Request a Demo
1. A registrant may appoint a representative to apply for chemical substances registration pursuant to Article 2 Paragraph 2 of the Regulation of New and Existing Chemical Substances Registration (hereinafter referred to as “Regulation”) .
2. The representative should be a natural person possessing the nationality of Taiwan, or a juristic person, an institute or an organization that is constituted or registered by laws.
3. For the acts of the representative, the legal effect is still assigned to the manufacturer or importer of the chemical substance.
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 Article 2 Paragraph 1 of the Regulation.
A person who manufactures or imports chemical substances in Taiwan should apply to the central competent authority for chemical registration pursuant to Article 30 Paragraph 1 of the Toxic Chemical Substances Control Act (hereinafter referred to as “Act”).
To ensure acquisition of chemical registration data, in coordination with the practical trade mode of chemical substances, the chemical substances manufacturer or importer shall appoint a representative to apply for chemical registration pursuant to Paragraph 2 Article 2 of the Regulation, or establish a branch in Taiwan to do the registration. The representative should possess the nationality of Taiwan, and should supply a notarized appointment letter when applying for the chemical substances registration.
According to Article 2 of the Regulation, the registrant may appoint a representative to do the registration and a notarized or authenticated appointment letter shall be supplied.
The registrant in Article 2 Paragraph 1 of the Regulation refers to 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, who should apply for chemical substances registration to the central competent authority pursuant to Article 30 of the Act.
As for the same new chemical substance manufactured or imported by different plants under a same company, please sum up the quantity of the substance and register it based on the corresponding tonnage level.
1. A person who manufactures or imports chemical substances in Taiwan should apply to the central competent authority for chemical registration pursuant to Article 30 Paragraph 1 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 Article 2 Paragraph 1 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 Article 2 Paragraph 2 of the Regulation.
4. The representative should be set up in Taiwan and should supply a notarized or authenticated appointment letter when applying for chemical registration.
5. The importer (registrant) in Taiwan cannot access the information if confidentiality has been applied for by the representative.
The application of the existing chemical registration is as follows:
1. The registrant who is eligible for chemical registration 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 Article 2 Paragraph 1 of the Regulation.
2. The importer in Taiwan can register as a registrant, or he can appoint a representative to apply for the chemical registration pursuant to Article 2 Paragraph 2 of the Regulation.
3. The representative should be set up in Taiwan and should supply a notarized appointment or authenticated letter when applying for chemical registration.
1. Although the finished product falls into the scope of registration exemption as specified in Article 4 Paragraph 1 Item 9 of the Regulation, the exemption depends on the status of the substance.
2. If the foreign company is unwilling to provide the related components information, it cannot be exempt as the finished product.
3. Please firstly determine whether the chemical substance is exempt from registration according to the Regulation. If it is not eligible for exemption, the original manufacturer is required to provide identification information of the substances in favor of registration application, or appointment of a representative to register according to Article 2 Paragraph 2 of the Regulation can be considered.
Manufacture or import of existing and new chemical substances shall only be allowed when the registration is approved pursuant to Article 30 of the Act. For those cannot provide complete substance identification information, the registration may not be approved. You are recommended to ask the original manufacturer of chemical substances to provide relevant substance identification information in favor of registration application, or consider to appoint a representative to register according to Article 2 of the Regulation.
The representative system is adopted mainly for cases where a foreign company intends to export chemical products to Taiwan while is unwilling to provide components information for CBI concern. At this time, the manufacturer in Taiwan can appoint a representative, and the representative can obtain the substance information from the foreign company and complete the registration. For representative qualification, please refer to Article 2 Paragraph 2 of the Regulation.
1. Generally, the commodities directly sold to the public or consumers can be deemed as finished products exempt from registration pursuant to Article 4 Paragraph 1 Item 9 of the Regulation. However, for commodities which are chemicals obviously, they should finish registration according to the Regulation (such as hydrochloric acid for the toilet cleaning).
2. Before entering the market, for chemical substances used for processing the commodity, the upstream importer or manufacturer of the chemical substances should register pursuant to Article 30 Paragraph 1 of the Act.
If the detergent you mentioned is a commodity can be directly sold in the market to end consumers after importation, it can be deemed as a finished product pursuant to Article 4 Paragraph 1 Item 9 of the Regulation. Thus, it is exempt from registration.
1. Generally, the commodities directly sold to the public or consumers can be deemed as finished products exempt from registration pursuant to Article 4 Paragraph 1 Item 9 of the Regulation. However, for commodities which are chemicals obviously, they should finish registration according to the Regulation (such as hydrochloric acid for the toilet cleaning).
2. Before entering the market, for chemical substances used for processing the commodity, the upstream importer or manufacturer of the chemical substances should register pursuant to Article 30 Paragraph 1 of the Act.
The paint, when imported, does not belong to the above mentioned “commodities directly sold to the public or consumers in the market”. So it does not fall into the scope of finished products as specified in Article 4 Paragraph 1 Item 9 of the Regulation. The paint can be regarded as a mixture pursuant to Article 4 Paragraph 1 Item 8 of the Regulation and registration is required for each component respectively.
1. Generally, the commodities directly sold to the public or consumers can be deemed as finished products exempt from registration pursuant to Article 4 Paragraph 1 Item 9 of the Regulation. However, for commodities which are chemicals obviously, they should finish registration according to the Regulation (such as hydrochloric acid for the toilet cleaning).
2. Mouthwashes and toothpastes belong to cosmetics as defined by the Cosmetic Hygiene and Safety Act, which are exempt from the management of the Regulation.
3. Before entering the market, for chemical substances used for processing the commodity, the upstream importer or manufacturer of the chemical substances should register pursuant to Article 30 Paragraph 1 of the Act.
Mouthwashes and toothpastes are commodities that can be directly sold in the market after importation, thus, they are exempt from registration pursuant to Article 4 of the Regulation.
According to Article 3 Paragraph 1 of the Regulation, chemical substances produced by natural or complex reaction, which cannot be sufficiently identified by chemical composition due to the variability in composition and proportion, are known as UVCB (Unknown or Variable composition Complex reaction products and Biological materials). UVCB can be registered as a single substance, e.g. oil substances (such as diesel oil), animal and plant extracts (such as citrus extract), etc.
Substances conforming to the definition of UVCB can be registered as a single chemical substance.
It should be determined pursuant to Article 4 Paragraph 1 Item 7 of the Regulation whether the substance is of commercial application in terms of manufacturing. If the by-products or impurities cannot be removed or reduced due to product processing or product restriction, they can be exempt from registration. However, if the by-products or impurities can be separated and processed into other products or can be directly sold, they should be identified as of commercial value, and should be registered.
The content of single impurity is acceptable below 10% (w/w) and the total impurities shall not exceed 20% (w/w) of the chemical substance.
Inseparable intermediates refer to inseparable substances during the reaction process. Generally, these substances are generated and consumed during a series of reactions, and the following conditions should all be met.
1. Closed reaction system.
2. Completely consumed in chemical reactions.
3. The chemical reaction cannot be interrupted.
4. The intermediates will not be released into the environment.
“Inseparable” means that the intermediates failing to or not intended to be removed or eliminated from the reaction equipment during chemical synthesis. The reaction equipment include the reactive tank, pipeline, and other facilities making the substances pass continuously or intermittently, excluding the storage facilities or related container after manufacturing the substances.
Plant A and Plant B in this case are two different sites and have two different manufacture procedures, so the chemical substance should be registered.
Take Bendiocarb as an example, Bendiocarb is a pesticide protomer (active ingredient of pesticide). According to Article 4 Paragraph 2 Item 14 of the Regulation, Bendiocarb is governed by the Environmental Agents Control Act, so it does not need registration. However, its raw materials, e.g. 2,2 dimethylpropane and pyrogallol are not governed by the Agro-pesticides Management Act. In case of importing or manufacturing these chemical substances, registration is still required.
If a chemical substance is designed to produce in a specific solid shape, then applies to other manufacture procedures after changing the shape, it belongs to the scope of mixtures rather than finished products. Such kind of substances includes polymer granules, so the PET plastic pellet for industrial use belongs to the scope of mixtures.
The whole mixture pursuant to Article 4 Paragraph 1 Item 8 of the Regulation does not need registration, while individual component in the mixture should be registered pursuant to the Regulation.
For chemical substances entering the bonded area by bonded methods, they can be exempt from registration if they conform to the descriptions of chemical substances under customs supervision in Article 4 of the Regulation that they are only under temporary storage before re-exportation. Although the bonded factory conforms to provisions, it may not have the characteristics of temporary storage for re-exportation and considering the fact of manufacturing or importing chemical substances, registration is required.
In addition, if the goods are subsequently imported into the bonded factory from the bonded warehouse or logistics center, in this case, the "owner" on the customs declaration of the bonded warehouse or logistics center shall be the registrant of chemical substances under bond.
Inseparable intermediates refer to inseparable substances during the reaction process. Generally, these substances are generated and consumed during a series of reactions, and the following conditions should all be met.
1. Closed reaction system.
2. Completely consumed in chemical reactions.
3. The chemical reaction cannot be interrupted.
4. The intermediates will not be released into the environment.
“Inseparable” means that the intermediates failing to or not intended to be removed or eliminated from the reaction equipment during chemical synthesis. The reaction equipment include the reactive tank, pipeline, and other facilities making the substances pass continuously or intermittently, excluding the storage facilities or related container after manufacturing the substances.
The whole mixture pursuant to Article 4 Paragraph 1 Item 8 of the Regulation does not need registration, while individual component in the mixture should be registered pursuant to the Regulation.
Thus, for the same chemical substance in different mixtures, the total amount of the substance should be calculated and summed up from the corresponding concentration of mixtures. The substance should be identified based on CAS No. or the serial No. issued by the authority. A same substance with different concentration in mixtures cannot be registered under lower registration tonnage level respectively.
If the food flavorings fall into the scope of food additives as defined in Article 4 Paragraph 2 Item 8 of the Regulation, the registration is exempt. However, if the raw materials are imported, it is necessary to confirm whether they belong to food additives as defined by the Act Governing Food Safety and Sanitation. If the raw materials do not belong to food additives, the registration is required.
If they fall into the scope of cosmetics as defined in Article 4 Paragraph 2 Item 7 of the Regulation, the registration is exempt. However, if the raw materials are imported, it is necessary to confirm whether they belong to cosmetics as defined by the Cosmetic Hygiene and Safety Act. If not, the raw materials of cosmetics should be registered.
If a chemical substance is designed to produce in a specific solid shape, then applies to other manufacture procedures after changing the shape, it does not fall into the scope of finished products pursuant to Article 3 Paragraph 4 of the Regulation.
Thus, EPS belongs to mixtures. The whole mixture pursuant to Article 4 Paragraph 1 Item 8 of the Regulation does not need registration, while individual component in the mixture should be registered pursuant to the Regulation.
The whole mixture pursuant to Article 4 Article 4 Paragraph 1 Item 8 of the Regulation does not need registration, while individual component in the mixture should be registered pursuant to the Regulation.
Your company produces D after mixing the raw materials of A, B and C. This manufacture procedure produces another chemical substance, which conforms to the definition of manufacture of chemical substances, so the generated substance D should be registered. If raw materials of A, B and C are purchased domestically, there is no need to do registration. However, if the raw materials are imported, registration is required.
Medicaments as defined by the Pharmaceutical Affairs Act pursuant to Article 4 Paragraph 2 Item 5 of the Regulation are exempt from registration. However, if the medicament hasn’t obtained medicine certificate under the Pharmaceutical Affairs Act, chemical registration is required according to the Regulation.
According to Article 4 Paragraph 1 Iten 2 of the Regulation, a chemical substance along with machines or equipment for trial run is exempt from registration, since it is of small quantity at the phase of trial run and there will be low risk for exposure to this substance.
According to Article 4 Paragraph 1 Item 1 of the Regulation, naturally occurring substances refer to substances processed only by manual, gravitational or mechanical methods, or by water dissolution, water extraction, distillation, thermal dehydration, or by extraction from air, etc. without any chemical changes; or biological substances or naturally occurring polymers that have not been chemically modified. They are exempt from registration.
If the sulphur is produced by chemical reactions, it does not conform to the definition of natural substances in the Regulation, and registration is required.
According to Article 4 Paragraph 1 Item 9 of the Regulation, for finished products possess a specific shape or design formed during manufacture, registration is exempt.
Medical devices falls into the scope of finished products, so there is no need to do chemical registration.
The whole mixture pursuant to Article 4 Paragraph 1 Item 8 of the Regulation does not need registration, while individual component in the mixture should be registered pursuant to the Regulation. The quantity of manufacture or importation is calculated by composition proportion into the quantities of pure substances.
After revision of the Regulation, toxic chemical substances are excluded/exempted items, so there is no need to do registration and reporting. The registrant can apply to the central competent authority to revoke the original approved registration and cancel the registration code, so as to avoid the duplicated control and data collection between the registration system and various ministries. If you do not cancel the registration code, you should still submit annual report in accordance with the law.
The whole mixture pursuant to Article 4 Paragraph 1 Item 8 of the Regulation does not need registration, while individual component in the mixture should be registered pursuant to the Regulation. The quantity of manufacture or importation is calculated by composition proportion into the quantities of pure substances.
For mixture products, the individual component should be registered respectively. For the same chemical substance in different mixtures, the total amount of the substance (as pure substance) should be calculated and summed up according to its corresponding proportions in different products. Registration is required pursuant to the Regulation based on the corresponding tonnage level.
For a new chemical substances fulfilling the criteria of the substances used for the purposes of PPORD, or for R&D, according to Article 8 of the Regulation, the importer shall provide the document (such as documentary evidence of proving the new chemical substances are used for R&D or PPORD) and forms which required by central competent authority when submitting the documents for registration application. If the importer is entrusted by the research & development institute to import new chemical substances, the importer shall apply uses authentication for R&D or PPORD from Taiwan EPA in the form of official document and attachment (power of attorney and application form). Only the importer who obtains the approval can import the new chemical substances for the purpose of R&D and PPORD. It is not allowed to use the new chemical substances for other purposes.
1. According to the Article 10 Paragraph 1 and Article 17 Paragraph 1 of the Regulation, co-registrants, or the early and late registrants of the same chemical substance, may apply for join registration under agreement and share substance information required for joint registration.
2. Due to the confidentiality of company information, we do not assist in providing the information of company who need to register the same chemical substance.
According to Article 5 of the Regulation, before applying for registration, please fill in the PLC confirmation form and submit it to the competent authority for prior verification in order to prove that the new chemical substance complies with the definition of PLC under Article 3 Paragraph 7 of the Regulation.
According to Article 30 Paragraph 1 of the Act, an importer of new chemcial substances must apply for registration and obtain approval in advance before importation.
The importer of new chemical substances must apply for registration and obtain registration No. before importation. If the central competent authority finds out that the importer imports new chemical substances without registration, the importer would be punished by NT$200,000 ~ NT$2 million and be ordered to make correction within the given period in accordance to Article 56 of the Act. The penalty is imposed on violations each time. If the importer fails to make the correction within the given period for more than two times, it will be ordered to suspend work, suspend business or return export. Thus, we need to reminder you to complete the registration of new chemical substances before importation in case of any violation.
According to the note e of Appendix 2 of the Regulation, after registration applications have been approved, the registrants shall proactively provide supplementary information based on the quantity thresholds when the actual manufactured or imported quantity increase leads to an increase in levels according to Article 29 of the Regulation.
Thus, a registrant can manufacture or import the new chemical substance during the validity of the registration code if he has finished the Level 1 of standard registration. He shall proactively provide supplementary information required by the Level 2 of standard registration if the actual manufactured or imported quantity increase leads to Level 2.
Although it will not affect the manufacture or import activities of the substance, please be sure to pay attention to the actual manufactured or imported quantity, and proactively supplement minimum information after increasing to higher levels in line with the relevant provisions of the Act. This is to avoid the occurrence where penality will be imposed if too much data lacks and it cannot be submitted within the period given by the competent authority after inspection.
Surfactants could be polymer. However, please be noted that polymer according to Article 3 Paragraph 5 of the Regulation should meet the following criteria:
1. A macro-molecular chemical substance consisting of molecules characterized by the sequence of one or more types of monomer units.
2. A molecule contains at least three monomer units covalently bound; such molecules take over 50% of the weight of that substance, and the amount of the said molecules presenting the same molecular weight must be less than 50% of the weight of that substance.
3. Differences in the molecular weight are primarily attributable to differences in the number of monomer units.
If the surfactant fails to comply with the above criteria, it is considered as a general new chemical substance. Please apply for registration according to amount level of general new chemical substances.
According to Article 3 Paragraph 1 of the Regulation, chemical substance refers to a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any unintended constituent deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.
Therefore, for the registration of a chemical substance, there is no restriction on its state which means the chemical substance in the solid, liquid or gaseous state does not need to be registered respectively. However, the total amount shall be calculated accordingly and register the substance based on the tonnage level.
1. According to the Article 10 Paragraph 1 and Article 17 Paragraph 1 of the Regulation, co-registrants, or the early and late registrants of the same chemical substance, may apply for join registration under agreement and share substance information required for joint registration.
2. Due to the confidentiality of company information, we do not assist in providing the information of company who need to register the same chemical substance.
3. At present, we do not offer such service. It is suggested that the registrant who has the demand for joint registration of the same new chemical substance could find the co-registrants by consulting some associations.
If you have obtained Registration No. for standard registration of a new chemical substance in accordance to “Chapter 2 New Chemical Registration” of the Regulation and included the substance on the inventory of existing chemical substance, it is regarded as that you have completed the standard registration of existing chemical substances. You do not need to comply with phase 1 registration of existing chemical substances.
According to Article 15 Paragraph 1 of the Regulation, for existing chemical substances first manufactured or imported in annual quantity of 100 kilograms or more, the registrant shall within 6 months from the date of occurrence of the fact, apply for the phase 1 registration and attach information as specified in Appendix 7. However, according to Article 15 Paragraph 3 of the Regulation, for existing chemical substances manufactured or imported in annual quantity less than 100 kilograms, registration may be made in accordance with paragraph 1. Thus, for existing chemicals manufactured or imported in quantities less than 100kg, you can choose whether or not apply for phase I registration.
According to Article 15 of the Regulation, the annual volume of existing chemical substances shall be calculated in the calendar year, i.e. from January 1 to December 31 of the current year.
The supplementary existing chemical substance nomination in previous years which collected information from the industry is to build the inventory of chemical substance in Taiwan. However, we do not have enough chemical substance information for source management. In addition, we haven’t built up the database of all chemical substance operations from all manufacturers and importers. It still needs the joint effort from the industry to manage chemical substances effectively. The EPA’s registration regulation is to establish source management of chemicals in terms of manufacture and importation. Therefore, registration is required.
According to Article 15 of the Regulation, the importer that imports existing chemical substances must apply for registration and obtain approval in advance before importation. If the central competent authority finds out that the importer imports existing chemical substances without registration, the importer would be punished by NT$30,000 ~ NT$300,000 in accordance to Article 56 of the Act. The penalty is imposed on violations each time. If the importer fails to make the correction within the given period for more than two times, it will be ordered to suspend work, suspend business or return export.
According to Article 15 of the Regulation, for existing chemical substances first manufactured or imported in annual quantity of 100 kilograms or more, the registrant shall within 6 months from the date of occurrence of the fact, apply for the phase 1 registration accordingly. No existing chemical substance shall be manufactured or imported, unless the registration approval is obtained within the specified period.
Chemical substances which have been included on the Ministry of Labor's inventory of existing chemical substance on CSNN website, are listed as existing chemical substances in Taiwan. According to Article 15 Paragraph 1 of the Regulation, for existing chemical substances first manufactured or imported in annual quantity of 100 kilograms or more, the registrant shall within 6 months from the date of occurrence of the fact, apply for the phase 1 registration and attach information as specified in Appendix 7. No existing chemical substance shall be manufactured or imported, unless the registration approval is obtained within the specified period.
If you want to check whether an imported or manufactured substance is an existing chemical substance, you can search via: https://csnn.osha.gov.tw/content/home/Substance_Home.aspx
According to Article 25 of the Regulation, the review periods of all the applications accepted by the central competent authority are as follows:
1. PLC prior verification, new chemical substances small quantity registration, PLC small quantity registration, existing chemical substances phase 1 registration, protection of confidential information, and corresponding extension: 7 working days from the date of receipt of the application
2. New chemical substances simplified registration and the inclusion in the inventory of existing chemical substances: 14 working days from the date of receipt of the application
3. New chemical substances standard registration: 45 working days from the date of receipt of the application
4. Existing chemical substances standard registration: 90 working days from the date of receipt of the application
The central competent authority shall notify the registrants if the review periods mentioned above are extended. The number of extensions is limited to one. In addition, according to Article 26, the review periods shall be calculated anew from the date that the central competent authority receives the supplementated or corrected data submitted by the registrant.
According to Article 26 of the Regulation, should the review procedure find documents inadequate, mistaken, or unspecific, the central competent authority shall notify the registrant to provide a correction.
According to Article 26 of the Regulation, the registrant shall provide a correction within 30 working days from the date of receiving the notification from the central competent authority. The said corrections shall be given only twice. However, if the failure to provide a correction within this limited period is caused by scientific or technical factors, this requirement shall not apply to registrants who report to the central competent authority and obtain its consent. The application shall be rejected if the registrant fails to make the correction within the limited period or fails to make the correction within a given period more than two times. In addition, the period of correction is not included in the review period.
According to Article 19 of the Regulation, information on chemical substances registered and approved by the central competent authority shall be disseminated to the public, including:
1. Registrant information
2. Names of chemical substances
3. Manufacture or import conditions
4. Classification and labelling
5. Guidance on safe use
6. Physical and chemical properties
7. Toxicological and ecotoxicological information
8. Hazard assessment
9. Exposure assessment
According to Article 20 of the Regulation, the business secrets shall conform to the following conditions:
1. They are not known to persons generally involved in information of this type;
2. They have economic value, actual or potential, due to their secretive nature; and
3. The owners have taken reasonable measures to maintain their secrecy.
According to Article 20 of the Regulation, registered information determined to be business secrets shall be protected and kept confidential, including:
1. Registrant information
2. Substance identification
3. Information on manufacturing and importing
4. use information
Please be noted that information related to human health and environmental safety must be made public.
Registrants should determine the protection items in the chemical substance information and registration application form when applying for registration. The below information should be provided in the form:
(1) Statement of chemical substance with information protection in other countries.
(2) Statement indicating if the chemical substance is new chemical substance in other countries.
(3) Current information protection measures for chemical substance.
(4) The situation and possibilities of chemical substance information publicity by other government authorities.
(5) The patent application situation of chemical substance.
If the chemical substance is under information protection in other countries, the registrant should provide related evidence documents. If there is no evidence documents or the documents cannot be provided for certain reasons, the registrant should specify the situation in the form. The related evidence documents are provided voluntarily and the self-declaration can also be accepted.
