Ms Yang Jinyu, an official from Legislative Affairs Office of China’s State Council, announced the breaking news that the Regulations Concerning the Hygiene Supervision over Cosmetics (1989) is being amended. It is the overriding regulation with regard to cosmetics in China.
On 20-21 September, 2012, The 1st Cosmetics Safety and Public Policy Conference was held by Shanghai Food and Drug Administration, in Rendezvous Merry Hotel, Shanghai. Chinese officials, experts from home and abroad, deputies from multinational cooperations, such as L’Oreal, Johnson&Johnson, Beiersdorf, were invited to attend this conference and make profound speeches on cosmetic regulations and supervision in China, Europe, USA and Japan, risk assessment of cosmetics and animal alternative testing development.
It is well-known that China has become the third largest cosmetic market in the world after US and Japan and will maintain a sound momentum of development in the following decades. However, at present, Chinese cosmetic market suffers from illegal manufacturers, banned cosmetic ingredients, over-the-limit restricted ingredients, advertising extra functions or efficacy to mislead consumers as well as designing labels violating the relevant standard. Meanwhile, the revision and update of regulations lag behind the development of cosmetic industry compared with its counterpart in US, Europe and Japan. Unlike the continuous adjustment of European Union’s Cosmetic Directive 76/768/EEC, the overarching Regulations Concerning Hygiene Supervision over Cosmetics (hereinafter referred to as Regulations), published by China Ministry of Health on November 13, 1989, has never been amended since then, leaving it insufficient to oversee the whole cosmetic industry, and incompatible with the lower-level cosmetic regulations in the entire framework. .
Ms Yang Jinyu, an official from Legislative Affairs Office of China’s State Council, announced the breaking news that the overriding Regulations 1989 is currently being amended by State Food and Drug Administration (SFDA) which is in major charge of cosmetic supervision in China.
Considering that China still adopts the cosmetic regulatory system which necessitates the pre-market permit, which is not the common approach adopted by US and EU countries. Further, the great emphasis is always put on the pre-market permit and the post-market supervision is relatively weak. Ms Yang expressed that she was not a big fan of the current licensing system and believed that China should lower the pre-market barrier for the administrative licensing of cosmetics, but reinforce the supervision over products already on the market instead.
Nevertheless, before the release of the updated overarching cosmetic regulation, which probably will take 2 or 3 years, the production enterprises should stay in compliance with the existing regulations. China divides cosmetics into special use cosmetics (SUC), non-special use cosmetics (non-SUC) and new cosmetic raw materials. Different obligations are summarized for the corresponding types of cosmetic products.
Type |
Obligation |
Authority |
Certificate |
Validity Date (year) |
Imported SUC |
Administrative licensing (pre-market) |
SFDA |
Administrative license |
4 |
Imported non-SUC |
Record keeping (pre-market) |
SFDA |
Record keeping certificate |
4 |
Domestic SUC |
Administrative licensing (pre-market) |
SFDA |
Administrative license |
4 |
Domestic non-SUC |
Record keeping (post-market) |
Provincial FDA |
Record keeping certificate |
4 |
New cosmetic raw materials |
Administrative licensing (pre-market) |
SFDA |
An approval announcement on SFDA’s website |
/ |
Manufacturers of imported cosmetics and new ingredients are required to designate a legally-registered responsible agent in China to fulfill registration. The approval of new ingredient is quite difficult in China. Since SFDA started to take charge of cosmetics from 2008, only three substances, PM-Lysine(CAS 543700-70-5), Dimethoxytolyl Propylresorcinol (CAS 869743-37-3) and Phenylethyl Resorcinol (CAS 85-27-8), are announced to be approved.
Reference Links
- Regulations concerning the Hygiene Supervision over Cosmetics (full text in Chinese)