Chapter 4 Registration and Reporting of Chemical Substances
Those that manufacture or import certain quantities of existed chemical substances each year shall apply to register chemical substance data from the competent authority before the specified deadline. Those enterprises of manufacturing or importing new chemical substances shall apply to register chemical substance data from the competent authority 90 days prior to the aforementioned activities. Both abovementioned existed and new chemical substances (it is called registered chemical substance thereafter) shall be allowed to manufacture or import after approval of their registration.
The manufacturer or importer shall proactively maintain and update the data in Paragraph 1 of approved and registered chemical substances.
Chemical substances subject to registration must be regularly declared in compliance with the central competent authority's regulations.
The registered content of chemical substance data in Paragraph 1 includes status of manufacture or import, physical, and chemical, toxicological, exposure characteristics, as well as hazardous assessment, and other data items designated to be included in registration by the central competent authority. Based on the annual quantities of manufacture and import along with the substance type, registration may be divided into standard registration, simplified registration, and small quantity registration.
The central competent authority shall make registered regulations for the various types of the chemical substances in Paragraphs 1 to 4, including quantity increments, status of manufacture or import, physical, chemical, toxicological, and exposure characteristics, as well as hazardous assessment along with other required documents, for example, registration deadline, the standard registration, simplified registration, small quantity registration, common registration approaches, review procedures, approval/rejection, revocation or cancellation of registration approval, prohibited or restricted handling approaches, data reporting or addition following registration, document preservation methods, information disclosure, business secret protection methods, and other binding matters.
If the central competent authority judges that the characteristics of a new chemical substance in compliant with the definition of a toxic chemical substance or chemical substance of very concern, an additional clause shall be appended at the time of registration requiring the submission of chemical substance hazard information, updated registered report data or regular reporting of handling conditions and, when necessary, prohibit or restrict the chemical substance’s handling. When discovered after approval and registration, the central competent authority may also modify or add required or prohibited or restricted items.
If the central competent authority confirms that the toxicity of a new chemical substance in compliant with the definition of toxic chemical substance classes as prescribed in Article 3, the substance shall be announced as prescribed in Paragraph 1, Article 8. If the characteristics of said chemical substance meet the definition of a chemical substance of very concern, the substance shall be announced as prescribed in Paragraph 1, Article 24.
Registration and declaration may be performed individually or through joint consultation.
When different parties apply to register the same chemical substance jointly or sequentially, they may use common data needed for registration through consultation, and do not need to repeat testing.
When data is used jointly through consultation in Paragraph 1, if the parties involved cannot negotiate the apportionment of expenses entailed by the acquisition of necessary data, the central competent authority may determine an average apportionment at the request of the registrants, and permit the use of the registration data after the parties have paid their respective shares of expenses.
The approved chemical substance data for registration should be used to manage chemical substances those are utilized by the industry competent authority. Moreover, the data should be provided as the basis for assessment, screening and announcement of toxic chemical substances and chemical substances of high concern. The same applies in the case of data reported for future reference.
With regard to the handling and management of chemical substances whose registration has been approved, apart from their announcement as toxic chemical substances or chemical substances of very concern and handling in compliance with this Act, the chemical substances shall be handled in compliance with the laws and regulations of other central industry competent authorities.
The central competent authority may commission management of the approved registration and other relevant matters concerning existing chemical substances and new chemical substances to a nonprofit organization established with funding from the central competent authority, an administrative corporation, or relevant professional group; implementation procedures concerning the qualifying criteria, commissioning review and approval, commissioned time period, cancellation, revocation and other binding matters shall be determined by the central competent authority.