Draft Rules for New Substance and Existing Substance Registration under Revised TCSCA
18 Sep 2014 by CIRS
Draft rules for the registration of new and existing chemical substances under the revised Toxic Chemical Substances Control Act (TCSCA) was published by Taiwan's Environmental Protection Administration (EPA) on 25 August, the draft is on public consultation stage and the rule will takes effect in 11th December 2014. CIRS summaries major points of the rules. For more info, please see below.
NEW ! Mr. Jefferson Shih from DG Specialty Inc will give a public speech on Registration requirements under the revised Toxic Chemical Substance Control Act (TCSCA) in Taiwan during the 4th Shanghai Summit Meeting on Chemical Regulations in China, Korea and Japan (SMCR 2014), 15-16 October, Shanghai. If you are interested in this topic, please register our meeting. Registration before Oct 1 will avail an Early-bird rate in registration fees. More info please click here.
New Substance Notification & Management
- Standard Registration
- New substances manufactured or imported into Taiwan, >1t/y; or
- New substances used for scientific research or PPORD, >100t/y; or
- On-site isolated intermediate, >100t/y;
- CMR substances upon authority’s confirmation;
- 4 Levels: Level 1 (1-100t/y), Level 2 (100-1000t/y), Level 3 (1000-10000t/y), Level 4 (>10000t/y+);
- Required data: legal entity info, substance identification, physicochemical data, toxicology data, eco-toxicology data, hazard assessment and exposure assessment (only for level 2 or above), C&L, guidance on safe use, etc.
- Level 1 data requirements similar to level I under REACH;
- Level 1 data is required for PPORD substance or on-sited intermediate>100t/y;
- Registration certificate valid for 5 years
- New substances added to existing substance inventory after 5 years;
- Review period: 45 working days;
- Simplified Registration
- New substances, 0.1t/y~1t/y; or
- New substances used for scientific research or PPORD, 1~100t/y; or
- On-site isolated intermediate, 1~100t/y;
- Required info: legal entity info, substance identification, information on manufacture & use, C&L, guidance on safe use and some physicochemical data;
- Registration certificate valid only for 2 years;
- Review period: 14 working days.
- Small Quantity Registration
- New substances, <0.1t/y; or
New substances used for scientific research or PPORD, <1t/y; or
- On-site isolated intermediate, <1t/y;
- Registration certificate valid only for 2 years;
- Required information: legal entity information, substance identification, use, volume.
- Reporting of volume & renewal 3 months prior to expiration (Article 13);
- Review period: 7 working days.
- Polymer of Low Concern Confirmation
- PLC>=1t/y, subject to small quantity registration requirement, substance added to existing inventory after 5 years.
- Registration certificate valid for 5 years.
- PLC<1t/y, exempt,
- Joint Submission (Article 11)
- No accumulated tonnage rules;
- The tonnage band of a later registrant shall not be higher than a previous registrant;
- Authority may get involved in deciding how to share the costs.
- Substances exported to Taiwan between 2012 and 2014 (article 16)
- Subject to existing substance registration requirement;
- Companies need to provide documentary evidence.
- New substances exported to Taiwan in 2015 (article 17)
- Subject to small quantity registration;
- Valid for two years, renewal not allowed;
Existing Substance Registration & Management
- Pre-registration (Article 18)
- Target: Existing substances with volume > 100kg/y;
- Period: 1 Sept 2015- 31 March 2016;
- Volume calculation rules: 3 years average or the highest volume in three years in case of interrupted supply;
- Information required: legal entity info, use & volume;
- Companies will be issued with a registration number and be required to show this number when selling chemicals.
- Late Pre-registration(Article 19)
- Target: Existing substances with volume > 100kg/y manufactured or imported for the first time after 31 March 2015;
- Period: To be announced separately.
- Selection of Existing Substances Subject to Standard Registration (Article 20)
- Authorities will announce existing substances subject to standard registration and set different deadlines for different tonnage bands;
- The lists will be published in a step-wise approach;
- Registration Update (Article 28)
- Needed in case of legal entity information change and use change;
- Substance name may be kept confidential upon company’s request.
- Notarized appointment letter required.
Please Notice: Proposed date of entry into force: 11 Dec 2014 http://gazette.nat.gov.tw/EG_FileManager/eguploadpub/eg020163/ch07/type3/gov60/num22/Eg.htm
Registration information includes manufacturing or importing details, the physical, chemical, and toxicology data, exposure and hazard assessment data and other information designated by the central competent authority. According to substance type and the quantities of manufacturing or importing, there are 3 types of registration: standard registration, simplified registration and small volume registration.
However, guidance on data required for those three types of registration has not been published yet.
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