Request a Demo
1. Environmental Protection Administration (EPA): Please go to the homepage of the EPA → Policies and Regulations → Environmental Protection Regulations → Competent Regulations Inquiry System → Regulations and Orders → EPA Decree: Revise the "Regulation of New and Existing Chemical Substances Registration"
2. Information website of the Gazette of the Executive Yuan: Please go to the homepage of the Gazette of the Executive Yuan → search for "Regulation of New and Existing Chemical Substances Registration"
3. National Laws and Regulations Database: Please go to the home page of the National Laws and Regulations Database → search for "Regulation of New and Existing Chemical Substances Registration"
4. Chemical substance registration platform: Please go to the homepage of the chemical substance registration platform → Regulations and registration data download → Regulations/guidance/tool download → Regulation of New and Existing Chemical Substances Registration- revision instructions and comparison table of provisions
The registers should provide or refer to corresponding estimation model (QSAR, read-across, etc.) of Taiwan, the USA, EU, Japan or OECD to replace tests. The items, for which tests can be replaced, should refer to the testing guidance formulated by Taiwan EPA for chemical registration. The testing guidance is accessible on the website of chemical substance registration platform. Experts statement can be used as supporting proof document.
According to the polymer description in Item 5, Paragraph 1, Article 3 of the Regulation, polymer refers to a chemical substance that fits the following criteria:
1. A molecule contains at least three monomer units covalently bond; Such molecules take more than 50% of the weight of the whole polymer.
2. The above mentioned molecules presenting the same molecular weight must be less than 50% of the polymer. For example: polymer A is combined of several molecules B, while B is polymerized of three monomers C. If B weighs more than 50% of polymer A, it will not be identified as polymer and it is only applicable for new chemical substance or existing chemical substance registration.
According to Article 3 of the Regulation, PLC refers to a substance that is evaluated by the central competent authority and meets one of following conditions:
1. A polymer with an average molecular weight between 1,000 to 10,000 Daltons, contains oligomers of molecular weights below 500 Daltons in amount of less than 10%; oligomers below 1,000 Daltons in amount of less than 25%. And there is no functional group of high concern or of high-activity.
2. A polymer with an average molecular weight over 10,000 Daltons, contains oligomers of molecular weights below 500 Daltons in amount of less than 2%; oligomers below 1,000 Daltons in amount of less than 5% .
3. Polyester polymers
4. Insoluble Polymers
For polymers which cannot dissolve in water and most organic solvents, please refer to section 4 of PLC application form, “Insoluble polymers”, to apply for the prior verification of PLC.
According to Article 3 of the Regulation, PLC refers to a substance that is evaluated by the central competent authority and meets one of following conditions:
1. A polymer with an average molecular weight between 1,000 to 10,000 Daltons, contains oligomers of molecular weights below 500 Daltons in amount of less than 10%; oligomers below 1,000 Daltons in amount of less than 25%. And there is no functional group of high concern or of high-activity (isocyanate, acrylate, aziridine, diamine, amine, vinysulfone, expoxy group, sulfoacid).
2. A polymer with an average molecular weight over 10,000 Daltons, contains oligomers of molecular weights below 500 Daltons in amount of less than 2%; oligomers below 1,000 Daltons in amount of less than 5% .
3. Polyester polymers
4. Insoluble Polymers
Chinese/English name of a chemical substance must refer to the nomenclature system.
The English chemical names must refer to the International Union for Pure and Applied Chemistry Name(s), IUPAC Name(s) or Chemical Abstracts (CA) Preferred Index Name(s).
The Chinese chemical names must refer to chemical naming rules of the National Education Research Institution. Please refer to the translation of a single chemical phrase on the national education research institution website (http://terms.naer.edu.tw/）(ex: type in “2-Propenoic acid”, it will be translated into “2-丙烯酸”) and professional chemical personnel’s assistance will be highly appreciated.
If this chemical substance has been registered when it is manufactured or imported, then it is not necessary to make registration when it is returned back. However, if the chemical substance has not been registered when it is manufactured or imported, then it requires registration when it is turned back.
