Registration Regulations Revised to Strengthen Control of Chemical Substance Source Information

  • Date:2019-04-20
  • Department:Chemicals Administration Ministry of Environment

The EPA announced the revised Regulations of New and Existing Chemical Substances Registration ( 新化 學物質及既有化學物質資料登錄辦法 ), mandating submitting information of 106 existing chemical substances within two to three years for standard registration. Registrars are required to annually submit information of chemical substances according to ranges differentiated by substance amount. In this way, the EPA expects to effectively keep track of substances that have wider domestic flows and higher risk potentials but less known. The enhanced information control will also strengthen the foundation of interministerial controls on risks of chemical substances.

Formulated to improve information needed for various authorities to manage chemical substances, the Regulations took effect on 11 December 2014. The EPA proceeded with the revision by looking at previous implementation experiences, opinions continuously collected from stakeholders, and changes in international chemical substance registration system. References have also been taken from the authorities’ need for interdepartmental controls on chemical substances as well as the Regulations on New Chemical Substances Registration ( 新化學物質登記管理辦 法 ), established by the Ministry of Labor (MOL). The goal is to avoid repeated

The EPA said that it has combined the unit responsible for chemical substance registration with the MOL and even further incorporated the two authorities’ relevant regulations in the revision. For risks and exposure assessment information, registration is mandatory with annual manufacturing or importing amount of ten metric tons, originally 1,000 metric tons before revision, to better collect source information of chemical substances. The annual registration period was adjusted to the period from April to September, same time when the MOL conducts chemical product report management, in order to lighten enterprises’ burdens.

To simplify procedures and increase convenience, the revised regulations specify that, in the first phase, registration must be submitted within six months after the annual amount of existing chemical substances reaches 100 kilograms. New regulations include that existing chemical substances must apply for information protection and that information protection length increases up to five years for registration of small amounts of polymer of low concern (PLC). These changes were made to meet enterprises’ practical needs. With Documents replaced with codes in registration and an appeal mechanism newly added, enterprises no longer need to reapply and keep documents and also have gained an access to administrative remedy.

The EPA emphasized that a grace period would be provided regarding the abovementioned regulations about standard registration for existing chemical substances and annual amount reports. Registrars will have time to adapt before the promulgation on 1 January 2020. Promotions and meetings will be held after the announcement. Manufacturers and importers are urged to proceed with registration accordingly and submit information based on the manufactured or imported amount. It includes information regarding manufacturing, importing, physical and chemical nature, toxicity, exposure, risk assessment of chemical substances, as well as that specified a Chemical Substances Registration Platform

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Source: EPA Major Environmental Policies, April 2019

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  • Update:2024-10-24