South Korea: New regulations in conjunction with the Act on Registration, Evaluation, etc. of Chemicals

 

South Korea published two new draft regulations linked with the Act on Registration, Evaluation, etc. of Chemicals, also known as the K-REACH (Korean REACH, legislation mirroring the EU Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals.

These are:

• “Regulation on Designation, etc. of Substances subject to Permission”
• Partial amendment of the ‘Enforcement Rule of the Act on Registration, Evaluation, etc. of Chemicals’

The first regulation lays down rules for the designation of chemical substances subject to permission:

1) Initial Determination by the Ministry

The Ministry of Environment (ME) sets the method to select candidate substance(s) for substance(s) subject to permission, given each candidate substance’s hazard whether it meets the standard of “MOE Public Notice on Substance subject to Intensive Control” or not, total amount distributed in Korea, the scope of its users, and relevant overseas regulations.

2)  Public consultation for each candidate substance

ME publishes each candidate substance’s name, distributed amount, relevant overseas regulations and the period of public consultation beforehand. Then, ME conducts detailed survey on distribution of the candidate substance and reviews its risk, and makes the results available to the public, and carries out a consultation regarding hazards, specific uses, and alternative substances and technologies, and so forth.

3) Discussion with manufacturer, importer, user, etc.

Based on the results of the public consultation about each candidate substance, ME sets the priority of candidate substances to designate substances subject to permission. Then, ME discusses with manufacturers, importers and (downstream) users according to the priority in order to determine which use will be exempted from permission, how long the grace period of permission will be, and so on.

4)  Procedure for designating and publicly announcing substance(s) subject to permission

ME establishes and informs its plan for designating substance(s) subject to permission. Then, ME designates and publicly announces substance(s) subject to permission after the deliberation of the Chemicals Evaluation Committee.

5) Data protection, etc.

ME prohibits disclosure of confidential business information (CBI) that may happen when reviewing the submitted data in the process of designating candidate substance(s) and substance(s) subject to permission.

 

The second regulation defines in an even mor detailed way how the Ministry of Environment selects substances subject to permission:

A. Designation of candidate substance for substance subject to permission (Article 34-2, newly added)

When designating candidate(s) of substance(s) subject to permission, the Ministry of Environment (ME) selects the candidate substance(s) based on the priority. The priority is set by considering comprehensively the chemical substance’s hazard whether it meets the standard of “MOE Public Notice on Substance subject to Intensive Control” or not, its total amount distributed in Korea, and the scope of its users as well as whether foreign government or international organization regulates the chemical substance or not.

B. Data requirements for chemical substance manufactured or imported equal to or more than 0.1 ton but less than one ton per year

When a chemical substance is manufactured or imported equal to or more than 0.1 ton but less than one ton per year, it is allowed to waive environmental hazard data from data requirements for registration if the chemical substance’s water solubility is less than 1mg/l or if the chemical substance is used as intermediate or process regulator.

C. Application for exemption confirmation from notification of R&D substance

When a chemical substance is intended to import for R&D purpose, and its estimated annual importing amount is less than 100kg, overseas manufacturer or producer may not provide the chemical substance’s name and identity number (e.g. CAS number) by insisting such information as CBI. In this case, it is allowed not to specify the chemical substance’s name and identify number on an application form for exemption confirmation from notification of chemical substance if the chemical substance’s SDS is submitted with the application form.