Overview

According to the Pesticide Registration Data Requirements, the registration of chemical pesticide technical materials is divided into three categories: new technical materials, non-identical technical materials, and identical technical materials. Among these, the registration of identical technical materials requires far less documentation, is less costly, and the registration process is significantly faster, typically taking around 1 year as compared to 4 years for new technical materials.

To successfully register an identical technical material, it is important to follow the guidelines set out in Annex 10 of the Pesticide Registration Data Requirements titled "Identification Criteria for Identical Pesticides". This involves several key steps, such as ensuring the correct evaluation of the technical material’s data, verifying the consistency of the technical material, and preparing the necessary registration documents. Additionally, keeping an eye on the approval process at the Ministry of Agriculture and Rural Affairs will help improve the chances of successful registration.

It is also important to note that when selecting a pesticide to register as identical, ensure that the first registration of the pesticide has passed its 6-year protection period, and the original product used for comparison must meet the new Pesticide Registration Data Requirements.

Criteria for Identifying Identical Technical Materials

The identification of identical technical materials is carried out in two phases according to Annex 10 of the Pesticide Registration Data Requirements:

Phase One: Product Chemical Data Evaluation

The new technical material (M2) can be considered identical to the reference product (M1) if the following conditions are met:

1. M2's active ingredient content is not lower than M1.
2. M2's relevant impurity limit is not higher than M1.
3. M2’s other major control indicators are equal to or better than M1.
4. M2 does not have new relevant impurities compared to M1.
5. M2’s non-relevant impurity limits increase by no more than 50% in relative terms or 0.3% in absolute terms compared to M1, making a decision with a larger value.
6. M2 does not have new non-relevant impurities compared to M1.
7. M2’s results for Salmonella Typhimurium or reverse mutation tests are equal to or better than M1.

If any of the following conditions are not met: 1, 3, or 7, M2 will be considered a non-identical technical material.If 1, 3, and 7 are met but conditions 2, 4, 5, or 6 are not met, the product must proceed to the second phase of evaluation.

Phase Two: Toxicological and Environmental Impact Data Evaluation

Toxicological Data Evaluation M2's toxicological data are considered equivalent to M1’s if the acute toxicity test result coefficient is no greater than 2 (or higher but within reasonable trial dose escalation limits). If the test outcomes for both positive and negative results are consistent, M2’s toxicological data are considered equivalent to M1.If M2 and M1’s acute toxicity results cannot be considered equivalent, additional evaluations will be required, including sub-acute to chronic toxicity, reproductive toxicity, mutagenicity, carcinogenicity, and other tests.If the toxicological effects on the same organs are consistent and there is no significant change in NOEL (No Observable Effect Level) or NOAEL (No Observable Adverse Effect Level), the data will be considered equivalent.Environmental Impact Data Evaluation If M2's environmental impact data are compared to M1’s in the following tests—bird acute oral toxicity, fish acute toxicity, Daphnia magna acute activity inhibition, honeybee acute contact toxicity, and silkworm acute toxicity—and the coefficient is no greater than 5 (or higher but within reasonable trial dose escalation limits), M2’s environmental data are considered equivalent to M1’s.

Required Documentation for Registration of Identical Technical Materials

For the registration of identical technical materials (M2), the following documents are required:

For M1 (Reference Product):

• The manufacturer’s name and registration certificate number.

For M2 (New Product):

• Manufacturing process, full component analysis report, physicochemical properties, product quality specifications, and Salmonella Typhimurium/reverse mutation test results.

Toxicological Data (If Required for M2):

• Acute oral, dermal, and inhalation toxicity tests, eye irritation tests, skin irritation tests, and skin sensitization tests.
• Sub-chronic (acute) toxicity tests, including a 90-day rat feeding study, and 28-day dermal or inhalation toxicity tests. Additionally, mutagenicity, in vitro mammalian cell gene mutation, in vitro mammalian cell chromosome aberration tests, and in vivo mammalian bone marrow micronucleus tests.

Environmental Impact Data (If Required for M2):

• Bird acute oral toxicity, fish acute toxicity, Daphnia magna acute activity inhibition, honeybee acute contact toxicity, and silkworm acute toxicity tests.

Authorization:

• If the M1 registration holder has authorized M2’s registration, an original signed and stamped authorization letter is required.

Approval Process for Identical Technical Materials

When reviewing registration materials for identical technical materials, the Institute Control of Agrochemicals, Ministry of Agriculture and Rural Affairs (ICAMA) will conduct a review through various departments: quality evaluation, toxicology review, and environmental review. Each department will provide an evaluation and equivalency judgment, which will be consolidated by the Integrated Policy Department to form the final conclusion.It is crucial, when preparing for registration, to ensure that the technical material is accurately identified as identical and that the complete set of documents required for registration is prepared, in order to maximize the chances of success.