Younes Maged, Aggett Peter, Aguilar Fernando, Crebelli Riccardo, Filipič Metka, Frutos Maria Jose, Galtier Pierre, Gott David, Gundert-Remy Ursula, Kuhnle Gunter Georg, Lambré Claude, Leblanc Jean-Charles, Lillegaard Inger Therese, Moldeus Peter, Mortensen Alicja, Oskarsson Agneta, Stankovic Ivan, Waalkens-Berendsen Ine, Woutersen Rudolf Antonius, Wright Matthew, Brimer Leon, Lindtner Oliver, Mosesso Pasquale, Christodoulidou Anna, Ioannidou Sofia, Lodi Federica, Dusemund Birgit
EFSA J. 2018 Apr 26;16(4):e05238. doi: 10.2903/j.efsa.2018.5238. eCollection 2018 Apr.
The present opinion deals with the re-evaluation of the safety of food-grade carrageenan (E 407) and processes Eucheuma seaweed (E 407a) used as food additives. Because of the structural similarities, the Panel concluded that processed Eucheuma seaweed can be included in the evaluation of food-grade carrageenan. Poligeenan (average molecular weight 10-20 kDa) has not been authorised as a food additive and is not used in any food applications. In its evaluation of carrageenan (E 407) and processed Eucheuma seaweed (E 407a), the Panel noted that the ADME database was sufficient to conclude that carrageenan was not absorbed intact; in a subchronic toxicity study performed with carrageenan almost complying with the EU specification for E 407 in rats, the no-observed-adverse-effect level (NOAEL) was 3,400-3,900 mg/kg body weight (bw) per day, the highest dose tested; no adverse effects have been detected in chronic toxicity studies with carrageenan in rats up to 7,500 mg/kg bw per day, the highest dose tested; there was no concern with respect to the carcinogenicity of carrageenan; carrageenan and processed Eucheuma seaweed did not raise a concern with respect to genotoxicity; the NOAEL of sodium and calcium carrageenan for prenatal developmental dietary toxicity studies were the highest dose tested; the safety of processed Eucheuma seaweed was sufficiently covered by the toxicological evaluation of carrageenan; data were adequate for a refined exposure assessment for 41 out of 79 food categories. However, the Panel noted uncertainties as regards the chemistry, the exposure assessment and biological and toxicological data. Overall, taking into account the lack of adequate data to address these uncertainties, the Panel concluded that the existing group acceptable daily intake (ADI) for carrageenan (E 407) and processed Eucheuma seaweed (E 407a) of 75 mg/kg bw per day should be considered temporary, while the database should be improved within 5 years after publication of this opinion.
本意见涉及对用作食品添加剂的食品级卡拉胶（E 407）和经加工的麒麟菜属海藻（E 407a）安全性的重新评估。由于结构相似，专家小组得出结论，经加工的麒麟菜属海藻可纳入食品级卡拉胶的评估中。聚硫酸酯多糖（平均分子量10 - 20 kDa）未被批准作为食品添加剂，也未用于任何食品应用中。在对卡拉胶（E 407）和经加工的麒麟菜属海藻（E 407a）的评估中，专家小组指出，吸收、分布、代谢和排泄（ADME）数据库足以得出卡拉胶不会完整吸收的结论；在一项用几乎符合欧盟E 407规格的卡拉胶对大鼠进行的亚慢性毒性研究中，未观察到有害作用水平（NOAEL）为每天3400 - 3900毫克/千克体重（bw），这是测试的最高剂量；在对大鼠进行的高达每天7500毫克/千克bw的卡拉胶慢性毒性研究中未检测到有害影响，这是测试的最高剂量；卡拉胶的致癌性不存在问题；卡拉胶和经加工的麒麟菜属海藻在遗传毒性方面不存在问题；用于产前发育膳食毒性研究的钠和钙卡拉胶的NOAEL是测试的最高剂量；经加工的麒麟菜属海藻的安全性已通过卡拉胶的毒理学评估充分涵盖；对于79种食品类别中的41种，数据足以进行精细的暴露评估。然而，专家小组指出在化学、暴露评估以及生物学和毒理学数据方面存在不确定性。总体而言，考虑到缺乏解决这些不确定性的充分数据，专家小组得出结论，卡拉胶（E 407）和经加工的麒麟菜属海藻（E 407a）目前每天75毫克/千克bw的群体可接受每日摄入量（ADI）应被视为临时的，同时应在本意见发布后的5年内改进数据库。
