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How to Comply with Chemicals Control Act (CCA) in Korea

By Little Pro on 2017-06-14 Views:  Update:2017-06-29

If you export a chemical product to South Korea, you not only need to comply with K-REACH, but also need to comply with Korean Chemicals Control Act (CCA). The CCA (previously toxic chemicals control act or TCCA) passed national assembly in May in 2013 and it comes into force in Jan 2015. It is a new law focusing on chemical reporting and chemical accident prevention. In this article, we will summarize the major obligations of chemical manufacturers and importers under CCA and how to prepare a letter of confirmation for CCA.

Obligations of Chemical Manufacturers and Importers

 Article  Description
Article 5 (Duties of Business Operators)
  • General requirements on business operators to take necessary measures to prevent any harm to human health or the environment caused by chemicals.
Article 9 (Confirmation of Chemicals)
  • Any person who intends to manufacture or import a chemical shall confirm whether the relevant chemical or any ingredient is a regulated substance and submit the details to the Ministry of Environment (prior to manufacture or import).
Article 13 and 14 (Criteria for Handling Hazardous Chemicals and PPE)
  • Where any person handles hazardous chemicals, he/she shall meet certain criteria for handlinghazardous chemicals (i.e, maintaining a qualified facility, wearing of Personal Protective Equipment)
Article 15 (Restrictions, etc. on Quantity of Hazardous Chemicals Displayed or Stored)
  • Where a person who handles hazardous chemicals intends to display or store hazardous chemicals in excess of a certain quantity prescribed by the Ministry of Environment, he/she shall prepare a plan for display or storage and obtain confirmation from the Minister of Environment in advance.
Article 16 (Labeling, etc. of Hazardous Chemicals)
  • Any person who handles a hazardous chemical shall affix a label to the package or container of  hazardous chemicals
Article 18 (Prohibition against Handling of Prohibited Substances)
  • No person shall handle prohibited substances.
  • Prior permission from MOE is required for manufacturing, importing or selling prohibited substances for research use. 
Article 19 (Permission to Manufacture, Import, or Use Substances Requiring Permission, etc.)
  • Any person who intends to manufacture, import or use a substance requiring permission shall obtain permission from the Minister of Environment in advance.
Article 20 (Permission to Import Restricted Substances and Declaration for Import of Toxic Substances)
  • Any person who intends to import a toxic substance shall report the kind and purposes of the toxic substance to the Minister of Environment
  • Any person who intends to import a restricted substance shall obtain permission from the Minister of Environment in advance.
Article 23, 24, 25, 26 (Requirements on handling facilities)
  • Set out documentation and criteria, etc. for disposition, installation and management of handling facilities

While CCA has also set out many obligations for government bodies, we will only focus on how to comply with CCA from an industry perspective and how to prepare the confirmation of chemicals under article 9.

Scope of CCA

The CCA does not apply to:

  1. Radioactive substances;
  2. Medicines and non-pharmaceutical of the Pharmaceutical Affairs Act;
  3. Narcotics under subparagraph 1 of Article 2 of the Act on the Control of Narcotics, etc.;
  4. Cosmetics and raw materials used for cosmetics under subparagraph 1 of Article 2 of the Cosmetics Act;
  5. Pesticides and technical ingredients under subparagraphs 1 and 3 of Article 2 of the Pesticide Control Act;
  6. Fertilizers under subparagraph 1 of Article 2 of the Fertilizer Control Act;
  7. Foods, food additives, appliances, containers, and packages under subparagraphs 1, 2, 4, and 5 of Article 2 of the Food Sanitation Act;
  8. Livestock feed under subparagraph 1 of Article 2 of the Control of Livestock and Fish Feed Act;
  9. Explosives under Article 2 (3) of the Control of Firearms, Knives, Swords, Explosives, etc. Act;
  10. Military supplies (excluding conventional items) under Article the Act on the Management of Military Supplies;
  11. Functional health foods under subparagraph 1 of Article 3 of the Functional Health Foods Act;
  12. Medical devices under Article 2 (1) of the Medical Devices Act;
  13. Toxic gases under the High-Pressure Gas Safety Control Act.

How to Comply with CCA

Firstly, you need to check the regulatory status of all substances in your chemical product, indicate wether your product contains any regulated substance below and submit the details to Korea Chemicals Management Association (KCMA) prior to manufacture or import. 

  1. Existing chemical substances subject to registration under K-REACH;
  2. New chemical substances under K-REACH;
  3. Toxic substances;
  4. Substances requiring permission;
  5. Restricted substances;
  6. Prohibited substances;
  7. Substances requiring preparation for accidents.

You can click the following link, input the English name or CAS no. to check the regulatory status of each substance. 

Korea CCA

Secondly, you need to get additional approval if your product contains any regulated substance above. If your product contains any new substances or existing substances subject to registration, you need to register them with the national institute of enviromental research (NIER). If your product contains restricted or prohibited substances, you need to obtain prior permission from regional environmental office. If you manufacture or import toxic chemicals, you need to declare its kind and use to the regional environmental office.

Finally, you need to label your products correctly and ensure that your handling facilities meet all criteria or requirements set out in the CCA.

Letter of Confirmation for Manufacture and Importation

Manufacturer or Importer of chemicals shall submit a Written Confirmation of Details for Chemical Product to KCMA after conducting careful self-evaluation. Only one submission is needed for each product. If importers do not know detailed product composition, they could request suppliers to issue a signed confirmation letter confirming whether the product contains any regulated substance. The example of the confirmation letter is given below.

Letter of Confirmation CCA

If you do not know how to check the regulatory status of each substance in your product, you could also apply for MoE to issue a confirmation certificate. You need to provide 100% product composition for this application. 

References

 

 Tags: Topics - KoreaREACH-like Regulation and Registration

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