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The Project for Establishing the Techniques for Risk Assessment of Chemical Substances

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The purpose of the project was to assist the competent authority in reviewing and replying the risk assessment information on chemical substances in registration dossier, and to improve the writing guidelines, risk assessment tools and environmental release factors needed when evaluating the risk of chemical substances. A total of 12 cases of new chemical substances and 175 cases of existing chemical substances were reviewed, of which 151 cases have completed the registration dossier this year. In order to complete the risk assessment information required for registers, we assisted in holding 2 training courses and compiled practical training handout to provide teaching assistance. During the reviewing, we also completed the frequently asked questions about the review doubts and consultation, which can be offered to registers to improve the efficiency of the review, or can be used as a reference by the competent authority for improvement of the registration policy. In terms of completing the tools required for the registration, we referred to the review experience and expert opinions to complete the revision of the draft guidelines for writing the hazard and exposure assessment of existing chemical substances and proposed the adjustment suggestions for the registration tools. After studied the applicability of aboard existing hazard and exposure assessment tools, we completed planning, construction, testing and validation of the domestic hazard and exposure assessment tools and completed the user manuals for application by the registers. Because of the difference between the default value of the exposure assessment tools and actual situation in Taiwan, a preliminary local parameters investigation was conducted. We studied the international environmental release parameter information, including EU chemical risk assessment reports, specific environmental release category, technical guidance document on risk assessment and emission scenario document and then proposed the citation principle, the feasibility assessment of local environmental release parameter establishment and short-, medium- and long-term establishment targets.
Keyword
Chemical Substances Registration, Hazard and Exposure Assessment Tool, Environmental Release Factor
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