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MFDS implemented this draft on April 1, 2022. Check the detailed amendments in the latest version of Regulation on Safety Standards, etc. for Cosmetics at ChemLinked News.
On December 27, 2021, the Ministry of Food and Drug Safety (MFDS) issued a notification to solicit public opinions on the draft of Regulation on Safety Standards, etc. for Cosmetics1. The draft proposed new prohibited ingredients and the management of unintentionally added ingredients. The consultation period is set to end on January 17, 2022.
1. New Prohibited Ingredients
(1) Perfluorinated Compounds
The following eight 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 |
(+/-)-2-(2,4-Dichlorophenyl)-3-(1H-1,2,3-triazol-1-yl)propyl-1,1,2,2-tetrafluoroethylether (Tetraconazole-ISO) | (+/-)-2-(2,4-디클로로페닐)-3-(1H-1,2,3-트리아졸-1-일)프로필-1,1,2,2-테트라플루오로에틸에터(테트라코나졸-ISO) |
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 Persistent Organic Pollutants Control Act2 are prohibited from being added into cosmetic products, as these substances can pose hazards to people and ecosystems.
(3) 1,2,4-Trihydroxybenzene
1,2,4-Trihydroxybenzene is forbidden from being used in cosmetics following the result of the latest risk evaluation.
2. Restricted Ingredients
(1) The draft specifies that "Benzalkonium Chloride" cannot be used in the spray-type cosmetics.
(2) New restricted colorants in hair dye products and their use limits are proposed:
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 |
| - | Used as oxidizing agent in hair dye (including dye remove and hair bleach) |
Leaf powder of Indigofera tinctoria （인디고페라 엽가루） | In non-oxidative hair dye: 25% | Prohibited in other products |
Ferrous sulfate heptahydrate (황산철수화물, FeSO4·7H2O) | In non-oxidative hair dye: 6% | Prohibited in oxidative hair dye |
Silver sulfate (황산은) | In non-oxidative hair dye: 0.4% | Prohibited in oxidative hair dye |
Hematein (헤마테인) | In non-oxidative hair dye: 0.1% | Prohibited in oxidative hair dye |
3. Management of the unintentionally added ingredients
The draft clarified two exceptions of unintentionally adding prohibited ingredients into cosmetics.
(1) Radioactive substances cannot be used in cosmetics. However, suppose the cosmetic is detected as radioactive when using natural minerals as the raw material. In this case, the safety standard shall comply with the Act on Protective Action Guidelines Against Radiation in the Natural Environment4.
(2) Marijuana cannot be used in cosmetics. However, according to Narcotics Control Act5, “δ-9-Tetra hydrocannabinol (THC)” and “Cannabidiol (CBD)" are excluded from marijuana category, which can be used in food products as per the Food Code6. The draft specifies that these substances can be used in cosmetics as well.
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