South Korea Regulatory News

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

The Consumer Chemical Products and Biocide Safety Act amendment, often known as K-BPR, was promulgated on 24 March, and 26 May 2020 and will be enforced on 1 January 2021. The following section outlin...

The Consumer Chemical Products and Biocide Safety Act amendment, often known as K-BPR, was promulgated on 24 March, and 26 May 2020 and will be enforced on 1 January 2021. The following section outlines a brief background of K-BPR and the significant changes from the recent amendment.

The K-BPR was enforced on 1 January 2019 and regulates safety management of consumer products and biocides. This is achieved by assessment or notification of consumer chemical products’ risks, authorization of biocidal chemical substances and products.

On 31 December 2019, 741 biocide active substances were announced by the Ministry of Environment (MoE). Unlike the EU-BPR, manufacturers and importers shall submit an ‘approval plan’ by 31 December 2020 to be eligible for grace periods. Once they submit the approval plan, they can manufacture and import their substances during the grace periods. Currently K-BPR has no rules for only representative (OR) and only the manufacturer or importer based in South Korea can submit the approval plan.  

Major updates

From 1 January 2021, non-Korean manufacturers and exporters of biocidal substances can appoint an OR based in South Korea to gain approval of the use of biocidal active substances, grace period reporting and new risk reporting.

The MoE will disclose information on the notified and approved consumer products including the product name, manufacturer or importer details and the main components of the product etc. Subsequent announcement has not been released yet, about how the information be circulated.

The amendment includes provision for minimizing vertebrate animal testing when producing test data required under K-BPR.

If biocidal products and treated articles contain a banned substance, one year of a grace period is applied to manufacturers and importers of biocidal products and two years for treated articles manufacturers and importers. In case where treated articles’ manufacturers and importers cannot comply with safety and labelling standards, the MoE grants one year to address this issue once they justify reasons.  

Consumer chemical products and biocidal substances used for research and development purposes do not require approval from the MoE. Besides, if required test data are already submitted under K-REACH after 1 January 2019, data submission for biocidal products will be exempted.

Affected stakeholders and implications

The K-BPR amendment as outlined above will be enforced on 1 January 2021.

Chemical manufacturers and importers shall submit an approval plan to gain grace periods.

Overseas manufacturers and importers can appoint an OR to fulfill obligations under K-BPR from 1 January 2021.

Relevant Services provided by GPC Korea

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

Updated: 17 July 2020

To reduce negative impacts from COVID-19 pandemic, the Ministry of Environment (MoE) plans to skip some documents required for new chemical substance registration from 1 January 2020 to 31 December 2021. This applies to new substances manufactured and imported in quantities between 100kg to 1 ton per year. The MoE will notify the list of chemical substances that are subject to this temporary amendment.

Affected stakeholders and implications

Once the MoE confirms the list of the chemicals, concerning substance manufacturers and importers can skip to submit the required documents when registration.

Updated: 17 July 2020

A South Korea’s industry support group published a list of 332 substances that require prompt CICO establishment. These substances are the cases where pre-registrants of a concerning chemical ha...

A South Korea’s industry support group published a list of 332 substances that require prompt CICO establishment. These substances are the cases where pre-registrants of a concerning chemical have not selected a Lead Registrant (LR) or no activities have been observed. The reason why the industry support group released this list is due to concerns of not meeting registration deadline on 31 December 2021.

Manufacturers and importers of existing chemicals in quantities exceeding 1 ton per year shall register their chemical substances before grace periods. The grace periods depend on the tonnage of the manufactured and imported chemicals, which are described as below.

The list of 332 substances can be found on the right sidebar, ‘Downloadable Content’.  

Affected stakeholders and implications

Manufacturers and importers should initiate dossier preparation and communicate other co-registrants and LR in a CICO to register existing substances at more than 1000 tons per year and designated CMR substances at more than 1 ton per year by the registration deadline (31 December 2021).

Update: 17 July 2020

Unlike EU-REACH, K-REACH requires manufacturers and importers to register polymers. Based on definitions and scope of polymer registration specified in K-REACH, they shall either register manufactured...

Unlike EU-REACH, K-REACH requires manufacturers and importers to register polymers. Based on definitions and scope of polymer registration specified in K-REACH, they shall either register manufactured and imported polymers or apply for an exemption certificate. This article will introduce key definitions, scope, major obligations, and processes of registration/exemption.

Scope

Key definition (K-REACH Enforcement Decree Article 2)

• Monomer: a chemical substance forms a polymer in combination with at least two other molecules and a reactant that forms a part of the polymer engaging in such chemical reaction
• Monomer unit: a structure where monomers are repeated in a polymer
• Polymer is
  • Composed of molecules in which at least one kind of monomer unit is continuously repeated,
  • Representing the characteristic distribution of molecular weights in accordance with repetitive numbers of monomer units in each molecule,
  • Molecules consisted of at least three monomer units forming a covalent bond with at least one monomer unit or other reactants be >= 50%
  • Molecules of the same molecular weight are < 50% of the weight ratio
• Number average molecular weight (Mn): the value obtained by dividing the total molecular weight of all molecules consisting of a polymer by the total number of molecules

Exempted polymers

Polymers are exempted from registration and reporting (often called “polymers having less concern”, K-REACH Enforcement Decree Article 11, paragraph 1) when their:

• Mn >= 10,000 & the contents of molecules weighted < 1,000 is less than 5% & the contents of molecules weighted < 500 is less than 2%
• 1,000 =< Mn molecular weight < 10,000 & the contents of molecules weighted < 1,000 is less than 25% & the contents of molecules weighted < 500 is less than 10%

Non-exempted polymers

Although polymers meeting exemption criteria, the outlined polymers require registration and reporting (K-REACH Enforcement Decree Article 11, paragraph 2):

• A cationic polymer (except the one used in solid form, not dissolved and soluble in water)
• A polymer whose Mn < 10,000 & having an unreacted monomer >= 0.1% by weight which are,
  • A hazardous substance,
  • A substance subject to intensive control,
  • A non-phase-in substance (excluding the ones have had a hazard review)

Polymer registration process

The polymer registration process is alike with Existing and New substance registration. Polymer registration starts from identifying a substance and join a CICO, which is a substance registration committee like a SEIF under EU-REACH. After a CICO is formed, Lead Registrant (LR) and all potential registrants sign a CICO agreement. Often, a consulting company works on behalf of LR to manage a CICO, figure out data requirements and prepare required dossiers. After confirming data requirements and finalizing data purchase negotiation, Active members and LR pay for the data so that they can submit them to the authority. When all dossier is ready then LR proceeds an application then gain a registration certificate.  

Polymer exemption

When? Once before you manufacture and import to South Korea

Required information?

• Monomer information
• Polymer structure (formula)
• Mn and contents of molecule weight (%)
• A proof showing a concerned substance meets the criteria of polymer exemption
  • A cationic polymer: polymer structure formula should prove that a concerned substance is not a cationic polymer
  • A proof showing that contents do not contain unreacted monomers consisted of a hazardous, a substance subject to intensive control and a non-phase-in substance is not more than 0.1 by weight (Mn < 10,000)

Affected stakeholders and implications

Who? All companies who manufacture and import “polymer” over 1 ton per year

When?

• If you have pre-registered your substance, you need to register before your grace periods end.
• If you have not pre-registered your substance, you need to register or apply for an exemption before the substance is manufactured and imported to Korea.

What? Identify and pre-register your substance. Then either register the substance or get an exemption certificate

How? If you are foreign manufacturers, you need to appoint an only representative (OR) then your OR will proceed registration for you. Please note that OR will need your chemical information for registration and you need to give proper information such as chemical identification number and importers’ contacts etc.

Relevant Services provided by GPCKOREA

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

Last update: 18 September 2020

South Korea restricts the contents of Heavy metals, Phthalates, and Nitrosamines in children’s products since 4 June 2020. As a result, manufacturer and importer of children’s products sho...

South Korea restricts the contents of Heavy metals, Phthalates, and Nitrosamines in children’s products since 4 June 2020. As a result, manufacturer and importer of children’s products should test products to ensure not to exceed the maximum thresholds.

Children’s Products Safety Special Act is to limit the contents of hazardous substances in children’s products such as toys and textiles intended to be used by children aged under 13. The Ministry of Trade, Industry, and Energy set out subordinate regulations along with the Act since 2017.

Heavy metals contents in paints, coatings, and paper should not exceed the maximum limits as follows.

• antimony – 60mg/kg;
• arsenic – 25mg/kg;
• barium – 1,000mg/kg;
• cadmium – 75mg/kg;
• chromium – 60mg/kg;
• lead – 90mg/kg;
• mercury – 60mg/kg; and
• selenium – 500mg/kg. 

The total contents of lead and cadmium shall not be more than 100mg/kg and 75mg/kg, respectively.

The phthalates including DEHP (Di-(2-ethylhexyl) phthalate), DBP (Dibutyl phthalate), BBP (Benzyl butyl phthalate), DINP (Diisononyl phthalate), DIDP (Diisodecyl phthalate), DnOP (Di-n-octyl phthalate) should not exceed 0.1%.

For oral products used by infants aged under 36 months, such as dummies and toothbrushes, Nitrosamines, and potential substances that can produce Nitrosamines – which can increase the risk of cancer- should not be more than 0.01mg/kg.

Formaldehyde in textiles contacting with skin should not exceed 75mg/kg. Aromatic amines are limited to 30mg/kg, which is applied to dyed textiles. The pH of all products should be in the range of 4.0-7.5. 

Affected stakeholders and implications

Children’s products manufacturer and importer should comply with a new standard by testing their products. The contents of Heavy metals, Phthalates, and Nitrosamines in children’s products are restricted.

Last update: 10/22/2020