HS Code:
Certified Reference Materials (CRMs) fall under HS Code 3822, which includes diagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents whether or not on a backing, and certified reference materials. CRMs are standardized substances used to calibrate instruments, validate methods, and ensure accuracy in measurements across industries such as pharmaceuticals, environmental testing, and food safety. These materials are critical for quality control and compliance with international standards.
Total Trade Volume
USD 25.6 billion
Data from 2022
Source
United Nations Comtrade Database
Average Rate
4.5%
Highest Rate
10% (applied by certain developing countries)
Lowest Rate
0% (under free trade agreements like EU-US agreements)
Growing demand in pharmaceutical and biotech sectors
Increased need for CRMs to ensure compliance with stringent regulatory standards like GMP and FDA guidelines, driving market growth.
2021-2023
Rise in environmental testing requirements
Heightened focus on pollution control and climate change initiatives has boosted demand for CRMs in environmental analysis.
2020-2022
Adoption of automation and digital calibration tools
Technological advancements are influencing the development of CRMs compatible with automated systems, reshaping market dynamics.
2022-2023
The European Union introduced stricter guidelines under REACH for the import and use of CRMs containing hazardous substances, requiring detailed safety data sheets.
June 2023
Increased compliance costs for exporters to the EU but improved safety and standardization.
A bilateral agreement reduced tariffs on certain laboratory reagents and CRMs, facilitating smoother trade between the two largest economies.
March 2023
Boosted trade volumes between the US and China, benefiting exporters and reducing costs for end-users.
More countries are mandating ISO 17034 accreditation for CRM producers to ensure quality and reliability in international trade.
January 2023
Enhanced trust in CRM products but raised entry barriers for smaller producers.