For a new chemical substance that is not listed in the announced inventory, manufacturers or importers shall not manufacture or import any chemicals containing such new chemical substance prior to submitting a chemical safety assessment report (hereinafter referred to as "assessment report") to the central competent authority and receiving registration approval for the new substance.
The manufactures or importers pursuant to the previous paragraph may appoint a domestic company or institute, as a representative to apply for registration approval.
But if Toxic Chemical Substances Control Act of the central authority in charge of environmental protection has otherwise provision governing chemical substances listed in the announced inventory pursuant to paragraph 1, the provisions of that act shall prevail.

Manufactures or importers, to apply for registration approval, shall submit assessment reports according to the guidance and registration tools designated by the central competent authority, based on the registration type of the new chemical substance.
Registration approval types and the content required for assessment reports submitted are as follows:
1.Standard registration as specified in Appendix 1.
2.Simplified registration as specified in Appendix 2.
3.Small quantity registration as specified in Appendix 3.
The aforementioned new chemical substances belonging to simplified registration, small quantity registration, or are designated by the central competent authority may be exempted from the requirement to apply for registration approval of Paragraph 1 if the manufacturers or importers have obtained the registration approval by the central authority in charge of environmental protection, in accordance with the Toxic Chemical Substances Control Act.

• Appendix 1 Standard Registration- Information Requirement of Chemical Safety Assessment Report.PDF
• Appendix 1 Standard Registration- Information Requirement of Chemical Safety Assessment Report.doc
• Appendix 2 Simplified Registration-Information Requirement of Chemical Safety Assessment Report.PDF
• Appendix 2 Simplified Registration-Information Requirement of Chemical Safety Assessment Report.doc
• Appendix 3 Small Quantity Registration-Information Requirement of Chemical Safety Assessment Report.PDF
• Appendix 3 Small Quantity Registration-Information Requirement of Chemical Safety Assessment Report.doc

A manufacture or importer applying for new chemical substances registration approval, pursuant to the previous article shall select the type of registration depending on its annual manufactured or imported quantity as specified in Appendix 4.
For a new chemical substance pursuant to the previous paragraph and conforming to the following conditions, its registration type may be selected depending on its annual manufactured or imported quantity as specified in Appendix 5.
1. A substance used for Scientific Research and Development
2. A substance used for Product and Process Orientated Research and Development, PPORD
3. On-site Isolated Intermediates
4. Polymers or Polymers of Low Concern (PLC)
A registrant applying for registration approval of Polymer of Low Concern pursuant to subparagraph 4 of the previous paragraph, shall submit prior verification application to the central competent authority and obtain confirmation document in compliance with Article 2, subparagraph 15.
Required documentsofthe preceding Paragraph may be exempted if the substance has been verified as PLC by the central authority in charge of environmental protection in accordance with the Toxic Chemical Substances Control Act.

• Appendix 4 Annual Manufactured or Imported Volume and Registration Types-1.PDF
• Appendix 4 Annual Manufactured or Imported Volume and Registration Types-1.doc
• Appendix 5 Annual Manufactured or Imported Volume and Registration Types -2.PDF
• Appendix 5 Annual Manufactured or Imported Volume and Registration Types -2.doc

For a new chemical substance that satisfies the conditions to apply for registration approval using simplified registration or small quantity registration pursuant to the previous two Articles, the central competent authority may subject the applicant to apply the provisions for standard registration if the substance is identified as a substance of CMR, category 1.

For a new chemical substance fulfilling the criteria of the substances used for the purpose of Scientific Research and Development, or for Product and Process Orientated Research and Development; or designated and announced by the central competent authority, its assessment reports shall be filed through registration tools by the applicant. In addition, relevant information designated by the central competent authority shall be submitted as well.

Two or more manufactures or importers applying for registration for the same new chemical substance may jointly submit application for registration approval. Quantities shall be aggregated for all substances approved under joint submission.
For a new chemical substance granted under registration approval by the central competent authority, with consent of the original registrant, an applicant may apply to the central competent authority for joint registration approval, within the valid period of the registration approval document.
Issue date and valid period of the registration document granted under joint registration, pursuant to the previous paragraph, shall remain the same as the original registration document. But the date on which above modification to the joint registration approved shall be noted; that the type of registration according to the aggregated quantities under joint registration shall be noted, as well.
The central competent authority may subject new chemical substances to certain registration type or joint submission where the national annual manufactured or imported quantity of the same new chemical substance reaches certain amount.

For a new chemical substance that is manufactured or imported before these Regulations take effect, from January 1st, 2015 to March 31st, 2015, manufactures or importers may apply to the central competent authority for registration approval by attaching documents evidencing its manufacture or importation and assessment reports as specified in Appendix 6.
This new chemical substance shall not be subject to the restriction of Article 6 or Article 7.
The aforementioned registration approval document is valid for one year, which shall not be extended upon expiration.

• Appendix 6 Information Requirement of Safety Assessment Reports for New Chemical Substances Manufactured or Imported before These Regulations Taking Effect.PDF
• Appendix 6 Information Requirement of Safety Assessment Reports for New Chemical Substances Manufactured or Imported before These Regulations Taking Effect.doc

For a new chemical substance manufactured or imported during the period from the effective date of these Regulations to December 31st, 2015, the manufacturer or importer may apply for registration approval within the aforementioned period, along with assessment reports, according to the requirement of small quantity registration. This new chemical substance shall therefore be not subjected to the restriction of Article 6 or Article 7.
The aforementioned registration approval document is valid for one year, which shall not be extended upon expiration.