On July 10, 2025, the Ministry of Food and Drug Safety (MFDS) of South Korea announced the latest revision to the Enforcement Rules of the Cosmetics Act (Prime Ministerial Decree No. 1970). The amendment introduces systematic adjustments in key areas, including functional cosmetics, customized cosmetics, and cosmetics for infants and young children.
Key Revisions include:
1. Expansion of the Scope of Functional Cosmetics: A new category has been added to functional cosmetics- “products that help reduce the appearance of red stretch marks caused by pregnancy”.
2. Comprehensive Upgrade of the Regulatory Framework for Customized Cosmetics:
- The mixing and dispensing areas for customized cosmetics must be separated or clearly partitioned from spaces used for other purposes to ensure hygiene and safety.
- Companies are allowed to temporarily carry out sales activities outside of the registered business location for a period not exceeding one month, provided that prior notification is submitted.
- A new qualification examination system for Customized Cosmetics Compounding Managers has been introduced to standardize professional credentials.
3. Optimization of the Functional Cosmetics Review System:
- For ingredients that have already been reviewed or have established standards, the submission requirements for review materials have been simplified.
- Certain products are now eligible for a “notification system” in place of the conventional “pre-market review system,” enhancing administrative efficiency.
4. Enhanced Safety Standards for Infant and Children’s Cosmetics:
- Age classifications have been clearly defined: infants are under 3 years old, and children are between 4 and 13 years old.
- Companies are required to prepare and retain safety data prior to product launch to ensure product suitability for the target age group.
- A usage survey must be conducted every five years, and risk mitigation plans must be formulated to strengthen post-market surveillance.
5. Official Implementation of the Certification System for Natural and Organic Cosmetics:
- The procedures for certification application, modification, and renewal have been clearly established.
- Designation criteria for certification bodies have been set, including personnel qualifications, facility requirements, and management systems.
About CIRS
The CIRS cosmetic team is dedicated to ensuring that cosmetic products meet stringent global regulatory standards. It can provide one-stop services covering the whole life-cycle of a personal care product, which includes cosmetic ingredient development, physical/chemical tests, toxicological tests (in vivo & in vitro), efficacy studies (in vivo & in vitro), ingredient registration, and product registration.
Our services in South Korea include, but are not limited to:
- Korean Cosmetics Product Notification & Registration (General Cosmetics, Functional Cosmetics);
- Standardization of Cosmetic Ingredient Names in Korea;
- Korean Cosmetics Label Review; and
- Quality Inspection.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
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