Taiwan Regulatory News

On May 27 Taiwan’s Environmental Protection Administration (EPA) proposed an amendment to the Regulation on New and Existing Chemical Substances. The regulation was first published in 2014 a...

On May 27 Taiwan’s Environmental Protection Administration (EPA) proposed an amendment to the Regulation on New and Existing Chemical Substances. The regulation was first published in 2014 and had previously been amended in March 2019. The legal basis for chemical registration in Taiwan is the Toxic and Concerned Chemical Substance Control Act (TCCSCA), which was enacted on 16 January 2019, amended, and renamed from Toxic Chemical Substance Control Act. The current chemical registration system has been in place since 1st January 2020.

To raise awareness in the chemical sector, Taiwan’s environmental authorities have brought an active conversation with stakeholders, notably by organizing public seminars. These seminars have provided stakeholders with key information on the obligation to register chemicals, as well as practical information on data submission. Taiwan’s environmental authorities expect individual chemical manufacturers or importers to prepare dossiers for standard registration (for chemicals listed in 106 Priority Existing Chemicals (PECs) list). Due to the COVID-19 outbreak, some of the seminars had to be postponed. Last month, EPA updated the fee structure for chemical registration by reducing fee for registrants who use non-animal testing alternatives and for those who need to extend the period of confidentiality.

It had been speculated that the EPA would move the registration deadline following concerns raised by manufacturing and importing associations over their members’ capacity to complete registration in time. Authorities then announced that they would give chemical manufacturers and importers sufficient time for data preparation. According to the recently published amendment, registrants will therefore have 4 years to complete their obligation for standard registration for 106 PECs. Companies that obtained Phase One Registration Code after January 1, 2020 are required to complete the Standard Registration (106 PECs) within four years. For the first batch of 106 PECs, the deadline to extended one more year to December 31, 2023 for quantity above 1 tonne per year. The valid CBI claims for New Chemical Substance is also extended to 5 years irrespective of tonnage.

The amendment also specifies that registration obligation of chemicals that are considered controlled chemicals and concerned chemicals are exempted from registration. The list of Controlled chemicals contains 19 chemicals and is regulated under the Regulations Governing Designation and Handling Permission of Controlled Chemicals. Before handling the Controlled Chemicals, a handler shall apply to the central competent authority for permission. No handling shall be commenced without permission. The list of controlled chemicals will be updated by the central competent authority from time to time.

Considering low exposure risk for onsite Isolated Intermediates, the amendment also changes the requirement for standard registration of new chemical substances under the category of onsite Isolated Intermediates. Standard registration is required only if the annual tonnage is above 10 tonnes. 

The amendment also confirms that registrant will be issued a registration number once they submit information in appendix 3 (one to seven item) and after these have been reviewed by the Authority. Hazard assessment and exposure assessment can be submitted at later stage as communicated by the authority.

Appendix 3: Information items to be submitted for Standard Registration:

1. Information on the registrant and basic identification of the substance
2. Information on manufacture, use and exposure of the substance
3. Hazards classification and labelling
4. Safe use information
5. Physical and chemical properties
6. Toxicological information
7. Ecotoxicological information
8. Hazard assessment
9. Exposure assessment

The proposal for amending the draft of chemical substance registration is open for public consultation until July 26. GPC can forward your suggestions or feedback to the Taiwanese authority before the deadline.

Taiwan’s Environmental Protection Administration (EPA) has published the modification of the fee structure for chemical registration on April 7, 2021. In response to the international trend ...

Taiwan’s Environmental Protection Administration (EPA) has published the modification of the fee structure for chemical registration on April 7, 2021. In response to the international trend of reducing the use of animal testing, the registration fee of those based on the designated non-animal testing alternatives is adjusted from NTD 50,000 to 37,000. 

After public consultation, the EPA also decides to reduce the application fee for extending the confidentiality period and simplified registration.

Under the TCCSCA, registrants can apply for CBI for items such as information on the registrant, manufacturing/import information, use information and chemical identities. The valid period for CBI is two years for simplified registration and small quantity registration and five years for standard registration.

Below is the updated government fee structure for chemical registration in Taiwan. 

last update: 2021-04-08

The Ministry of Health and Welfare in Taiwan circulated a list of Prohibited ingredients in Cosmetic Products on 3 December 2020. After 60 days of publication consultation, the list is now expecte...

The Ministry of Health and Welfare in Taiwan circulated a list of Prohibited ingredients in Cosmetic Products on 3 December 2020. After 60 days of publication consultation, the list is now expected to come into force on 1 July 2021. Cosmetic products that contain these ingredients need to follow the instruction, otherwise it is banned from importing, manufacturing and selling. The legal base of this list is Cosmetic Hygiene and Safety Act.  

255 substances have been newly added to the list and the use of 40 substances in cosmetic products has been modified, most of them are prohibited in use in hair dyes related products. 

Another update from Cosmetic regulation in Taiwan is Taiwan's membership in International Cooperation on Cosmetics Regulation (ICCR). After four years as an observer member, from December 2020 Taiwan had officially become a member of ICCR, a voluntary international group of cosmetic regulatory authorities from Brazil, Canada, the European Union, Japan, the Republic of Korea, and the United States. The members meet on an annual basis to discuss cosmetics safety and regulation and have dialogues with cosmetics industry trade associations. 

Download the draft list 

update: 2021-02-11

The EPA showed its intention to grant the extension of the deadline for Standard Registration of 106 PECs as chemical manufacturing and import associations in Taiwan raised their concerns over the...

The EPA showed its intention to grant the extension of the deadline for Standard Registration of 106 PECs as chemical manufacturing and import associations in Taiwan raised their concerns over the preparation for dossiers in public seminars in October this year. Now the EPA has confirmed to extend the deadline of Standard Registration to Dec. 31, 2020, regardless of the tonnage.

Currently, registrants can get the registration number of Standard Registration even if they have not submitted hazard and exposure assessment (Item 8 and 9 in dossier report). The date for later submission of these two items will be clarified later when the guidance is updated.

According to the amended Toxic and Concerned Chemical Substance Control Act, Taiwan’s EPA has to regularly review its fee scheme. According to the proposed revision on “the Toxic Ch...

According to the amended Toxic and Concerned Chemical Substance Control Act, Taiwan’s EPA has to regularly review its fee scheme.

According to the proposed revision on “the Toxic Chemical Substances Handling Application and Chemical Substances Registration Fee Scheme” in September 2020, 25 % discount on the review fee is proposed for SMEs with additional discount possibilities if companies adopt alternative testing methods or submit their PECs registration one year ahead of the deadline.

At the public meetings, the EPA highlighted that registrants may submit the registration dossier without hazard and exposure assessments and the revised guideline for PEC standard registration may expand to multi-source data.

With 60 days for public comments, the EPA is expected to announce a new fee scheme and PECs registration deadlines.

Companies should expect longer time for dossier preparation and back-and-forth conversation within the supply chain. It is also important to note that join-registration is not mandatory. Contact GPC (compliance@gpcregulatory.com) to prepare your dossier now and gain lead time.

Source: https://flora2.eri.com.tw/seminarchemist/

In June, Taiwan’s EPA published official guidance on how to prepare a standard registration dossier for the first list of 106 Priority Existing Substances (PECs). Companies are required to submi...

In June, Taiwan’s EPA published official guidance on how to prepare a standard registration dossier for the first list of 106 Priority Existing Substances (PECs). Companies are required to submit nine information items to the authorities. Because of the impact of COVID 19, the EPA is allowing companies to submit the first seven information items while leaving the item number eight and nice (hazard assessment and exposure assessment, which are generally taking most of the time for preparation) for later submission. Companies will receive a registration completion code after submitting the first seven items.

Standard Pecs registration – information items  

1. basic information on substance identification and the registrant;
2. substances manufacture and use information, exposure information;
3. GHS hazard classification;
4. safe use information;
5. physical and chemical properties;
6. toxicological information;
7. ecotoxicological information;
8. a hazard assessment report; and
9. an exposure assessment report.

Previously, testing labs were all required to adhere to OECD guidelines or be ISO certified, but the guidance does not mention if universities and colleges need to follow those standards," said C...

Previously, testing labs were all required to adhere to OECD guidelines or be ISO certified, but the guidance does not mention if universities and colleges need to follow those standards," said Chia-Sui Hsu from Global Product Compliance (GPC). See more...