Insights on Chinese Cosmetics Regulations

Industry expert Jincong Li speaks with the Chinese American Cosmetic Professional Association (CACPA) about critical regulatory issues impacting the world’s No. 2 personal care market.

CACPA: Could you please introduce the main changes to Chinese cosmetics laws and regulations over the past three years to professionals in the global cosmetics industry?

Jincong Li: State Council Order No. 727, “Regulations on the Supervision and Administration of Cosmetics,” enacted on Jan. 3, 2020, and effective from Jan. 1, 2021, marked a significant update in China’s cosmetic regulations. During the past three years, the National Medical Products Administration (NMPA) introduced supporting regulations that impact areas such as cosmetic registration, safety assessment, efficacy claims and production standards. It means the regulations have been comprehensively updated and revised to further strengthen supervision and management of cosmetic production and operation over the past 30 years. It represents a new phase in China’s cosmetic supervision and administration.

CACPA: The registration of new cosmetic raw materials in China has always been a topic of great interest. Could you please introduce the progress and issues in practice you have observed in recent years?

Jincong Li: According to publicly released data, a total of 14 new cosmetic raw materials were approved from 2004 to 2020. The issue of new regulations in 2021 largely accelerated the filling of new ingredients. As of Dec. 30, 2023, 95 new ingredients (65% domestic, 35% imported) were filed, entering a three-year safety monitoring period. After the monitoring period, the NMPA will make the final decision and determine whether to include them in the catalog of used cosmetic ingredients.

During the process of new ingredient filing, some registrants or filers have faced challenges in understanding the classification and conditions of the new ingredients. This led to issues such as unclear differentiation between new and existing ingredients, functionalities of ingredients exceeding cosmetic definitions, and incorrect determination of new ingredient conditions. To address this, the National Institute for Food and Drug Control (NIFDC) issued several new guidelines to guide and standardize cosmetic new ingredient filling and registration.

Jincong Li: What changes are there for prohibited and restricted ingredients in cosmetics?

CACPA: China’s regulations regarding prohibited and restricted ingredients are mostly aligned with the EU regulations (EC) No 1223/2009, although some ingredients may be different, such as α-hydroxy acids, and their salts and esters. Besides, the regulations for some high-risk ingredients such as nanomaterials are also based on the assessment of SCCS (Scientific Committee on Consumer Safety. Notably, there are some new changes and requirements in the regulation of children’s cosmetics (for those aged 12 and below) in China. NIFDC has issued the “Technical Guidance Principles for Children’s Cosmetics,” which sets higher requirements for the restricted ingredients, permitted preservatives, sunscreens, colorants, etc., in children’s cosmetics formulations. The design of formulations for children’s cosmetics should follow the principles of safety priority, essential efficacy and minimalist formulation. It should reasonably use restricted ingredients, fragrances and other ingredients under the premise of safety and essential efficacy. For example, when the usage of preservatives in leave-on products approaches the limits (over 90%), or when using five or more preservatives in a formulation, relevant scientific evidence should be provided to explain the scientific basis and necessity of the types and amounts of ingredients used, along with a series of new requirements.

CACPA: What are the new requirements for cosmetic safety?

Jincong Li: First, on Jan. 1, 2024, new requirements went into effect for ingredient safety supervision. Registrants and filers must provide all safety-related information for ingredients required by “Management Regulations for the Registration and Filing Data of Cosmetic New Ingredients.” Cosmetic ingredient manufacturers can use an online registration platform to submit this information.

It follows a Jan. 1, 2022 edict that cosmetic registrants and filers must conduct safety assessments and submit assessment data according to the “Technical Guidelines for Cosmetic Safety Assessment (2021 Edition)” when applying for special cosmetic registration or before filing for ordinary cosmetics. The safety assessment report has a simplified version until May 1, 2024, and a complete version thereafter (CPSR). In summary, these changes require filers to provide a Product Information File (PIF), similar to EU regulations. The change is the latest and maybe most significant in China’s cosmetic safety regulation.

CACPA: Have there been any new developments in regulations regarding animal testing in recent years?

Jincong Li: Chinese cosmetic regulations currently include 40 toxicological testing methods, comprising 30 animal testing methods and 10 alternative methods, categorized into local toxicity and systemic toxicity. When registering or filing cosmetic products and ingredients, the methods specified in the “Cosmetic Safety Technical Specification” must be chosen.

Currently, the most conducted toxicological tests are under local toxicity and genotoxicity. Options of in vitro tests are available other than animal tests. In terms of systemic toxicity testing, Chinese cosmetic regulations have not yet introduced alternative methods to animal testing. Companies opting not to conduct animal testing, or those situated in regions where animal testing is prohibited, encounter significant challenges in fulfilling Chinese regulatory requirements. Nevertheless, NIFDC is investing heavily in research to accelerate the creation and validation of new alternative methods to animal testing.

CACPA: Any new regulations on cosmetic labels and claims?

Jincong Li: As of May 1, 2022, NMPA issued the “Cosmetic Labeling Management Measures.” General cosmetic efficacy claims are managed through filing, including various categories. Special cosmetic efficacy claims require registration. Special cosmetic efficacy includes whitening and spot removal, sun protection, hair dyeing/perming, anti-hair loss, and new effects; such as, products for pregnant and lactating women.

Previously approved cosmetics with claims related to hair growth, depilation, breast enhancement, slimming, deodorizing, etc., have a five-year transition period. After that, production, import and sale are prohibited. Depilatory and deodorizing cosmetics are included in general cosmetics, managed through filing. Claims of hair growth efficacy are no longer allowed; related products can be adjusted to claim anti-hair loss efficacy and managed through registration. Products claiming breast enhancement and slimming can no longer be registered as cosmetics. Soaps that claim to have special cosmetic effects are managed as cosmetics.

Children’s cosmetics are categorized for “infants and young children (under 3 years old)” and “kids (3-13 years old),” with limited efficacy claims allowed.

CACPA: What are the main issues reflected in the big data from the “Cosmetics Forbidden Words” website regarding cosmetic claims?

Jincong Li: A few examples of claims that are against the Chinese regulation are:

• Claims such as “medical,” “medicine,” “stem cell” and “treatment” are considered as explicitly or implicitly claiming medical effects.

• Words such as “facial sculpting,” “anti-aging” and “blue light resistance” are considered exaggerations.

• V-Shape design or use of red cross on pack are considered creating misleading impressions.

• Claims such as “professional,” “world class” and “number one” are considered arbitrary claims using extreme language.

It is important to note that certain claims mentioned above are widely used in products within the US and EU markets. Therefore, when introducing these products to the Chinese market, it is essential to conform to the local regulations regarding claims.

CACPA: What are the new requirements for evaluating the efficacy of cosmetics, and what challenges have been observed in the implementation process?

Jincong Li: NMPA issued efficacy claim evaluation guidelines on April 8, 2021. Since Jan. 1, 2022, cosmetic registrants must assess claims according to these standards and upload an abstract to an NMPA-designated website, when applying for special cosmetic registration or filing for ordinary cosmetics. The methods for evaluating efficacy claims include literature data, research data, human efficacy evaluation trials, consumer use tests and laboratory experiments. In order to ensure the scientific, authenticity and reliability of the evaluation, so as to comply with legal claims, registrants should carry out corresponding tests according to the requirements of the “Cosmetic Efficacy Claim Evaluation.” Currently, the “Cosmetic Safety Technical Specification” mandates only three mandatory efficacy evaluation methods: sunscreen (UVA/UVB/water resistance), whitening and spot removal and anti-hair loss. Other efficacy claim evaluation methods mainly rely on industrial standards or methods established by companies themselves.

CACPA: Have there been changes in the import regulations for imported cosmetics?

Jincong Li: According to Article 61 of the “Regulations on the Registration and Filing of Cosmetics,” when determining whether a cosmetic is imported or domestically produced, the key criterion is whether the “final step that is in contact with the bulk (filling/packaging)” during production, whether completed within or outside the country. If the process is completed abroad, it is considered as an imported product.

For imported products with formulations designed specifically for the Chinese market (excluding those manufactured abroad through OEM), documentation must be submitted explaining the formulation design based on Chinese consumer skin types and preferences. Additionally, data from consumer tests or human efficacy trials conducted on Chinese consumers within China should be provided.

CACPA: Are there new requirements in the regulatory system for the production and sale of cosmetics?

Jincong Li: On Dec. 29, 2022, NMPA issued regulations to ensure that enterprises fulfill their main responsibility for cosmetic quality and safety. The regulations aim to strengthen the awareness of quality and safety responsibilities, regulate cosmetic quality and safety management practices, and emphasize the implementation of responsibilities to individuals involved.

On Oct. 20, 2022, NMPA issued standards which include new inspection points for supervising and inspecting cosmetic registrants and filers who commission production. The inspection includes 24 items, with nine key items and 15 general items. Enterprises determined to have “serious defects in the production quality management system” during inspection should be investigated and filed according to relevant regulations.

The Impact of Cosmetic Regulations

In recent years, with the development of the social economy, the consumption of cosmetics in China has maintained rapid growth, making it the world’s second-largest cosmetics consumption market after the US. The adjustments to China’s cosmetics regulations since 2020 have accelerated the “weeding out” of low-quality manufacturers among domestic enterprises. Currently, the number of companies registering and filing cosmetics in China has been reduced from over 70,000 before the new regulations to just over 10,000. Among them, there are over 5,000 companies holding production licenses, and the number of valid registered and filed products has exceeded one million. At the same time, new market trends such as online shopping for cosmetics, online sales platforms and live streaming sales channels will bring new challenges to regulation.

Future Chinese regulatory efforts will continue to focus on “quality and safety.” This will involve strengthening market sampling inspections, monitoring adverse reactions and implementing measures such as a digitized intelligent risk monitoring platform. There will be intensified penalties for illegal products and companies, extending to individuals, in line with the demand for “the most severe penalties.” The goal is to ensure the quality and safety of cosmetics, safeguard consumer health and promoting the healthy and rapid development of the cosmetics industry. 

For more information contact Jincong Li at 407538790@qq.com. For CACPA, cosmetic2022@cacpausa.org; www.cacpausa.org