Regulatory Requirements

John Unsworth
7th April 2010


The registration of pesticides and their formulations by government agencies began after World War II and was given further impetus by the publication of Rachel Carson’s book “Silent Spring” in 1962. Since that time the regulatory process for pesticides has become more stringent and, in order to compare the properties of different pesticides, the requirements for registration have become more formalised. This has resulted in a large number of documents being published which give detailed instructions on which studies are needed, how to report results etc.


An excellent source of information on pesticide regulation can be found on the OECD web site1, where a search using the word “pesticides” yields many useful documents. These include links to other regulatory sites2, guidance on the preparation of documents for pesticide registration3 and the launch of an initiative for a global regulatory scheme by 20144. Whilst countries in the OECD respect the OECD initiatives on pesticide regulation many have their own systems in place.


United States - The US Environmental Protection Agency (EPA) web page on registration5 explains that “Pesticide registration is the process through which EPA examines the ingredients of a pesticide; the site or crop on which it is to be used; the amount, frequency and timing of its use; and storage and disposal practices. EPA evaluates the pesticide to ensure that it will not have unreasonable adverse effects on humans, the environment and non-target species. A pesticide cannot be legally used if it has not been registered with EPA's Office of Pesticide Programs”. The EPA has separate review processes for three categories of pesticides: conventional, biopesticides and antimicrobials.


The US Environmental Protection Agency (EPA) regulates pesticides under broad authority granted in two major statutes. These statutes are:


            The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)


The Food, Drug and Cosmetic Act (FFDCA)


Both FIFRA and FFDCA were amended by the Food Quality Protection Act (FQPA) of 1996 such that the EPA must find that a pesticide poses “a reasonable certainty of no harm” before it can be registered for use on food or feed6. 


On the EPA web site details can be found on the federal registration procedure for the United States, with links to other EPA web sites that give a more detailed description of the requirements and procedures for registration5. As well as Federal registration individual states may also have special registration requirements e.g. California7 and Arizona8.

Europe - In the EU a distinction is drawn between plant protection products and biocides and these products are regulated under two different directives. The main legal instrument that governs crop protection products in Europe is Directive 91/414/EEC9, which will be superseded by Directive 2009/128/EC10, and Directive 98/8/EEC11 governs biocides.  Whilst there are many similarities there are also differences in the regulatory requirements for the two classes of product. Directive 91/414/EEC regulates the placing of crop protection products on the market and harmonises national product approval requirements throughout Europe. The approval process consists of two main stages: in the first, the active substance must be approved at the EU level, and in the second, formulations (products) for national markets must be registered by the Member States.

Directive 91/414/EEC  states that “active substances cannot be used in plant protection products unless they are included in a positive EU list”. An EU programme of evaluation to create this list is underway. Most of the active substances under evaluation are pesticides but many – such as growth regulators, pheromones etc. – are not. All plant protection uses are covered; not just those in agriculture. Pesticides used in other areas, for example as veterinary drugs or as biocides, are covered by other legislation. Once a substance is included in the positive list Member States may authorize the use of products containing them.Individual European countries also issue registration information for pesticides e.g. Finland12 and the UK13.

 Many other countries have information on their regulatory requirements, including Australia14, Canada15 and Japan16.


It is also worth remembering that apart from official government sites there are other sites from, for example, Trade Associations17,18 which also contain useful information on regulatory requirements and up-to-date interpretation of current guidelines.


The International Code of Conduct on the Distribution and Use of Pesticides19 is the globally accepted standard for pesticide management. It was first adopted by FAO and its member countries in 1985 and the revised version adopted in 2002. The Code of Conduct recognizes that: “In the absence of an effective pesticide registration process and of a governmental infrastructure for controlling the availability of pesticides, some countries importing pesticides must heavily rely on the pesticide industry to promote the safe and proper distribution and use of pesticides. In these circumstances foreign manufacturers, exporters and importers, as well as local formulators, distributors, repackers, advisers and users, must accept a share of the responsibility for safety and efficiency in distribution and use.”



  1.       1. Organisation for Economic Co-operation and Development (OECD), Home Page


      2.     Organisation for Economic Co-operation and Development (OECD), WWW Pesticide Sites in OECD Countries and Other Organisations,2340,en_2649_34383_1933455_1_1_1_1,00.html


      3.     Organisation for Economic Co-operation and Development, OECD Guidance Documents for Pesticide Registration



  1.        4. Organisation for Economic Co-operation and Development, A Global Approach to the Regulation of Agricultural Pesticides - A Vision for the Future


      5.     US Environmental Protection Agency, Pesticides, Registering Pesticides


  1.       6.  US Environmental Protection Agency, Pesticides, Accomplishments Under the Food Quality Protection Act (FQPA), August 2006


      7.     California Department of Pesticide Registration, Registration Forms and Instructions



      8.     Arizona Department of State, Arizona Administrative Code, Title, Agriculture, Chapter 3. Department of Agriculture, Environmental Services Division



9.     Europa, Plant Protection Products, Directive 91/414/EEC



10.   Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009,

            Establishing a Framework for Community Action to Achieve the Sustainable Use of Pesticides,   Official Journal of the European Union L 309/71, 24 November 2009



   11.  Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market



12.  Finnish Food Safety Authority (Evira), Registration of Plant Protection Products       of_plant_protection_products/


13.  UK Health and Safety Executive, Chemicals Regulation Directorate, Pesticides, Applicant Advice



14.  Australian Pesticides and Veterinary Medicines Authority (APVMA), Product Registration



15.  Health Canada, Consumer Product Safety, The Regulation of Pesticides in Canada



16.  Japanese Food and Agricultural Materials Inspection Center (FAMIC), Data Requirement and Test Guideline



17.  CropLife International, Position Papers



18.  European Crop Protection Association (ECPA), Reading Room



      19.  Food and Agriculture Organisation (FAO), International Code of Conduct on the Distribution and Use of Pesticides, Rome 2003






Last modified 7th April 2010


Date added: 2010-05-08 01:07:24   
Last Updated 2010-05-10 04:31:43   
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