By Rennee Karlik, Regulatory Compliance Specialist
Many different factors can add to the complexity of authoring a Safety Data Sheet (SDS). Some of the factors can include complex supplier SDSs as mixture ingredients, large number of ingredients, constantly changing suppliers, constantly changing formulations based on supply, and UVCBs. While some of these topics we have covered in other posts, today we will focus specifically on UVCBs.
The composition of a chemical product is fundamental to the determination of any product hazard classifications and the preparation of a safety data sheet. For most products, the composition is provided along with the concentration of any ingredients in the product formula. We are essentially given a recipe and the product “Input” is known. However, many chemical products do not have a recipe or “Known Input” which adds complexity and time to hazard determination and safety data sheet preparation.
UVCBs (Unknown or Variable Composition, Complex Reaction Products and Biological Materials)
A UVCB cannot be sufficiently identified by its chemical composition, because
- The number of constituents is relatively large and/or
- The composition is, to a significant part, unknown and/or
- The variability of composition is relatively large or poorly predictable.
The uncertainty and variability of UVCB product composition is due to the “Input” (starting materials). They are products derived from crude compounds, obtained in impure form from nature. The composition of crude compounds is further varied by fluctuations in the source and manufacturing/recovery processes.
The crude compounds may be of:
- biological origin (e.g. wood, extracts)
- mineral origin (stone, quartz)
- petroleum origin (crude)
All of the following must be considered and evaluated when classifying a UVCB and preparing a safety data sheet:
- Product source “Input” (biological or non-biological)
- Process applied to the product source (chemical reaction, refining, extraction, fractioning, etc.
- Any data that eludes to the composition (chromatographic, spectral, typical).
- All possible constituents and concentration ranges.
The main industrial sectors that produce and/or use UVCBs include:
- base metals processing
- iron and steel manufacturing
- aluminum smelting
- automotive parts manufacturing
- pulp and paper manufacturing
- cement manufacturing
- construction materials manufacturing
- flavoring and fragrance manufacturing
Consult With Regulatory Experts
If you are struggling to navigate product SDSs that contain UVCBs, our regulatory experts are here to advise. TotalSDS is an advanced authoring solution that can help you author more effectively in-house and our software subscriptions now include regulatory support hours with our Global Regulatory Team.