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中新网9月19日电 据“市说新语”微信公众号消息,近日,《全国人民代表大会常务委员会关于修改〈中华人民共和国食品安全法〉的决定》将婴幼儿配方液态乳(以下简称婴配液态乳)纳入注册管理。对此,市场监管总局组织修订了《婴幼儿配方乳粉产品配方注册管理办法》,明确婴配液态乳产品配方注册适用该办法,向社会公开征求意见。同时,市场监管总局还就婴配液态乳产品配方注册相关配套文件公开征求意见。
与婴幼儿配方乳粉相比,婴配液态乳对于微生物和稳定性控制需更加严格,市场监管总局制定的《婴幼儿配方液态乳产品配方注册申请材料项目与要求(征求意见稿)》,重点从三方面明确了注册要求:一是对生乳中嗜冷菌、耐热芽孢菌等原辅料微生物风险控制提出要求;二是对产品研发中稳定性保持提出要求,要求制定产品体系稳定的内控评价标准、评价指标及检测方法等;三是对生产工艺验证、产品检验以及灭菌效果验证等提出具体要求。
市场监管总局还制定了《婴幼儿配方液态乳货架期产品稳定性研究指南(征求意见稿)》,明确稳定性研究的基本原则、试验样品和项目、试验方法、报告内容和稳定性重点试验项目,指导企业开展货架期产品稳定性研究。
市场监管总局将根据征求意见情况,尽快修改完善并发布相关文件,保证企业能够按时申请婴配液态乳注册。
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