Photo taken by ChemLinked reporter Fang Lin on 13 September 2014, Shenzhen
The second draft of China’s new pesticide regulation was completed and agreed upon by other ministries and will be submitted to the Executive Meeting of the State Council for further discussion;
Category management on pesticide adjuvants will be implemented;
China will implement further control on paraquat;
In the short term ICAMA will continue issuing custom notifications for these products to ensure continued exportation;
The public information system for pending pesticide registrations will be expanded to include the authorization information of environmental and efficacy data. This new requirement will guarantee the authenticity of data material and the intellectual property of its stakeholders;
By the end of August, ICAMA received a total of 3536 applications for pesticide registration and approved 2830 of them. They included 14 registrations for new pesticide, 302 TC registrations, 2447 registrations for field crop pesticides, 227 registrations for health pesticide, 875 insecticides, 751 fungicides, 707 herbicides and 48 plant growth regulators. On day one of an industrial summit in Shenzhen, ICAMA Director Sui Pengfei summarized the regulatory tasks and future initiatives in China pesticide management.
Performance Review
China has publically announced all pesticide registrations since January 12 2014. Since then, the applicant, pesticide name, active ingredient(s), content, formulation type, toxicity, crop, target, dosage, application method and registration number of the technical material of formulated products of all pending applications have been released on ICAMA’s website form public comment. The information has been made public every week over the past 8 months in total 2314 pending applications were announced. 10 applications were finally rejected after public consultation. 3 were rejected due to patent infringement, 3 applications were identified as including false information about the TC/TK provider, and 2 applications for export-only purpose were rejected for data protection reason and 2 applications for erroneous information.
The public consultation process has helped crack down on the undocumented production of unregistered active ingredients. Mr. Sui revealed that the information made publically available will be expanded to include authorization information of environmental and efficacy data, which would guarantee the authenticity of data material and the intellectual property of its stakeholders.
In late 2012, ICAMA initiated joint review with its provincial subordinates. The provincial authorities in Zhejiang, Hebei, Shandong and Jiangsu are involved in the preliminary review on efficacy and chemical data which greatly accelerates the review process. In 2013, 10 more provincial/city subordinates entered the joint review process. The scope of this collaboration will also be expanded to include more work duties for provincial authorities allowing the ministerial level authorities to focus on more important issues.
In the past the ICAMA granted registration for “export-only purpose”. This registration category was however strongly opposed by both domestic and foreign authorities. The data requirement on this registration category was relatively low. In general pesticides for export only registration required a certificate of its registration status in another country and other trivial product information. In practice the documents of overseas registration were usually forged and the intellectual property of the initial registrant of this pesticide was often infringed. As such the institute terminated the acceptance and approval of all export-only registration applications.
To facilitate the registration on minor-crop use pesticide, ICAMA has drafted a special provision on pesticide registration for minor-crop use pesticide, which detailed the scope, procedure, data requirements and timeline. Registration under this category will be greatly facilitated with a streamlined registration process, data sharing, joint study provisions and reduced time requirements. It is expected that the total approval process will be reduced to 90 days. The supporting legal text is also ready for publication
The institute has also progressed on the post-registration management of problematic active ingredients. The registration of chlorsulfuron, metsulfuron-methyl, ethametsulfuron and paraquat AS were all removed under MoA Announcement 2032 and Announcement 1745. The reassessment of 2, 4-D butylate and other 4 active ingredients was also launched. The registration of paraquat AS registration was terminated as of 1 Jul 2014 and domestic producers are seeking registration of alternatives to this formulation. ICAMA has warned that the herbicide still poses a threat to occupational health during the production process and the authority is now considering further control measures.
Future Prospect for the Pesticide Industry
Mr. Sui announced that the second revised draft of the new pesticide regulation was completed and agreed upon by other ministries. The legal text will be submitted to the Executive Meeting of the State Council for further discussion, which will be held during October 2014. If approved by the State Council the new regulation would be promulgated shortly after.
In the meantime, MoA will work on the rule-making or revision of supporting policies including:
Data Requirement on Pesticide Registration;
Measures for the Management of Pesticide Label and Manual (Major Revision);
Measures for the Control of Adjuvants in Pesticide;
Measures for the Management of Pesticide Registration;
Articles for the Expert Committee of Pesticide Registration
The last three measures will be newly established. Mr. Sui revealed that category management will be adopted in China. All pesticide adjuvants will be classified as adjuvant permitted to be used in pesticide formulation, adjuvant banned/restricted to be used in pesticide formulation and exempted adjuvant. Temporary registration is likely to be terminated allowing the Expert Committee to focus on data review of full registration. In the past the committee was composed of experts from MoA, MEP, MIIT, NHFPC and other ministries and departments, which made it difficult to reach the consensus on registrations and applications. MoA will be designated as the new committee lead with final say on registration and application issues.
Risk assessment will be adopted for registration of all new pesticide products and several assessment models will be published in the near future. Meanwhile, the Ministry is to monitor pesticide environmental impact in the Yangtze River Delta, Pearl River Delta and Bohai Regions as the production and application of pesticide in these regions is extremely important both economically and environmentally.
