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Efficacy Guidelines

Introduction

The Efficacy pages are currently under re-development to update and reflect the requirements under Regulation 1107/2009.  Key changes will reflect zonal assessments.  A brief summary of relevant information is provided below, which is available either on EU SANCO, or European Plant Protection Organisation (EPPO) websites.

Information on National Efficacy requirements were contained in Chapter 8 of 'The Data Requirements Handbook', and a number of UK specific guidance relating to UK crops, pests and situations of use.

This guidance has now been removed from these pages, although a complete copy can still be fully accessed via Efficacy Data Requirements Handbook chapter on National Archive.Where they are still relevant either to UK-only applications or zonal applications under 1107/2009, information has been retained here but you will need to access the archive link for full details.

Data requirements and accompanying guidance

a) Active Substance

Commission Regulation (EU) No 283/2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009

SANCO/10054/2013 (rev. 3) 'Guidance document on data requirements on efficacy for the dossier to be submitted for the approval of new active substances contained in plant protection products

SANCO/2012/11251 (rev. 4) 'Guidance document on the renewal of active substances to be assessed in compliance with Regulation (EU) No 844/2012 (the Renewal Regulation)

b) Product Authorisations

Commission Regulation (EU) No 284/2013setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009

SANCO/10055/2013 (rev 4) 'Guidance document on the efficacy composition of core dossier and national addenda submitted to support the authorization of plant protection products under regulation (EC) no1107/2209 of the EU parliament and council on placing of plant protection products on the market'

(Please also refer to UK Guidance 103 – see below – for Article 80 5b product re-registrations governed by the transitional arrangements).

EPPO Standards in relation to Generating Data to Support Efficacy Zonal Authorisations

Reference should be to all current EPPO standards, both general standards on addressing Efficacy data requirements, and any relevant specific crop/target standards.

In addition EPPO have developed a specific area on zonal efficacy assessments:

Applicants should follow EPPO PP 1/278 'Principles of zonal data production and evaluation', and also refer to the accompanying examples.  This is an area under development and more examples may be added.  As part of this, applicants should be aware and understand the relationship between EPPO comparability regions and EU regulation zones (illustrated below).

EU vs EPPO Zones

The EPPO minor use tables also provide useful indications on what are considered key pests on various crops, as well as appropriate extrapolations. ('Minor uses of plant protection products and extrapolation tables).

UK Additional Guidance

Below is further current guidance that applicants should refer to when making an application for uses in the UK.  This guidance covers:

General Guidance on Generating Data and Submitting Applications


Number

Title

Notes

101

Guidelines for the preparation of a Biological Assessment Dossier.

Revised May 2008
Also see EPPO Standard 1/181.

103

Efficacy Requirements for the Re-registration of Products Considered under the Transitional Arrangements of Regulation 1107/2009

Revised July 2012

110

Official Recognition of Efficacy Testing Organisations.

Revised July 2012

117

Groundwater metabolites - guidance on efficacy aspects

Application or Situation Specific Guidelines


Number

Title

Notes

211

Efficacy Data Requirements for Home Garden Products.

Crop Safety Guidelines


Number

Title

Notes

302

Cleaning Application Equipment – Efficacy Aspects

303

Effects on Non-Target Crops of Highly Active Herbicides – Including Mixtures and Sequences

305

Cleaning Application Equipment – Small scale jar test protocol

Crop Specific Guidelines


Number

Title

Notes

403

Provision of information on tree canopy size in efficacy and residue trials in apple orchards.
(HDC tree fruit dosing leaflet).

Updated Jan 2013.

406

Data requirements for Turf Fungicides, Herbicides, Insecticides and Plant Growth Regulators.

Chemical and Control Specific Guidelines: Resistance Management and tank mixtures/sequences


Number

Title

Notes

601

Resistance Warnings on Labels of Insecticide and Acaricide Products.

Revised May 2008.

602

Resistance Warnings and Restrictions on Labels of Professional Herbicide Products.

Revised Sept 2007.

603

Fungicide Resistance: label advice and restrictions.

Draft issued February 2008. Please send any comments to Environment@hse.gov.uk.

604

Efficacy Data Required For Tank Mixtures and Sequences of Pesticides.

606

Resistance risk analysis and use of resistance management strategies.

Revised May 2008.

611

Guidance on the Restriction of Use of High Resistance Risk Herbicides.

Issued June 2007.

617

Re-registration of Triazole uses in cereals: fungicide resistance issues

Issued July 2012.

Other efficacy related guidance

Title Notes

'Efficacy Assessments: UK Product Labelling and National Issues/Addenda'

Applicants are advised to use a dRR when submitting an Efficacy UK Addenda.  This annotated version includes advice on when a UK-specific addendum would be required, and what information would be expected in this document.  It also includes efficacy related UK labelling requirements, including claims for levels of control. This is currently a DRAFT document.

Tank mixture of plant protection products – Updated UK Requirements

Qualified recommendations

Advice on data requirements for including qualified recommendations for minor use on product labels.

Groundwater metabolites

Further to SANCO/221/2000-rev.10, issued 25 February 2003, CRD provides additional advice on the efficacy aspects of determining relevant groundwater metabolites in Efficacy guideline 117 - Groundwater metabolites - guidance on efficacy aspects (issued 14 October 2010, pdf, 6 pages, 140 kb).

UK guidance on plant protection pesticide (PPP) formulation changes- efficacy requirements  
Updated 2017-03-28