1

Pesticide Market Access & Regulatory Management in Saudi Arabia  

Mohannad Al MajathoubPhD

Director of Business Development, Agri Sciences

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:Crop protection importance.Saudi Arabia rules & regulations

history.

4

Crop protection importance

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.

6

Global Geographical Share: 2013 (%)

North America; 20.60%

Latin America; 20.80%

Asia; 23.10%

Europe; 31.70%

Middle East & Africa; 3.80%

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.

9

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

10

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

11

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

12

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.

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 .

Quality control

14

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.

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 .

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

17

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

18

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

19

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  

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.

21

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 .

22

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%

24