South Korea Revises the Functional Cosmetics Evaluation Regulation

On June 30, 2021, the Ministry of Food and Drug Safety (MFDS) published the latest version of the Functional Cosmetics Evaluation Regulation¹. It adds the ISO testing method as the permitted SPF testing method, specifies the requirements of raw materials' origin and development process dossiers, and clarifies the standards for claiming "water resistance". The details are as below:

1. Newly Added Method for Determining of Ultraviolet-blocking Index

MFDS permitted the ISO testing method as the method for determining the UV-blocking index. The relevant test documents can be deemed as the basis of setting the cosmetic's UV-blocking index.

Present

Basis of setting the cosmetic's UV-blocking index:

Testing methods in Attached table 3 of the regulation²
JCIA testing method
FDA testing method
Cosmetics Europe testing method
AS/NZS testing method

Basis of setting the cosmetic's UV-blocking index:

Testing methods in Attached table 3 of the regulation²
JCIA testing method
FDA testing method
Cosmetics Europe testing method
AS/NZS testing method
ISO testing method (newly added)

*SPF: ISO 24444

Waterproof sunscreen products: ISO 16217

UVA: ISO 24442

2. Requirements of Raw Material's Origin and Development Process

The dossier of raw material's origin and development process is one of the required submission documents for functional cosmetic evaluation. However, the previous description of the dossier requirement was obscure.

To optimize the provision, the authority specified that the dossier of raw material's origin and development process should include the following information：

a) Who found the material, where and when the material was found, which material was found by being extracted from/separated from/compounded by what;

b) When and where the relevant human application test was taken;

c) Information about domestic/foreign certificates, usage situation, etc.

3. Standards for Claiming Water Resistance

The regulation specified that the cosmetics can claim the "내수성(water resistance)" or "지속내수성(very water resistance)" if the confidence interval(CI) ≥ 50% in accordance of the testing methods in Attached Table 3².