Turck Dominique, Bohn Torsten, Castenmiller Jacqueline, Hirsch-Ernst Karen Ildico, Knutsen Helle Katrine, Maciuk Alexander, Mangelsdorf Inge, McArdle Harry J, Naska Androniki, Pentieva Kristina, Siani Alfonso, Thies Frank, Tsabouri Sophia, Vinceti Marco, Marchelli Rosangela, Van Loveren Hendrik, Valtueña Martínez Silvia, de Henauw Stefaan
EFSA J. 2023 Sep 25;21(9):e08240. doi: 10.2903/j.efsa.2023.8240. eCollection 2023 Sep.
Following a request from the European Commission, the Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to review a scientific assessment related to a notification from DuPont Nutrition Biosciences Aps on behenic acid from mustard seeds to be used in the manufacturing of certain emulsifiers pursuant to Article 21(2) of Regulation (EU) No 1169/2011 - for permanent exemption from labelling. The EC requested EFSA to consider comments raised by the German authorities in relation to: (a) the maximum amount of mustard protein that could be consumed from the emulsifiers manufactured from behenic acid (E470a, E471 and E477) on a single occasion and (b) the minimal observed eliciting dose (MOED) triggering allergic reactions in mustard-allergic individuals. The maximum amount of mustard protein content in behenic acid was re-assessed in view of new analytical data provided by the applicant. Intake estimates by the EFSA ANS Panel for E471 (adults) were used as a proxy for the combined intake (E470a, E471 and E477). Food challenge data and systematic reviews thereof deriving population minimal observed eliciting dose distributions for mustard protein were used to calculate the MOED and estimate the risk. The margin of exposure between the MOED (0.26 mg mustard protein) and the maximum amount of mustard protein that could be consumed from the emulsifiers on a single occasion (0.00895475 mg) is 29. It is predicted that between 0.1% and 1% of the mustard allergic population would react with mild objective symptoms to that dose. Overall, the assessment is conservative, particularly in relation to the exposure. Based on the information and data available, the NDA Panel concludes that it is extremely unlikely (≤ 1% probability) that oral consumption of emulsifiers to be manufactured using behenic acid from mustard seeds (i.e. E470a, E471 and E477) will trigger an allergic reaction in mustard-allergic individuals under the proposed conditions of use.
应欧盟委员会的要求,营养、新型食品及食品过敏原专家小组(NDA)被要求根据欧盟第1169/2011号法规第21(2)条,对杜邦营养生物科学公司提交的一份关于用于制造某些乳化剂的芥菜籽中山嵛酸的通知的科学评估进行审查,以申请永久豁免标签标注。欧盟委员会要求欧洲食品安全局考虑德国当局提出的相关意见:(a) 单次食用由山嵛酸(E470a、E471和E477)制造的乳化剂可能摄入的最大芥菜籽蛋白量;(b) 引发芥末过敏个体过敏反应的最低观察诱发剂量(MOED)。鉴于申请人提供的新分析数据,对山嵛酸中的芥菜籽蛋白最大含量进行了重新评估。欧洲食品安全局ANS专家小组对E471(成人)的摄入量估计值被用作E470a、E471和E477联合摄入量的替代值。食品激发试验数据及其系统评价得出的芥菜籽蛋白人群最低观察诱发剂量分布,用于计算最低观察诱发剂量并估计风险。最低观察诱发剂量(0.26毫克芥菜籽蛋白)与单次食用乳化剂可能摄入的最大芥菜籽蛋白量(0.00895475毫克)之间的暴露边际为29。预计0.1%至1%的芥末过敏人群会对该剂量产生轻度客观症状反应。总体而言,该评估较为保守,尤其是在暴露方面。根据现有信息和数据,NDA专家小组得出结论,在拟议的使用条件下,口服由芥菜籽中提取的山嵛酸制造的乳化剂(即E470a、E471和E477)极不可能(概率≤1%)引发芥末过敏个体的过敏反应。