China is a global pioneer in the industrialization of recombinant collagen, leading in large-scale production and commercial application. With advantages in safety, functionality, and sustainability, recombinant collagen is gaining wider adoption across medical aesthetics, cosmetics, and functional nutrition.
This article provides an overview of the regulatory requirements for recombinant collagen in China, focusing on its use in both the cosmetic and food sectors.
In China, Recombinant collagen's applications are primarily focused in the medical aesthetics industry. The National Medical Products Administration (NMPA) of China has issued guidelines including the Naming Guidelines for Recombinant Collagen Biomaterials and the Classification Principles for Recombinant Collagen Medical Products. Additionally, industry standards such as YY/T 1849-2022 Recombinant Collagen and YY/T 1888-2023 Recombinant Humanized Collagen Protein have been released for medical devices.
According to the NMPA's relevant Q&A on Medical Aesthetic Products, recombinant collagen is produced using DNA recombinant technology, allowing the amino acid sequence to be designed and optimized according to specific needs. For example, recombinant humanized collagen contains repeat units that match the amino acid sequences of specific functional regions found in human collagen.
According to the FAQs on the Administration of New Cosmetic Ingredient Registration and Notification, ingredients that fall under an existing category entry in the Inventory of Existing Cosmetic Ingredients in China (IECIC, 2021 Edition) are not classified as new cosmetic ingredients, even if their production methods or sources differ.
Collagen is listed in the IECIC as such a category ingredient, encompassing a wide range of collagen types and production methods—including those derived from animal tissues and those produced via recombinant technology, such as Type I and Type III collagen.
As recombinant collagen falls under collagen category, it is considered an existing cosmetic ingredient in China and can be lawfully used in cosmetics without the need for new ingredient registration or notification.
Currently, China's Safety and Technical Standards for Cosmetics (STSC) does not yet include a specific definition or testing method standard for recombinant collagen used in cosmetics, particularly in terms of ingredient identification and content determination.
However, according to the standard revision plan released by the National Institutes for Food and Drug Control (NIFDC), a dedicated standard for collagen-based cosmetic products is already under development.
In the capital market, several Chinese companies specializing in recombinant collagen have gone public. Notable examples include Giant Biogene (巨子生物), JinboBio (锦波生物), and Marubi Co., Ltd. (丸美股份). In addition, Trautec Medical (创健医疗) has attracted strategic investment from major international beauty groups such as Shiseido and LVMH, further highlighting the global interest in China's recombinant collagen sector.
Recombinant collagen is synthesized through genetic engineering and offers significant advantages over animal-derived collagen in terms of safety, production control, and functional customization.
Despite its potential, recombinant collagen has not yet been officially approved for food use in China, and no official standards or regulatory specifications specific to recombinant collagen have been issued to date.
Globally, recombinant collagen has not yet been approved for use in food in the European Union. In the United States, there are currently no recombinant collagen ingredients that have successfully passed FDA approval under either the GRAS (Generally Recognized as Safe) process or the New Dietary Ingredient (NDI) notification pathway. However, outside of official regulatory pathways, two Chinese companies—Trautec Medical (创健医疗) and Jland Biotech (聚源生物)—are reported to have completed self-affirmed GRAS assessments for their recombinant collagen products.
