China's ICAMA issues regulations on the registration of export-only pesticides

On 8th June, the Institute for the Control of Agrochemicals of Ministry of Agriculture and Rural Affairs recently issued an announcement of regulation (Ref No. 269) pertaining to the registration of export-only pesticide (JD registration).

Industry voices from home and abroad generally believe that this regulation will be beneficial to China's pesticide exports, and will also help overseas pesticide companies to revitalize its registration resources and find suitable product suppliers.

The following is the full content of the announcement (subject to the original text of announcement of the Ministry).

1.Range of export-only pesticide registration (JD registration) application

In terms of products granted overseas pesticide registration or an import license in an importer’s country/region, the manufacturer may apply for export-only pesticide registration if one of the following conditions are fulfilled:

1)A manufacturer that has been granted in China a registration for pesticide technical applies for registration of the pesticide technical with same active ingredient at a different level of content.

2)A manufacturer that has been granted, in China, registration for pesticide technical or single formulation applying for registration of a single formulation with the same active ingredient with different contents or types of formulation.

3)A manufacturer that has been granted, in China, registration for ready-mixtures can apply for registration of ready-mixtures with the same active ingredient at different levels of content, mix ratios or types of formulation.

If the active ingredient of a ready-mixture outnumbers the specifications in Article 8 of the Measures for the Administration of the Pesticide Registration, the outnumbered active ingredient shall be registered in China.

4)A novel pesticide technical manufacturer applying for registration of pesticide technical or its formulations.

5)Other circumstances as prescribed by the administrative regulations of the ministry.

2.Documentation requirements for export-only pesticide registration applications for non-novel pesticides

1)The pesticide registration application form (for export only).

2)Valid overseas registration and proof or approval document from the importing country/region. If the name addressed in the proof document is inconsistent with the name of the manufacturer applying for registration, then supportive and convincing documents are required to be provided to justify relevant business collaboration.

3)A manufacturer’s “Letter of Commitment” promising that the product will not be sold in China, signed by a legal representative and stamped with the company seal.

4)Relevant information, such as detailed product description, overseas registration data brief and source of pesticide technicals.

5)Product chemical data (product quality standard, test report and full composition analysis of pesticide technicals), toxicological test data (acute oral, derma and inhalation toxicity tests), as well as information on the toxic symptom, first aid and cure measures.

6)Copies of pesticide production permits corresponding to the range of product under application.

3.Documentation requirements for export-only pesticide registration applications for novel pesticides

For export-only registration applications for novel pesticides, besides the above items 1 to 5 requirements for non-novel pesticide registration, the following additional information must be provided:

1)Physiochemical property information on active ingredients and pesticide technicals, as well as on the standard substance.

2)Pesticide technical data brief or information reference covering dermal irritation, eye irritation, skin sensitization, acute neurotoxicity, sub-chronic oral toxicity, sub-chronic (acute) dermal toxicity, inhalation toxicity, mutagenicity, teratogenicity, two-generation reproduction toxicity, chronic toxicity and carcinogenicity, metabolization and toxicokinetics.

3)Copies of a pesticide technical’s environment impact assessment, work safety evaluation and approval-related documents.

With regards to an application for registration of export-only novel pesticide formulations, documents shall be provided as per the non-novel pesticide registration requirements.

4.Miscellaneous

1)Export-only pesticide registration applications will be processed in accordance with the procedures pertaining to pesticide registrations, registrations of change, registrations of renewal, and review and approval. The pesticide registration certificate code number shall be “EX + Year + Serial Number,” for example, “EX20200001,” with an “export-only” indication on the certificate.

2)In the event of an identical or similar formulation being granted registration in China, no export-only registrations shall be granted, and renewals of granted registrations shall be one time only.

3)For applications for registration of export-only technical concentrates, the applicant must be the pesticide technical manufacturer while documents must be provided for relevant formations.

4)In terms of granted registrations for export-only novel pesticide technicals, the product must be produced and exported only after a relevant production permit is obtained.

5)Export-only pesticide products can only be exported to countries/regions where overseas registration or import license is granted.

6)The sale of export-only pesticide products in China is prohibited, and breaches will be penalized according to the provisions concerning the absence of registration in China, as stipulated in the Regulations on Pesticide Administration.

7)The announcement shall take effect on the day of its issue.