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On May 30, 2023, by MoE Announcement No. 2023-102, South Korea’s Ministry of Environment (MoE) made public the amendments to the Regulations on Preparation of Information Protection Application, Information Protection Management, Etc. (hereinafter referred to as the Regulation), which further specify definitions of some terms and update the naming rules for generic names of chemicals requiring Confidential Business Information (CBI) protection.
Background
According to K-REACH and its Enforcement Rules, registered or notified chemical substances and mixtures containing such substances are required to transmit required information in the supply chain, including the registration/notification number, substance names, hazards and risk information, and safety use information, etc. Companies who have CBI concerns shall apply for non-disclosure of relevant chemical information under K-REACH and get approval from the MoE. The Regulation was developed to specify how to prepare for the CBI protection application and how to manage the protected information. It was first issued on December 30, 2014, and took effect on January 1, 2015. The first revision of the Regulation was in 2018, which came into force on January 1, 2019. Recently, the MoE released its second revision, which will be in force on January 1, 2024.
Main updates
Regarding Article 2, Paragraph 3 of the Regulation
Further clarifying the definition of “Generic Name”
Previously, the term “Generic Name” in the Regulation referred to “The name of a chemical substance named by the applicant as per the methods specified in the Regulation as its alternative chemical name for the purpose of information protection”. According to the revised Regulation, the word ‘applicant’ in this paragraph is specified as “someone who applies for information protection under Article 45 of K-REACH or who should provide chemical safety information under Article 29 of K-REACH and Article 35 of K-REACH Enforcement Rules”.
Regarding Annex - Naming Rules for Generic Name to the Regulation
Updating naming rules for polymer compounds and reaction products
Previously, according to Paragraph 4 in the Annex, the generic name of a polymer compound or a reaction product can be named by using the generic names of their monomers or reactants. However, the names of hazardous substances contained in the monomers or reactants cannot be generic names. As per the amendments this time, the naming rules are updated. The revised Paragraph 4 in the Annex is:
“The generic name of a polymer compound or a reaction product can be named by using the generic names of their monomers or reactants. However, if the unreacted monomer or unreacted reactant is 0.1% by weight or more and is a hazardous chemical substance, the generic name of this monomer or reactant cannot be used.”
Adding naming rules for mixtures
The revised Regulation adds a new paragraph (Paragraph 8) in the Annex to specify that if anyone who transfers a mixture does not intend to provide the names of the chemical substances contained in the mixture in the chemical information safety information pursuant to Article 35, Paragraph 2 of K-REACH, the generic names named in accordance with “EU Manual - How to prepare a request for use of an alternative chemical name for a substance in a mixture” can be used.
