By Little Pro on 2015-12-31 Views: Update:2017-01-18
According to the article 10 of K-REACH, any person who intends to manufacture or import a new chemical substance or at least one ton per year of a designated existing chemical substance subject to registration shall register the chemical substance before he/she manufactures or imports. This article has been updated according to the latest K-REACH presidential decree published in the end of 2014.
The following information is required. Hazard data requirement increases with tonnage band.
There are two types of exemptions from registration under K-REACH. One type does not require prior confirmation while the other one requires companies to apply for the prior Confirmation of Registration Exemption.
|Exemptions not requiring confirmation.||
|Exemptions requiring Confirmation of Registration Exemption.(*)||
For onsite isolated intermediates and polymers that do not qualify for confirmation of registration exemptions, K-REACH also offers reduced data requirements. For intermediates, only physio-chemical data is required. For 100-1000t/y new polymer, data requirement is the same as 1-10t/y regular new substances.
Not all existing substances require registration under K-REACH. The MoE will designate certain existing substances subject to registration based on their hazards and volume. A grace period of 3 years will be given to those designated existing substances once they are published.
The first list of 510 designated existing substances subject to registration is published on 1 July 2015. Substances on the list shall be registered before 1 July 2018 if they are in amounts exceeding one tonne per year. Joint submission for those substances are mandatory. If you wish to find out who is the lead registrant for the designated existing chemical substances, please click the links below.
Risk assessment report is required for substances manufactured or imported with a volume of at least 10t/y and substances deemed as one requiring risk assessment based on the result of hazard assessment. However, risk assessment report does not always need to be submitted with a registration dossier together. Grace periods are given according to the following schedule.
|Tonnage band||Required date|
Joint submission of existing substance registration is mandatory under K-REACH. Opt-out is possible when:
Any person who transfers a chemical substance registered or a mixture containing such chemical substance shall prepare and provide information such as the registration number and name of the relevant chemical substance, information on hazards and risks, and safe uses, to any person who acquires the chemical substance. Such information is usually communicated via SDSs.