KOR/775
WTO/TBT
KR South Korea
  • 71 - Chemical technology
2018-08-10
2018-06-12

Non-phase-in substance & Phase-in Substance, carcinogenic or mutagenic substance

Revised version of the Enforcement Decree of the Act on Registration and Evaluation, etc. of Chemical Substances, 64 pages, Korean Revised version of the Enforcement Rules of the Act on Registration and Evaluation, etc. of Chemical Substances, 131 pages, Korean

- Name of Law: Revised version of the Enforcement Decree of the Act on Registration and Evaluation, etc. of Chemical Substances

- Major Contents:

A. Definition of transported isolated intermediate (as amended Article 2(1))

Under the Act on Registration and Evaluation of Chemical Substances, non-isolated and on-site isolated intermediates not exposed to consumers are exempted from registration or for its registration under REACH. Therefore, the Ministry of Environment developed a definition of transported isolated intermediate as follows "which is generated during manufacturing process and transported to other production asked to submit less data than other substances. However, transported isolated intermediate does not have relevant provision in the Act. The EU asks simplified data requirements site, and then used and exhausted all", so as to waive some data submission in registration dossier.

B. Grace period for existing substances (as amended Article 10) For manufacturing or importing existing substance from 10 to 100 ton per year, manufacturer or importer should register the substance by 31 December in 2027, and register those from one to ten ton per year by 31 December in 2030.

C. Total amount of substance in the Korea market to be designated as subject to registration (as developed Article 10(3))

For existing substance that a company manufactures or imports less than one ton per year, which is exempted from registration, but the total amount of the v substances as subject to registration after deliberation of the Chemical Substance Evaluation Committee in accordance with Article 10(5).

D. Registration exemption (as amended Article 11)

When substance is exported as a whole, it is exempted from registration regardless of its amount. For high molecular compound with less than 10,000 of number average molecular weight, it shall be registered when hazardous substance, priority substance or new substance remains more than 0.1% in weight ratio based on unreacted monomer.

E. Less data requirements for substance registration (as amended Article 13)

For chemical substance of low concerns, the Ministry of Environment simplifies data requirements in order to operate the current registration system in more reasonable manner. When manufacturer or importer of existing substance notifies the competent authorities of the substance or its changed information in accordance with Article 10(3) and, as the result, it is revealed that the substance does not fall under classification and labelling of health or environmental hazard, the Ministry of Environment allows to register the substance with less data by waiving several data requirements in registration dossier. Provided that manufacturer or importer who notifies the substance or its changed information for consumer use, they are not the subject to the waiving of data requirements.

F. New penalty criteria (as developed Article 15(2))

Fine is imposed lower than 5% of the total sales of the concerned company under the law. In this case, the total sales is the average annual sales of three consecutive business years just before the business year when the company committed the violation.

G. Concentration-based information provision (as developed in Article 20(2))

The information on registered or notified substance should be provided regardless of its concentration. In addition, the information on unregistered hazardous substance should be provided when the hazardous substance is contained more than the mixture classification criterion in accordance with the ME Public Notice "Regulation on Classification and Labelling, etc. of Chemical Substances", even though the hazardous substance does not meet its mixture criterion in accordance with the ME Public Notice "Designation of Hazardous, Restricted and Banned Substances".

- Name of Law: Revised version of the Enforcement Rules of the Act on Registration and Evaluation, etc. of Chemical Substances

- Major Contents:

A. New notification system for existing substances and their changed information (as amended Article 3)

Manufacturer or importer of existing substance should submit a notification to the Korea Environment Corporation (KECO) through the Chemical Substance Data Processing System before manufacturing or importing the substance. When the tonnage band manufactured or imported is changed, manufacturer or importer should submit a notification on the changed tonnage band before the changed tonnage band is applied. When other information is changed such as classification, labelling, intended use and so on, manufacturer or importer should submit a notification on the changed information within one month after the date when the change occurs.

B. Registration method (as amended Article 5) When existing substance poses low risk concerns, the substance is allowed to submit less data (except the case when it does not have classification and labelling on health and environmental hazards, and except a person who notifies the substance for consumer use). In this case, manufacturer or importer can submit less hazard data that is generally applied to the tonnage band from one to ten ton per year, regardless the actual amount manufactured or imported. For transported isolated intermediate, its manufacturer or importer can submit less hazard data, if appropriate, even to the extent of data requirements that are generally applied to the tonnage band from one to ten ton per year (when manufactured over 1,000 ton per year).

C. Notification and notice regarding new substance (as developed Article 6(2))

Manufacturer or importer of new substance less than 100kg should submit required documents, including a notification on OR appointment and an application for data protection, to the National Institute of Environmental Research (NIER) before manufacturing or importing the new substance. Then, the NIER gives a notice within seven days (or within 14 days in maximum) from the date when the documents are received.

D. Joint submission method and procedure for joint registration (as amended Article 17)

Based on notification of existing substances and their changed information, manufacturers and importers of the same substance should form a consortium if it manufactures or imports the substance for consumer use. Even though some existing substances have the same chemical name or identity, it may be inappropriate to consider them as the same substance because their characteristics as high molecular compound are clearly different. In this case, separate consortium may be formed.

E. Information provision regarding chemical substance (as amended Article 35, and developed Article 35(2))

1) Based on classification and labelling of chemical substance having health and environmental hazards, its information such as components and contents may not be provided if the Ministry of Environment (ME) approves to do so.

- In this case, "application not to provide information" should be submitted to the Ministry of Environment (ME). Then, the ME decides whether it accepts the application or not based on a deliberation of the Information Provision Deliberation Committee (which is newly established under Article 7), and informs the applicant of its decision in accordance with Article 35(2).

2) When mixture contains chemical substance with higher risks on human body, including carcinogenic, mutagenic and reproductive toxic substances (CMRs) or hazardous substances, relevant information should be provided if its concentration is higher than its mixture classification criterion in accordance with the ME Public Notice "Regulation on Classification and Labelling, etc. of Chemical Substances".

F. Removal of provisions regarding management of risk-concerned products (by abrogating Article 43, 44, 47 and 48) As the management of household chemical products, including products of risk concerns, is transferred to the Consumer Chemical Products and Biocides Safety Act, the Ministry of Environment abrogated relevant provisions: including risk assessment method, data submission on substances contained in risk-concerned products that are not designated and announced yet, withdrawal order and so on.