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全球首创!北京尚捷优蓝“安色®”高分子着色剂获国家药监局批准作为化妆品着色剂使用
Cai Fu Zai Xian· 2025-11-04 09:26
Core Viewpoint - The approval of "Anse® Luoshen Zhu" as the world's first high molecular coloring agent for cosmetics marks a significant breakthrough in China's cosmetic raw material sector, transitioning from a follower to a leader in coloring technology [1][10]. Group 1: Product Approval - "Anse® Luoshen Zhu" is the first domestically developed cosmetic raw material approved by the National Medical Products Administration (NMPA) since the implementation of the new regulations in 2021 [1]. - The product received its registration number "Guo Zhuang Yuan Zhu Zi 20250002" and was officially approved on October 30, 2025 [2]. Group 2: Technological Innovation - The product utilizes a fourth-generation water-based polyurethane synthesis technology, embedding color groups in a stable structure that exceeds skin permeability thresholds, thus addressing safety concerns associated with traditional small molecular coloring agents [3]. - This innovation establishes a new technical pathway for "non-percutaneous coloring," significantly enhancing safety in cosmetic applications [3]. Group 3: Safety and Performance Standards - "Anse® Luoshen Zhu" is characterized by high molecular weight, ensuring that coloring agents do not penetrate the skin barrier, effectively eliminating transdermal absorption risks [4]. - The product exhibits excellent performance in terms of migration resistance, solvent resistance, and thermal stability, maintaining color stability across various formulations [4]. - The manufacturing process is environmentally friendly, free from organic solvents and toxic heavy metals, aligning with sustainable development principles [4]. Group 4: Regulatory Support - The successful registration of "Anse® Luoshen Zhu" reflects the NMPA's commitment to supporting innovation in new raw materials through scientific regulation and precise evaluation [6]. - The regulatory framework has facilitated the approval process for high-tech raw materials, demonstrating a pragmatic approach to innovation [6]. Group 5: Future Development - The approval of "Anse® Luoshen Zhu" lays a solid foundation for the development of subsequent products in the "Anse®" series, with plans for further research and registration of additional colorants [8]. - The company aims to meet the diverse safety coloring needs of the cosmetics industry by introducing more reliable high molecular coloring agents in the future [8].