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South Korea Amended the Registration Procedures for Multi-component Reactants

from CIRS by

On October 20, 2022, South Korea made amendments to the guidelines on registration procedures for existing chemical substances. The guidelines provide specific pre-registration and registration procedures for substances that are identified as existing chemical substances under Article 3 of the Notice on Existing Chemical Substances (Notice No.2021-160) yet cannot be searched as existing chemical substances on the National Chemicals Information System (NCIS). The amendments mainly focused on the pre-registration and registration procedures of multi-component reactants.

Previously on August 12, 2021, South Korea added three types of substances under the definition of existing chemical substances according to Notice No. 2021-160. These include:

  • Hydrates or anhydrous substances of the existing chemical substances shall be identified as existing chemical substances;
  • Reactants containing two or more components are generally regarded as existing chemical substances if every component is an existing chemical substance (Components of reactants are complex to isolate and reactants are circulated and processed in the market.); and
  • If one existing chemical substance contains two or more isomers, then each isomer can be identified as an existing chemical substance.

Under the current procedures, the registration procedures for reactants with two or more components are:

(1) Applicants submit documents certifying that the substances are existing chemical substances NIER; and

(2) NIER will generate a unique KE number for reactants that have been identified as existing chemicals. Pre-registration and full registration will be done according to the KE number.

The above procedures are amended as:

(1) Applicants submit documents certifying that the substances are existing chemical substances NIER; and

(2) Pre-registration and registration shall be done in the following way if the substances are identified as existing chemical substances:

If reactants are named as “Mixture (reaction mass) of X+Y+(···Z)” (ranked by their component contents). Applicants can at first pre-register the substance “X” based on its KE number, and join the consortium of “X”. Then, applicants can make an application to establish an individual consortium and apply for full registration.

Applicants should fill in the “Information and grounds for identifying reactants” column in the system when making an application for individual groups.

  • Information: Reactant Name (CAS Number) (KE No.+KE No.+KE No. Reactants)
  • Grounds: Permission documents from NIER
  • Korea,Registration,Procedure,Chemical,Existing,Substance

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