Regulatory Developments

Taiwan's CLA Releases Operational Guidelines for Nominating Existing Chemical Substances for Listing on National Inventory

July 1, 2010 PRINT

Taiwan's Council of Labor Affairs of the Executive Yuan (CLA) has developed and released operational guidelines for nominating existing chemical substances for listing on a national Inventory. Through creation of a national Inventory, Taiwan intends to strengthen its control over the manufacture, import, and use of chemicals in Taiwan, thus improving its national chemical management. It is a preparatory process for establishing the National Existing Chemical Substance Inventory. Once completed, the Inventory will serve as the basis of future New Chemical Notification (NCN) requirements.

As discussed below, the nomination process for listing substances on the Inventory is now underway and will close in December 2010. Both domestic and non-domestic manufacturers and importers may nominate substances. Substances not nominated or otherwise exempted will be subject to NCN procedures currently slated to be implemented in June 2011. More information is available online.

The Existing Chemical Substances Nomination (ECN)

The formal ECN process was initiated on October 30, 2009. All substances, including polymers, manufactured or imported from January 1, 1993, until December 31, 2010, are eligible for nomination through the ECN process. After this date, the CLA will consolidate all nominations and announce in June 2011 the resulting National Chemical Substance Inventory, which will also coincide with the implementation of the NCN regulations.

Taiwan has not set a beginning and closing date on the reopening of the Inventory for the nomination of "interim substances." Qualifying substances (those imported or manufactured from January 1, 1993, until June 30, 2011) will reportedly always remain eligible for nomination, and Taiwan will presumably formally add them to the Inventory during subsequent updates. It is critical that during the reopening phase of the Inventory that nominators recognize the necessity to generate and maintain sufficient evidentiary documentation, evidence of import and/or manufacture, to support a nomination during this time period. The key difference between the current nomination phase and the reopening time period is the need to generate and maintain evidentiary documentation to support the nomination.

Exemptions

When a chemical substance meets one of the following conditions, it is exempted from notification under the ECN process:

  • Substances and polymers that occur in nature, without physicochemical treatment;
  • Polymers for which the 2% rule is applicable;
  • Chemical substances contained in experimental machines and equipments;
  • Non-isolated intermediates in reactors or reaction process;
  • Mixtures (but the new substances in the mixture are not excluded);
  • Articles;
  • Chemical substances under the supervision of Customs;
  • Chemical substances for national defense purposes;
  • Incidental reaction products (by-products) or impurities with no commercial value; and
  • Wastes.

The 2% Polymer Rule

Polymer manufacturers can change monomers that contribute a weight percent less than or equal to 2% to the nominated polymer without changing the name of the polymer or having to undertake the nomination again.

Information Requirements

There is no fee to nominate chemical substances to the Inventory. The following information must be included in the nomination: company information; substance name (International Union of Pure and Applied Chemistry (IUPAC) names in English and Chinese along with other, common names); Chemical Abstract Service (CAS) number; and the tonnage band of the manufactured or imported substance based on the figures for three years prior to notification.

Inventory Nomination Process

Nominations must be submitted using the nomination form and then via the online tool developed by Taiwan. Taiwanese manufacturers, importers, users, processors, and sellers of chemical substances are eligible to nominate, as well as non-Taiwanese-based companies that export their products to Taiwan. Non-domestic nominators must provide a local contact, however.

Experience to Date

The Acta Group EU, Ltd (Acta EU), with associates in Taiwan, has successfully completed the notification of many substances to the Taiwan authorities. The most efficient business process is when the client initially completes the form in English, and Acta EU then quickly reviews the notification form and forwards it to its associates in Taiwan to confirm or prepare appropriate translations in Chinese. In addition, Acta EU's associates in Taiwan can serve as the local contact. As such, they will complete the nomination process using the online tool and their contact details. Hence, the company name is not necessarily notified to the Taiwan authorities, only the nominator's name is known. For many companies, the masking of the company name is of benefit.


 
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