- Department:Chemicals Administration Ministry of Environment
Since the implementation of the Regulation of New and Existing Chemical Substances Registration, the chemical substances registration system has been online for more than two years. The EPA serves as the hub of the registration system, having received a total of 11,912 submissions, and listing 26,829 chemical substances, during Phase 1 of existing chemical substance registration up to 31 Dec 2016. The Toxic and Chemical Substances Bureau (TCSB) of the EPA will announce the first batch of existing chemical substances that are subject to the standard registration before the end of 2017.
Based on the authority given by the Toxic Chemical Substances Control Act, the EPA announced the Regulation of New and Existing Chemical Substances Registration on 11 Dec 2014 and officially launched the chemical substances registration system to build up data needed for all governmental agencies’ controls on chemical substances.
Legal basis
The EPA has been implementing controls on chemical substances based on the Toxic Chemical Substances Control Act. The amendments to the act added provisions for the chemical substances registration system on 11 Dec 2013, and related regulations have been drafted for implementation since then.
The registration system involves a variety of chemical substance industries, each with a large number of operating enterprises, with relevant review standards, registration tools, and instructions that are all highly technical. In addition, the Ministry of Labor (MOL) has also implemented the Occupational Safety and Health Act and its relevant registration regulations. Under the coordination of the National Development Council, the EPA serves as the registration window to launch the single-window registration system. This practice simplifies the previous procedure of submitting duplicate registrations to two agencies and effectively lightens burdens on enterprises, an example of successful interministerial efforts to streamline administration for public convenience.
The registration regulations focus on requiring enterprises manufacturing or importing new chemical substances to submit registrations ahead of conducting their operations. Based on the purpose of use and the tonnage of the new chemical substances, the registration has to be submitted as standard, simplified, or small-amount registration. Only after the registration is approved can the enterprise start manufacturing or importing the substance. Enterprises that manufacture or import more than 100 kilograms of existing chemical substances have to complete the Phase 1 registrations for existing chemical substances. The EPA will announce the standard registration lists for existing chemical substances in different phases in the future, and manufacturing and import can continue only after the registrations are completed accordingly.
Results of chemical substance registration
Since the launch of the chemical substances registration system, a common registration platform was co-established by the EPA and the Ministry of Labor (MOL). On 8 September 2015, the MOL announced a list of 101,089 existing chemical substances. In accordance with legal requirements, the EPA had requested all enterprises that imported or manufactured over 100 kg of existing chemical substances annually to abide by the Phase 1 chemical substance registration starting from 1 September 2015 to 31 March 2016.
During this period, the EPA received over 10,000 submissions and checked more than 156,000 separate items of information. Analysis showed that over 25,000 substances were registered, of which the top use was for purposes at industrial sites (37.27%), followed by usage for formulation (32.48%). The categories of products are much more diverse.
By 31 Dec 2016, the EPA had received over 11,912 submissions of Phase 1 existing chemical substances registration, consisting of 26,829 chemical substances. The registration of existing chemical substances is crucial for building up a complete database on these chemicals. The registry will be used as a reference for evaluating which substances will be announced as part of the first batch of chemicals that should be registered through standard registration, and also for the later work of determining toxic chemical substances that need to be controlled.
The EPA expects to announce by the end of 2017 the first batch of designated existing chemicals for standard registration. Details of these chemicals need to be submitted according to volumes, tonnages and items stated in the regulations. The information to be submitted includes hazard category and labeling, physical and chemical properties, and safety information. Chemicals evaluated to be toxic will be announced as toxic chemical substances and subject to controls for operations like manufacturing, import, export, sale, shipping, use, storage, and disposal in order to reduce the public’s exposure to risks.
For registration of new chemical substances, a total of 1,230 submissions were processed between 11 Dec 2014 and 31 Dec 2016. A total of 507 submissions also had been processed for prior evaluations of low-profile polymers.
Through the establishment of the chemical substances registration center and the registration platform in the past two years, the EPA has provided customized promotions to over 3,700 enterprises via official letters and emails; organized 40 seminars on the related regulations, system operation and international exchange conventions, with more than 5,900 participants; and replied to questions in over 8,500 phone calls, 2,200 emails, 600 instant messages, and 70 messages on Facebook.
Future outlook
The EPA established the Toxic and Chemical Substances Bureau (TCSB) on 28 Dec 2016 as a designated competent authority, which will carry out chemical substances registration more efficiently. Yet it will still rely on joint cooperation with relevant ministries, industries, and academia. The TCSB will keep conducting rolling reviews and updating registration tools, provide Q&A services, and disseminate information to assist enterprises to submit registrations. The TCSB will also promote the system via thorough communications, continuing to collect information on experiences and methods of chemical substances control systems and technical management in the European Union, the US, and Korea, as references for future policies.
The Chemical Substances Registration Platform website (https://tcscachemreg.moenv.gov.tw/Epareg/content/masterpage/index.aspx)
Source: EPA Environmental Policy Monthly, p.1-4, Vol. XX, Issue 2, 2017
