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

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Presentation on theme: "Pesticide Pesticide Market Access & Regulatory Management in Saudi Arabia Mohannad Al Majathoub PhD Director of Business Development, Agri Sciences 1."— Presentation transcript:

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

2 2 -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. Contents:

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

4 Crop protection importance 4

5 History: The first regulations of the trade with agricultural pesticides started in 1976. 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

6 6 Global Geographical Share: 2013 (%)

7

8 Increased Governmental Investment Diversification in Saudi Arabia.  Total budget in 2014 is 228 billion $ with 16.3 billion $ allocated to the water & agricultural infrastructure.  The Kingdom of Saudi Arabia with a population of 28 million is the largest individual market in the region. 8

9 Cultivated area and production of major crops grown in Saudi Arabia 2012 CropCultivated area (ha)Production (tonnes) 2012 Wheat2000001100000 Barley220015000 Sorghum8000033125 Cucumbers3400230000 Tomato16700525000 Eggplant400060000 Watermelon18000370000 Carrots16571458000 Melons11000200000 Okra400051500 Onion4200105000 Squash 6500128000 Potato17000450000 Dates1600001050000 Citrus11500100000 Grapes14300150000 9

10 Saudi Arabia Pesticides Market in 2013 (US$M) Crop GroupHerbicidesInsecticidesFungicidesOthers Grand Total Cereals16106234 Maize10001 Rice00000 Soybean00000 Rape00000 Sunflower00000 Cotton00000 Sugarbeet00000 Sugarcane00000 Potato11002 Vine11204 Pome fruit00000 Other F&V MAINLY Dates, Watermelons, citrus & tomato) etc887023 Other crops00000 Grand Total272015264 10

11 LEADING Active ingredients Or LEADING BRAND DATA Sector Active ingredientsActive value (US $m) HerbicidesGlyphosate2,88 Dicamba2,48 2,4-D2,22 InsecticidesDimethoate2,68 Lambda- cyhalothrin1,74 Alpha- cypermethrin1,12 Diazinon0,74 Cypermethrin0,73 FungicidesPropiconazole1,95 Epoxiconazole1,92 Tebuconazole1,67 Thiophanate0,64 Spiroxamine0,64 11

12 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

13  13 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 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. Quality control

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

15  Certificates required for formulated product 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

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

17 Monitoring and follow-up 17

18 Monitoring and follow-up 18

19 Banded pesticides 19 CARBARYLBENDIOCARBETHOPROPHOS DIMETHOATEBINAPACRYLETHYLAN MANCOZEBBOMYLETHYLENE DIBROMIDE DICOFOLBROMOPHOS ETHYLETHYLENE CHLOROBROMIDE ZINEBBHCETHYLENE OXIDE CARBOFURANCALCIUM CYANIDEEPN ENDOSULFANECAPTANFENAMIPHOS DICLOFOP METHYLCHLORANILFENSULFOTHION PROPARGITECHLORDANEPENTA CHLORPYRIFOSCHLORMEPHOSPHORATE SIMAZINECHLOROPICRINPHOSFOLAN METHOMYLCHLOROTHIOPHOSPHOSOHAMIDONE BENOMYLCYCLOHEXIMIDEPROTHOATE QUINTOZENECYHEXATINSCHRADAN CHLOROTHALONILDAMINOZIDESILVEX ETHOPROPHOSDEMETONSODIUM CYANIDE PROPOXURDICHLOROPROPANESODIUM FLUOROACETATE METHIOCARBDICHLORVOSTERBUFOS OXYDEMETON-METHYLDICROTOPHOSTERPENE POLYCHLORINATES S_METHYL_DEMETONDIELDRINTHALLIUM SULPHATE METHOXYCHLORDIMEFOXTHIONAZIN TETRADIFONDINITROAMINETOXAPHANE BROMADIOLONEDINOSEB ACETATETDE ACROLEINDINOSEBTEPP ACRYLONITRILEDISULFOTON ALDICARBDBCP ALDRINDDT AMITROLEDNOC ARSENICAL COMPOUNDSENDRIN AZINPHOS ETHYLERBON AZINPHOS METHYLETHIPHON

20 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

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

22 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

23 Top selling public health pesticides used in Saudi Arabia Product 17200LTemephos 50% 8750 kgTemephos 1% 5000LFenitrothion 50% -Permethrin 2000 kgFenitrothion 40% 9500 kgDeltamethrin 25% 8000 LPirimiphos 50% 5000LLambdacyhalothrin 10% 10000LEtofenprox 10% 10000LCyfluthrin 1.5% 2000 kgDiflubenzuron 0.5% 9000 kgPyriproxyfen 0.5%

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