Since the outbreak of COVID-19, the US EPA has issued a series of friendly policies to encourage companies to register disinfectants to meet the demands for disinfectants by US citizens. Driven by both market demands and government policies, many Chinese companies seize this opportunity and access the disinfectant market in America.

To date, REACH24H has assisted dozens of companies in disinfectant registration. We have sorted out the following issues of concern for companies to better comply with disinfectant regulations in the US.

State Registration & Supplemental Registration

Finishing EPA federal registration and obtaining an EPA product registration certificate are only the beginning steps to entering the US market, while state registration is a critical one for the future sale and distribution of disinfectants in various states.

Registration requirements (review fees and review time) vary from state to state. The total amount of review fee in 51 states is about $12,500, and the review time generally lasts 1-3 months. At present, due to the heavy evaluation workload of state officials, the review time will be delayed accordingly. We highly recommend companies build market plans in advance in face of the delayed review.

In order to meet the needs of distributors, companies also need to apply for supplemental registration before entering each state, to obtain the supplemental registration certificate, by notifying the EPA of distributor information. Because the distributors tend to distribute under their own brands. If the cooperative relationship with distributors no longer exists, companies also have the right to cancel the supplemental registration certificate.

Amendment Registration

Registration amendments are required when any changes in composition, labelling and packaging of registered products occur. See the complete requirements: How to Amend a Registered Pesticide Product under the U.S. EPA?

The specific amendment registration requirements for the disinfectant products are summarized as follows:

1. New Efficacy Claims Addition

Most companies only carry out basic bacterial testing on the disinfectant at the beginning, which is the bare-minimum testing for disinfectant claims. However, in the marketing stage, companies are hoping to claim a wider range of efficacy (effective against a wider range of bacteria, fungi, and viruses) for disinfectants. That’s where companies should apply for amendment registrations. Additional efficacy tests and review fees are required for the approval from US EPA.

2. Formula Change

Changing the fragrance composition is a minor formulation change under certain requirements, thus only an application is required to be submitted to the US EPA, and the review period is shorter than the general amendment applications. In addition, for supplier change of inert ingredients on the Commodity Inert Ingredient List, no notification is required. 

Keep the Validity of Disinfectant Registration Certificate

Besides meeting the data requirements in support of the EPA’s registration review, companies also need to submit an annual report for the establishment and pay the annual registration maintenance fee to EPA every year. The annual fee changes every year, and for 2022 the annual fee is $3660.

In addition, most states renew disinfectant products every year, and a few states renew every two years. Renewal fees are required as well.

Reprinted from: ChemLinked

Contact Us

If you need any help in disinfectant registration in the US market, please feel free to contact us.

Tel: +86 0571-8700663

E-mail：customer@reach24h.com