K-REACH aims to ensure that chemicals placed on the South Korean market do not adversely affect human health or the environment. The legislation came into force on January 1, 2019 and applies to chemicals already manufactured or imported into South Korea in annual quantities of 1 tonne or more and new chemicals at 0.1 tonne or more. It also applies to polymers, unlike REACH in the EU. Under K-REACH, manufacturers or importers must register chemicals with the Ministry of Environment (MOE) via the NIER.
We have a long history of supporting clients through regulatory processes. As our partner, you will benefit from insight gained from previous regulatory successes under EU-REACH and K-REACH.
Complying with K-REACH requirements for a chemical
K-REACH submission is a multistage process with deadlines and information requirements that vary based on the type of chemical and the annual tonnage used. K-REACH regulations are evolving, so endpoint requirements can change. In addition, the use of a chemical may change, which can require further notifications. Also, within Korea, businesses will need specific information to ensure compliance with the Korean Chemicals Control Act (CCA). To comply with K-REACH, you need to fully understand the current legislation and how it is applied. This means knowing what tests are needed, how to interpret them in line with regulatory guidance and how to compile the data into a comprehensive dossier.
Understanding your role as a single, lead or co-registrant under K-REACH
With the ‘one substance, one dossier’ K-REACH rule, if other companies already manufacture or import the same chemical, you need to work with them in a Chemical Substance Information Communicative Organization (CICO). This means identifying, negotiating and contracting with other registrants, and understanding how to fulfil your agreed role. For new substances or if non-disclosure of confidential information is required, you may need to apply as a single registrant.
Registering for K-REACH when based outside South Korea
If you are an overseas manufacturer wishing to register a chemical substance under K-REACH, you need to appoint an Only Representative (OR) registrant who is based in South Korea. The OR takes on the legal responsibility of complying with K-REACH requirements on your behalf. Both ORs and importers can register chemical substances. However, the importer does not act on behalf of the overseas manufacturer when registering materials, so it may be imported from multiple overseas manufacturers. Therefore, if overseas manufacturers want to register substances, they must do so after an OR appointment.