Transcript Slide 1

Pesticide Market Access &
Regulatory Management in Saudi
Arabia
Mohannad Al Majathoub
PhD
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.
 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
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
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
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
1
0
0
2
1
1
2
0
4
0
0
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
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

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:
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

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
Dossier requirements

Technical data information

Finished product data
information

Physical & chemical properties

Product composition in details

Impurities data

Specification of the product

Toxicological data

Uses and application rates

Eco-toxicological data


Residue data

Maximum residue limits
Method of analysis with the
calculation sheet and
chromatographs.

Method of analysis for
technical and residue analysis
in soil, water and air.

Storage stability at hot and cold
test .

Material safety data sheet MSDS

Proposed label

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
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%
17200L
Temephos 1%
8750 kg
Fenitrothion 50%
5000L
Permethrin
-
Fenitrothion 40%
2000 kg
Deltamethrin 25%
9500 kg
Pirimiphos 50%
8000 L
Lambdacyhalothrin
10%
5000L
Etofenprox 10%
10000L
Cyfluthrin 1.5%
10000L
Diflubenzuron 0.5%
2000 kg
Pyriproxyfen 0.5%
9000 kg
24