Colorcon, Inc., 公司于2017年10月3日提交了本次应用申请,提议合成氧化铁的限量为,按照标签剂量每天5毫克铁元素。
美国食品药品管理局经过评估认为,合成氧化铁用于片剂和胶囊型膳食补充剂不会对人体健康产生影响,无需环境评估或者环境影响声明。
部分原文报道如下:
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Colorcon, Inc., proposing that the color additive regulations be amended by expanding the permitted uses of synthetic iron oxide as a color additive to include use in dietary supplement tablets and capsules.