Taiwan Regulatory News

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...

According to Taiwan’s Toxic and Concerned Chemical Substance Control Act (TCCSCA), new and existing substances must be registered in Taiwan. The first batch of 106 PECs was published on 11 March...

According to Taiwan’s Toxic and Concerned Chemical Substance Control Act (TCCSCA), new and existing substances must be registered in Taiwan. The first batch of 106 PECs was published on 11 March 2019. Taiwan’s EPA published the draft of Guidance for Standard Registration of Designated Chemical Substances by stages in September 2019. After a long waiting, the official guidance for standard registration, Guidance on Existing Chemical Substances Standard Registration (1st version), was released on 9 June 2020. In comparison with the Guidance published in September 2019, the new guidance accepts data from more choices. According to recently published guidance, reports from laboratories of universities in Taiwan are acceptable for data on chemical and physical properties. For toxicological and ecotoxicological information, Taiwan’s EPA accepts reports from laboratories of universities in Taiwan and laboratories with certification of ISO 17025. If animal testing is required for obtaining toxicological and ecotoxicological information, the experiment must form an Institutional Animal Care and Use Committee (IACUC) and follow Animal Protection Law (enforced on 16 December 2018).   

According to recently released guidance, a registration number will be issued after registrants submit information (1) to (6) in Appendix 7 (see table below). Taiwan’s EPA reserves the right to ask registrants to provide information on hazard assessment (7) and exposure assessment (8) later.  

The recently published Guidance can be seen as an effort from Taiwan’s EPA to facilitate companies to comply with standard registration of 106 PECs. Companies are recommended to set up their regulatory team to fulfil their obligations or contact compliance service providers to learn about their options (e.g. joint registration and benefits of registration via Third Party Representative).