Generic Versus Original Materials and Regulatory Compliance
The choice of antimicrobial agents has grown significantly over the past several years.
Many generic products are produced claiming to have an “identical” composition to
the original. It is critical to understand whether the composition of the antimicrobial
agent that is to used is the exact same as the original source in which the regulatory
data (US EPA, EU BPD) was been generated. Based on past studies it is apparent
that not all antimicrobial technologies that share the same USEPA files are the same.
Differences in the performance, shelf life and application of antimicrobials that share the same EPA data files can occur when the processes used to manufacture the materials differ. These processing differences can even affect the final chemical structure of the antimicrobial. Because of these differences, studies performed using one antimicrobial should not be used to reference the performance of another antimicrobial that was registered with the same file but manufactured at another location using a slightly different process. Always ask to see microbiological and durability performance data that was generated using the specific antimicrobial that you are considering using. Each antimicrobial producer needs to be validated separately for its specific performance. When using the exact same antimicrobial agent from the same producer, one can then link back to historical uses and safety profiles. The same consistency in manufacturing exists for many different antimicrobial agents but the key is to be certain that those same manufacturing conditions exist today that were present when the antimicrobial was first registered with USEPA or the EUBPR.