In June, Taiwan’s EPA published official guidance on how to prepare a standard registration dossier for the first list of 106 Priority Existing Substances (PECs). Companies are required to submit nine information items to the authorities. Because of the impact of COVID 19, the EPA is allowing companies to submit the first seven information items while leaving the item number eight and nice (hazard assessment and exposure assessment, which are generally taking most of the time for preparation) for later submission. Companies will receive a registration completion code after submitting the first seven items.
Standard Pecs registration – information items
Previously, testing labs were all required to adhere to OECD guidelines or be ISO certified, but the guidance does not mention if universities and colleges need to follow those standards," said Chia-Sui Hsu from Global Product Compliance (GPC). See more...
According to Taiwan’s Toxic and Concerned Chemical Substance Control Act (TCCSCA), new and existing substances must be registered in Taiwan. The first batch of 106 PECs was published on 11 March 2019. Taiwan’s EPA published the draft of Guidance for Standard Registration of Designated Chemical Substances by stages in September 2019. After a long waiting, the official guidance for standard registration, Guidance on Existing Chemical Substances Standard Registration (1st version), was released on 9 June 2020. In comparison with the Guidance published in September 2019, the new guidance accepts data from more choices. According to recently published guidance, reports from laboratories of universities in Taiwan are acceptable for data on chemical and physical properties. For toxicological and ecotoxicological information, Taiwan’s EPA accepts reports from laboratories of universities in Taiwan and laboratories with certification of ISO 17025. If animal testing is required for obtaining toxicological and ecotoxicological information, the experiment must form an Institutional Animal Care and Use Committee (IACUC) and follow Animal Protection Law (enforced on 16 December 2018).
According to recently released guidance, a registration number will be issued after registrants submit information (1) to (6) in Appendix 7 (see table below). Taiwan’s EPA reserves the right to ask registrants to provide information on hazard assessment (7) and exposure assessment (8) later.
The recently published Guidance can be seen as an effort from Taiwan’s EPA to facilitate companies to comply with standard registration of 106 PECs. Companies are recommended to set up their regulatory team to fulfil their obligations or contact compliance service providers to learn about their options (e.g. joint registration and benefits of registration via Third Party Representative).
On March 11, 2019, Taiwan’s EPA published the amended regulation on New and Existing Chemical Substances, specifying Standard Registration for 106 existing chemical substances. From 1 January 2020, manufacturers or importers who manufacture or import any Existing Chemical Substance in an annual amount of 100 kilograms or more, should apply for the Phase One Registration within 6 months from the date of manufacture/import. The amendment also includes a requirement of annual reporting. Annual reporting requires importers/manufacturers to report the volume of manufacture or importation of registered new and existing substances from the previous calendar year between 1st April and 30th September. Information for annual reporting include:
Non-Taiwanese manufacturers for business reasons that want to maintain the confidentiality of its product compositions and do not want to share with their Taiwanese clients (importers), may ask the importers to nominate a Third Party Representative (TPR) who can prepare and submit the annual reporting without having to revel the composition details of the product. Reporting is required to be submitted separately for each importer. GPC Regulatory – provides these services and you may contact us on [email protected] for the TPR services.
In addition, GPC Regulatory can support you to comply with various aspects of TCCSCA such as Phase-One Registration(s), Priority Existing Chemicals (PEC) registration(s) and new substance registration(s) and submitting them as a your TPR.
My understanding from speaking with the Toxic and Chemical Substance Bureau is that the EPA’s plan to delay the Pecs deadline is partly due to the pandemic. But it is also because Taiwanese enterprises are still not familiar with standard registration procedure and the EPA wants to offer some time for companies to adjust," said Chia-Sui Hsu from Swedish consultancy Global Product Compliance (GPC). See more...