Taiwan New and Existing Chemical Registration FAQs - Vol.1 Legal Basis

1. Is it necessary to register for selling of a chemical substance which is purchased in Taiwan? [§30]

Pursuant to Paragraph 1, Article 30 of the Toxic Chemical Substances Control Act (hereinafter referred to as “Act”), those that manufacture or import existing chemical substances with quantities reaching a specific amount each year shall apply to the central competent authority for chemical registration by the designated deadlines; those manufacturing or importing new chemical substances shall apply to the central competent authority for chemical registration 90 days prior to commencement of manufacturing or import. Manufacture or import of said existing and new chemical substances shall only be allowed when the registration is approved.

The Regulation of New and Existing Chemical Substances Registration (hereinafter referred to as “Regulation”) only focuses on source management on the manufacture or import of chemical substances, i.e. manufacturers or importers of chemical substances should apply to the central competent authority for registration. Other activities, e.g. sale, export, operation, storage or discarding, do not fall in the scope of the Regulation, so chemical registration is unnecessary.

2. As a foreign company, I want to export the chemical substances to Taiwan. Is it an essential prerequisite to establish a company or branch in Taiwan before export? Is there any other method?

1). A person who manufactures or imports chemical substances in Taiwan should apply to the central competent authority for chemical registration pursuant to Paragraph 1, Article 30 of the Act.

2). The registrant should be a natural person, a juristic person, an unincorporated body having a representative or manager, an administrative authority, or a person who may be the subject of rights and obligations under other laws pursuant to Paragraph 1, Article 2 of the Regulation.

3). The importer in Taiwan can register as a registrant, or he can appoint a representative to apply for the chemical registration pursuant to Paragraph 2, Article 2 of the Regulation.

3. Who should do the registration if a company entrusts another company to produce after importing the raw materials, the contract manufacturer or the entrusting company? [§30]

A person who manufactures or imports chemical substances in Taiwan should apply to the central competent authority for chemical registration pursuant to Paragraph 1, Article 30 of the Act.

Although the contract manufacturer does not have ownership of chemical substances, he is the one actually conducts manufacturing activities. Thus, the actual manufacturer (contract manufacturer) should do the registration.

4. Will a chemical product be allowed to import if only the chemical ingredients that have been provided with CAS No. by manufacturer are registered? [§30]

Pursuant to Paragraph 1, Article 30 of the Act, those that manufacture or import existing chemical substances with quantities reaching a specific amount each year shall apply to the central competent authority for chemical registration by the designated deadlines; those manufacturing or importing new chemical substances shall apply to the central competent authority for chemical registration 90 days prior to commencement of manufacturing or import. Manufacturing or import of said existing and new chemical substances shall only be allowed when the registration is approved.

For those who cannot provide complete substance identification information, the registration may not be approved. The original manufacturer of chemical substances is required to provide relevant substance identification information to the importer in favor of registration application, or appointment of a representative to register according to Article 2 of the Regulation can be considered.

5. A small quantity of chemicals is imported by our company for experiments only. Are they exempt from registration? [§5]

Firstly you should confirm whether the chemical substance is listed in Taiwan’s Existing Chemical Substance Inventory (TCSI) via the online platform, in favor of the determination of registration type subsequently. If it is an imported new chemical substance and does not apply to the uses of scientific research and development defined by the Regulation, for a general new chemical substance<100kg/year, the small quantity registration shall apply; and the simplified registration is applicable for a general new chemical substance of 100kg or more while less than 1 ton per year.

6. For existing chemical substances that with manufacture or import activities while haven’t been registered, what’s the punishment? [§56]

Pursuant to Paragraph 2, Article 56 of the Act, a fine of NT$30,000 to NT$300,000 shall be imposed on those who fail to gain approval of registration pursuant to Paragraph 1, Article 30 prior to manufacturing or importing existing chemical substances. In addition, correction shall be ordered to be made within a given time period; those that do not make the correction by the deadline may be fined per violation, and be ordered to suspend work, suspend business or return export when failing to make the correction within a given time period for more than 2 times.

7. If the registration is approved with attaching conditions while the requirements haven’t been complied with truthfully, what’s the punishment? [§56]

Pursuant to Paragraph 3, Article 56 of the Act, a fine of NT$100,000 to NT$500,000 shall be imposed on those that violate issued attaching conditions pursuant to Paragraph 1, Article 31. In addition, correction shall be ordered to be made within a given time period; for those that do not make the correction by the deadline, the approval of registration may be canceled. Recall and destruction of such chemical substances, their compounds and articles shall be carried out by its manufacturer or importer. When necessary, the competent authority can recall and destroy such chemical substances on behalf of the manufacturer or the importer and collect necessary handling expenses.