Korea's MFDS Proposes In Vitro Test Methods for Sunscreen SPF and PA Evaluation

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Korea's Ministry of Food and Drug Safety (MFDS) has proposed amendments that would introduce internationally standardized in vitro test methods — ISO 23675 and ISO 24443 — for evaluating sunscreen SPF and PA. The proposed changes are expected to significantly cut testing time and cost while bringing Korea's requirements in line with international standards.

The amendments were issued as advance notices on August 19, 2026, with public comments accepted through September 18, 2026.

 

Key Takeaways

  • The amendments target two regulations — the Regulation on the Review of Functional Cosmetics and the Regulation on Substantiation of Claims in Cosmetic Labeling and Advertising — introducing ISO-standard in vitro test methods for SPF and PA and clarifying the related review and evaluation criteria.
  • Currently, only in vivo (human) testing is permitted for evaluating sunscreen protection. Under the proposal, both in vivo and in vitro testing would be allowed.
  • Using automated equipment, in vitro testing could cut the testing period from about one month to two days, and the cost from roughly KRW 6 million to KRW 3.5 million.
  • The goal is to ease the testing burden on companies, strengthen the global competitiveness of K-beauty exports, and harmonize Korean regulation with international standards.

 

Notes

• In vitro: A method of testing UV protection using a PMMA (polymethyl methacrylate) plate instead of human skin.

• SPF: An index indicating protection against UVB (290-320 nm)

• PA: A grade indicating protection against UVA (320-400 nm)



Key Amendments

1. Introduction of Internationally Standardized In Vitro Test Methods

  • ISO-standardized in vitro sunscreen test methods — ISO 23675 and ISO 24443 — will be adopted as official domestic test methods.
  • The use of automated testing equipment is expected to significantly reduce the time and cost required for product development and evaluation.

Category

Before Amendment

After Amendment

Accepted Test Methods

In vivo testing only

Both in vivo and in vitro testing accepted

Testing Period

In vivo: approx. 1 month

In vitro: approx. 2 days

Testing Cost

In vivo: approx. KRW 6 million

In vitro: approx. KRW 3.5 million

 

2. Clarification of Substantiation Requirements for SPF and PA Labeling and Advertising

  • Clear criteria will be established so that SPF and PA may be labeled or advertised only when substantiated by in vivo or in vitro testing.

 

Frequently Asked Questions (FAQ)

Q. Can in vivo testing still be used after the amendment takes effect?

Yes. Companies may choose either an in vivo or an in vitro test method.

Q. What is required to label or advertise SPF and PA?

Substantiating data demonstrating the relevant function through either in vivo or in vitro testing must be submitted.

Q. What do ISO 23675 and ISO 24443 evaluate?

ISO 23675: Cosmetics — Sun protection test methods — In vitro determination of sun protection factor (SPF)

ISO 24443: Cosmetics — Determination of sunscreen UVA photoprotection in vitro


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