K-REACH - Act on Registration and Evaluation of Chemical Substances, South Korea

  •   18 Sep 2013
  •    Nadine He
    Korean regulation:
    Act on Registration and Evaluation of Chemical Substances—"K-REACH"
    Competent Authority
    Ministry of the Environment (MoE)
    History
    Passed30 April 2013
    Published22 May 2013
    Come into force1 Jan 2015 (Law No. 11789)
    Revised27 Jan 2016
    Come into force28 Jan 2017 (Law No. 13891)
    Other legislation
    K-REACH Enforcement Decree
    K-REACH Enforcement Rules
    Status: In force

    Korea MOE

    The Act on Registration and Evaluation of Chemicals of Korea (a.k.a “K-REACH”) was passed on Apr 30, 2013 and slightly revised on Jan 27, 2016. It is regarded as the first REACH-style chemical regulation adopted in an Asian country. K-REACH manages new chemical substances, existing chemical substances and downstream products by prescribing the requirements for registration, hazard evaluation and risk assessment.

    This webpage is designed to assist non-Korean companies, particularly SMEs, in identifying their obligations under K-REACH so they can take the necessary steps to ensure compliance with this regulation.

    Note: On 9 Jan 2017, South Korea’s Ministry of Environment notified the Committee on Technical Barriers to Trade under World Trade Organization (WTO) of a proposed revision to the Act on Registration and Evaluation of Chemical Substances (K-REACH). The amendments to K-REACH were paseed by South Korea's Cabinet on 8 Aug 2017. The next step is to submit the draft to the National Assembly for approval. It is expected that the amended K-REACH will enter into force on 1 July 2018.

    Contents

     

    Management Framework for substances and products

    The chart below is a conceptual representation of the K-REACH framework. Chemicals and products (mixtures and articles) are regulated differently as illustrated. K-REACH came into force on 1 Jan 2015, which requires the mandatory reporting, registration and notification of manufactured and imported new chemical substances, existing chemical substances, and products containing hazardous substances.

    Fig. 1 - Framework of K-REACH (Act on Registration and Evaluation of Chemical Substance, South Korea)

    1. The information concerning the volume and uses of the existing chemical substances (≥1 ton/y) and all new chemical substances should be reported annually.
    2. The priority evaluation chemicals (PECs) selected from the Korean Existing Chemicals Inventory (KECI) which are, manufactured or imported at or over 1 ton per year, are required for registration (including certain chemicals likely to cause significant damage to human health and environment even < 1 t/y) , so do all new chemical substances regardless of tonnage. 
    3. K-REACH will allow the Ministry of the Environment (MoE) to perform hazard evaluation and risk assessment. According to the results of hazard evaluation, MoE will designate toxic chemical substances. Based on the hazard evaluation and risk assessment, MoE will impose production and importing requirements necessitating substances undergo authorization, restriction or prohibition.
    4. Product notification will be required if the hazardous chemical substances contained in the product exceed 1 ton/y and 0.1% weight ratio threshold
    5. Appropriate safety and labeling criteria will be issued by the MoE for the high risk concerned products based on the results of  risk assessment.

     

    Who is affected

    Manufacturers or importers of new chemicals and priority evaluation chemicals (PECs) shall submit registration to the Ministry of Environmental (MOE) prior to manufacture and import. However companies established outside of Korea are not bound by the obligations of K-REACH, the responsibility for fulfilling K-REACH registration lies with the corresponding importers established in Korea, or with the “only representative (OR)” based in Korea.

    Manufactures, importers and ORs will be responsible for

    • Annual Reporting
    • Registration
    • Information communication with downstream users and sellers
    • Products Notification
    • Other activities

    Importers in Korea may turn to their non-Korean suppliers and request information that they may need to fulfill their regulatory obligations.

    Downstream users and sellers are also required to comply with certain aspects of K-REACH. Sellers in Korea should fulfill the annual reporting obligation under K-REACH, the same as manufacturers, importers and ORs. The sellers mentioned above are those selling chemicals to be used as raw materials in workplace. However, the downstream users are exempted from reporting obligations. As for information exchange, a two-way communication mechanism is adopted to involve manufacturers, importers and their downstream users and sellers in the same supply chain. 

     

    History

    Fig. 2 - History of K-REACH (Act on Registration and Evaluation of Chemical Substances, South Korea)

    Korea has been working on its own “REACH-style” regulation for the registration and evaluation of chemicals since 2011. The final version of K-REACH was passed by the National Assembly on 30 April 2013, and came into force on 1 Jan 2015.

    Since its notification to the WTO on 9 March 2011 (G/TBT/N/KOR/305), the draft proposal has been revised several times focusing on the registration, evaluation, authorization and restriction of new chemicals and existing chemicals that are manufactured in or imported to Korea.

    1. MoE's initial draft (25 Feb 2011)
    2. MoE's final version submitted to National Assembly (28 Sep 2012)
    3. National Assembly member’s version (8 April 2013)
    4. Environment and Labor Committee’s compromise version (24 April 2013)
    5. National Assembly’s final version (30 April 2013)

    The Act has been slightly revised on 27 Jan 2016 (no major impacts on the compliance work) and the amendments came into force on 28 Jan 2017. 

    Main Contents of K-REACH Regulation

    Fig. 5 -  English Translation of K-REACH Subordinate Statutes: Enforcement Decree and Enforcement Rules (Draft)

    Fig. 4 - Ebook29: K-REACH : A Comparative Analysis With EU-REACH and China REACH

    Fig. 3 - Ebook 23: Act on Registration and Evaluation of Chemical Substances, South Korea

    The legislative text consists of 8 chapters, 54 articles and an addendum

    1. General rules (article 1-7)
    2. Registration of chemicals (article 8-17)
    3. Hazard evaluation and risk assessment (article 18-24)
    4. Designation and change of chemicals subject to Authorization (article 25-28)
    5. Information communication (article 29-31)
    6. Management of products with high risk concern (article 32-37)
    7. Supplementary provisions (article 38-48)
    8. Penalties (article 49-54)
    9. Addendum (article 1-7)

    A translation in English and Chinese is available on Chemlinked, which is free to download for our standard or corporate members. This translation is provided for reference purpose only.

     

    How to comply

    K-REACH: Annual Reporting

    Since the issuance of the first MoE K-REACH draft there has been a debate on reporting frequency requirements, vacillating between compulsory annual reporting or  biennial reporting. The official K-REACH stipulates that the manufacturers, importers or sellers should report annually to MoE the volume and uses etc. of all new chemical substances and existing chemical substances at or above 1 ton/year in the previous year. It should be noted that downstream users are exempted from the annual reporting requirement.

    Industry stakeholders have greeted annual reporting requirements with disdain and outrage after previously voicing serious concerns over far less stringent reporting requirements as mandated by the TCCA (every 4 years). Major concerns revolve around the lack of information in the supply chain and confidentiality issues as stumbling blocks on the road to regulatory compliance. However, as the first Asian country to adopt the EU REACH-like chemical management regulation, a comprehensive collection of chemical information is a fundamental step required by the Korean authority. Considering the fact that it is only necessary to register priority evaluation chemicals (PECs) and new chemical substances, the reporting obligations should facilitate the management of relatively safer chemicals. The substances tonnage and usage information of the previous year (1 Jan-31 Dec) is required to be submitted by 30 Jun. 

    Exemption of reporting:

    1. Chemical substances imported which are incorporated into machines
    2. Chemical substances imported along with machines or devices for trial run
    3. Chemical substances in products in solid form, performing certain functions and are not released during use
    4. Others prescribed by the President Decree for R&D

    Latest update (Aug 2017): According to the proposed revision to K-REACH, the annual reporting system will be abolished. Instead, a pre-registration system will be adopted. According to the authority, there is no need for duplicate reporting as South Korea’s Chemicals Control Act (CCA) already requires statistical survey on chemical substances. The establishment of a pre-registration system is for companies planning to register phase-in (existing) substances and will streamline mandatory joint registration of identical substances.

    K-REACH: Registration

    As stipulated in K-REACH, the manufacturers or importers of new chemicals and priority evaluation chemicals (PECs) shall submit registration to the Ministry of Environmental (MoE) prior to manufacture and import. The tonnage threshold for existing chemical registration has been finally set as 1 ton per year, consistent with EU REACH and Japan CSCL, while the pre-registration process is left out.

    Chemical substances subject to Registration

    1. All new chemical substances (regardless of tonnage)
    2. PECs over 1 ton per year (Final Batch 1 list of 510 PECs has been issued on 1 Jul 2015)
    3. Certain chemical substances likely to cause significant damage to human health and environment even under the 1 tonne per year threshold

    Exemption from registration:

    1. Chemical substances imported which are incorporated into machines
    2. Chemical substances imported along with machines or devices for trial run
    3. Chemical substances in products in solid form, performing certain functions and are not released during use
    4. Manufactured or imported less than 10 ton per annum for the purpose of export only (Confirmation of Registration Exemption is required)
    5. Others prescribed by the President Decree(Confirmation of Registration Exemption is required)

    Fig. 6 - Registration timeline of K-REACH (Act on Registration and Evaluation of Chemical Substances, South Korea)

    Existing chemical registration

    K-REACH only requires the PECs designated by the MoE to be registered. This regime is unlike the EU REACH which covers all existing chemicals indiscriminately.

    PriorityCriteria for designation of existing chemical substance for registration
    HazardExposureNumber of substances
    Priority 1

    CMR or PBT

    HPV

    20-20,000 ton

    ≥20,000 ton

    372
    Priority 2

    CMR or PBT

    H410(R50/53) or Toxic chemical

    HPV

    1-20 ton

    10-20,000 ton

    1,000-20,000 ton

    791
    Priority 3

    H410(R50/53) or Toxic chemical

    HPV

    1-10 ton

    100-1,000 ton

    923

    Source: MoE Public Hearing, 27 Jun 2011

    According to MoE’s public hearing on 27 June 2011, the prority list of 2,086 substances has been drafted. The criteria for designation of PECs are specified in the table as above. The PECs will be screened from existing chemicals based on the exposure, hazard information and trading volume, etc. The final PECs list will contain around 2,000 to 2,500 chemicals and will be categorized as priority 1, 2 and 3 chemical substances. The lists will be issued every three years and registration obligations for each list will be postponed for a three-year grace period from the publication date of the priority list. The list of priority 1 substances containing 510 substances has been published on 1 Jul 2015.The second batch will be announced in 2018 and the third batch is expected to be announced in 2021.

    The PECs over 1 tonne per year should be registered. However, due to concerns for human health and the environment, some chemicals even less than 1 ton per year will still be subject to registration, which will be designated by the MoE through discussion with relevant ministries.

    Latest update (Aug 2017): According to the proposed revision to K-REACH, the system for designation of priority existing chemicals (PECs) in three batches for joint registration will be deleted. Instead, a phase-in registration mechanism for around 7000 existing chemical substances (≥1t/y) will be applied. MoE is currently preparing the whole list. In addition, phase-in deadlines will be set based on tonnage band (1-10 t/y, 10-100 t/y, 100-1000 t/y, >1000 t/y), which is similar to EU REACH. It should be noted that the deadline of 30 Jun 2018 for registration of the 510 PECs under current K-REACH regulation will still apply.

    New Chemical Registration

    • Previous

      The Notification System of New Chemicals in Korea has been governed by Toxic Chemical Control Act (TCCA) of the MoE and Occupational Safety and Health Act (OSHA) of the Ministry of Employment and Labor (MoEL). The Korea Existing Chemicals Inventory (KECI) contains around 36,000 chemicals that were domestically circulated in Korea prior to Feb 2, 1991 or those published by MoE through hazard evaluation under TCCA after Feb 2, 1991. Those not listed in the KECI are regarded as new chemical substances subject to new chemical registration.

      The manufacturers and importers of new chemical substances exceeding 0.1 tonne per year are required to apply to MoEL and MoE for the notification or apply to Korea Chemicals Management Association (KCMA) for the confirmation of exemption prior to market entry.

    • Current
      Registration of new chemical substances was transferred to K-REACH from 1 Jan 2015. All new chemical substances regardless of tonnge are required to be registered. However, a simplified registration with less data requirements would be applicable for new chemical substances in low volume below 1 t/y (threshold below will be reduced to 0.1 t/y after 2020).

    Re-registration and Notification of changes

    In cases of modification of volume (manufacture or import), usage or hazardous properties, re-registration reflecting all updates and amendments should be submitted. For example, if the manufacture or import tonnage of the registered substance exceeds the tonnage quantity within the registered tonnage band, the registrant must re-register to increase the tonnage band, which also applies to change of uses, hazard and risk information, etc. As for the change of applicant information, the registrant should notify changes to MoE. The corresponding supplementary materials required for re-registration of changes and notification of changes will be specified in subordinate statutes.

    • Changes in Re-registration: change of tonnage band, change of uses, hazard and risk information, etc.
    • Changes in Notification: change of applicant information, e.g. name of registrant, address, representative.

     

    K-REACH: Data Submission

    K-REACH adopts 4 levels of tonnage band with higher tonnage bands requiring more data submission. The information below is required for data submission,

    1. Company information (Name, address and representative of the manufacturer or the importer etc.)
    2. Chemical identification information (chemical name, molecular formula and chemical structure etc.)
    3. Use information
    4. Classification and labeling
    5. Physicochemical properties
    6. Toxicological information
    7. Risk assessment information for substance at or above 10 ton per year
    8. Guidance on safe use (including personal protective devices and measures for explosion, fire or leak)
    9. Other information

    Table1. Number of Testing Items under K-REACH

    Data requirement

    0.1-1 t/y

    (from 1 Jan 2020 for new chemical only)

    1-10 t/y

    10-100 t/y

    100-1,000 t/y

    >1,000 t/y

    Physical and Chemical Properties58111313
    Human Health Hazards24101115
    Environmental Hazards2351319
    Total915263747

    (Summarized from the K-REACH subordinate statutes)

    Testing Data requirements

    Table2. Physiochemical Testing Items under K-REACH

     Required Tests

    0.1-1 t/y

    (from 1 Jan 2020)

    1-10 t/y10-100 t/y100-1,000 t/y>1,000 t/y
    Physicochemical Properties TestingPhysical state
    Water solubility
    Melting/freezing point
    Boiling point
    Vapor pressure
    Partition coefficient n-octanol/water 
    Relative density 
    Granulometry 
    Flammability  
    Explosive property  
    Oxidizing property  
    Viscosity   OO
    Dissociation costant   OO

    Table3. Toxicological Testing Items under K-REACH

     Required TestsTesting Method OECD TG

    0.1-1 t/y

    (from 1 Jan 2020)

    1-10 t/y10-100 t/y100-1,000 t/y>1,000 t/y
    Toxicology Properties TestingAcute oral toxicity420/423/425
    Acute dermal toxicity (or inhalation)402, 403  √ (O)√ (O)√ (O)
    Skin corrosion/irritation404 
    Eye corrosion/irritation405  
    Skin sensitization406/429 
    Ames test471
    In vitro chromosome aberration473/487  
    In vitro gene mammalian or in vivo chromosome aberration476, 474/475  
    Additional mutation test(germ cell mutagenicity etc.)    OO
    Repeated toxicity (28 days)407/410/412  
    Repeated toxicity (90 days)408/409, 411, 413    O
    Carcinogenicity451/453    O
    Screening for reproductive/development toxicity421/422  OOO
    Pre‐natal developmental toxicity study414    O
    Two‐generation reproductive toxicity416    O

    Table4. Eco-toxicological Testing Items under K-REACH

     Required TestsTesting Method OECD TG

    0.1-1 t/y

    (from 1 Jan 2020)

    1-10 t/y10-100 t/y100-1,000 t/y>1,000 t/y
    Ecotoxicology Properties TestingShort-term fish toxicity203
    Short-term daphnid toxicity202 
    Algae growth inhibition201  
    Long-term fish toxicity210/212/215   OO
    Long-term daphnid toxicity211   OO
    Short-term toxicity to plants299/227   OO
    Long-term toxicity testing on plants     O
    Short-term toxicity to invertebrates (earthworm)207   OO
    Long-term toxicity testing on invertebrates (earthworm) 222    O
    Long-term toxicity to sediment organisms218/219    O
    Activated sludge respiration inhibition test209   OO
    Ready biodegradability301/310
    Hydrolysis as a function of pH111  
    Inherent biodegradability302   OO
    Identification of degradation products    OO
    Bioconcentration305    O
    Adsorption/desorption screening test106/121   OO
    Additional adsorption/desorption screening     O
    Fate and behavior in the environment     O

     Note: “O” means that the testing plan can be submitted instead of the complete testing report

     

    Vertebrate animal testing

    K-REACH prohibits repetitive generation of vertebrate animal test data. If vertebrate test data is already available, the potential registrant should petition the owner of this data to prevent duplication of experimental data thereby minimizing animal testing. If refusal of data sharing is justified arising from confidentiality issues, submission without vertebrate test data may be accepted if prior consent is given by the MoE. In cases of refusal to share vertebrate test data (without justification) the data owners can be punished by having their own test data deemed inadmissible . The period for data protection under K-REACH is 15 years, after which, the data can be freely used regardless of any objections from the data owner.

     

    K-REACH: Hazard Evaluation & Risk Assessment

    Fig. 7 - Hazard Evaluation & Risk Assessment of K-REACH (Act on Registration and Evaluation of Chemical Substances, South Korea)

    The MoE will conduct hazard evaluation on the registered substances. MoE may require additional data from the registrant if deemed necessary for hazard evaluation. The toxic chemical substances will be designated based on the hazard evaluation outcome, which is consistent with the criteria under the previous TCCA. The information, such as the chemical name, hazard properties will be disclosed to the public for reference after hazard evaluation. Generic names can be used for publication if data protection applies. However, once it is designated as toxic chemical, the generic name cannot be adopted.

    Risk assessment is required for substances manufactured or imported for 10 tons or more per year, or when the result of hazard evaluation implies the necessity of further risk assessment. Based on the hazard evaluation and risk assessment, MoE will designate the substances subject to authorization, restriction or prohibition. Generally, the SVHC such as CMRs and PBTs will be designated for authorization with specific sunset date. Only those authorized before the deadline can continue to be circulated on the market after the sunset date. However, the status of chemicals for authorization is subject to change due to the possible development of new technology or substituted chemicals, etc.

    The chemicals manufactured or imported at 100 ton per year will require risk assessment requirement from 1 Jan 2015. For those between 10 ton and 100 ton per year, there are 4 corresponding extended deadlines,

    1. 70 ton/year: Jan 1, 2017
    2. 50 ton/year: Jan 1, 2018
    3. 20 ton/year: Jan 1, 2019
    4. 10 ton/year: Jan 1, 2020

     

    K-REACH: Joint Submission

    Joint submission of registration dossiers on the same chemicals is an obligation under K-REACH with the goal of reducing the burden on the industry and avoiding duplicate generation of test data. The individual submission could be applicable in special cases if approved by MoE in advance.

    A pre-set institution like the Substance Information Exchange Forum (SIEF) will be established for chemical information exchange, with settled consortium agreement on data production and cost sharing. The SIEF is a borrowed concept from EU REACH, like EU REACH the co-registrants will be required to purchase distinct endpoint data from the lead registrant (LR) and use them in their own separate dossiers.

    Opt-out is possible when:

    1. Exposure of Confidential Business Information (CBI) causes commercial damage
    2. Joint submission requires higher cost than individual submission
    3. Other causes listed in Presidential Decree
    4. “Confirmation of Individual Submission” from MoE in advance

    Data sharing:

    1. Permission to use for the registration from data owner is required
    2. The period of data compensation under K-REACH is 15 years, after which the data is available to be used freely
    3. Enquiry of existing available data can be made to MoE

     

    K-REACH: Information Communication

    Fig. 8 - Information Communication of K-REACH (Act on Registration and Evaluation of Chemical Substances, South Korea)

    K-REACH adopts a two-way communication mechanism under which the suppliers should provide chemical information to recipients, and vice versa. The manufacturer and importer of registered substances or mixtures containing registered substances should provide registration No., chemical name, hazard & risk information, safe use information to the downstream user and seller. Downstream users and sellers should also provide its manufacturer or importer the use, exposure, volume of use or sale, safe use information etc. upon request. If any changes occur, the updates should be informed to upperstream and downstream parties within one month.

     

    K-REACH: Product Management

    Under K-REACH, the definition of a "product" covers both mixtures and articles for consumer use. Product notification is required for manufacturers or importers if the hazardous chemical substance content contained in the product exceeds 1 ton per year and the content exceeds 0.1% weight ratio threshold. Although finished articles which do not release chemicals are exempted, the requirements on product notification will affect nearly all types of consumer products.

    The hazardous chemical substances include toxic chemical substances, substances subject to authorization, restriction and prohibition. The name of hazardous substance, content, hazard information, use of the hazardous chemical substance in the product should be notified to MoE. However, if the hazardous substance has already been registered under K-REACH, the product can be manufactured or imported without production notification if the "Exemption Confirmation of Notification" from MoE is obtained in advance.

    The list of high risk concerned products was published by MoE considering their potential risks posed to human health and environment, including detergent products, coating/adhesive products, air freshener products, dye products, biocidal products, etc. Manufacture or importation of risk concerned products requires product testing in some specialized institutes every three years to verify compliance with the safety standards and keep testing reports for inspections.

    Latest update: The risk concerned products currently managed under K-REACH will be covered by a new Act, namely the "Act on Safety Management of Consumer Chemical Products and Biocides”(K-BPR). The name of “risk concerned product” will be changed to “household chemical product subject to suitability confirmation”. South Korea’s Cabinet passed the new Act in Aug of 2017, which is still awaiting final approval from the National Assembly. If approved it will come into force on January 1, 2019. 

     

    Summary & Advice for Stakeholders 

    The manufacturers, importers and foreign companies exporting to Korea should keep track of new chemical substances and PECs contained in their products, and pay attention to whether the volumes of PEC substance exceeds the 1 ton registration threshold. Foreign companies not based in Korea should accomplish registration and the follow-up obligations by designating an OR. Here is a brief summary of obligations under Korea REACH.

    ObligationsManufacturer/Importer/OR
    Annual reportingVolume, uses, etc. of new chemical substances and existing chemical substances at or above 1 ton/year in the previous year
    RegistrationJoint submission is of obligation, with individual submission applicable in special cases; or apply for exemption; higher tonnage band, more data requirements.
    Registration renewalRe-registration of changes concerning tonnage, uses, hazard& risk information, and notification of change in applicant information
    Information communicationRegistration No., chemical name, hazard & risk information, safe use information need to be passed to downstream users and sellers; if changes occur, the updates should be informed to any upper and down-stream parties no later than 1 month.
    Product notificationName of hazardous substance, content, hazard information, use of the hazardous chemical substance in the product should be notified to MoE
    High risk concerned productFollow the restriction or prohibition on the use of some hazardous substances in high risk concerned products and pay attention to the threshold for substance content, migration or evaporation.

     

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