Taiwan Regulatory News

Two amendments were announced to mandate inspection requirements for commodities subject to Restriction of Hazardous Substances (RoHS) regulation in Taiwan on February 24 and March 15, 2022. They were...

Two amendments were announced to mandate inspection requirements for commodities subject to Restriction of Hazardous Substances (RoHS) regulation in Taiwan on February 24 and March 15, 2022. They were announced by the Bureau of Standards, Metrology and Inspection (BSMI), Ministry of Economic Affairs (MOEA) of Taiwan. The effective date of these revised inspection standards is February 22, 2022, whereas the old standards are invalid starting from January 1, 2024.

A total of 53 commodities are subject to RoHS regulation, and Section 5 “Marking of Presence” of CNS 15663 (2013) is included in all these inspection standards. The two new amendments cover the requirements for commodities like printers, storage devices (i.e. hard disk drives, HDD), monitors, etc., as shown in the table below.

For a commodity subject to a declaration of conformity, the declaration of conformity will be invalid from January 1, 2025, according to the explanations of these notices. It is therefore recommended for manufacturers or importers concerned to update the declaration of conformity accordingly before December 31, 2024.

To further explain the application scope for all the products, an explanation of exemption conditions is made, “Products belonging to medical devices or telecommunications terminal devices are excluded”. For some products with expanded application scope, for instance, “machines for receiving, converting, transmitting, or reproducing sound, images, or other data”, a gateway is added to the application scope of inspection standards; a rechargeable electric pencil sharpener is as well added to the application scope of the inspection standard of pencil sharpener, which will be subject to products imported or manufactured in Taiwan after January 1, 2024.

CNS 15598-1 (revised in 2020) limits requirements for mercury content in cold cathode fluorescent lamps and induction lamps (<500 mm: 3.5 mg or less, 500 mm ~ 1500 mm: 5 mg or less, > 1500 mm: 13 mg or less).

* CNS 15663: Guidance to Reduction of the Restricted Chemical Substances in Electrical and Electronic Equipment (Taiwan national standard related to RoHS).

The amendments to the “List of Ingredients Prohibited from Using in the Cosmetic Products” were made on April 27, 2022, by the Ministry of Health and Welfare of Taiwan. The statement stipulates th...

The amendments to the “List of Ingredients Prohibited from Using in the Cosmetic Products” were made on April 27, 2022, by the Ministry of Health and Welfare of Taiwan. The statement stipulates that cosmetics should not contain mercury, lead, or other ingredients banned for use by the central competent authority, formulated from the upper-level law of the List, Article 6, Paragraph 1 of the Cosmetic Hygiene and Safety Act.

Conclusively, the manufacture, importation, sale, supply, or display (for the purpose of sale or supply) of cosmetics that contain the ingredients listed in the statement is prohibited. This revision mainly focused on 4 ingredients - Alanroot oil (Inula helenium L.), Rauwolfia serpentina L., alkaloids and their salts, Yohimbine and its salts, and Tripterygium wilfordii Hook.f., which together with the newly-revised list will come into effect from July 1, 2022.

To prevent and handle the environmental and health concerns arising from the use of the substance; polyvinyl chloride (PVC) in Food Contact Materials (FCMs), Taiwanese authority is making efforts to b...

To prevent and handle the environmental and health concerns arising from the use of the substance; polyvinyl chloride (PVC) in Food Contact Materials (FCMs), Taiwanese authority is making efforts to ban the production, import, and sale of FCMs that contain PVC, currently scheduled from July 1, 2023.

The ban applies to both food/plate packaging materials as well as designated recyclable or disposable tableware containers produced with PVC. The categories of products affected include those intended for animal food, dairy products, drinks, and seasonings.

Plate packaging materials are defined as the plastic lining, blister and plate containers, which must be recycled in accordance with Taiwan’s Waste Disposal Act. Plasticisers like phthalates are added to make PVC flexible. The potential migration of plasticisers into foods or drinks brought about by the use of PVC dwells in FCMs containing PVC, which can moreover release toxicants such as dioxins and heavy metals into the environment as the items are burnt in disposal management, according to an Environmental Protection Agency (EPA) announcement.

Under Taiwanese food packaging standards, some other types of phthalates, i.e. DEHP, DBP, BBP, DNOP, DIDP, DINP, DMP and DEP, have either been banned or restricted previously by the EPA. The recycling fees for PVC packaging are also gradually raised so as to steer the industries to safer chemical usage alternatives.

The Occupational Safety and Health Administration, Ministry of Labor of Taiwan released a question-and-answer format of the SDS checklist on April 21, 2022. This is to encourage the downstream users a...

The Occupational Safety and Health Administration, Ministry of Labor of Taiwan released a question-and-answer format of the SDS checklist on April 21, 2022. This is to encourage the downstream users and companies of chemicals to verify the contents of SDS provided by the upstream manufacturers. Further, it will make upstream manufacturers verify their own Safety Data Sheet (SDS) more carefully.

Verification of items categorized under the following 5 groups is required:

1. Conformity of contents to be listed in accordance with related laws and regulations
2. Whether the information on hazardous ingredients is appropriate or not
3. Consistency with GHS classification
4. Whether the SDS test data is appropriate or not
5. Consistency of content description in SDS.

For example, a clearer indication of category 2 “If the information on hazardous ingredients is appropriate or not” of the checklist is listed in the following table with the options of Yes/No/Unconfirmed to be chosen from:

On November 15th, 2021, Taiwan’s EPA published a draft regulation that would restrict the production, import, and sale of flat packaging materials containing polyvinyl chloride (PVC). The draft ...

On November 15th, 2021, Taiwan’s EPA published a draft regulation that would restrict the production, import, and sale of flat packaging materials containing polyvinyl chloride (PVC). The draft regulation is based on Article 21 of Taiwan’s Waste Disposal Act. This draft regulation, "Restriction on the Production, Importation, and Sales of Plate Packaging Material Containing Polyvinyl Chloride (PVC), Designated Recyclable Containers and Non-plate Disposable Tableware Containers" is under public consultation and the deadline for comment is January 17th.  

Polyvinyl Chloride (PVC) is one of the most widely used polymers in the world. Due to its versatile nature, PVC is extensively used in everyday life. In the draft, several concerns about PVC usage are listed, including: 

• Stabilizers are often added to PVC products to facilitate its heat resistance and this may be contaminated with heavy metal like lead or cadmium and may be hazard to human health.  

• PVC material is not resistant to oil/soluble corrosion and has the possibility of plasticizers penetrating into food and increasing carcinogenic risks and exposures to environmental hormones.  

• At the waste stage of PVC, dioxin may be generated after incineration and release of lead, cadmium and other heavy metals (due to addition of the stabilizer) into the air. 

According to the draft, from 1st of November 2022, PVC will be prohibited in plate packaging materials for animal food, dairy products, drinking water, seasonings and alcohol. Plate packaging materials, in the draft regulation, are defined as the plastic lining, blister, and plate containers. Plastic lining is the topless packaging material that is used to cushion and protect the substances or products contained inside, while blister containers are processed PVC plates used in the same way. 

PVCs and packaging materials containing PVC manufactured before 1st of November 2022 would not be affected by the ban. 

PVC packaging has been banned or restricted in a number of countries around the world, such as Canada, Spain, South Korea and the Czech Republic. Taiwan’s proposal for banning the use of PVC in plate packaging materials is a step further to this effort. EPA also mentioned it will steer industry toward alternative material and increase consumers’ awareness of the subject.  

Last Update: 2022-01-10

On November 23rd, 2021, Taiwan’s Environmental Protection Agency amended the Regulations of New and Existing Chemical Substances Registration and extended the submission of 106 PECs to 5 years. ...

On November 23rd, 2021, Taiwan’s Environmental Protection Agency amended the Regulations of New and Existing Chemical Substances Registration and extended the submission of 106 PECs to 5 years. Considering the impacts of COVID on the industry, companies will need extra effort and time for supply chain communication. Taiwan’s EPA then decided to extend the submission deadline for Standard Registration of all tonnages to 5 years. Standard Registration is applicable to 106 Priority Existing Chemicals (PECs) and the list remains the same.

In the draft amendment published on May 27th, EPA mentioned that registrants are encouraged to use non-animal testing alternatives with reduced fee incentives. This suggestion was postponed in the latest amendment by EPA due to the extra resource that will be needed for data review and supply chain communication.  

For the substances that initially had submission deadline within 3 years, the updated deadline would now be 2024.

Last update: 2021-12-21 

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.