Business Guidance: South Korean Solid Soap, Black Hair Powder and Hair Removal Wax Newly Transformed from Chemicals to Cosmetics

This article guides overseas enterprises to comply with the cosmetic requirements for the solid soap, black hair powder and hair removal wax. The ingredient limits, label standards, and export procedures are presented.

As the grace period ends on December 31, 2020, the solid soap, black hair powder and hair removal wax will be officially managed as cosmetics. The relevant enterprises should comply with the Cosmetics Act ^[1] and other related supporting rules. This article will help companies comprehensively understand the relevant requirements.

1. Background Introduction

The solid soap, black hair powder and hair removal wax had been managed as chemical industry products. However, considering these products were exposed to human bodies, on December 31, 2018, MFDS (Ministry of Food and Drug Safety) amended theEnforcement Rule of the Cosmetics Act^[2] and designated the solid soap, black hair powder and hair removal wax as cosmetics. A grace period till December 31, 2020 was given to enterprises for preparations.

In addition, some follow-up provisions were changed to align with the category transformation. On July 30, 2019, South Korea revised the Cosmetics Act to exempt the business of repackaging solid soaps in small quantities from customized cosmetics sales registration ^[3].

Explanation:

Cosmetics repackaged by dividing the contents of a manufactured or imported cosmetic into smaller amounts are subject to "custom cosmetics" in South Korea. Relevant enterprises need to finish the "customized cosmetic sales registration" before conducting the relevant businesses.

However, it was regarded as inappropriate to consider “simply cutting and repacking a soap into smaller amounts” as a custom cosmetic business, though solid soap is cosmetic. Therefore MFDS excluded the business of repackaging solid soaps in small quantities from customized cosmetics sales registration.

On March 1, and July 20, 2020, South Korea respectively permitted "Pigment Red 5" and "Pigment Violet 23 and Pigment Green 7" as colorants for solid soaps by amending the Types, Standards and Test Methods of Cosmetic Color Additives ^[4]. (Find all permitted colorants for cosmetics at ChemLinked Cosme-list: Permitted Colorants Used in Cosmetics ^[5])

2. Cosmetic Standards

The solid soap, black hair powder and hair removal wax shall follow the cosmetic ingredient and label standards after 2021.

2.1 Ingredient Standard

As stated in Regulation on Safety Standards, etc. for Cosmetics ^[6], prohibited ingredients noticed by MFDS cannot be added in cosmetics. Furthermore, the manufacturer shall use restricted ingredients under specific conditions. (Find the detailed prohibited ingredients, restricted ingredients and the use conditions at ChemLinked Cosme-List^[7])

2.2 Label Requirement

The items below shall be labelled on the solid soap, black hair powder and hair removal wax following Article 10 of Cosmetics Act^[1]:

a) Product name;

b) Trade name and address of the business operator;

c) All ingredients;

d) Volume or weight of contents;

e) Manufacturing number;

f) Use-by date;

g) Price;

h) For a functional cosmetic, the word "functional cosmetic" or a functional cosmetic logo;

i) Cautions for use;

j) Manufacturing country, manufacturing company’s name and location.

3. Export Procedure

To export the solid soap, black hair powder or hair removal wax to South Korea, the business entity needs to follow South Korean's cosmetics import requirements.

Initially, the exporter should establish a "responsible cosmetic distributor" as an importer to take charge of the cosmetic's quality and safety in S. Korea. The importer needs to apply for the registration of "responsible cosmetic distribution business" to MFDS, reporting the product’s ingredients and manufacture methods.

Each time prior to exporting, the importer should submit an "entry notice of imported products" to Korea Pharmaceutical Traders Association (KPTA) and get an approval. KPTA has announced to accept the application and issue the approvals for the imported solid soap, black hair powder, and hair removal wax after December 1, 2019.

The dossiers for applying the approval include: