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2026-09-157 min read1

Cosmetics Safety Assessment Becomes Mandatory from 2028 — Phased Timelines by Company Size and Product Type, and a Preparation Roadmap for SME Responsible Distributors

Korea's cosmetics safety assessment requirement phases in from 2028, with start dates that vary by company size (KRW 1 billion in annual performance) and product type. This guide covers SKU-level date mapping, securing ingredient toxicity data, and a 12-month preparation roadmap for SME responsible distributors.

KITIM Consulting Team

From 2028, Cosmetics Companies Must Prove Their Own Safety

The axis of cosmetics regulation is shifting. Until now, safety management in Korea has centered on ingredient compliance — observing prohibited and restricted substance lists and disclosing full ingredient labels. The cosmetics safety assessment system, phased in from 2028, goes a step further: it requires companies to demonstrate for themselves that a product is safe for human use under normal conditions of use.

The assessment report must cover directions for use and dosage, physical and chemical properties, stability, presence of hazardous substances, exposure levels, toxicological information, and any history of adverse events. The EU has required the same through its CPSR (Cosmetic Product Safety Report) framework for years. For companies already exporting to the EU or ASEAN, or planning to, this domestic rollout is an opportunity to consolidate two regulatory regimes into a single documentation system. For domestically focused SME responsible distributors, however, it introduces a category of documentation burden they have never faced.

The key point is this: full ingredient labeling and restricted-substance management alone will not satisfy the new requirement.

When Does It Apply to Us? Two Tracks by Company Size

The trickiest aspect of this system is that the start date is not uniform. Companies fall into two tracks by size, and within each track the start year varies by product type (per the draft rules issued for public comment on July 8, 2026).

  • Companies with annual production or import performance of KRW 1 billion or more, or registered on or after December 30, 2025: 2028 for functional cosmetics → 2029 for infant and children's cosmetics → 2030 for newly manufactured or imported products → 2031 for all products
  • Companies under KRW 1 billion: 2029 for infant and children's cosmetics → 2031 for all products
  • Here is where practitioners most often slip. Even within one company, the applicable year differs by product type. A company with KRW 2 billion in annual performance that holds both a functional cosmetic and an infant lotion faces 2028 for the functional product, 2029 for the infant product, and 2031 for its remaining existing products. Even a small company at KRW 800 million must comply from 2029, not 2031, for any infant or children's cosmetics.

    This is why a company-level conclusion of "we're 2031" is dangerous. You must lay out your product list and build a table mapping the applicable year to each individual SKU. For a company with 100 SKUs, the number of items landing in the 2028 column is effectively your workload for the next two years.

    The Real Bottleneck Is Ingredient Data Access, Not Paperwork

    Many companies interpret preparation as "filling out a report template." The actual bottleneck lies elsewhere.

    The core of the report — per-ingredient toxicological data and exposure calculations — is not something you can produce in-house. It has to come from your raw material suppliers and OEM/ODM manufacturers. And not at the level of the MSDS you typically receive: you need toxicity test data and impurity profiles covering heavy metals, 1,4-dioxane, nitrosamines and the like.

    The problem is that most supply contracts currently in force say nothing about an obligation to provide this data. If you request it in 2028 and the supplier refuses on grounds of trade secrecy, your only remaining option at that point is to change the ingredient. Reformulation triggers repeat stability testing and, for functional products, a fresh review — multiplying both cost and timeline.

    That is precisely why the data-provision clause needs to go into the contracts you are signing today. Decisions to make alongside it:

  • How to secure a Safety Assessor: develop internal staff to meet the qualification requirements, or outsource to an external specialist firm
  • Audit your ingredient data coverage: what percentage of the ingredients currently in use have toxicological data on file
  • Design a feedback loop into development: an internal process ensuring assessment findings inform new product formulation
  • How to Use Government Support Programs at No Cost

    Fortunately, there is a route where the government covers the preparation cost.

    The MFDS Cosmetics Safety Assessment Adoption Support Program was funded with KRW 1.5 billion in 2026, with consulting and expert advisory costs fully covered by the government. As of July 31, 2026, 588 companies had received tailored consulting, against a 2026 recruitment target of 1,500 SME responsible distributors.

    The 2026 round closed with April applications. The practical opportunity, therefore, is the 2027 announcement. But starting preparation only after the notice drops is too late. Consulting produces results only when the company arrives with its product list and ingredient data already organized; otherwise the consultant spends the entire cycle just mapping your current state.

    Zero-cost preparation you can do right now:

  • Have your designated staff read through the MFDS online guidance videos and the draft implementation criteria issued for public comment
  • Designate a safety assessment owner — even if the role is combined with the quality assurance manager, document the responsibility explicitly
  • Align terminology — standardize internal definitions for terms such as "exposure level," "margin of safety (MoS)," and "impurity"
  • A 12-Month Preparation Checklist

    If you fall under the 2028 bracket, time is not generous. Here is a breakdown by quarter.

    Months 0–3

  • Build the SKU-level applicable-year mapping table (per product, not per company)
  • Designate the safety assessment owner and document the role
  • Audit data coverage across all ingredients — quantify what percentage have toxicological data on file
  • Prepare application materials for the 2027 government support program (the 2026 round took applications in April, so be ready for an early-year call)
  • Months 4–9

  • Amend raw material and OEM supply contracts to include a safety data provision clause
  • Select priority items (functional products, export SKUs) and draft one pilot report — only by actually writing one do the data gaps become visible
  • Begin evaluating substitute materials for ingredients with confirmed data gaps
  • Months 10–12

  • Finalize how the assessor will be secured (internal development vs. outsourcing)
  • Set the rollout schedule across the full product portfolio
  • KITIM Consulting

    Cosmetics safety assessment is not a one-off documentation exercise. It means building a new system that runs from raw material sourcing through product development. Misjudging your applicable date and deferring preparation can leave you unable to sell affected products in 2028.

    KITIM supports responsible distributors through each stage of this preparation: diagnosing the applicable date for each SKU, designing a system for securing ingredient data, reviewing supply contract clauses, and connecting you to MFDS support programs. If you want to know what your company needs to prepare and by when, we encourage you to start with our free corporate diagnosis. We will map your applicable years and priority tasks based on your product mix and company size.

    Cosmetics Safety AssessmentCosmetics Act AmendmentResponsible DistributorSafety Assessment ReportCosmetics RegulationSME Cosmetics
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