Q1: Is the active ingredient registration for the manufacturer, not for the active ingredient?
A1: There are two types of cases for judging whether an active ingredient is registered or not, and it is usually easy to confuse it.
1. Judging whether the product registration type is new active ingredient registration, whether the active ingredient has been registered at this time is judged for the active ingredient, as long as the active ingredient has product registration, it is the existing active ingredient, otherwise it is the new active ingredient .
2. To determine whether the source of the active ingredient used in a specific preparation product is registered. At this time, whether the active ingredient is registered refers to whether the active ingredient produced by the specific manufacturer used in the preparation product has been registered by the US EPA.
Q2: Does the formulation have any impact on the US EPA pesticide registration? For example, oil, will the United States assess the risk of this dosage form? Oil is used as an adjuvant, are there any restrictions in the adjuvant library? For example, are the categories of different oils such as olive oil in the auxiliaries library?
A2: The dosage form will have an impact on the data requirements for the US EPA pesticide registration. For example, in some physical and chemical nodes, only the water preparation needs to provide data, and the solid preparation does not.
Unlike Chinese pesticides, the United States has promulgated documents to specify the corresponding data requirements for specific formulations, but requires companies to conduct data gap analysis on a data-by-data basis according to product characteristics and the data requirements of EPA pesticide registration in the United States to see whether to provide data, so the data Gap analysis is very important work for US EPA pesticide registration.
The U.S. EPA requires that the adjuvants used in pesticide products must be in the U.S. EPA adjuvant library, and the usage and dosage meet the corresponding regulatory requirements. The specific use restriction of an adjuvant requires the enterprise to provide more detailed adjuvant information, including the adjuvant name, CAS number and use, and RUIO experts can assist in judgment on the basis of these data.
Q3: For the same active ingredient, is there any difference between the registration of two products of field pesticides and non-field pesticides? Especially in terms of time cost and difficulty.
A3: The essential difference between field pesticides and non-field pesticides is that pesticides are used in different scenarios. Essentially, what affects the registration of these two types of pesticides is whether the use is for food.
Generally speaking, the time, cost and difficulty of registration of pesticides for food use are greater than those for non-food pesticides. This is because food use requires the provision of residue data and an application to establish a residue limit or a limit waiver.
For a specific active ingredient, if it is the first time to apply for food use, it is generally more difficult than non-food use. If it is an old product, and the registered product itself has food use and non-food use, then the registration of ordinary new products is not much different for different uses.
Q4: Can Formulation Exemption (processor exemption) be submitted without the authorization of the active ingredient registration Holder (holder), and whether the corresponding preparation needs to pay the original drug data citation fee to the Holder (holder) after obtaining the certificate.
A4: From the perspective of registration, as long as the technical product used in the production of the preparation product is indeed the purchased and registered technical product, the preparation product does not require the authorization of the active ingredient Holder (holder) when submitting the registration application. After applying for a processor exemption, if the prepared product uses a registered original drug, there is no need to pay the original drug data citation fee to the original drug holder (holder).
Q5: Biostimulants, if they are classified as pesticides, cannot be exempted, right?
A5: Yes, if the label of the biostimulant claims to be for pesticide use, after it is classified as a pesticide, then US EPA pesticide registration is required.
Q6: It is an isomer with the active ingredient registered by the US EPA. Can I apply for the application of their advanced test data?
A6: In this case, it is necessary to compare the differences between the isomers first. If the difference in structure does not cause changes in toxicity, you can consider citing high-level test data through data bridging. When bridging, you need to Discuss in detail why the cited material is applicable to the different isomers.
Q7: Can the registration bypass the parent drug and directly register the preparation? Or in other words, we can provide the technical data of the parent drug, but will not provide the strain of the parent drug to foreign countries. In this case, is it possible to directly register the preparation, or register the original drug but not provide the parent plant of the original drug?
A7: The US EPA pesticide registration generally only needs to provide technical data, and does not need to provide the strain. However, if the US EPA requires it, the company will also need to provide the virus strain to the official, especially in the case of new substance registration.
Q8: Is the registration of new use related to the registration of common new products?
A8: US EPA registration is generally judged in the order of new substances, new uses and general new products.
It is first necessary to determine whether the active ingredient is registered. If it is unregistered, it belongs to the registration of new active ingredients; if it is registered, it is judged whether it is a new use, if it is a new use, it belongs to the registration of new use; if it is not a new use, it belongs to the general new product registration.
Q9: What are the new uses: such as adding new crops?
A9: New crops are a common reason for applying for new use registration. However, new uses in US EPA registration are not just new uses. Any situation that leads to a significant increase in exposure levels or new changes in exposure routes may cause Classified as new use registration.
For example, the application of a pesticide has not changed, but the usage and dosage of the product have changed, which will lead to an increase in exposure. In this case, it is possible to register for a new use.
Q10: Can biostimulants be exempted from registration in the United States, whether they are used as pesticides or fertilizers? Are pesticide and fertilizer registrations regulated by the US EPA?
A10: If biostimulants are used for plant growth regulators, they need to be registered with the US EPA for pesticides; if they are used for fertilizers, they need to be registered as fertilizers. Fertilizers are not federally registered and are regulated by each state.
Q11: What is the difference between US state registration and federal registration?
A11: To enter the U.S. market, pesticide products need to be registered with the federal government. After the federal registration is completed, the state registration is required when entering the states that need to be traded. State registration is much simpler than federal registration. Generally, based on the information in the federal registration, go to each state and then go through the process.
Q12: Are microbial fertilizers exempt from registration in the United States?
A12: For fertilizer use, it is exempt from U.S. EPA pesticide registration, but requires fertilizer registration according to fertilizer regulations.
Q13: Are all active ingredients applicable to the direct registration of preparations bypassing the parent drug?
A13: For US EPA-registered active ingredients, you can directly apply for preparation registration without first registering the technical/parent drug. However, in this case, if the original drug/parent drug used is from an unregistered source, a full set of active ingredient information still needs to be provided when the preparation is registered, but it is not necessary to obtain the original drug/parent drug registration certificate before applying for the registration of the preparation.
Q14: Do herbicides for genetically modified crops need to be registered in the US EPA? any request?
A14: Registration is required, and the requirements are consistent with the general US EPA pesticide registration requirements. GM crops are just one crop category.
SOURCE: REACH24H
