South Korea Regulatory News

Chemical Regulations Updates in 2020 K-REACH K-REACH requires registration for all existing chemicals manufactured and imported to South Korea in quantities exceeding 1 ton per year. Joint r...

Chemical Regulations Updates in 2020

K-REACH

K-REACH requires registration for all existing chemicals manufactured and imported to South Korea in quantities exceeding 1 ton per year. Joint registration is mandatory under K-REACH unless the MoE authorizes a business 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. 

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) more than 1 ton per year.

Over 17,045 substances were pre-registered by the end of January 2021, according to the Ministry of Environment (MoE) in South Korea. After the pre-registration, the next step is to join a Chemical Information Communicative Organization (CICO, corresponding to SIEF in EU-REACH) of a pre-registered substance and prepare registration dossier.

On 2 November, the MoE in South Korea announced the revised K-REACH rules. The reason is to ensure effective implementation of the K-REACH regulation. First, registrants can enjoy an extended deadline for change registration. The deadline is extended up to 1 year, and the authority's confirmation is required. Chemical Classification and Labeling standards between different ministries will be harmonized to enhance consistency. Finally, the government's registration fees will be exempted for SMEs manufacturing and importing 1-10 t/y, if they register their substances before 2022.

K-BPR

K-BPR, also known as the Consumer Chemical Products and Biocide Safety Management Law, regulates safe consumer products and biocidal products. Essential requirements for these regulations consist of chemical risk assessment and authorization. It took into force on 1 January 2019 and its recent amendment in 2020 which has been enforced since 1 January 2021.

The amendment includes that non-Korean manufacturer can appoint an Only Representative to register biocidal active substance. Dossier submission will be exempted once submitted for K-REACH compliance, and the MoE will disclose the chemical ingredients list in the detergents, air fresheners and disinfectants.

Trade status

According to UN Comtrade's analytics[1], India is the 8th largest chemical supplier to South Korea, indicating a continuous increase in export since 2013. To India, South Korea remains 6th largest chemical supplier following China, USA, Germany, Japan and Netherlands. DGCI analytics[2] shows that Organic chemicals are India's 3rd largest commodity exported to South Korea in recent years. 

Table 1. India's Exports of Chemical Products to South Korea[3]

Summary

Given trade statistics in recent years, it can be expected that chemicals will continue to be one of the crucial commodities in the trade between India and South Korea. As South Korea has tightened chemical regulations for safe chemical use, it might become a potential barrier for Indian chemical exporters. The Indian exporters shall appoint the Only Representative with a legal entity in South Korea to prevent non-compliance and meet regulatory requirements. In order to comply with the relevant regulations, it is necessary to proactively inform Indian exporters the recent regulatory updates. Also, collecting industry opinions about challenges and recommendations would be helpful for regulatory improvement.

Last update: 2021-02-12

[1] https://comtrade.un.org/labs/data-explorer

[2] http://www.dgcisanalytics.in/dgcis/EXIM-Analytics

[3] https://www.trademap.org/Index.aspx?AspxAutoDetectCookieSupport=1

South Korea added three substances in the 741 existing biocidal substance list therefore, the total number of biocidal chemicals in the existing list becomes 744 entries. It includes: Chlori...

South Korea added three substances in the 741 existing biocidal substance list therefore, the total number of biocidal chemicals in the existing list becomes 744 entries. It includes:

• Chlorine dioxide generated from sodium chlorite by oxidation (CAS 10049-04-4)
• Active chlorine released from sodium chlorosulfamate (CAS 13637-90-6)
• Active chlorine generated from sodium chloride by electrolysis

Each substance has limited use, for instance, the first substance (CAS 10049-04-4) can only be used as a disinfectant; The second substance as preservatives for materials and equipment; and the third substance as a disinfectant. Once They all have extended full registration deadline of 2029 December 31.

In the same announcement, the MoE updated full registration deadline for 34 substances in the existing 741 biocidal list and the allowed uses.

Affected stakeholders and implications

Manufacturer and importer of the biocidal substances in the existing list shall submit an Approval Plan to benefit from the extended full registration deadline. In the case of a non-Korean manufacturer, one can appoint an Only Representative to comply with K-BPR obligations.

Update: 2021-1-13

The recent MSDS amendment in South Korea was enforced on 16 January 2021. This amendment requires chemical manufacturers and importers to deliver and submit an MSDS to the competent auth...

The recent MSDS amendment in South Korea was enforced on 16 January 2021. This amendment requires chemical manufacturers and importers to deliver and submit an MSDS to the competent authority (Korean Occupational Safety and Health Agency, KOSHA) via the IT system. Besides, an MSDS has to be submitted before the manufacture and import; and the due date for submission varies depending on the tonnage band. At the earliest, it should be done by 2022 January 16 for those who manufacture and import more than 1000 tpa and the latest due date will be 2026 for less than 1 tpa tonnage band.

The second important aspect of the MSDS amendment is that non-disclosure of Confidential Business Information in an MSDS shall be approved in advance. Substance information that considers as confidential for instance, substance name and contents shall not be left blank but should be written with alternative names or contents. Last but not the least, according to the amended MSDS regulation, non-Korean manufacturers should appoint an Only Representative to fulfill their responsibility of submitting an MSDS.

Affected stakeholders and implications

Manufacturer and importer of chemical substances should submit an MSDS to the KOSHA via the IT system. As a non-Korean manufacturer, you can appoint an Only Representative to comply with regulatory obligations. GPC Korea provides services including drafting an MSDS and submitting the MSDS to the authority as an OR. GPC Korea will keep your MSDS up-to-date according to the recent regulatory requirements and translate it into a local language. 

Update: 2021-01-14

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