CHAPTER 8: GUIDANCE ON EFFICACY REQUIREMENTS

1 Chemicals Regulation Directorate Data REQUIREMENTS handbook 26/11/2010 CHAPTER 8 - 1 EFFICACY CHAPTER 8: GUIDANCE ON EFFICACY REQUIREMENTS CONTENTS Section Page 1 Introduction 2 EFFICACY REQUIREMENTS 2 Meeting EFFICACY REQUIREMENTS 2 Contact information 3 2 Scope of EFFICACY REQUIREMENTS 4 Legislative basis 4 Areas to be addressed under PPPR 4 Differences in areas addressed under COPR 7 3 Meeting EFFICACY REQUIREMENTS 8 Introduction 8 Presentation of EFFICACY information 9 Levels of control expected to be demonstrated 10 Overseas evidence 12 Extrapolation 14 Public domain evidence 15 Data owned by others 16 Experimental Data 16

2 Conducting field trials 18 4 Situation-Specific GUIDANCE on Meeting EFFICACY REQUIREMENTS 25 Extrapolation between glasshouse or growth room tests and outdoor use 25 Biological Control Agents and pheromones 25 Comparability of pesticide formulations 26 GUIDANCE on extrapolation in specific situations 32 Numbers of trials required for major crops. 36 Pest populations required in trials 36 Information required in support of peripheral label claims 38 5 EFFICACY Guidelines 42 Chemicals Regulation Directorate Data REQUIREMENTS handbook 26/11/2010 CHAPTER 8 - 2 EFFICACY 1.

3 Introduction The intrinsic biological activity of pesticides poses the potential for risks to operators, consumers and the environment. Whilst methods are available to reduce exposure and thus, reduce any risks ( the use of protective clothing), no risk, however small, can be considered acceptable unless there is a proven benefit from the use of the pesticide. The main purpose of the EFFICACY consideration is to ensure that when a pesticide is used as recommended on the label, a consistent benefit will be achieved. These GUIDANCE notes are intended to provide an outline of the EFFICACY REQUIREMENTS for approval and how these may be met.

4 It is impracticable to set rigid guidelines for all types of pesticides, thus the information given is intended only as GUIDANCE , and the Environment Branch of CRD is always willing to discuss individual situations with applicants in more detail where necessary. EFFICACY REQUIREMENTS The areas that need to be addressed in an EFFICACY submission are broadly comparable for COPR and PPPR but with some changes of emphasis and a few additions in the more recent legislation. If you are applying to register a pesticide you will need to have done the following.

5 Lxviii) Provided evidence to support all the claims for control that you have included on the label. lxix) Demonstrated that the product is safe to the crops on which you recommend its use. lxx) Demonstrated an acceptable level of safety to adjacent and following crops. lxxi) Supported all peripheral claims such as rainfastness, use of mixtures, safety to beneficial insects etc. In some cases you may also be required to lxxii) Consider and address the risk of resistance developing to an active substance. lxxiii) Justify the dose you propose to specify on the label.

6 Meeting EFFICACY REQUIREMENTS The information we require you to provide may come from a range of sources, detailed below, and must be presented in a suitable format, either as an EFFICACY overview (for COPR applications only) or preferably as a Biological Assessment Dossier (BAD). OECD format dossiers are also acceptable, provided all Annex III EFFICACY REQUIREMENTS are addressed and the data summarised in an appropriate format (see ). In all cases you are advised to read the relevant detailed guidelines that follow.

7 Chemicals Regulation Directorate Data REQUIREMENTS handbook 26/11/2010 CHAPTER 8 - 3 EFFICACY Table : Sources of information to meet EFFICACY REQUIREMENTS . Extrapolation Provided a sound database is available it may be possible to extrapolate information from one target or crop to another closely related one, between different cropping situations or between closely related formulations. Public Domain Evidence Suitable information in published papers and books, including the Weed Control handbook . Data owned by others Where data are protected they may be used if a suitable letter of access is provided by the owner.

8 Where confidential data are no longer protected they may be used to support an application but remain confidential. Trials data A programme of trials can be used to generate data specific to a given product application. Trials can be conducted in the UK or overseas though for the latter you should provide an acceptable case detailing why they are applicable to UK conditions. If you are planning to conduct trials please ensure you are familiar with any relevant GUIDANCE , such as EPPO guidelines. Please note that most EFFICACY data generated in the UK since 1998 must have been produced by an Officially Recognised organisation.

9 Other dates apply for elsewhere in the EU. Further details are in section Contact information Should you have any query relating to EFFICACY , please use one of the following contact addresses: Environment Branch Tel: 01904 455775 CRD Mallard House Fax: 01904 455711 Kings Pool 3 Peasholme Green Email: York YO1 7PX Chemicals Regulation Directorate Data REQUIREMENTS handbook 26/11/2010 CHAPTER 8 - 4 EFFICACY 2. Scope of EFFICACY REQUIREMENTS Legislative basis The EFFICACY REQUIREMENTS for the registration of pesticides in the UK are defined in the Control of Pesticides Regulations 1986 (COPR), as amended and the Plant Protection Products Regulations 1995 (PPPR) as amended.

10 Under COPR pesticides can only be approved when Ministers are satisfied that they can be used safely and effectively. CRD's REQUIREMENTS for approval were previously outlined in the Registration handbook and separate EFFICACY guidelines. The PPPR implement the EC Council Directive 91/414/EEC which lays down specific REQUIREMENTS for the information necessary for evaluating EFFICACY . These are detailed below. COPR will continue until all existing EC active substances are reviewed and placed on Annex I (positive list). PPPR will apply to new active substances coming onto the UK market and existing EC reviewed active substances that obtain Annex I listing.