Date: Jan 31, 2011
1. Radioactive substances under the Atomic Energy Act;
2. Pharmaceuticals and non-pharmaceutical drugs under the Pharmaceutical Affairs Act;
3. Narcotics under the Act on the Control of Narcotics;
4. Cosmetics under the Cosmetics Act (including raw materials requiring safety review in
accordance with Article 4, Section 3 of the Cosmetics Act and cosmetic ingredients designated and announced by the Korea Food and Drug Administration);
5. Ingredients and agrochemicals under the Agrochemicals Control Act;
6. Fertilizers under the Fertilizer Control Act;
7. Foods and food additives under the Food Sanitation Act;
8. Livestock feeds under the Act on Control of Livestock and Fish Feeds.
II. Registration – Preliminary Requirements to Set Priorities
Notification of the Manufacture or Import of Chemical Substances (Article 9)
A manufacturer or importer of an existing chemical must submit by the end of February of each year certain information, as specified by the MOE, including the quantities produced or imported in the previous year.
Designation of Priority Chemical Substances (Article 10)
After reviewing the above data submitted on existing chemicals as well as hazard data, the MOE will designate certain existing chemicals as "priority chemicals." Priority chemicals are existing chemicals that pose potential risk to human health or the environment and require further risk assessment, and are announced by the MOE.
III. Registration Requirements
"1. Chemicals contained in machines
2. Chemicals imported together with machines or devices for trial operation
3. Chemicals contained in finished products of a solid form that have specific function, and are not released in their normal use
4. Among chemicals that are exempt from registration as stipulated in a Presidential Decree, those chemicals which are confirmed by the Minister of the Environment (hereinafter, "Registration Exemption Confirmation")" (Article 15).
Data required for registration (Article 16)
Other requirements relating to registration
Registrants are required to update their registrations with information on new uses, new data on chemical hazards to humans and the environment, etc (Article 19). Producers are required to submit joint registration dossiers unless specifically permitted to submit an individual dossier (Article 20). Producers are required to submit "Data Use Approval" documentation within registration dossiers where relevant (Article 21). Existing studies involving vertebrate animals must not be repeated by producers (Article 22).
This Article is part of a series on REACH-like developments around the world. The Brussels office of Keller and Heckman LLP has been assisting clients on REACH since its entry into force in 2007, and is now expanding its focus to include related developments in other countries such as Korea, Turkey, and Switzerland. For further information, contact Herb Estreicher (Tel: 01-202-434-4334; +32 (0)2 645 50 96; e-mail at firstname.lastname@example.org) or Marcus Navin-Jones (Tel: +32 (0)2 645 50 97); e-mail at email@example.com)