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 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 (ARECs) Task Force on Support for Industry in Complying with Chemical Safety Rules
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 -
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. - 27 -
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". - 28 -
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