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