The Ministry of Environment of Korea (MoE) published the Act on Registration and Evaluation, etc of Chemical Substances (known as K-REACH) on January 1, 2015. K-REACH aims to protect public health and the environment. This is achieved by four procedures: notification or registration, evaluation, authorization, and restriction of chemicals.
Under K-REACH, manufacturers or importers of a new chemical substance must register the substances before manufacturing or importing. Substances less than 100 Kg/year only require notification and do not need to go through hazard evaluation.
Manufacturers or importers of a Priority Existing Chemicals (PEC) substance must register the substances before manufacturing or importing. Pre-registration of PEC substances is impossible as the transition period has already passed.
Existing substances above 1 Tonne Per Annum (TPA) must be registered within grace periods. Only companies that carried out pre-registration can be entitled to the grace periods. The grace periods vary based on the tonnage band. After the grace periods for each tonnage band, existing substances within that tonnage band cannot be registered, and they should be noted before placing the substances in Korea.
In addition to K-REACH, GPC Korea also provides the following services:
K-BPR
The Consumer Chemical Products and Biocide Safety Management Law (known as K-BPR) concerns the placing on the market and using hazardous consumer chemicals and biocidal products, which aims to protect public health and the environment from these chemicals and products. K-BPR was taken into force on January 1, 2019, and its recent amendment was promulgated on March 24, and May 26, 2020. Its enforcement will start on January 1, 2021.
Cosmetic Act
The Cosmetic Act in South Korea aims to develop the cosmetics industry and improve public health. It has been enforced since July 1, 2000, and the recent amendment came into force on April 7, 2020.
KOSHA & MSDS
MSDS is one part of the Occupational Safety and Health Act (KOSHA). The purpose of this Act is to maintain and promote the safety and health of people providing labor by establishing stands on industrial safety and health.
The Cosmetic Act
In developing the cosmetics industry and improving public health, the Act regulate matters concerning the manufacture, sale, import, and export, etc of cosmetics. The Cosmetic Act has been enforced since July 1, 2000, and the recent amendment came into force on April 7, 2020.
Relevant documents are uploaded in the right-side bar ‘Downloadable Content’.
Scope of the Cosmetic Act
According to the Cosmetic Act, cosmetics include two main categories: functional cosmetics and general cosmetics. Some articles in the Cosmetic Act particularly applies to functional cosmetics. For instance, a person or company who is involved in the sale of a functional cosmetic should process examinations of the safety and effectiveness of each product and report it to MFDS (Ministry of Food and Drug Safety).
1) Functional cosmetics: As determined by ordinance of the Prime Minister, these cosmetics include the following:
2) General cosmetics: These include all cosmetics excluding functional cosmetics.
Main requirement of the Cosmetic Act
1. Main requirement for manufacturers and manufacturer-seller
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Manufacturer |
Manufacturer-Seller |
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Definition |
Manufacturing all or part of the cosmetics* (*This excludes manufacturing secondary packaging or labelling) |
Distributing or selling manufactured or imported cosmetics, or offering or supplying cosmetics to import agency business |
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Main requirement |
-Follow manufacturer-seller’s request and guidance ∙ supervision based on quality control standard -Prepare and keep documents including manufacturing control standards, product standards, manufacturing control records and quality control records -Manage hygiene of manufacturing plants, facilities and equipment -Inspect facilities and equipment regularly to maintain and keep it, in order not to disturb operation -Do not place any object that might cause harm and ensure there is no release or leakage of harmful substances |
-Follow quality control standards -Follow safety control standards -Keep product standards and quality control records received from manufacturers -Prepare and keep import control records attached to imported cosmetics -Distribute products after thorough quality inspection by serial number
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*** Anyone who violates these matters shall be fined up to 2 million KRW.
2. Contents to be stated on primary or secondary packages
*** Anyone who violates these matters shall be fined up to 2 million KRW.
3. Prohibition of false labelling and advertising
***Anyone who violates these matters shall either be sentenced up to one year imprisonment or fined up to 10 million KRW.
Cosmetic management system
Source: MFDS (Ministry of Food and Drug Safety)
