Introduction to EPA Compliance for Disinfectant Export to the United States

Release time:

2020-07-27 11:45

The magical 2020 is already halfway through, the international new crown epidemic still shows no sign of stopping, the number of confirmed cases in the United States has exceeded 4 million, and the demand for disinfectants is in short supply. However, it is not as easy for disinfectants to enter the U.S. market as expected. Compared with the FDA registration for hand sanitizer, disinfectants for surfaces of objects are under the jurisdiction of EPA, and the registration steps are much more complicated.

What is EPA?

EPA The Environmental Protection Agency of the United States Environmental Protection Agency is a functional department of the United States government, mainly responsible for environmental protection, including the protection of air quality, water, soil, animals and plants. The U.S. EPA enforces its law under Title 40 of the United States Code of Federal Regulations (40 CFR).

As people use more and more insecticidal, antibacterial, pesticide and other products in their daily life and production, these active agents and devices will inevitably have a certain impact on the environment (including water, soil, animals and plants, etc.). In order to facilitate better management of bactericidal, antibacterial and insecticide products, the U.S. EPA has enacted the Federal Insecticide, Fungicide and Rodenticide Act, the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Products regulated by the Act include devices (which work by physical principles) and active agents (various chemical components). Disinfectant water and disinfectant for the surface of objects are among them.

EPA Certification Process

For products subject to the FIFRA Act, distributors and manufacturing plants must register with the EPA. Among them, distributors in the United States need to obtain a company number (Company Number or EPA Register Number), and any factory that produces and distributes these devices or active agents must obtain an EPA trade number (EPA Establishment Number). A company number or registration number can be associated with multiple trade numbers.

After obtaining the relevant number, the manufacturer's trade name (EPA Establishment Number) must be marked on the outer package. At the same time, packaging and labeling should meet the requirements of EPA regulations.

Any factory that has obtained EPA registration must report to EPA the sales volume of the previous year, including specific product categories, models and sales quantities, before March 1 of each year. Manufacturers registered for the first time must submit to EPA the sales volume of the previous year within one month after obtaining the EPA firm name.

For fungicides, pesticides and other products, if the active ingredients not approved by EPA are applicable, relevant information must be submitted to EPA to prove the safety of the active ingredients on the link. At the same time, the label of such products must also be filed with the EPA.

Currently, EPA-regulated products include:

Device	Mosquito killing lamp, mosquito repellent lamp, water purifier, ultrasonic rodent repellent, various sterilizers, sterilizers, etc. kill and expel harmful animals (including insects) through physical principles, as well as devices with sterilization, sterilization and antibacterial functions
active agent	Insect repellent, antibacterial agent, bactericide, insect attractant, disinfectant, disinfectant, nematicide, fumigant, herbicide, defoliant, desiccant, anti-fouling agent, insecticide, plant growth regulator, rodenticide, algaecide, algaecide, molluscicide, water purification agent and other insecticides, sterilization, antibacterial chemicals containing active ingredients