Cosmetics

Proposed amendments to the "Regulation on Safety Standards etc. of Cosmetics" (55 page(s), in Korean)

The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea is amending the "Regulation on Safety Standards etc. of Cosmetics". The proposed amendments seek to:

1)         Prohibit the use of "Tagetes erecta flower extract or oil" in cosmetics

2)         Restrict the use of ingredients in cosmetics as stated below:

A.           Tagetes minuta flower extract or oil

Standards for the use of this ingredient are as follows:

(a)          The content should be no greater than 0.01% in leave-on products. (b)          The content should be no greater than 0.1% in rinse-off products. (c)          The content of Alpha-terthienyl in the ingredient should be no greater than            0.35%. (d)          The ingredient should not be used in sunscreen products and products     marketed for exposure to natural/artificial UV light

B.           Tagetes patula flower extract or oil

Standards for the use of this ingredient are as follows:

(a)          The content should be no greater than 0.01% in leave-on products. (b)          The content should be no greater than 0.1% in rinse-off products. (c)          The content of Alpha-terthienyl in the ingredient should be no greater than            0.35%. (d)          The ingredient should not be used in sunscreen products and products     marketed for exposure to natural/artificial UV light

C. Peanut oil, extracts and derivatives

The maximum concentration of peanut proteins in the ingredients should not exceed 0.5ppm.

D. Hydrolysed wheat protein

The maximum average molecular weight of peptides in this ingredient should be not more than 3.5kDa.

3)         Lower the concentration limit of preservatives as stated below:

A.           Methylisothiazolinone: 0.01% → 0.0015% in rinse-off products

B.           Dimethyloxazolidine: 0.1% → 0.05%

C.           p-Chloro-m-cresol: 0.2% → 0.04%

D.           Chlorophene: 0.2% → 0.05%

E.           Propionic acid and its salts: 2% → 0.9%

4)      Add new ingredients allowed for use as hair dye to "Annex 2. The list of hair dye ingredients" as below while establishing their concentration limits when the ingredients are to be used in oxidative hair dye products

A.           2-Amino-3-hydroxypyridine (1.0%)

B.           4-Amino-m-cresol (1.5%)

C.           Hydroxypropyl Bis(N-Hydroxyethyl-phenylenediamine) HCl (0.4%)

D.           5-Amino-6-chloro-o-cresol (0.5%)

E.           6-Hydroxyindole (0.5%)

F.           1-Hydroxyethyl-4,5-Diaminopyrazole Sulfate (3.0%)

G.           Hydroxybenzomorpholine (1.0%)

5)      Expand the ban on two preservatives (Salicylic acid and its salts, Iodopropynyl butylcarbamate(IPBC))

The two preservatives which are already prohibited from use in cosmetics for infants 3 years of age or younger would be additionally banned in cosmetics that intend to label and promote as cosmetics for children.

6)      Establish the test standards and methods (net contents, alkali remains) for solid soaps for face wash*

*        Solid soaps for face wash will be classified as cosmetics as of December 31,2019.

7)         Set the scope of the ingredients allowed for use in customized cosmetics

All ingredients except the following can be used in customized cosmetics.

A.           Prohibited cosmetic ingredients

B.           Restricted cosmetic ingredients

C.       Ingredients that demonstrate the efficacy of the functional cosmetics notified by the Minister of Food and Drug Safety (except in the case where the relevant authority went through an examination or submitted a report on the functional cosmetics) 

8)         Clarify or modify the terms in the regulation