EFSA J. 2016 Jun 15;14(6):e04508. doi: 10.2903/j.efsa.2016.4508. eCollection 2016 Jun.
The additive under assessment, ferric oxide, contains between 57% and 69% iron (Fe). The EFSA FEEDAP Panel could not conclude on the safety of ferric oxide for the target animals owing to that (i) the application of ferric oxide red is for all animal species, (ii) lifetime administration to animals is not excluded and (iii) a sufficient biological and toxicological database was not available. Regarding (i) the very low absorption of iron from the ferric oxide by target animals and (ii) the homoeostatic regulation of iron metabolism in animals, any influence of feeding the ferric oxide on the iron content of edible tissues and products is not expected. The use of ferric oxide in animal nutrition is unlikely to result in a direct exposure of the consumer to this oxide. Consequently, the supplementation of feed for food-producing animals with ferric oxide would likely not constitute a risk to consumers. Ferric oxide is an irritant to skin and eyes by mechanical action. Owing to the nickel content in the additive, the ferric oxide should be regarded as dermal and respiratory sensitiser. Inhalation of ferric oxide, and the contained chromium and nickel, is a hazard; as exposure by inhalation is likely, handling ferric oxide would be a risk for the users. As there is concern about the possible genotoxicity of ferric oxide, any route of exposure should be considered as hazardous. Iron oxides are ubiquitous in the environment. Any additional input from the nutritional use of ferric oxide in food-producing animals is considered negligible. It is unlikely that the use of the additive in animal nutrition would pose a risk to the environment. Ferric oxide should not be considered as iron source capable to meet iron requirements of animals.
所评估的添加剂三氧化二铁含铁(Fe)量在57%至69%之间。由于以下原因,欧洲食品安全局动物饲料添加剂和产品(FEEDAP)小组无法就三氧化二铁对目标动物的安全性得出结论:(i)三氧化二铁红适用于所有动物物种;(ii)不排除对动物进行终生投喂;(iii)缺乏充分的生物学和毒理学数据库。鉴于(i)目标动物对三氧化二铁中铁的吸收极低,以及(ii)动物体内铁代谢的稳态调节,预计投喂三氧化二铁对可食用组织和产品中的铁含量不会产生任何影响。在动物营养中使用三氧化二铁不太可能导致消费者直接接触该氧化物。因此,在用于食品生产动物的饲料中添加三氧化二铁可能不会对消费者构成风险。三氧化二铁通过机械作用对皮肤和眼睛有刺激性。由于该添加剂中含有镍,三氧化二铁应被视为皮肤和呼吸道致敏剂。吸入三氧化二铁及其所含的铬和镍具有危害性;由于可能会发生吸入暴露,处理三氧化二铁对使用者来说存在风险。由于担心三氧化二铁可能具有遗传毒性,任何暴露途径都应被视为具有危险性。铁氧化物在环境中普遍存在。食品生产动物营养使用三氧化二铁带来的任何额外输入可忽略不计。在动物营养中使用该添加剂不太可能对环境构成风险。三氧化二铁不应被视为能够满足动物铁需求的铁源。