Final Countdown for Phase I Existing Substance Registration in Taiwan

Are you ready for the March 31 deadline?

18 February 2016

The clock is ticking for Taiwan’s Phase I Existing Substance Registration. According to Taiwan Environmental Protection Administration (EPA)’s Regulation of New & Existing Chemical Substance Registration, all existing substances manufactured in or imported into Taiwan, if its quantity exceeds 100 kg per annum, must be registered before March 31, 2016 by the Taiwan manufacturers or importers in question. Those who fail to register on time may be subject to penalties including a maximum fine of NTD 300,000, suspension of business or shipment return.

The gigantic amount of substances (>100,000) included in Taiwan Chemical Substance Inventory (TCSI) and the relatively low trigger volume (>100 kg/year) make the Phase 1 registration a considerable workload for the industry, despite a limited information requirement. It is therefore highly recommended that a company should check their product inventory in terms of substance identity and annual volume and make sure their products are duly registered.

Companies outside Taiwan should actively communicate with their Taiwan importer(s) to support them with the registration. In cases where there is confidential business information (e.g. ingredient, recipe, etc.) that would not be disclosed to a downstream customer (e.g. Taiwan importer), a Third Party Representative (TPR) can be designated to submit the registration on behalf of their Taiwan importer.

To help companies better understand and to comply with the regulation requirements, a seminar was organized by Intertek in Taipei on Jan 28, 2016, aiming at Taiwan chemicals regulation. In this one-day seminar, experiences of Intertek gained from completed Phase 1 registration cases as well as some practical or outstanding issues were exchanged among participants.

With extensive regulatory experience and strong expertise, Intertek has successfully supported more than 15 companies in Taiwan regulatory compliance activities for nearly 600 chemical substances, including chemical nomination, existing substance evaluation and Phase 1 registration. Should you have any inquiry on chemical regulation in Taiwan, please feel free to contact us.

Today’s expert blogger is Eric Zhu. Eric is part of the regulatory affairs group in China and is focus on Toxicological endpoints and assessment under China new chemical notification. This includes registration/notification, regulatory consultancy. His daily work covers data gap analysis, technical dossier preparation, development of risk assessment report, supplementary preparations, for REACH and China new chemical registration.