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Taiwan chemical registration, you need to know those things!
Release time:
2020-06-01 11:29
On January 1, 2020, Taiwan's existing material standard registration was officially opened, and Taiwan's chemical substance registration quickly became a hot spot in the industry. Many companies came to our company to consult and understand Taiwan's registration, so what is the matter with Taiwan's chemical substance registration? What should companies prepare? This article will help you understand the ins and outs of Taiwan's chemical substance registration and help you easily deal with registration matters.
Legal Basis
The current regulations on the management of chemical substances in Taiwan, the "Measures for the Registration of New Chemical Substances and Existing Chemical Substances" (hereinafter referred to as the "Registration Measures") under the "Toxicity and Concerned Chemical Substances Management Act" (TCSCA, referred to as the "Toxic Control Act") and the "New Chemical Substances Registration Management Measures" under the "Occupational Safety and Health Act" (OSHA, referred to as "Occupational Safety Act") has been implemented for nearly 5 years. At the beginning of the formulation, the regulation referred to the idea of EU REACH, and formulated two stages of pre-registration and standard registration for existing substances, but it is different from the chemical management regulations in other regions.
The standard registration of the first batch of existing substances will be officially launched on January 1, 2020. In 2019, as the year before the official registration was launched, the competent authority successively introduced the revised version of the "Registration Method", the draft registration guide, and supporting documents and facilities such as the information sharing platform.
On September 30, 2019, the draft guidelines for the registration of existing chemical substance standards-"Guidelines for the registration of existing chemical substance standards should be completed in stages (Draft)" was revised and released again, and more detailed provisions were put forward on the acceptance of data requirements and data types compared with the March version. In addition, the acceptance of non-test methods and test plans has been increased. For example, in the ecotoxicology section, the test plan has been expanded from only 6 nodes in the March edition of the Guide to 11 nodes. Although the "Guide" has been updated to the second version, it is still a draft version. As an important supporting material for the registration of existing material standards, the final draft will be released before the official implementation of the registration of existing material standards according to the official plan.
Basis for judgment of substance classification
Chemical substances included in the list of existing chemical substances (or list of announcements) of the central competent authority are called existing chemical substances, and chemical substances not included in the list of existing chemical substances (or list of announcements) are new chemical substances. Substances included in the List of Existing Chemical Substances are as follows:
• Chemical substances manufactured or imported between 1 January 1993 and 31 December 2011
Chemical substances produced or imported before December 11, 2014 can apply for the approval of existing chemical substances (closing on March 31, 2015) and enter the inventory of existing chemical substances.
The list query URL is as follows:
http://csnn.osha.gov.tw/content/home/Substance_Home.aspx
The list mainly includes CAS No.,Serial No. (CBI or substances without CAS No.), English name, Chinese name, etc.
Login person
Manufacturers or importers in Taiwan can log in directly as lodgers for source management, or they can appoint a third-party agency TPR, which requires a letter of appointment.
Note:
The applicant must be a Taiwanese legal entity or a natural person.
For foreign companies, the applicant must be a branch (legal entity) in Taiwan.
Substance Scope
TCSCA Login Scope: Existing Chemicals, New Chemicals
OSHA Logon Scope: New Chemicals
Circumstances subject to exemption:
Natural substances that have not been chemically treated
Chemical substances in machinery or equipment accompanying commissioning
Inseparable intermediate products
Chemical substances related to national security or defense needs
Chemical substances under customs supervision
Waste discharged or generated during the production process
No commercial byproducts or impurities
Finished products
Monomer content lower than 2% polymer
Exempted circumstances-substances or articles already subject to other regulations:
Pesticides
feed additive
Fertilizer
Drugs
Cosmetics
Alcohol and tobacco
radioactive material
Explosives
environmental drug use
Toxic chemicals, etc.
Registration process
Registration System for Chemical Substances
Data information required for registration
Physical and chemical data requirements
Health and Ecotoxicological Data Requirements
Existing Chemical Logging Schedule
Summary
The basic idea of Taiwan's chemical registration is as follows:
1. According to the material information to confirm the application of new chemical substances or existing chemical substances registered, confirm the annual export volume.
2. Confirm whether it is the source input or manufacturer, the downstream user does not have the responsibility to log in, and the foreign manufacturer can complete the login through the third party agent (TRP).
3. Determine the login type, prepare data, organize login files and reports.
4. Submit the login materials for approval by the relevant departments in Taiwan.
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