New Regulations Streamline Access to the Cosmetics Market in China
The cosmetics market in China is growing exponentially year on year. As market demand grows product safety and quality become increasingly important. In recognition of this, the current regulations, “Regulations on Hygiene Supervision of Cosmetics will be replaced by the Regulations on Supervision and Administration of Cosmetics (“New Regulation”) to come into effect from 1 January 2021.
With the new regulation the National Medical Products Administration (“NMPA”) receives new powers to administer and supervise cosmetic products and cosmetic manufacturers
Below are some of the key changes:
1. Easier to Import Non-special Use Cosmetics
Foreign cosmetic companies have long been frustrated by bureaucratic hurdles for the import of non-special use cosmetics. The New Regulation now provides that non-special use cosmetics, either manufactured domestically or imported, only require a filing with the competent NMPA branch which will simplify foreign cosmetic import into China.
2. Special Use Cosmetics are more narrowly defined
Special use cosmetics will still be subject to registration before being allowed to be manufactured or imported into China. However, the scope of what constitutes special use cosmetics in the New Regulation has been narrowed from 9 to 6 categories going forward.
The special use cosmetics categories include:
1) hair dye products;
2) hair perm products;
3) spots removal and skin whitening products;
4) sunscreen products;
5) hair loss prevention products; and
6) other products which claim a new function.
Products for hair removal, breast shaping, fitness, and deodorizing have been removed from the list and are now considered to be non-special cosmetics and therefore only require registration filing with the NMPA.
3. New Cosmetics Ingredients
The New Regulation provides that new ingredients, except for higher risk ingredients which are antiseptic, sunscreen, colorant, hair dye, and freckle whitening among others will be admitted on a registration basis with the NMPA rather than requiring approval. High-risk new ingredients will still be subject to pre-use approval for registration with the NMPA.
4. Simplified Licensing: Two into One
The New Regulation states that the Cosmetics Manufacturing License and the Cosmetics Manufacturer Sanitary License which are currently required will be combined into one. Cosmetics manufacturers will only need to apply to the NMPA for a Cosmetics Manufacturing License.
5. Supplementary Testing
Under the New Regulation NMPA may carry out supplementary tests if current tests are considered insufficient to guard against adulteration or illegal use of restricted or forbidden ingredients in cosmetic products.
6. Efficacy Claims
The New Regulation sets out Chinese language labelling requirements and prohibits the use of any false or exaggerating or misleading descriptions as to the efficacy of products in the context of advertising. Additionally, claims of efficacy of cosmetic products must be supported by sufficient scientific evidence, such as research data, assessment reports or relevant literature. Cosmetic manufacturers are responsible for such claims and must disclose a summary of the scientific evidence on designated websites.
7. Overseas On-Site Inspection of Foreign Manufacturers
The New Regulation permits the NMPA the power to carry out overseas on-site inspection in respect of manufacturers of imported cosmetics in order to ensure the manufacturers have met Good Manufacturing Practice (GMP) requirements and to ensure the registration or filing documentation submitted by importers are true and valid. In this aspect inspection is akin to that carried out by inspection authorities on foreign dairy product manufacturers.
Our Take-Away
For foreign cosmetics manufacturers, the New Regulation provides streamlined market access and less red tape. Conversely, the New Regulation will increase the ambit of supervisory measures available to Chinese authorities. For more specific information on any of the material contained in this article please contact Richard Kimber on +61 8 8210 1213 or rkimber@normans.com.au or Liyan Guo on +61 8 8210 1290 or lguo@normans.com.au.
