The Act on the Registration and Evaluation of Chemicals (also known as Korea REACH) was passed in the plenary session of the National Assembly in Korea on April 30, 2013 and has come into force on 1st January 2015. The purpose of this Act is to protect public health and the environment through the following provisions:
- Registration of chemical substances.
- Screening of hazardous chemical substances.
- Hazard and risk assessment of products containing chemical substances and hazardous substances.
- Sharing information of chemical substance.
The Korean Ministry of Environment (MoE) is responsible for the registration and evaluation of chemical substance under this Act.
Scope of Korea REACH (K-REACH)
The scope of K-REACH applies to all chemical substance usage. The scope of registration applies to the following:
- New chemical substances irrespective of volume
- Designated existing substance >= 1 t/y
- Substances <= 1 t/y but causing serious damage to public health and environment
Also the polymers need to be registered as the substance. There are certain reduce requirements available for some substances (<1 t/y new substance, PLC, R&D substances etc.) listed in the Precedential Decree.
Exemptions within K-REACH
Korea REACH does not apply to:
- Radioactive substances of the Atomic Energy Act;
- Pharmaceuticals and non-pharmaceutical drugs of the Pharmaceutical Affairs Act;
- Narcotics of the Act on the Control of Narcotics;
- Cosmetics and materials of the Cosmetics Act;
- Ingredients and agrochemicals of the Agrochemicals Control Act;
- Fertilizers of the Fertilizer Control Act;
- Food, food additives, tools, containers and package of the Food Sanitization Act;
- Livestock feeds of the Act on Control of Livestock and Fish Feeds;
- Ammunitions of the Act on the Control of Firearms, Swords, Explosives;
- Military supplies of the Act on the Management of Military Supplies and of the Defence Acquisition Program Act (except for commercial goods under Article 3 of the Act on the Management of Military Supplies;
- Health functional food of the Health Functional Food Act;
- Medical devices of the Medical Device Act.
Who can register?
Manufacturers or importers in Korea shall register the follow substances:
- New chemical substances;
- Designated existing substances manufactured, imported or sold more than 1 tonne/year.
Similar to EU-REACH, foreign manufacturers exporting chemical substances or products containing hazardous chemical substance into South Korea may appoint an “Only Representative” to fulfil relevant obligations under K-REACH. The qualification of an only representative and the list of designated existing substances are to be decided by MoE.
Similar to EU-REACH, Korea REACH also requires joint submission:
- Hazard data will be submitted by a lead registrant on behalf of other registrants and joint registrants will submit their own dossier individually;
- Any person who intends to submit a registration later may use registration data submitted by another applicant after obtaining the ownerâ€™s permission;
- Any person who intends to submit a registration may inquire with the MOE about previous registration data of the same chemical substance
Individual submission (or Opt Out) is possible when:
- Exposure of confidential business information (CBI) causes commercial damage;
- Joint submission costs more than individual submission;
- Other cases as listed in the Presidential Decree;
However, a Confirmation of Individual Submission from the Ministry of Environment (MoE) is required for individual submission.
Deadlines of registration for designated existing substances are to be set by MoE.
- The 1st list: 3 years from the publication date
- The 2nd list: 5 years from the publication date
- The 3rd list: 8 years from the publication date
Any person who intends to manufacture or import an existing chemical substance to be registered will be allowed to manufacture or import without registration during the above grace period.
The first list of 510 chemicals is published by the MoE on 1st July 2015 which has the deadline of registration as 30th June 2018.