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Conflicts Unsettled on Taiwan Legislation on Nanomaterial and New Chemical Substance Management

Taiwan Legislative Yuan will start the next-round review of the proposed draft Toxic Chemical Substance Control Act (TCSCA) on April 17 and 18. The main concern will be focused on nanomaterial and new chemical substance management.

The Taiwan Legislative Yuan intends to incorporate the definition of nanomaterial into the Taiwan TCSCA, while dissenting opinion is expressed from the EPA that a separate legislative framework should be established for this hot-discussed substance. The widespread use of nanomaterial has led ECHA to believe that detailed information on nanomaterial in registration dossiers to demonstrate its safe use is a requisite, however, the legislative decision has been up in the air for months. It has not been determined whether it should be regulated into REACH's main text/annexes, or as some member states recommended, formulate a new legislation on nanomaterial. It seems that the Taiwan legislators want to step forward at least to engrave the definition of nanomaterial into Taiwan’s superior Act to be prepared for the subsequent legislation. For Taiwan, the opinions on the legislative move for nanomaterial currently remain split, while China will not consider incorporating them in the country’s GHS system, in view of the inadequate testing capability.

As for the Taiwan new chemical substance notification (Taiwan NCN), the legislators expressed the intention that the Taiwan EPA should determine whether the new chemical substances registered falls into the scope of toxic chemical substance prior to entering Taiwan’s market. Possible categorization of the substances into the four classes under TCSCA should be done by the EPA to realize follow-up management. However, the limited capability makes the EPA reluctant to take over this responsibility from the Legislative Yuan. Besides, the categorization is time-consuming and is likely to harm the enterprise competitiveness in Taiwan’s market. From the legislator’s perspectives, any new chemical substances pouring into the Taiwan’s market should be proved either safe or risk controllable. Classification of the new chemical substances will serve as the basis for the post-notification management.

China manages the new chemical substance in a different manner. The new chemical substances registered will be merged into other inventories subject to different legislative system after being listed into the IECSC 5 years from the first day of manufacture or import. Since Taiwan has a standardized substance management system under the TCSCA, it is feasible to tackle the registered new chemical substance in the same system of the existing chemical substance. However, worries exist that the information submitted in the dossier cannot sufficiently justify the regulatory category of the new chemical substances registered due to their little known hazard properties.

The Taiwan legislature holds two regular sessions, from February to May and from September to December, respectively. In the last review meeting on 21 March 2013, consensus has been reached on the terms that the initial registration requirements will be imposed on Class 4 toxic chemical substances.  The draft TCSCA could be approved within the first session without dissenting opinions. However, it is not yet known when the review on the TCSCA draft will be completed, since further consensus is needed for the above mentioned conflict in terms of the nanomaterial and new chemical substance management.

On April 10 and 11, the Taiwan Occupational Safety and Health Act (OSHA) is under assessment by the Taiwan Legislative Yuan. Since the requirements for Taiwan new chemical substance notification is also included into this Act, chances are that the similar terms in the TCSCA draft will also be questioned. It is expected that the amendments to the TCSCA and OSHA would bring great impact on the management on new chemical substance. 

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