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Taiwan-- Existing Chemical Substance Nomination Regulation



The Council of Labor Affairs ("CLA") of Taiwan promulgated the Existing Chemical Substance Nomination Regulation ("ECS Nomination Regulation") on November 2, 2009. The ECS Nomination Regulation is enacted to encourage voluntary nomination of existing chemical substance to assist the CLA in establishing the National Existing Chemical Substance Inventory. The deadline for nominating existing chemical substances is December 31, 2010 and the promulgation of the National Existing Chemical Substance Inventory is expected to occur around June 2011. This alert sheet highlights some key points in the ECS Nomination Regulation and the benefits of early nomination.

I. Background
(I) ECS Nomination Regulation
This regulation is the currently effective nomination regulation, which encourages voluntary nomination to assist the CLA in establishing the existing chemical substance inventory. Prior to the deadline (December 31, 2010), nomination does NOT require administration fees or supporting documents (i.e. MSDS, or testing report).

(II) New Chemical Substance Notification Regulation
The New Chemical Substance Notification Regulation ("NCS Notification Regulation") is scheduled to be promulgated after the CLA promulgates the existing chemical substance inventory. Any chemical substance which is not included in the existing chemical substance inventory will be considered the "new" chemical substance. The details of the NCS Notification Regulation have not been officially released. According to the Safety and Health Technology Center ("SHTC"), the project coordinator appointed by the CLA, the proposal of the NCS Notification Regulation may prescribe longer review periods and mandatory submission of supporting documentations as well as administration fees. Furthermore, the contemplated policy for a new chemical substance is to require the new chemical substance to be notified with the SHTC, and without such notification the new chemical substance would be prohibited from being manufactured, sold, or used in Taiwan.

As the requirements mandated by the CLA would increase along with the enforcement of the NCS Notification Regulation, early nomination is cost-efficient.

II. Nominator
Any local or overseas company or organization which imports, manufactures, handles, uses or sells chemical substance in Taiwan can be a nominator. Nomination can also be conducted through a contracted agent or organization.

III. Required Information for ECS Nomination
Nominator must use the Nomination Tool(s) provided by SHTC to submit the following information:
(1). The basic information of the Nominator;
(2). Chemical Abstracts Service Registry Number (CAS No.);
(3). Chinese/English/Other names of substances;
(4). Average annual production (manufactured, imported, or both) by weight (tonnage), during the three years prior to the nomination.

IV. Data protection
The basic information and the average annual production are protected automatically.
If for purpose of protection of proprietary information such as formula or compounds, the nominator may consider protecting the CAS Number and Chinese/English names of chemical substances by applying for data protection and must demonstrate the need for data protection. The application process includes providing the preferred generic names for approval. If approved, a protection period of five years will be granted for not disclosing the CAS Number and names of the chemical substances, and only the approved generic name and serial number will be used as the identity of the chemical substance. During the six months prior to expiration of the five-year term, the nominator is entitled to apply for one additional five-year term.

It is in the company's interest to nominate substances via the data protection mechanism for the purpose of protecting confidentiality. As the nomination requires a local contact person, conducting the nomination via a reliable firm or institution may be desirable. If you have any inquiry about the ECS nomination process, please do not hesitate to contact us.

Best regards,

Bo-Sen Von / Yung-Cheng Hsieh (Coordinator)
Lee and Li, Attorneys-at-Law, Hsinchu Office
5F, Science Park Life Hub, 1 Industry E. 2nd Rd.,
Hsinchu Science Park, Hsinchu, Taiwan 30075, R.O.C.
Tel: 886-3-5799911 ext. 211/ 268
Fax: 886-3-5797880
E-mail: bosenvon@leeandli.com / yungcheng@leeandli.com
Cc: garychen@leeandli.com


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