Under the background of increasingly strict regulation of the cosmetic industry, the safety of raw materials has become the core element of product competitiveness. (hereinafter referred to as “Sunshine Bio”) has always been adhering to the corporate vision of “making people more beautiful, healthier and happier through modern green biotechnology”. Recently, the company's self-developed hydrolyzed sponge raw materials have successfully completed the safety assessment report of cosmetic raw materials, marking a new safety and technology benchmark for the industry. Recently, the hydrolyzed sponge raw material independently developed by the company successfully completed the safety assessment report of cosmetic raw materials, marking the establishment of a new safety and technology benchmark for the industry.
According to the current Chinese regulations and the latest requirements of the National Drug Administration (NMPA), from May 2025, cosmetic filings (including general cosmetics and new ingredients) must submit a complete Cosmetic Ingredient Safety Assessment Report, which is one of the core documents for cosmetic registration filing compliance.
Core regulatory basis
Regulations on the Supervision and Administration of Cosmetics (State Council Decree No. 727)
Article 21: Clearly require new cosmetic raw materials and products to submit safety assessment information for registration/filing.
Measures for the Administration of Cosmetics Registration and Filing (NMPA Decree No. 35)
Article 28: Provides that the safety assessment report as a mandatory material for the record
Article 34: new raw materials need to complete a complete safety assessment
Technical Guidelines for Safety Assessment of Cosmetics (Circular No. 51 of 2021)
Simplified assessment pathway will be canceled from May 2025, and all ingredients must provide a complete assessment report
Hunan sunshine Bio-technology has adopted the internationally advanced Reconstructed Human Epidermis (RhE) model to systematically evaluate the skin irritation of the hydrolyzed sponge raw material developed by the company according to the OECD TG 439 standard. Under the conditions of this test, the hydrolyzed sponges in this batch are not skin irritants and are classified as unclassified by GHS.
Through the reconstruction of human epidermal model test report for the toxicological basis of comprehensive analysis, according to the knowledge and data currently available, the product hydrolysis sponge, the main components of hydrolysis sponge (99.0%), calcium silicate (0.7%) and sodium silicate (0.3%); by the security assessment, hydrolysis sponge in the formulation of all types of products with a maximum addition amount of 14.0%, and at the same time on the raw materials may be present in the microorganisms, Heavy metals have been controlled, the test results are in line with the quality control requirements; all types of cosmetics in the normal as well as reasonable and foreseeable conditions of use, will not pose potential risks to human health.
As a hydrolyzed sponge segment market share of the leading enterprises, we have a lot of work, so that more companies feel at ease with hydrolyzed sponge, standardization and development of hydrolyzed sponge production standards, quality control standards, application standards, and to make it become a national, international standards and continue to move forward.
