GUIDANCE on Compliance Procedures - of the Act on Registration and Evaluation, etc. of Chemical Substances - Chemical Watch

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GUIDANCE on Compliance Procedures - of the Act on Registration and Evaluation, etc. of Chemical Substances - Chemical Watch
GUIDANCE
on Compliance Procedures
 the Act on Registration and Evaluation, etc. of
of
Chemical Substances
GUIDANCE on Compliance Procedures - of the Act on Registration and Evaluation, etc. of Chemical Substances - Chemical Watch
GUIDANCE on Compliance Procedures - of the Act on Registration and Evaluation, etc. of Chemical Substances - Chemical Watch
Guidance on Compliance Procedures
of the Act on Registration and Evaluation, etc.
      of Chemical Substances (ARECs)

                   Task Force on Support for Industry in
                   Complying with Chemical Safety Rules
GUIDANCE on Compliance Procedures - of the Act on Registration and Evaluation, etc. of Chemical Substances - Chemical Watch
GUIDANCE on Compliance Procedures - of the Act on Registration and Evaluation, etc. of Chemical Substances - Chemical Watch
1. Overview of ARECs
The previous Toxic Chemicals Control Act has been revised as the Act on Registration and
Evaluation, etc. of Chemical Substances (hereinafter referred to as "ARECs") and the
Chemicals Control Act (hereinafter referred to as "CCA"), and they came into effect on
January 1, 2015. Both ARECs and CCA aim at preventing any harm to human health and
the environment caused by chemicals and properly controlling toxic chemicals, ultimately
securing healthy and safe environment.

ARECs is merely composed of the registration and evaluation system for chemical
substances and the safety management system for chemical products. Under ARECs,
chemical substances subject to hazard examination were expanded from non-phase-in
substances to phase-in substances. Definition of non-phase-in substances was also revised
from those manufactured and imported over 0.1 ton annually to all non-phase-in substances.

                                          - 5 -
GUIDANCE on Compliance Procedures - of the Act on Registration and Evaluation, etc. of Chemical Substances - Chemical Watch
2. Glossary of ARECs
○ Key Terms

      Terms                                             Definition
                     A chemical substance means an element, its compounds and substances
    Chemical         obtained by artificial chemical reaction therewith, and substances obtained by
    Substance        chemical modification, extraction, purification of substances in their natural
                     state
   Manufacturer      Any person who manufactures (or synthesizes) a chemical substance within
                     the territory of Republic of Korea
     Importer        Taxpayers according to Article 19 of the Customs Act
                     - Chemical substances domestically distributed for commercial purposes prior
                     to February 2, 1991 and publicly announced by the Minister of Environment
     Phase-in        after consultation with the Minister of Employment and Labor
    Substance        - Chemical substances went through hazard examination after February 2,
                     1991 pursuant to the former Toxic Chemicals Control Act and publicly
                     announced by the Minister of Environment

   Non-phase-in
    Substance        All chemical substances excluding phase-in substances

                     Phase-in substances deemed necessary to register for hazard examination
     Phase-in        under Article 18 of ARECs or risk assessment under Article 24 of ARECs,
 Substance subject   and publicly announced by the Minister of Environment after deliberation of
  to Registration
                     the Chemical Substance Evaluation Committee under Article 7 of ARECs.
                     Hazardous chemical substances as designated and publicly announced by the
 Toxic Substance     Minister of Environment in accordance with the standards prescribed by
                     Presidential Decree
                     Chemical substances with risk concerns that the Minister of Environment
                     publicly announces, after consultation with the head of relevant central
    Substances       administrative agency pursuant to Article 25 and deliberation of the Chemical
    subject to
                     Substance Evaluation Committee under Article 7, in order to have such
   Authorization
                     substances manufactured, imported, or used only with authorization of the
                     Minister of Environment

                     Chemical substances deemed to pose high risk, when used for a certain
                     purpose, that the Minister of Environment publicly announces pursuant to
    Restricted       Article 27, after consultation with the head of relevant central administrative
    Substance        agency and deliberation of the Chemical Substance Evaluation Committee
                     under Article 7, in order to prevent such substances from being manufactured,
                     imported, sold, stored/preserved, transported, or used for such purpose

                     Chemical substances deemed to pose high risk that the Minister of
                     Environment publicly announces pursuant to Article 27, after consultation
    Prohibited       with the head of relevant central administrative agency and deliberation of
    Substance        the Chemical Substance Evaluation Committee under Article 7, in order to
                     prohibit such substance from being manufactured, imported, sold,
                     stored/preserved, transported, or used for any purpose

    Hazardous        Any toxic substance, substance subject to authorization, restricted substance,
    Chemical         prohibited substance, and other chemical substances that pose, or are likely to
    Substance        pose a hazard or risk

                                                - 6 -
3. Confirmation of Phase-in substances and Substances under Regulation
  ○ Confirmation of chemicals through the National Chemicals Information System (http://ncis.nier.go.kr/)

  A. Click "Chemical Search" at the website of NCIS.

  B. Type the chemical name or CAS No. in the search box.

                                                 - 7 -
C. Click the chemical name or a link to read more chemical information.

D. Details of chemical information

 - Phase-in substances subject to registration, phase-in substances, toxic substances or
   accident prevention substances

                                        - 8 -
4. Report of Substance Manufacturing

○ Reporting Process

  Chemical substance (product)?

                 Yes

                                   No
       Subject to ARECs?                   Apply relevant laws and regulations

                 Yes

                                  Yes
  Non-phase-in substances?                  Subject to report exemption?

                 No                                           No

                                                   Subject to report
                                           (Regional Environmental Office)

 Manufacture·Import·Sell more      No
                                                    No report duty
     than 1 ton annually?

                 Yes

                                  Yes
 Subject to report exemption?                       No report duty

                No

       Subject to report
(Regional Environmental Office)

                                   - 9 -
A. Overview of Reporting System

 - The reported data is used as a source to designate phase-in substances subject to
   registration. Through the data, the authorities can identify the current status of
   manufacture, import and sales of chemical substances and figure out those having
   obligation of joint registration for the same phase-in substance subject to registration.

B. Subjects to Report

 - A person who manufactures, imports or sells a non-phase-in substance or more than 1 ton per
   year of a phase-in substance

 - An overseas manufacturer or producer who appoints an only representative (OR) who can meet
   the obligation on behalf of domestic importer

 - A person who is commissioned to manufacture a chemical substance

C. Required Data

 - Information on manufacturer, importer and seller of chemical substance (company name,
    location, contact number, etc.)

 - Information on OR appointed by overseas manufacturer (company name, location, contact
 number, etc.)

 - Information on chemical substance (name, CAS number, etc.)

 - Use of chemical substance, including manufacture, import and sales volume of each use

 - In the case of commissioned manufacturer, commission certificate including the information on
   the commissioned person or a copy of commission contact

 - In the case of OR appointed by overseas manufacturer, declaration certificate on OR
    appointment

D. Exemption from Report

 - A chemical substance imported as an internal part of machinery

 - A chemical substance imported along with a machine or equipment for the purpose of a
   trial run

 - A chemical substance contained as solid form in a product and is not released when
   using the product

 - A chemical substance imported or manufactured for the purpose of research and
development

 - Non-isolated intermediate

                                             - 10 -
- Phase-in substance proved its lower risk with sufficient data and also announced by the
    Ministry of Environment

E. Competent Authority

 - Regional environmental offices

F. Report Period

 - Report the previous year’s data until June 30 of the next year
 - Report of change

        Category                    Reporting Deadline                  Contents
   Change of information                                       Company name, location,
                         1 month from the date of change
   on reporter                                                 contact number, etc.
                         1 month from the date of knowing      Change within use
   Change of use
                         the change                            classification system

                                             - 11 -
5. Registration of Chemicals

○ Registration Process

 Chemical substance (product)?

                Yes

                                            No                    Apply relevant laws and
      Subject to ARECs?
                                                                        regulations

                Yes

     Manufacture or import
 non-phase-in substance or more
     than 1 ton per year of                 No                   Exclusion from registration
  phase-in substance subject to
           registration?

                Yes

   Subject to confirmation on              Yes
                                                                Exemption from registration
     registration exemption
   according to Article 11 of                                 (Korea Chemicals Management
   ARECs and Article 11 of                                   Association, KCMA, in accordance
                                                                 with Article 53 of CCA)
      Enforcement Decree?
                No

  Receipt on confirmation of                                       Considered as confirmed
 hazard examination exemption                                registration exemption according to
   according to the previous               Yes
            TCCA?                                                  Article 4 of Addenda

                No

                                           Yes
                                                                Registration of small volume

           Subject to
                                     Annual volume of
          registration            manufacture or import is
                                      less than 1 ton?
      (National Institute of
                                            No
 Environmental Research, NIER)                                      General registration

                                            - 12 -
A. Overview of Registration System

 - Regulation to manage chemical substances based on a principle of ‘No market, No data’

 - Regulation to identify hazard data of substances placing on the Korean market and evaluate risks
   given substances' uses and exposure levels.

B. Subjects to Registration

 - A person who manufactures or imports non-phase-in substances or over 1 ton per year of
   phase-in substances subject to registration

C. Required Data

 - Chemical substance’s identification, use, classification & labelling, properties, hazard and risk data

           Category               Registration Criteria                                   Content
 1. Manufacturer/Importer
                                                                   - Company name, location, a representative
    Information
                                                                   - Identification information including name,
 2. Chemical Information
                                                                    molecular or structural formula
                              - Non-phase-in substances            - Use classification system, confirmed use,
 3. Use
                                                                    prohibited use
                              - Phase-in Substances subject
                                to Registration                    - Specification of Globally Harmonized System of
 4. Classification/Labeling                                         Classification and Labeling of Chemicals (GHS)
                              (Over 1 ton/year)                     category
 5. Physical/Chemical
    Properties                                                     - Differentiation, given the tonnage band

 6. Hazard                                                         - Submission of test data or test summary

                              - Over 100 ton a year

                              (Phased reinforcement)
                                                                   - Hazard examination
                              (over 100 tons from Jan. 1, 2015
                                                                   - Exposure assessment
 7. Risk                      over 70 tons from Jan. 1, 2017
                                                                    (exposure scenario/exposure prediction)
                              over 50 tons from Jan. 1, 2018
                                                                   - Preparing in order of safety confirmation
                              over 20 tons from Jan. 1, 2019

                              over 10 tons from Jan. 1, 2020)
                                                                   - Personal Protective Equipment (PPE) and
 8. Guideline on Safe Use     - Non-phase-in substances              emergency measures against explosion, fire and
                              - Phase-in substances subject          leakage
                                to registration (Over 1
 9. Exposure Data               ton/year)                          - Exposure data related to the use

※ The test data on physical/chemical properties and hazards to human health and the
  environment is differentiated based on the tonnage band.

                                                          - 13 -
D. Registration Method

 - Registration dossier should be submitted to the National Institute of Environmental Research
   (NIER), before manufacturing or importing chemical substances. (ARECs IT system,
   https://kreach.me.go.kr/opeweb/main.do)

E. Registration Period

        Category                                    Registration Point
      Non-phase-in
                          - Registration prior to manufacture or import
       substances
                          - Possible to manufacture or import without registration during the
   Phase-in substances   grace period
       Subject to
      Registration         ※ Grace period: three years from the date when phase-in substances
                         subject to registration are publicly notified

F. Request on Individual Submission of Registration Dossier

○ A person who intends to individually submit registration dossier shall submit a
  confirmation form for individual submission first (please refer to the form in Annex
  10) to the KCMA, in accordance with Article 15(1) of ARECs and Article 18(1) of the
  Enforcement Decree.

  Applicable Provision                      Reasons for Individual Submission
                         - Where it is expected that a trade secret is disclosed, thereby causing
      Article 15(1)
                           considerable commercial loss
       of ARECs
                         - Where joint submission costs more than individual submission
                         - When the classification and labelling of chemicals are different for
     Article 14 of         the same test category
  Enforcement Decree,
        ARECs            - When opinion differs from the joint submission representative on test
                           data selection for the same test category

                                               - 14 -
G. Confirmation Application for Registration Exemption

             Chemicals Subject to Registration Exemption                  Application      Period

1. A chemical substance that is an internal part of an imported machine
                                                                          Applying
2. A chemical substance imported along with a machine or equipment        for
   for the purpose of a trial run                                         exemption           -
                                                                          is not
3. A chemical substance which is contained as solid form in product       needed
   and is not released when the product is used
1. A chemical substance manufactured/imported less than 10 tons per
   year to be entirely exported

2. A chemical substance manufactured/imported less than 10 tons per                       Once a
   year to be used to manufacture a chemical substance which will be                       year
   exported as a whole
3. A chemical substance for the purpose of test, analysis, chemical
   research such as reagent, et.
4. A chemical substance for the purpose of research and development,
   (e.g. development of chemical substance or product,                                   By R&D
   renovation/development of production processing, testing of new                        Project
   application of a chemical, trial manufacturing)
5. Polymer compounds of low concerns
                                                                          Applying
    a. A polymers with number average molecular weight greater than       for
       10,000: molecular weight under 1,000 is less than 5% and           exemption
       molecular weight under 500 is less than 2 %                        is needed

    b. A polymers with number average molecular over 1,000 but less
       than 10,000: molecular weight under 1,000 is less than 25%,
       molecular weight under 500 is less than 10 %                                     First one time
6. Substance for surface treatment (when both the material to get
   surface treatment or the substance for surface treatment is not non
   phase-in substance or phase-in substance subject to registration).

7. Non-isolated intermediates

8. Isolated intermediates that their leak and exposure are blocked from
   production to consumption, with technical methods

                                              - 15 -
6. Declaration of Products Containing Hazardous Substances
○ Declaration Process

 Chemical substance (product)?

                     Yes

 Subject to ARECs?                         No       Apply relevant laws and regulations

                     Yes

 Total volume of each hazardous
 substance in product manufactured        No
 or imported more than 1 ton per                    Excluded from Declaration
 year?

                     Yes

 A chemical substance which is
 contained in a product functioning in    Yes
                                                    Excluded from Declaration
 a specific solid form and not released
 when the product is in use?

                     No

 Is    the   hazardous  substance                   Confirmation of declaration exemption
                                          Yes
 contained in the product subject
 to confirmation of declaration                       (KCMA, in accordance with Article 53 of
 exemption ?                                                          CCA)

                     No

 Declaration   of    the   products
 containing hazardous substances

 (Regional environmental offices)

                                           - 16 -
A. Overview of Declaration System

 - This system is to protect public health from potential risks of products containing
   hazardous substances by means of understanding the current status of hazardous
   substances in products.

 - Hazard and risk data of chemical substances and safety data of products containing
   hazardous chemicals are managed in an integrated way, by collecting basic data through
   the system to designate products of risk concerns, perform risk assessment and set up
   safety and labelling standards of products containing hazardous substances

B. Subjects to Declaration

 - A person who produces or imports a product containing hazardous chemical substance
   (When the hazardous substance exceeds 0.1% of the product and its annual total volume
   exceeds 1 ton for each hazardous substance)

C. Required Data

 - A product’s user manual

 - Pictures of a product

 - For commissioned manufacturer, a commissioned person’s information and documents proving
   the commission such as a copy of commission contract

 - For an only representative (OR) appointed by an overseas manufacturer, a confirmation
   receipt on OR appointment

D. Competent Authority

 - Declaration → Regional Environmental Office

 - Confirmation of declaration exemption → Korea Chemicals Management Association, KCMA

E. Declaration Period

                   Category                                   Declaration Period

                                                - After annual accumulation volume exceeds 1
 1. When annual volume is known                   ton, it must be declared prior to the product’s
                                                  production·import
                                                - After declaration prior to its production or
 2. When the annual volume is uncertain but
                                                  import, the declaration form must be
    is expected to exceed 1 ton
                                                  submitted by April 30 of the next year
 3. When the annual volume does not exceed
                                                - No obligation to declare
    1 ton

                                              - 17 -
F. Subject to Declaration Exemption

 - Where an exposure to chemical substance can be blocked when the product is used for
   general purposes

 - Where a chemical substance was registered to be used for the same use

                                         - 18 -
7. Information Offering
(1) Information Offering on Chemicals (transferor -> transferee)

A. Overview of Information Offering

 - This system aims at sharing the safety data of substances within the supply chain,
   including risk and hazard data of chemical substances or mixtures, in order to manage
   chemical substances in workplace in a sound and safe manner. .

B. Subjects to Information Offering

 - A person who transfers a registered chemical substance or a mixture containing a
   registered substance (When a change of the information is made once after offering
   relevant information, a transferor and a transferee also have an obligation to inform of
   the change)

C. Required Information

 Category                                           Contents
     1      Name, company name, location and phone number of information provider
     2      Product name, substance (generic) name, registration number, CAS NO.
     3      Classification/labelling
     4      Permissible use or restricted use
            Physicochemical properties, information on hazard to human health and the
     5
            environment
            Exposure scenario (summary), hazard data including measures for hazard reduction,
     6
            etc.
     7      Contents of hazard substance when a hazard substance is contained
            Safety data including handling methods, emergency responses, tips to prevent leak,
     8
            and methods to discard personal protective equipments
     9      Regulative information according to relevant laws and regulations

D. Period of Information Offering
 - Chemical Substances’ safety data shall be provided before or at a time when transferring
   a registered substance or mixture
 - When a transferor hands over a substance repeatedly to the same transferee, it is
   allowed to share the relevant data only the first time of transfer.

                                                - 19 -
E. Notice on Changes

  Category                                       Changes
             When new physicochemical property or hazard is confirmed as a result of
      1
             hazard examination
      2      When new risk is confirmed as a result of risk assessment

      3      When new use is confirmed

      4      When new regulation is confirmed

(2) Information Offering by Users (Upstream↔Downstream)
A. Overview of Information Offering
 - This is to make manufacturers or importers identify a chemical substance' use and
   exposure data accurately while fulfilling their obligations to report and register.
 - This is also to utilize safety data for safe and sound management of chemical
   substances, by means of sharing safety data between manufacturers/importers and
   downstream user/sellers of chemical substances.
B. Subjects to Information Offering
 - Between manufacturers/importers and downstream users/sellers of chemical substances or
   mixtures
C. Information offered by Upstream Users

  Category                                       Content
      1      Company name or name of manufacturer or importer

      2      Chemical substance's name (generic name) and product's name

      3      Volume of manufacturing or import (omittable)

      4      Permissible use or Restricted use
             Information on safe use, including handling method and emergency responses
      5
             against fire, etc.
      6      Physicochemical properties, hazard data

      7      Regulative information according to relevant laws and regulations

                                             - 20 -
D. Information offered by Downstream Users

  Category                                         Contents

       1      Company name or name of downstream user and seller

       2      Chemical substance and product's name

       3      Use and sales volumes (omittable)

       4      Specific description on use

       5      Exposure data

       6      Information on actions taken for safe use

E. Period of Information Offering

 - Offer information within 1 month from the date of request on safety data

(3) Notice for Chemical Information Offering (Government→Declarer)

A. Notice Details

 - Notice to the registrants and declarers of the products containing hazardous substances
   when new information was confirmed or substances were designated as hazardous
   substances as a result of hazard examination or risk assessment for an active information
   offering and information exchange among downstream users

(4) Information Offering on Products Containing Hazardous Substances (Transferor→Transferee, Consumer)

A. Overview of Information Offering

 - To prevent any harm to public health from products containing hazardous substances,
   this system aims at sharing information on hazardous substance in the products, method
   of use and precaution on handling within the supply chain.

B. Subjects to Information Offering

 - A person who transfers a declared product containing hazardous chemicals (including
   confirmed declaration exemption). If any change is made on the information which is
   already declared, a person who received the information as well as a person who offer
   the information should notify the Competent Authorities of the change.

                                                - 21 -
C. Required Information

 Category                                         Contents

     1       Product name

     2       Name and content of hazardous substance in product

     3       Permissible uses or Restricted use

     4       Specific method and condition for safe use

     5       Precaution for handling, including measures against exposure

D. Period of Information Offering
 - Offer information before or at the time when transferring a product containing hazardous
   substance
 - Offer information at no cost within 45 days from the date of request raised by a
   product consumer
E. Notice on Changes

 Category                                         Changes
            When new physicochemical property or hazard is confirmed as a result of hazard
    1
            examination
    2       When new risk is confirmed as a result of risk assessment

    3       When new use is confirmed for chemical substance or those contained in mixture

    4       When new regulation on chemical substance is confirmed

                                              - 22 -
8. Registration by OR (Overseas Manufacturers or Producers)

A. Overview
- A system to prevent overseas manufactures or producers from avoiding information
  offering on products containing hazardous substances to domestic importers due to
  confidential business information
- The OR system allows overseas manufactures or producers to comply with ARECs by
  appointing a person who meets the qualification.

B. Requirements for Appointment
 - Nationality of the Republic of Korea
 - A person having an address (a business office for corporation) in the Republic of Korea

C. How to Appoint OR
 - A person appointed by overseas manufacturer or producer shall submit the appropriate
   documents (please refer to Annex 33 of the Enforcement Rules) to the head of
   appropriate Regional Environment Office, the president of NIER and the president of
   KCMA in accordance with Article 53 of the Chemicals Control Act
 - Documents which verify the requirements (nationality of the Republic of Korea or an
   address in the Republic of Korea)
 - Documents which verify the appointment or, if appropriate, dismissal (a copy of
    appointment agreement, etc.)

D. Competent Agency
 - National Institute of Environmental Research
 - Regional environment offices
 - Korea Chemicals Management Association

                                           - 23 -
9. Competent Authorities by Work

                                                                               Processing and
                                                               Competent
 Regulation     Category                 Work                                    Declaration
                                                               Authorities
                                                                                   Period
                Phase-in
               substances      Report on manufacturing           Regional
                              chemicals/report on changes      environment     every June 30th
                                     (over 1 ton)                 office

                                Designation of phase-in
                                                               Ministry of     once in every 3
                                 substances subject to
                                                               Environment          years
                                      registration

                                   Registration of over          National          30 days
                              1ton of manufactured and         Institute of
                                       imported               Environmental    (Grace period of
                              substances(individual/joint)   Research (NIER)       3 years)

                                                                                 Declaration

                                                                                   (3 days)
              Non-phase-in     Registration/declaration of
                                                                  NIER           Registration
              substances or              change
  ARECs           phase-in                                                      (7 days or 1
                substances                                                         month)
                Subject to
               Registration                                  Korea Chemicals
                                    Confirmation of
              over 1 ton/y                                     Management
                               individual submission of                            14 days
                                                               Association
                                  registration dossier
                                                                (KCMA)

                                    Confirmation of
                                disagreement on use of            NIER             14 days
                                   veterbrate test data

                                                              A person who
                                                                transfers a
                                                                 registered
                               Information Offering on        substance or a
                                                                                      -
                                     substances                   mixture
                                                               containing a
                                                                 registered
                                                                 substance

                                              - 24 -
Notice for Information
                                                              NIER         -
                                      Offering
            Non-phase-in
              substances        Registration of small
             (under 1         amount of manufactured
                                                              NIER       7 days
           ton/year; under   and imported non-phase-in
             100kg since             substances
                2020)

             Exemption
                                   Confirmation of
                from                                         KCMA        3 days
                               registration exemption
             Registration

                                                           Ministry of
            Designation of     Designation/notification                    -
                                                           Environment
               substances
              subject to
             authorization   Report on the review about
                                                             KCMA          -
                                    grace period

              Restricted
                                                           Ministry of
             /Prohibited       Designation/notification                    -
                                                           Environment
             substances

                                 Report on products          Regional
                                containing hazardous       environment   7 days
                                     substances               offices
             Products of
            risk concerns
                             Exemption from declaration
                               of products containing        KCMA        7 days
                                hazardous substances

                                                             NIER,
             Designated/
                             Designation and Prohibition     Regional
              Prohibited       document by overseas        environment   7 days
                             manufactures and producers      offices,
             Substances
                                                             KCMA

※ The grace period of registration is 3 years from the date of announcing phase-in
  substances subject to registration in accordance with Article 9 of ARECs.

                                            - 25 -
10. FAQ

A. Reporting
○ Are phase-in substances subject to report?
 - When phase-in substances are manufactured, imported and sold over 1 ton per year,
   they should be reported.
○ Do all sellers have an obligation to report?
 - Anyone sells chemical substances to those who use them as a raw material in
   workplace should fulfill the obligation to report. However, if a person directly sells
   products to end users does not have the obligation.
○ When using a substance for multiple uses, should it be reported by use?
 - In principle, it is required to report uses of each substance. In this case, it is allowed
   to write down multiple uses by substance.
○ Is it necessary to report a change if the volume of imported substance is changed after
   reporting?
 - Any change on importer (company name, location, contact number, etc.) or use of
    chemical substance should be reported.
○ Is there any measure at institutional level when it is difficult to receive the data that
   can verify components of imported item?
 - When an importer cannot fulfill the obligation under Article 8 (Report) and Article 10
   (Registration) of ARECs due to unavoidable reason, including where its overseas
   manufacturer does not want to unveil confidential business information, the overseas
   manufacturer can appoint an only representative (OR) who meet the qualification under
   Article 38, and then have the OR fulfill the obligation.

B. Registration
○ Should each component be registered when importing a mixture?
 - All non-phase-in substances in a mixture and over 1 ton per year of phase-in substances
   subject to registration should be registered respectively.
○ It is prescribed that a manufacturer or importer has an obligation to register. Does a
   user have no obligation to register?
 - A downstream user, who only uses a substance or mixture after purchasing it from a
    domestic company, does not have any obligation to register.
○ When importing a tiny amount of reagent for R&D, is it subject to registration? If so,
   what are the necessary data and procedures?
 - In accordance with Article 10(1) of the Enforcement Decree of ARECs, the substances
   which are intended to manufacture or import for scientific experiments, analysis or
   researches, such as a reagent, are subject to application for confirmation of registration
   exemption. (once a year before importing the substance)
 - To be confirmed registration exemption by the authorities, it is required to submit an
   application form in Annex 6 according to Article 13(1) of the Enforcement Decree with
   evidential documents to the president of KCMA.

                                           - 26 -
C. Declaration
○ When is the declaration period of products containing hazardous substances?
 - If the annual volume (January 1 to December 31) of a product is known and it exceeds
   1 ton per year, declaration should be made before production or import. If the annual
   volume is unclear but expected to exceed 1 ton, it is required to make a
   pre-declaration, and then submit the declaration form until April 30 next year.
○ A company produces cleaning product A and B containing hazardous substances.
   Product A is to remove impurities in pipes of factory and Product B is to clean the
   floor and the walls outside the building. In this case, what needs to be declared and
   not to be declared?
 - Since Product A is used to remove impurities in pipes used for production, it is
   excluded from declaration obligation. However, Product B is subject to declaration as it
   is used ultimately by end users.
○ Does “products containing hazardous substances” under Article 32(1) of ARECs mean
    the products containing hazardous substances among “products of risk concerns” under
    Article 2(16) of the Act or all products containing hazardous substances?
 - "Products containing hazardous substances” under Article 32(1) of ARECs fall under the
   products under Article 2(15) of the Act and also have hazardous chemical substances.

D. Information Offering
○ Is it possible to use MSDS of the Ministry of Employment and Labor with additional
    information instead of a designated form?
 - If MSDS needs to be produced and provided in accordance with Article 41 of the
   Occupational Safety and Health Act, it is allowed to submit MSDS, with additional
   safety data on chemical substance (e.g. risk data) in a form of Annex 26.
○ Under Article 29, a person who transfers registered substance or mixture containing
   registered substance under Article 10 of ARECs “shall provide relevant information ~
   (omitted) ~ after writing it down to the transferee.” What does the registered substances
   mean and how to provide information when transferring chemicals?
 - If non-phase-in substances or over 1 ton per year of phase-in substances subject to
    registration are registered under Article 10 of ARECs, they are the registered
    substances. When an imported substance is transferred to other domestic company, it is
    required to provide chemical safety data by filling out Annex 25. In this case, in
    accordance with Article 29(1), it is required to provide MSDS in accordance with
    Article 41 of the Occupational Safety and Health Act with chemical safety data (e.g.
   risk data) written in a form of Annex 26.

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11. Annex

              Category                                  Contents
   Report of Chemical substances'
                                       ARECs Annex 1
      manufacturing and etc.

                                       ARECs Annex 2
     Registration and Registration
                                       ARECs Annex 3
  Exemption of Chemical Substances
                                       ARECs Annex 6

                                       ARECs Annex 25

        Information Offering           ARECs Annex 26

                                       ARECs Annex 27

                                       ARECs Annex 28
  Declaration of products containing
 hazardous substances & Confirmation   ARECs Annex 30
       of declaration exemption
                                       ARECs Annex 32

 Registration by an OR appointed by    ARECs Annex 33
 overseas manufacturers or importers   ARECs Annex 34

※ The above forms can be downloaded from the website of the Ministry of Government
  Legislation by searching "Act on Registration, Evaluation and etc. of Chemical
  Substances".

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