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Chapter 3 Existing Chemical Substances Registration
Article 15
For an existing chemical substance first manufactured or imported in annual quantity of 100 kilograms or more, a registrant shall, within 6 months from the date of occurrence of the fact, apply for the phase 1 registration and attach information, as specified in Appendix 7. No existing chemical substance shall be manufactured or imported, unless the registration approval is obtained within the specified period.
The central competent authority is to issue a phase 1 registration number to a registrant whose registration application is approved, pursuant to the preceding paragraph.
Registration for existing chemical substances, manufactured or imported in annual quantity less than 100 kilograms, may be made in accordance with paragraph 1. After the registration application is approved, the abovementioned existing chemical substances are subject to the Regulations.
Article 16
The central competent authority may, by stages, designate the lists of existing chemical substances subject to standard registration, including the names of the chemical substances, quantity thresholds and deadlines for registration, based on the circumstances of the phase 1 registration of existing chemical substances.
The quantity thresholds subject to the standard registration of existing chemical substances designated by stages pursuant to the previous paragraph are specified in Appendix 8, whereas the designated lists and deadlines are specified in Appendix 9.
Registrants manufacturing or importing any existing chemical substances listed in Appendix 9 shall apply for the standard registration of such existing chemical substances and attach information, as specified in Appendixes 3 and 4.
On-site isolated intermediates may be exempted from needing an application for the standard registration of existing chemical substances pursuant to the provisions of the preceding three paragraphs.
Registrants manufacturing or importing existing chemical substances, which are not any of the chemical substances listed in Appendix 9 or do not meet the quantity thresholds in Appendix 8, may apply for the registration of chemical substances pursuant to paragraph 3.
Article 17
When different registrants, pursuant to Article 16, paragraphs 2 or 5, apply to register the same existing chemical substance jointly or sequentially, they may use common data needed for the registration through consultation.
The existing chemical substance, subjected to the joint registration pursuant to the preceding paragraph, is to be registered according to Article 16, paragraph 3.
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 share of expenses has been paid.
Article 18
The central competent authority issues the completion number for the standard registration of an existing chemical substance to those who apply and complete information registration specified in Appendix 3 pursuant to the provisions of the previous two Articles.
Upon acquisition of the completion number as described in the previous paragraph, the registrant shall complete information registration specified in Appendix 4 proactively or before the due date decided by the central competent authority.