South Korea Consults on Regulation for Preparation and Storage of Infants and Children Cosmetic Safety Data

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, the draft of Regulation on the Preparation and Storage of Infants and Children Cosmetic Safety Data was published and opened to public opinions on June 3, 2020.^[3] The consultation period is set to end by June 24, 2020.

The main contents of the draft 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 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 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 Information.

2. Safety Assessment Materials

The safety assessment materials consist of:

Assessments data on the safety of the ingredients and final products;
Information about the abnormal situations after use;
Results of the evaluations on the ingredients, final products, abnormal cases, etc.

3. Proof of Product Efficacy and Effects

For functional cosmetics, the result of the examination conducted by MFDS or the reports of the safety and effects of the product can serve as proof 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. ^[4]

II. Methods for Storing Safety Data

The responsible sales managers shall keep the product safety dataeither 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, ^[5] 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.