Authorization of Sanitizers and Disinfectants in the United States

Depending on the product’s intended use, the finished product can be regulated by either the U.S. Environmental Protection Agency (EPA) or the U.S. Food and Drug Administration and must be registered before sale or distribution in the United States.

In the U.S., sanitizers and disinfectants can be regulated by one, or both of the following agencies:

  1. U.S. Environmental Protection Agency (EPA) under FIFRA (Federal Insecticide Fungicide and Rodenticide Act)
  2. U.S. Food and Drug Administration (FDA)

Environmental Protection Agency

Surface disinfectants are categorized as pesticides in the U.S., and FIFRA regulates the distribution, sale and use. Pesticides are any substances or mixture of substances intended to prevent, destroy, or repel pests.  A “pest” is defined as: “(1) any insect, rodent, nematode, fungus, weed, or (2) any other form of terrestrial or aquatic plant or animal life or virus, bacteria, or other micro-organism (except viruses, bacteria, or other micro-organisms on or in living man or other animals)”.

Antimicrobial Pesticides: Under FIFRA, chemical disinfectants are considered “antimicrobial” pesticides. Antimicrobial Pesticides are defined as substances or mixture of substances intended to destroy or suppress the growth of harmful microbiological organisms, and pesticides that protect inanimate objects and surfaces from organisms such as bacterial, viruses of fungi. The information required for product registration is dependent on the PRIA (Pesticide Registration Improvement Extension Act) 4 category. The PRIA category is determined based on the active ingredient in the product and whether products that are identical or similar in composition and use have been registered with the EPA.

Our scientific and regulatory experts can help with product registration to obtain market approval in the U.S. Our services include:

  • Identification of appropriate PRIA Category for antimicrobial pesticide products based on efficacy claims and active ingredients
  • Obtaining a company and establishment number
  • Preparation and submission of the appropriate application based on PRIA Category
  • Product label review
  • Act as a liaison between the EPA and our client during the application review process
  • State agency registration support once the product is registered with the EPA
  • Monitoring annual federal and state level registrant obligations

Food and Drug Administration

Disinfectants used on medical devices, or for use on or in living humans or animals are regulated by the FDA. In the U.S., hand sanitizers are regulated by the FDA as over the counter (OTC) drugs. Foreign and domestic manufacturers are required to register their establishment and list the drug with the FDA.

The regulatory routes to market are:

  • OTC Monograph 
  • New Drug Application

Intertek Can Help With:

  • Identifying the regulatory route to market for hand sanitizers in the U.S.
  • Label review of the product against U.S. OTC drug requirements
  • Establishment registration
  • Drug listing

 

 
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