Pesticide Pesticide Market Access & Regulatory Management in Saudi Arabia Mohannad Al Majathoub PhD...
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Transcript of Pesticide Pesticide Market Access & Regulatory Management in Saudi Arabia Mohannad Al Majathoub PhD...
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Pesticide Market Access & Regulatory Management in Saudi Arabia
Mohannad Al MajathoubPhD
Director of Business Development, Agri Sciences
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- 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:
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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.
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Global Geographical Share: 2013 (%)
North America; 20.60%
Latin America; 20.80%
Asia; 23.10%
Europe; 31.70%
Middle East & Africa; 3.80%
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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.
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Cultivated area and production of major crops grown in Saudi Arabia 2012
Crop Cultivated area (ha)
Production (tonnes)
2012 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
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Saudi Arabia Pesticides Market in 2013 (US$M)
Crop Group Herbicides Insecticides Fungicides OthersGrand Total
Cereals 16 10 6 2 34Maize 1 0 0 0 1Rice 0 0 0 0 0Soybean 0 0 0 0 0Rape 0 0 0 0 0Sunflower 0 0 0 0 0Cotton 0 0 0 0 0Sugarbeet 0 0 0 0 0Sugarcane 0 0 0 0 0Potato 1 1 0 0 2Vine 1 1 2 0 4Pome fruit 0 0 0 0 0Other F&V MAINLY Dates, Watermelons, citrus & tomato) etc 8 8 7 0 23Other crops 0 0 0 0 0Grand Total 27 20 15 2 64
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LEADING Active ingredients Or LEADING BRAND DATA
SectorActive ingredients Active value (US $m)
Herbicides Glyphosate 2,88Dicamba 2,482,4-D 2,22
Insecticides Dimethoate 2,68Lambda-cyhalothrin 1,74Alpha-cypermethrin 1,12Diazinon 0,74Cypermethrin 0,73
Fungicides Propiconazole 1,95Epoxiconazole 1,92Tebuconazole 1,67Thiophanate 0,64Spiroxamine 0,64
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Registration procedureApplication 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.
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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
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Dossier requirements & certificates:
From technical suppliersRegistration 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.
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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 .
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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
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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
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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
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Banded pesticidesCARBARYL BENDIOCARB ETHOPROPHOSDIMETHOATE BINAPACRYL ETHYLANMANCOZEB BOMYL ETHYLENE DIBROMIDEDICOFOL BROMOPHOS ETHYL ETHYLENE CHLOROBROMIDEZINEB BHC ETHYLENE OXIDECARBOFURAN CALCIUM CYANIDE EPNENDOSULFANE CAPTAN FENAMIPHOSDICLOFOP METHYL CHLORANIL FENSULFOTHIONPROPARGITE CHLORDANE PENTACHLORPYRIFOS CHLORMEPHOS PHORATESIMAZINE CHLOROPICRIN PHOSFOLANMETHOMYL CHLOROTHIOPHOS PHOSOHAMIDONEBENOMYL CYCLOHEXIMIDE PROTHOATEQUINTOZENE CYHEXATIN SCHRADANCHLOROTHALONIL DAMINOZIDE SILVEXETHOPROPHOS DEMETON SODIUM CYANIDEPROPOXUR DICHLOROPROPANE SODIUM FLUOROACETATEMETHIOCARB DICHLORVOS TERBUFOSOXYDEMETON-METHYL DICROTOPHOS TERPENE POLYCHLORINATESS_METHYL_DEMETON DIELDRIN THALLIUM SULPHATEMETHOXYCHLOR DIMEFOX THIONAZINTETRADIFON DINITROAMINE TOXAPHANEBROMADIOLONE DINOSEB ACETATE TDEACROLEIN DINOSEB TEPPACRYLONITRILE DISULFOTON ALDICARB DBCP ALDRIN DDT AMITROLE DNOC ARSENICAL COMPOUNDS ENDRIN AZINPHOS ETHYL ERBON AZINPHOS METHYL ETHIPHON
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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.
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Amount of pesticide consumption During 1997-2010Year Pesticides consumption
(Ton)
2006 *330375
2007 *399337
2008 *348000
2009 *337830
2010 *322772
* Including Locust Control works and Date Palm control .
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Public health insecticidesRegistration, 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
Top selling public health pesticides used in Saudi Arabia
Product
17200L Temephos 50%
8750 kg Temephos 1%
5000L Fenitrothion 50%
- Permethrin
2000 kg Fenitrothion 40%
9500 kg Deltamethrin 25%
8000 L Pirimiphos 50%
5000L Lambdacyhalothrin 10%
10000L Etofenprox 10%
10000L Cyfluthrin 1.5%
2000 kg Diflubenzuron 0.5%
9000 kg Pyriproxyfen 0.5%