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By now, many companies manufacturing and importing chemicals in Korea are well aware of Korea’s Act on the Registration and Evaluation of Chemicals (K-REACH). But newcomers must be fully aware of their commitment to ensure compliance in the Korean market.
Implemented in 2015 and last revised in January this year, the purpose of K-REACH is to protect public health and the environment in Korea through the registration of chemical substances, screening of hazardous chemical substances and assessment of risks and hazards of products containing chemical substances.
However, from my observations, there are still many smaller companies who seem to not be fully aware of the intricacies of the regulation and its difference to other market’s REACH regulations. To gain a better understanding of K-REACH, here are a few insights.
The Korean Ministry of Environment’s deadline for the pre-notification of existing substances exceeding one ton per year passed recently on June 30, 2019. Now only pre-notified existing substances can benefit from registration grace periods, which can permit the manufacture or import of those substances without full registration.
However, there is still a late pre-registration process that exists under K-REACH and applies to companies that are newly manufacturing or importing substances after the pre-registration deadline.
Companies who have already registered their existing substances should take note that if there is any change in the use or tonnage band of their substance, then the pre-notification must be updated within a month. It is possible that this requirement may apply up to the completion of full registration.
Looking ahead, the next set of deadlines for companies manufacturing or importing existing substances are:
Although it is over two years until the next deadline, preparation is key!
K-REACH is based on the actual chemical substance and not a finished product. If companies import an existing substance of less than one ton per year from multiple individual suppliers, they will have to register the substance if the total amount imported exceeds one ton per year.
Suppliers then need to consider appointing an OR (Only Representative) in Korea to register their substance. This presents another difficulty – due to confidentiality, most suppliers are not willing to reveal the full composition of their substance unless they are guaranteed to see over one ton per year of their substance imported.
It’s also important to remember that substances that are already on Korea’s “Existing Chemicals List” may still be subject to registration procedures as and when designated by the Ministry of Environment.
To date, there are an estimated 44,000 types of chemicals in use in Korea with approximately 300 new chemicals introduced to the market each year.
An important task is to calculate the maximum tonnage carefully to identify the data needed for that tonnage band. Using an OR can help companies to identify all uses for a substance as this will influence exposure scenarios and the risk assessment. Manufacturers may even need to reach out to their downstream users to attain more accurate information on the applications of a substance.
As chemical regulations become more complex and difficult to get to grips with, the need to stay compliant with international and domestic market regulations is getting more challenging by the day. For manufacturers and importers with an eye on Korea, it is crucial to gain a good understanding of the screening and registration process of products containing chemical and hazardous substances.
Finally, you need to know who you can work with to help make your market entry as efficient and effective as possible. DKSH Korea, for example, is a qualified regulatory partner who is knowledgeable in the local market and experienced in undertaking the registration and notification process. To support your business growth, DKSH Korea’s Regulatory Affairs team keep a close eye on all regulation changes to ensure effective market entry and an uninterrupted supply chain. Drop me a line if you are keen to better understand K-REACH and the role it plays for your business entering the Korean market.
Jina Ban is based in Seoul, South Korea. She is currently Specialist, Regulatory Affairs at DKSH Korea Ltd.