👋 - Kishan Babuji
We’re rolling out a three-part series this week on the major regulatory shifts across Asian markets. The first issue covers China, Taiwan, and South Korea. The second is a deep dive into Japan, featuring a guest piece from Jiwon Koh. The final issue focuses on ASEAN and the broader regional trends shaping the industry.
Regulatory Bytes From Karen
Regulators across Asia spent 2025 refining safety frameworks, tightening ingredient controls, and modernizing how dossiers and labels are managed. China, Korea, Taiwan, Japan, and ASEAN members led with substantive moves on safety assessments, ingredient lists, and digital tools, with clear implications for product development, claims, and lifecycle compliance.
China: From CSAR Maturity to Digital Supervision
China’s 2025 agenda was all about deepening the Cosmetic Supervision and Administration Regulation (CSAR) implementation and building a more data‑driven oversight system.
Full safety assessments are now the norm. From 2025, cosmetic registrations and notifications must include complete safety assessment reports aligned with the latest CSAR technical rules, retiring earlier, lighter formats. This raises expectations for toxicology, exposure, and margin‑of‑safety justifications.
Risk monitoring got its own dedicated measure. New Administrative Measures on Cosmetic Safety Risk Monitoring and Evaluation (effective mid‑2025) formalize how risks are tracked across manufacturing, circulation, and use, and clarify enterprise responsibilities for signal detection and reporting.
Ingredient innovation is being actively encouraged. China’s National Medical Products Administration (NMPA) issued supportive provisions for new cosmetic ingredients (NCIs), including clearer pathways to pair novel ingredients with special‑use products and to leverage a “smart submission and review” system.
The Inventory of Existing Cosmetic Ingredients in China (IECIC) and test methods are in motion. An October IECIC update added new ingredients and revised dozens of entries, while The National Institutes for Food and Drug Control (NIFDC) drove multiple rounds of method and standard projects, especially around alternative tests and high‑risk product categories. One significant change to the IECIC is the removal of the “highest permissible use” levels previously associated with ingredients listed on the 2021 inventory.
The future is e‑labels and personalization. An electronic labeling pilot (launching 2026) and expansion of pilots for personalized cosmetics and in‑store compounding further blur the line between products and services, with data and traceability at the center.
What it means for you: China now expects EU‑style technical depth in safety files, plus readiness for dynamic IECIC changes and more visible post‑market risk management. Digital readiness (e‑labels, structured data submissions) is fast moving from “nice to have” to “entry ticket.”
South Korea: Safety Assessments and Functional Cosmetics 2.0
Korea’s Ministry of Food and Drug Safety (MFDS) continued transforming the market into one of the most technically demanding in Asia.
Safety assessments are now a formal obligation. A 2025 amendment to the Cosmetics Act requires manufacturers and responsible sellers to conduct and document internal safety assessments, backed by expert review.
Dedicated Cosmetic Safety Information Centers are being rolled out. These centers support ingredient risk assessment, method development, and public communication, signaling a long‑term, institutional approach to cosmetic safety science.
Ingredient standards have been tightened. Revised Cosmetic Safety Standards adjusted concentration limits and conditions of use for several UV filters and other actives while introducing a new UV filter under strict parameters.
Functional and customized cosmetics are more tightly defined. Updated Enforcement Rules clarified categories, introduced tougher rules for infant/child products, and further structured the framework for customized and in‑store mixed cosmetics.
What it means for you: Korea now functions like a hybrid between a cosmetic and therapeutic regime for many “functional” products. Robust safety assessments, careful UV filter strategy, and category mapping (general vs. functional vs. customized) are critical for avoiding rework or enforcement.
Taiwan: Registration Timelines and High‑Risk Categories
Taiwan is mid‑way through a multi‑year transition to a fully modernized cosmetic regime.
High‑risk categories now face full registration. From July 1, 2025, registration and product information files are mandatory for baby cosmetics, eye and lip products, and non‑medicinal oral care, with general cosmetics to follow in 2026.
As a reminder, starting July 1, 2024, Taiwan unified cosmetics under the Cosmetic Hygiene and Safety Act, eliminating the distinction between specific-purpose and general cosmetics, requiring all cosmetics to register before manufacture, import, or sale.
Labeling is evolving, especially for sprays. 2025 guidance for spray cosmetics targets inhalation and eye/respiratory risk, with strengthened warning statements, usage instructions, and, in some cases, graphic elements.
Ingredient controls are tightening on a delayed schedule. Prohibited lists were refreshed and staged bans (such as for boric acid) set for 2026, allowing industry limited transition time for reformulation.
What it means for you: Treat Taiwan more like a “registration plus PIF” market than a pure notification system. Prioritize high‑risk categories and aerosols in your 2025–26 remediation plan and track phased ingredient bans against your regional reformulation roadmap.
