Registration and Evaluation of Chemicals Act

Recently a series of chemical accidents, in particular the deaths and injuries caused by certain humidifier disinfectants, has raised a growing concern about the hazards that chemicals pose to human health and the environment. Amid the increasing fear of chemical risks, the Ministry of Environment (the “MOE”) has enacted the Registration and Evaluation of Chemicals Act (the “Act”) to protect the public’s health and the environment against risks from chemicals. The Act implements a preventive risk management system by requiring the registration and evaluation of chemicals prior to their production or import. The risk management system under the Act rests on the principle of “no data, no market”: if a chemical is not registered and thus no data is available, it cannot be sold in the Korean market.

Registration, Evaluation and Classification of Chemicals

Unlike the previous chemical risk management system which only required the registration and evaluation of chemicals that newly entered into the Korean market, the new system under the Act requires that not only a new entrant but also an existing chemical be registered and evaluated (if the existing chemical is produced or imported in the amount of over a ton annually), beginning on January 1, 2015.

When applying for registration, companies must submit to the MOE information on the properties, toxicity or hazard, and uses of the chemicals that they intend to produce or import. Upon the companies’ submission of the required information, the MOE evaluates the toxicity and hazard of the chemicals, taking into account the uses of the chemicals and the effects of the exposure to the chemicals. Depending on each chemical’s toxicity or hazard level, the MOE classifies the chemicals into four different categories: “toxic chemicals”, “prohibited chemicals”, “restricted chemicals” and “permitted chemicals”.

Control of Products Containing Toxic or Hazardous Chemicals

The Act also provides for measures to control the potential health and environmental risks from products containing toxic or hazardous chemicals (“Products”). Under the Act, companies must submit to the MOE information on the names, contents, toxicity or hazard, and uses of chemicals contained in the Products that they intend to produce or import prior to their production or import. A risk assessment of a Product is also required when there is a potential risk to the public’s health and the environment. If a Product is assessed as not satisfying the safety and labeling standards established and announced by the MOE, the sale of such a Product will be prohibited. If a Product poses a hazard to the public’s health, the MOE may discard the Product or withdraw it from the market or take such emergency measures as the MOE deems appropriate.

Integration of Control of Chemicals and Chemical Products

The new system under the Act integrates the risk management of chemicals and the risk management of Products, and thus can more effectively control Products, including household items such as air freshener or deodorant. It should also be noted that under the Act, when companies transfer registered chemicals or chemical compounds, they must share the information on their toxicity or hazard, or safe uses with the transferee.

The MOE will set up an IT system to electronically process the report, registration and evaluation of chemicals and Products.