FAO and WHO Specifications for
Pesticides
Dr. M.D. Müller
After a presentation of Dr. Gero Vaagt
Chief Plant Protection Officer
Specifications are a priority in Plant
Production for FAO
 Voluntary standards to reduce risks
with using pesticides
 To contribute to the improvement in
agricultural production while
safeguarding applicator safety, health
of consumers and protect the
environment
How are FAO and WHO specifications
used?
 As part of a buyers contract: the
garantee that the buyer gets the quality
which is achievable
 As a standard for competent authorities
to check whether the quality on the
market is that as registered.
Specifications are intended to
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Garantee security of the products
By avoiding additional, unforeseen risks to the
user, to the consumer of agricultural
commodities and to the environment
Garantee efficacy
maintain quality also after certain storage
to avoid fraud, loss of money and .
What is the aim of FAO and WHO
specifications for pesticides
 To make sure that the pesticides
which comply with the specification
provide satisfactory results for the
purpose they were developed for and
do not show unexpected risks
Quality of pesticides
 Statistics established by FAO and WHO
estimate that 30% of pesticides on sale in
developing countries are substandard. Also
in industrialized countries 25 % of
pesticides examined in Belgium, in UK 12
% and in Germany 17 % were of inferior
quality
Control of Risks
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A national control of pesticide quality is needed
to monitor pesticides on the market
Without an adequate control, an even higher
proportion of pesticides would have
insufficient quality
The users have no possibility to check the
quality of the pesticides they buy
It is the responsibility of the government, of
manufacturers and of suppliers to check the
quality of pesticide
What is a specification?
 A list of criteria and parameters
...which allows a pesticide quality control
laboratory to check and to distinguish
between good and bad products of the
same type
 Fundamental properties are not verified
…therefore do specifications not relate to
the activity of the active ingredient...
…nevertheless they assist the user in
choosing the right product for his purpose
What makes a “good” product
 Correct appearance
 Contains the correct amount of active
ingredient
 Contains the minimum of relevant
impurities
 Does have acceptable physical-chemical
properties
 Does keep the correct content, acceptable
physical properties upon storage and does
not show unacceptable increase of relevant
impurities.
The FAO Manual on Specifications
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The 1st Edition of the Manual was published in
1971 and was the basis for 360 specifications “old
procedure”
The 5th Edition of the Manual in 1999 contains a
new procedure for development of specifications,
in which the requirements were significantly
enlarged.
The FAO/WHO Manual on
Specifications contd.
 Today, the 2010 Edition of the FAO/WHO
Manual on Specifications is available
 The FAO/WHO specifications are the basis
for the registration of pesticides in the EU,
in the countries of Andean Community and
in many other
The specifications are a source of
international harmonization
 Agricultural pesticides - FAO.
 Public Health Pesticides: WHO
linked with the efficacy testing by
WHOPES
 The manufacturers provide the data
package
New and old procedure by FAO
 Prior to 1999, 360 pesticide specifications
were published under “old procedure”
 Since 1999, specifications for more than
140 compounds under the “new procedure”
were elaborated and published
Main differences
between old and new procedure
 Specifications under the new procedure are
applicable only to the material evaluated by
the Panel of Experts of FAO and WHO
 The new procedure defines nevertheless a
process, how equivalence with a product of
a second manufacturer can be established.
Global pesticide market
Estimated at $27700 million (2003)
Western Europe 20%
Eastern Europe 3%
North America 30%
Far East 26%
26%
Latin America 14%
Others 7%
7%
20%
3%
14%
30%
Pesticide Market in the EU
• 20 % of pesticides sold worldwide are used in EU (appr. US
dollars 5.6 billion $)
• Distribution of pesticides in EU 2002:
• Patent protected
27%
• Generics
73%
• Estimates foresee more than 90 % generics in EU in 2011
Procedure for the development of
specifications
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Industry proposes the inclusion of new or revised
specifications into the program.
A member of the JMPS is designated as evaluator
of the data package.
The proposer presents draft specifications with
supporting information for a preliminary evaluation
for completeness.
FAO contacts the registration authorities of the
country where the product is registered for a risk
assessment.
Procedure for the development of
specifications (contd.)
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The evaluator checks whether the data package
meets the criterial for an evaluation within JMPS
The data on impurity profile are compared to those
held by the national authority
The JMPS meets one time per year and adopts or
rejects the specification
The specifications, once adopted, are published
together with the evaluation report. The process
takes approx. 18 months.
Elaboración de las Especificaciones de Plaguicidas para el uso en Agricultura y Salud Pública
FIRST PROPOSER
SUBSEQUENT PROPOSER
DRAFT SPECS AND SUPPORTING
DOCUMENTS
DRAFT SPECS AND (REDUCED)
SUPPORTING DOCUMENTATION
FAO/WHO
EVALUATION OF DATA
JOINT MEETING FOR PESTICIDE SPECIFICATIONS (JMPS)
SPECIFICATIONS AND
EVAL. FOR TC OR TK
EQUIVALENT
TO
REFERENCE
EFFICACY
TESTING(WHOPES)
PUBLICATION OF SPECS AND EVALUATION
FOR WHO – PUBLIC HEALTH
NOT EQUIVALENT
CORRECTED OR REJECTED
SPECIFICATION
PUBLICATION OF SPECS AND EVALUATION
AGRICULTURAL PESTICIDES FAO
FAO/WHO Programme of Specifications
Year
2005
Products
Proposer(s)
FAO
Clofentezine TC, SC
Chlorothalonil
Copper , cupric hydroxide and oxychloride
(to include copper calcium oxychloride), Bordeaux mixture, tribasic
copper sulphate
and cupric oxide
Cymoxanil
Diquat dibromide, SL
Ethofumesate TK,SC,EC,SE,OD
Nicosulfuron TC, WG
Pendimethalin TC,TK,EC
Rimsulfuron TC, WG
Makhteshim
Caffaro SpA, Vischim Srl,
SDS Biotech K.K.
European Union Copper
Task Force
Oxon
Syngenta
Bayer
Dupont
Industria Prodotti Chimici
Dupont
WHO
IR3535
Permethrin long-lasting insecticidal net
S-bioallethrin TC
Permethrin/S-bioallethrin EW
Temephos
Merck
Sumitomo
Sumitomo
Bayer
BASF
FAO & WHO
Alpha-cypermethrin TC, SC, WP
Bendiocarb TC, WP
Deltamethrin TC, WP
Deltamethrin TC, SC, WT, WG, WP, EC
Permethrin TC
Permethrin TC, EC
Pyriproxyfen TC,GR
Spinosad TC,GR,SC
BASF, Tagros
Agros
Agros
Tagros
Sumitomo
Tagros
Sumitomo
DAS
FAO/WHO Programme of Specifications
Year
2006
Products
Proposer(s)
FAO
Carbaryl TC,
Clodinafop propargyl …
Chlorothalonil TC
Clofentezine TC, SC
Fosetyl-Al TC, WG, WP
Propanil TC
Propaquizafop TC, EC
Bayer
Syngenta
Sipcam Agro USA, Inc.
Makhteshim
Bayer
Proficol, S.A.
Makhteshim
WHO
Alpha-cypermethrin LN
Bacillus thuringiensis israelensis WG, DT
Permethrin LN
Transflutrin TC
BASF
Valent BioSciences
Sumitomo
Bayer
FAO & WHO
Bendiocarb TC, WP
Chlorpyrifos TC, EC, UL
Deltamethrin TC
Dimethoate TC, EC
Etofenprox TC, EW, WP
Lambda-cyhalothrin TC, WP
rs-Methoprene TC, EC
Permethrin TC, EC
Argos
Cheminova, ACME Org.
Herbana Ind.
JSC Trans oil, Ukraine
Mitsui
Tagros
Babolna Bio
Tagros
Development of specifications
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Description in the FAO/WHO specification Manual,
Rome 2010
Accessible through:
http://www.fao.org/agriculture/crops/corethemes/theme/pests/pm/jmps/en/
It is not an international registration process
WHO uses same procedure.
Basis of specifications
 Formulations are prepared from technical
active ingredients (TC or TK).
 TC/TK specifications are indispensable for
the development of formulation
specifications.
 TC/TK specifications are simple - but a lot
of data are required to support such a
specification
A TC/TK SPECIFICATION
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Identity
structure, molecular weight etc.
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Manufacturing method (confidential data)
starting materials, solvents, conditions.
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Content of active ingredient in the technical
material (confidential data)
Data in g/kg for five typical batches, including the
manufacturing specification
A TC/TK SPECIFICATION... (continued)
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Physical and chemical properties:
vapor pressure, melting point, solubility in water
etc.
Methods used to check the quality (CIPAC
Methods!)
Toxicology data
tox package acute, subchronic and chronic
A TC/TK SPECIFICATION... (continued)
 Ecotoxicology
toxicity to fish, Daphnia, algae, birds, etc.
 Evaluation of risks
to be provided by IPCS, JMPR, national
authorities
These data is evaluated to
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identify relevant impurities;
make sure that all clauses are sufficiently
supported;
 avoid that undue advantage is created by a
specification
RELEVANT IMPURITIES
 Are those which can adversely influence
toxicological endpoints, or ecotox,
phytootoxicity, ecotoxicology, may
contaminate crops, may have adverese
effect on the stability of the pesticide etc.

Water or insolubles may be relevant in
certain cases
RELEVANT IMPURITIES (contind.)
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Are limited to such an extent that higher
amounts may increase the risk of the pesticide
during handling and use.
Methods. Peer validated methods are needed
to determine the content of these impurities.
The maximum permitted concentration is
expressed relative to the active ingredient
EQUIVALENCE
 More than one manufacturer of a certain
active may exist
 In most cases, all qualities of a certain
active can be controlled with the same
specification.
 In certain cases, a separate specification
or a modified specification may be
necessary.
FAO specification for paraquat, 2003 I
FAO specification for paraquat, 2003 II
CIPAC method Handbook G
CIPAC Methods: on CD ROM or in print, latest is Handbook N
EQUIVALENCE DETERMINATION
FOLLOWING THE “NEW PROCEDURE”
The aim is to determine whether or not:
• an existing specification is applicable to the similar
product of a second manufacturer
• the additional product may give rise to additional
dangers or major risks as compared to the product
the specification is based upon (not worse...)
Who can establish equivalence?
• FAO/WHO JMPS or a national authority.
• The national registration authorities cannot
establish equivalence by laboratory studies…
Who can establish
equivalence?(contd.)
• FAO/WHO cannot judge on national specifications….
• Users of pesticides and manufacturers cannot
evaluate equivalence….
• The confidential information is not disclosed to third
parties and is rigorously protected.
Official liaisons of FAO with other
organizations in developing
specifications
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With PCS or JMPR (for ADI and ARfD).
"Rotterdam Convention" (PIC).
With EU and national authorities
With CIPAC, AOAC International, OECD,
etc., for methods of analysis and
determination of physical properties.
Publications

FAO - evaluations and specifications :
http://www.fao.org/ag/agp/agpp/pesticid/

WHO - evaluations and specifications :
en:http://www.who.int/ctd/whopes/
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Plant Production and Protection Division - Plan Protection Service - Pesticide Management Unit
 Who we are
 Mission
 Staff
Welcome to FAO Pesticide Management
Pesticide Management is an activity carried out within the overall framework of the Plant
Protection Service of FAO. It is designed to work together with member countries as a partner to
introduce sustainable and environmentally sound agricultural practices which reduce the health
hazard associated with the use of pesticides.
Of particular concern are countries where living and working conditions make pesticide use more
hazardous. The International Code of Conduct on the Safe Use and Distribution of
Pesticides is providing solutions for this particular problem.
The environmental and health impact of pesticides is being reduced through the implementation
of a number of concrete programmes on pesticide management, including:
residue analysis
product standards setting and methods to analyze them
prevention of accumulation of obsolete stocks of pesticides and means to dispose them
exchange of information on national actions taken to control pesticides
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Plant Production and Protection Division - Plan Protection Service - Pesticide Management Unit
Programmes
International Code of Conduct
 Maximum Pesticide Residue
Levels (MRLs)
 Pesticide Specifications
 Prevention/
Disposal of Obsolete Pesticides
 Prior Informed Consent –
Rotterdam Convention (PIC)
 Management of Pesticides
Programmes
Welcome to the Plant Protection Service (AGPP)
The Plant Protection Service of FAO addresses international aspects of plant protection and closely
cooperates with regional and national plant protection organizations and programmes. The
programme addresses plant quarantine in the Secretariat to the International Plant Protection
Convention, setting standards, exchanging information and fostering cooperation. Concerning
pesticide management, the programme promotes the implementation of the International Code of
Conduct on the Distribution and Use of Pesticides; it implements with UNEP the PIC procedure on
banned and severely restricted pesticides and, with WHO, makes recommendations for maximum
residue levels.
On Pest Management, the Service supports the establishment of Integrated Pest Management
Programmes. including the application of Biological Control and weed management.
The Plant Protection programme provides regular updates on the desert locust situation through the
Desert Locust Information Service. A forum for countries to discuss and take action on locust
management is provided through the Desert Locust Control Committee and several Sub-regional
Commissions. The programme also technically supports and coordinates migratory pest control
operations, where so required.
Through the EMPRES programme, the Service assists in early warning, early reaction and research
on pests of a transboundary nature. Initial emphasis is on migratory pests, in particular the
strengthening and support of the Desert Locust Management System. A cooperative programme has
been developed in the Central Region and is being extended to West Africa.
Plant Protection Officers in the regions provide regional, sub-regional and national dimensions to the
Programme.
Plant Protection posts exist in the Regional Offices in Africa (Ghana), Asia and the Pacific (Thailand),
Latin America (Chile), and the Near East (Cairo), and in the sub-regional office in Tunis, Barbados
and Western Samoa. A Locust Officer is posted in Algeria.
For information
Niek Van der Graaff
Chief, Plant Protection Service
FAO Pesticide Management
Pesticide Specifications and Quality Control
Standards
FAO Specifications for Plant Protection Products
FAO Specifications for Plant Protection Products - (based on the old procedure).
Based on the old procedure (developed up to 1999), copies available for immediate download
(Word 6.0 format or PDF Format) are highlighted and next to the
green arrow.
FAO Specifications for Plant Protection Products - (following the new procedure).
Following the New Procedure (introduced in 1999) copies available for immediate download
(PDF - format) are highlighted and next to the
brown arrow.
Withdrawal of 27 outdated/obsolete pesticide specifications
Programme for the development of FAO/WHO Specifications, 2002 - 2006
Status Report of the Development of FAO Specifications
Meetings on Pesticide Specifications
Call for submission of applications to establish a roster of experts as candidates for
membership of the FAO Panel of the JMPS
FAO Pesticide Management
FAO Specifications for Plant Protection Products
New Specifications List
|A|B|C|D|E|F|G|H|I|L|M|N|O|P|Q|S|T|V|Z
SPECIFICATION
YEAR
bentazone
1999
bensulfuron-methyl
2002
beta-cyfluthrin
1999
|A|B|C|D|E|F|G|H|I|L|M|N|O|P|Q|S|T|V|Z
SPECIFICATION
YEAR
chlorpyrifos
2002
A|B|C|D|E|F|G|H|I|L|M|N|O|P|Q|S|T|V|Z
SPECIFICATION
YEAR
dazomet
2001
dicamba
2001
Outlook
 New technologies for control of pests
may require new specifications and
possibly adapted procedures
 The evolution of science and technology
may lead to different evaluation of risks
and risk management.
Conclusions

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FAO and WHO specifications are accepted
worldwide and promote the commercialization
of good quality pesticides and desencourage
that of low quality.
The procedures to develop specifications are
transparent and sufficiently flexible and the
specifications are easily accessible.
FAO and WHO cooperate with other
organizations like CIPAC to make best use of
available resources.
Thank you for your attention