1. What is the difference in the definition of special cosmetics between the Regulations Concerning the Hygiene Supervision Over Cosmetics and the Cosmetics Supervision and Administration Regulations (CSAR)?
According to the Regulations Concerning the Hygiene Supervision Over Cosmetics, special-use cosmetics include 9 types: hair growth, hair dye, hair perm, depilation, breast beauty, bodybuilding, deodorization, anti-spot, and sunscreen. The CSAR stipulates that cosmetics used for hair dye, hair perm, anti-spot and whitening, sunscreen, and anti-hair loss, as well as cosmetics claiming new functions, are special cosmetics. Products used for hair growth, depilation, breast beauty, bodybuilding, and deodorization are no longer managed as special cosmetics.
2. How are products used for hair growth, depilation, breast beauty, bodybuilding, and deodorization managed now?
Products that have been adjusted to general cosmetic management: (1) products that claim anti-hair broken in the original hair growth category; (2) Among the original breast beauty products, products that achieve the effect of shaping the chest by tightening the chest skin; (3) Products that achieve deodorization effects by covering off odors in the original deodorization products; (4) In the original depilation products, products whose hair removal effect is mainly achieved through physical means or chemical means (such as softening hair follicles).
Products gradually included in drug regulation: (1) In the original hair growth products, products that stimulate hair growth through the regulation of physiological functions; Among the original bodybuilding, breast beauty products, products that achieve physical fitness or breast beautification by affecting the body's fat metabolism or distribution; (3) Products in the original deodorization category that achieve deodorization effects by affecting the secretion of sweat glands.
3. Before the implementation of the CSAR, how to manage the products that have already obtained registration for hair growth, depilation, breast beauty, bodybuilding, and deodorization during transition period?
Cosmetics used for hair growth, depilation, breast beauty, bodybuilding, and deodorization that have been registered before the implementation of the CSAR, and whose registration certificates are still valid at the time of implementation of the CSAR, until December 31, 2025, from January 1, 2021, can continue to be listed, and enterprises can continue to produce, import, and sell them, regardless of the expiry date of the valid period of the original registration certificates. While, after the transition period expires, these cosmetics cannot continue to be listed, and enterprises shall stop production, import, and sales.
4. During the transitional period, after the expiration of the administrative license approval period for five types of original special-use cosmetics, including hair growth, depilation, breast beauty, bodybuilding, and deodorization, do you need to apply for an extension, can you continue to sell them?
According to the NMPA Announcement on Matters Related to Further Clarify the Management of the Original Special Use Cosmetics During Transition Period (No.150, 2021), during the transition period, the NMPA will no longer accept other administrative license applications for changes, reissues, or extensions of five categories of original special use cosmetics, including hair growth, depilation, breast beauty, bodybuilding, deodorization. If there are any changes in matters that do not involve safety or efficacy claims, the cosmetic registrant shall promptly file with the NMPA. During the transitional period, after the expiration of the administrative license for five categories of original special-use cosmetics, they can still be produced, imported, and sold. After the transitional period expires, they cannot continue to be produced, imported, or sold.
5. After the expiration of transition period of five categories of original special-use cosmetics, including hair growth, depilation, breast beauty, bodybuilding, and deodorization, if they still need to be produced, imported, and sold, what should be done?
You can choose to apply for general cosmetic filing or drug registration based on different management methods after classification adjustment. After general cosmetic filing or drug registration, enterprises can produce, import, or sell their newly filed or registered products in accordance with the CSAR and the Drug Administration Law, without being subject to a 5-year transition period.
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