Taiwan New Chemical Substance-Existing Chemical Substance Registration

Understanding Taiwan Existing/New Chemical Substance Registration The key regulations as for Taiwan chemical control are 'Toxic Chemical Substance Control Act' Amended and effective on Dec. 11th of 2013, and 'Occupational Safety and Health Act' Amended and effective on July 3rd of 2013. These Regulations cover key requirements on chemicals for its manufacture, storage, usage, trading and transportation. Administration of 'Toxic Chemical Substance Control Act' (TCSC) is the responsibility of Taiwan EPA. Administration of 'Occupational Safety and Health Act' (OSHA) is the responsibility of Taiwan Ministry of Labor (MOL). The fracture is as below, 'Regulation of New and Existing Chemical Substance Registration' issued by Taiwan EPA (effective from December 11th of 2014) and 'The Regulation of New Chemical Substances Registration' issued by Taiwan MOL (effective from January 1st of 2015) are the 2 regulations requiring registration of new chemical substances (NCS) and of existing chemical substances (ECS).  Under both regulations, only Taiwan local manufacturer/importer can make the registration, a foreign company who exports chemical substances to Taiwan can not proceed the registration. For Confidential Business Information (CBI) protection, a Third Party Representative (TPR) (a company registered locally in Taiwan) can be used to provide the CBI to Taiwan Chemical Registration Center (CRC), thus the CBI will not be disclosed to Taiwan importers when Taiwan local manufacturer/importer can make the registration. The TPR nomination letter shall be notarized by notary offices (private or Taiwan court) in Taiwan It is learnt that Taiwan EPA and MOL are considering to allow EU-like OR system, thus a foreign company can also proceed the registration NCS shall be registered to CRC and approved prior to the import into Taiwan and prior to the manufacture in Taiwan. ECS shall be registered within 90 days from the date when the annual quantity of an ECS reaches 100kg. Each importer/manufacturer in Taiwan shall make his own registration even for a same chemical substance, while surely joint registration can be selected. The following summarize the management of the 2 regulations. Confirm whether a chemical substance is new to Taiwan NCS are these chemical substances not listed in TCSI (Taiwan Chemical Substance Inventory), which collects around 101,089 substances manufactured/imported in Taiwan before Dec. 11th of 2014 - the effective date of EPA Regulation. Some substance in TCSI are kept confidential (Confidential part of the Inventory, which shows only their generic names).Companies can verify themselves by searching TCSI. The website is csnn.osha.gov.tw/content/home/Substance_Query_Q.aspx. While Taiwan CRC does not assist the verification even for the confidential part of the inventory. If a company can not confirm a substance is ECS, the company needs to treat it as NCS and makes the registration prior to the export to Taiwan. NCS and ECS exemptedFollowing chemicals are exempted for registration:  (1) Substances which occur in nature.  (2) Chemical substances used in machines or equipment for test-run purposes.  (3) Inseparable intermediates from chemical reactions in the reaction vessel or production process.  (4) Chemical substances for national defense purposes.  (5) Chemical substances under customs supervision.  (6) Waste.  (7) By-product or impurity that is of no commercial application  (8) Articles.  (9) Matters governed by the following respective laws, e.g. cosmetics, drugs, medicine, Montreal Protocol chemicals, … Registration Types for NCSThere are 3 registration types and two prior confirmations:Prior confirmation for Scientific Research and Development (R&D[ R&D refers to any scientific experimentation, education, analysis, or chemical research carried out under strictly controlled conditions.]): NCS sample (<1,000 kg/year) for R&D activity in Taiwan, a confirmation letter signed by the Taiwan importer and the scientific research entity shall be submitted to Taiwan EPA. After an acknowledge letter returned by EPA is received by the Taiwan importer, the NCS sample can be sent to Taiwan. Taiwan EPA may make on-site inspection for the R&D activity within one year time.Prior confirmation for Polymer of Low Concern (PLC[ (PLC) refers to a substance that is evaluated by Taiwan CRC and fulfills any one of the following conditions,  2.1 A polymer with an average molecular weight in a range of 1,000 to 10,000 Daltons, contains oligomers of molecular weights below 500 Daltons in amount of less than 10%; oligomers below 1,000 Daltons in amount of less than 25%. And the polymer does not contain any of high concerned chemical groups e.g. amines, etc..  2.2 A polymer with an average molecular weight over 10,000 Daltons, contains oligomers of molecular weights below 500 Daltons in amount of less than 2%; oligomers below 1,000 Daltons in amount of less than 5%.  2.3 Polyester polymers with monomers/reactants as designated by Taiwan authority.  2.4 Insoluble polymers (not soluble in water, N-Octanol, N-Heptane, Tetrahydrofuran (THF), Dimethylformamide (DMF)).]): after a polymer is confirmed by CRC as PLC, the Taiwan importer/manufacturer can import/manufacture annually maximum 1 ton of the polymer without registration.  Small Quantity Registration (SQR): for PLC with annual quantity ≥ 1 ton, other polymers with annual quantity < 1 ton, NCS for PPORD[ PPORD refers to any scientific development related to product development or the further development of a NCS, in the course of which pilot plant or production trials are used to develop the production process or to test the fields of application of the NCS .] with annual quantity < 1 ton, On-site Isolated Intermediates[ refers to intermediates that are produced and consumed on the same site.] with annual quantity < 1 ton, non CMR NCS with annual quantity < 0.1 ton, a SQR can be made. Simplified Registration (SR): for non-PLC polymers with annual quantity 1~10 ton, NCS for PPORD with annual quantity 1~10 ton, On-site Isolated Intermediates with annual quantity 1~10 ton, non CMR NCS with annual quantity < 1 ton, a SR can be made. Standard Registration: for other substance, standard registration can be made.There are 4 quantity levels for Standard registration,Level 1: non-PLC polymers with annual quantity ≥10 ton, NCS for PPORD with annual quantity ≥10 ton, On-site Isolated Intermediates with annual quantity ≥10 ton, CMR NCS with annual quantity < 1 ton, non CMR NCS with annual quantity 1~10 ton, a Level 1 Typical Registration can be made. Level 2: CMR NCS with annual quantity 1~10 ton, non CMR NCS with annual quantity 10~100 ton, a Level 2 Typical Registration can be made.  Level 3: CMR NCS with annual quantity 10~100 ton, non CMR NCS with annual quantity 100~1,000 ton, a Level 3 Typical Registration can be made. Level 4: CMR NCS with annual quantity ≥100 ton, non CMR NCS with annual quantity ≥1,000 ton, a Level 4 Typical Registration can be made. The following table summarizes the different registration types. Approval Validation and Listing into TCSI for NCS:★ 1 year for Prior confirmation for R&D. The substance can not be listed in TCSI.★ 2 years for Simplified Registration and other Small Quantity Registrations. The substance can not be listed in TCSI.★ 5 years for Small Quantity Registration of Low Concern Polymer, then the substance is listed into TCSI.★ 5 years for Standard Registration, then the substance is listed in TCSI.★ No time limitation for validation of prior confirmation for PLC.★ Registrant can apply for advancing the listing of the NCS by Standard Registration and by Small Quantity Registration of Low Concern Polymer into TCSI. Listing NCS as Toxic ChemicalsToxic Chemical List as published by Taiwan EPA contains around 250 chemicals and are classified into 4 categories. Taiwan local companies shall obtain approvals for operation (manufacture, import, export, trading, transportation, usage, storage, waste disposal) of these chemicals above certain quantity or products containing these toxic chemicals above certain concentration and quantity. Registered NCS will be added into the Toxic Chemical List if a NCS is evaluated meeting the criteria of toxic chemical. CBI for NCS:Registrant can apply for CBI for NCS registration: CBI for NCS identification, name of registrant, usage of NCS, activity type (import or manufacture). For CBI of each item Taiwan authority charges about 400 US dollars.The CBI application is valid for 5 years for Standard registration, 2 years for SR and for SQR. CBI can be renewed before the validation expires with same CBI fee be paid. Data requirement for registrationDifferent registration types have different test data requirement. For prior confirmation of PLC, polymer molecular distribution analysis report (e.g. GPC report) is needed.For small quantity registration, IR spectrum etc. is needed.For SR, melting point, boiling point, density, LogKow and water solubility test reports are needed. For Standard Registration, typically data below (Table 1) are needed (for both NCS and ECS), No. Test Item L1 L2 L3 L4 NMR/IR/UV √ √ √ √ Physical state √ √ √ √ Melting point √ √ √ √ Boiling point √ √ √ √ Density √ √ √ √ LogKow √ √ √ √ Water solubility √ √ √ √ Vapor pressure √ √ √ Flash point √ √ √ Flammability √ √ √ Explosivity property √ √ √ Oxidizing property √ √ √ pH √ √ √ Self-ignition temperature √ √ √ Viscosity √ √ Corrosion to metal √ √ Acute oral toxicity √ √ √ √ Acute dermal toxicity √ √ √ Acute inhalation toxicity ● ● ● Acute skin irritation √ √ √ √ Acute eye irritation √ √ √ √ Skin sensitization √ √ √ √ AMES test √ √ √ In vitro Chromosome aberration (473) √ √ Micronucleus Test (474) In vivo Gene Mutation Test (475) √ P P Toxicokinetics P P P 28d toxicity √ √ √ 90d toxicity ● √ √ Chronic toxicity ● ● Prenatal Developmental Toxicity (414) √ √ √ 2-Generation Reprod. Toxicity (416) ● √ Carcinogenicity (451) P Algae growth inhibition (201) √ √ √ √ Daphnia acute toxicity (202) √ √ √ √ Ready biodegradation test (301) √ √ √ √ Inherent biodegradation (302) ● ● ● ● Possible degrade. test (303~309) ● ● Hydrolysis Function pH (111) ● ● ● Fish acute toxicity (203) √ √ √ Activated sludge (209) ● ● ● Adsorption/desorption (106) ● ● ● Daphnia magna reproduction (211) ● ● Chronic fish toxicity ● ● Acute toxicity to Earthworm (207) ● ● Plant growth test (208) ● Earthworm Reprod. (220, 222) ● Plant vigour test (227) ● Bioaccumulation (305) ● Soil microorganisms (216 or 217) ● Degrad. simulation test (303, 308, 309) ● Degradation in soil (304A, 307) ● Sediment-water toxicity (218, 219, 225) ● P: Test plan. Whether to conduct these tests will be as required by Taiwan authority. ●: Possibly needed.Further remark: some tests can be exempted under certain conditions. 1). Data sourceData from the following source are theoretically acceptable for Taiwan NCS registration: test report by qualified labs, published authoritative literatures, or data generated from method including QSAR, etc. For physic-chemical property data, the test can be by in-house lab of the substance's manufacturer. If the test is by external lab, then the lab shall be GLP lab or ISO 17025 lab, or APLAC MRA lab (Asia Pacific Laboratory Accreditation Cooperation Mutual Recognition Arrangement), or lab recognized by Taiwan Accreditation Foundation (TAF). QSAR data can be one option. For toxic property data, the test data should be by qualified lab (GLP lab, APLAC MRA lab, TAF lab), or by QSAR for certain items e.g. skin and eye irritation. For eco-toxic property data, the test data should be by qualified lab (GLP lab, APLAC MRA lab, TAF lab). 2). Data sharingData sharing by different registrants are allowed by accumulating the notification quantity together. Data sharing is not mandatory. ECS ManagementFirst Stage Registration:ECS manufactured/imported in/to Taiwan with quantity >100kg in any year of (2012~2015), a SQR shall be made between Sep. 1st of 2015 ~ Mar. 31st of 2016.ECS manufactured/imported in/to Taiwan with annual quantity >100kg from the year 2016, a SQR shall be made within 90 days from the date when the quantity reaches 100kg. Second Stage Registration: Taiwan EPA will announce 'Designated List of Existing Chemical Substances Subject to Standard Registration' in several batches, including quantity threshold and the deadline for registration. Registrants (manufacturer/importer in Taiwan) shall make the registration within the deadline announced. Example：Scanned New Chemical Registration Certificate of Taiwan Service from Randis ChemWise • Randis ChemWise 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. • In the meantime, confidential business information is not disclosed to affiliate manufacturers in Taiwan or downstream importers in Taiwan.