켐토피아 뉴스레터

NEWS LETTER 2020.(VOL.50)

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Chemtopia gives honest consultation to clients

[Newsletter No.50] Full Revision of (M)SDS System in Korea : Promulgation of Subordinate Ordinance

The obligation to submit SDS to KOSHA has become clear as the full revision bill of Enforcement Decree and Rule of Occupational Safety and Health Act was announced in December 2019. While the relevant detailed notice is expected to come out around this April, all companies will have to prepare for in-house verification of SDS reliability in advance starting from this year.

ISSUE & FOCUS

Ⅰ. Obligation for submission of SDS
Ⅱ. Approval of SDS trade secrets
III. Industry advice

Ⅰ. Obligation for submission of SDS

○ SDS submission method and period (Article 157, Enforcement Rule of the Occupational Safety and Health Act)

► Submitter: Manufacturer or importer
► Submission period: Electronic submission to KOSHA (Korea Occupational Safety and Health) before manufacture or import of substances subject to making SDS.
► Penalty: An administrative penalty of not more than 5 million KRW shall be imposed to any business owner who fails to submit SDS or data on components substances not listed on the SDS.

○ SDS sections to be changed and its submission period (Article 159, Enforcement Rule of the Occupational Safety and Health Act)

► Submit without any delay when falling under any of the following changes:

1) Change of a product name (limited to cases where the name and content of components are not changed);

2) Change in the name and content of chemical substances corresponding to GHS classification criteria among chemical substances constituting substances subject to SDS (limited to cases where the name of a product is not changed but only the name and content of components are changed);

3) Change in the hazardousness to health and the environment and physical dangerousness

► Penalty: An administrative penalty of not more than 3 million KRW shall be imposed to any person who fails to provide the changed SDS.

○ How to provide SDS (Article 160, Enforcement Rule of the Occupational Safety and Health Act)

► Provide SDS including the number assigned on submitting SDS via the SDS IT system;
► When handing over or providing the same product to any identical counterparty, he or she may not provide SDS additionally unless there is any change in the SDS but shall provide it if there is any request from the counterparty.

○ When providing any chemical substance that is not classified, make sure to notify in writing that it is not classified.

► When providing the relevant information with SDS, it is considered as having notified it in writing;
► The person, notified in writing about the relevant information, shall keep the document handy within the place of business.

Ⅱ. Approval of SDS trade secrets

○ Documents submitted to apply for approval of non-disclosure or its extension (Article 161, Enforcement Rule of the Occupational Safety and Health Act)

1. Evidence document which proves that the name and content of a chemical substance to be listed as alternative data are trade secrets;
2. Alternative data (Name and content in substitution for the name and content of a chemical substance);
3. The name and content of a chemical substance, hazardousness to health and the environment and physical dangerousness information as alternative data;
SDS;
4. The name and content of a chemical substance that is not classified according to GHS criteria;
5. Other documents that are required to approve the name and content of a chemical substance as alternative data, determined and notified by the Minister of Employment and Labor.

(However, the above-mentioned data 1 to 6 may be omitted when an application for approval is filed to include as alternative data the name and content of a chemical substance on SDS regarding the R&D chemical substances or products determined and notified by the Minister of Employment and Labor.)

○ Application for approval of extension

An application for approval of extension shall be filed 30 days earlier than expiration date.

► Penalty: An administrative penalty of not more than 5 million KRW shall be imposed to any person who has prepared alternative data without receiving the approval of the Minister of Employment and Labor and failed to provide information on the name and content of a chemical substance on the alternative data despite the request for provision of non-disclosure information.

○ Criteria, procedures, methods, etc. for approval of non-disclosure and its extension (Article 162, Enforcement Rule of the Occupational Safety and Health Act)

► KOSHA shall determine whether or not to approve non-disclosure and extension application and notify the result within one month after receipt of the application. However, they may extend the review period to be within 10 days when it is difficult to make a decision owing to unavoidable circumstances;
► For R&D chemical substances and products, KOSHA shall notify the result of approval within 2 weeks after application;
► KOSHA may request correction or supplementation on submitted data (In that cases, the above notification period doesn’t include the period from request for correction or supplementation to submission of relevant data).

○ Procedures for filing an objection, reviewing the approval of non-disclosure, etc. (Article 163, Enforcement Rule of the Occupational Safety and Health Act)

► If there is any objection to the result of approval, make sure to file a reason for objection within 30 days from notification;
► KOSHA shall review the details of objection and notify the result within 20 days from receipt of objection.

○ Appointment requirements for person(s) appointed by overseas manufacturers, reporting procedures, etc. (Article 166, Enforcement Rule of the Occupational Safety and Health Act)

Documents required for appointment:

► Documents to show resident of Korea or corporation having an address within the Korea;
► A copy of a written appointment agreement or documents evidencing dismissal;

With those documents, reginal employment and labor offices shall issue the certificate of report within 7 days.

► Penalty: An administrative penalty of not more than 5 million KRW shall be imposed to any overseas manufacturer who falsely performs any of the above tasks.

○ Preparation of SDS and submission period (Article 9, Supplementary Provision)

► The annual quantity of manufacture and import for material subject to SDS is >1,000 tons: No later than Jan. 16, 2022;
► The annual quantity of manufacture and import for material subject to SDS is 100 to 1,000 tons: No later than Jan. 16, 2023;
► The annual quantity of manufacture and import for material subject to SDS is 10 to 100 tons: No later than Jan. 16, 2024;
► The annual quantity of manufacture and import for material subject to SDS is 1 to 10 tons: No later than Jan. 16, 2025;
► The annual quantity of manufacture and import for material subject to SDS is <1 ton: No later than Jan. 16, 2026.

III. Industry advice

○ Continuous monitoring is required as detailed notice is expected to come out around this April;
○ It is important to verify the reliability of in-house SDS and prepare for revision of SDS as its submission to KOSHA becomes mandatory;
○ It is also critical to establish in-house policies on chemical substances subject to trade secrets by preliminarily screening out highly risky or highly hazardous chemical substances with little possibility of getting approval, etc.
○ For imported products, consider submitting SDS or filing an application for review through legal representatives, like consultancy;
○ It is necessary to follow up through SDS updating on ever-changing legislations or information.

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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