1. What is KOSHA?

The Korea Occupational Safety and Health Agency (KOSHA) is the main government organization which aims to protect the health and safety of Korean workers. Its primary goal is to reduce occupational accidents, prevent diseases and improve safety standards in the workplaces. KOSHA stipulates the Occupational Safety and Health Act (OSHA) to regulate format, Confidential Business Information (CBI), and submission obligations for Material Safety Data Sheets (MSDS) under the following clauses:

• Article 110: Preparation and submission of Material Safety Data Sheets
• Article 111: Provision of Material Safety Data Sheets
• Article 112: Approval of non-disclosure of Material Safety Data Sheets
• Article 113: Submission of Information by persons appointed by overseas manufacturers

2. Scope of Exemption

1. Health functional Food under Article 3, Paragraph 1 of the Health Functional Food Act;
2. Agricultural pesticides under Article 2, Paragraph 1 of the Pesticide Control Act;
3. Narcotics and psychotropic substances as defined in Items 2 and 3 of Article 2 of the Narcotics Control Act;
4. Fertilizers under Article 2, Paragraph 1 of the Fertilizer Control Act;
5. Feed under Article 2, Paragraph 1 of the Feed Control Act;
6. Raw materials as under Paragraph 2, Article 2 of the Act on Protective Guidelines against Radiation in the Natural Environment;
7. Household and disinfectants for consumer use under Paragraph 4 and 8 of Article 3 of the Consumer Chemical Products and Biocides Safety Control Act (K-BPR);
8. Food and food additives under Paragraphs 1 and 2 of Article 2 of the Food Sanitation Act;
9. Pharmaceuticals and medical supplies under Paragraph 4 and 7 of Article 2 of the Pharmaceutical Affairs Act;
10. Radioactive substances under Paragraph 5 of Article 2 of the Nuclear Safety Act;
11. Sanitary products as defined in Article 2, Paragraph 1 of the Sanitary Products Control Act;
12. Medical devices under Paragraph 1, Article 2 of the Medical Device Act; Advanced biopharmaceuticals under Paragraph 5, Article 2 of the Act on the Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals;
13. Gunpowder under Paragraph 3 of Article 2 of the Safety Management Act for Guns, Swords, Explosives, etc.;
14. Wastes under in Paragraph 1, Article 2 of the Waste Management Act;
15. Cosmetics under Paragraph 1, Article 2 of the Cosmetic Act;
16. Single substances or mixtures provided for the general consumers, excluding those specified in the above-mentioned (1) to (15) (including chemical substances or mixtures required at workplaces for the general consumer population);
17. Chemical substances or chemicals designated and notified by the Minister of Employment and Labor for research and development purposes; and
18. Chemical substances recognized by the Minister of Employment and Labor as having a low degree of hazard such as toxicity and explosiveness, as announced in the notice → Notice No. 2020-130, Article 3 by the Ministry of Employment and Labor (applicable exclusions).

3. MSDS Compilation

MSDS, Material Safety Data Sheets, are physical papers providing safety information relating to hazardous chemicals in the workplace. MSDS consists of the following16 Sections:

Note: Information of product importer and OR (Only Representative) should be included in Section 1 and an emergency phone number (Korean number) of the importer should also be included.

4. KOSHA MSDS Submission

(1) Substances requiring MSDS submission

Chemical substances or mixtures falling under the classification standards prescribed in Article 104 of the OSHA (GHS Hazard Classification).

(2) Grace period for MSDS submission and CBI application

• New products: Manufacturers and importers of new products should submit (M)SDS to MoEL prior to manufacturing or import from 16 January 2021 (no grace period);
• Existing products: Chemicals that have been circulated in Korean market before 6 January 2021.

Deadlines for MSDS compilation and CBI application:

(3) Who shall submit MSDS?

• Manufacturers/Importers in South Korea;
• Only Representatives (OR) in South Korea appointed by the non-Korean manufacturer.

(4) How to submit MSDS?

One can submit MSDS through the online submission (MOEL website: http://msds.kosha.or.kr)

(5) What materials shall be submitted with MSDS?

• Chemical product classification (R&D or non-R&D);
• Product identifier, volume manufactured or imported (per year);
• Korean manufacturer, importer and OR;
• Letter of Confirmation (LOC) signed by non-Korean manufacturers;
• MSDS written in Korean language;
• Classification information of uses (selected from 48 categories); and
• All ingredients without hazard classification must be submitted to MOEL.

(6) Submission period: 1-2 weeks

(7) MSDS submission sesults

MSDS number:

The MSDS number shall be added in the MSDS document. 

(8) MSDS should be resubmitted if any of the following circumstances occurs:

1. Product name is changed (only if the name and content of hazardous ingredients remain unchanged);
2. Name of hazardous ingredients and their contents is changed (only if the product name remains unchanged);
3. Hazard classification information is changed (information involving physical and chemical, health, environment);
4. Precautionary information is changed; or
5. Other key information, e.g., physical and chemical properties.

5. CBI Application

(1) Substances not applicable to CBI application:

The following substances are not required to apply for CBI under Article 16 of the MoEL No. 2023-9:

• Hazardous or dangerous Substances prohibited from manufacture under Article 117 of the KOSHA;
• Hazardous or dangerous Substances with permission to manufacture under Article 118 of the KOSHA;
• Controlled Hazardous Substances under Section 420 of the KOSHA Standard Regulations;
• Hazardous Factors in workplaces measurements under Schedule 21 of the KOSHA Implementation Regulations;
• Hazardous factors for special health examination under Schedule 22 of the KOSHA Implementation Regulations; and
• Chemical substances specified in Paragraph 2, Article 35 of the K-REACH Implementation Regulations (available on the NCIS website).

Note: Ingredients that are generally regarded as posing significant hazards to human health are not allowed to conduct CBI application.

(2) Materials required for CBI application:

1. Documents to be submitted: MSDS in Korean language, POA, Information sheet for CBI Claim, LOC (required if its content below 100%)
2. Information required

• Supporting Information: Information that meets the criteria for business confidentiality;
  Non-disclosure: Who is aware of the substantial information regarding chemical substances under a CBI application?
  Confidentiality Management: Does the company manage its employees by having them sign confidentiality agreement and using computers equipped with security systems? Economic Benefits: What are the potential losses for the company if the business confidential information on chemical substances is disclosed? What advantages might this confer on competitors?
• Alternative Information (Chemical Substance Name and Content)
  Alternative name (generic name): Please refer to the Guidelines for the Preparation of CBI Application and the Management of Application Materials published by the Ministry of the Environment.

Alternative content (%):

• If the component content below 25%, alternative content may be ±10%;
• If the component content ≥20%, the alternative content may be ±20%;
• The content range of non-CBI component content shall be ±5%.  

• Names and contents of hazardous components to conduct CBI application, as well as the health hazard, environmental hazard and physical hazards of these components;            
• Names and contents of other non-hazardous components (or only disclose hazardous components in MSDS, submission of MSDS and LOC);
• MSDS compiled in Korean language;
• Other documents required by the MoEL (information of the applicant, product identifier, activity type (manufacture/import), etc.)

Note: ① and ⑥ are not required for R&D chemical substances or mixtures when applying for registration of alternative substances.

(3) Review period: 1 month (R&D products: 2 weeks)

(4) Submission result: approval code for CBI

Sample of regular products:

Sample of R&D products:

(5) Validity period and extension period:

The validity period for CBI protection is 5 years. Applicants may apply for 5-year extension of the validity period within 30 days before its expiration.

(6) Modification of MSDS: Section 3 of MSDS should be modified if products containing CBI substance. 

6. Summary

7. Penalties

Any of the following circumstances shall be imposed with a fine (up to 5 Million Korean Won):

1. Existing products do not submit MSDS within the grace period;
2. Products with hazard classifications do not submit MSDS or lack of necessary information in MSDS; and
3. CBI substances without official approval or falsifying information.

Reference

• KOSHA regulation: South Korea Ministry of Government Legistration