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

On May 11, 2020, South Korean MFDS unveiled a draft of “Regulation on the Examination of Designation and Changes of Cosmetics Ingredients Using Standards." This draft specifies the scope of restricted ingredients, required application dossiers, application procedure, results notification, etc.

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 provisions 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]

Previously there wasn't any guideline or regulation specifying this provision for the industry until MFDS published the draft of Regulation on the Examination of Designation and Changes of Cosmetics Ingredients Usage Standards in May 11, 2020. ^[2]

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, hair dyes, etc., not listed in Annex 2 of Regulation on Safety Standards, etc. for Cosmetics ^[3]
b.	Colorants not listed in Annex 1 of Types, Standards and Test Methods of Cosmetic Color Additives^[4]
c.	Materials listed in Annex 2 of Regulation on Safety Standards, etc. for Cosmetics or Annex 1 of Types, Standards, and Test Methods of Cosmetic Color Additives whose using standards are to be amended.

2. Required Application Dossiers

This draft 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 (safety can be exempted if warranties are submitted);
Standards and results of relevant experiment methods.

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 ^[5]. The public consultation period will last until June 1, 2020. Any suggestions can be sent to [email protected].