Adding a Registered New Substance to Existing Chemical Substance Inventory: How Long Do You Need to Wait?
Little Pro on 2017-08-29
Many countries require a company to register a new chemical substance prior to producing or importing the substance. Before getting listed in existing chemical substance inventory, a new chemical substance can only be manufactured or imported by the registrant unless others also submit their own registrations. After a substance is added to existing chemical substance inventory, others may manufacture, import or use the same substance without additional registrations. In this article we will summarize how long you may need to wait for a registered new substance to be added to existing chemical substance inventory. EU, USA, Canada, China, Japan, Korea, Taiwan, Australia and Philippines are covered.
EU: Never
EU uses European Inventory of Existing Commercial Chemical Substances (EINECS) and European List of Notified Chemical Substances (ELINCS) to differentiate new substances from existing chemical substances. However, a registered new substance will not be added to EINECS since all >=1t/y new substances and existing substances require registration under REACH regulation. Turkey and Switzerland are the same as the EU.
USA: 30 Days
If a substance is not listed on TSCA Inventory, a pre-manufacture notice (PMN) must be submitted. After a PMN has been reviewed, the applicant must provide a Notice of Commencement of Manufacture or Import (NOC) to EPA within 30 calendar days of the date the substance is first manufactured or imported for nonexempt commercial purposes. Once a complete NOC is received by EPA, the reported substance is considered to be on the TSCA Inventory and becomes an “existing chemical substance.” Since the EPA receives approximately 400 NOCs each year, the TSCA Inventory almost changes on a daily basis.
Note:Substances reported through exemption submissions and exempt uses (i.e, low volume, exempt polymers) do not require an NOC and are not added to the Inventory.
Ref: https://www.epa.gov/tsca-inventory/about-tsca-chemical-substance-inventory#howare
Canada: Depends
There are 2 lists in Canada: Domestic Substance List (DSL) and Non-domestic Substance List (NDSL). The DSL is the sole standard against which a substance is judged to be "new" to Canada. Substances listed on NDSL are still regarded as “new substances” and require less notification info requirements.
After a new substance notification has been approved, applicants can apply for additions to DSL. The following conditions need to be met.
- A notice stating that applicant has manufactured or imported the substance has been submitted;
- The quantity of manufacture or import in a given calendar year has exceeded volume triggers (>10t/y for substances not on NDSL/DSL, 5t/y or 1t/y for substances on NDSL depending on use)
In Canada, a company may delay DSL listings by choosing not to file a “Notice of Manufacture/Import”. However, a notice of exceeding prescribed quantity must be filed within 30 days of exceeding the required DSL listing threshold.
Note: Polymers qualify for DSL listings in Canada. Contained site-limited intermediates, R&D use and export-only substances do not qualify for DSL listings.
Ref:http://laws-lois.justice.gc.ca/eng/regulations/SOR-2005-247/page-4.html#h-19
China: 5 Years
After a new chemical substance notification has been approved by the Chinese Ministry of Environmental Protection (China MEP), the substance will be put into different categories based on the severity of their hazards: general chemical substances, hazardous chemical substances, and hazardous chemical substances for priority environmental management. General new chemical substances are added to the Inventory of Existing Chemical Substances in China (IECSC) 5 years since the date of the first manufacture or import (not approval date!). For hazardous chemical substances (including substances for priority environmental management), registrants must submit additional use and safety info to MEP and apply for their listings 6 months prior to the end of 5 years.
Note: Only regular notification for >=1t/y new substances trigger IECSC listings. Substances notified under simplified notifications (i.e, <1t/y, polymer or PPORD use) will not qualify for IECSC listings.
Ref: China MEP Order 7 Article 41
Japan: 5 Years and 1 Year
Both Chemical Substance Control Law (CSCL) and Industrial Safety and Health Law (ISHL) require a new substance to be notified prior to its production and importation. New substances notified with standard notification under CSCL and regarded as “safe” will be added onto the inventory of existing and notified chemical substances (ENCS) 5 years since its notification. New substances notified under ISHL will be added to ISHL list after 1 year since its notification.
Ref: New Substance Notification in Japan
Korea: 3 Years and Uncertainty
A notified new substance notified under old TCCA is added to Korea Existing Chemicals List (KECL) when the MoE has completed hazard reviews and announced it. This usually takes about 3 years.
Under the new draft K-REACH regulation, it is not clear whether and when notified new substances under K-REACH will be added to KECL since all new substances and >=1t/y existing chemical substances may require registrations in the future.
Ref: http://elaw.klri.re.kr/kor_service/lawView.do?hseq=31605&lang=ENG
Taiwan: 5 Years
Five years after the standard registration for the new chemical substances or the small amount registration for the polymer of low concern has been completed, the Central Competent Authority (i.e, EPA) will include them in Taiwan Chemical Substance Inventory (TCSI).
Ref: Guidance for New and Existing Chemical Substances Registration, Page 71. (English version available for a small fee)
Australia: 5 Years or Shorter
A notified new chemical substance will be added to Australian Inventory of Chemical Substances (AICS) 5 years after an assessment certificate has been issued. However, applicants can apply for early listings.
Ref: https://www.nicnas.gov.au/chemical-inventory-AICS/listing-chemicals-on-aics
Philippines: Similar to US TSCA
Once a new chemical substance has been assessed and approved by DENR-EMB for import and manufacture, the applicant is granted a clearance to import and manufacture the new chemical substance. The notified new substance will only be added to PICCS after the Notice of Commencement of Manufacture or Import Form has been submitted.
Ref: http://119.92.161.2/embgovph/chemical/Permitings/Pre-ManufacturePre-ImportationNotification.aspx
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