Since the outbreak of COVID-19 at the end of 2019, the U.S. EPA has issued a series of friendly policies to encourage companies to register disinfectants in order to ensure the demands for disinfectants by U.S. citizens. Driven by both market demand and government policies, many Chinese companies took advantage of this opportunity to layout the U.S. disinfectant market. Some companies went round and round and returned to REACH24H when the registration by other consulting agencies did not go smoothly. Up to now, REACH24H has assisted dozens of companies in the registration of disinfectants. In order to better arrange future markets and plans in advance, REACH24H has sorted out the following issues of concern to companies.
A.State Registration and Supplemental Registration
As you all know, completing EPA federal registration and obtaining an EPA product registration certificate is only the first step in entering the U.S. market. State registration is a critical step in the successful sale and distribution of disinfectants in various states.
Registration requirements, including 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 from 1 to 3 months. At present, due to the heavy evaluation workload of state officials, the review time will be delayed accordingly. REACH24H reminds companies to make relevant market layouts in advance.
In addition, most companies will have their own distributors in the states, and the distributors usually hope to distribute under their own brands. Therefore, in order to meet the needs of distributors, companies also need to apply for supplemental registration before entering each state, aiming to notify the EPA of distributor information and obtain the supplemental registration certificate. Of course, if the cooperative relationship with distributors no longer exists, companies also have the autonomy to cancel the supplemental registration certificate.
B. Amendment Registration
Due to factors such as market trade demands, companies often need to amend the registration of disinfectant products that have completed EPA federal registration. The overall amendment registration requirements can be found in the previous news.
The specific amendment registration requirements for the disinfectant products are summarized as follows:
1. Adding New Efficacy Claims
In the early stage, in order to enter the U.S market as soon as possible and to speed up the testing progress of disinfectant efficacy, most companies only carry out basic bacterial testing on the disinfectant, which is the necessary testing for disinfectant claims. In the later stage, due to the need for marketing and promotion, companies hope to claim that the disinfectant products are effective against a wider range of bacteria, fungi, and viruses, and the companies can then apply for amendment registrations. They need to carry out the additional efficacy tests, pay the official review fee, and will get the approval from EPA.
2. Formula Change
In order to meet the diversified market needs of disinfectant products, some disinfection wipe products often contain a variety of fragrances. If the company wants to change the fragrance ingredients or replace the fragrance suppliers in the later stage, what should the company do?
As long as certain requirements are met, changing the fragrance composition is a minor formulation change, only an application is required to be submitted to the 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.
C. How to Keep the Disinfectant Registration Certificate Valid
To ensure that the disinfectant product registration certificate is in a valid state, in addition to meeting the data required 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 every two years. Renewal is also subject to renewal fees.
The future market layout of each company is different. If the above interpretation cannot solve your questions, welcome to consult REACH24H, and REACH24H will make a detailed customized plan for you.
Something Wrong? At Chemlinked we do our utmost to provide you with accurate information. However sometimes errors slip under the radar, we’re only human. That’s where you our vigilant reader come in! If you notice any errors contact us on: email@example.com Budding Journalist ? Send us your news on: firstname.lastname@example.org