By Liyuan Ji, CACPA 

How is the cosmetic industry in China adapting to the new regulations on safety assessment? This is a question that many professionals ponder as they navigate the “Technical Guidelines for Cosmetic Safety Assessment (2021 Edition)” issued by the National Medical Products Administration (NMPA).¹ Chinese cosmetic registrants now face stringent requirements for safety assessments. The ruling became mandatory on May 1, 2024. These guidelines highlight the need for detailed toxicological test results, which may include animal testing if alternative methods are not recognized. This balance between regulatory compliance and the increasing demand for cruelty-free products is creating a dilemma in the industry.

To navigate this dilemma, the Chinese American Cosmetic Professional Association (CACPA) invited Jincong Li, a local expert and influencer in cosmetic regulations, to provide insights and perspectives from the front lines.

The Chinese American Cosmetic Professional Association (CACPA) is a non-profit organization. It aims to enhance communication, learning and mutual development among professionals in the cosmetics industry. CACPA also serves as a platform for exchange and collaboration between the cosmetics industries in China and the US.

Jincong Li is an expert in Chinese cosmetics regulations and the founder of the “Cosmetics Forbidden Words’’ website. He is vice director of the Cosmetic Policy and Regulations Committee of the Guangdong Institute of Cosmetics Science and Technology. He is currently a regulatory consultant for multiple cosmetics companies in China. His social media account, “Jincong Li,’’ interprets Chinese cosmetic regulations. It has nearly 20,000 followers. 

Liyuan Ji, a member of the CACPA and a cosmetic scientist, serves as the head of formulation development at Compass Beauty. With more than five years of experience in skincare formulation and clinical research, Ji is a skilled science communicator.

Liyuan Ji: Could you walk us through the development of alternative animal testing methods in China’s cosmetic industry? 

Jincong Li: In 2010, China’s former National Food and Drug Administration issued guidelines promoting risk assessments for cosmetics, allowing for exemptions from toxicological tests if product safety could be fully confirmed.² By 2016, alternative methods like in vitro 3T3 Neutral Red Uptake (NRU) Phototoxicity Test were officially incorporated into China’s cosmetic standards.³ 

On February 26, 2021, the NMPA issued the “Regulations on the Management of Cosmetic Registration and Filing Materials.” These regulations were updated to exempt certain cosmetics from toxicological reports if their safety could be adequately assessed except in the following cases: 

1. The product is claimed to be used for infants and children; 

2. The product uses new cosmetic ingredients that are still under safety monitoring; 

3. The registrant, domestic responsible person and manufacturer are listed as key supervision objects.⁴

To overcome technical trade barriers, the National Institutes for Food and Drug Control (NIFDC) established a national working group in 2018. This group collaborates with various institutions to research and validate new alternative testing methods, aiming to continuously improve the system for alternative toxicological methods in the cosmetic industry.

Liyuan Ji: With growing global consumer resistance to animal testing, which countries and regions have implemented bans, and how has this affected their markets?

Jincong Li: As of now, countries or regions that have introduced regulations to ban cosmetic animal testing include: the European Union, India, Israel, New Zealand, Taiwan (China), South Korea, Turkey, Switzerland, and California (US).^5,6 Consequently, beauty brands aiming to enter these markets must strictly adhere to local laws and regulations, ensuring their products do not involve any animal testing. This requirement has further propelled the application and development of alternative animal testing technologies in China.

Liyuan Ji: What are the current alternative methods to animal testing in Chinese cosmetic industry? What are their latest trends, breakthroughs and bottlenecks?

Jincong Li: The standard system for the safety evaluation of cosmetics in China includes animal testing, in vitro genotoxicity testing and human safety testing. Among these, the alternative methods to animal testing specified in the “Technical Specification for Cosmetic Safety” (referred to as “Technical Specification”) include tests for eye irritation, skin sensitization, phototoxicity and genotoxicity, which have been widely applied in the safety assessment of cosmetics and their ingredients.

As of March 2024, China has incorporated 11 alternative methods to animal testing into the “Technical Specification,” including three for genetic toxicology and the 3T3 phototoxicity method. However, despite these advancements, there are no specific standards yet for alternative methods to assess local toxicity, such as skin irritation and corrosivity. Therefore, in this area, traditional animal testing experiments are still required. This is undoubtedly an urgent issue to be addressed, as evaluating skin irritation/corrosivity is a crucial component of cosmetic safety assessments. The cosmetic registration and filing process in China requires compliance with various regulations and is conducted within a government-designated inspection system, making animal testing the only current option for final products needing skin irritation tests.

Liyuan Ji: With the advancements in Chinese regulations, what are the latest developments and challenges in toxicological testing for cosmetic ingredients?

Jincong Li: Under China’s current regulations for cosmetic ingredient safety assessment, there is no mandatory requirement for testing ingredients according to the methods specified in the “Technical Specification.” Companies can opt to use standard methods issued by authoritative organizations or other industry standards from different countries or regions, such as the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) in the United States, the European Union Reference Laboratory for Alternatives to Animal Testing (EURL-ECVAM), the Japanese Center for the Validation of Alternative Methods (JaCVAM), the Korean Center for the Validation of Alternative Methods (KoCVAM) and the OECD Guidelines for the Testing of Chemicals.

Since cosmetic ingredients come from various industries (for example, pharmaceuticals, agriculture and biotechnology) and are not directly regulated by cosmetic authorities, these companies typically prioritize the use of standard testing methods from the domestic chemical industry. The adoption of these chemical standards is widely recognized and ensures the quality and safety of ingredients, complying with industry regulatory requirements.

Although considerable research into alternative methods exists, the “Technical Specification” primarily adopts internationally recognized methods, such as those by the OECD. Yet, the broad implementation of these methods is hindered by obstacles like high expenses, challenges in acquiring raw materials and the lack of domestically manufactured supporting equipment.

Furthermore, there are concerns that with the implementation of the complete safety assessment policy for cosmetics in China starting May 1, 2024, both domestic and foreign brands or registrants may inevitably face animal testing in stages such as raw material sourcing, research and development, and testing. This is particularly true for assessing cosmetic ingredients that lack authoritative safety evaluations or established safe usage limits. Addressing the challenges of evaluating dose-response relationships in systemic toxicity and describing toxicological endpoints will pose new challenges for the industry.

Liyuan Ji: Indeed, to advance alternative animal testing and address the challenges, cosmetics companies rely highly on government policies and need more relevant regulations. How do these policies and technological advancements influence the development of alternative methods and their impact on the industry?

Jincong Li: Since January 1, 2022, cosmetics must undergo efficacy claim evaluations according to the “Cosmetic Efficacy Claim Evaluation Specification,” with the claim summary submitted to NMPA. Currently, in vitro tests, including organs, tissues, cells, microorganisms and physicochemical tests, are primarily used for efficacy claim evaluations in China’s cosmetics industry as alternatives.

For example, zebrafish model has been widely used in evaluating cosmetic efficacy^16,17 including soothing, anti-wrinkle, firming, moisturizing, acne removal, oil control, whitening, non-irritating and hypoallergenic benefits. Although fish embryos are not considered animals under EU animal protection laws¹⁸ and are strongly recommended by international scientists as an alternative to animal testing, they have not yet been included in the “Technical Specification.” Consequently, companies using zebrafish-related models for toxicological assessments may still be under the risk of non-recognition.

There are over 10,000 cosmetic registration and filing companies in China, with more than 5,000 holding production licenses. As of now, there are over one million validly registered and filed products, with hundreds of thousands of products registered and filed each year, and thousands of used cosmetic ingredients lacking toxicological endpoints. China has become the world’s second-largest cosmetics consumer market after the US. The ongoing improvement of alternative animal methods in cosmetic evaluations, promises significant future growth in the field of toxicological testing.

Liyuan Ji: For cosmetics companies in the Chinese market, what are the current strategies that can effectively avoid or exempt the risks of animal testing and safety assessment under the updated regulation?

Jincong Li: These developments may have several impacts on the R&D and market strategies of cosmetics companies in China. Here are some guidelines to mitigate potential risks:

• Ingredient Selection: Companies are encouraged to use ingredients with safety assessment conclusions or safe dosages issued by international authoritative organizations. Additionally, they should avoid ingredients that necessitate animal testing.
• Avoidance of New Ingredients: It is advisable for products not to include new ingredients that are still under safety monitoring.
• Cross-Border E-commerce: Companies can enter the Chinese market through cross-border e-commerce platforms that offer direct mail services. This method bypasses some of the traditional regulatory challenges faced by foreign companies.
• Contract Manufacturing: Foreign brands can authorize domestic production enterprises for contract manufacturing.

Liyuan Ji: Lastly, what are the differences in attitudes towards animal testing between Chinese and international consumers? How do these attitudes affect the market and companies’ R&D strategies?

Jincong Li: Compared to regions like the EU, Japan and South Korea, China’s modern cosmetics industry is relatively young. Therefore, there’s a wide range of opinions on animal testing. Some consumers care more about how well a product works, its cost and their personal preferences. Others might not make a direct connection between animal testing and animal-derived ingredients, paying more attention to the ingredients list, the brand’s reputation and other customer reviews. 

The lack of public education and comprehensive animal protection legislation in China has led to unclear consumer attitudes toward animal testing. Nevertheless, there has been a notable shift in recent years as societal values and consumer demands increasingly lean toward more ethical considerations. Currently, the “cruelty-free” beauty brands available in China are predominantly imports, representing a significant opportunity for more ethical beauty brands. 

Conclusion

We greatly appreciate the valuable insights provided by our esteemed guest, Jincong Li, as we navigate the challenges presented by the evolution of animal testing and alternative methods under China’s new regulations.

The growing global¹⁹ and Chinese consumer resistance to animal testing is driving the industry toward more ethical and sustainable practices. This shift is clearly supported by the Chinese government’s efforts to update regulations and promote alternative testing methods. While these regulations may not cover all types of cosmetic products, they provide significant opportunities for conducting cosmetic assessments and represent a critical step toward a global cruelty-free cosmetics market. This dialogue underscores the industry’s ongoing journey toward ethical standards and enhanced consumer safety. 

References:

1. National Medical Products Administration Announcement on the Release of the “Technical Guidelines for Cosmetic Safety Assessment (2021 Edition)” (2021 No. 51), N.M.P. Administration, Editor. 2021-04-09.
2. Notice on Printing and Distributing the Guidelines for Risk Assessment of Potentially Harmful Substances in Cosmetics, in [2010]339, C.N.F.a.D. Administration, Editor. 2010-08-23.
3. Announcement by the General Administration on Including the In Vitro 3T3 Neutral Red Uptake Phototoxicity Test Method for Cosmetic Chemical Raw Materials into the Cosmetic Safety Technical Specification (2015 Edition), N.M.P. Administration, Editor. 2016-11-11.
4. National Medical Products Administration Announcement on the Release of the “Regulations on the Management of Cosmetic Registration and Filing Data” (2021 No. 32) in 2021-03-04, N.M.P. Administration, Editor. 2021-03-04.
5. Xing, S. Comparative Study on the Safety Evaluation Systems of Cosmetics in the European Union and China. 2019-12-31; Available from: http://m.cnpharm.com/c/2019-12-31/699711.shtml.
6. Sreedhar, D., et al., Ban of Cosmetic Testing on Animals: A Brief Overview. International Journal of Current Research and Review, 2020. 12: p. 113-116.
7. Test No. 471: Bacterial Reverse Mutation Test. OECD Guidelines for the Testing of Chemicals, Section 4, 2020.
8. Test No. 473: In Vitro Mammalian Chromosomal Aberration Test. OECD Guidelines for the Testing of Chemicals, Section 4, 2016.
9. Test No. 476: In Vitro Mammalian Cell Gene Mutation Tests using the Hprt and xprt genes. 2015.
10. OECD, Test No. 491: Short Time Exposure In Vitro Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage. 2023.
11. OECD, Test No. 460: Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants. 2023.
12. OECD, Test No. 442E: In Vitro Skin Sensitisation. 2023.
13. OECD, Test No. 442C: In Chemico Skin Sensitisation. 2023.
14. OECD, Test No. 432: In Vitro 3T3 NRU Phototoxicity Test. 2019.
15. OECD, Test No. 495: Ros (Reactive Oxygen Species) Assay for Photoreactivity. 2019.
16. Lajis, A.F.B., A Zebrafish Embryo as an Animal Model for the Treatment of Hyperpigmentation in Cosmetic Dermatology Medicine. Medicina (Kaunas), 2018. 54(3).
17. Lin, F.J., et al., Recent development in zebrafish model for bioactivity and safety evaluation of natural products. Crit Rev Food Sci Nutr, 2022. 62(31): p. 8646-8674.
18. Strähle, U., et al., Zebrafish embryos as an alternative to animal experiments—a commentary on the definition of the onset of protected life stages in animal welfare regulations. Reprod Toxicol, 2012. 33(2): p. 128-32.
19. Grappe, C.G., et al., “Not tested on animals”: how consumers react to cruelty-free cosmetics proposed by manufacturers and retailers? International Journal of Retail & Distribution Management, 2021. 49(11): p. 1532-1553.

Chinese American Cosmetic Professional Association

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