Regulation for Disinfectants in the US

Regulation for Disinfectants in the US

Most of us have come across the terms 'Disinfectants' and 'Sanitizers' during COVID-19. Both the products fall under antimicrobial pesticides. While disinfectants and sanitizers are commonly referred as same, the major difference between them is that the disinfectants kill the microbes, bacteria and virus on the surface whereas the sanitizers reduce their numbers.

The US Food and Drug Administration (US FDA) regulates sanitizers, antiseptic washes, and antibacterial soaps for use on people, whereas the US Environmental Protection Agency (US EPA) regulates Surface disinfectant products under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Under the FIFRA, the disinfectants are termed as “antimicrobial pesticides” or “substances/mixtures that are expected to destroy or suppress the growth of harmful microbiological organisms and protect surfaces and objects from bacteria, viruses or fungi”.

Disinfectants undergo rigorous EPA testing to reach the higher bar set for effectiveness than surface sanitizing products. There are many products registered with EPA as both disinfectants and sanitizers when tested using both the standards. Before registering their products with the EPA, manufacturers must submit data pertaining to product chemistry, toxicity and efficacy, along with the proposed labeling, for review. FIFRA requires that all labels have the following information:

  • Product/brand name or trademark
  • EPA registration number
  • EPA establishment number
  • List of ingredients
  • Child hazard warning statement
  • Signal word
  • First aid statement
  • Skull and crossbones symbol, along with the word “Poison”
  • Net contents/net weight
  • Precautionary statements
  • Directions for use
  • Storage and disposal instructions
  • Warranty statement

FIFRA also recommends following the label use directions and safety precautions carefully. Any registered disinfectant, when used in a manner inconsistent with its labeling, could result in an ineffective application and is subject to potential enforcement action.

Therefore, to register the disinfectants with the EPA, manufacturers are advised to provide the required information mentioned above without any errors. Avoid hassles by reaching out to Freyr for faster market entry. Stay updated. Stay compliant.