Regulatory Approaches to Cosmetic Safety and Safety Assessment Regulations Focusing on Republic of Korea, the United States, the European Union, Japan, China, and Taiwan

Abstract

Cosmetic safety assessment has shifted from focusing on individual ingredient toxicity to evaluating final product safety, driven by growing consumer safety awareness and global market growth. This study compares cosmetic safety regulations in Korea, the United States (US), the European Union (EU), Japan, China, and Taiwan, analyzing scope of application, timing of report preparation, responsible entities, the structure of the report, and the roles and qualifications of safety assessors. The US, EU, China, and Taiwan require safety assessments for all cosmetics, whereas Korea restricts them to products for infants and young children. Additionally, report preparation before marketing is mandatory in the US, EU, Taiwan, and Korea, while China requires preliminary data submission at the new product registration. Notably, the EU, China, and Taiwan emphasize professional expertise, mandating that safety assessors possess both relevant academic qualifications and practical experience. In contrast, Japan lacks a distinct cosmetic safety assessment system. In the future, Korea should enhance its framework by mandating pre-market safety substantiation, fostering collaboration among stakeholders, issuing clear guidelines, and cultivating qualified professionals.