Willson International has been receiving inquiries from clients regarding the importation of sanitizer. It is important to know that the importation of this common household item is highly regulated, regardless if it is for sale or intercompany use.
To import sanitizer into the United States, certain participating government agency regulations must be satisfied. Some of this information can be found on the sanitizer label.
If the product may be utilized to disinfect surfaces, the Environmental Protection Agency (EPA) considers it a pesticide. For example, the label may include language such as, “kills germs, bacteria and viruses on pre-cleaned environmental surfaces.” Pesticides require EPA Notice of Arrival (NOA) entries. To complete an NOA entry, the following requirements must be met:
- EPA Registration of the pesticide product
- EPA 3540-1 form
- PDF copies of labels
- Statement of intended use
- Chemical Abstract Service (CAS) or Pesticides Control Number
- Carrier’s name, address, and contact information
- Complete entry documentation including the PAPS # and port of entry in advance of crossing (EPA strongly recommends five (5) days’ notice)
- Toxic Substance Control Act (TSCA) certification form required
If the sanitizer is used on the skin for either consumer or healthcare professional use, it is regulated by the U.S. Food and Drug Administration (FDA) as a drug product. This designation requires foreign manufacturers of over-the-counter (OTC) drugs to register with the FDA and submit a listing of drugs in commercial distribution before the drugs are imported.
Additionally, the FDA Product Code, Intended Use Code, Manufacturer name/address, and an “Affirmation of Compliance Code” must be transmitted to the FDA to obtain release. The FDA product code is determined according to the hand sanitizer’s active ingredient. Examples of active ingredients include ethyl alcohol, isopropyl alcohol, or benzalkonium chloride.
This level of import regulation requires the use of Willson professional services. Based on the individual product, composition, and use, there are circumstances where a sanitizer may be regulated by both the EPA and the FDA.
If your company decides to ship these products, please contact the U.S. Regulatory Team in advance of booking your carrier. We can be reached at transitionus@willsonintl.com.