South Korea Implements the Regulation on the Examination of Designation and Changes of Cosmetics Ingredient Standards

Background

In South Korea, restricted ingredients, such as preservatives, colorants, and sunblocks, shall be used under limitation requirements.

If a cosmetic manufacturer, responsible cosmetic distributor intends to use a restricted ingredient that has no standards specified in the requirements mentioned above or wishes to amend the usage standards thereof, he/she could apply to the MFDS (Minister of Food and Drug Safety), as per Article 8 (6) of Cosmetics Act. ^[1]

As there wasn’t any guideline or requirements specifying this provision for the industry, on May 11, 2020, MFDS published the draft of the Regulation on the Examination of Designation and Changes of Cosmetics Ingredients Usage Standards ^[2], and soon after announced its implementation on June 15, 2020. ^[3]

The main contents include:

1. The Scope of Restricted Ingredients

The scope of restricted ingredients whose usage standards may be newly designated or changed are:

a.	Preservatives, sunblocks, etc., not listed in Annex 2 of Regulation on Safety Standards, etc. for Cosmetics ^[4]
b.	Colorants not listed in Annex 1 of Types, Standards and Test Methods of Cosmetic Color Additives ^[5]
c.	Ingredients listed in Annex 2 of Regulation on Safety Standards, etc. for Cosmetics ^[4] or Annex 1 of Types, Standards and Test Methods of Cosmetic Color Additives ^[^5]are to be amended.

2. Required Application Dossiers

This regulation formulates the scope of dossiers as listed below; it also details the requirements individually:

Summary of dossiers submitted;
Information of the relevant raw material, including the origin of the material, R&D process, using standards and using status at home and aboard;
Characteristics of the raw material;

Data of safety and efficacy

a. Safe assessment

(*can be exempted when warranties are submitted)

(1) Single dose toxicity test data

(2) Skin irritation test data

(3) Skin sensitization test data

(4) Mucous membrane irritation test data

(5) Phototoxicity test data

(6) Photosensitization test data

(7) Repeated dose toxicity test data

(8) Data on reproductive toxicity test, mutagenicity test and carcinogenicity test

(9) Inhalation Toxicity Test data

(10) Human skin irritation test data

(11) Percutaneous absorption test data

b. Efficacy assessment

(1) Purpose of use, the scope of application

(2) Usage amount

c. Data on setting the usage standard

Test report on standards and test methods of raw materials

3. Application Procedure

The applicant shall submit the dossiers to MFDS. If the files submitted are not sufficient, MFDS will ask the applicant to supplement the application dossier within 60 days. The application may be deemed unsuccessful if the applicant fails to re-submit the application dossier in the specified time as required, or if the dossier or documents submitted are non-compliant. The applicant can apply for reconsideration within 30 days of receiving the formal notification of application rejection.

If approved, the newly designated restricted ingredients or restricted ingredients with the new usage standards will be notified on the homepage of the MFDS website^[6].