South Korea Implements Amended Standards for Functional Cosmetics Evaluation Dossiers

New exemptions on requirements for functional cosmetic manufacturers to provide safety and efficacy documentation are offered. Functional ingredients can be used in product name. Exemptions on requirements to record information on manufacturing methods are also included...

Takehome:

New exemptions on requirements for functional cosmetic manufacturers to provide safety and efficacy documentation are offered.
Functional ingredients can be used in product name.
Exemptions on requirements to record information on manufacturing methods are also included.

On June 17, 2019, South Korea released and implemented the amended Standards for Evaluation Dossiers of Functional Cosmetics ^[1]. The main amendments are as follows:

1. Expand the scope of exemptions offered to functional cosmetics

1) Functional cosmetics which contain ingredients designated in Korean Functional Cosmetics Codex (KFCC) ^[2]can be exempt from submission of documents related to safety.

2) Functional cosmetics which contain the following ingredients can be exempt from requirements to submit safety and efficacy documentation provided specific ingredient usage limits are adhered to:

Products	Ingredients	Limitation
Products that can relieve acnes	Salicylic Acid	0.5%
Hair dying products	2-Amino-3-Hydroxypyridine	1.0%
	Hydroxypropyl Bis(N-Hydroxyethyl-p-Phenylenediamine) HCI	0.4%
	1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate	3.0%
	Hydroxybenzomorpholine	1.0%
	6-Hydroxyindole	0.5%
/	Hydrogen Peroxide	12.0%

And 2 categories of hair dye products are newly included in the scope of products exempt from submission of documents related to safety and efficacy, 1) 3-step oxidation hair dyes and 2) 3-step hair-decolorant products.

2. Functional ingredients are allowed to be used in product name

In the past, if enterprises submitted a human trial test report during functional cosmetics evaluation, then the enterprise could be exempt from requirements to submit a product efficacy test report. However, under these circumstances cosmetics enterprise which did not submit a product efficacy test report, were not able to use the name or a description of efficacy of the functional ingredients in the product name.

Under the amended regulatory framework, the functional ingredient name can be used in the product name even if the product efficacy test report is not submitted. It is important to note that use of a description of the functional ingredient efficacy is still not allowed to be added on the product description or label.

3. Exemptions on requirements to record manufacturing method information are also included:

Exemptions on requirements to record manufacturing method information are also offered to reagents designated in MFDS accredited Codes, such as the United States Pharmacopoeia.