Newsletter
Taiwan—New & Existing Chemical Substances Registration Regulation
Taiwan—New & Existing Chemical Substances Registration Regulation
The Toxic Chemical Substances Control Act (TCSCA) has been amended on December 11, 2013, and will take effect on December 11, 2014. This Act is enacted and amended to prevent toxic chemical substances from polluting the environment and endangering human health, and to manage all relevant information on domestic chemical substances to serve as a basis for toxic chemical substances screening, selection and assessment.
According to the TCSCA, the manufacturer or importer of existing chemical substances with quantities reaching a specific amount each year shall apply to the Environmental Protection Administration (EPA) for chemical substances information registration by the designated deadlines; those manufacturing or importing new chemical substances shall apply to the EPA for chemical substances information registration 90 days prior to commencement of manufacturing or import. The details of the matters, such as the deadline of registration, registration documents, classification of chemical substances, quantity tonnage, and related information of the chemical substances, are stipulated in the draft New and Existing Chemical Substances Registration Regulation ("Chemical Substances Registration Regulation"), which is expected to take effect on December 21, 2014. This alert sheet highlights some of the key points in the draft Chemical Substances Registration Regulation.
I. Background
(I) Definition of New or Existing Chemical Substances
The Council of Labor Affairs ("CLA") of Taiwan promulgated the Existing Chemical Substances Nomination Regulation ("ECS Nomination Regulation") on November 2, 2009, the additional ECS Nomination Regulation on April 18, 2012, and the second additional ECS Nomination on May 26, 2014, respectively. Those ECS Nomination Regulations are enacted to encourage voluntary nomination of existing chemical substances so as to assist the CLA in establishing the National Existing Chemical Substances Inventory. The nomination is now closed as of July 31, 2014. Any chemical substance not listed in the National Existing Chemical Substances Inventory will be considered a new chemical substance. The National Existing Chemical Substances Inventory also applies to the TCSCA and Chemical Substances Registration Regulation.
(II) Chemical Substances Registration Regulation
To manage all relevant information on domestic chemical substances, the TCSCA has been amended on December 11, 2013. One of the important amendments is the adoption of a registration system replicating the REACH program/act of the European Union promulgated on June 1, 2007. The TCSCA further authorizes the EPA to enact the regulations. The EPA publicly announced the Draft of Chemical Substances Registration Regulation on August 25, 2014, and is expected to take effect on December 21, 2014.
II. New Chemical Substances Registration
The manufacturer or importer of new chemical substances shall apply to the EPA for chemical substances information registration 90 days prior to commencement of manufacturing or import. A fine of NT$200,000 (about USD 7,000) to NT$2 million (about USD 70,000) shall be imposed on those who fail to obtain approval of registration prior to manufacturing or importing new chemical substances. In addition, corrections shall be ordered to be made within a given time period; and failure to correct by the deadline will result in one fine per violation. Those who fail to make the correction within a given time period after two (2) violations will be ordered to suspend work, business or reship the imported chemical substance back to the origin of shipment the imported chemical substance.
The required information for registration is based on the quantity tonnage of the new chemical substances manufactured or imported. If the quantity of the new chemical substances for scientific or developmental purposes is more than 100 tons per year or the quantity of the new chemical substances for other purposes is more than 1 ton per year, the manufacturer or importer shall submit the following information (hereinafter "full registration"):
(1) The basic identification information of the registrant and the chemical substance;
(2) The information relating to the manufacture, import, usage and exposure of the chemical substance;
(3) The classification and labeling of the hazard for the chemical substance;
(4) The safety information for use;
(5) Chemical and physical properties of the chemical substance;
(6) Toxicity of the chemical substance;
(7) Eco-toxicity of the chemical substance;
(8) Hazard assessment; and
(9) Exposure risk assessment.
The contents of items (5) to (8) depend on the type of chemical substances published by the EPA. The period of validity for full registration is 5 years.
The simplified registration or small amount registration is available if the quantity of the new chemical substances manufactured or imported is less than the aforementioned. For the simplified registration, only the information of the items (1) to (5) is required; for the small amount registration, only the information of the items (1) to (2) is required. The period of validity for the simplified registration or small amount registration is 2 years. An extension period may be granted by the EPA for the simplified registration or small amount registration.
III. Existing Chemical Substances Registration
A chemical substance listed in the National Existing Chemical Substances Inventory is deemed as an existing chemical substance. In addition, a new chemical substance is considered an existing chemical substance five (5) years after the full registration.
If the quantity of the existing chemical substance manufactured or imported has amounted to more than 100 kg per year for any purpose, the manufacturer or importer shall submit the following information to the EPA for the first stage of the existing chemical substance registration:
(1) The basic information of the registrant
(2) The basic identification information of the chemical substance, such as CAS No. or the serial number in the National Existing Chemical Substances Inventory; and
(3) The information relating to the amounts of manufacture, amount of import and usage.
The first stage of the registration shall be submitted from September 1, 2015 to March 31, 2016. Other information may be requested to be submitted in the following stage of the registration. However, the EPA has not yet promulgated the details.
For any violation of the regulations on existing chemical substances registration, a fine of NT$30,000 (about USD 1,000) to NT$300,000 (about USD 10,000) shall be imposed and the correction shall be ordered to be made within a given time period. Failure to correct by the deadline will result in one fine per violation. Those who fail to make the correction within a given time period after two (2) violations will be ordered to suspend work, business or reship the imported chemical substance back to the origin of shipment.
IV. Data Protection
In principle, the registration information shall be disseminated to the public. Nevertheless, the EPA possesses the authority to maintain confidentiality of information involving national defense, industrial or commercial confidentialities subject to the approval by the central competent authority upon the application submitted by the manufacturer or importer. Notwithstanding the confidentiality, the EPA may still disclose the information if (1) it is necessary for benefitting the public; (2) it is necessary for protecting human health; or (3) it is consented to by the manufacturer or importer.
During the 3 to 6 months prior to the registration, the registrant may to apply for a 5-year term of confidentiality. The registrant is entitled to apply for one additional 5-year term within 3 months prior to the expiration. Only one extension is allowed.
It is in the company’s best interest to submit the registration of the new or existing chemical substances for the purpose of compliance with the regulations and seeking confidentiality protection via the data protection mechanism. If you have any inquiry about the New and Existing Chemical Substances Registration, please do not hesitate to contact us.
Best regards,
Bo-Sen Von / Yung-Cheng Hsieh (Coordinator)
Lee and Li, Attorneys-at-Law, Hsinchu Office
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