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    Interpretation: What You Need to Know About Announcement No. 269, Which Is Exclusively for the Export of Pesticide Products


    Release Date:

    2020-06-12

    Amid the industry’s eager anticipation, a much‑awaited policy measure has finally been implemented. On June 8—just one day after the Ministry of Agriculture and Rural Affairs of the People’s Republic of China issued Announcement No. 269, announcing that all medium- and high‑risk areas nationwide had been cleared of COVID‑19 cases—the pesticide export sector has ushered in its own spring of favorable policies.

     

    (See the announcement for details) After much anticipation, it’s finally here! The Ministry of Agriculture and Rural Affairs has issued a registration announcement for pesticide products restricted to export. One article)

     

    Below, we will walk you through the potential benefits and associated uncertainties of Policy 269, sentence by sentence.

     

    The first provision in the announcement clearly states that the prerequisite for applying solely for export pesticide registration is that the product must have obtained pesticide registration abroad or an import authorization from the importing country (or region). However, whether “obtaining pesticide registration” also encompasses registration of the registrant or supplier, and whether “import authorization” likewise includes emergency-use permits or trial-use authorizations, remains to be clarified through further policy interpretation. That said, given the requirement in Article 2, Paragraph (2)—“If the supporting documents do not match the name of the applicant enterprise, compelling evidence of a business partnership must be provided”—it is highly likely that supplier registration will be permitted.

     

    In addition to new active ingredients, having previously registered similar products domestically is another prerequisite for applying for export‑only registration of pesticides. Consequently, manufacturers with a large number of registrations for both technical-grade materials and formulated products stand to benefit most from the policy incentives. Moreover, Article 4, Paragraph (2), which stipulates that “if an identical or similar formulation has already been registered within China, export‑only registration for that pesticide product will not be approved,” further reinforces this advantage.

     

    Article 1, Paragraph (1), which states, “This enterprise has already obtained active‑ingredient registration within China and is applying for active‑ingredient registration for the same active ingredient at a different concentration,” is intended to address the issue of discrepancies between domestic and foreign active‑ingredient registration concentrations. It removes the restriction that new active‑ingredient registrations may not be lower than existing registered concentrations, thereby allowing products with higher domestic concentrations and lower foreign concentrations to be exported.

     

    According to Article 1 of the announcement, except for new pesticides, applications for registration of pesticide formulations intended solely for export must involve either a new active‑ingredient concentration or a new formulation. However, whether the concentration requirements for such export‑only registrations are subject to the domestic registration concentration‑gradient policy remains to be clarified through further interpretation of that policy. Under the current gradient‑management policy, as stipulated in Article 8 of the Measures for the Administration of Pesticides: “For single‑component products with the same active ingredient and formulation, the number of concentration gradients shall not exceed three. For mixed‑formulation products, the number of active ingredients shall not exceed two; for herbicides, seed treatments, pheromones, and similar products, the number of active ingredients shall not exceed three. For mixed‑formulation products with identical active ingredients and formulations, the number of mixing ratios shall not exceed three, and the total number of concentration gradients for any given ratio shall not exceed three. Pesticides with low active‑ingredient content that are used directly without dilution or dispersion shall be classified separately.”

     

    According to the data‑submission requirements set out in Article 2 of the announcement, the most significant benefit lies in the export of new active ingredients. Compared with the five reports previously required for non‑new‑pesticide export registration—namely, five batches of analytical and quality‑control test reports, as well as oral, dermal, and inhalation toxicity studies—the only additional requirement is information on the physicochemical properties of the active ingredient and the technical grade material; all other data may be either retrieved or submitted as summaries. However, specific reporting details—such as the applicability of older‑report standards, testing guidelines, and laboratory accreditation criteria—will require further clarification through policy interpretation. Based on this, it is anticipated that applications for export‑only registration of active ingredients whose patent protection has recently expired will surge. Consequently, the workload of the Department’s Quality Division and Toxicology Division is likely to increase sharply in the near term. This also underscores, from another perspective, that China’s pesticide exports remain largely confined to a “physicochemical‑plus‑toxicity” stage.

     

    Conversely, pursuant to Article 3, Paragraph (3) of the announcement, “Applications for the registration of new pesticide formulations intended solely for export shall submit documentation in accordance with the requirements for non‑new‑pesticide registration.” Accordingly, from the standpoint of data‑submission requirements, applications for export‑only registration of new pesticide formulations are relatively the most stringent. However, since non‑new‑pesticide registration is further subdivided into several categories, the specific category applicable and whether non‑essential efficacy and residue studies must be conducted domestically remain subject to further policy clarification.

     

    According to Article 4, Paragraph 3 of the announcement, “Applications for registration solely for the export of the active ingredient shall be submitted by the manufacturer of the technical-grade active ingredient.” For products such as microbial or plant‑derived formulations that are registered only at the active‑ingredient level and not at the technical‑grade level, further clarification of the relevant policies is required.

     

    Other matters that require further clarification through policy include the specific review timeline, the validity period of the relevant certificates, and whether renewals are permitted.

     

    By significantly reducing domestic enterprises’ compliance costs for export, Announcement No. 269 represents a regulatory relief for production companies that primarily export, particularly in the context of inconsistent pesticide registration requirements between China and other markets. Eligible companies should closely monitor international pesticide market trends, especially for products whose patent protection has recently expired, and identify strategic entry points. For instance, recent severe locust infestations in Africa and Southeast Asia have prompted international organizations such as the FAO to increase procurement of ultra‑low‑volume formulations to support aerial spraying operations. However, at present, China has only nine registered insecticidal ultra‑low‑volume liquid formulations, including 4% abamectin–thiamethoxam, 5% chlorantraniliprole, 3% flonicamid, 6% emamectin benzoate–indoxacarb, 20% diazinon, 3% thiamethoxam, 3% indoxacarb, 1.5% avermectin, 5% nitenpyram, 1% avermectin benzoate, and 4 g/L fipronil.

     
     

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