On 1 April, China MoA released the drafts of 5 supporting regulations for the newly promulgated pesticide regulation, which were currently under internal consultation among governmental departments including NDRC, MIIT, MPS, MEP, MOFCOM, NHFPC, SAIC, AQSIQ, SAWS, SFDA, SFB (State Forestry Bureau), SGB (State Grain Bureau), GSMC (General Supply and Marketing Cooperative) and all provincial agricultural departments.
The 5 supporting drafts will be issued under ministerial regulation, which reflects the regulatory prospects of pesticide regulation, production, marketing, label and manual, as well as the accreditation of pesticide labs:
- Administrative Measures for the Registration of Pesticide;
- Administrative Measures for the Production of Pesticide;
- Administrative Measures for the Marketing of Pesticide;
- Administrative Measures for the label and Manual of Pesticide;
- Administrative Measures for the Experimentation of Pesticide Registration;
Risk Assessment and Benefit Evaluation as a prerequisite for pesticide registration applications
The “Risk Assessment Report” and the” Benefit Evaluation Report” are now required during application. The reports should be fully supported by the product chemical, toxicological, efficacy, ecotoxicological and environmental properties and should help demonstrate the safety, efficacy and economic advantages over registered product.
On the basis of hazard and toxicity of inert ingredient, MoA will maintain updates on the “List of Restricted/Prohibited Inert Ingredients(Adjuvant)”. If the inert ingredient was exclusively used for formulation, additional testing report on the inert ingredient will be required.
All registered pesticides are subject to a safety risk surveillance system. Pesticide active ingredients which have been registered for over 15 years will be periodically revaluated by MoA.
The number of registrations will be further decreased by the limitation on content level. MoA Announcement 946 and Announcement 1158 specified that pesticide with same formulation type and AI composition (including multiple compound formulations under same AI ratio) can be registered at maximum of 5 content levels. The draft reduces the content levels from 5 to 3 and multiple compounded pesticides can combine a maximum of 3 active ingredients.
Natural enemy pesticides are exempt from registration and minor-crop registration applicants can use/extrapolate existing data from crops within the same group. MoA will permit the emergency use of unregistered pesticide if there is no registered pesticide for certain minor-crop use or occurrence of new pests.
Restrictive Terms on Pesticide Production
MoA will adopt “one license, one company”. A certificate will be specified with the company name, registered address, legal representative (technical executives), production scope (permitted products), production address and expiry date. The construction of new enterprise and relocation of existing enterprise of chemical pesticide are required to locate/move to chemical industrial parks at provincial level. Phased out techniques and equipment that is prohibited/restricted by the State will not allowed to be utilized/ expanded. Existing producers located outside the city industrial park will not be allowed to expand its production scope.
Marketing and Online Sales
The entry criteria has been broadened from only 7 types of entities(marketing entities under the state owned supply and marketing cooperatives, plant protection station, soil& fertilizer station, agricultural and forestry technology extension organization, pesticide production enterprises and other entities prescribed by the State Council) to all entities equipped with qualified technicians (56 hour professional training), operating area(no less than 30 square meters) and storage area(no less than 50 square meters), ventilation and firefighting facility, bar code identification device and computerized systems.
For online sale of pesticide, the marketing license number, registered address and contact information is compulsory to display on webpages. If specific product was exhibited, the pesticide registration number, production license number and photo of label should be displayed.
The marketing of public health pesticide, natural enemy and if a pesticide producer sells a pesticide within its production scope are all exempt from marketing license requirements.
Electronic Traceability Code
- Electronic traceability codes must be mandatorily included on pesticide labels. In addition, specific information should be labeled for quality assurance and safety consideration:
- Technical product should be labeled with “For Formulating Use Only” unless direct use is permitted.
- Restricted pesticide should be labeled with “Restricted Use” and restriction conditions/requirement;
- Restricted Pesticide and general-use pesticide for food crop use should be labeled with safety interval;
- Rodenticides should be labeled with specific identifiers and anti-counterfeit mark;
If the pesticide was processed by a 3rd party or sub-packed, the production license number, name and contact information of the appointed consignee and the processing and sub-package date should be included;
MoA will accept the study report on product chemistry and toxicity obtained from overseas GLP-compliant laboratories from a country which has mutual or multilateral agreement on data acceptance with China. The study on efficacy, residue and environmental impact must be carried out in China. The draft of pesticide registration will also accelerate the establishment of new national MRLs and facilitate China’s contribution to the formation of international residue standards. If a pesticide was firstly registered on a crop, suggested MRL should be proposed after dietary risk assessment. For active ingredients and crops which China has already established an MRL for, a validation study is sufficient. If the established MRL was based on residue data which was generated outside China, the applicant will be required to conduct the study in China.