NAVIGATE K-REACH REGULATIONS WITH EASE
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Experienced team of regulatory consultants and scientists with wide-ranging experience of global chemical registrations including 20 registrations under K-REACH
Expertise in building and maintaining chemical dossiers aligned to REACH requirements, your local regulations and chemical usage
Supporting you through the scientific, technical and administrative burden of K-REACH testing and submissions
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.
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.
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.
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.
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.
Our regulatory scientists have extensive experience of working in consortia under EU-REACH and with CICOs in South 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.
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 Only Representative services.
The exit of the UK from the EU impacts UK-based manufacturers or importers wanting to maintain access to the EEA market. It could also impact downstream processes. Find out more about how we can help you to navigate Brexit complexities:
