On 21 July 2020, China’s National Medical Products Administration (NMPA) published the draft Measures on the Administration of Cosmetic Registration (the Draft Registration Measures) for public consultation until 20 August 20201.
The Draft Registration Measures are part of the anticipated series of implementation rules of the long-awaited Regulations on the Supervision and Administration of Cosmetics (the Revised Cosmetic Regulations), which the State Council published on 29 June 2020 and will enter into force on 1 January 2021. The Revised Cosmetic Regulations will supersede the current cosmetic regulatory regime in China that is governed by the current Regulations on Hygienic Supervision of Cosmetics, which have been in service since 1990.
Among other things, the significantly reformed cosmetic registration regime, which is the core of cosmetic regulation, has been in the spotlight. This legal update comments on the key features of the Draft Registration Measures.
The Fundamental Principles
The New Registration Regime
The Revised Cosmetic Regulations lay down a new registration regime where:
- The “high-risk” new cosmetic ingredients stipulated by these Regulations (namely preservatives, sunscreens, colorants, hair dyes, and whitening agents) are subject to “registration”;
- The other new cosmetic ingredients are subject to “filing” (a much simpler process than registration);
- The cosmetic products for special use (namely cosmetic products used for the purposes of hair-dyeing, hair-perming, freckle removal and whitening, sun protection and anti-hair loss, as well as cosmetic products claiming a new function) are subject to “registration”;
- The cosmetic products for non-special use (namely cosmetic products other than the cosmetic products for special use) are subject to “filing”.
Registrants and Notifiers
The Draft Registration Measures reiterate that the “registrants” (i.e., companies submitting a registration) and “notifiers” (i.e., companies submitting the filing) are responsible for the product’s safety and claims, and bear the obligation to submit a registration or filing for their products.
The Draft Registration Measures further clarify that a “registrant” and a “notifier” refer to enterprises or other organisations which can assume civil liabilities independently and place the product on the market in their own name. The registrant or notifier located outside China is required to designate a “responsible person” located within China, who will proceed with the registration or filing in the name of that registrant or notifier.
Registration and Filing of New Cosmetic Ingredients
Under the current framework, a new cosmetic ingredient must be registered before it can be used in China, but getting such a registration has been extremely difficult in the last decade. With the new filing option and the safety monitoring period that the Revised Cosmetic Regulations introduce , the legislature intends to speed up the regulatory process so as to enable the use of more new cosmetic ingredients in China.
What Is a New Cosmetic Ingredient?
It has been an established practice, which the Revised Cosmetic Regulations and the Draft Registration Measures confirm, that the cosmetic ingredients falling outside the Inventory of Existing Cosmetic Ingredients of China (IECIC) are considered as new cosmetic ingredients, including those which have been registered or filed but have not been included in the IECIC, meaning that the new ingredient registration/filing is company-specific.
Interestingly, the Draft Registration Measures also provide that an ingredient will be considered as a new cosmetic ingredient if it is intended to be used “for the purposes other than the uses and the safety use level of an existing cosmetic ingredient”. This new requirement needs clarification, however, as it appears to imply that, in the future:
- Either the IECIC will be thoroughly amended to add uses and a safety use level for each of the substance listed therein; or
- The new ingredient registration and filing will specify the intended uses and safety-use level, and any use falling outside these specifications will require a new registration or filing; or
- This refers to the use restrictions provided by the Safety and Technical Standards for Cosmetics for certain ingredients.
The Draft Registration Measures reiterate that the filing is completed after a notifier has submitted the requested information. These Measures also provide more details on the registration process and, in particular, provide the registrants with the possibility to request a “review” of the technical evaluation conclusion, if that conclusion indicates a failure to pass the technical evaluation (which is the essence of the registration process). Upon receipt of a request for “review”, the technical evaluation department of the NMPA will decide whether there is a need to revise the original conclusions.
The Safety Monitoring
After a new cosmetic ingredient has been successfully registered or filed, it will be subject to a three-year safety monitoring, which is the highlight of the new regime. While the Revised Cosmetic Regulations provide that the three-year period starts from the date when the new ingredient is “used”, the Draft Registration Measures provide that such a period will start from the date when the registration or filing is completed.
During the safety monitoring, among other things, the registrants and notifiers of the registered/filed new ingredients and of the cosmetic products using such ingredients will have an obligation to report to the NMPA or its local branches any adverse effects or other safety issues triggered by these ingredients. Depending on the circumstances, the outcome of such reporting could include an order to suspend the use of the ingredients, an order to suspend the manufacture or import of the relevant cosmetic products, and cancellation of the registration or filing of the ingredients.
Upon termination of the three-year monitoring period, while the Revised Cosmetic Regulations provide that a registered/filed new ingredient should be included in the IECIC if no safety issue has been identified during that period, the Draft Registration Measures require the NMPA to organise an assessment of the registered/filed new ingredients to identify any safety issue.
Registration and Filing of Cosmetic Products
The Draft Registration Measures provide more details on the registration and filing process for cosmetic products. In particular, they give the registrants of cosmetic products the right to request a “review” of the technical evaluation.
Importantly, the Draft Registration Measures shed light on the definitions of a “domestically produced product” and an “imported product”. According to these Measures, a cosmetic product will be considered as a “domestically produced product” if the last production process in contact with the contents of the product is completed within China; on the contrary, if such a process is completed outside China, that cosmetic product would be considered as an “imported product”.
Under the Revised Cosmetic Regulations, the registration or filing of an imported cosmetic product needs to demonstrate that such a product has already been placed on the market in the “producing country (region)”. The Draft Registration Measures appear to specify that the “producing country (region)” refers to either the country (region) where the “place of registration” of the registrant or notifier is or the country (region) where the “place of production” is located.
Enforcement & Penalties
The NMPA has the power to inspect any entity and individual that is “involved” in the registration or filing dossiers, which could go beyond the registrants or notifiers and impact any actor along the relevant supply chain. In particular, during the technical evaluation of the registration process, where the NMPA suspects any false information or the like, it has the power to perform an on-site verification within and outside China.
After a registration or filing is done, the NMPA or its local branches are empowered to, among other things, cancel a registration/filing; order the suspension of the use of a registered/filed new ingredient or order the suspension of the manufacture or import of a registered/filed cosmetic product, depending upon the circumstances, such as whether a registered or filed cosmetic product is considered to have posed safety risks after re-assessment, or that false information was provided in a filing dossier.
The Draft Registration Measures specify the penalties that apply for non-compliance with the registration and filing requirements. In particular, such Measures shed light on the penalties applicable for unlawful acts relating to the registration and filing of new cosmetic ingredients, noting that the penalties provided by the Revised Cosmetic Regulations appear to be unclear on this front as they focus on the companies of (finished) cosmetic products.
This new regulatory regime will affect companies involved in the cosmetic business in China. In particular, companies which will be considered as or intend to act as the registrants or notifiers of a new cosmetic ingredient or a cosmetic product should carefully assess the requirements of the Draft Registration Measures and submit comments if necessary.
While, generally speaking, the Draft Registration Measures shed light on many registration/filing-related aspects, other NMPA implementing rules and guidelines have yet to clarify various outstanding issues , which, as anticipated by the Draft Registration Measures, include: the detailed data requirements for the registration and filing of both new ingredients and cosmetic products, the key criteria for the technical evaluation, the making of cosmetic product claims and the reporting of adverse effects.