萬國法律事務所

パテント部シニアバイスマネジャー簡玉如が書いたIP Blog第二期：New Chemical Substance Regulation Comes into Force

New Chemical Substance Regulation Comes into Force

Selene Chien
Senior Patent Deputy Manager
MS. in Toxicology
selene.chien@taiwanlaw.com

From the end of 2014 and the beginning of 2015, all new chemical substances manufactured in or imported to Taiwan shall be registered in Environmental Protection Administration (EPA) and Occupational Safety and Health Administration (OSHA) based on the Toxic Chemical Substances Control Act and the Occupational Safety and Health Act, respectively; or they are not allowed to be manufactured in or imported to Taiwan. An inventory of chemical substances (the “original inventory”) has been built up by the Ministry of Labor in Taiwan in 2012. The chemical substances not listed in the inventory are identified as “new chemical substance” now. According to the regulations published by EPA and OSHA respectively, by December 31, 2015, only basic information is requested for all substances in the two registration systems, and the registered chemical substances are allowed to be manufactured or imported for 1 year. After that, the registrations shall be renewed based on the manufactured/imported quantity/volume, toxicity and use of the chemical substance to be registered.

The OSHA regulation focused on the “new” chemical substances only. Therefore, the chemical substances which have been listed in the inventory (i.e. the “existing” chemical substances) need not be registered in the OSHA system.

In the EPA system, if the quantity/volume of one existing chemical substance does not exceeds the level of 100kg, the further registration is not needed, too. But if the annual average imported/manufactured quantity/volume of the existing chemical substance in the three-year term before the EPA registration exceeds 100kg, or if the highest quantity/volume of the existing chemical substance in any year of the three years before the EPA registration exceeds 100kg, a “phase I registration” is required during September 1, 2015 to March 31, 2016 in the EPA system by submitting basic information of the registrant, the chemical substance and its manufacture and use.

The EPA system allows the chemical substances not listed in the inventory but manufactured in or imported to Taiwan before December 11, 2014 to be registered as an “existing” chemical substance. It should be noted that if the chemical substance is not in the original inventory, it is still considered as a “new” chemical substance in the OSHA system. Briefly, if one chemical substance is not in the original inventory, but it is manufactured in or imported to Taiwan before December 11, 2014, it shall be registered in the OSHA system as a “new” chemical substance, and registered in the EPA system as an “existing” chemical substance by March 31, 2015.

The EPA and OSHA registrations shall be made by Taiwanese citizen, or local manufacturers or importers registered in Ministry of Economic Affairs Certificate Authority (MOEACA). For foreign companies which intend to export chemical substances to Taiwan, their local branch or importers can submit the registrations. Since only Taiwanese citizen or company can apply for EPA and OSHA registrations, those who do not have a local branch have to cooperate with their Taiwanese importers. If they intend not to disclose their product secrets to the importers, they can negotiate with their importers and request the importers to mandate an attorney for the registrations. Thus, the chemical substances can be registered by the attorney with the MOEACA IC card from the importer, and the product secrets will not be disclosed to the importers. After registrations, only the public health and safety associated information will be published, and the other information such as who is the applicant will not be disclosed. The EPA and OSHA registration systems are expected to be combined within about one year, but the schedule is not given yet. There are still some differences in the two systems, such as the definition of the terms used in the two systems, the scope and interpretation of the registration requirements, and others. For example, “toxic chemicals” are specifically controlled by the Toxic Chemical Substances Control Act governed by EPA, and they are excluded in the OSHA system. For those companies manufacturing in or exporting/importing chemical substances to Taiwan, continuously watching how these two systems will combine and work in concordance is needed in recent years.

The OSHA website for chemical registration:
http://csnn.osha.gov.tw/content/login/Login.aspx

The EPA website for chemical registration:
http://tcscachemreg.epa.gov.tw/content/masterpage/index.aspx