Formpak Active

This article discusses how to use Concentration Limits on Safety Data Sheets and how they are calculated.

Section 16 of an EC Safety Data Sheet can contain Concentration Limits for various hazards. These can be used to determine if a particular hazard should apply to a downstream product.

Concentration Limits are related to Total Fractional Values (TFVs). Concentration Limits are given for Risk phrases with TFVs of greater than or equal to one.

Concentration Limts and Total Fractional Values are related in the following way:

Concentration Limit = 100% / Total Fractional Value

Example:
A formulation contains 25% of ingredients classified as R36, and none of those ingredients have a Specific Concentration Limit for R36. The General Concentration Limit for R36 is 20%, therefore:

Concentration Limit = 100 / TFV
TFV = (Concentration / General Concentration Limit)
TFV = 25 / 20
TFV = 1.25
Concentration Limit = 100% / 1.25
Concentration Limit = 80%

Rephrasing this: the product can be used at up to 80% in a non-hazardous formulation before a requirement to label the product as R36.

Please note that there can be other requirements to label in addition to R phrases. An example of this is Lower Level Allergens, where the General Concentration Limit for R43 is 1%, but there is an additional requirement to disclose R43 ingredients with a concentration of 0.1% of over if the formulation itself is not classified as R43.