What is K-REACH?
Korea REACH (K-REACH) refers to ‘The Act on Registration and Evaluation, etc. of Chemical Substances’, which was promulgated by the Ministry of Environment of Korea (MoE) and came into force on 1 Jan 2015. The Act is well-known as Korea REACH due to its similarity to the EU REACH regulation. Early in the year 2016, Korea MoE initiated the amendment of the Act, and on 28 Feb 2018, the newly revised K-REACH regulation was approved by National Assembly and finally implemented on 1 Jan 2019. Under current K-REACH, any company who intends to manufacture or import a new chemical substance for greater than 0.1 t/a or existing chemical substance for greater than 1 t/a shall do registration before manufacture or import. Additionally, K-REACH also adopts the concepts of pre-registration under EU REACH, which requires all >=1t/a existing chemical substances to apply for pre-registration between 1 Jan 2019 to 30 June 2019 to benefit from the grace periods.
How to comply with K-REACH?
K-REACH uses the Only Representative (OR) concept and allows non-Korean companies to register through an OR on their behalf. The Ministry of Environment (MoE) is responsible for the registration and evaluation of chemical substances under K-REACH.
Ways to Comply with K-REACH
1. Appoint an OR set up branch offices in South Korea
2. Entrust local importers to comply with K-REACH
Note: Non-Korean companies can prevent their valuable substance information from being disclosed to the public and their importers in Korea by appointing an OR.
Registration
Substances Subject to Registration
1. New chemical substances (>=0.1 t/a)
2. Existing chemical substances (>=1 t/a)
3. New chemical substances and existing chemical substances designated by MOE for their total domestic volume exceeds the standard set by the Presidential Decree (total 1 t/a for new chemicals, total 10 t/a for existing chemicals)
Information Required for Registration
The following information is required for registration:
- The name, address, and representative of a manufacturer or an importer or an only representative;
- Information that identifies a chemical substance including its name, molecular formula, and graphic formula;
- Identified uses of the chemical substance;
- Classification and labeling of the chemical substance;
- Physical and chemical properties;
- Hazard data (tox. /eco-tox. data);
- The risk associated with the chemical substance including exposure scenarios describing how to handle and control it (Applicable only when the substance is manufactured or imported in 10 tons or more per year);
- Guidance on safe uses (including protective equipment's, response to an explosion, a fire, or a leak);
- Other information specified in the Environment Ministerial Decree
Registration Types
Existing chemicals: Pre-registration, Joint Registration
1. Pre-registration
Companies who manufacture or import existing chemical substances for greater than 1 t/a shall do pre-registration between 1 Jan 2019 to 30 Jun 2019 to benefit from the grace periods.
2. Joint Registration
After pre-registration, companies will be granted a certain grace period for their chemicals according to the hazard and tonnage band. They need to do joint registration on the same chemicals before the grace period expires, which is similar to EU REACH.
3. Polymer Registration
Polymer registration requires less data on the properties of the polymer, e.g. acid/base stability test, and residual monomer contents test than normal (non-polymer) registration.
In accordance with paragraph 3 article 2 of the K-REACH Enforcement decree, a polymer is defined as a substance that meets the following criteria:
- It shall be composed of molecules in which at least one kind of monomer unit is continuously repeated;
- It shall show the characteristic distribution of molecular weights in accordance with repetitive numbers of monomer units in each molecule;
- Its molecules that at least three monomer units form a covalent bond with at least one monomer unit or other reactants shall be at least 50 percent; and
- Its molecules of the same molecular weight shall be not more than 50 percent of the weight ratio.
New chemicals: Simplified Registration, Standard Registration
1. Simplified Registration
0.1-1t/a new substance before 31 Dec 2019.
2. Standard Registration
>= 1 t/a new substances & 0.1-1t/a new substance after 31 Dec 2019
Grace Period
1. New substances don’t have a grace period, all new chemical substances should be subject to registration prior to manufacture or import.
2. The grace period for 510 PECs has expired since 1 July 2018, now registration of 510 PECs should be finished before manufacture or import.
3. The grace period for existing substances (exclude the 510 PECs) is as below.
Notification
1. New substances < 0.1 t/a
2. Substances that have received exemption approval under the previous ‘Toxic Chemical Control Act (TCCA)：
– New substances under 0.1 t/a
– New polymers which are composed of existing monomers and meet one of the below criteria:
1) Polymer with Mn over 10,000 D which contains oligomers with a molecular weight of less than 1,000 is over 5% or oligomers with a molecular weight of less than 500 is over 2%.
2) Polymer with Mn between 1000-10,000 D which contains oligomers with a molecular weight of less than 1,000 is over 25% or oligomers with a molecular weight of less than 500 is over 10%.
3) Cationic polymer
4) Polymer with Mn under 10,000, which contains residual monomer of hazardous chemical, or priority management chemical exceeding 0.1%.
Registration Exemption Application
-Chemical substance imported/manufactured for export-only use, including substance imported/manufactured to make export-only products
-Chemical reagents
-Surface treated substances
-Non-isolated intermediates or on-site isolated intermediates which can be technically blocked from leakage or exposure
-Polymer of low concern (PLC)
-Substances for R&D use
The MoE is responsible for the registration and evaluation of chemicals (substances/polymers) under K-REACH. MoE is supported by:
- The National Institute of Environmental Research (NIER)
Responsible for registrations, reduced registrations, amendments to registrations, and registration inquiries. - The Korea Environment Corporation (KECO)
Responsible for applications for pre-registration and confirmation of exemptions from registration. - The Ministry of Environment and Labor (MoEL)
Responsible for the associated South Korea Occupational Safety and Health Act (OSHA) and the regulation of chemicals in the workplace (e.g., United Nations Globally Harmonized System of Classification and Labelling of Chemicals [UN GHS] implementation).
An amendment to K-REACH, which was implemented on 01 January 2019, introduced changes within the regulation, including the need for pre-registration of existing substances. This pre-registration was required to be completed by 30 June 2019. Going forward, companies must:
- Check if their products are within the scope of K-REACH
- Identity their obligations under K-REACH, including:
- Pre-registration of substances;
- Tonnage band registration;
- Simplified registration; and
- Exemptions from registration or Confirmation of Exemption from registration.
Risk Assessment
1. Risk assessment is required for substances manufactured or imported for 10 tons or more per year
2. Depending on annual tonnage, the deadlines of submitting risk assessment are listed as follows:
Product Notification
Subject to Product Notification
Priority Management Chemicals (PMC) are present in a product exceeding a specific threshold (above 1 ton/year & 0.1% w/w).
Scope of K-REACH
Korea REACH does not apply to:
- Radioactive substances of the Atomic Energy Act;
- Pharmaceuticals and non-pharmaceutical drugs of the Pharmaceutical Affairs Act;
- Narcotics of the Act on the Control of Narcotics;
- Cosmetics and materials of the Cosmetics Act;
- Ingredients and agrochemicals of the Agrochemicals Control Act;
- Fertilizers of the Fertilizer Control Act;
- Food, food additives, tools, containers, and a package of the Food Sanitization Act;
- Livestock feeds of the Act on Control of Livestock and Fish Feeds;
- Ammunitions of the Act on the Control of Firearms, Swords, Explosives;
- Military supplies of the Act on the Management of Military Supplies and of the Defense Acquisition Program Act (except for commercial goods under Article 3 of the Act on the Management of Military Supplies;
- Health functional food of the Health Functional Food Act;
- Medical devices of the Medical Device Act.
- Personal care products of Act on the Safety of Personal Care Products.
- Biocidal products of Consumer Chemicals and Biocide Safety Act.
What is PMC?
Priority Management Chemicals (PMC) mean risk-posing chemical substances which fall under any of the following criteria. Now PMC list has been announced by MoE which includes two sub-lists with 672 substances in total. The first list (204 substances) will come into force on 1 July 2019. The second list (468 substances) will come into force on 1 July 2021.
-CMR substances and substances with endocrine-disrupting properties (EDC)
-Bio-accumulative and persistent substances (vPvB or PBT)
-Substances which may damage organs such as lungs, kidneys after repeated exposure (STOT)
-Other substances which may give the same level of concern
Product Management under K-REACH
Notification of products
Enterprises that manufacture or import any product containing any substance of priority control shall notify the Minister of Environment before manufacturing or importing if the product corresponds to both of the following requirements:
1) The content of the individual substance of priority control per one product exceeds 0.1 weight percent; and
2) The gross weight by the substance of the substances of priority control contained in the total products exceeds one ton per year.
Substances falling under any of the following are substances of priority control:
- A substance which may be or are concerned to be carcinogenic, mutagenic, toxic for reproduction, or disruptive to the endocrine system to human beings or animals;
- A substance which is easily accumulated in the bodies of human beings, animals, or plants and remains in the environment for a long period of time;
- A substance which may damage organs such as lungs, livers, and kidneys of human beings if human beings are exposed for a long period of time or repeatedly to such substance; and
- A substance that may give the same level or higher level of serious risk to human beings, animals, or plants compared with the above substances.
What to Notify?
1. Notifier information
2. Chemical information of PMC
3. Content and hazard information of PMC
4. Exposure information
5. Uses 6. Classification and label
Penalty and fine under K-REACH
Imprisonment for not more than 5 years or by a fine not exceeding 100 million won would be applied to a person who does not comply with the relevant obligations under K-REACH. The fine for violation may also be imposed on the basis of total sales of the company (no more than 5%) according to the amended K-REACH.
The Ways to Comply with K-REACH
Note: Non-Korean companies can prevent their valuable substance information from being disclosed to the public and their importers in Korea while appointing an OR.
Note: The Ministry of Employment and Labor (MOEL) requires companies exporting chemicals and products into Korea to provide Korea SDS and labeling.
Risk Assessment
1. Risk assessment is required for substances manufactured or imported for 10 tons or more per year
2. Depending on annual tonnage, the deadlines for the submission of risk assessment are listed as follows:
|
Enforcement Date |
1 Jan 2015 |
1 Jan 2017 |
1 Jan 2018 |
1 Jan 2019 |
1 Jan 2020 |
|
Criteria |
100 t/y |
70 t/y |
50 t/y |
20 t/y |
10 t/y |
Industry's Obligations under Amended K-REACH
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Obligation |
Target |
Who/When |
|---|---|---|
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Pre-notification |
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Registration |
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Product Notification |
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How to Comply with Amended K-REACH - for Foreign Companies
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Items |
What to Do |
|---|---|
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Regulatory Check and Pre-notification |
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Registration |
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Product Notification |
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Restriction/Authorization |
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Comparison between EU REACH and K-REACH
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Items |
EU REACH |
K-REACH |
|---|---|---|
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Registration Target |
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Tonnage Band |
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Polymer |
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Only Representative |
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Pre-registration of Existing Substances |
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SVHC notification |
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Restriction/authorization |
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