LOGO. Pesticide Management. Template. in China. Andy Shen, Yangnong Chemical. Singapore Sep. 2, 2014

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1 LOGO Pesticide Management Template in China Andy Shen, Yangnong Chemical Singapore Sep. 2, 2014

2 Topics 1 China Pesticide Industry 2 Regulatory System of Pesticide in China 3 Improvement of Pesticide Management 4 Draft New Regulations of Pesticide Management

3 1 China Pesticide Industry 2 Regulatory System of Pesticide in China 3 Improvement of Pesticide Management 4 Draft New Regulations of Pesticide Management

4 China Pesticide Industry Pesticide Registration in China Till end of % 1.5% Number of Registrations 3273 Temporary Registrations 555 Formal Registratons % 27.6% 38.1% Insecticide Fungicide Herbicide PGR Others Source: ICAMA

5 China Pesticide Industry China Pesticide Industry in 2013 Thousand Tons & Million USD Import Export Volume +/-% Amount +/-% Volume +/-% Amount +/-% Pesticide Insecticide Fungicide Herbicide Source: CCPIA

6 China Pesticide Industry Top 20 Pesticide Companies in the world 2013 Company $ Reported % change % change (2012) (million) currency $ reported ranking (million) 1 (1) Syngenta 10,923 $10, (10,318) ($10,318) 2 (2) Bayer 10,420 $7, CropScience (9,544) ($7,421) 3 (3) BASF 6,943 $5, (6,018) ($4,679) 4 (4) Dow 5,546 $5, AgroSciences (5,042) ($5,042) 5 (5) Monsanto 4,521 $4, (3,715) ($3,715) 6 (6) DuPont 3,557 $3, (3,173) ($3,173) 7 (7) Adama 2,876 $2, (formerly MAI) (2,649) ($2,649) 8 (10) FMC 2,146 $2, (1,764) ($1,764) 9 (8) Nufarm 2,078 Aus$2, (2,135) (Aus$2,061) 10 (9) Sumitomo 2, , Chemical (1,953) ( 156,221) 11 (11) UPL 1,715 Rs 99, (1,585) (Rs 84,750) 12 (12) Arysta 1, , LifeScience (1,524) ( 121,900) 13 (13) Cheminova 1,101 DKK 6, (1,028) (DKK 5,949) 14 (17) Wynca 574 Yuan 3, Chemical (449) (Yuan 2,832) 15 (16) Huapont- 570 Yuan 3, Nutrichem (479) (Yuan 3,023) 16 (15) Kumiai , Chemical (551) ( 44,072) 17 (14) Ishihara , Sangyo Kaisha (540) ( 43,200) 18 (-) Sipcam-Oxon 501 $ (433) ($337) 19 (-) Nanjing 482 Yuan 2, Redsun (432) (Yuan 2,724) 20 (-) Jiangsu Yangnong 480 Yuan 2, (347) (Yuan 2,187) 2013 Company $ Reported % change % change (2012) (million) currency $ reported ranking (million) 14 (17) Wynca 574 Yuan 3, Chemical (449) (Yuan 2,832) 15 (16) Huapont- 570 Yuan 3, Nutrichem (479) (Yuan 3,023) 19 (-) Nanjing Redsun 482 Yuan 2, (432) (Yuan 2,724) 20 (-) Jiangsu Yangnong 480 Yuan 2, (347) (Yuan 2,187) Source: Agrow

7 1 China Pesticide Industry 2 Regulatory System of Pesticide in China 3 Improvement of Pesticide Management 4 Draft New Regulations of Pesticide Management

8 Regulatory System of Pesticide in China Regulations of Pesticide Management Issued: Decree No.216 of State Council, May 8, 1997 Measures for the Implementation of the Regulations of Pesticide Management Issued: Decree No.20 of MoA, Jul 23, 1999 Data Requirements on Pesticide Registration Issued: Decree No.10 of MoA, Dec 8, 2007

9 Regulatory System of Pesticide in China Chapter 1 General Principles Chapter 5 Use of Pesticide Chapter 2 Registration of Pesticide Chapter 3 Production of Pesticide Regulations of Pesticide Management Chapter 6 Other Rules Chapter 7 Penalty Provisions Chapter 4 Trade of Pesticide Chapter 8 Supplementary Provisions

10 Regulatory System of Pesticide in China Regulations of Pesticide Management 1 Definition and Range of Pesticide in China Pesticide is one substance or mixture of substances and its formulations intended for preventing or controlling any disease, pest, weed which is harmful to agriculture and forestry, or any other harmful plant, with the purpose of regulating the plant, insect growth in the chemical synthesis form, or sourced from the plant or natural resources. Insecticide Fungicide Herbicide Rodenticide Molluscicide IGR PGR Acaricide Termiticide Fumigant for warehousing Preservative for Agricultural and Forest Products Household Insecticide

11 Regulatory System of Pesticide in China Regulations of Pesticide Management 2 Pesticide Management System Pesticide Registration System MoA Pesticide Production License System AQSIQ MIIT

12 Regulatory System of Pesticide in China Regulations of Pesticide Management 3 Pesticide Registration System 1 Field Trial Phase 2 Temporary Registration Phase 3 Formal Registration Phase

13 Regulatory System of Pesticide in China Regulations of Pesticide Management 4 Protection of Undisclosed Data Article 10: The Authority will protect the undisclosed data generated by the applicant for the first registration of the pesticide containing new A.I. Within 6 years from the date of registration, MoA should not grant any registration to other applicants using the data mentioned in this Article without the consent of the registrant; except in the case that the data are generated by the applicants themselves.

14 Regulatory System of Pesticide in China Measures for the Implementation of the Regulations of Pesticide Management Authority for Pesticide Registration ICAMA (Institute for the Control of Agrochemicals, MoA, PRC) is the Authority for Pesticide Registration in China. Authentication System for Test Unit All test units executing Bio-efficacy test, Residue test, Toxicity test and Environmental Effect test for the purpose of Pesticide registration should be authenticated by MoA. Valid Period of Registration Temporary Registration: 1 Year. Should be renewed every year. Accumulative valid period can t exceed 3 Years. Formal Registration: 5 Years.

15 Regulatory System of Pesticide in China Data Requirements on Pesticide Registration Household Use Bio-pesticide Technical Grade Technical Concentration New Special Pesticide Rodenticide Botanical Pesticide Microbial Pesticide Formulated Pesticide Pesticide With New A.I. Repacking Expend Scope of Use Amend Application Method Amend Use Dosage Amendment Renewal Registration Type New Formulated Pesticide Me-too New Formulation Small Optimization New Mixture Formulation New Content New Penetrant Technical Grade Formulated Pesticide

16 Regulatory System of Pesticide in China Data Requirements on Pesticide Registration Example: Pesticide with New A.I. Application Form Summary Product Chemistry Data Toxicology Data Environmental Effect Data Label MSDS Bio-efficacy Data Residue Data Other Information

17 1 China Pesticide Industry 2 Regulatory System of Pesticide in China 3 Improvement of Pesticide Management 4 Draft New Regulations of Pesticide Management

18 Improvement of Pesticide Management Announcement of Authorities Minutes of Meeting of Registration Evaluation Committee of Experts Protect Agricultural production and Environment Ensure Quality and Safety of Agricultural Products Ensure safety of human and livestock

19 Improvement of Pesticide Management Management of Long Residue Herbicides Announcement No. 671 of MOA, Minutes of 10 th Meeting of 8 th Committee, Minutes of 13 th Meeting of 8 th Committee, Metsulfuron-methyl, Chlorsulfuron, Ethametsulfuron-methyl

20 Improvement of Pesticide Management Management of Fipronil Announcement No of MoA, MIIT & MEP, Minutes of 70 th Meeting of 3 rd Committee for Temporary Registration Fipronil

21 Improvement of Pesticide Management Management of High Toxic Pesticides Announcement No of MoA, MEP, MIIT, SAIC and AQSIQ, Fenamiphos, Fonofos, Phosfolan-methyl, Calcium phosphide, Magnesium phosphide, Zinc phosphide, Cadusafos, Coumaphos, Sulfotep, Terbufos, Methidathion, Phorate, Isofenphos-methyl, Carbofuran, Methomyl, Ethoprophos, Aldicarb, Aluminium phosphide, Omethoate, Isocarbophos, Methyl bromide, Endosulfan

22 Improvement of Pesticide Management Management of Paraquat Aqueous Solution Announcement No of MoA, MIIT and AQSIQ, Paraquat Aqueous Solution

23 1 China Pesticide Industry 2 Regulatory System of Pesticide in China 3 Improvement of Pesticide Management 4 Draft New Regulations of Pesticide Management

24 Draft New Regulations of Pesticide Management Start revision work for New Regulations of Pesticide Management from Continuously improve and revise New Regulations in past years.

25 Draft New Regulations of Pesticide Management Highlight 1: Pesticide Registration Management 1 Field Trial Phase 2 Temporary Registration Phase 3 Formal Registration Phase

26 Draft New Regulations of Pesticide Management Highlight 2: Management of Trade of Pesticide Licensing system to trade of pesticide

27 Draft New Regulations of Pesticide Management Highlight 3: Management of Use of Pesticide Define the management of the waste of pesticide

28 Draft New Regulations of Pesticide Management Highlight 4: Supervision Management of Pesticide Establish Recall System

29 Draft New Regulations of Pesticide Management Highlight 5: Reevaluation System of Pesticide

30 Draft New Regulations of Pesticide Management Highlight 6: Legal Liability Increase the penalty for violating the Regulations

31 Summary China is a very important country for pesticide in the world. China started formal management of pesticide from ICAMA is the key authority for pesticide registration. China is keeping perfecting the Regulations of Pesticide Management to encourage environmental friendly and low risk pesticide products. The regulatory system is becoming more perfect; the management is becoming stricter; the penalty is becoming more severe.

32 Thank You!

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