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  • Pre-announcement of (draft for) administration for public notification of partial revision of provisions on the Cosmetics safety standard, etc.
    • Competent Ministry : Ministry of Food and Drug Safety
    • Advance Publication of Legislation : 2021-12-27
    • Opinion Submission Deadline : 2022-01-17

1. Reason for revision

    The aim is to protect national health by strengthening the safety control of cosmetics with the new designation of raw materials that cannot be used for cosmetics or through the establishment of restrictions in uses in consideration of other laws and foreign regulatory trends and to strengthen the competitiveness of the cosmetics industry by adding hair dye ingredients considering the examinations of and foreign regulations on functional cosmetics and by establishing exceptions in cases wherein the safety range is secured for the hazard assessment of raw materials that cannot be used for cosmetics or unintended inclusion is possible.

2. Main contents

A. Addition of raw materials that cannot be used for cosmetics and strengthening of the standard on the restriction of uses (Table 1 and Table 2 of the draft)

 - Residual contaminants, some perfluorinated compounds, and 1,2,4-trihydroxybenzene are added to unusable raw materials.

 -  Benzalkonium Chloride (BKC) of preservative cannot be used for spray-type products. 

B. Establishment of exceptional conditions of raw materials that cannot be used for cosmetics (Table 1 of draft) 

 - Establishment of control standards of hemp that may be unintentionally included in the parts excluded from hemp

 - Establishment of allowable limit of radioactive materials that may naturally exist in living surroundings

 - Establishment of allowable limit of Fluorescent Brightener 367 among fluorescent brighteners that cannot be used for cosmetics, based on the hazard assessment result

C. Addition of raw materials that can be used for hair dyes and establishment of upper limit of concentration (Table 2 of draft)

 - Ten kinds of raw materials are added as the ones to be used for hair dyes, and upper limits of concentrations are established based on past examinations of functional cosmetics.

D. Clarification of the names of raw materials and improvement of terms to meet revised upper statutes (Table 2 and Table 3 of draft)

 - As the upper limit of use of p-methylaminophenol is 0.68% of sulfate based on sulfate only, the term is improved for the same expression with other raw materials.

 - The term “cosmetics manufacturer/distributor” was changed to “cosmetics chief distributor” with the amendment of the Cosmetics Act (Law No. 15488, promulgation on March 13, 2018, enforcement on March 14, 2019), and such change is reflected.

Regulatory effect assessment
  • 화장품 안전기준 등에 관한 규정(규제영향분석서)_20211224.hwp [download]
Legislative proposal (draft)
  • 2. 화장품 안전기준 등에 관한 규정 일부개정고시안(국조실 제출).hwp [download]