Frequently Asked Questions

All chemical substances except the following are subject to K-REACH.  

  1. Radioactive material defined in subparagraph 5 of Article 2 of the Nuclear Safety Act;
  2. Drugs defined in subparagraph 4 of Article 2 of the Pharmaceutical Affairs Act and quasi-drugs defined in subparagraph 7 of the said Article;
  3. Narcotics defined in subparagraph 1 of Article 2 of the Narcotics Control Act;
  4. Cosmetics defined in subparagraph 1 of Article 2 of the Cosmetics Act and raw materials used for cosmetics;
  5. Pesticides defined in subparagraph 1 of Article 2 of the Pesticide Control Act and active ingredients defined in subparagraph 3 of the said Article;
  6. Fertilizers defined in subparagraph 1 of Article 2 of the Fertilizer Control Act;
  7. Foods defined in subparagraph 1 of Article 2 of the Food Sanitation Act, food additives defined in subparagraph 2 of the said Article, apparatus defined in subparagraph 4 of the said Article, containers and packages defined in subparagraph 5 of the said Article;
  8. Feed defined in subparagraph 1 of Article 2 of the Control of Livestock and Fish Feed Act;
  9. Explosives defined in Article 2 (3) of the Act on Control of Guns, Swords, and Explosives;
  10. Munitions defined in Article 2 of the Act on the Management of Military Supplies and subparagraph 2 of Article 3 of the Defense Acquisition Program Act (excluding ordinary commodities prescribed in Article 3 of the Act on the Management of Military Supplies);
  11. Health functional foods defined in subparagraph 1 of Article 3 of the Health 
  12. Functional Foods Act;
  13. Medical devices defined in Article 2 (1) of the Medical Devices Act;
  14. Hygiene products defined in subparagraph 1 of Article 2 of the Hygiene Products Control Act;
  15. Biocidal substances and biocidal products defined in subparagraphs 7 and 8 of Article 3 of the Act on Safety Control of Consumer Chemical Products and Biocides.

As per K-REACH Article 3(2), Cosmetics defined in subparagraph 1 of Article 2 of the Cosmetics Act and raw materials used for cosmetics are not subject to pre-registration.

The term "polymer" under K-REACH refers to chemical substances satisfying all the following requirements.

  1. It shall be composed of molecules in which at least one kind of monomer unit is continuously repeated;
  2. It shall represent the characteristic distribution of molecular weights in accordance with repetitive numbers of monomer units in each molecule;
  3. 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;
  4. Its molecules of the same molecular weight shall be not more than 50 percent of the weight ratio. 

 

According to the K-REACH Article 10, those who intend to manufacture or import more than one ton per year need to register substance. After pre-registration, companies can get a grace period that allows manufacturer and importer to continue their business. During the grace period, companies can prepare co-registration and technical dossiers. The grace period applies as follows.

  • The existing substance ≥ 1000 tpa  ~ until 2021
  • 100 tpa < The existing substance ≤ 1000 tpa  ~ until 2024
  • 10 tpa < The existing substance ≤ 100 tpa ~ until 2027
  • 1 tpa < The existing substance ≤ 100 tpa ~ until 2030

According to the K-REACH Article 10, a person who intends to manufacture and import a existing chemical substance more than one ton per year needs to register before manufacture or import. To get the grace period, the pre-registration is required. However, there is no obligation if a company manufactures or imports less than one ton per year. 

No, pre-registration is necessary if a person has manufactured and imported the existing substance for more than 1 ton per year in 2016, 2017 and 2018. While proceeding the pre-registration, the person can continue to manufacture and import the concerned chemicals. 

 

Those who intend to manufacture and import existing chemical substances more than one ton per year may be subject to the grace period after the pre-registration deadline (2019.6.30) once completing the late pre-registration. However, in order to facilitate joint registration, we recommend that you make late pre-registration as soon as possible.

New chemical substances are not subject to pre-registration. During the grace period, one must report (less than 100kg per year) or register (more than 100kg per year) before manufacture and import.

When there changes after the registration is completed, a company must report the changes by submitting a change registration application.

Change registration

Change report

The cases and its deadline

When the tonnage band increases

Within 1 month after the change in the tonnage

Within 1 month after the change in the registrant name, address and the representative

When the use is changed

Within 1 month after noticing the change

When new hazards and risks information is discovered

Within 6 months after noticing the change

 

 

The procedure of co-registration for a company who wants to register its chemical substance is as follows:

1) Join a chemical substance information communicative organization (CICO)
2) Select a representative of the CICO
3) Sign an agreement for the CICO management
4) Prepare dossier for registration
5) Issue a registration confirmation letter

Registration is completed only after a registration confirmation letter is issued and registration must be done prior to manufacture and import.


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