To apply for new chemical substances registration approval, manufacturers or importers shall refer to the following registration types based on estimated annual manufactured or imported quantity:
I.Standard registration: at 1 ton or more
II.Simplified registration: at 100 kilograms or more, but less than 1 ton
III.Small quantity registration: less than 100 kilograms
If the uses or properties of a new chemical substance to be manufactured or imported meets any of the following circumstances, its registration type shall be selected by referring to the estimated annual manufactured or imported quantity, as specified in Appendix 1.
I.A substance used for the purpose of SRD
II.A substance used for the purpose of PPORD
III.An On-site Isolated Intermediate
IV.Polymer
V.Prior verified Polymer of Low Concern, PLC

• Appendix 1 Registration Types for New Chemical Substances by Estimated Annual Manufactured or Imported Quantity and Uses or Properties.pdf

The quantity thresholds for standard registration are specified in Appendix 2.
The registration information items of each registration type are specified as follows:
I.Standard registration: as specified in Appendixes 3 and 4
II.Simplified registration: as specified in Appendix 5
III.Small quantity registration: as specified in Appendix 6

• Appendix 2 Quantity Thresholds for New Chemical Substances Subject to Standard Registration.pdf
• Appendix 3 Information Items, Regarding Registrants and Substances, of New and Existing Chemical Substances Subject to Standard Registration.pdf
• Appendix 4 Information Items, Regarding Hazard and Exposure Assessment, of New and Existing Chemical Substances Subject to Standard Registration.pdf
• Appendix 5 Information Items of New Chemical Substances Subject to Simplified Registration.pdf
• Appendix 6 Information Items of New Chemical Substances Subject to Small Quantity Registration.pdf

For a manufactured or imported new chemical substance undergoing application for simplified registration or small quantity registration pursuant to the previous two Articles, the central competent authority may demand the registrant to register data in accordance with the requirements of standard registration if the new chemical substance is identified as a CMR substance.

For a new chemical substance meeting the circumstances of being a substance used for the purposes of SRD or PPORD; or having other special forms, in addition to registering the new chemical substance in accordance with the required information items of the Regulations, the registrant shall fill in and submit the following documents to the central competent authority:
I.Registration form for SRD and PPORD
II.Registration form for nanoscale chemical substances

Upon reviewing information of a new chemical substance submitted by a registrant, the central competent authority shall approve the registration along with an incidental provision to prohibit or restrict handling, and shall require the registrant to regularly report handling conditions, update registration report data, or submit chemical substances hazard information, if the central competent authority determines that there is a concern over the toxicological characteristics of a new chemical substance conforming to the definitions of Class 1, Class 2, or Class 3 toxic chemical substances.
Upon reviewing information of a new chemical substance submitted by a registrant, the central competent authority shall approve the registration along with an incidental provision to restrict handling, and shall require the registrant to submit information on exposure assessment and risk assessment, update registration report data, or submit chemical substances hazard information, if the central competent authority determines that there is a concern of environmental pollution or any threat to human health.

When different registrants apply to register the same new chemical substance jointly or sequentially, they may use common data needed for the registration through consultation.
The new chemical substance, subjected to the joint registration pursuant to the preceding paragraph, is to be registered according to the Regulations, for which the overall quantity of the joint registration shall be the sum of the individual quantities from each co-registrant.
By taking into account the overall manufactured or imported quantity of the new chemical substances registered and approved, the central competent authority may require registrants to apply for the new registration under the designated registration type or to apply for joint registration.
For a joint registration that is agreed upon by co-registrants, but for which no agreement has been reached on the cost sharing of the registration data, the central competent authority may determine an average apportionment at the request of the application’s registrants. The registration data can be used after the registrants have paid their respective shares of expenses according to the decision made by the central competent authority.

The central competent authority issues the registration number for a new chemical substance that is registered and approved.

The valid period of the new chemical substances registration approval is 5 years.
Upon agreements for the joint registration for early and late registrants, the valid periods of such joint registration for the late registrants shall be consistent with those periods for the early registrants.

A registrant, to extend the valid period of the registration approval, shall make an application to the central competent authority three to six months prior to its expiration. Information on estimated quantity of new chemical substances manufactured or imported for the following year shall be submitted to the central competent authority at the same time. Upon approval of the central competent authority, the extension shall be granted pursuant to the previous Article.
If the central competent authority is unable to make the rejection/approval decision for the extensions before the original approval registration expires, those who file the extension application pursuant to the preceding paragraph may continue to manufacture or import the new chemical substances, in compliance with the situation specified in the originally approved registration, until the review is completed.
If the central competent authority is unable to make the rejection/approval decision for the extensions before the original approval registration expires, those who fail to file the extension application pursuant to paragraph 1 shall stop manufacturing or importing the new chemical substances after the original approval registration expires. If a registrant does not apply for an extension before the original approval registration expires, the original approval registration becomes ineffective exactly on the following day of the expiration day specified in the original approval registration. A new application for registration shall be made in order to continue manufacturing or importing such chemical substances.
If the registration type intended for extension is inconsistent with the original approval registration, a new application for registration shall be made.

A new chemical substance registered and approved under any one of following circumstances may be included in the inventory of existing chemical substances by the central competent authority:
I.It shall be at least 5 years after the standard registration is filed and completed;
II.It shall be at least 5 years after the PLC registration is filed and completed in accordance with the small quantity registration; or
III.A new chemical substance becomes a toxic or concerned chemical substance announced by the central competent authority.
A registrant may apply for inclusion in the inventory of existing chemical substances, when a new chemical substance has been registered and approved for any of the following registrations:
I.Standard registration filed and completed through submission of information on hazard assessment and exposure assessment, or
II.PLC registration in accordance with the small quantity registration.
A new chemical substance registered and approved, which has been included in the inventory of existing chemical substances pursuant to the provisions of the preceding two paragraphs, is subject to the related rules of registered and approved existing chemical substances.