South Korea Modifies the Cosmetic Safety Standard: Ingredients and CAS No.

As the Ministry of Food and Drug Safety (MDFS) revealed on November 30, 2023, modifications related to seven prohibited ingredients and three restricted ingredients are included in the Regulation on Safety Standards, etc. for Cosmetics¹. Besides, the prohibited ingredients and restricted ingredients are added with the relevant CAS No. and chemical name. The regulation is effective on November 30, 2023, except for the changes related to the hair dye ingredients, which will be implemented six months later.

background information

South Korea adopts the negative list to regulate ingredients used in cosmetics. No enterprises shall use an ingredient that is listed under the Attached Table 1 of the Regulation (Prohibited Ingredient List) to manufacture cosmetics. For restricted ingredients, the business entity shall use them following the specified requirements listed in the Attached Table 2 (Restricted Ingredient List).

Amendments are specified as below:

1. Seven Prohibited Ingredients are Newly Designated (effective on May 30, 2024)

Following the risk assessment results, the authority designated seven restricted ingredients as new prohibited ingredients, including：

2-Nitro-p-Phenylenediamine (2-니트로-p-페닐렌디아민) and its salts
2-Amino-4-nitrophenol (2-아미노-4-니트로페놀)
2-Amino-5-nitrophenol (2-아미노-5-니트로페놀)
2-Amino-5-nitrophenol Sulfate(황산 2-아미노-5-니트로페놀)
o-Aminophenol Sulfate(황산 o-아미노페놀)
o-chloro-p-Phenylenediamine Sulfate (황산 o-클로로-p-페닐렌디아민)
m-Phenylenediamine Sulfate (황산 m-페닐렌디아민)

2. Specified Requirements for Three Restricted Ingredients are Modified

(1) Hair Dye ingredients (effective on May 30, 2024)

The concentration upper limits for two restricted hair dye ingredients are lowered:

Ingredients

Previous Limits

Present Limits

염산 2,4-디아미노페놀

2,4-Diaminophenol Sulfate

In oxidative hair dye: 0.5 %

In oxidative hair dye: 0.02 %

과붕산나트륨

과붕산나트륨일수화물

Sodium Perborate

Monohydrate of Sodium Perborate

Hydrogen peroxide in hair dye(including desalting agents and decoloring agents): 12.0 %

Hydrogen peroxide in hair dye(including desalting agents and decoloring agents): 7.0 %

(2) UV-filter Ingredient

A new UV-filter ingredient is newly included in the Restricted Ingredient List for Cosmetics:

Korean name	English name	Usage limits	Remarks
메톡시프로필아미노사이클로헥시닐리덴에톡시에틸사이아노아세테이트	Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate	Maximum concentration: 3%	This ingredient should not be used in applications that may lead to exposure of the user's lungs by inhalation; This ingredient cannot be used in cosmetics containing nitrosating agents.

3. Addition of CAS No. and Chemical Names

MFDS inserted the CAS No. and general chemical names for the prohibited and restricted ingredients. However, the authority also added a note indicating that these CAS numbers are to help enterprises easily find the ingredient information; Other chemical substances with different CAS Numbers may also apply. Therefore, enterprises are suggested to double- check the Korean names of the ingredients for exact information.