Chuangjian Medical Secures GRAS Certification for Recombinant Human-like Type III Collagen, Gaining U.S. Market Access

In January 2025, Trautec Medical’s food-grade recombinant humanized Type III collagen obtained GRAS certification. GRAS (Generally Recognized as Safe) is a product safety certification framework established by the U.S. Food and Drug Administration (FDA), demonstrating that a food ingredient is safe for human health when used according to its intended purpose and at specified concentrations. With high recognition across North America and worldwide, GRAS status serves as a crucial credential for novel food ingredients entering international markets. This achievement signifies that Trautec Medical’s recombinant humanized collagen has gained international acceptance in the food sector, marking a significant milestone in the company’s diversified global expansion strategy.

Supporting Documentation for the Use of Recombinant Collagen in Food as Generally Recognized as Safe (GRAS)

GRAS Expert Panel Conclusion: The recombinant collagen from Jiangsu Trautec Medical meets food-grade specifications and can be safely used as an ingredient in foods and beverages.

In recent years, market demand for functional foods has continued to grow. Research data show that the global market for oral collagen products reached $4.5 billion in 2023 and is projected to reach approximately $9.1 billion by 2032, with a compound annual growth rate (CAGR) of 8.2%.¹。

E-commerce data shows that in the 12 months leading up to May 2024, sales in the e-commerce market for oral anti-aging products within the nutritional supplements category increased by 27.5% year-on-year. Driven by ingredient innovation and technological breakthroughs, collagen has become an indispensable "star ingredient" in oral beauty products, accounting for 54.8% of the sales share.²。

Behind this trend is the drive from modern consumers’ multiple demands for safety, health, anti-aging beauty, and convenience. Especially in the domestic market, with the accelerating pace of life, consumers areCombining Nutritional Supplementation with Lifestyle Compatibilityfood demand has become more urgent.

GRAS certification is one of the most transparent and robust food regulatory programs worldwide, with stringent requirements. Companies must independently provide reliable scientific data to demonstrate that the ingredient is safe for human health under its intended conditions of use. Such data may include clinical studies, toxicological studies, animal experimental results, or historical evidence of use.

Recently, Trautec Medical, in collaboration with a team from China Agricultural University, published a paper titled “Recombinant HumanizedFood Safety of Type III CollagenSexEvaluation》academic paper, the study was conducted in accordance with Chinese food safety standards and relevant OECD guidelines, covering genotoxicity tests such as bacterial reverse mutation (Ames test), mouse sperm abnormality, and mammalian in vivo micronucleus assays, as well as acute oral toxicity, 90-day subchronic toxicity, and embryo-fetal developmental toxicity studies. The data demonstrated that Trautec’s recombinant humanized type III collagen poses no risk of genotoxic mutagenicity, exhibits no acute or subchronic toxicity, has no adverse effects on embryos, and carries an extremely low risk of allergy, thereby confirming the high safety profile of Trautec’s recombinant humanized type III collagen as a food ingredient.

Academic Paper on Comprehensive Toxicological Testing and Allergy Risk Assessment of Recombinant Humanized Type III Collagen (RHTypeIII) Validates Its Safety for Food Applications.

A scientifically rigorous research protocol, coupled with robust experimental data and results, has secured unanimous recognition from multiple authoritative experts in the U.S. scientific community regarding the high safety profile of Trautec Medical’s recombinant humanized Type III collagen as a food ingredient, thereby earning GRAS certification. This achievement signifies that Trautec Medical has successfully passed the stringent global food regulatory standards—a major milestone built upon years of accumulation and expertise—propelling China’s originally developed recombinant collagen significantly forward in the global collagen food market.

Under the premise of ensuring safety, the high activity and high biocompatibility of recombinant humanized collagen, along with its anti-aging benefits such as improving skin elasticity, promoting neocollagenesis, and enhancing skin hydration, will deliver broader and more significant value in daily life through various forms including capsules, tablets, oral liquids, powders, and gummies.

Recombinant collagen produced via synthetic biology not only boasts advantages such as high molecular purity, absence of viral transmission risks, and minimal cytotoxicity and immunogenicity, but also features resource efficiency, renewable raw materials, clean and efficient processes, and environmental friendliness. It offers shorter production cycles, lower carbon emissions, and avoids the natural resource consumption associated with traditional animal husbandry. Its non-animal origin and eco-friendly profile align closely with current health-conscious and sustainable consumption principles.

Since its establishment in 2015, Trautec Medical has chosen Pichia pastoris, which offers higher yield limits, facilitates purification, and ensures greater safety, to build recombinant collagen cell factories. It has taken the lead in achieving ultra-large-scale stable fermentation technology with a capacity of 30 tons, and its product quality has been highly recognized by numerous leading brands both domestically and internationally. The mature industrialization of recombinant humanized collagen ensures safety and traceability while enabling efficient production, driving the functional food sector toward high value-added and green development.

In recent years, Trautec Medical has been actively expanding into overseas markets. The recent GRAS certification marks a significant milestone in the diversified application of Trautec’s recombinant collagen and its expansion into international markets. Moving forward, the company will accelerate the innovative application of synthetic biology technologies and its global outreach, providing consumers worldwide with more safe, effective, and high-quality products and solutions.

1. Collagen Oral Product Market Research Report 2032

2. EarlyData E-commerce Market Intelligence

3. White Paper on the Development of China’s High-Quality Collagen Industry, Chinese Academy of International Trade and Economic Cooperation