Global chemical substance notification deadlines continue to populate the regulatory horizon. For companies active in worldwide markets, it’s crucial to review and meet all important notification and registration deadlines in each country. This article focuses on South Korea’s policy and explains why it’s essential to meet these deadlines.
In 2006, when the European Union (EU) kicked off its Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, it sparked a seemingly unending series of country-specific chemical notification/registration regulatory requirements critically important as a prerequisite to engage in global commerce. Many countries, including the U.S., have since undertaken and updated their chemical notification programs. Presently, Asian countries, most notably South Korea, are updating their chemical programs.
The South Korea amended its Act on Registration and Evaluation, etc., of Chemical Substances (K-REACH) on January 1, 2019. All existing chemical substances (i.e., substances listed on South Korea’s current chemical inventory) manufactured in or imported to South Korea at greater than or equal to one ton per year are now subject to registration. This means if you are manufacturing chemical substances in or exporting into the South Korean market, you need to be aware of these registration requirements.
Existing chemical substances must be pre-registered by June 30, 2019. Pre-registered substances benefit from registration grace periods that allow those substances to be imported without full registrations.
Who needs to pre-register? Any person manufacturing or importing existing chemical substances greater than or equal to one ton per year. Just as with the EU’s REACH regulation, foreign manufacturers/producers who export existing chemicals to South Korea may appoint an “Only Representative,” as the legal entity, to pre-register chemical substances on their behalf. This is an especially useful tool allowing companies without “boots on the ground” to work with a local entity to discharge their chemical registration obligations.
How do you determine if you have an existing chemical substance? Search the Korea Existing Chemicals List for substance status. Substances not listed, designated priority existing chemicals (PEC), or considered exempt are not eligible for pre-registration.
What are the consequences if pre-registration isn’t complete by deadline? If a substance isn’t pre-registered by June 30, 2019, the registration grace period is inapplicable. Substances not pre-registered will require registration before manufacture or import. Substances not pre-registered or registered are subject to suspension of manufacture/import/use/sales. For commercial entities with business interests in South Korea, any suspension or cessation of business operations would have devastating consequences and could result in lost sales, contractual disputes and related misadventures.
What information is needed to pre-register? To pre-register an existing chemical, the following information is necessary:
• The name of the chemical substance;
• Expected annual manufacture/import quantity;
• Classification and labels of the substance;
• Use details;
• Name/contact information of the manufacturer or importer; and
• Any other information specified under the Ordinance of the Ministry of Environment.
Global commerce requires chemical accountability; chemical notification and registration requirements are here to stay and will proliferate over time. It’s critically important for stakeholders to recognize this fact of business life, institutionalize this new reality, and monitor and comply with all such requirements. The consequences of failing to do so are significant. Global commerce can come to a dead stop for an entity that is ill-prepared to demonstrate compliance. Such failure can invite regulatory sanctions, commercial peril, and brand reputational damage, among other unpleasant and costly consequences. The good news is many opportunities exist to find and secure support for satisfying these requirements and thus ensure commercial continuity.
LYNN L. BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at firstname.lastname@example.org
Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on conventional, biobased, and nanoscale chemical industry issues. She served as chair of the American Bar Association Section of Environment, Energy, and Resources (2005-2006). The views expressed herein are solely those of the author. This column is not intended to provide, nor should be construed as, legal advice.