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药监局:儿童化妆品不鼓励用基因技术制备原料--亲稳舆论引导监测室
2012-10-19
中新网10月19日电 国家食品药品监督管理局今日在其官方网站公布《儿童化妆品申报与审评指南》。《指南》明确,儿童化妆品应选用有一定安全使用历史的化妆品原料,不鼓励使用基因技术、纳米技术等制备的原料。
Beijing on October 19, state food and drug administration today announced in its official website[Children's cosmetics declaration and evaluation guidelines].[guide]clear,Children's cosmetics should choose the safe use of history has a certain cosmetics raw materials,Don't encourage use of gene technology/The preparation of nanometer technology, raw material.
《指南》明确,儿童化妆品系指供年龄在12岁以下(含12岁)儿童使用的化妆品。《指南》对配方原则做了明确要求:
[guide]clear,Children's cosmetics means for under the age of twelve(Contain 12 years old)Children's use of cosmetics.[guide]The principle of formula made specific requirements:
一是应最大限度地减少配方所用原料的种类。
One is to should minimize the formula of raw materials used types.
二是选择香精、着色剂、防腐剂及表面活性剂时,应坚持有效基础上的少用、不用原则,同时应关注其可能产生的不良反应。
The second is to choose essence/stain/Preservatives and surface active agent when,Should be insisted on the basis of effective with less/Don't principle,At the same time should pay close attention to its possible adverse reaction.
三是儿童化妆品配方不宜使用具有诸如美白、祛斑、去痘、脱毛、止汗、除臭、育发、染发、烫发、健美、美乳等功效的成分。
The third is children's cosmetics formula is unfavorable use such as whitening/spot/Inside fire/depilatory/hidroschesis/deodorization/Brood hair/hair/marcel/Strong and handsome/Breast beauty effect such as ingredients.
四是应选用有一定安全使用历史的化妆品原料,不鼓励使用基因技术、纳米技术等制备的原料。
The fourth is should choose the safe use of history has a certain cosmetics raw materials,Don't encourage use of gene technology/The preparation of nanometer technology, raw material.
五是应了解配方所使用原料的来源、组成、杂质、理化性质、适用范围、安全用量、注意事项等有关信息并备查。
5 it is should know the formula used by the source of raw materials/composition/impurity/Physical and chemical properties/scope/Safety dosage/Matters needing attention and other relevant information and reference.
在安全性方面,《指南》明确提出,申报企业应对儿童化妆品的安全性进行研究与评价,确保产品使用安全。申报企业应根据儿童的特点,对儿童化妆品所使用原料进行安全性风险评估。此外,应结合产品的使用方式(如用后是否冲洗),加强对配方中使用香精、乙醇等有机溶剂、阳离子表面活性剂以及透皮促进剂等原料的儿童化妆品的安全性风险评估。
In the safety,[guide]Clearly put forward,Declaration enterprise to children's cosmetics safety research and evaluation,Ensure product use safety.Declaration enterprise should be based on the characteristic of children,On children's cosmetics raw materials used by the safety risk assessment.In addition,Should be combined with the use of the products mode(If use whether after washing),Strengthen the formula used in essence/Ethanol, and other organic solvents/Cationic surfactant and transdermal accelerator for the raw materials such as children's cosmetics safety risk assessment.
《指南》明确,明示适用于儿童的化妆品,应按照《化妆品行政许可申报受理规定》规定的儿童化妆品要求申报。未明示适用于儿童的化妆品,其产品包装不得以图案或其他形式显示或暗示为儿童用化妆品。
[guide]clear,Express is suitable for children's cosmetics,Should according to[Cosmetics administrative licensing provisions filing acceptance]The provisions of the children's cosmetics requirements to declare.Not express is suitable for children's cosmetics,Its products in packaging design or other forms display or implied in cosmetics for children.
《指南》提出,作为儿童化妆品的申报资料,应包括基于安全性考虑的配方设计原则(含配方整体分析报告)、原料的选择原则和要求、生产工艺及质量控制等内容。此外,配方整体分析报告应从安全性角度结合配方所使用原料进行分析。
[guide]Put forward,As children's cosmetics declaration material,Should include based on safety consideration of formula design principles(Including formula overall analysis report)/The selection of raw material principles and requirements/The production process and quality control, etc.In addition,Formula overall analysis report should be combined with safety Angle formula used raw material to carry on the analysis.
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