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).
Covance has a long history of supporting clients through regulatory processes. As our partner, you will benefit from insight gained from previous regulatory successes under REACH and K-REACH.
- Experienced team of regulatory scientists with wide-ranging experience of global chemical registrations including 20 registrations under K-REACH
- Expertise in building and maintaining chemical dossiers aligned to your local regulations and chemical usage
- Supporting you through the scientific, technical and administrative burden of K-REACH submissions
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 its annual tonnage usage. 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. That 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 fulfill 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
To register for K-REACH, you need to be based in South Korea. If you are not, then you need an Only Representative (OR) registrant who is in South Korea. The OR takes on the legal responsibility of complying with K-REACH requirements on your behalf.
Guiding you and your chemical through the entire K-REACH registration process
Our dedicated team comprises over 40 experienced regulatory scientists situated across key markets, including South Korea. The regulatory team works in close collaboration with our in-house study teams to optimize K-REACH compliance and registration success. We understand how QSAR and read-across data are less accepted for K-REACH than for REACH, and we can identify whether there are waivers for your chemical. Where there are not, our study teams can develop intelligent testing strategies tailored to you. Our expertise has been amassed from a range of chemical types such as biofuels, fatty acids and enzymes.
Extensive consortium experience as both lead and co-registrants
Our regulatory scientists have extensive experience working in consortia under REACH in the EU and with CICOs in Korea under K-REACH. This includes acting as lead registrant as well as co-registrant. As your partner, we can drive a registration forward, negotiate access to CICOs or to K-REACH dossiers and data, and manage all the technical and administrative aspects of registration and submission.
Experienced REACH OR for multiple companies and chemicals
Allow our dedicated team of regulatory specialists to take on the legal responsibilities for your K-REACH registration via our Korean office. Find out more about our OR services here: