Korea's Cosmetic Safety Assessment Starts in 2028: Five Things to Prepare Now

What exactly is changing?

The safety assessment system requires cosmetic businesses to scientifically evaluate product safety and to prepare and retain the related documentation. MFDS describes it as a way to raise K-beauty safety standards and build a management framework aligned with global requirements. Ingredient and labeling rules already existed; what changes is the requirement to hold safety assessment records at the finished-product level.

What has been published so far centers on the timeline and scope criteria. Detailed document formats and review procedures may still be refined before the start date, so treat the schedule below as a guide for sequencing preparation and confirm final requirements through MFDS announcements.

1. Find out which year applies to you

Timing depends on company size and product type. Companies with annual production or import performance of 1 billion won or more—or registered after 30 December 2025—begin in 2028 with functional cosmetics reviewed or reported after 30 December 2025. Coverage then extends to infant and children's cosmetics in 2029, to cosmetics first manufactured or imported after 30 December 2025 in 2030, and to all products in 2031.

Companies under 1 billion won in annual performance begin in 2029 with infant and children's cosmetics and reach all products in 2031. Smaller scale does not mean exemption—only a different starting point.

• 1bn won and above: 2028 functional → 2029 infant and children's → 2030 newly manufactured or imported → 2031 all products
• Under 1bn won: 2029 infant and children's → 2031 all products
• The reference line is whether review, report, manufacture, or import occurred after 30 December 2025

2. Functional and children's products come first

The order—functional cosmetics first, then infant and children's products—is itself a signal. Documentation requirements tighten first for categories that already carry review or reporting procedures and for those where safety sensitivity is highest. If a functional or kids line is in development, schedule its preparation ahead of other items.

3. The bottleneck is people, not paperwork

The most common concern raised across the industry is a shortage of people able to perform the assessment. Smaller companies often run with a few staff sharing quality management and regulatory duties, and safety assessment work now lands on the same team. Both small and large companies report a shortage of personnel meeting the qualification criteria for safety assessors.

MFDS has said it will strengthen support by designating dedicated institutions, training specialists, and developing assessment methods. For a brand, the practical decision is whether to build internal capability or rely on a manufacturer or external assessment capacity—and to decide before the deadline arrives.

4. Records are hard to assemble after the product is finished

A safety assessment depends on organized information: the formula, raw material specifications, concentrations, application area and amount, and the intended user. Reconstructing this after launch means chasing suppliers and repeating tests, which stretches timelines. Recording the evidence at the moment the formula is fixed costs less than recovering it later.

5. Domestic preparation overlaps with export preparation

From 7 to 9 September, MFDS hosted the first meeting of the Global Cosmetic Regulatory Authority Summit (GCORAS) at the Plaza Hotel in Seoul. Fifteen institutions from twelve countries attended, including ASEAN members, Middle Eastern countries such as the UAE, and Brazil and Mexico in Latin America; participating countries were described as accounting for roughly 46% of the world's cosmetic exports.

The stated backdrop was rising technical barriers as major countries adopt safety assessment systems, mandate GMP, and expand halal certification. Rather than preparing for domestic assessment separately from destination-market requirements, design one documentation set that can be reused across markets.

The first question for the brief

Write 'when does this new product become subject to safety assessment?' on the first page of the brief. Three checks—the company's annual performance band, whether the item is functional or for infants and children, and whether review, report, manufacture, or import falls after 30 December 2025—are enough to identify the starting point. The next question is who prepares the records and where they are kept.