草案中列出了提交许可申请时所需的信息和数据,涉及具体配方的安全性和适用性,以及配方对降低婴儿乳蛋白过敏风险的效果。
本次指南还需进一步审议与更新完善。
部分原文报道如下:
EFSA has launched a public consultation on its draft guidance for the preparation and presentation of applications for authorisation of infant or follow-on formulae manufactured from protein hydrolysates.
The guidance document specifies what kind of information and data applicants need to submit. It covers applications for the assessment of the safety and suitability of the specific formula and applications on the formula's efficacy in reducing the risk of infants becoming allergic to milk proteins.
EFSA invites interested parties to submit written comments by 3 March 2017.
原文链接:http://www.efsa.europa.eu/sites/default/files/consultation/170113a.pdf
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