New Regulation Interpretation | With the new regulations on cosmetic ingredients now in effect, Recombinant Keratin is entering a golden period of accelerated industrialization.

Category: Company News

Release time: 2026-07-27

Overview: On July 15, the new regulations on cosmetic raw materials officially came into effect, shifting oversight from “strict entry, lenient management” to “risk-based classification.” This analysis explores how Recombinant Keratin is leveraging policy benefits—such as lower filing thresholds and clearer submission pathways—to enter a golden period of accelerated industrialization, as well as Hemos Bio’s core technological advantages in this field.

On July 15, the National Medical Products Administration revised… Regulations on the Registration, Filing, and Data Management of New Cosmetic Ingredients (hereinafter referred to as the “New Regulations”) and the accompanying documents issued by the National Institute for Food and Drug Control Technical General Rules for the Registration and Filing of New Cosmetic Ingredients (Hereinafter referred to as the “Technical General Provisions”) has officially come into force, and the 2021 edition of the original “Regulations” has been simultaneously repealed. 
 

This revision has completed a systematic overhaul of China’s regulatory framework for new cosmetic ingredients, marking a shift in the industry from “ Strict entry, lenient management “Turn to” Risk-based classification and targeted burden reduction “Stage.”

 

To Recombinant Keratin For this category of biotechnology raw materials, the new regulations represent both an iterative upgrade of the compliance framework and a concentrated realization of policy benefits: Lowered application thresholds, shortened listing timelines, and a clear path for innovation. Raw-material companies with a strong portfolio of core technologies will be the first to seize market opportunities.

 

01

Changes in the new regulations: from “uniform and stringent” to “risk-based classification”


 

 

The core shift in this new regulation is from uniform, across-the-board oversight to refined, risk‑based management supported by evidence. This transformation is reflected in three key areas:

 

▶ The high-risk category has been narrowed, and the scope of filing has been expanded.

The original Regulations classified ten categories of functional ingredients—preservatives, sunscreens, colorants, hair dyes, spot‑removing and whitening agents, anti‑hair loss products, acne‑treatment products, anti‑wrinkle products, anti‑dandruff products, and deodorants—as subject to “higher‑risk” registration management. The new Regulations, in strict alignment with the Regulations on the Supervision and Administration of Cosmetics, retain registration management only for five high‑risk functional categories—preservatives, sunscreens, colorants, hair dyes, and spot‑removing and whitening agents—while reclassifying all other functions to filing‑based management.

▶ Streamlined submission documents and scientifically justified exemptions from toxicology studies.

The new Regulations clearly specify that certain functions are based on supporting documentation, test method specifications, and validation data, Accelerated testing Data from long-term stability studies and similar submissions are no longer required; companies shall retain such records for their own reference, with regulatory authorities able to access them as needed. Provided that the safety assessment conclusions remain unaffected, existing data that comply with national standards or internationally recognized methods may be directly reused. Furthermore, certain toxicological studies may, on the basis of robust scientific justification, be eligible for exemption or reduction, thereby avoiding redundant testing.

▶ Exempt from animal testing; safety assessments aligned with international standards.

The new Regulations encourage the use of animal‑alternative methods recognized by internationally authoritative organizations for safety assessment and permit enterprises to employ novel strategies and approaches in conducting raw‑material safety evaluations.

 

02

Compliance Dividend: The Core Impact of Recombinant Keratin


 

 

Recombinant Keratin is a novel biomaterial prepared through microbial fermentation, expression, and purification, based on the human keratin gene and leveraging synthetic biology technologies. Its technical characteristics are highly aligned with the new regulatory guidelines, and it will unlock the following benefits:

 

▶ The application process is clear, and market-based efficiency has improved.

The core application scenarios of Recombinant Keratin are concentrated in skin barrier repair, hair strengthening and restoration, oral soft tissue repair, and anti-wrinkle firming—none of which fall within the scope of Class 5 high-risk efficacy claims. As such, it is managed under a filing-based system, which can significantly reduce upfront compliance costs and greatly accelerate time to market.

▶ Shen’s identity positioning is clear, aligning with compliance policy channels.

The “Technical General Rules” explicitly classify raw materials produced using biotechnologies such as “genetic engineering, cell engineering, and fermentation engineering” as “novel biotechnology-derived ingredients.” Recombinant Keratin is precisely prepared through genetic engineering, successfully deciphering and reconstructing the functional gene sequence of human keratin, and manufactured based on synthetic biology techniques, fully aligning with the compliant declaration pathway for this category of ingredients.

 

03

Raw Material Advantage: Why Recombinant Keratin?

 

Recombinant Keratin has attracted considerable attention due to its unique technical advantages and efficacy: 
 

▶ Security Advantages

Recombinant Keratin through Preparation by genetic engineering techniques It features a single, well‑controlled component and can achieve a purity of up to 99.9%. It is non‑immunogenic, non‑cytotoxic, and exhibits excellent biocompatibility, fundamentally eliminating the viral contamination risks and immunogenicity concerns associated with animal‑derived extracts.

▶ Functional advantages

Based on human keratin gene sequences, it exhibits high homology with human tissues, fully preserving the natural structure and functional domains of human keratin, and possesses Skin barrier repair, hair strength and repair, oral soft tissue repair, anti-wrinkle and firming And multiple core benefits.

▶ Industrialization advantages

Hemos Bioscience As the world’s first institution to achieve mass production of Recombinant Keratin, it has established a complete industrial chain platform. Recombinant Keratin has been widely applied in Hair care, skin care, oral care and other fields, it holds great potential for applications in the beauty and personal care sector.

 

The implementation of the new regulations represents a proactive response by regulators to the industry’s call for innovation, and it further embodies the regulatory principle of “safety first, innovation encouraged,” thereby reducing burdens and enhancing efficiency for raw-material innovators with core technologies.

 

For Recombinant Keratin, the filing threshold has been lowered, the application process is now clearer, and R&D costs have decreased, ushering in a golden window for its transition from the laboratory to industrialization. 
 

When compliance ceases to be an obstacle to innovation, technological prowess will become the key factor determining market position. With proprietary core technologies, stable mass-production capabilities, and a robust quality system, Hemos Bioscience will accelerate its efforts to seize market opportunities, driving China’s original bio‑ingredients from “catching up” to “leading the way,” and becoming a pivotal force for differentiated competition among domestic beauty and personal-care brands.

Keywords: New Regulation Interpretation | With the new regulations on cosmetic ingredients now in effect, Recombinant Keratin is entering a golden period of accelerated industrialization.

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Next: A delegation from Chongqing Yufu Holding Group and Chongqing Machinery & Electrical Group paid a visit to Hemos Bioscience for inspection and exchange.

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