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2013年2月1日起正式实施《儿童化妆品申报与审评指南》 发布时间: 2013-01-17 18:36 点击:

 

2013年2月1日起正式实施《儿童化妆品申报与审评指南》
In February 1, 2013 the formal implementation of " the guidelines for application and review of children's cosmetics "
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。《儿童化妆品申报与审评指南》对配方原则做了明确要求:
Cosmetics line for children under the age of 12 with the use of 12 years old of children's cosmetics. " The guidelines for application and review of " children's cosmetics made explicit requirements for the formulation of principles:
 一是应最大限度地减少配方所用原料的种类。
One should be kind to minimize the formulation of raw materials used.
 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 two is the choice of fragrance, colorants, preservatives and surface active agent, should insist on the basis of effective with less, no principle, also should pay 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。
Three is the children's cosmetics formula should not be used with whitening, freckle, acne, such as hair removal, antiperspirant, deodorant, hair, hair coloring, perming, fitness, beauty breast efficacy component.
 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。
Four is a certain cosmetics raw materials should be selected the safe use of history, do not encourage the use of gene technology, nanotechnology and other raw material for the preparation of.
 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。
Five is the source of raw materials used, should know the formula composition, impurities, physicochemical properties, scope of application, the safe dosage, notes and other relevant information and reference.
《儿童化妆品申报与审评指南》由国家食品药品监督管理局制定,将于今年2月1日起正式实施。该《指南》要求,儿童化妆品应最大限度地减少配方原料的种类,不宜使用具有诸如美白、祛斑等功效的原料,尽量少用、不用香精、着色剂、防腐剂及表面活性剂等。
" The guidelines for application and review of " children's cosmetics formulated by the State Food and drug administration, will be officially implemented in February 1st this year. The " guide " requirements, children's cosmetics should be to minimize the formulation of raw materials, should not be used with such as whitening, freckle effect of raw material, use less as far as possible, without fragrance, colorants, preservatives and surface active agent.
      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 aspect of safety, " guide " clearly put forward, research and evaluation declaration enterprise to children's cosmetics safety, ensure the use safety of the product. The declaration enterprise should according to the characteristics of children, safety risk assessment of children's cosmetics raw material used. In addition, should be combined with the use of products such as whether to rinse after use, strengthening the safety risk assessment on the formula used in essence, ethanol and other organic solvents, cationic surface active agent and transdermal enhancers raw materials such as children's cosmetics.
    《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 " clearly, expressly for children's cosmetics, should be in accordance with the " administrative license of cosmetics application requirements " provisions of the children's cosmetics requirements to declare. Not expressly for children's cosmetics, the packaging shall not in patterns or other forms of display or hint for the 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 ", as the children's cosmetics declaration data, based on security considerations should include the principles of formulation design formula of the whole analysis report, containing material selection principle and requirement, production process and quality control etc.. In addition, formulation of overall analysis report from the angle of security with the formula of raw materials used by the analysis.
2013年2月1日起正式实施《儿童化妆品申报与审评指南》
In February 1, 2013 the formal implementation of " the guidelines for application and review of children's cosmetics "
 

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