Introduction
Recently, the environmental authority in the Taiwan region (hereinafter referred to as the Competent Authority) has initially selected 28 existing chemical substances for the second batch that will be prioritized for data collection and assessment. This selection is based on international GHS classification standards and screening principles targeting significant hazards (such as carcinogenicity, mutagenicity, reproductive and developmental toxicity, chronic aquatic toxicity, and endocrine-disrupting properties).
Initial List of the Second Batch of Existing Chemical Substances
No. | CAS No. | English Name | Chinese Name |
1 | 65996-93-2 | Pitch, coal tar, high-temp. | 高温煤焦油沥青 |
2 | 75-28-5 | Isobutane | 异丁烷 |
3 | 8002-05-09 | Petroleum | 原油 |
4 | 8007-45-2 | Coal tar | 煤焦油 |
5 | 64741-88-4 | Distillates (petroleum), solvent-refined heavy paraffinic | 溶剂精制重石蜡馏分 (石油) |
6 | 72623-87-1 | Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based | C20-50 加氢处理中性润滑油(石油) |
7 | 64742-52-5 | Distillates (petroleum), hydrotreated heavy naphthenic | 加氢处理重环烷烃馏分 (石油) |
8 | 630-08-0 | Carbon monoxide | 一氧化碳 |
9 | 98-73-7 | 4-tert-butylbenzoic acid | 4-叔丁基苯甲酸 |
10 | 58-55-9 | Theophylline | 茶碱 |
11 | 10043-35-3 | Boric acid | 硼酸 |
12 | 7681-52-9 | Sodium hypochlorite | 次氯酸钠 |
13 | 7758-98-7 | Copper sulfate | 硫酸铜 |
14 | 1317-38-0 | Copper(II) oxide | 氧化铜(II) |
15 | 7758-99-8 | Copper sulfate pentahydrate | 五水硫酸铜 |
16 | 7440-66-6 | Zinc | 锌 |
17 | 85535-85-9 | Alkanes, C14-17, chloro | 中链氯化石蜡 |
18 | 75-86-5 | 2-hydroxy-2-methylpropionitrile | 2-羟基-2-甲基丙腈 |
19 | 7733-02-0 | Zinc sulfate | 硫酸锌 |
20 | 31570-04-04 | Tris(2,4-ditert-butylphenyl) phosphite | 三(2,4-二叔丁基苯基)亚磷酸酯 |
21 | 96-49-1 | Ethylene carbonate | 碳酸乙烯酯 |
22 | 25155-25-3 | 1,4-Di-(2-tert-butylperoxyisopropyl)benzene | 1,4-双叔丁基过氧异丙基苯 |
23 | 1327-41-9 | Aluminum chloride, basic | 氯化铝(碱式) |
24 | 67774-74-7 | Benzene, C10-13-alkyl derivs. | 苯,C10-13烷基衍生物 |
25 | 53306-54-0 | Bis(2-propylheptyl) phthalate | 邻苯二甲酸二(2-丙基庚)酯 |
26 | 64741-56-6 | Residues (petroleum), vacuum | 真空残留物(石油) |
27 | 84961-70-6 | Benzene, mono-C10-13-alkyl derivatives, distillation residues | 苯,单C10-13烷基衍生物,蒸馏残留物 |
28 | 12070-12-1 | Tungsten(IV) carbide | 碳化钨(IV) |
Remarks:
1. The table above is not the final list of existing chemical substances designated for supplementary data registration in the second phase.
2. The chemical substances in the table above are subject to the CAS No., and the English and Chinese names are for reference only.
It should be noted that this list is currently only a preliminary screening result and not the final version. The ultimately determined list will be subject to the Competent Authority's subsequent revision and publication of the Regulations of New and Existing Chemical Substances Registration.
Implementation Framework for the Phase II Existing Chemical Substances
Based on the experience gained from implementing the first batch of 106 existing chemical substances and feedback from various parties, and in conjunction with the current registration status in the Taiwan region and international practices, the Competent Authority has planned the subsequent implementation framework.
Starting from the second batch, the implementation method will be adjusted:
Proactive Data Collection: The Competent Authority will screen substances in batches and take the lead in allocating resources to proactively collect, collate, and analyze publicly available international hazard information
Targeted Data Submission: Based on this analysis, the Competent Authority will specify the registrants responsible for submitting the necessary missing (gap) data. Not all registrants will need to submit the gap data.
Testing Methods: Priority will be given to non-animal alternative testing methods.
Joint Registration: The joint registration mechanism will be promoted to encourage cooperation among operators and share data, thereby reducing the burden on individual operators.
Focus on Exposure and Use: The Competent Authority will emphasize that designated registrants provide exposure scenarios and use information to accelerate the risk assessment process. This will facilitate the timely implementation of measures such as case-by-case restrictions or public announcements for control.
The overall model shifts from being primarily driven by registrants' self-registration to a public-private partnership model. The final goal is to transition from a data-collection orientation to risk management and regulatory control by mastering the risk and implementing timely management actions.
Recommendations for Enterprises
In comparison to the first batch, the Competent Authority in the Taiwan region will be more proactive in advancing the registration and management of existing chemical substances in the second and subsequent phases.
For enterprises intending to export to or manufacture the second batch of existing substances in the Taiwan region, an early understanding and adaptation to the relevant management requirements will help with advanced planning and effective response.
REACH24H recommends that all companies involved in chemical business with the Taiwan region, especially those with an annual manufacturing or import volume of existing substances exceeding 1 ton, should take the following actions as soon as possible:
Substance/Mixture Inventory Check: Confirm whether the existing substance belongs to the second batch of existing chemical substances list.
Data Preparation in Advance: Collect and organize detailed use and operational scenario information for the substance to prepare for future exposure assessment.
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