South Korea Regulatory News

The Ministry of Environment (MoE) in South Korea updated the list of pre-registered substances, which in total becomes 17,096 substances. The list includes 1,800 substances that are manufactured ...

The Ministry of Environment (MoE) in South Korea updated the list of pre-registered substances, which in total becomes 17,096 substances. The list includes 1,800 substances that are manufactured and imported more than 1000 tpa and 78 CMR substances. The full registration deadline for these substances is by 31 December this year.

The MoE indicates no extension to the 2021 registration deadline though there was three months extension for 510 Priority Existing Chemicals (PEC) registration in 2018. 

Companies shall aim to complete full registration at least three months before the deadline as it might take some time to get a registration certificate due to a compliance check. The MoE regularly monitors pre-registration status e.g. tonnage band so that the companies can meet the deadline. 

Last update: 2021-05-11

The Ministry of Environment in South Korea plans to include lubricants in the list of products subject to safety checks. 39 consumer products have been listed in K-BPR that will need safety c...

The Ministry of Environment in South Korea plans to include lubricants in the list of products subject to safety checks. 39 consumer products have been listed in K-BPR that will need safety checks. The draft amendment proposed to include lubricants under the 'coatings' category. Once this draft is approved and implemented, lubricants manufacturers and importers should obtain a certificate of effectiveness and efficacy. 

Moreover, the amendment bans the following five substances in lubricants:

• vinyl chloride;
• tetrachloroethylene;
• trichloroethylene;
• dichloromethane; and
• ethylene dichloride.

Further, it restricts the following substances: 

• formaldehyde – 70 milligrams per kilogram (mg/kg) or less;
• acetaldehyde – 50mg/kg or less;
• benzene – less than 10mg/kg;
• bis(2-ethylhexyl)phthalate – 800mg/kg or less;
• naphthalene – 100mg/kg or less; and
• nickel – 100mg/kg or less.

Last updates: 2021-04-16

A new chemical risk assessment reporting system also known as Chemical Accident Prevention Management Plan (CAPMP) has been in place since April 1 in South Korea. This new syst...

A new chemical risk assessment reporting system also known as Chemical Accident Prevention Management Plan (CAPMP) has been in place since April 1 in South Korea. This new system integrates two existing risk reporting systems - an off-site consequence analysis report and a risk management plan. This reporting system is expected to reduce redundancy and processing time. 

Any facilities managing controlled substances under Chemical Control Act (CCA) should submit to this new plan. Depending on the risks of a substance and its amounts, facilities are categorized into two groups - Group one and two.

Basic information of the substances, risk management plan, and onsite emergency plan are required for all facilities regardless of the facility category. On the other hand, Group one facilities where they have more risks to human and the environment should submit an off-site emergency plan. 

All the submitted reports will be reviewed and inspected by the National Institute of Chemical Safety (NICS). If the reports are not approved, the facilities should re-submit within two months. The reports should be updated every five years.

Last update: 2021-04-16

The Ministry of Environment (MoE) in South Korea has announced late pre-registration criteria on 23 February. Existing substances are chemicals that have been circulated in South Korea before 199...

The Ministry of Environment (MoE) in South Korea has announced late pre-registration criteria on 23 February. Existing substances are chemicals that have been circulated in South Korea before 1991 or nominated by the MoE after the hazards assessment. The initial pre-registration was 30 June 2019.

Late pre-registration is allowed when:

• A company is manufacturing/importing existing substances more than one tonne per year for the first time in South Korea
• The existing substances that the ministry has added to the inventory recently
• The importers initially notified the existing substance but OR will proceed with full registration

Companies that have done pre-registration can continue to manufacture or import chemicals without registration. The first full registration deadline is December 2021, for existing chemicals manufactured or imported more than 1000 tonnes per year and CMR substances manufactured or imported more than 1 tonne per year. 

Last update: 18 March 2021 

Persistent Organic Pollutants (PoPs) will be added to the priority control substance list under K-REACH. The Ministry of Environment in South Korea published the national PoPs management plan on 2...

Persistent Organic Pollutants (PoPs) will be added to the priority control substance list under K-REACH. The Ministry of Environment in South Korea published the national PoPs management plan on 28 January. However, the implementation date is not yet decided.

According to this new plan, manufacturers producing products with priority control substances will need to submit an additional report. The new national plan applies to the years 2021-25 and the substances that are subject to this new plan includes PCBs, PFASs e.g. perfluorooctanoic acid (PFOA), and perfluorooctanesulfonic acid (PFOS). 

Last update: 18 March 2021 

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

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