Compliance work required for companies exporting to the United States after the US EPA disinfectant registration

Since the outbreak of the new crown epidemic at the end of 2019, in order to protect the needs of American citizens for the use of disinfectants, the US EPA (Environmental Protection Agency) has issued a series of friendly policies to encourage companies to register disinfectant products
.
Driven by market demand and government policies, many domestic disinfection companies have taken this opportunity to deploy in the US market
.
Up to now, REO has assisted dozens of domestic and foreign companies in the registration of EPA disinfectants in the United States.
In order to do a good job in the next market arrangement and planning, we have organized and answered some of the questions that companies are concerned about as follows.
Be inspired and helpful
.

1.
State Registration and Distributor Registration

As everyone knows, the completion of the EPA federal registration and the EPA product registration certificate for the disinfectant is only the first stepping stone to enter the US market.
If the product can be successfully sold and distributed in various states of the United States, the state registration of the product is the most important thing.
important step
.

Registration requirements, including review fees and cycles, vary from state to state
.
The total review fee for 51 states is about $12,500, and the review cycle is generally 1-3 months.
At present, due to the relatively large review load of state officials, the review cycle will be delayed according to the official workload
.
In this regard, REIO reminds enterprises to make relevant market layouts in advance to effectively avoid some unnecessary risks and losses
.

In addition, most businesses will have their own distributors in various states, and distributors usually want to distribute products under their own brand names
.
Then, in order to meet the needs of distributors, enterprises also need to register distributors for distributors before entering each state.
The purpose is to notify EPA officials of distributor information and obtain distributor registration certificates
.
Of course, if there is no longer a cooperative relationship with the distributor in the later stage, the enterprise also has the autonomy to cancel the distributor registration certificate
.

2.
Change registration

Due to subsequent market trade demands and other factors, companies often need to change the registration of disinfectant products that have completed federal registration.
For the overall change registration requirements, please refer to - How to do the US EPA pesticide change registration?

Among them, the specific requirements for the change of disinfectant products are organized as follows:

1.
Add a new efficacy claim

In the early stage, in order for disinfectants to enter the U.
S.
market as soon as possible and to speed up the progress of product efficacy testing, most companies only conduct basic bacteria tests on products, which are the basic tests that products can claim to be disinfected
.
In the later stage, due to the needs of marketing and promotion, when the product wants to claim that it has killing effect on more bacteria, fungi and viruses, the enterprise can change the registration, complete the corresponding drug efficacy test, pay the official review fee and pass the EPA official review.

.

2.
Change some adjuvant ingredients

Q: In order to meet the diversified needs of market products, some disinfectant wipes often have multiple fragrances.
If the company wants to change the fragrance ingredients or change other fragrance suppliers in the later stage, what should the company do in this case?

Answer: As long as some requirements are met, changing the flavor composition is a minor formula change, and only needs to submit an application to the official, which is faster than the ordinary change registration review cycle
.
In addition, for the additives in the Commodity Inert Ingredient List, there is no need to notify the official when the source of the supplier is changed
.

3.
How to make the product registration certificate continue to be valid?

To ensure that the product registration certificate is in a valid state, in addition to meeting the EPA (United States Environmental Protection Agency) re-evaluation data supplementary requirements during the EPA re-evaluation period, the enterprise also needs to submit an annual report for the factory and pay the EPA annual product maintenance fee every year.
Fees vary from year to year and are known to be $3,660 in 2022
.

In addition, most states need to update and maintain products every year, and a small number of states also need to pay update and maintenance fees every two years
.

 3.
Other situations

The follow-up layout of each company’s market is different.
If the above interpretation cannot solve your doubts, please come to consult with REO, and we will develop a detailed customized plan for you to efficiently and targetedly solve your different needs
.