South Korea - Draft Partial Amendment of the Enforcement Decree of the Act on Registration, Evaluation, etc. of Chemicals

​South Korea Ministry of Environment (ME) announced Draft partial amendment of the Enforcement Decree of the Act on Registration, Evaluation, etc. of Chemicals and Draft partial amendment of the Enforcement Rule of the Act on Registration, Evaluation, etc. of Chemicals.

Name of Law: "Draft partial amendment of the Enforcement Decree of the Act on Registration, Evaluation, etc. of Chemicals"

- Major Contents:
A. Additional chemical substances that can be waived some of data requirements for registration (Article 13)

1) Polymers that are intended to manufacture or import less than 1,000 ton/y.

2) Chemical substances that relevant data is already submitted to obtain an approval of biocidal substance in accordance with the “Act on Consumer Chemical Products and Biocides Safety”.

B. Improved procedure for designation of authorization substances (Article 19)

1) When intending to designate authorization substance(s), the Ministry of Environment (ME) selects and announces the candidate substance(s) beforehand.

2) When it is necessary to perform risk review on candidate substance, ME surveys the current status of its distribution on the market first, and then designates it as an authorization substance, if appropriate. 

3) When intending to designate authorization substance or provide grace period of authorization, ME establishes and operates a consultative group consisting of manufacturers, importers and users of the concerned chemical substance, with a view to listen to the voice of stakeholders.

C. ME can request the information on export and import of chemical substances (Article 29(3))

1) When it is recognized to be necessary for checking whether registration or notification is completed regarding manufacture or import of chemical substance, ME can request the Korea Customs Service to provide export, import or return declarations under Article 245(2) of the “Enforcement Decree of the Customs Act”.

D. Improvement of the provisions related to entrusted works (Article 19)

1) Regarding a permission for use of hazard data under Article 19(2) of the Act on Registration and Evaluation of Chemical Substances, ME entrusts relevant works (i.e. collection of the fees to use the hazard data) to the Korea Environment Corporation (KECO).    

2) ME entrusts the following works to the Korea Chemicals Management Association (KCMA) that is established pursuant to Article 53 of the Chemicals Control Act: the works to support the communication of chemicals information under Article 29(1) of the Act on Registration and Evaluation of Chemical Substances; the works for administrative, technical and financial support that the industry has and utilizes existing vertebrate test data under Article 42(2) of the “Act on Registration and Evaluation of Chemical Substances.”

Name of Law: "Draft partial amendment of the Enforcement Rule of the Act on Registration, Evaluation, etc. of Chemicals"

- Major Contents:
A. Additional chemical substances that can be waived some of data requirements for registration (Article 5)

1) For polymers that are intended to manufacture or import less than 1,000 ton/y, ME waives the risk data requirements under Article 5(1)2 of the Enforcement Rule of the Act on Registration and Evaluation of Chemical Substances.

2) ME waives some data requirements for registration if such data is already submitted to obtain an approval of biocidal substance in accordance with the Act on Consumer Chemical Products and Biocides Safety.

B. Submission of the opinion about hazard review results (Article 24)

1) If there is an opinion about results of hazard review, those received the results may submit his/her opinion to the National Institute for Environmental Research (NIER) within 20 days from the date when he/she receives the review results.

C. Methods to prepare and provide the chemical safety information (Article 36)

1) When an existing substance is still within the grace period of registration and not registered yet, or when a substance is registered without submission of risk data as its manufacture/import amount is less than 10 ton/y, a person who provides MSDS within the supply chain shall include registration or notification number of the chemical substance in MSDS.    

D. Additional data to be submitted to register nanomaterials (Attachment 1)

1) ME requests the submission of the data, including particle size, particle size distribution, particle shape and length/diameter ratio, when applying for registration of nanomaterials.