Regulatory outlook and update on K-REACH

The purpose of K-REACH is to protect public health and the environment through two provisions. First, the registration/notification of chemical substances. Enterprises that intend to manufacture or import the following substances to South Korea are obligated to complete K-REACH registration:

• At least 0.1 ton/year of a new chemical substance.
• Existing substances manufactured, imported, or sold in quantities greater than 1 ton per year.

New substances manufactured or imported in quantities greater than 0.1 ton/year shall be registered prior to manufacture or importation. A grace period will be granted to existing substances to be manufactured or imported in quantities greater than 1 ton/year. Foreign manufacturers exporting chemical substances or products containing hazardous chemical substance into South Korea may appoint an Only Representative to fulfil relevant obligations.

Exemption from Registration or Notification

Substances falling under any of the following subparagraphs are subject to exemption from registration:

• A chemical substance imported as contained in machinery.
• A chemical substance imported along with machinery or
• equipment for a test run.
• A chemical substance in a product in solid state with specific shape for a certain function and not discharged during its use.
• A chemical substance designated and publicly notified by the
• Minister of Environment after deliberation by the Chemical
• Substance Evaluation Committee which has extremely low risk.
• Impurities, by-products, minerals, ores, glass, vegetable fats/oil, hydrogen, and oxygen, etc.
• A substance itself existing in the nature or a substance obtained by using manpower, machine or gravity to the substance existing in the nature or by selecting after dissolving or floating thereof in the water.
• A base composing DNA or RNA, nucleoside which is a combination of base and sugar.
• The following substances will also be exempted from registration or notification after obtaining confirmation of exemption from registration. Application for confirmation of exemption from registration shall be made via the Chemical Substance Information Processing System before manufacturing or importation of the substance:
• Reagents for test, research, or inspection.
• A chemical substance for demo production, such application may be submitted within 30 days from the date such substance has been manufactured or imported (within 14 days until 31 December 2018).

Transported Isolated Intermediates (TII) Registration

A transported Isolated intermediate is defined under K-REACH as a substance that is manufactured to be used to manufacture another substance and the entire amount of the intermediate substance must also be consumed during the final substance production. In addition to this the intermediate substance must be used under strictly controlled conditions by specially trained staff and accurate use records must be maintained. As part of the registration process the use of a particular substance must be indicated in the dossier, under K-REACH Use number 33. Intermediate is an available option and for each registration type Intermediate use is as follows.

• Top 10 Use for New Chemical Substance Notification (<0.1).
• Top 10 Use for Non-PEC Existing Chemical Substance Registration.
• Top 10 Use for PEC Registration.
• Top 10 Use for New Chemical Substance Registration.

The Advantage of intermediate Use is that the information requirements for such substances is significantly reduced across all tonnage bands.

While the data requirements for TII registration are reduced, making it an attractive option for many companies, it is not without its downsides. In the initial registration phase TII Justification must be submitted to the MoE to prove that the substance satisfies the TII requirements. Additionally, all users of the substance must satisfy the requirements, meaning that not only should the initial manufacturer comply with the requirements but also all downstream users of the substance during its lifecycle.

There are also additional post registration obligations that must be completed following the completion of a TII registration for both the registrant and the users of the substance.

• Users
• Required to maintain accurate records of the use of the substance.
• The substance must be handled by trained personnel throughout the supply chain.
• Registrant
• Update TII Justification to add new users satisfying the requirements.
• Update the Registration dossier with TII Justification for new users.

Finally, potential registrants should consider limitations of a TII registration under K-REACH, as listed above the conditions of the registration not only apply to the registrant but all users of the substance. This means that if a single user of the substance is not compliant with the requirements this may lead to issues with the authorities. A potential registrant should conduct due diligence on current and future users to ensure that they are operating withing the requirements of the TII registration.

100-1,000T registration deadline

The full registration deadline for substances in the 100-1000 tonnage band is the end of 2024. Based on the most recent statistics the MoE is expecting approximately 1100 individual substances to be fully registered for this coming deadline. For both Lead registrants and Co-Registrants, it is important to be proactive as while the deadline is the end of 2024, this is the date that registration must be completed. Currently it is expected that Lead-Registrant will require approximately 3 months with NIER, while Co-Registrants can only submit their registration once the Lead registrant (LR) has completed their registration and should expect 1-2 months with NIER. Before the LR can consider submitting the registration they must fulfil the testing requirements for their substance. Such testing data can be obtained in several ways including:

• From data already owned by the LR.
• From data made available by the Active members of the CICO (Korean version of the SEIF).
• By performing the testing directly with a qualified laboratory.
• If the data is not available from the LR, or another member of the CICO and the testing must be completed the following considerations should be made.
• Endpoint 28d Repeat Toxicity (oral) will be the most time critical,
• full testing will take approximately six months.
• The Pre-requisite for 28d Repeat Toxicity (oral): Acute Toxicity (oral), requires approximately three months to complete.
• The Pre-requisite for Acute Toxicity (oral): Skin irritation requires approximately three months to complete.
• Currently lab capacity is low for extended studies
• The Eco-toxicity endpoint: acute fish/daphnia has at least 12 months waiting period.

A further mandatory section of the Registration dossier is the Chemical Safety Report (CSR), assuming that the Exposure Scenarios have been collect from the Downstream Users (DU) the expected timeline for CSR authoring for the LR and the DU is approximately one month.