South Korea Implements the Regulation for Preparation and Storage of Infants and Children Cosmetic Safety Data

The required safety data of infants and children's cosmetics are detailed, including the product and manufacturing information, safety assessment documents, proofs of product efficacy and effects. The methods for preparing and storing safety data are specified.

In South Korea, cosmetics users are getting younger. According to the data provided by SK Planet ^[1], the sales of children cosmetics on the local E-commerce platform 11st rose 29 percent. The sales of lipstick for children skyrocketed 549 percent YOY in 2017. To enhance the management of the safety of cosmetics for younger consumers, MFDS optimized the Cosmetics Act on January 16, 2020. ^[2] It specified that the responsible sales managers should establish and retain product safety data for cosmetics claimed or advertised as infant or children cosmetics. To detail the matters relevant to the safety data preparation, MFDS implemented the Regulation on the Preparation and Storage of Infants and Children Cosmetic Safety Data on July 24, 2020. ^[3]

The main contents are specified as the following.

I. Methods for Preparation of Safety Data

The responsible sales managers shall establish the safety data consisting of the below documents:

1. Product and Manufacturing Method Information

The information about the product and manufacturing method includes the following:

a. Product Information

Product name;

Product efficacy and effects (for functional cosmetics);

Precautions for use;

Name and concentrations of ingredients;

Storage conditions;

Expiry date or period-after-opening (PAO).

b. Manufacturing Method Information

Each step of the cosmetics manufacturing process for infants and children shall be involved in the manufacturing method information.

If the above information is indicated in the product standard or the imported product records, the copies of the standard or record can be used as the alternatives of the Product and Manufacturing Method Information.

2. Safety Assessment Documents

The safety assessment documents consist of:

Assessments data on the safety of the ingredients and final products;
Data on the collection, review, assessment and measures to deal with the abnormal cases after use;
Results of the assessments on the ingredients, final products, abnormal cases, etc.

3. Proofs of Product Efficacy and Effects

Concerned with the functional cosmetics, the result of the examination conducted by MFDS and the reports of the safety and effects of the product as stipulated under the Enforcement Rule of the Cosmetics Act ^[4] can serve as proofs of efficacy.

It is required to submit the empirical data for the claims and advertisements for infants and children cosmetics. The empirical data can be provided following the Regulations on the Demonstration of Labeling and Advertisement for Cosmetic Products. ^[5]

II. Methods for Storing Safety Data

The responsible sales managers shall keep the product safety data either in paper or electronic form. The backup files shall be stored as well in case of a data loss.

The responsible sales managers can remove the files when the required preservation period ends.

As per Article 10-3 of Enforcement Rule of the Cosmetics Act, the safety data shall be preserved until 1) one year after the expiry date of the finally manufactured/imported product or 2) three years after the Period-after-opening of the finally manufactured/imported product.

Transitional Measures

The safety data of infants and children cosmetics prepared and stored prior to the implementation of this regulation can be considered to have been prepared and stored in accordance with this regulation.