Scientific Opinion on the re-evaluation of mixed carotenes (E 160a (i)) and beta-carotene (E 160a (ii)) as a food additive
Scientific Opinion on the re-evaluation of mixed carotenes (E 160a (i)) and beta-carotene (E 160a (ii)) as a food additive
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DOI：
10.2903/j.efsa.2012.2593
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发表时间：
2012-03-01
期刊：
影响因子：
3.3
通讯作者：
Wright, M. C.
中科院分区：
文献类型：
--
作者：
Aguilar, F.;Crebelli, R.;Wright, M. C.
食品添加剂和食品中添加的营养源专家组提供了一个科学意见，重新评估混合胡萝卜素[E 160 a（i）]和β-胡萝卜素[E 160 a（ii）]用作食品着色物质时的安全性。混合胡萝卜素[E 160 a（i）]和β-胡萝卜素[E 160 a（ii）]在欧盟被批准作为食品添加剂，并已由JECFA（最近于2001年）和SCF（1997年和2000年）进行了评估。两个委员会都确定了每日允许摄入量为0-5毫克/千克体重/天。在该观点中，混合胡萝卜素根据委员会指令2008/128/EC定义，并且由两组物质组成：植物胡萝卜素和藻类胡萝卜素。β-胡萝卜素包括（合成的）β-胡萝卜素和通过真菌三孢布拉氏霉菌发酵获得的β-胡萝卜素。评估小组注意到：（一）混合胡萝卜素的规格不充分，需要更新;（二）大多数毒理学研究是在啮齿动物身上进行的，尽管啮齿动物与人类不同，能非常有效地将β-胡萝卜素转化为维生素A。专家小组得出结论，根据现有数据集，无法确定混合胡萝卜素和β-胡萝卜素的ADI，从棕榈果油、胡萝卜和藻类中提取的（合成）β-胡萝卜素和混合β-胡萝卜素作为食用色素不存在安全问题，只要从这种用途中摄入的β-胡萝卜素作为食品添加剂和食品补充剂，不超过正常食用天然存在的食物可能摄入的量（5-10 mg/天）。这将确定，这些用途所产生的β-胡萝卜素接触量将保持在15毫克/天以下，流行病学研究没有发现β-胡萝卜素的补充摄入量会增加癌症风险。此外，专家小组无法就混合胡萝卜素的使用安全性得出结论[E 160 a（i）]（C）欧洲食品安全局，2012年
The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of mixed carotenes [E 160a (i)] and beta-carotene [E 160a (ii)] when used as food colouring substances. Mixed carotenes [E 160a (i)] and beta-carotene [E 160a (ii)] are authorised as food additives in the EU and have been evaluated previously by the JECFA the latest in 2001 and by the SCF in 1997 and 2000. Both Committees established an Acceptable Daily Intake (ADI) of 0-5 mg/kg bw/day. In this opinion the mixed carotenes are defined according to the Commission Directive 2008/128/EC and consist of two groups of substances: plant carotenes and algal carotenes. beta-Carotene comprises (synthetic) beta-carotene and beta-carotene obtained by fermentation of the fungus Blakeslea trispora. The Panel noted (i) that the specifications of mixed carotenes are inadequate and need to be updated, (ii) that most toxicological studies have been performed with rodents, although rodents, in contrast to humans, very efficiently convert beta-carotene to vitamin A. The Panel concluded that based on the presently available dataset, no ADIs for mixed carotenes and beta-carotene can be established and that the use of (synthetic) beta-carotene and mixed beta-carotenes obtained from palm fruit oil, carrots and algae as food colour is not of safety concern, provided the intake from this use as a food additive and as food supplement, is not more than the amount likely to be ingested from the regular consumption of the foods in which they occur naturally (5-10 mg/day). This would ascertain that the exposure to beta-carotene from these uses would remain below 15 mg/day, the level of supplemental intake of beta-carotene for which epidemiological studies did not reveal any increased cancer risk. Furthermore, the Panel could not conclude on the safety in use of mixed carotenes [E 160a (i)] (C) European Food Safety Authority, 2012