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[Newsletter No.51] Enforcement of full revision of Korea MSDS in January 16th 2021

Date :2021.01.08

NEWS LETTER 2021.(VOL.51)

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Chemtopia gives honest consultation to clients

ISSUE & FOCUS

  • Ⅰ. Major changes in the amended MSDS regulation
  • Ⅱ. Industry advice








Ⅰ. Major changes in the amended MSDS regulation

The following table shows a summary of major changes in the KOSHA’s amended regulation.  

 

1. SDS submission method

     [1] 48 use description is in [Appendix 5] of the notice. Please refer to the attached file.

 

 

2. SDS submission period, exemption, and penalty

Submission of SDS has to be completed before manufacture or import of the product, though grace 
 period is given to currently circulated products in the Korean market as follows:

-      The annual quantity of manufacture and import for the product subject to MSDS is
        >1,000 tons: Until January 16, 2022;
-      The annual quantity of manufacture and import for the product subject to MSDS is
        100 to 1,000 tons: Until January 16, 2023;

-      The annual quantity of manufacture and import for the product subject to MSDS is
       10 to 100 tons: Until January 16, 2024;
-      The annual quantity of manufacture and import for the product subject to MSDS is
       1 to 10 tons: Until January 16, 2025;
-      The annual quantity of manufacture and import for the product subject to MSDS is
       <1 ton: Until January 16, 2026.

 

IF MSDS disclosing 100% of components, the MSDS can be submitted to the authority via the IT system without submission of any additional document. However, if the MSDS has any non-disclosed components having classification, these components should be either disclosed on MSDS or obtain approval of trade secret in advance. In case that 100% of components are not disclosed on MSDS and non-disclosed components have no classification, the approval of trade secret is not necessary, but additional documents, such as Letter of Confirmation (LoC) are required to submit. A sample letter of confirmation is shown below. 

 

 

Products controlled under other laws, consumer products, chemicals, or products for R&D purpose including reagents are exempted from MSDS submission. Below are newly added in the amendment as products controlled under other laws. Please be aware that there must be more other exempted products controlled under other laws, not listed below, so consultation is needed to confirm it.
-    Dietary supplements under Health Functional Foods Act
 -  
Raw material substances under Act on Safety Control of Radioactive Rays around Living Environment
-    Household chemical products for general consumers among household chemical products subject to safety confirmation and biocidal products under Act on Safety Control of Household Chemical Products and Biocidal Products
-    Hygiene products under Hygiene Products Control Act
-   Advanced biomedicines under Act on Safety and Support of Advanced Regenerative Medicine and Advanced Biomedicine

Scope of chemicals or products used for Research and Development (R&D) is as follows:
-    Chemicals or products for scientific experiments, analysis, or research, such as reagents;
-    Chemicals or products for the development of other chemicals or products, etc.;
-    Chemicals or products for improvement and development of production processes;
-    Chemicals or products for testing application fields of chemicals in workplaces;
-   Chemicals or products for pilot manufacturing of chemicals or pilot production of chemical      products, etc.

For any failure to submit MSDS, an administrative penalty of less than 5 million KRW (5,000 USD) shall be imposed per product.

 

3. Approval of SDS trade secrets

If a substance is subject to trade secret, an application for approval of MSDS trade secrets should be submitted. After its approval, the submission of MSDS with this approval number can be done. The below tables show how to apply for MSDS trade secrets.

■  Application for approval of MSDS trade secrets

 

 

■  Preparation of trade secret data
How to fill in alternative content
  ① If the original content of a non-disclosure ingredient is less than 25%
  : Write in the range of ±10%
  ② If the original content of a non-disclosure ingredient is 25% and above
  : Write in the range of ±20%

How to fill in alternative names
Follow the preparation method of nomenclature of generic names proposed by the Ministry of Environment (MOE Notification No. 2018-237 Appendix Nomenclature of generic names under Regulations on the preparation method of an application for data protection and management method of protected data, etc.). 

 

4. Person appointed by overseas manufacturers (Only Representative) 

In the case of exported chemicals into Korea, an overseas manufacturer may appoint a representative, on behalf of a domestic importer, to prepare and submit information and data necessary for MSDS application, non-disclosure approval, etc.

Scope of OR work is preparation and submission of MSDS, approval for MSDS trade secret, approval for the extension of validity, the appeal of rejected application, and delivery of approved MSDS to importers.

 

5. Changes in GHS classification and its naming

The amended KOSHA includes certain changes in GHS classification and warning signals. The purpose of these changes is to follow the UN GHS standard. For instance, sub-categories (1A, 1B, 1C) is newly added to skin corrosion/ skin irritation. This sub-categorization can be applied when the data to support this sub-categorization exists. And, if it is difficult to classify a CMR substance into 1A or 1B, it is possible to classify a substance to category 1. Detailed changes in GHS cut-off value and warning signal are summarized below:

 

■  Changes in GHS cut-off value

* Note: For any substances having classification and being contained in the product higher than the cut-off limit, it is essential to include those substances in MSDS. 

 

■  Changes in the entries of warning signal

When any chemical is subject to UN Recommendations on the Transport of Dangerous Goods (RTDG)」, the pictogram of RTDG may be indicated on the relevant container on behalf of 「Globally Harmonized System (GHS)」. And, it is not allowed to use both RTDG and GHS’s pictograms at the same time. Instead, one pictogram should be indicated and it is recommended to use pictograms from GHS.

Ⅱ. Industry advice

It is recommended to review all in-house MSDS against the amended public notice and to verify the annual manufactured or imported tonnage of existing products and to get ready to submit MSDS within a given grace period by tonnage. Note that no grace period is granted to a new product after the enforcement date, January 16th, 2021.

 

It is also important to verify and list chemicals subject to the approval of MSDS trade secret and prepare documents for trade secret substances requiring approval. For foreign companies, professional consultation with a consultancy for OR appointment will be essential concerning the issue of trade secret information and MSDS approval, if they are reluctant to disclose 100% components on MSDS or to importers. 

 

** You can watch MSDS webinar at https://vimeo.com/ondemand/chemtopiamsds/490632291. You also can watch other Chemtopia’s webinar series at https://vimeo.com/chemtopia. Please click below link.

Chemtopia Co., Ltd. provides corresponding services to comply with amended and legislated regulations :

· Chemical registration service including Pre-registration, OR service, Read-across or QSAR approach, CSR preparation, Data sharing and negotiation
· Chemical inventory for regulatory tracking
· Support of regulatory monitoring and volume tracking with chemical management system
· Provision of domestic and foreign chemical regulatory database
· MSDS and label authoring system
· Test arranging & its monitoring with domestic and foreign test institutes

This newsletter is available in Korean, English, and Japanese

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