Introduction of Chemical Existing/New Substance Registration in Taiwan

 

1. Registration is ruled by 2 regulations in parallel.

 

    The Regulation of New Chemical Substances Registration

•    Issued by Ministry of Labor of Taiwan (OSHA-MOL)

•    Effective from Jan. 1^st of 2015

 

Regulation of New and Existing Chemical Substances Registration

•    Issued by EPA of Taiwan

•    Effective from Dec. 11^th of 2014

 

1) Different Points of the 2 Regulations

EPA:

•    Manages both Existing and New Chemical Substances

•    New chemicals: chemicals not in TCSI (Taiwan Chemical Substance Inventory i.e. the Existing chemical substance inventory.

•    Requires environmental hazard information for Standard Registration.

MOL:

•    Manages only New Chemical Substances.

•    No requirement on environmental hazards for Standard Registration.

 

2) Same Points of the 2 Regulations

•    Both refers to TCSI issued by MOL.

•    Exemption scope, procedures, data requirements, registration types of both Regulations are closely similar.

•    Importers and manufacturers inside Taiwan shall make the registration, companies outside Taiwan can not make the registration

•    For confidential protection, overseas suppliers can provide chemical information to 3rdparty Agent (e.g. Randis).

 

•    Different registrants of same substance may apply for Joint Registration, with summed quantity.

 

2. Taiwan New Chemical Substance Registration

     •    Transition period: new chemical substances (NCS) to Taiwan in year 2015 can make a one-year-valid registration by providing only basic information of the substance and of the registrant.

     •    Afterwards from Januanry 1st 2016, normal registration requirements should be followed: Small Quantity Registration ,Simplified Registration, Standard Registration

 

1)  New Chemical Substance Registration- Information needed

     •    Small Quantity Registration:  Registrant’s basic information, Chemical substance’s basic information, Quantity and usage

     •    Simplified Registration:  Information for Small quantity Registration, and Melting point, Boiling point, Density, Logkow, Water solubility

     •    Standard Registration: 4 levels: 1~10 ton; 10~100 ton; 100~1000 ton; >1000 ton.  Information needed for Simplified Registration, and further properties on physic-chemical properties, toxicological properties e.g. oral toxicity etc., ecotoxicological properties e.g. toxicity testing on fish hazard assessment, exposure assessment

 

2)  New Chemical Substance Registration-Approval and Listing into TCSI

     •    Approval Validity Period 

5 years for Standard Registration, then the substance is included in TCSI.

5 years for Small Quantity Registration of Low Concern Polymer, then the substance is included in TCSI.

2 years for Simplified Registration and other Small Quantity Registrations. The substance can not be listed in TCSI.

     •    Advance TCSI Listing

Registrant can apply for the listing of the substance by Standard Registration and by Small Quantity Registration of Low Concern Polymer.

 

3. Taiwan Existing Chemical Substance Registration (EPA)

          First Stage:

     •    manufactured/imported in/to Taiwan with quantity >100kg in any year of past 3 years, shall make the registration between Sep. 1stof 2015 ~ Mar. 31stof 2016.

     •    From Apr. 1stof 2016, manufactured/imported in/to Taiwan with quantity > 100kg/year shall make the registration at the time to be announced by government.

 

The registration shall be made by manufacturers/importers inside Taiwan.

Again, for confidential protection, overseas suppliers can provide chemical information to 3rdparty Agent (e.g. Randis).

    

     2nd stage: Standard Registration

     •    EPA may announce Designated List of Existing Chemical Substances Subject to Standard Registration in stages, including quantity threshold and the deadline for registration.

     •    Registrants shall make the registration within the deadline announced.

 

4. Taiwan Chemical Registration Flow Chart

 

 

---  Service from Randis ChemWise

     •    Randis ChemWise (Taiwan) Co., Ltd. ---subsidiary wholly owned by Randis ChemWise (Shanghai) Co., Ltd. ---can help the whole process of the registrations, including new chemical substances and existing chemical substances.

     •    The registrant shall be your affiliate manufacturers in Taiwan or your downstream importers in Taiwan. Randis ChemWise can complete the whole registration process for them.

     •    In the meantime, confidential business information is not disclosed to affiliate manufacturers in Taiwan or downstream importers in Taiwan.