|Regulations Concerning the Hygiene Supervision over Cosmetics|
|Main Supporting Rules|
|1 Jul 2007||Hygienic Standard for Cosmetics|
|1 Apr 2010||Requirements for Application and Acceptance of Administrative Licensing for Cosmetics|
|1 Jul 2011||Guidance on Application and Review of New Cosmetic Ingredients|
|1 Oct 2009||GB 5296.3-2008 General Labeling for Cosmetics|
China's current cosmetic regulatory system is founded on the overarching "Regulations Concerning the Hygiene Supervision over Cosmetics (1989)", supported by a series of subsidiary rules, standards and guidance documents issued by the former regulator, the Ministry of Health (MOH) and the current competent authority, National Medical Products Administration (NMPA).
In the last two decades, China's cosmetics industry has undergone tremendous change. Currently, the Chinese cosmetic market ranks as the third largest globally and is also the worlds' emerging market, exhibiting the greatest average annual growth rate. To make the cosmetic regulatory framework consistent with the current industry situation, in the second half of 2013, the former CFDA (now NMPA) initiated a program to reform Hygiene Supervision of Cosmetics Regulation 1989 aiming to further standardize cosmetic production and operation as well as reinforce cosmetic supervision and administration and the written draft was released in 2015. All stakeholders will be significantly affected by the revised regulation. The amendment is not simply a refinement of its predecessor but represents a complete overhaul, which will see the definition, classification and registration requirements of cosmetics completely changed. Once effective, the new regulation will necessitate that, both domestic and overseas cosmetic companies adopt new compliance strategies.
Promulgated by the former MOH and acts as the overriding regulation for cosmetics in China
1 Jan 1990
In force, but
|The revision of Regulations concerning the Hygiene Supervision over Cosmetics 1989||/||A draft|
|The draft for second public consultation of Regulations concerning the Hygiene Supervision over Cosmetics 1989||/||The draft for second public consultation|
|For Product||The revised version of Hygienic Standard for Cosmetics 2007||1 Dec 2016||In force, but being revised|
A GMP-like guidance for cosmetic manufacturers in China
1 Jan 2008
Specifies registration dossiers for imported cosmetics, domestic special use cosmetics and new cosmetic ingredient
1 Apr 2010
|Requirements for Filing of Domestic Non-special Use Cosmetic Products 《国产非特殊用途化妆品备案要求》||Guidance for filing of domestic non-special use cosmetics||30 Jun 2014||In Force|
|Guidelines for Registration Review and Approval of Domestic Special Use Cosmetics《国产特殊用途化妆品审批服务指南》||Guidance for registration review and approval of domestic special use cosmetics||1 Dec 2017||In Force|
|Guidelines for Registration Review and Approval of Imported Special Use Cosmetic Products《首次进口的化妆品审批——进口特殊用途化妆品的审批服务指南》||Guidance for registration review and approval of imported special use cosmetics||1 Dec 2017||In Force|
|Guidelines for Registration Review and Approval of Imported Non-special Use Cosmetic Products《首次进口的化妆品审批——进口非特殊用途的化妆品的审批服务指南》||Guidance for registration review and approval of imported non-special use cosmetics||1 Dec 2017||In Force|
Formulated especially for registration of new cosmetic ingredients
1 Dec 2017
Formulated especially for registration of children’s cosmetics
1 Feb 2013
Sets out Testing requirements for imported cosmetics, domestic special use cosmetics and new cosmetic ingredient
11 Feb 2010
Standardizes required info in label and instruction of cosmetic products
Details required info on cosmetic labels
1 Oct 2009
Details requirements for naming
Ingredients included in it need not registration
Import & Export
Regulating the import and export of cosmetics
1 Feb 2012
During the 2018 NPC conference, the Stated Council launched government institution reform, and established “State Administration for Market Regulation” to fully regulate cosmetics in place of three institutions: CFDA, AQSIQ and SAIC. There sets an independent Drug Administration Bureau named "National Medical Products Administration" under the “State Administration for Market Regulation”.
1. SAMR major responsibilities include:
- Market management
SAMR is responsible for development, oversight and enforcement of regulation, policy and standards related to market supervision. It will also develop standardization strategies to create an honest and fair market environment.
- Market entity registration
It is responsible for registration of market entities conducting business in China, including representative office of overseas enterprises.
- Quality and safety supervision
SAMR will carry out risk monitoring on product quality and safety, as well as implement national sampling inspection across the country.
- Standardization work
SAMR is obliged to notify new GB standards to the public and draft GB/T standards.
In addition, SAMR should coordinate with other ministries to optimize market supervision with major interactions summarized below:
- NMPA is responsible for formulating cosmetic regulatory systems, as well as licensing, inspection and penalties for cosmetics research and manufacture.
- SAMR should cooperate with Ministry of agriculture and rural affairs to establish mechanisms related to origin exit market access and traceability.
- National Health Commission (NHC) should give timely feedback on results of risk assessment studies to SAMR to guide policy.
- An information sharing system should be set up between SAMR and GAC to avoid redundancy and overlap of administrative duties and to aid in information dissemination related to safety and quality issues associated with import/export cosmetics.
NMPA's major responsibilities include:
- Safety Supervision Management
NMPA is responsible for cosmetics, drug and medical devices' safety supervision management, including formulating supervision policies, drafting regulations, supervising its implementation, as well as formulating management and service policies that encourage new technologies for cosmetics, drug and medical devices.
- Standard Management
NMPA is obliged to draft cosmetic standards, formulate a cosmetic classification management system and supervise its implementation.
- Registration Management
NMPA is responsible for formulating cosmetic, drug and medical device registration management system. It will also strictly conduct market entry review and approval.
- Quality Control
NMPA is responsible for formulating cosmetic, drug and medical device quality control practices.
- Post-market Risk Management
NMPA will carry out monitoring, evaluation, rectifications and recalls associated with cosmetic adverse reactions, as well as undertake cosmetic safety emergency management.
- Supervision and Inspection
NMPA is obliged to formulate inspection rules, penalize illegal activities in cosmetic registration and manufacturing.
- Foreign Exchange and Cooperation
NMPA will participate in the formulation of international regulatory rules and standard.
3. NMPA consists of 9 subordinate departments, including a “Cosmetic Safety Supervision Department”(化妆品监督管理司), which will undertake cosmetics registration and filing, drafting and supervising the implementation of cosmetic standards, classification rules, technical guidelines and censorship, as well as conducting on-site and sampling inspection, penalizing illegal activities and monitoring adverse reactions.
5. China General Administration of Customs is responsbible for import and export inspection of cosmetics.
Before being used, marketed or imported into China, cosmetic products must get approval from NMPA or provincial Medical Products Administration according to the product category.
Cosmetic products refer to chemical products for daily use intended to be applied on any external part of human body (such as skin, hair, nails, lips etc.) by spreading, spraying or other similar ways to keep the body clean, eliminate unpleasant odor, protect skin, and improve appearance and beauty.
Cosmetics have various definitions in different countries (regions). How to determine whether a product falls in the scope of cosmetics in China? You may take into consideration the following three aspects:
Smearing, spraying or other similar ways like rubbing
Oral administration or injection
Applied body parts
Any external part of the human body, such as skin, hair, nails, lips
Teeth or oral mucosa
Functions and purposes of use
Skin care, to make the body hygienic, to eliminate undesirable odors, to enhance the beauty of the appearance
Prevent and treat diseases
Cosmetic products in China are divided into two categories.
non-special use cosmetics
special use cosmetics
In the second draft of Regulations concerning the Supervision and Administration over Cosmetics, China has changed the classification and categories of cosmetics. In the draft cosmetics are regulated as general cosmetics and special cosmetics. Special cosmetics include:
- Hair dye products
- Hair perming products
- Whitening products
- Other special cosmetics deemed by the CFDA
The draft defines general cosmetics as all other cosmetics not classified as special cosmetics. The former CFDA is responsible for formulating and publishing the cosmetic categories inventory and will also adjust the scope of special cosmetics based on the monitoring of cosmetics adverse reaction and R&D outcomes. It is estimated that breast beauty products and slimming products are likely to be managed as pharmaceutical products once it is enfored.
In the draft for second public consultation of Regulations concerning the Hygiene Supervision over Cosmetics 1989, special use cosmetics are adjusted as following 5 categories:
- Hair dye products
- Hair perming products
- Whitening products
- Other cosmetics claimed new efficacies
At present, imported special use cosmetics, domestic special use cosmetics and new cosmetic ingredients require pre-market registration with NMPA, while domestic non-special use cosmetics are subject to pre-market filing with the provincial Medical Products Administration, imported non-speical use cosmetics are subject to filing with NMPA or the provincial Medical Products Administration in the 11 FTZs. The registration of non-SUC is less stringent and demanding than that of SUC.
|Imported non-SUC||Pre-market filing||Filing certificate||NMPA or Provincial Medical Products Administration in the 11 FTZs|
|Imported SUC||Pre-market administrative licensing||Administrative license||NMPA|
|Domestic non-SUC||Pre-market online filing||no certificate||Provincial Medical Products Administration|
|Domestic SUC||Pre-market administrative licensing||Administrative license||NMPA|
|New ingredient||Pre-market administrative licensing||NMPA’s approval announcement||NMPA|
► The filing of domestic non-special use cosmetics
Cosmetics manufacturers shall notify provincial Medical Products Administration through an online platform of the product formula and sales packaging (including labels and instructions for use) prior to marketing. Applicants are required to record the product information, including formula, packaging, description of production process, product technical requirements and testing reports for future examination. In order to assist producers in China, SAMR (the former CFDA) has prepared a guidance document, “Requirements for Filing of Domestic Non-special Use Cosmetic Products”, which details all information required and the filing procedures.