Cosmetics Responsible Distributor Compliance in Korea — Quality and Safety Management, Annual Reports, Manager Training

A cosmetics responsible distributor (화장품책임판매업) is registered with the Ministry of Food and Drug Safety under the Cosmetics Act. After registration, the business must follow the quality control standards and post-sale safety management standards, report last year's production or import results by the end of February each year, report the ingredient list before distribution or sale, and have its responsible manager trained every year. Breaching these duties can lead to a business suspension or an administrative fine.

Initial requirements are covered in our responsible distributor registration guide, and changes of name, address or manager in our change registration guide. This page covers the ongoing duties.

Quality control and post-sale safety standards

The distributor must follow both standards, and the responsible manager carries out the work. Businesses that make, outsource or import cosmetics follow every item below. E-commerce import agency sellers follow only the two standards, part of the import record and safety reporting.

Duty	What it means
Quality procedure manual	Written procedures for manufacturing and quality control, defects, recalls, training, documents and shipment records
Batch quality testing	Test each batch before release, unless the maker and distributor are the same or a designated testing body has batch results
Outsourced manufacturing	Supervise the contract maker and keep its product standards and quality records
Record keeping	Keep quality and maker supervision records for 3 years from manufacture (import date for imports)
Import record	Product name, country and maker, import quantity and test results by batch, and buyers
Safety information	Collect and review safety information, take steps such as recall or sales suspension, and report new data such as side effects

Products containing 0.5% or more of retinol, ascorbic acid, tocopherol, peroxides or enzymes need stability test data kept for 1 year after the expiry date. Under the disposition standards, failing to prepare the quality procedure manual means a 3-month suspension of sales at the 1st violation, and failing to review safety information means a 1-month suspension of sales of the business or the product.

Production or import reports and ingredient lists

There are two reports. Last year's production or import results are due by the end of February each year, and the list of ingredients used in manufacture is due before the product is distributed or sold.

1. Total last year's production or import volume for each product.
2. Report it by the end of February through a cosmetics industry association, such as the Korea Cosmetic Association.
3. Report the ingredient list before launching a new product.
4. Report again if a formula change alters the reported list.

Distributors that import with a standard customs pre-declaration filed as an electronic trade document may skip the import report and the ingredient list. Failing to report is subject to an administrative fine.

Responsible manager training

The responsible manager must take training on cosmetics safety and quality control every year. The first session is due within 6 months of starting the job, then a refresher once every year, and each session runs 4 to 8 hours. Missing training is subject to an administrative fine, and a distributor that breaches its duties can be ordered to attend training.

If the business has 10 or fewer regular employees and the owner (or the representative of a corporation) is qualified, the owner may act as the manager. When a manager leaves, a notice of non-engagement can be filed with the regional food and drug office, and the new manager requires a change registration.

YouSun Administrative Agency (Chief Administrative Agent Jung Yu-sun)