IFRA Maximum Pragmatic Level
IFRA advise some applications require a Maximum Pragmatic Level. The IFRA Categories are:
Category 8 Hair Styling Aids 2%
Category 9 Rinse-off Hair Conditioners 5%
Category 10 Hard Surface Cleaners 2.5%
Maximum Pragmatic Level: Practical considerations require setting a default maximum level of the fragrance ingredients identified as dermal sensitisers for some product types. This pragmatic level is defined as that “not exceeding the usual concentration of the fragrance compound in the finished product”. In Table 1 these levels are indicated in the column identified as “Maximum Pragmatic Level”. If the Acceptable Exposure Level (AEL) derived from the QRA for a fragrance ingredient in a specific product type is less than the concentration identified as the “Maximum Pragmatic Level”, the AEL will take precedence and be applied. IFRA and RIFM will determine whether the AEL or the “Maximum Pragmatic Level” should be applied. The appropriate value will be given in the IFRA Standard.
The pragmatic level used is NOT meant to be a maximum use level for fragrance oils (or fragrance mixtures or fragrance compounds) in consumer products. It is used to set limits for individual fragrance ingredients (not fragrance oils or fragrance mixtures or fragrance compounds) when the QRA AEL gives an unusual and unrealistic maximum use level for a fragrance ingredient.
This information is based on data from IFRA 48, QRA booklet v 7.1 July 2015
So, the maximum pragmatic level applies to the limited raw materials. When you review the IFRA limits for Categories 8, 9 and 10 no raw material limits are above the maximum pragmatic level – some are set at the level, but none above them. Therefore IFRA are already applying the maximum pragmatic level as limits in these cases. This being the case there is no additional IFRA calculations required.