Bio: Dr. Ni Lin, MD/PhD, Associate Professor at the Center of Safety & Technology Evaluation for Cosmetics, China National Institutes for Food and Drug Control (NIFDC), mainly engaged in premarket cosmetics review, safety assessment of cosmetics, and research on NAMs for cosmetics and drug safety evaluation. She has drafted several technical guidelines for cosmetic toxicology tests and safety assessments, participated in the development, optimization, and validation of alternative methods for cosmetics and drugs, and led research projects on NAMs for safety assessment. Dr. Lin serves as a committee member for the Organoid and Organ-on-Chip Specialty Committee of the China Society of Toxicology. She earned her PhD in Pharmacology and Toxicology at the Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS & PUMC) and completed postdoctoral research at NIFDC working on microfluidic organ-on-a-chip technology for drug toxicology evaluation.

Abstract: Cosmetics are consumer products that meet people's desire for beauty, and their quality and safety directly impact consumers’ health. The Regulations on the Supervision and Administration of Cosmetics establish a dedicated safety assessment system, which requires quality and safety personnel to evaluate cosmetic products comprehensively before they are marketed. On one hand, as the cosmetics industry and regulatory authorities continue to deepen their exploration and accumulation of experience in safety assessment practices, on the other hand, the ongoing emergence of new technologies and ingredients in cosmetics has collectively driven the continuous update of technical guidelines and regulations for safety assessment to keep pace with developments in the cosmetic industry and regulatory requirements. Considerable attention has been given to applying risk assessment approaches for cosmetics and ensuring their regulatory compliance, including approaches such as the threshold of toxicological concern (TTC), read-across (RA), in silico predictive models, integrated approaches to testing and assessment (IATA), and the validation and acceptance of alternative methods. Furthermore, the development and regulatory scientific research on new approach methodologies (NAMs), such as organoids and organ-on-a-chip, as well as NAMs-based next-generation risk assessment (NGRA), have attracted significant focus and advanced rapidly in China. This presentation will provide an overview of the progress on regulations and technical guidelines for the risk assessment of cosmetics within China's regulatory framework, with a primary focus on alternative methods. It will also present the research and projects on NAMs hosted by NIFDC, and discuss current and future practices and developments in cosmetic safety assessment.