1. Introduction

1.1. Scope of specifications

The term "pesticide" is considered to embrace active ingredients in any form, irrespective of whether, or to what extent, they have been formulated for application. The term is usually associated with materials intended to kill or control pests (insecticides, fungicides, herbicides, etc.) but, for the present purposes, it also embraces certain materials to control the behaviour or physiology of pests (e.g. insect repellents and insect growth regulators) or of crops during production or storage.

FAO and WHO specifications relate only to pesticides produced by manufacturers whose data on those pesticides have been evaluated as satisfactory by the FAO/WHO Joint Meeting on Pesticide Specifications (JMPS).

The specifications encompass the physical appearance of the material, its content of active ingredient and any relevant impurities, and its physical properties.

The specifications do not encompass the chemical characteristics of the formulants, other than where they influence the physical characteristics (which are taken to include characteristics such as pH, acidity and alkalinity). The specifications do not include clauses which define the fundamental properties of the active ingredient and this includes the efficacy of the pesticide^[10]. Data on the efficacy of pesticides are not evaluated by the JMPS. FAO specifications for agricultural pesticides are developed only after registration by the manufacturer in one or more countries and the efficacy of these pesticides is usually inferred from this evidence. However, the efficacy of the active ingredient and formulations of public health pesticides will be evaluated in laboratory and field trials by the WHO Pesticide Evaluation Scheme (WHOPES), usually when the WHO/FAO specification for the technical material is developed. WHO specifications for formulations are published, following satisfactory evaluation of safety and efficacy. In special cases, where specifications are required during evaluation of the efficacy of a novel product for public health for example, WHO may introduce an interim specification for a formulation and may also introduce an interim guideline specification for the same purpose.

FAO/WHO specifications are intended for quality assurance and risk management. The hazards and risks associated with pesticides are considered, for specifications purposes, by the WHO Programme on Chemical Safety (WHO/PCS). This involves provision of an opinion by WHO/PCS on summary data, which takes account of evaluations by the FAO/WHO Joint Meeting on Pesticide Residues (JMPR) and/or national registration authorities. In the absence of evaluation by bodies such as these, the WHO/PCS conducts a detailed assessment of original studies before the JMPS proceeds with the development of specifications. An important aspect of the assessment of hazards and risks is to determine the links between (i) the hazard and purity/impurity profile data submitted, and (ii) the purity/impurity profile data submitted and the limits for purity/impurities applied in normal manufacturing production. FAO and WHO recognise that generation of replicate data on all potential/actual hazards by each manufacturer of a pesticide may be unnecessary and ethically undesirable. The lack of direct links in (i), above, does not preclude development or extension of a specification but proposers are required to disclose the links, or lack of them, to ensure that JMPS recommendations are based upon a properly informed assessment of hazards and risks.

1.2. The JMPS

The JMPS is composed of scientists collectively possessing expert knowledge of the development of specifications. Their opinions and recommendations to FAO/WHO are provided in their individual expert capacities, not as representatives of their countries or organizations. Experts appointed by FAO are drawn from the FAO Panel on Pesticide Specifications, Registration Requirements, Application Standards and Prior Informed Consent. Experts appointed by WHO are drawn from the WHO Panel of Experts on Vector Biology and Control, together with a representative of the WHO/PCS.

FAO and WHO may also invite academic or government experts with special skills or knowledge to attend the JMPS as special advisors.

In addition, industry experts may be invited for either of two purposes. Firstly, they may be invited to provide explanations or additional information in support of specifications proposed by their own company (there is no access to other companies’ information or proposals). Secondly, industry scientists with special skills or knowledge of technical issues (not related to a particular company’s proposals or specifications) may be invited. Industry experts do not, and the other additional experts may not, participate in drafting the recommendations of the JMPS (see also 2.3).

The primary function of the JMPS is to produce recommendations to FAO and/or WHO on the adoption, extension, modification or withdrawal of specifications.

1.3. Liaison with other international organizations, international conventions and national regulatory authorities

1.3.1 Collaborative International Pesticides Analytical Council (CIPAC) and AOAC International (AOAC)

Wherever practicable, the test methods cited in FAO/WHO specifications should have been evaluated by inter-laboratory trials.

CIPAC and AOAC publish methods of analysis which have been accepted after collaborative testing (which may include peer verification). CIPAC also tests and publishes methods for the determination of physical properties. Methods to be used in support of FAO and WHO specifications may be validated by other organizations but, with few exceptions, the methods currently in use have been produced by CIPAC and AOAC. Methods for determination of the active ingredient or of a physical property, other than those validated by CIPAC or AOAC, are accepted by the JMPS on a case-by-case basis. In cases of dispute, designated referee methods should be used. Where available, those produced by CIPAC and AOAC will normally be considered the referee methods (unless they have been proven inferior to another method).

1.3.2 FAO/WHO Joint Meeting on Pesticide Residues (JMPR)

The principal function of the JMPR is to make recommendations on the acceptable daily intake (ADI), acute reference dose (acute RfD) and maximum residue limits (MRLs) for pesticides, to FAO, WHO and the Codex Committee on Pesticide Residues. In its 1999 report, the JMPR proposed that its evaluation of the toxicology and residues of a pesticide should, as far as practicable, be conducted following the development of FAO/WHO specifications for that pesticide. The proposal was accepted by the Codex Committee on Pesticide Residues in 2001. The procedure enables the JMPR to take account of the impurities, especially relevant impurities, in its evaluations. Ideally, the JMPR and JMPS evaluations should be conducted in the same year, because this ensures comparability of data provided and minimises duplication of effort in providing the data. FAO and WHO recognise that it will take several years to harmonise the JMPS and JMPR agendas for this purpose.

1.3.3 Rotterdam Convention on Prior Informed Consent (PIC)

Existing FAO or WHO specifications for pesticides which are subject to the Rotterdam Convention, or could become subject to the Convention following consideration by the Interim Chemical Review Committee (ICRC), are prioritized for review, and withdrawal if appropriate, by the JMPS. Such specifications may be retained if by changing the formulation, or control of parameters such as the concentration of relevant impurities, the risks - to those handling or using the pesticide, or to the environment - are thereby acceptably reduced.

1.3.4 Stockholm Convention on Persistent Organic Pollutants (POP)

Existing FAO or WHO specifications for pesticides which are subject to the Stockholm Convention are prioritized for review and withdrawal by the JMPS, as required.

1.3.5 International Organization for Standardization (ISO)

English ISO^[11] common names, accepted by ISO, are adopted wherever possible.

1.3.6 International Nomenclature for Cosmetic Ingredients (INCI)

The standard names for insect repellents published by INCI are adopted where appropriate.

1.3.7 Organization for Economic Co-operation and Development (OECD)

The OECD references FAO and WHO specifications for active ingredients and formulations in its harmonised recommendations for registration.

1.3.8 United Nations Industrial Development Organization (UNIDO)

UNIDO co-operates with FAO and WHO in establishing technical specifications for active ingredients and formulations, and uses or recommends the use of such specifications in its technical assistance programmes.

1.3.9 National and regional registration authorities

As far as practicable and without prejudice to the progress of specifications development by any of the organizations, FAO, WHO and the JMPS seek harmonization of principles and specification requirements with registration authorities. Normally, WHO/PCS bases its evaluation of risks and hazards to the health and environment on the detailed evaluations made by national registration authorities. This cost- and time-efficient approach can be replaced by a WHO/PCS full evaluation of all data if either WHO/PCS or the JMPS recommends this course of action.

The European Community (EC) has harmonized pesticide registration and control systems in member countries and FAO specifications are an important feature of the authorization Directives. Specification requirements for agricultural pesticides in various developing countries are also being harmonized with those of FAO.

1.4. Participation by the Pesticide Industry

1.4.1 Development of specifications

The data on which FAO and WHO specifications are based are provided by the pesticides industry. Pesticide manufacturers are strongly encouraged to submit draft specifications and the supporting data to the JMPS for evaluation. As far as practicable, and where applicable, submissions should coincide with corresponding submissions to the JMPR (1.3.2, above).

1.4.2 WHOPES efficacy data requirements

Data on efficacy provided by industry at are assessed by WHOPES in deciding further laboratory and field testing requirements, prior to the development of formulation specifications by the JMPS. Efficacy data are not considered by the JMPS.

1.4.3 Changes affecting specifications after adoption by FAO and WHO

It is the responsibility of industry to inform FAO and/or WHO of any changes in manufacturing process which could affect the validity of specifications, and of any changes in manufacturer’s name or contact address. Such changes in manufacturing process should be evaluated by the JMPS. Failure to provide this information may lead to withdrawal of the specification.

1.4.4 Development of specification guidelines and principles

Industry is strongly encouraged to prepare draft guideline specifications for new formulation types for consideration by the JMPS. Comments on, or suggested amendments to, proposed or existing guidelines may come from industry, experts participating in the JMPS or any other interested party. Guidelines are kept under review by the JMPS. Guidelines and related matters are normally considered at open meetings (see glossary of terms, Appendix C) of the JMPS but are adopted by a closed meeting. As part of a continuing process by FAO and WHO to consider specification principles, representatives of all pesticide manufacturers are strongly encouraged to participate in open meetings of the JMPS. Industry groups (for example, CropLife International and the European Crop Care Association, ECCA) may be invited to provide technical experts as advisers to special consultation sessions of the JMPS, to facilitate a fully informed deliberation of issues. Industry experts are not involved in preparing JMPS recommendations to FAO and WHO.

1.5. Purpose and use of specifications

1.5.1 Purpose

In general, specifications may be used:

(i) as part of a contract of sale, so that a buyer may purchase a pesticide with some guarantee of the quality expected; and

(ii) by the competent authority to check that the quality of the formulation on the market is the same as that registered.

FAO/WHO specifications are intended to enhance confidence in the purchase and use of pesticides and thus to contribute to human and environmental safety, as well as to more sustainable agricultural production and improved public health. FAO/WHO specifications may be used by national authorities as an international point of reference but are not intended to replace national or international registration requirements.

1.5.2 Requirements

In order to characterize a pesticide, it is necessary to be able to determine its composition and chemical and physical properties.

It is clearly not practicable to test all possible chemical and physical properties. The parameters critically related to identity and quality are identified and limits for these parameters selected to form the basis of a specification. A specification should be brief but it must be unambiguous and supported by appropriate test methods to determine whether the material conforms with the limits established. The specification itself does not define biological efficacy nor give information on hazards but this type of information (e.g. flash point, explosive properties) may accompany a specification, even though it does not form a part of the specification.

1.5.3 Basis of contract

A specification may be used as part of a contract of sale, to ensure delivery of good quality pesticides.

Pesticides should continue to be fit for use after storage for at least two years in the unopened, original containers, provided that (i) they have not been unduly exposed to extremes of temperature, humidity and/or light; (ii) that labels (for example, prepared according to FAO labelling guidelines^[12]) do not indicate a shorter shelf-life; and (iii) that any special instructions from the manufacturer have been followed.

1.5.4 Official control of pesticides

Where appropriate, FAO and WHO specifications should be linked to registration requirements so that they can also be used in the official control of pesticides, to ensure as far as possible that the quality of the pesticide supplied is the same as that registered. The guidelines provided in this Manual may also be used as a framework of criteria and/or parameters for the assessment of formulations for which FAO or WHO specifications do not exist.

Ultimately the competent authorities decide whether or not a particular pesticide shall be used in their country.

WHOPES recommendations on the use of public health pesticides expedite the local registration of products to be used for the control of vectors and pest of public health importance and minimize requirements for local testing of products that have given satisfactory results in similar circumstances. Reports of WHOPES evaluations of public health pesticides are available on request from the address given in section 1.6.

1.5.5 Role of specifications in the world market

Harmonization of relevant national and/or international standards through the use of FAO and WHO specifications should facilitate world trade in pesticides.

FAO and WHO specifications are designed to reflect generally acceptable product standards. The specifications provide an international point of reference against which products can be judged, either for regulatory purposes or in commercial dealings, and thus help to prevent the trading of inferior products. They define the essential chemical and physical properties that may be linked to the efficacy and safe use of a product.

1.6. Access to FAO and WHO specifications

Users of specifications are advised that these are subject to a continuing process of up-dating and that it is essential that only the most recent version is used. In case of doubt, confirmation of the most recent version may be obtained from FAO or WHO.

Copies of current FAO specifications may be obtained from the Sales & Marketing Group, FAO, Viale delle Terme di Caracalla, 00100 Rome, Italy.

Copies of current WHO specifications may be obtained from the WHO Pesticide Evaluation Scheme, Communicable Disease Control, Prevention and Eradication, World Health Organization, 1211 Geneva 27, Switzerland.