化妝品監(jiān)督管理
時間(TIME)：2021-03-07 09:42:14
01 化妝品的定義 Definition of Cosmetics
化妝品，是指以涂擦、噴灑或者其他類似方法，施用于皮膚、毛發(fā)、指甲、口唇等人體表面，以清潔、保護、美化、修飾為目的的日用化學工業(yè)產(chǎn)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 化妝品的分類 Classification of Cosmetics
化妝品分為特殊化妝品和普通化妝品。用于染發(fā)、燙發(fā)、祛斑美白、防曬、防脫發(fā)的化妝品以及宣稱新功效的化妝品為特殊化妝品；特殊化妝品以外的化妝品為普通化妝品。
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
牙膏參照本條例有關普通化妝品的規(guī)定進行管理。
Toothpaste is managed in accordance with the regulations on ordinary cosmetics
香皂不適用本條例，但是宣稱具有特殊化妝品功效的適用本條例。
Soap does not apply to this regulation, but it is applicable to soaps that claim to have special cosmetic effects.
04 特殊化妝品 Special cosmetics
對特殊化妝品實行注冊管理。特殊化妝品經(jīng)國務院藥品監(jiān)督管理部門注冊后方可進口。
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.
特殊化妝品注冊或者普通化妝品備案時，應當提交下列資料
1. 注冊申請人、備案人的名稱、地址、聯(lián)系方式
2. 生產(chǎn)企業(yè)的名稱、地址、聯(lián)系方式
3. 產(chǎn)品名稱
4. 產(chǎn)品配方或者產(chǎn)品全成分
5. 產(chǎn)品執(zhí)行的標準
6. 產(chǎn)品標簽樣稿
7. 產(chǎn)品檢驗報告
8. 產(chǎn)品安全評估資料
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 普通化妝品 Ordinary cosmetics
對普通化妝品實行備案管理。進口普通化妝品應當在進口前向國務院藥品監(jiān)督管理部門備案.
Record management has been implemented for ordinary cosmetics, which shall be filed with the drug regulatory department under the State Council before import.
首次申請注冊或備案，申請人、備案人應當具備下列條件
1. 是依法設立的企業(yè)或者其他組織
2. 有與申請注冊、進行備案的產(chǎn)品相適應的質(zhì)量管理體系
3. 有化妝品不良反應監(jiān)測與評價能力的資料
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 境外注冊人、備案人特別注意 Special attention to overseas registrants and recorders:
根據(jù)《化妝品監(jiān)督管理條例》的規(guī)定，境外化妝品注冊人、備案人應當指定我國境內(nèi)的企業(yè)法人辦理化妝品注冊、備案，協(xié)助開展化妝品不良反應監(jiān)測、實施產(chǎn)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 化妝品標簽要求 Cosmetic label requirements
化妝品的最小銷售單元應當有標簽。標簽應當符合相關法律、行政法規(guī)、強制性國家標準，內(nèi)容真實、完整、準確。進口化妝品可以直接使用中文標簽，也可以加貼中文標簽；加貼中文標簽的，中文標簽內(nèi)容應當與原標簽內(nèi)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.
應當標注內(nèi)容
1. 產(chǎn)品名稱、特殊化妝品注冊證編號
2. 注冊人、備案人、受托生產(chǎn)企業(yè)的名稱、地址
3. 化妝品生產(chǎn)許可證編號
4. 產(chǎn)品執(zhí)行的標準編號
5. 全成分
6. 凈含量
7. 使用期限、使用方法以及必要的安全警示
8. 法律、行政法規(guī)和強制性國家標準規(guī)定應當標注的其他內(nèi)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
禁止標注內(nèi)容
1. 明示或者暗示具有醫(yī)療作用的內(nèi)容
2. 虛假或者引人誤解的內(nèi)容
3. 違反社會公序良俗的內(nèi)容
4. 法律、行政法規(guī)禁止標注的其他內(nèi)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 海關對進出口化妝品監(jiān)管 Customs supervision on import and export cosmetics
按照《化妝品監(jiān)督管理條例》的規(guī)定，出入境檢驗檢疫機構(gòu)（海關）依照《中華人民共和國進出口商品檢驗法》的規(guī)定對進口的化妝品實施檢驗；檢驗不合格的，不得進口。
另外，根據(jù)《進出口化妝品檢驗檢疫監(jiān)督管理辦法》，海關對進出口化妝品的生產(chǎn)經(jīng)營者實施分類管理制度；對進口化妝品的收貨人、出口化妝品的生產(chǎn)企業(yè)和發(fā)貨人實施誠信管理。對有不良記錄的，應當加強檢驗檢疫和監(jiān)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 企業(yè)在進出口化妝品時注意事項 What should enterprise pay attention to when importing and exporting cosmetics
企業(yè)進口化妝品，應當對擬進口的化妝品是否已經(jīng)注冊或者備案以及是否符合《化妝品監(jiān)督管理條例》和強制性國家標準、技術(shù)規(guī)范進行審核；審核不合格的，不得進口。進口商應當如實記錄進口化妝品的信息，記錄保存期限應當符合條例的規(guī)定。出口的化妝品應當符合進口國（地區(qū)）的標準或者合同要求。
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 相關政策 Relevant Policy
2021年1月1日《化妝品監(jiān)督管理條例》（中華人民共和國國務院第727號令）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
