Chemical substances registration establishes a mechanism of source control and management for Taiwan. Under the “Toxic Chemical Substances Control Act” (TCSCA), enterprises manufacturing or importing new chemical substances or a given quantity of existing chemical substances shall register those substances in accordance with "Registration of New and Existing Chemical Substances". Undergoing standard registration, the enterprises must submitted papers including the information of toxicity and ecotoxicity to the government. Due to the fact that this registration system has just implemented for more than two years yet, there is still much room for improvements. There are three main objectives in this project. First, updates of internationally-recognized test methods; Second, the execution and review capacities for testing results in Taiwan; Third, enhancement on international exchanges of academic research and practical experience. At the beginning of this project, ninety-seven internationally-recognized OECD test guidelines (TGs) has been reorganized into an inventory of test and alternative methods. In addition, eleven test methods announced by Environmental Analysis Laboratory (EAL) of EPA are also recommended to be added. Our suvey showed that execution capacity of these TAF GLP-accredited laboratories for ecotoxicity test is much inefficient than those for toxicity test. Though some laboratories in domestic academic organizations could also handle the ecotoxicity tests, they have neither TAF GLP accreditation nor consider to gain it. For increasing the execution capacity in ecotoxicity test, the EAL-announced laboratories are suggested to be incorporated. In the respect of result review, there are thirdty-nine experts in Taiwan could assist data review of toxicity testing, ecotoxicity testing, and QSAR analysis for chemical substances registering cases. As review references to alternative test methods for toxicity and ecotoxicity of chemical substances registration, we have further prepared guidelines and requirements for experts to review alternative test methods in this project. On the other hand, we have practically run preliminary validation process of alternative methods, including in vitro assay and QSAR analysis, for “skin irritation” and “skin sensitisation”. The results showed that these alternative test methods could be worthy for further validation researches and suitable to used in Taiwan. Our team members attended “The 10th World Congress on Alternatives and Animals in the Life Sciences” in U.S. for collecting informations about development and trends of alternative test methods either in academic research or regulatory acceptance. During the congress, we also met some international experts of alternative researches for practical experience exchanges and training course consultations. Then we have designed an agenda of “Workshop of Practical Alternative Test Methods for Toxicology and EcoToxicology” for domestic laboratorian and reviewers in chemical substances registrations. At last, we had held two domestic expert meetings of toxicology and ecotoxicology for chemical substances registration respectively. The experts reviewed our works, and further offered their recommendations for current situation and future development, such as regulatory update, use of alternative methods, promotion of training courses and workshops, and establishment of a communication platform between enterprises, regulatory agencies and academia. Expecting to address the related issue of chemical substances registration, so that Taiwan's chemical regulatory system and industrial development could converge with international trends.

Chemical Substances Registration;Toxicity and Ecotoxicity Test Guidelines;Alternative Test Methods