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首页> 美国卫生研究院文献>EFSA Journal >Scientific opinion on the evaluation of authorised ferric sodium EDTA as an ingredient in the context of Regulation (EC) 258/97 on novel foods and Regulation (EU) 609/2013 on food intended for infants and young children food for special medical purposes and total diet replacement for weight control
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Scientific opinion on the evaluation of authorised ferric sodium EDTA as an ingredient in the context of Regulation (EC) 258/97 on novel foods and Regulation (EU) 609/2013 on food intended for infants and young children food for special medical purposes and total diet replacement for weight control

机译：关于在关于新食品的法规（EC）258/97和针对婴幼儿食品特殊医学用途的食品的法规（EC）258/97和法规（EU）609/2013的范围内评估授权的三价铁钠的科学意见全部饮食替代以控制体重

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The present opinion deals with the evaluation of the proposed increase of the currently authorised maximum amounts of ferric sodium ethylenediaminetetraacetic acid ( ) as a novel food ingredient used as a source of iron, and its extension of use in processed cereal‐based foods and baby foods. The applicant also provided information on two forms of ferric sodium , one previously assessed by and a new one of finer consistency. To support the proposed changes to the uses of ferric sodium , the applicant proposed a revision of the current acceptable daily intake ( ) for , derived from that set for the food additive calcium disodium (E 385). The Panel confirmed that ferric sodium is a source from which iron is bioavailable. In assessing the safety of the proposed revision to the existing specifications for the novel food ingredient ferric sodium , the Panel noted that this would not discriminate between the previously evaluated substance and the one of finer consistency. In particular, the Panel noted that particle size was not one of the proposed parameters for the revised specifications. The Panel noted that it was not possible to determine whether particles of ferric sodium in the nano range were present in the product with finer consistency in the solid form. The toxicological data submitted did not add any new relevant information to the database on which the current for is based. Consequently, the Panel concluded that there was no sound scientific justification to increase the for and hence increase the use levels of ferric sodium or introduce additional uses as proposed by the applicant. The Panel recommended that additional toxicological data should be provided to address the shortcomings in the available toxicity database prior to the re‐evaluation of calcium disodium (E 385).
机译：本意见涉及对拟议增加目前批准的最大限量的提议，该提议是将乙二胺四乙酸三钠铁盐用作铁的新型食品成分，并扩大其在谷物加工食品和婴儿食品中的用途。申请人还提供了两种形式的铁钠的信息，一种是先前由铁合金评估过的，另一种是较精细的。为了支持对铁钠用途的拟议更改，申请人提议对当前可接受的每日摄入量（）进行修订，该摄入量源自食品添加剂钙二钠（E385）的设定值。专家小组确认，铁钠是生物可利用铁的来源。在评估针对新型食品成分铁钠的现有规范的拟议修订的安全性时，专家小组指出，这不会区分先前评估的物质和一致性更高的物质。小组特别指出，粒度不是修订后的规格的建议参数之一。专家小组指出，无法确定产品中是否存在纳米级的铁钠颗粒，并且固体形式的浓度更高。提交的毒理学数据未向当前依据的数据库添加任何新的相关信息。因此，小组认为，没有合理的科学理由来增加铁酸钠的用量，从而增加铁钠的使用量或引入申请人提出的其他用途。专家小组建议在重新评估钙二钠（E385）之前，应提供更多的毒理学数据，以解决可用毒性数据库中的缺点。

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