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[Newsletter No. 32] A full revision (draft) of Industrial Safety and Health Law (ISHL)

Date :2019.03.26

NEWS LETTER 2019.(VOL.32)

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Chemtopia gives honest consultation to clients

[Newsletter No. 32] A full revision (draft) of Industrial Safety and Health Law (ISHL)

Dear precious clients,

On February 9th, 2018, a full revision (draft) of Industrial Safety and Health Law (ISHL) is announced. This full revision includes introduction of MSDS audit system MSDS audit system and we would like to share about this detail with you.

The key of this revision is that all MSDS of chemicals and chemical products being circulated in Korea may need to be submitted to the Ministry of Employment and Labor (MoEL). Also, in case that chemical component or content considered as CBI are included in MSDS, it needs to be reviewed and approved, hence it is expected that an increase of expense for industry to prepare an application for this review is inevitable.

ISSUE & FOCUS

I. Obligation of Submitting MSDS
II. Introduction of MSDS Audit System for CBI protection
III.Introduction of OR system
IV. Countermeasure of Industry

I. Obligation of Submitting MSDS

Ⅰ. Obligation of Submitting MSDS

1. MSDS submission
Those who manufacture or import a chemical substance or a mixture containing this chemical substance need to prepare and submit MSDSs to the Minster of MoEL (Article 113 of ISHL amendment (draft)).

- Product name

- Chemical name and its contents corresponding to hazard and risk classification standard on MSDS

- Handling precaution for Safety and health

- Human health and environmental hazard and physical risk

- Others designated by the MoEL’s presidential decree

2. Duty of submitting a changed MSDS
If a chemical composition or other components designated by the MoEL are changed on MSDS, those changes need to be reflected on MSDS and submitted to the Minister of the MoEL.

3. Duty of revising and submitting MSDS every 5 years
Those who make MSDS and then provide it, need to submit MSDS to the Minister of the MoEL within 5 years after the amendment is implemented

II. Introduction of MSDS Audit System for CBI protection

II. Introduction of MSDS Audit System for CBI

Manufacturers / importers of chemical substances are obligate to prepare MSDS and should list the name and the content of chemical substance. However, if they are reluctant to disclose the information, they can write down a substituted names and content of the chemical with the approval of the Minister of MoEL after the audit.

1. Applicant

- Chemical manufacturer/importer with obligation to prepare MSDS.

However, a company just using chemical cannot apply for CBI.

2. Applicable information

- Section 3 of MSDS : Name and content of components

- Exempt from CBI (3,610 species)
: Prohibited chemicalssuch as manufacturing, chemicals subject to authorization, hazardous chemicals under control by ⌜Industrial Safety and Health Law⌟ and toxic chemicals by ⌜Chemical Control Act⌟

- Chemicals that cannot be applied for CBI
: Highly hazardous classified substances for human health and environment are basically prohibited from applying for CBI.

- 5,995 species classified as highly hazardous substances for human health and environment among 18,737 species of MSDS database of Korea Occupational Safety and Healy Agency (KOSHA)

3. Object of MSDS audit on CBI
It is to classify object of CBI according to hazards and risks classification of chemical components.

- Highly hazardous substances for human health and environment: Exclusion of applying CBI
- Hazard/Risk substance: Substance to be audit
- Substances not classified as hazardous or risky: Substance to be subject to simple audit

4. Contents of CBI audit
- Review of alternative information: Name and content that may substitute chemical name and content ("Alternative information")
- Necessity of non-disclosure of CBI application contents, suitability of MSDS, and review of the suitability of alternative information

5. CBI audit
- The audit result shall be notified to applicant.
- CBI approval shall be valid for 3 years. If applicant wants its extension, he/she can renew it.
- Approval shall be cancelled if it is approved by fraud or other wrongful means

6. CBI audit agency
- A department of KOSHA and its professional staff shall make frequent inspections.

7. Enforcement date and interim measures
- When making inspections of existing MSDS containing CBI, grace period will be set in accordance with manufacturing and importing volume.

8. Fee and penalty
- Fee : For applying CBI audit
1) General audit : Approx. US $100/MSDS
2) Simple audit : Approx. US $50/MSDS

- Penalty : It shall be imposed no more than US $5,000 per case in case of missing audit

III.Introduction of OR system

Only Representative (OR) appointed by overseas manufacturer may submit MSDS and apply for CBI audit. In other words, a person who intends to export to Korea a chemical subject to MSDS shall appoint a person (OR) who is qualified as prescribed by the MoEL’s presidential decree to carry out the following tasks:

- Submission of MSDS and its composition
- Application for approval of CBI

* But, it shall be reported to the Minister of MoEL about OR appointment by the overseas manufacturer.

IV. Countermeasure of Industry

Ⅳ. Industry’s Countermeasures
Please submit your comments/opinions on the proposed amendment via Pre-Announcement of
Legislative Center’s online site (http://opinion.lawmaking.go.kr) by March 21st, 2018.

- Re-organization of company’s MSDS
: All MSDS needs to be submitted to the MoEL and to be renewed every five years (But, it is obligated to submit a changed MSDS when there are any changes), therefore it is necessary to secure the reliability of the hazard classification and MSDS contents for all MSDS. Especially, it is necessary to secure the quality of MSDS with Section 2. Hazard classification and Section 15. Regulatory information

- Deciding object subject to CBI audit
: If apply for CBI audit, you should pay attention to the selection of the target, as it costs US $50-100 per substance and per product. To this end, it is necessary to continuously check the relevant information, as the results of the GHS classification by the KOSHA and other EU classification results such as EU CLP and other regulated substances of the Ministry of Environment and the Ministry of Employment are restricted.

- It is necessary that foreign manufacturer/exporter appoints OR to apply CBI audit and determines the subject of paying cost, if the substance’s information should be protected.

- Supply Chain Management
: In the case that chemicals subject to CBI audit are included in supply chain, each product containing such substance along supply chain are subject to CBI audit, so that it is very important to manage supply chain.

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

1203~6 Daerung post tower 7th, 48, Digital-ro No. 33,
Guro-Gu, SEOUL, 08377, KOREA

TEL : +82-2-826-9100, FAX : +82-2-877-0674

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