|Regulations concerning the Hygiene Supervision over Cosmetics|
National Market and Administration Bureau (tentative)
|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, China Food and Drug Administration (CFDA).
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, CFDA launched a far reaching campaign set on thoroughly amending the overarching cosmetics regulation. 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 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|
A fundamental standard for cosmetic products and ingredient, containing prohibited and restricted substance lists and testing methods
1 Jul 2007
In force, but will be repealed since December 1st 2016
|The revised version of Hygienic Standard for Cosmetics 2007||1 Dec 2016||To be enforced|
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
|Administrative Measures on Filing of Domestic Non-Special Use Cosmetics 《国产非特殊用途化妆品备案管理办法》||Guidance for filing of domestic non-special use cosmetics|
1 Oct 2011
|Requirements for Filing of Domestic Non-special Use Cosmetic Products 《国产非特殊用途化妆品备案要求》||New Guidance for filing of domestic non-special use cosmetics||30 Jun 2014||Replaces the above measures since 30 Jun 2014|
Formulated especially for registration of new cosmetic ingredients
1 Jul 2011
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
5 Feb 2 010
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 “National Market Supervision and Administration Bureau” to fully regulate cosmetics in place of three institutions: CFDA, AQSIQ AND SAIC. There sets an independent Drug Administration Bureau under the “National Market Supervision and Administration Bureau”.
The “National Market Supervision and Administration Bureau” take over overall authorities to manage cosmetics include:
- Major duty: Comprehensive Market Supervision and Management
- Unify information record system and set information publicizing and sharing mechanism
- Organize the law enforcement of comprehensive market supervising work
- Shoulder the law duty of comprehensive anti-monopoly action
- Standardize and maintain market order
- Organize and implement quality control
- Shoulder the duty of products and devices safety and quality supervision
- Unify the counting standard
- Shoulder the duty of product permission (registration or filing certification) and inspection and quarantine
More information awaits to be released.
1. China Food and Drug Administration (CFDA) was established on the basis of the former State Food and Drug Administration (SFDA), rebranded and elevated to a ministerial-level agency following a governmental restructuring in March 2014. CFDA is created to largely reduce the overlap of supervisory power shared by several departments and streamline regulation of food, drug and cosmetics safety.
In term of cosmetics, CFDA is in charge of comprehensive supervision on cosmetics, including domestic cosmetics production and registration of cosmetic products (special use cosmetics and imported non-special use cosmetics) and new ingredients, under which there are three sub-departments related to cosmetics:
Figure 1: Cosmetics-related Departments under CFDA (to be repealed)
- The Administrative Service Center is responsible for receiving cosmetics application cases and conducting format check on the dossiers submitted.
- The Dept. of Drug and Cosmetics Registration manages cosmetics administrative licensing and formulates cosmetics-related regulations.
- The Dept. of Drug and Cosmetics Supervision’s main duty is to oversee the production and operation activities of cosmetics nationwide and monitoring cosmetic undesirable effects.
2. The Cosmetic Registration Review Center under CFDA focuses on the technical review of cosmetic products and new cosmetic ingredients applying for registration. There is a technical Review Committee for cosmetics, mainly consisting of four distinct expert panels:
- Expert group to review product name/label
- Expert group to review product formula
- Expert group to review micro and chemical data
- Expert group to review toxicology data
3. The Food and Drug Administrations at provincial level under CFDA are in charge of registration of domestic non-special use cosmetics and issuance of cosmetics manufacturers’ production license, namely the Hygiene License for Production Enterprises of Cosmetics.
4. The General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ)’ main supervisory scope is the import and export inspection of cosmetics.
5. The State Administration for Industry & Commerce (SAIC) manages cosmetic advertising, cosmetics trade mark registration and commercial activities.
Before being used, marketed or imported into China, cosmetic products must get approval from CFDA or provincial FDAs 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 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.
At present, imported cosmetics, domestic special use cosmetics and new cosmetic ingredients require pre-market registration with CFDA, while domestic non-special use cosmetics are subject to post-market filing with the provincial FDA. The registration of non-SUC is less stringent and demanding than that of SUC.
|Imported non-SUC||Pre-market filing||Filing certificate||CFDA|
|Imported SUC||Pre-market administrative licensing||Administrative license||CFDA|
|Domestic non-SUC||Pre-market online filing||no certificate||Provincial FDA|
|Domestic SUC||Pre-market administrative licensing||Administrative license||CFDA|
|New ingredient||Pre-market administrative licensing||CFDA’s approval announcement||CFDA|
Cosmetics manufacturers shall notify provincial FDA 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, 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.