On June 8, 2020, the Chinese Ministry of Agricultural and Rural Affairs released the Announcement 269 to promulgate the scope, data requirements and enforcing details for the registration of pesticide under export-only purpose, a long-standing issue after China’s pesticide regulatory reform since 2017. The measure settled this time will help facilitate consolidation among Chinese agrochemical industry as SMEs would find it increasingly difficult to access such shortcut to overseas market.
Compare with the formal registration for domestic-use pesticide, an export-only pesticide can generally be exempted from mid-term and long-term toxicity and environmental impact tests, as well as residue and efficacy trials on formulation products. Under the previous regulation, this category of registration can almost be applied by any producer. With the effects of the Announcement on June 8, the applicants of this registration category are limited to:
- Only the enterprises who have formally registered a TC may apply the export-only registration of the TC in a different concentration;
- Only enterprises who have formally registered a TC or single-element formulation may apply for the export-only registration in a different concentration or formulation type;
- Only the enterprises who have formally registered a multi-element formulation may apply for export-only registration in a different concentration, proportion or formulation type. If the number of active ingredients exceeds the maximum limits (2 for general pesticides and 3 for herbicides, seed treatments and pheromone), the extra active ingredient should be formally registered;
- Only the licensed producers of new pesticides (containing an active ingredient not yet formally registered in China) may directly apply the export-only registration of the TC and formulation.
The Announcement specified the staged data requirements on non-new pesticides and TCs. For non-new pesticide and new formulated pesticides, the applicant shall submit:
- Application form for pesticide registration (export-only category);
- Documentary evidence indicating that the export destination has permitted the import of the pesticide proposed (the company name on the documentary evidence shall be consistent with that of the applicant, if not, the applicant shall supplement convincible evidence to prove the partnership with the company presented);
- Letter of commitment stating that the pesticide will not be used domestically;
- Product information, a summary on the data submitted for registration overseas and source of the TC used;
- Product Chemistry data (quality standard, quality test report and full-component test report for TC) and toxicity data (acute oral, acute dermal and acute inhalation), as well as information on poisoning symptom, first-aid and medical measures;
- Copy of pesticide production license.
The applicant of new TCs shall additionally submit following materials:
- Physic-chemical properties of TC and the active ingredient(s), as well as analytical standard(s);
- Summary or literature information on the skin irritation, eye irritation, skin sensitization, acute neurotoxicity, sub-chronic oral toxicity, sub-acute/chronic dermal toxicity, inhalation toxicity, mutagenicity, teratogenicity, two-generation reproductive toxicity, chronic toxicity, carcinogenicity and toxicokinetics data on the TC;
- The environmental impact statement and approval of the TC production facility;
MoARA has introduced new coding rules for export-only registration, starting with the code “EX” plus 4 digits indicating the year of approval and 3 digits indicating its sequential number.
After obtaining the export-only registration, enterprises are always subject to follow-up regulation. The registrant of export-only category may only export the pesticide to the designation who has permitted the import of the pesticide (indicated in the application materials). For new TC registered under export-only purpose, the applicant can only export the TC after obtaining the product license. But the biggest uncertainty faced by Chinese enterprises is their product densification strategy in the future: If a manufacturer registered a formulation under export-only purpose but other enterprises subsequently registered a me-too or similar formulation for domestic use, the formulation will not be approved for export-only purpose and previous registration can only be renewed once.
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