Mortensen Alicja, Aguilar Fernando, Crebelli Riccardo, Di Domenico Alessandro, Dusemund Birgit, Frutos Maria Jose, Galtier Pierre, Gott David, Gundert-Remy Ursula, Lambré Claude, Leblanc Jean-Charles, Lindtner Oliver, Moldeus Peter, Mosesso Pasquale, Parent-Massin Dominique, Oskarsson Agneta, Stankovic Ivan, Waalkens-Berendsen Ine, Wright Matthew, Younes Maged, Tobback Paul, Horvath Zsuzsanna, Tasiopoulou Stavroula, Woutersen Rudolf Antonius
EFSA J. 2017 Oct 5;15(10):e04911. doi: 10.2903/j.efsa.2017.4911. eCollection 2017 Oct.
Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient sources added to Food (ANS) was asked to deliver a scientific opinion on the re-evaluation of 12 modified starches (E 1404, E 1410, E 1412, E 1413, E 1414, E 1420, E 1422, E 1440, E 1442, E 1450, E 1451 and E 1452) authorised as food additives in the EU in accordance with Regulation (EC) No 1333/2008 and previously evaluated by JECFA and the SCF. Both committees allocated an acceptable daily intake (ADI) 'not specified'. In humans, modified starches are not absorbed intact but significantly hydrolysed by intestinal enzymes and then fermented by the intestinal microbiota. Using the read-across approach, the Panel considered that adequate data on short- and long-term toxicity and carcinogenicity, and reproductive toxicity are available. Based on analyses, modified starches are considered not to be of genotoxic concern. No treatment-related effects relevant for human risk assessment were observed in rats fed very high levels of modified starches (up to 31,000 mg/kg body weight (bw) per day). Modified starches (e.g. E 1450) were well tolerated in humans up to a single dose of 25,000 mg/person. Following the conceptual framework for the risk assessment of certain food additives, the Panel concluded that there is no safety concern for the use of modified starches as food additives at the reported uses and use levels for the general population and that there is no need for a numerical ADI. The combined exposure to E 1404-E 1451 at the 95th percentile of the refined (brand-loyal) exposure assessment scenario for the general population was up to 3,053 mg/kg bw per day. Exposure to E 1452 for food supplement consumers only at the 95th percentile was up to 22.1 mg/kg bw per day.
应欧盟委员会的要求，欧洲食品安全局食品添加剂和添加到食品中的营养源专家委员会（ANS）被要求就12种变性淀粉（E 1404、E 1410、E 1412、E 1413、E 1414、E 1420、E 1422、E 1440、E 1442、E 1450、E 1451和E 1452）的重新评估发表科学意见，这些变性淀粉已根据欧盟第1333/2008号法规被批准为食品添加剂，且之前已由食品添加剂联合专家委员会（JECFA）和食品科学委员会（SCF）进行过评估。两个委员会均未指定每日允许摄入量（ADI）。在人体中，变性淀粉不会完整吸收，而是会被肠道酶显著水解，然后由肠道微生物群发酵。通过采用交叉参照方法，专家委员会认为已有关于短期和长期毒性、致癌性以及生殖毒性的充分数据。基于分析，变性淀粉被认为不存在遗传毒性问题。在给大鼠喂食非常高剂量的变性淀粉（每天高达31,000毫克/千克体重）时，未观察到与处理相关的对人类风险评估有意义的影响。在人类中，高达单次剂量25,000毫克/人的变性淀粉（如E 1450）耐受性良好。按照某些食品添加剂风险评估的概念框架，专家委员会得出结论，对于一般人群在报告的使用方式和使用水平下将变性淀粉用作食品添加剂不存在安全担忧，且无需设定数值ADI。在一般人群精细（品牌忠诚）暴露评估情景的第95百分位数下，对E 1404 - E 1451的综合暴露量高达每天3,053毫克/千克体重。仅食品补充剂消费者在第95百分位数下对E 1452的暴露量高达每天22.1毫克/千克体重。
