Photo taken by ChemLinked reporter Fang Lin on 13 September 2014, Shenzhen
Registrants of an already fully registered product can extend the pesticide application scope to minor-crops;
Application scope extension will be facilitated by a streamlined process, data sharing, joint study and expedited registration;
These special provisions will only be applicable to single formulated products;
As a global issue, shortage of minor-crop pesticides is particularly serious in China. Despite China’s acknowledgement of the problem in 2008, 80% of minor crop vegetables and two thirds of the perennial pests that affect minor crops have no suitable registered pesticides for certain conditions, as surveyed in 2012. According to registration statistics of the top six domestic pesticide formulation companies, most formulation products were registered on only one crop for one target, while MNCs usually register one product on various kinds of crops and targets. China’s domestic products are on average registered on 1.1 kinds of crop/pest combination while the number of registered cop/pest combination of imported pesticide was 4. This marked difference accounts for the high number of domestic products used outside of their registered scope. For these reasons a draft of “Special Provision on Registration for Vegetable and Specialty Crop Use Pesticide” has been compiled and will be implemented in the near future. Mr. Shan Weili Division Director of Administration Department from ICAMA delivered some data requirements on registration management on minor-crop use pesticide.
The special provisions will be applicable only for products which obtain full registration in China. If the registrant wants to expand the use on minor-crop, it can apply for “Registration of Expansion of Application Scope” (Crop Expansion). Compared with the data requirement of traditional crop expansion, the expansion on minor crop will be greatly facilitated with a streamlined process, data sharing, joint study provisions and reduced time requirements. For example, efficacy and residue studies usually need to be carried out for 2 years but the duration of the studies will not be specified in the “Special Provision” and the applicant can file a dossier at any time once the data is adequate.
Efficacy Study
The plot efficacy trial should be carried out in at least 4 major crop cultivation regions. The study report should not only demonstrate the efficacy of the pesticide but also demonstrate the safety of the product when used, especially in regards to possible crop damage and usage instructions. If the study was jointly carried out by different applicants, each applicant should compile a study safety report:
If a company wants to expand the use of a pesticide targeting the same pest on more than one crop and the crops are classified as the same category for efficacy study. A representative crop can be chosen to conduct the study and the report is applicable to all other crops;
If the same active ingredient targeting the same pest is already registered on other crops, the field trial on the minor-crop could be exempted, but the applicant still needs to provide the safety report of the minor-crop;
Residue Study
The residue study should be carried out at 2 to 6 major cultivation areas. The studied crop can be different to the targeted minor crop, but they should be classified in the same crop category for a residue study, which was detailed in the MoA Announcement 1490, “Classification of Crop for Pesticide MRL Establishment”. If the product is to be used in a reservation area, the study report should include 1 to 2 test sites in the actual reservation area.
The study should focus on the edible/forage part of the crop. The tests on the plant could be halved and the final residue and dynamic test on soil and water could be waived;
If the products of different formulation type are composed of same active ingredient and utilized with the same application method, the applicant can choose a representative formulation type for the study and the study on other formulation type could be carried out at 1-2 sites. If the residue levels among different formulation types were generally the same, the data among different formulation types can be shared. If the residue levels vary in different formulation types, the full efficacy study should be carried out on each product.
If the product is used on a single crop targeting different pests with different dosing or time of pesticide application, the applicant should chose the circumstance with the largest residue impact for the study;
If the applicant has already obtained the full residue data of a representative crop in one category and complete the residue study of other representative crop of the same category, it can directly apply for crop expansion on another crop in the same category;
If several applicants conducted a joint study, the existing data held by different applicant can be shared;
China grants 6 years’ data protection to the initial registrant, the other on-going applicant may use the data for registration without the consent of the original registrant after the expiry of the protection. But if the data was gathered through joint study and the pesticide was even registered for more than 6 years, the data sharing/waive policy is still not applicable to other applicants. However, the participants of a joint study may authorize other applicants to use their registered data for crop expansion;
Review
Local government, industrial associations and pesticide enterprises are encouraged to apply for crop extension on minor crops. The joint study for different applicants will be promoted as well. The hard copy of such application material should be labeled with “Crop Extension on Minor Crop” and the approval process will be reduced to 90 days if appropriate. The institute will survey the registered products and periodically compile a combination list of products, crops and target pests. Pesticide companies can refer the list and decide the crop and range of their application.
Finally, Mr. Shan stressed that the Special Provision would only be applicable to single formulated products, majorly because the Special Provision provides considerable exemption for residue studies and the excepted data might not reflect the actual residue level of active ingredients in mixtures. If the crop expansion might have potential environmental impact, the applicant should submit additional environmental data in accordance with the MoA Order 10.
