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Comparison of Small Volume New Substance Registration

By Little Pro on 2017-02-08 Views:  Update:2017-02-08

New chemical substances in small volumes or low volumes are essential for research and development. They pose less risks because of their small quantity and thus benefit from registration exemption or reduced registration requirement. In this article, we will compare small volume exemption or reduced registration requirements for new chemical substances in small volumes in EU, USA, Canada, China, Japan, Korea, Taiwan, Australia, Philippines, etc.

Definition of New Chemical Substance

A new chemical substance is usually defined as a substance that is not listed in national existing chemical substance inventories. EU, USA, Canada, China, Japan, Korea, Taiwan, Australia and Philippine all have their own chemical inventories.  For more info about those inventories and how to search, please click here.

Please note that certain chemical products (i.,e pharmaceuticals, pesticides) are out of the scope of industrial chemical regulations and new substance notification requirements. 

Comparison of Small Volume Exemption for New Substances

Jurisdiction Requirement Note
EU: REACH 
  • <1t/y: Fully exempt from registration.
  • >=1t/y substances: registration
  • >=1t/y substances used for R&D: PPORD notification
  • Read more...
USA: TSCA
  • Small quantity for R&D use: fully exempt from PMN;
  • Other <10t/y new substance: application of low volume exemption (LVE)
Canada: CEPA
  • <100kg/y~1t/y (not on NDSL): Simplified schedule 4 notification 
  • Other new substances<1t/y (i.e, R&D use): fully exempt 
  • 1-10t/y polymer for R&D or export or intermediate use: fully exempt
  • Read more....
China: MEP order 7
  • <100kg/y for R&D use: scientific research record notification
  • Other <1t/y new substances: simplified notification
Japan: CSCL
  • Small quantity of new substances used for R&D: fully exempt
  • <1t/y: small amount confirmation
  • <10t/y (biodegradable and not bio-accumulative): low volume confirmation
Korea: K-REACH
  • Small quantity of new substances used for R&D: application of registration exemption.
  • <1t/y: simplified registration 
  • >=1t/y existing substances also require registration
  • Read more...
Taiwan: TCSCA
  • <100kg/y: small quantity registration
  • 100kg/y~1t/y: simplified registration
  • 1-10t/y for R&D use: simplified registration
  • All >0.1t/y existing substances also require phase I registration
  • Read more...
Australia: NICNAS
  • <100kg/y: fully exempt 
  • <1,000kg/y new substance (must meet low hazard criteria): low volume permit
Philippine: PMPIN
  • <1t/y: small quantity importation certificate
Switzerland: ChemO
  • <1t/y: fully exempt;
  • >1t/y for PPORD use: declaration.

Summary

In conclusion, EU (including Switzerland) , USA, Canada and Japan are more friendly to small volume new substances (<1t/y) used for R&D activities since they do not require any registrations. China, Korea, Taiwan and Philippine do provide reduced registration requirements for small volume new substances (<1t/y) or new substances for R&D use. However, companies still need to apply for simplified registrations from authorities.  

 

 Tags: Topics - RegistrationREACH-like Regulation and Registration

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