化妆品监督管理
时间(TIME):2021-03-07 09:42:14

01 化妆品的定义  Definition of Cosmetics

 

化妆品,是指以涂擦、喷洒或者其他类似方法,施用于皮肤、毛发、指甲、口唇等人体表面,以清洁、保护、美化、修饰为目的的日用化学工业产品。

Cosmetics refer to daily chemical industrial products that are applied to the skin, hair, nails, lips and other human surfaces by rubbing, spraying or other similar methods for the purpose of cleaning, protecting, beautifying and modifying.

 

02 化妆品的分类 Classification of Cosmetics

 

化妆品分为特殊化妆品和普通化妆品。用于染发、烫发、祛斑美白、防晒、防脱发的化妆品以及宣称新功效的化妆品为特殊化妆品;特殊化妆品以外的化妆品为普通化妆品。

Cosmetics are divided into special cosmetics and ordinary cosmetics. Cosmetics used for hair dyeing, perming, freckle whitening, sunscreen and anti-hair loss, as well as cosmetics claiming new efficacy are special cosmetics; cosmetics other than special cosmetics are ordinary cosmetics.

 

03 其他 Others

牙膏参照本条例有关普通化妆品的规定进行管理。

Toothpaste is managed in accordance with the regulations on ordinary cosmetics

香皂不适用本条例,但是宣称具有特殊化妆品功效的适用本条例。

Soap does not apply to this regulation, but it is applicable to soaps that claim to have special cosmetic effects.

 

04 特殊化妆品 Special cosmetics

对特殊化妆品实行注册管理。特殊化妆品经国务院药品监督管理部门注册后方可进口。

Registration management has been implemented for special cosmetics, which can only be imported after being registered by the drug regulatory department of the State Council.

 

特殊化妆品注册或者普通化妆品备案时,应当提交下列资料

1. 注册申请人、备案人的名称、地址、联系方式

2. 生产企业的名称、地址、联系方式

3. 产品名称

4. 产品配方或者产品全成分

5. 产品执行的标准

6. 产品标签样稿

7. 产品检验报告

8. 产品安全评估资料

 

The following documents shall be submitted when special cosmetics are registered or ordinary cosmetics are put on record

1. Name, address and contact information of registration applicant and filing person

2. Name, address and contact information of the manufacturer

3. Product name

4. Product formula or all ingredients

5. Standards for product implementation

6. Product label sample

7. Product inspection report

8. Product safety assessment data

 

05 普通化妆品 Ordinary  cosmetics

 

对普通化妆品实行备案管理。进口普通化妆品应当在进口前向国务院药品监督管理部门备案.

Record management has been implemented for ordinary cosmetics, which shall be filed with the drug regulatory department under the State Council before import.

 

首次申请注册或备案,申请人、备案人应当具备下列条件

1. 是依法设立的企业或者其他组织

2. 有与申请注册、进行备案的产品相适应的质量管理体系

3. 有化妆品不良反应监测与评价能力的资料

 

When applying for registration or filing for the first time, the applicant and the filing person shall meet the following requirements

1. Enterprise or other organization has been established in accordance with the law.

2. Having a quality management system suitable for the products applied for registration and put-on record.

3. Holding data on the ability to monitor and evaluate cosmetic adverse reactions

 

06 境外注册人、备案人特别注意 Special attention to overseas registrants and recorders:

根据《化妆品监督管理条例》的规定,境外化妆品注册人、备案人应当指定我国境内的企业法人办理化妆品注册、备案,协助开展化妆品不良反应监测、实施产品召回

 

According to the regulations on the Supervision and Administration of Cosmetics, the registrants and recorders of overseas cosmetics shall appoint the enterprise legal persons in China to register and record cosmetics, and assist in the monitoring of adverse reactions of cosmetics and the implementation of product recall.

 

07 化妆品标签要求  Cosmetic label requirements

化妆品的最小销售单元应当有标签。标签应当符合相关法律、行政法规、强制性国家标准,内容真实、完整、准确。进口化妆品可以直接使用中文标签,也可以加贴中文标签;加贴中文标签的,中文标签内容应当与原标签内容一致。

 

The minimum sales unit of cosmetics should be labeled. The label shall comply with relevant laws, administrative regulations and mandatory national standards, and the content shall be true, complete and accurate. Imported cosmetics may be labeled directly in Chinese or with additional Chinese labels; if additional Chinese labels are applied, the contents of the Chinese labels shall be consistent with those of the original labels.

 

 应当标注内容

1. 产品名称、特殊化妆品注册证编号

2. 注册人、备案人、受托生产企业的名称、地址

3. 化妆品生产许可证编号

4. 产品执行的标准编号

5. 全成分

6. 净含量

7. 使用期限、使用方法以及必要的安全警示

8. 法律、行政法规和强制性国家标准规定应当标注的其他内容

 

Contents to be marked

1. Product name and registration number of special cosmetics

2. The name and address of the registrant, the recorder and the entrusted production enterprise

3. Cosmetic production license number

4. Standard number of product execution

5. All ingredients

6. Net content

7. Service life, use method and necessary safety warning

8. Other contents that shall be marked according to laws, administrative regulations and mandatory national standards

 

 禁止标注内容

1. 明示或者暗示具有医疗作用的内容

2. 虚假或者引人误解的内容

3. 违反社会公序良俗的内容

4. 法律、行政法规禁止标注的其他内容

 

Prohibited contents

1. Express or imply the content with medical effect

2. False or misleading contents

3. Contents that violate public order and good mores

4. Other contents prohibited by laws and administrative regulations

 

08 海关对进出口化妆品监管 Customs supervision on import and export cosmetics

 

按照《化妆品监督管理条例》的规定,出入境检验检疫机构(海关)依照《中华人民共和国进出口商品检验法》的规定对进口的化妆品实施检验;检验不合格的,不得进口。

另外,根据《进出口化妆品检验检疫监督管理办法》,海关对进出口化妆品的生产经营者实施分类管理制度;对进口化妆品的收货人、出口化妆品的生产企业和发货人实施诚信管理。对有不良记录的,应当加强检验检疫和监督管理。

 

According to the regulations on the Supervision and Administration of Cosmetics, the entry-exit inspection and quarantine institution (Customs) shall inspect the imported cosmetics in accordance with the law of the people's Republic of China on the Inspection of Import and Export Commodities; those that fail to pass the inspection cannot be imported.

In addition, based to the measures for the Supervision and Administration of Inspection and Quarantine of Import and Export Cosmetics, the Customs implements a classified management system for the producers and operators of import and export cosmetics, and implements integrity management for the consignees of import cosmetics, manufacturers and consignors of export cosmetics. For those with bad records, inspection & quarantine, supervision administration shall be strengthened.

 

09 企业在进出口化妆品时注意事项 What should enterprise pay attention to when importing and exporting cosmetics

 

企业进口化妆品,应当对拟进口的化妆品是否已经注册或者备案以及是否符合化妆品监督管理条例和强制性国家标准、技术规范进行审核;审核不合格的,不得进口。进口商应当如实记录进口化妆品的信息,记录保存期限应当符合条例的规定。出口的化妆品应当符合进口国(地区)的标准或者合同要求。

 

When an enterprise imports the cosmetics, it shall examine whether the cosmetics to be imported have been registered or put-on record, and whether they are conformed to the regulations on the Supervision and Administration of Cosmetics, mandatory national standards and technical specifications; if failing to pass the examination, they shall not be imported. The importer shall truthfully record the information of imported cosmetics, and the retention period of the record shall comply with the provisions of the Regulations. The exported cosmetics shall meet the standards or agreement requirements of the importing country (region).

 

10 相关政策 Relevant Policy

2021年1月1日《化妆品监督管理条例》(中华人民共和国国务院第727号令)正式施行

On January 1, 2021, the regulations on the supervision and administration of cosmetics (Order No. 727 of the State Council of the people's Republic of China) came into effect

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