On June 29, 2020, the Chinese State Council released the Cosmetic Supervision and Administration Regulation. This Regulation consists of six chapters detailing the supervision and management of cosmetic products including ingredients, production, import and legal liabilities. This regulation will replace the Cosmetics Hygiene Administration Regulation.
The National Medical Products Administration (NMPA) also published two draft documents that detail the implementation of the Regulation. These are: The Administrative Measures for Cosmetic Registration and The Cosmetic Classification Rules and Catalog.
Definition and Classification of Cosmetics
The Regulation defines a cosmetic as “daily used industrial chemicals which can be used on the outer surface of human body, including skin, hairs, nails, lips, etc., for the purpose of cleaning, protecting, beautifying and making up, by way of smearing, spraying or other similar means.” It is important to note that deodorizing products have been removed from the scope.
In addition, cosmetic products are classified into two categories based on their inherent risk levels: special cosmetics or general cosmetics. Special cosmetics are subject to pre-market registration while general cosmetics are subject to notification to local administrative agencies.
Special cosmetics refer to cosmetic for hair dyeing or perming, anti-spot and whitening, sun-screening and anti-hair loss, as well as cosmetics with new function claims. A five-year transition period has been granted for special cosmetics that are not in compliance with the new rules.
For general cosmetics, the government is seeking to make the notification process less burdensome than the registration process. However, it is still too early to determine if this will be the case.
According to the draft Classification Rules, product categorization will be determined by the cosmetic’s function, use area, dosage, the intended user group, and method the cosmetic is applied.
Management of Cosmetic Ingredients
Under the Regulation, cosmetic ingredients are categorized either as existing ingredients or new ingredients. A new ingredient, depending on its risk level, is required to be registered or notified before it can be used in cosmetics for the first time in China. This also applies to ingredients that are commonly used worldwide but will be used in China for the first time. Approval for a new cosmetic ingredient is proprietary, this means that another manufacture using the same ingredient will either need to have a separate approval or request permission to use the ingredient from the original registrant/notifier.
Additionally, approved ingredients that will be used for a new purpose will be subjected to registration/notification. Ingredients sources from minerals, animals, plants, or biotechnologies are require specific documentation for product safety evaluation.
A Catalogue for cosmetic ingredients will be published specifying prohibited or restricted ingredients, special ingredients permitted for use and existing ingredients. Cosmetic ingredients that have been registered for three years without safety issues will be included in the Catalogue by the NMPA.
Cosmetic Registrants and Notifiers
To improve the management of cosmetic products, registrants and notifiers will be responsible for the safety and quality of the products, this also applies to overseas registrants/notifiers. The registrant/notifier will need to publish their information supporting product claims on a government website. Also, for new ingredients registrants/notifiers will need to submit annual reports on the ingredient’s safety and use to local authorities for 3 years.
The Cosmetic Supervision and Administration Regulation will take effect on January 1, 2021.
For more information on cosmetic labeling regulations, contact Nexreg today!