Introduction

In pesticide manufacturing, a Technical Concentrate (TC) refers to the material obtained from the production process that contains the active ingredient (AI) together with any associated impurities. It may also contain small amounts of essential additives required for stability or handling.

Importantly, the TC is not a ready-to-use pesticide product; it must be formulated before use. It serves as an intermediate product that is often traded between manufacturers and formulators, making it a key point in the supply chain where quality, composition, and regulatory compliance must be verified.

Understanding the regulatory requirements for TC pesticide registration—such as applicable data packages, permitted uses, and restrictions—is crucial for companies seeking market access in regions like China, the EU, or the US. The following FAQs will help industry stakeholders navigate these rules, avoid common compliance pitfalls, and prepare accurate, complete submissions for review by regulatory authorities.

What is the Definition of a Technical Concentrate?

Answer: A technical concentrate refers to a product obtained during the production process, consisting of the active ingredient (AI) and related impurities. It may contain small amounts of necessary adjuvants and appropriate diluents.

What are the Specific Requirements for Technical Concentrate Registration?

Answer: For chemical pesticides, registration of technical concentrate for new pesticides is generally not approved, except in cases where technical material registration cannot be applied for due to substance properties, technical, or safety reasons. For non-new chemical pesticides, if the applicant has not obtained technical material registration, registration of the pesticide’s technical concentrate will not be approved. If an applicant applies for technical concentrate registration after obtaining technical material registration, approval shall be strictly granted in principle, and the application shall be submitted to the National Pesticide Registration Review Committee for deliberation. Registration of technical concentrate is approved for microbial pesticides and plant-derived pesticides. Synthetic biochemical pesticides are treated as chemical pesticides; fermented or extracted biochemical pesticides may be approved for technical concentrate registration.

What Data Needs to Be Submitted for Technical Concentrate Registration?

Answer: For technical concentrate of new pesticides, registration applications shall be submitted in accordance with "Data Requirements for Technical Materials Annex I  technical concentrate". For applicants applying for technical concentrate registration after obtaining technical material registration, product chemical data shall be provided in accordance with the data requirements for formulations, but the room-temperature storage stability test report may be omitted. Toxicological data shall include data from six acute toxicity tests, and environmental impact data may be omitted.

Can Plant-Derived Pesticides be Exempted from Technical Concentrate Registration?

Answer: In principle, technical concentrate registration for plant-derived pesticides cannot be exempted. For registration of plant-derived pesticide formulations, the description of the technical concentrate source cannot be reduced or exempted either.

Can the Description of the Technical Concentrate Source for Plant-Derived Formulations be Reduced or Exempted?

Answer: No. Reduction or exemption of technical concentrate registration for plant-derived pesticides or the description of their technical concentrate source is not allowed, except for special cases reviewed by the Pesticide Registration Review Committee.