South Korea Implements the Cosmetic Safety Standards: Specifying New Prohibited and Restricted Ingredients

On April 1, 2022, the Ministry of Food and Drug Safety (MFDS) unveiled the updated Regulation on Safety Standards, etc. for Cosmetics¹. The Regulation designates new prohibited ingredients, specifies new restricted ingredients and their usage limits, and the exemption conditions of using prohibited ingredients. The details are as below:

1. Newly Added Prohibited Ingredients

(1) Perfluorinated Compounds

The following perfluorinated compounds are added to the prohibited ingredient inventory as they are hard to break down.

English name	Korean name
Nonadecafluorodecanoic acid	노나데카플루오로데카노익애씨드
Nickel(II) trifluoroacetate	니켈(Ⅱ)트리플루오로아세테이트
Sodium nonadecafluorodecanoate	소듐노나데카플루오로데카노에이트
Sodium heptadecafluorononanoate	소듐헵타데카플루오로노나노에이트
Ammonium nonadecafluorodecanoate	암모늄노나데카플루오로데카노에이트
Ammonium perfluorononanoate	암모늄퍼플루오로노나노에이트
Perfluorononanoic acid	퍼플루오로노나노익애씨드

(2) Persistent Pollutants

The “persistent pollutants” stipulated in the Article 2 (1) of the Persistent Organic Pollutants Control Act² are prohibited from being added to cosmetic products, as these substances can pose hazards to people and ecosystems.

2. Restricted Ingredients

(1) The preservative of “Benzalkonium Chloride (BKC)” cannot be used in spray-type cosmetics:

Ingredients

Use Limits

Remarks

Benzalkonium chloride, bromide, and saccharinate

(벤잘코늄클로라이드, 브로마이드 및 사카리네이트)

In rinse-off products: 0.1% as Benzalkonium chloride

In other products: 0.05% as Benzalkonium chloride

Benzalkonium Chloride is prohibited in spray-type cosmetics. (Newly added,)

(2) Restricted colorants in hair dye products and their use limits are newly added:

Raw materials	Use Limit	Remarks
Basic Orange 31 (염기성등색31호)	In oxidative hair dye: 0.5%	Other usage standards shall refer to Types, Standards, and Test Methods of Cosmetic Color Additives³
Basic Red 51 (염기성적색51호)	In oxidative hair dye: 0.5%	Other usage standards shall refer to Types, Standards, and Test Methods of Cosmetic Color Additives³
Basic Yellow 87 (염기성황색87호)	In oxidative hair dye: 1.0 %	Other usage standards shall refer to Types, Standards, and Test Methods of Cosmetic Color Additives³
Sodium persulfate （과황산나트륨） Ammonium Persulfate （과황산암모늄） Potassium persulfate (과황산칼륨)	-	Used as an oxidizing agent in hair dye (including dye removal and hair bleach)
Leaf powder of Indigofera tinctoria (인디고페라 엽가루)	In non-oxidative hair dye: 25%	Prohibited in other products
Hematein (헤마테인)	In non-oxidative hair dye: 0.1%	Prohibited in oxidative hair dye
Silver sulfate (황산은)	In non-oxidative hair dye: 0.4%	Prohibited in oxidative hair dye
Ferrous sulfate heptahydrate (황산철수화물, FeSO4·7H2O)	In non-oxidative hair dye: 6%	Prohibited in oxidative hair dye

(3) Other amendments

The "P-Methylaminophenol ( p-메칠아미노페놀 및 그 염류)" is clarified as "P-Methylaminophenol Sulfate (황산 p-메칠아미노페놀)". Its use limit is modified as "in oxidative hair dye: 0.68%".

Other terminologies are updated in accordance with the superordinate laws.

3. Exemption Conditions of using Prohibited Ingredients in Cosmetics

The Regulation also specifies the exemption situations of adding the following prohibited ingredients in cosmetic products:

(1) Radioactive substances cannot be used in cosmetics. However, when using natural minerals or other radioactive materials common in life, the product can also be detected as radioactive. In this situation, if the radioactive concentration and other items of the cosmetic products comply with the Article 15 “Safety Standards of Processed Products” of the Act on Protective Action Guidelines Against Radiation in the Natural Environment⁴, the cosmetic products are deemed as qualified.

(2) Marijuana cannot be used in cosmetics. However, according to Narcotics Control Act⁵, “δ-9-Tetra hydrocannabinol (THC)” and “Cannabidiol (CBD)" are excluded from the marijuana category, which can be used in food products as per the Food Code⁶. Therefore, these substances can be used in cosmetics as well.

(3) Fluorescent whitening agents cannot be used in cosmetics. However, following the latest risk examination result, Fluorescent Brightener 367 is allowed to be used in nail products. The “Fluorescent Brightener 367” in the base coat (베이스코트), undercoat (언더코트), nail polish (네일폴리시), nail enamel (네일에나멜), topcoat(탑코트) shall be less than 0.12%.

Implement Date

This regulation came into effect on April 1, 2022, along with its issuance. Nevertheless, the provisions of “Benzalkonium Chloride (BKC)” and the Leaf powder of Indigofera tinctoria are to be effective six months later. Furthermore, a two-year grace period is given to the products using these two ingredients.

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