South Korea Regulatory News

The “Occupational Safety and Health Act” was revised on January 15, 2019 and came into effect from January 16, 2020. In relation to this Act, the “Material Safety Data Sheet&rdqu...

The “Occupational Safety and Health Act” was revised on January 15, 2019 and came into effect from January 16, 2020. In relation to this Act, the “Material Safety Data Sheet” (MSDS) was recently revised and will be effective from January 16, 2021. Summary of the revised MSDS regulation in Korea:

• The definition of MSDS preparation and submitter is changed to a person who manufactures or imports (revised) chemical substances, etc. (Initially it was a person who transfers or provides chemical substances)
• Health functional foods and hygiene products have been added to the exclusion of MSDS preparation and submission.
• For R&D chemical substances, MSDS must be prepared, but submission obligations are exempt.
• If MSDSs are not submitted, a penalty of 5 million won (KRW) or less will be applicable.
• Previously it was possible for companies to hide name and content of the ingredients to secure the trade secret and recipes of the products. However as per the revised laws, an approval from Minister of Employment and Labor is required.
• Research and development (R&D) chemicals are subject to closed review, but the review process is simplified
• As per the revised regulation an administrative fine of not more than 5 million won (KRW) will be imposed on those who write alternative data without the approval of the Minister of Employment and Labor and those who do not provide the alternative name and content information despite the request for non-public information.
• If a chemical substance is likely to cause serious health hazards to workers then its information shall be submitted and notified to the Minister of Employment and Labor after deliberation by the Workers' Compensation Committee''

Korea MSDS – Comparison with the previous version

Submission of information, etc. by a person appointed by a foreign manufacturer (Article 113 of the Industrial Safety Act)

※ Additional data need to be submitted: proof of appointment (dismissal), such as proof of appointment requirements and a copy of the appointment contract

Special cases (grace period) for preparing and submitting MSDS

ㅇ Persons who have created or modified the existing MSDS according to the previous legislation at the time of enforcement date (January 16, 2021) (limited to those who manufactured or imported the target chemical substance among those who transferred or provided the target chemical substance) MSDS and data on the name and content of chemical substances must be submitted by the date determined by Ordinance of the Ministry of Labor.

※ The ‘Days determined by Ordinance of the Ministry of Employment and Labor’ in Article 8 of the Supplementary Regulations of the Industrial Safety Act No.

Last update: 12/11/2020

On November 2, the Ministry of Environment (MoE) in South Korea announced the revised K-REACH rules. The reason is to ensure effective implementation of the K-REACH regulation. Four main revisions...

On November 2, the Ministry of Environment (MoE) in South Korea announced the revised K-REACH rules. The reason is to ensure effective implementation of the K-REACH regulation. Four main revisions were proposed:

1. Registrants can have an extended deadline when changing the tonnage band and chemical usage of the registered substances

• Currently, change registration should be completed within one month after the changes in quantities or the usage
• Since toxicological data might be required due to changes in quantities and usage, the MoE makes it possible to extend the deadline of the change registration. It needs confirmation from the MoE and registrants can extend the deadline up to 1 year

2. Aligned confidentiality approval processes between the different competent authorities

• The competent authority under K-OSHA, the Ministry of Employment and Labor (MoEL), and the MoE can now coordinate together and share the information. It is expected to ease registrants’ burden to go through different approval processes  

3. Integrated different terms for chemical Classification and Labelling used in various ministries

• This will enhance consistency of the chemical Classification and Labelling and prevent confusion   

4. The government registration fees will be exempted for SMEs if they register their substances before 2022

• This is to encourage SMEs to register their substances early and Only applicable for those who have a grace period until 2030

Affected stakeholders and implications

Registrants who need to change their tonnage band or chemical usage can have 1 year to prepare toxicological data after getting confirmation from the MoE.

SMEs do not need to pay the government registration fees if they register before 2022.

Industries can refer to the consolidated version of chemical Classification and Labelling in South Korea.

Last update: 11/17/2020

Ministry of Environment (MoE) in South Korea announced detailed rules for companies that do not want to disclose confidential business information under K-REACH. These new rules outline processes ...

Ministry of Environment (MoE) in South Korea announced detailed rules for companies that do not want to disclose confidential business information under K-REACH. These new rules outline processes to get approval from the MoE along with official forms, which will come into force on 16 January 2021.

Businesses need to make an application to get approval. The application shall include reasons for not disclosing chemical information, and proof justifying the reasons. Approval is not required in cases where non-disclosure is already approved under the same rules or the Occupational Safety and Health Act (OSHA). Although non-disclosure is approved, businesses still need to provide substitute information in an MSDS if required.

Once an application is received, the Information Review Committee will check and evaluate the validity of the application, then provide the result within 30 days. The Committee might ask for additional information or interview. Applicants should respond to the Committee’s request, otherwise, the application will be withdrawn. In case the application is rejected, the applicant can appeal within 15 days after they received the result.

The MoE will review the rules every three years.

Affected stakeholders and implications

Companies who are subject to K-REACH and do not want to disclose chemical information due to confidentiality reasons can apply for non-disclosure of confidential information to the MoE. The new rules are applicable on 16 January 2021.

Last update: 11/10/2020 

The Ministry of Environment pre-announced partial amendments of the two subordinate laws (the Enforcement Decree and the Enforcement Rules) of the Consumer Chemical Products and Biocides Safety Act (K...

The Ministry of Environment pre-announced partial amendments of the two subordinate laws (the Enforcement Decree and the Enforcement Rules) of the Consumer Chemical Products and Biocides Safety Act (K-BPR) on 30 July 2020. The proposed date of adoption is after November 2020 and the amendments are expected to be enforced on 1 January 2021.

The main purpose of the two subordinate laws amendments is to specify details according to the K-BPR amendment adopted on 24 March 2020.

Major changes in the Enforcement Decree of the K-BPR

• Determined exemption list (substance or article) from compliance check, notification, or approval (the Article 1-2)
• Determined methods to apply for notification and approval of any changes occurred in the already notified or approved Consumer Chemical Products subject to Safety Check (the Article 5 & 6)
• Added similarity criteria that are applied to imported treated articles (the Article 23, paragraph 1)
• Added reasons to allow repeated vertebrate tests (the Article 25-2)
• Specified the minimum period of work experience required for technicians of testing institutes (the Article 33)
• Revised the list of additional works that can be done by a representative assigned by overseas manufacturer and information that the representative shall inform the importers (the Article 39-2)

Major changes in the Enforcement Rules of the K-BPR

• Outlined the procedure for confirming whether a substance or article is subject to exemption from compliance check, notification, or approval (the Article 1-2)
• Determined the list of changes to be notified or approved regarding the already notified or approved Consumer Chemical Products subject to Safety Check, and provided relevant application forms (the Article 5 & 6)
• Specified the list of information on Consumer Chemical Products subject to Safety Check that shall be disclosed to the public (the Article 7-2)
• Revised a joint submission procedure for approval, and relevant data requirements (the Article 15 & 16)
• Determined a method to allow a temporary exemption to biocidal products from the approval at a time of emergency (the Article 24 paragraph 6 -11)
• Prohibited displaying any indication or expression on packaging and advertisement if it claims effect or efficacy that is different to those notified to or get approved by the competent authorities (the Article 34)
• Specified a standard for manufacture or storage facilities to ensure quality management of approval-required products, and safety control standard thereof (the Article 36-2 & 40)
• Specified qualification of a representative to be assigned by the overseas manufacturer, and a procedure for notifying the competent authorities of the assignment or dismissal (the Article 50)

Affected stakeholders and implications

Chemical manufacturers, importers and only representative should be aware of major changes in the Consumer Chemical Products and Biocides Safety Act (K-BPR) and its two subordinate laws to comply with regulatory obligations of your concerned substance. Please note that these amendments will be enforced from 1 January 2021.  

Relevant Services provided by GPCKOREA

• Regulatory compliance support
• Only Representative to fulfil various obligations under K-REACH

Last update: 2 September 2020

The Chemical Product Safety Act, often known as K-BPR, enforced on 1st January 2019, regulates safety management of consumer products and biocidal products. The amendment of this Act was approved...

The Chemical Product Safety Act, often known as K-BPR, enforced on 1st January 2019, regulates safety management of consumer products and biocidal products. The amendment of this Act was approved by South Korea’s Parliament and Cabinet on 4 March 2020. It will enter into force from 1stJanuary 2021. Key summaries of the amendment are (* refers to the amendment that will come into force immediately from the approval date of the amendment): 

1. Non-Korean manufacturers can appoint an Only Representative (OR) to register biocidal active substances,
2. The defined biocidal active substances can be manufactured and imported during the transition periods*,
3. Data submission for biocidal products approval can be exempted when the data are already submitted under K-REACH*,
4. The Ministry of Environment discloses information on the notified and approved consumer products including the product name, manufacturer or importer details and the main components of the product etc.,
5. Measures to reduce vertebrate animal testing

For further information, please feel free to contact us compliance@gpcregulatory.com 

South Korea’s Occupational Safety and Health Act (often called KOSHA) amendment on material safety data sheets (MSDSs) takes into force on 16 January 2021. Chemical manufacturers and importers s...

South Korea’s Occupational Safety and Health Act (often called KOSHA) amendment on material safety data sheets (MSDSs) takes into force on 16 January 2021. Chemical manufacturers and importers shall prepare and submit an MSDS to the Ministry of Employment and Labor (MoEL). Besides, it becomes mandatory for a company to get a non-disclosure approval from the MoEL in the case where a company is reluctant to disclose certain chemical information in an MSDS. The following section outlines major changes in the amendment, affected stakeholders and its implications.

Major Updates

The KOSHA amendment implies changes in obligations and processes to prepare and submit an MSDS, which are summarized into four sections as follows: an MSDS preparation and submission; an MSDS provision; chemical information non-disclosure approval and only representative (OR) appointment.   

An MSDS preparation and submission

Chemical manufacturers and importers shall submit an MSDS for GHS classified chemicals or compounds (chemicals subject to MSDS) to the MoEL before manufacture and import. For non-GHS classified chemicals, they shall either include the name and content of chemicals in an MSDS or submit a confirmation document proving that chemicals are not GHS classified. In case of non-compliance, a penalty of not more than 5 million KRW (equivalent to 5,000 USD) will be charged.

Chemical manufacturers and importers are entitled to a grace period for an MSDS preparation and submission for a product that is already distributed on the market. The grace periods vary depending on the annual manufacture and import volume of the product.  

The below table shows a summary of the comparison before and after the amendment.  

An MSDS provision

Chemical suppliers shall provide an MSDS to their chemical recipients. Changes in the submitted MSDS shall be reported to the recipients accordingly. For those who failed to provide an MSDS to their chemical recipients, a penalty of not more than 5 million KRW (equivalent to 5,000 USD) will be charged. In case of negligence in reporting the changes of the MSDS, a penalty of not more than 300 million KRW (equivalent to 3,000 USD) will be charged.

Chemical information non-disclosure approval

Where a company does not want to reveal certain chemical information such as names and contents in an MSDS due to confidentiality reason, a pre-approval from the MoEL is required. For communication of the hazards and risks of such substances in the supply chain, alternative names for such substances and their composition shall be provided when submitting a pre-approval application. Once approved, it is valid for five years, which shall be renewed a month before the current approval period expires.

The authority shall inform the result of whether or not to approve an application within a month after the receipt of the application. Chemical substances used for R&D purpose have shortened and simplified process for the approval, for instance, the result shall be informed within two weeks of the application. A company objects to the authority’s decision can appeal within a month from the receipt of the decision, and then the appeal result shall be informed within 20 days.

Only Representative (OR) appointment

If overseas chemical manufacturers are reluctant to provide their chemical information to importers in South Korea, they can appoint an only representative (OR). On behalf of an overseas manufacturer, an OR submits an MSDS that includes chemical composition, its hazards, and risks; chemical information that is not GHS classified; and applies for MSDS non-disclosure approval.

Key affected stakeholders and implications

The KOSHA amendment on MSDS as outlined above will be enforced from 16 January 2021.

Chemical manufacturers and importers are obliged to submit MSDSs to the Ministry of Employment and Labor (MoEL). When there are changes in MSDSs, they shall revise and share them with their chemical buyers.

The deadlines for an MSDS submission depend on the volume of the chemicals they manufacture and import, for instance,

• the volume over 1,000 tons per year shall submit their MSDSs to MoEL by 16 January 2022
• the volume above 100 tons below 1,000 tons per year by 16 January 2023
• the volume above 10 tons below 100 tons per year by 16 January 2024
• the volume above 1 ton below 10 tons per year by 16 January 2025
• the volume less than 1 ton per year, by 16 January 2026 respectively

When companies are reluctant to disclose chemical information due to confidential reasons, non-disclosure approval from MoEL is required. They need to prepare technical information such as alternative names of the substances. Such companies shall be aware that substances having high risks and hazards might not be approved for non-disclosure approval.

Overseas manufacturers and exporters can appoint an OR to fulfil obligations under the KOSHA.

Relevant Services provided by GPCKOREA

• Regulatory compliance support
• Technical assistance for an MSDS preparation
• Only Representative to fulfil various obligations under KOSHA

Updated: 17 July 2020

The first registration deadline under K-REACH is by 31 December 2021, which applies to those who manufacture and import existing chemical substances exceeding 1,000 tons per year, or carcinogenic, mut...

The first registration deadline under K-REACH is by 31 December 2021, which applies to those who manufacture and import existing chemical substances exceeding 1,000 tons per year, or carcinogenic, mutagenic, or reproductive toxins (CMR) at more than 1 ton per year.

16,905 substances were pre-registered by the end of the pre-registration deadline according to the Ministry of Environment (MoE) in South Korea. The next step after the pre-registration is to join a Chemical Information Communicative Organization (CICO, corresponding to SIEF in EU-REACH) of a pre-registered substance and prepare registration. The following section explains how to comply with K-REACH registration and affected stakeholders. 

How to comply with K-REACH registration

K-REACH requires registration for all existing chemicals manufactured and imported in quantities exceeding 1 ton per year. Joint registration is mandatory under K-REACH unless a business is authorized by the MoE for individual registration. Joint registration refers to forming a consortium consisted of several potential registrants to submit all necessary dossier for chemical substance registration under K-REACH.  

Businesses who want to register their chemicals shall join a CICO through CICO online platform, where they can form a consortium and elect a Lead Registrant (LR). The role of LR and active members in a CICO is to decide essential rules needed for a CICO management and prepare dossier required for registration. Besides, they pay for the costs to prepare dossier and consortium management, which will be reimbursed when passive members join the consortium.

After the pre-registration deadline, several CICOs have been formed to prepare joint registration. Besides, some CICOs already selected their Lead Registrant (LR) and proceeded data gap analysis to identify data requirements for registration of their pre-registered substances.

To register a chemical substance before the registration deadline, it is recommended to join a CICO of a concerning chemical substance as soon as possible, especially when a business wants to join as an active member. Potential registrants shall prepare information on their substances and communicate with all the downstream users to collect all the required information.

Affected stakeholders and implications

By 31 December 2021, existing substances manufactured and imported at more than 1,000 tons and CMRs at more than 1 ton per year shall be registered. As a first step, manufacturers and importers join a CICO of a concerning chemical substance. Then gather the required information on the substance, including downstream users company information and their use of the substance.

Late pre-registration is possible for those who manufacture and import existing substances in quantities exceeding 1 ton per year for the first time after the pre-registration deadline. It is possible until 12 months before the relevant grace period deadlines for registration.

Overseas manufacturers and exporters can appoint GPCKOREA as an only representative to fulfill obligations under K-REACH.

Relevant Services provided by GPCKOREA

• Regulatory compliance support
• Only Representative to fulfil various obligations under K-REACH

Updated: 17 July 2020