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

  •   18 Jun 2019
  •    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 (Law No. 11789)
    Come into force1 Jan 2015
    Revised27 Jan 2016 (Law No. 13891)
    Come into force28 Jan 2017
    Revised20 Mar 2018 (Law No. 15512)
    Come into force1 Jan 2019
    Revised17 Apr 2018 (Law No. 15584)
    Come into force1 Jan 2019
    Other legislation
    K-REACH Enforcement Decree
    K-REACH Enforcement Rules
    Status: In force

    Korea MOE

    Last Updated: 2019-06-30

    The Act on Registration and Evaluation of Chemicals of Korea (a.k.a “K-REACH”) was passed on Apr 30th, 2013 and revised several times. 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.

    The revised K-REACH legislation is a significant deviation from the regulatory mechanisms outlined in the previous version. The amendments came into effect on Jan 1st, 2019, which sets out a plan of registering existing substances over 1 ton per year in the next 12 years. 

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

    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. 

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

    1. Pre-registration of existing chemical substances (≥1 ton per year) before 30 Jun 2019 is necessary to be eligible for the phase-in registration grace period.
    2. 510 PECs that have been published on 1 Jul 2015 are subject to joint registration before 30 June 2018.  They are not eligible for pre-registration/late pre-registration and are not subject to the phase-in registration grace period. PECs (≥ 1 t/a) should be registered immediately before manufacture/import.
    3. For new chemical substances<100kg/y, they only require notification rather than registration. 
    4. 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.
    5. Notification of products containing priority management substances (including hydrates) is required before manufacture or importation if the priority management substance contained in the product exceed 1 ton/y and 0.1% weight ratio threshold.

     

    Who is affected

    Korean manufacturers or importers have legal obligations to comply with K-REACH. Foreign manufacturers may appoint an Only Representative (OR) to fulfill relevant obligations under K-REACH. 

    Manufactures, importers and ORs will be responsible for

    • Pre-registration
    • Registration
    • Information communication with downstream users and sellers
    • Products Notification
    • Other activities

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

    South 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 South Korea.

    The latest amendments to K-REACH were promulgated by the president on 20 Mar 2018 as Law No. 15512, which is a significant deviation from the regulatory mechanisms outlined in the previous version. The revised K-REACH (effective on 1 Jan) is almost identical to EU REACH . Amendments regarding reduction of vertebrate animal testing during generation of registration data were incorporated into the revised version of K-REACH as Law No. 15584 on 17 Apr 2018. The new requirements came into force on 1 Jan 2019 as well as the other amendments.

     

    How to comply

    Existing Chemical Substances: Pre-registrtaion and Registration

    All existing chemical substances manufactured or imported at ≥ 1 ton per year are subject to pre-registration before 30 Jun 2019. The manufacture/import volume can be determined based on the records in year 2016 to 2018. Late pre-registration is applicable to chemicals manufactured or imported over 1 tone/year for the first time after the deadline and before the corresponding phase-in registration deadline.

    Pre-registration before 30 Jun 2019 is necessary to be eligible for the phase-in registration grace period. Phased-in registration of existing chemicals should be complied with based on tonnage band by 2030. However, designated CMR substances with a volume over 1 ton per year should be registered as a priority by 2021. The phase-in deadlines will be set based on tonnage band, as below

    • >1000 t/y; or designated CMRs (364 substances) above 1 t/y: by 2021
    • 100-1000 t/y: by 2024
    • 10-100 t/y: by 2027
    • 1-10 t/y: by 2030

    However, for the 510 PECs that were published on 1 Jul 2015, they were subject to joint registration before July of 2018. They are not eligible for pre-registration/late pre-registration and are not subject to the phase-in registration grace period. PECs (≥ 1 t/a) should be registered immediately before manufacture/import.

    New Chemical Substances: Notification and Registration

    The Korea Existing Chemicals Inventory (KECI) contains more than 44,000 chemicals that were domestically circulated in South Korea prior to Feb 2, 1991 or those published by MoE after 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.

    All new chemical substances regardless of tonnge are required to be registered. However, for new chemical substances<100kg/y, they only require notification rather than registration.  In addition, registration under K-OSHA shoulod also be complied with as before for new substances ≥0.1t/y. 

    K-REACH: Data Submission

    K-REACH adopts 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

    *For new chemical <100kg/y, only very simple information is required to submit, including manufacturer/importer information, chemical name and identity, uses, classification and labelling, etc. Before 2020, for new chemical<1t/y, only one test data (acute oral toxicity) should be submitted. 

    Table1. Number of Testing Items under K-REACH

    Data requirement

    0.1-1 t/y

    (for new chemical only from 2020)

    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

     

    Testing Data requirements

    Table2. Physiochemical Testing Items under K-REACH

     Required Tests

    0.1-1 t/y

    (for new chemical only from 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

    (for new chemical only from 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

    (for new chemical only from 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

    Amendments regarding reduction of vertebrate animal testing during generation of registration data have been passed and incorporated into the revised version of K-REACH as Law No. 15584 on 17 Apr 2018. The new requirements came into force on 1 Jan 2019. The authority will develop and adopt alternative tests to minimize the use of vertebrate animals (newly added Article 4 Paragraph 5 of K-REACH). In addition, industry also needs to prioritize alternative animal testing during data generation (newly added Article 5 Paragraph 5). The vertebrate animal testing minimizing principle is adopted as a new Article 16-2 during chemical registration, hazard evaluation and risk assessment. As stipulated in Revised Article 17, any person who intends to apply for registration shall confirm in advance if there is existing vertebrate animal test data. For more deatils, please see ChemLinked news

     

    K-REACH: Hazard Evaluation & Risk Assessment

    Fig. 5 - 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,

    • 100 ton/year: Jan 1, 2015
    • 70 ton/year: Jan 1, 2017
    • 50 ton/year: Jan 1, 2018
    • 20 ton/year: Jan 1, 2019
    • 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) is established for chemical information exchange. 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. 6 - 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. Nnotification of products containing priority management substances (including hydrates) is required before manufacture or importation if

    • The content of a priority management substance exceeds 0.1 % w/w; and
    • The total import weight of the priority management substance in products is over one tonne per year.

    In total 672 substances have been designated for priority management in Dec 2018, of which 204 substances will be effective from Jul 1st, 2019 and the other 468 substances effective from Jul 1st, 2021. Manufacturers or importers have legal obligations to notify the authority the name, use, content, hazards, simple exposure information, etc. of the priority management substance. However, the notification is not required if the substance has been registered under K-REACH.

    Webinar

    • Please click here to see a list of webinars about K-REACH.

    News

    • Please click here to see a list of news about K-REACH.

     

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