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Korea Toxic Chemicals Control Act (TCCA) and Korea REACH
The Korean Toxic Chemicals Control Act (TCCA) was implemented in 1991 by the Ministry of Environment (MOE) for the overall management and control of industrial chemicals in Korea. The latest revised version (Act No.895) took effect on 21 Mar 2008. The purpose of this Act is to prevent any risk caused by chemicals to human health.
The National Institute of Environmental Research (NIER) is responsible for new chemical notification under the Act. Korea Chemicals Management Association (KCMA) of MOE is responsible for accepting declaration for details of other chemicals and application for confirmation certificate.
Exemptions
The following products are out of scope of TCCA:
- (Radioactive substances as prescribed by the Atomic Energy Act
- Medicines, non-pharmaceutical drugs, and cosmetics as prescribed by the Pharmaceutical Affairs Act
- Narcotics and psychotropic drugs as prescribed by the Act on the Control of Narcotic Drugs and Other Analogous Substances
- Cosmetics as prescribed by the Cosmetics Act
- Technical ingredients and agrochemicals as prescribed by the Agrochemicals Control Act
- Fertilizers as prescribed by the Fertilizer Control Act
- Foods and food additives as prescribed by the Food Sanitation Act
- Livestock feeds as prescribed by the Control of Livestock and Fish Feed Act
- Explosives as prescribed by the Control of Firearms, Swords, Explosives, etc. Act
- Toxic gases as prescribed by the High-Pressure Gas Safety Control Act
Chemicals Regulated under TCCA
TCCA covers new chemicals, toxic chemicals, observational chemicals and restricted or banned chemicals. Other chemicals are not regulated by TCCA.Companies can go to the website of NIER, search the classified category of chemicals and take appropriate actions to comply.
For more information about how polymers are regulated in Korea and other countries, please click here.
The following picture illustrates how to determine category of chemicals and which actions shall be taken.
Korean Existing Chemicals Inventory (KECI) and New Chemical Notification
A new chemical means a chemical other than those defined as follows:
A chemical that was domestically commercialized prior to February 2, 1991 and was designated and published by the Minister of Environment in consultation with the Minister of Labor. The list of those is called the Korea Existing Chemicals Inventory (KECI).
Currently, there are around 40,000 chemicals in KECI. KECI can be accessed here:
http://ncis.nier.go.kr
Pursuant to the TCCA, manufacturers or importers of new chemical substances are required to make notification to relevant authorities prior to the commencement of their commercial activities if the volume of the new substance exceeds 0.1 ton per year.
Types of Notification and Data Requirement
- Simplified notification for chemical substance listed in 2 or more than 2 other nation's inventories before 1991;
- Semi-full notification for new chemical substances with volume below 1 ton per year;
- Full notification for other chemical substances;
You will find out specific data requirement for different types of notification by clicking here.
Exemption Rules for New Chemical Notification
Chemicals which fall into any of the categories below are totally exempted from the requirements of notification under TCCA:
- Substances in quantities of less than 100 kg a year per manufacturer or importer. Articles of a specific shape that contain chemicals for a specific function that are not likely to be released during use;
- Any chemicals imported with machine or equipment and serve as an essential and inseparable part of its functioning;
- Site limited, non-commercial R&D chemicals;
- Chemicals listed in Korean Existing Inventory (KECI). Chemicals not listed in the inventory, but were placed on the market before the implementation of TCCA in February of 1991;
- Block copolymer, if each block is listed in the KECI;
- Graft polymer, if the stem and all branches are listed in the KECI;
- Polymers that meet the 2% rules;
- Low concern polymer (application for exemption certificate is required);
- New chemicals for export only in quantities less than 10 MT cumulatively;
- New chemicals to be used as a non-isolated intermediate in specific processes
- New chemicals used for processes in which the possibilities of environmental emission or release at the workplace are negligible, such as in closed systems.
GHS in Korea
Before placing on the market, the substance or mixture should be classified and labeled if the hazard criterion is met. Classification and labeling recommendation based on GHS is mandatory in Korea.
Regulation for Classification & Labeling of Toxic Chemicals in Korea (Public Notice 2008-26) has set out grace period for GHS implementation in Korea. Substances need to classified and labeled according to GHS from 1 July 2011. Mixtures need to conform to the requirements of GHS from 1 July 2013.
In Feb 2012, The Ministry of Employment and Labor(MOEL) has issued revised Standard for Classification and Labeling of Chemical Substance and Material Safety Data Sheet by MoL Notice No 2012-14.
Compared to the old standard, the new standard mainly includes the following changes:
1. A new article regarding labeling information has been added(article 9);
2. Article 13: The recipient of a MSDS needs to issue a confirmation receipt;
3. Article 14: More information needs to be provided when SDS is updated or altered;
4. Article 20: This a new article regarding request for information not on MSDS;
5. Section 1 of SDS requires emergency contact info of supplier based in Korea;
6. Korean translations of some p and h statements have been updated(all updated statements are listed in purple red.) The English translations remain unchanged;
7. The classification criteria for environmental hazards have been updated to be consistent with EU CLP regulation(see last document).
More info about GHS in China, Korea and Japan can be found here.
Amendment of TCCA - the Act on the Registration and Evaluation of Chemicals (Korea REACH)
At the end of February 2011, the South Korean Ministry of the Environment (MOE) released a draft of “the Act on the Registration and Evaluation of Chemicals” for public consultation. The new REACH-like Act will overhaul the current TCCA and regulate both new and existing substances. The legislation is also known as" Korea REACH" and is expected to come into force in 2013.
The draft Act requires manufacturers and importers of chemicals to notify substances (i.e. submit data such as quantities of production or import in the previous year) to the MOE, which will then designate certain existing chemicals as “chemicals subject to assessment” for registration. Chemicals subject to assessment mean existing chemicals that might pose potential risks to human health or the environment and require further risk assessment, and are announced by the ministry.
- Pre-registration
Existing substances that have been designated as “chemicals subject to assessment” do not need to be registered before manufacture/import during the transitional period (up to 8 years) if they are pre-registered.
To pre-register, manufacturers or importers of existing chemicals subject to assessment manufactured or imported in quantities above 0.5 ton per year must submit a pre-registration to the ministry within 6 months since the publication of the chemical substances subject to assessment. The first pre-registration period is expected to start from 1 Jan 2014.
Similarly to REACH, the new act allows foreign legal entities to submit registration to authorities through the appointment of only representative. Late pre-registration is also possible.
- Registration
New substances shall be registered prior to manufacture or import. Existing substances will be a given a transitional period up to 8 years if pre-registered. Only two tonnage bands are available (>100t/y and <100t/y). Joint submission is also possible.
The picture below shows how to determine whether chemicals require pre-registration or registration under Korea REACH.
- Evaluation
The ministry will conduct hazard evaluations of the registration data submitted and then conduct a risk assessment (if necessary), which will be used as grounds for designating a substance as a priority substance for authorization or restriction.
- Authorization and Restriction
Substances on authorization list will not be allowed to be used, placed on the market or imported after a date to be set unless the company is granted an authorization. The restriction list will contain the list of all restricted substances, specifying which uses are restricted or even banned. Those two lists will be constantly updated by MOE.
Our Korea Chemical Compliance Services
- Search and confirm if a substance is new in Korea;
- Application of confirmation of exemption under TCCA;
- Dossier preparation and submission of new substance notification under TCCA(simplified, semi-full notification, full notification and polymer notification);
- Test monitoring/translation of study reports;
- Preparation of Korean SDS and label.
About Us and Contact
We have provided one-stop chemical inventory search services for many companies doing business in Asia (for example, China, Japan, Korea, Malaysia, and Philippine). We help them find out whether their chemicals are regulated in those countries or regions and offer free initial consultations about how to comply. We also prepare or translate GHS compliant SDS and label in accordance with their national chemical legislation at affordable prices.
If you have any questions about chemical compliance in the Asia-pacific region, please contact:
- Mr. Eric Xiong, China
Office
11F Building 1, Dongguan Hi-Tech Park, 1288 Chunbo Road, Binjiang District, Hangzhou 310052, China
Tel: +86-571 8720 6598 | Fax: +86-571 8720 6533
Email: Eric.xiong@cirs-reach.com
