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Back国家药监局公布《牙膏分类目录》
国家药监局公布《牙膏分类目录》
Health
中国新闻网5 hours agoHealth2 min readChinaView translation

国家药监局公布《牙膏分类目录》

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国家药监局发布《牙膏分类目录》,明确牙膏功效分类与宣称规范,要求备案人根据目录选取编码组合,防龋等类牙膏宣称用语需语义相同或相近,目录自2027年5月1日起施行,过渡期至2028年1月1日。

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Why It Matters

根据《化妆品监督管理条例》《牙膏监督管理办法》,国家药监局组织制定了《牙膏分类目录》以规范牙膏功能宣称。

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中新网10月15日电 据国家药监局网站消息,为加强牙膏监督管理,规范牙膏功效分类与宣称,维护消费者口腔健康,根据《化妆品监督管理条例》《牙膏监督管理办法》,国家药监局组织制定了《牙膏分类目录》(以下简称《目录》),现予公布。有关事项公告如下:

一、牙膏备案人在进行牙膏备案时,应当根据牙膏功效类别和使用人群,按照《目录》规定选取对应编码组合形成产品分类编码。同一款牙膏同时具备多个类别的功效、适配不同使用人群的,可以同时选择多个对应编码。

二、牙膏可以宣称的功效应当符合《目录》确定的范围:

(一)基础清洁类牙膏。该类牙膏的功效宣称用语应当限于《目录》中相应类别所列的功效宣称用语范围。

(二)防龋、抑牙菌斑、抗牙本质敏感、减轻牙龈问题类牙膏。上述类别牙膏的功效宣称用语应当与《目录》中相应类别所列的功效宣称用语在语义和功效本质上相同或者相近。

(三)去渍美白、抗牙石、减轻口臭类牙膏。上述类别牙膏的功效宣称用语参照《目录》中相应类别所列的功效宣称用语示例,并根据实际情况进行调整或者增加。

牙膏标签上描述产品颜色、气味、口味等感官体验内容,不属于功效宣称用语,不受《目录》中所列的功效宣称用语范围约束。

三、牙膏标签上标注的功效宣称用语与其他词语搭配使用时,应当符合法律法规、强制性国家标准、技术规范等相关要求,不得标注明示或者暗示具有医疗作用的内容等。

四、《目录》自2027年5月1日起施行。《目录》施行前已经备案的牙膏,备案人应当于2028年1月1日前完成备案信息变更,使其符合《目录》规定;在备案人完成备案信息变更之前已经生产、进口的牙膏,可以依法销售至产品保质期结束。

各级药品监管部门要指导督促牙膏备案人和牙膏生产企业落实本公告要求,规范牙膏功效分类与宣称;《目录》施行后,要加强监督检查,对不符合《目录》规定、违法宣称牙膏功效的行为依法予以查处。

五、国家药监局建立《目录》动态调整机制,结合科学研究进展、行业发展和牙膏监管工作实际,对《目录》适时调整。

附件:牙膏分类目录

Open Questions

  • 《目录》中具体包含哪些功效类别和对应的宣称用语?
  • 动态调整机制将如何具体运作?

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This article was originally published by 中国新闻网.

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