国内外法规对水解乳蛋白在婴幼儿配方食品中使用的规定

Overview of domestic and foreign standards and regulations for hydrolyzed milk proteins used in infant formula food

目的整理分析国内外对水解乳蛋白在婴幼儿配方食品中的应用规定及研究文献,为该类产品的研发、使用和监管提供参考。方法系统整理国内外水解乳蛋白在婴幼儿配方食品中使用的相关研究、法律法规和临床应用,并结合我国现状进行讨论分析。结果通过整理比较,我国相关法规及标准明确了水解乳蛋白在特殊医学用途婴儿配方食品中使用的技术要求;国际法典委员会和欧盟也对水解乳蛋白在婴儿配方食品中的使用有相应规定;美国虽未出台具体法规,但有大量的权威文献及科学研究资料;中国台湾地区食品标准对水解乳蛋白的使用要求与国际法典委员会一致;澳大利亚/新西兰、日本等国家和地区暂未查询到相关规定。结论我国应当借鉴国际先进经验,加强水解乳蛋白的基础性研究和临床研究,不断完善相关标准、法规和技术要求,促进并规范水解乳蛋白在婴幼儿配方食品中的应用。

Objective This paper reviewed the studies on hydrolyzed milk proteins used in infant formula food,and provides suggestions for research and development,supervision and clinical application of hydrolysate formulas. Methods Requirements in laws and regulations,clinical trial studies and related researches for hydrolyzed milk proteins and hydrolysate formulas were collected and analyzed. Results Regulations and standards for hydrolyzed milk proteins used in formula food for special medical purposes had been released in China; Codex Alimentarius Commission（ CAC） and European Union also had regulations and standards for hydrolyzed milk proteins used in infant formula; The US had a large number of literatures and studies for hypoallergenic infant formulas. The requirements of China Taiwan were in accordance with CAC. The relevant regulations of Australia,New Zealand,Japan and other countries and regions had not been found.Conclusion Scientific institutions should pay attention to the basic research of hydrolyzed milk proteins and hydrolysate formulas. Administration department should improve the standards and regulations.