Louro Henriqueta, Morales Patricia, Passamonti Sabina, Barat Baviera José Manuel, Degen Gisela, Gott David, Herman Lieve, Leblanc Jean-Charles, Moldeus Peter, Waalkens-Berendsen Ine, Wölfle Detlef, Civitella Consuelo, Ruggeri Laura, Tard Alexandra, Dino Borana, Vermeiren Sam

出版信息

EFSA J. 2024 Nov 4;22(11):e9045. doi: 10.2903/j.efsa.2024.9045. eCollection 2024 Nov.

DOI:10.2903/j.efsa.2024.9045
PMID:39502654
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11533382/
Abstract

The EFSA Panel on Food Additive and Flavourings (FAF Panel) evaluated the safety of proposed changes to the currently permitted uses of the food additive steviol glycosides (E 960a-d) and of a proposed modification of the current acceptable daily intake (ADI) from 4 mg/kg body weight (bw) per day to 6 or 16 mg/kg bw per day, expressed as steviol equivalents. Currently, steviol glycosides (E 960a-d) are authorised in the EU in 32 different food categories (FCs). An extension of use was proposed for four new uses within FC 7.2 'Fine bakery wares'. In addition, an increase of the maximum permitted levels (MPLs) for FC 14.1.3 'Fruit nectars' and for three uses within FC 14.1.4 'Flavoured drinks' was requested. Consequently, the Panel updated the exposure estimates using the protocol for assessing exposure to sweeteners, developed to consider the specificities related to consumers' exposure to this functional class of food additives. Considering the proposed extension of use and increase of the MPLs, together with the currently authorised uses (at the MPLs) of E 960a-d, the highest 95th percentiles of exposure are 4.1 and 6.9 mg/kg bw per day for infants and toddlers, respectively. Based on the currently available absorption, distribution, metabolism and excretion (ADME) dataset for steviol glycosides (E 960a-d), the Panel concluded that that there is insufficient justification to increase the current ADI of 4 mg/kg bw per day, expressed as steviol equivalents. With respect to the proposed extension of use and increase of the MPLs, the Panel concluded that the calculated, conservative, dietary exposure would result in an increased exceedance of the ADI for toddlers at the 95th percentile.

摘要

欧洲食品安全局食品添加剂和香料小组(FAF小组)评估了食品添加剂甜菊糖苷(E 960a - d)当前允许使用范围的拟议变更以及将当前每日可接受摄入量(ADI)从4毫克/千克体重(bw)/天修改为6或16毫克/千克bw/天(以甜菊醇当量表示)的安全性。目前,甜菊糖苷(E 960a - d)在欧盟被批准用于32种不同的食品类别(FCs)。有人提议将使用范围扩展至FC 7.2“精细烘焙食品”中的四种新用途。此外,还要求提高FC 14.1.3“水果花蜜”以及FC 14.1.4“调味饮料”中三种用途的最大允许含量(MPLs)。因此,该小组使用评估甜味剂暴露量的方案更新了暴露量估计值,该方案的制定是为了考虑与消费者接触这类功能性食品添加剂相关的特殊性。考虑到拟议的使用范围扩展和MPLs的增加,以及E 960a - d目前的授权用途(按MPLs),婴儿和幼儿暴露量的第95百分位数最高分别为4.1和6.9毫克/千克bw/天。基于目前可得的甜菊糖苷(E 960a - d)的吸收、分布、代谢和排泄(ADME)数据集,该小组得出结论,没有足够的理由将目前以甜菊醇当量表示的4毫克/千克bw/天的ADI提高。关于拟议的使用范围扩展和MPLs的增加,该小组得出结论,经计算得出的保守膳食暴露量将导致幼儿在第95百分位数时ADI超标情况增加。