We write to alert you to an important and imminent deadline. Consideration for confidential business information (CBI) for hazardous substance ingredient disclosure on safety data sheets (SDS) will require formal submission and approval in South Korea starting January 16, 2021.

Background

On January 15, 2019, the South Korean government announced a major amendment to the South Korean Occupational Safety and Health Act (K-OSHA). The amendment requires that companies provide a copy of the SDS to the Ministry of Employment and Labor (MoEL), and if companies wish to maintain non-disclosure of confidential formulation details, they must provide for review and approval those details to the MoEL. There is a grace period for the submission for entities that have prepared or updated the SDS in accordance with Article 41(1) or (6) of the Act prior to the revisions. The grace period is based on manufacturing or importation volumes.

Article 110 of K-OSHA includes provisions for the information to be included on the SDS and includes submission of the SDS to the MoEL. The SDS is to include disclosure of all hazardous substances contributing to the classification, with the weight percent concentration of each. For companies wishing to claim CBI, a formal application process, with review and approval by the MoEL, is required.

Hazardous substances requiring disclosure are those that meet the criteria defined in K-OSHA Enforcement Rule Article 141, which includes the Sixth Revised Edition (Rev. 6) of the United Nations (UN) Globally Harmonized System of Classification and Labeling of Chemicals (GHS). In addition, any chemical substance chosen by the MoEL as causing harmful factors is subject to consideration, as stated in Article 104.

Exemptions for the SDS submission include the following:

• Health functional foods, as defined in the Health Functional Foods Act;

• Source materials defined in the Act on Protective Action Guidelines against Radiation in the Natural Environment;

• Household chemical products subject to safety confirmation and biocidal products that are available for regular and/or daily consumer use as defined in the Act on Safety Management of Household Chemical Products and Biocides;

• Hygiene products as defined in the Hygiene Products Control Act;

• Medical devices as defined in the Medical Device Act;

• Other consumer use products, including products being used or handled in the workplace; and

• Chemical substances designated by the MoEL as used for Research and Development.

Approval for protecting CBI or non-disclosure for hazardous substances is subject to review by the MoEL, and if approved, is valid for five years with an option to renew for an additional five years after the original date of expiration. MoEL criteria for what is not eligible for non-disclosure includes any substance MoEL has publicly listed in an official Announcement. The Announcements include substances with concerns for causing serious health impairment; substances prohibited from manufacture; substances subject to Article 118 permissions; substances subject to control management; and substances noted in K-OSHA Enforcement Rule Annexes 21 and 22. In addition, chemical substances that are subject to Ministry of Environment (MoE) K-REACH Enforcement Rule Article 35(2) are not eligible. These substances are those designated as toxic, restricted, and/or prohibited; and those designated as carcinogens, mutagens, and/or toxic to reproduction (CMR) present at or above the classification threshold. The current list of designated CMR substances includes more than 350 substances.

The process for submitting the information requirements for approval of non-disclosure involves documentation that demonstrates the substances are eligible for non-disclosure, proposed alternative chemical names, the actual chemical name with weight percent concentration, and justification for non-disclosure of the substance. The MoEL will consider the confidential nature of the substance to determine if disclosure of the substance already exists in the market prior to proceeding with the approval of the application. Foreign manufacturers may appoint an Only Representative (OR) to submit CBI applications on their behalf. An OR must be a citizen of the Republic of Korea and domiciled in the Republic of Korea.

Substances that are not hazardous or do not present a hazard at the concentration present in mixtures do not require disclosure, and submission to the MoEL to protect CBI is not necessary. Mixtures that are not classified as hazardous do not require submission, and disclosure of CBI details is not required. Mixtures that contain hazardous substances, where substances are present at concentration levels that drive the hazard classification, require disclosure, and the SDS must be submitted. If any of the substances in that mixture are considered CBI, an application for non-disclosure approval is required. The submission will require 100 percent disclosure to MoEL. Substances that have previously been evaluated for CBI when registered under K-REACH are not subject to re-evaluation or submission under the K-OSHA amendments.

K-OSHA Addenda to Article 7 note that there is a grace period for entities that previously prepared an SDS in accordance with Article 41(1) or (6) of the former K-OSHA Act. Those meeting the exception may submit the SDS to MoEL within specified deadlines based on manufacture or importation volumes as noted in the table below.

Commentary

South Korean regulations continue to challenge chemical manufacturers and importers with new requirements that are difficult to implement and pose aggressive timeframes. The amendments to K-OSHA will require a review of SDS content and consideration for protecting CBI. Many will note that submission and approval for the protection of non-disclosure of hazardous ingredients is not a novel concept. Other countries require the disclosure of hazardous ingredients, especially for hazard classes with a greater degree of concern, with no options for protecting CBI. The United States currently maintains the most generous provisions for protection of trade secrets on the SDS, but as a global industry, it is a challenge to justify non-disclosure on a U.S. SDS for the purposes of protecting CBI and subsequent disclosure on the SDS for distribution of that same product outside the United States.

Companies wishing to maintain non-disclosure of hazardous substances on the SDS will need to evaluate the market and determine if during the application review MoEL will consider the non-disclosure justified. The list of substances not eligible for non-disclosure is equally challenging. In recent evaluations for registrations under K-REACH, MoE designated substances classified as corrosive as “toxic.” Toxic designations include environmental hazards as well. This further complicates issues for U.S. and Canadian manufacturers, as consideration for environmental classifications are not mandatory elements on the SDS in the United States and Canada.