South Korea drafted a mandatory cosmetics safety file on 8 July — the AI fake-expert ad ban buried in the same text will get the headlines, not the KRW 1 billion threshold that pulls almost every exporter into the first compliance wave

What actually happened on 8 July

MFDS published a legislative pre-announcement of amendments to the Enforcement Decree and Enforcement Rules of the Cosmetics Act, opening a public comment period that runs from 8 July to 18 August 2026. The centrepiece is a new Cosmetic Safety Assessment system: business operators will be required to prepare and retain safety assessment materials for their cosmetic products, with the draft setting the required content and retention period for those records, qualification standards for who may act as a safety assessor, and a designation procedure for a Cosmetics Safety Information Center to support the system. The obligation is not immediate. It phases in from 2028, starting with functional cosmetics from businesses whose annual production or import performance reaches KRW 1 billion or more, plus any newly registered business, before expanding to cover all cosmetic products and businesses by 2031. The same draft bundles in a set of smaller operational changes: designation of which cosmetics employees may subdivide and sell in refill formats, an exemption for import-agency-type distribution safety managers from continuing-education requirements, an expanded scope of information businesses must disclose to regulators, a ban on advertising that uses AI to impersonate or fabricate expert endorsements, and new validity-period standards for the medical certificates submitted with cosmetics manufacturing registration.

The numbers behind the draft

One date marks when the consultation opened and how long brands have to comment. One marks when the obligation actually starts to bite, and for whom. The gap between the two phase-in years is the story most coverage will miss.

The real subject: Korea is moving from registration to a maintained safety file

Korea's cosmetics regime has long centred on product notification and registration — a one-time event, filed and largely forgotten. What this draft proposes is structurally different: a Cosmetic Safety Assessment system that requires businesses to build and retain, per product, a safety assessment file with defined content and a defined retention period, prepared or reviewed by someone meeting new qualification standards as a safety assessor. That is the same logic already familiar to any brand managing the EU's Cosmetic Product Safety Report or Product Information File — safety substantiation as a maintained, retrievable document tied to a specific SKU, not a one-off registration form. Read the draft as 'Korea bans AI in cosmetics advertising' and the 2028 date looks irrelevant to most compliance teams. Read it as 'Korea is introducing a PIF-style safety dossier requirement, gated by a production or import threshold that most exporters clear immediately,' and 2028 becomes the date a brand needs an assessor, a documented process and per-SKU records in place — with the KRW 1 billion threshold determining whether that date is 2028 or 2031 for any given business.

Why it matters for brands

Retail, consumer-goods and luxury brands with cosmetics or personal-care lines sold in Korea should not treat this as a 2028 problem to revisit later. The KRW 1 billion production-or-import threshold is a volume test, not a company-size test — a mid-sized international brand can clear it well before it clears any definition of 'large enterprise.' Brands that already manage ingredient composition, test data and safety substantiation as structured, SKU-level records — because they've built a CPSR or PIF for the EU, for instance — have most of the raw material this system will require; the task is mapping that existing data to Korea's forthcoming content and retention requirements and to a qualified assessor. Brands that manage safety substantiation as scattered PDFs per market have a longer runway only on paper: the comment period closes 18 August 2026, the phase-in start is already fixed at 2028, and building a maintained, assessor-reviewed safety file from a standing start takes considerably longer than the 18-month gap between MFDS's announcement and the first businesses' compliance date.

Two ways to read the 8 July draft