Pesticide Market Access Regulatory Management in Saudi Arabia

Pesticide Market Access & Regulatory Management in Saudi Arabia Mohannad Al Majathoub Ph. D Director of Business Development, Agri Sciences 1

Contents: - Introduction : Where to start? - Market Access - Pesticide registration requirements (main steps & timing). - Data requirements for bio-pesticides. - Dossier requirements and certificates. - Efficacy test protocols. - Pesticides labeling. - Residue monitoring system. - Registration cost. - Public health pesticides. 2

INTRODUCTION: Crop protection importance. Saudi Arabia rules & regulations history. 3

Crop protection importance 4

History: The first regulations of pesticides started in 1976. the trade with agricultural In 2004 the Supreme Council of the Gulf Cooperation Council (GCC) approved ‘’The regulation of agricultural pesticides in the countries of the Cooperation Council for the Arab Gulf States’’. In 2006 the Cabinet approved the application of this law in the Kingdom after the issuance of its Executive Regulations. 5

Global Geographical Share: 2013 (%) Middle East & Africa; 3. 80% North America; 20. 60% Europe; 31. 70% Latin America; 20. 80% Asia; 23. 10% 6

Increased Governmental Investment Diversification in Saudi Arabia. v Total budget in 2014 is 228 billion $ with 16. 3 billion $ allocated to the water & agricultural infrastructure. v The Kingdom of Saudi Arabia with a population of 28 million is the largest individual market in the region. 8

Cultivated area and production of major crops grown in Saudi Arabia 2012 Crop Cultivated area (ha) Production (tonnes) 2012 Wheat 200000 1100000 Barley 2200 15000 Sorghum 80000 33125 Cucumbers 3400 230000 Tomato 16700 525000 Eggplant 4000 60000 Watermelon 18000 370000 Carrots 165714 58000 Melons 11000 200000 Okra 4000 51500 Onion 4200 105000 Squash 6500 128000 Potato 17000 450000 Dates 160000 1050000 Citrus 11500 100000 Grapes 14300 150000 9

Saudi Arabia Pesticides Market in 2013 (US$M) Crop Group Cereals Maize Rice Soybean Rape Sunflower Cotton Sugarbeet Sugarcane Potato Vine Pome fruit Other F&V MAINLY Dates, Watermelons, citrus & tomato) etc Other crops Grand Total Grand Herbicides Insecticides Fungicides Others Total 16 10 6 2 34 1 0 0 0 0 0 0 0 0 0 0 1 1 0 0 2 1 1 2 0 4 0 0 0 8 0 27 8 0 20 7 0 15 0 0 2 23 0 64 10

LEADING Active ingredients Or LEADING BRAND DATA Sector Herbicides Insecticides Fungicides Active ingredients Glyphosate Dicamba 2, 4 -D Active value (US $m) 2, 88 2, 48 2, 22 Dimethoate Lambdacyhalothrin Alphacypermethrin Diazinon Cypermethrin 2, 68 Propiconazole Epoxiconazole Tebuconazole Thiophanate Spiroxamine 1, 95 1, 92 1, 67 0, 64 1, 74 1, 12 0, 74 0, 73 11

Registration procedure Application form for the Registration of Middle East and North African Countries is required. Developing and submitting of application and dossier. Field trials assessment for new pesticides that have not been previously registered or re-registered. Confirm the sources of raw materials and finished products to be approved by EPA , FAO And WHO and not banned or prohibited. All documents must be handled to registration authorities as a hard copy, in hands, personally. 12

Quality control v The ministry of agriculture owns its special accredited laboratories which make all the requested analysis for the formulated product and residue analysis according to the CIPAC standards 13

Dossier requirements & certificates: q. From technical suppliers ü Registration certificate of active technical ingredient issued from Governmental authority such as Ministry of Agriculture, ICAMA ( CHINA ) duly legalized. ü Free sale certificate from the manufacture of technical grade duly legalized. 14

q Certificates required formulated product ü Legalized Free Sale Certificate. Legalized Certificate of Registration. Legalized Certificate of analysis from the producer. Authorization letter from the producer of the finished product to the exporter. Certificate of storage stability. 15

Dossier requirements Technical data information Finished product data information q Physical & chemical properties Product composition in details q Specification of the product q Impurities data q Uses and application rates q Toxicological data q q Eco-toxicological data q Residue data Method of analysis with the calculation sheet and chromatographs. q Maximum residue limits q q Method of analysis for technical and residue analysis in soil, water and air. Storage stability at hot and cold test. q Material safety data sheet MSDS q Proposed label q q Environmental fate 16

Monitoring and follow-up Bio-efficacy carried by MOA to ensure the efficiency of the registered products according to Saudi Arabia climates and conditions. Costs vary greatly depending on number of crops and pests 17

Monitoring and follow-up �Controlling the banned and the restricted pesticides according to EPA list. �Re-new the expired products after analysis or dispose according to scientific standards. �Inspection for stores and warehouses to make sure their commitment to the safety standards 18

Banded pesticides CARBARYL DIMETHOATE MANCOZEB DICOFOL ZINEB CARBOFURAN ENDOSULFANE DICLOFOP METHYL PROPARGITE CHLORPYRIFOS SIMAZINE METHOMYL BENOMYL QUINTOZENE CHLOROTHALONIL ETHOPROPHOS PROPOXUR METHIOCARB OXYDEMETON-METHYL S_METHYL_DEMETON METHOXYCHLOR TETRADIFON BROMADIOLONE ACROLEIN ACRYLONITRILE ALDICARB ALDRIN AMITROLE ARSENICAL COMPOUNDS AZINPHOS ETHYL AZINPHOS METHYL BENDIOCARB BINAPACRYL BOMYL BROMOPHOS ETHYL BHC CALCIUM CYANIDE CAPTAN CHLORANIL CHLORDANE CHLORMEPHOS CHLOROPICRIN CHLOROTHIOPHOS CYCLOHEXIMIDE CYHEXATIN DAMINOZIDE DEMETON DICHLOROPROPANE DICHLORVOS DICROTOPHOS DIELDRIN DIMEFOX DINITROAMINE DINOSEB ACETATE DINOSEB DISULFOTON DBCP DDT DNOC ENDRIN ERBON ETHIPHON ETHOPROPHOS ETHYLAN ETHYLENE DIBROMIDE ETHYLENE CHLOROBROMIDE ETHYLENE OXIDE EPN FENAMIPHOS FENSULFOTHION PENTA PHORATE PHOSFOLAN PHOSOHAMIDONE PROTHOATE SCHRADAN SILVEX SODIUM CYANIDE SODIUM FLUOROACETATE TERBUFOS TERPENE POLYCHLORINATES THALLIUM SULPHATE THIONAZIN TOXAPHANE TDE TEPP 19

Statistical figures The number of companies licensed to import agricultural pesticides in the kingdom more than 50 companies. Numbers of active ingredients registered in Saudi Arabia more than 300. Number of finished products more than 2000 trade name. The registration procedure takes about 1 -2 years including the field trial. 20

Amount of pesticide consumption During 1997 -2010 Year Pesticides consumption (Ton) 2006 *330375 2007 *399337 2008 *348000 2009 *337830 2010 *322772 * Including Locust Control works and Date Palm control. 21

Public health insecticides Registration, legislation, and licensing • All public health pesticides are registered, legislated and licensed through the Ministry of Agriculture. • MOH is not responsible for legislation and licensing • A certificate of analysis for the pesticide is required from the supplier. There are four factories manufacturing pesticides for public health and agriculture. MOH follows the WHO specifications regarding pesticide safety and efficacy 22

Top selling public health pesticides used in Saudi Arabia Product Temephos 50% 17200 L Temephos 1% 8750 kg Fenitrothion 50% 5000 L Permethrin - Fenitrothion 40% 2000 kg Deltamethrin 25% 9500 kg Pirimiphos 50% 8000 L Lambdacyhalothrin 10% 5000 L Etofenprox 10% 10000 L Cyfluthrin 1. 5% 10000 L Diflubenzuron 0. 5% 2000 kg Pyriproxyfen 0. 5% 9000 kg

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