Amendments to New and Existing Chemical Substances Registration Regulations Preannounced


The main points of the amendments preannounced on 9 March 2018 are as follows:

1. The text for registration categories as well as the different grades were combined and are now presented as an attached table. This was done in response to adjustments to the chemical substances registration one-stop processing window and regulation coordination. The amendments also refer to and include relevant regulations for the registration of new chemical substances from the Ministry of Labor.

2. Data for chemical substances that have been approved will have a registration number and will not be issued any further registration documents.

3. Criteria for the production or importation of existing chemical substances are to be clarified when annual volumes exceed 100 kilograms. Registrants that meet this criterion must complete the first phase of the registration within six months. Registrants that have not been approved by the end of that time will not be permitted to produce or import the chemical substance. Registrants producing or importing chemicals with yearly volumes less than 100 kilograms may voluntarily apply for registration.

4.The existing chemicals that have already been registered as part of phase one include chemicals that circulate widely within Taiwan or are potentially highly dangerous, or there is a lack of information regarding the chemical. 106 substances are selected and prioritized to complete the registration process for existing chemicals.

5. Regulations were added stating registrants of phase one existing chemical substances have to also apply to the central competent authority for confidentiality. Additional time for applying for confidentiality is given to approved registrants who then recognize the need for confidentiality in registering data.

6. Beginning on 1 January 2019, approved registrants must provide information on the amount of the new or existing chemical substance produced or imported during the previous year. This amendment was made in order to have a clearer understanding of the volume of new and existing chemical substances. It will also provide references for follow-up assessments for different levels of control.

7. If a new signer has doubts about the results of the review, the signer may specify in writing the reasons for the claims and submit the application.

Environmental Protection Administration, R.O.C.(Taiwan)
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