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Efficacy Guidelines

Introduction

The Efficacy guidelines contain information additional to the general guidance in the redrafted registration handbook (now renamed the Data Requirements Handbook). In many cases they have been developed in collaboration with the Crop Protection Association (CPA) through the Efficacy working group. They are arranged in a number of sections;

Latest Update:

Revision of Efficacy guideline '103 - Efficacy Requirements for the UK Re-registration of Products Considered under the Transitional Arrangements of Regulation 1107/2009'

This guideline explains how to address the UK efficacy requirements for the existing products at re-registration and should be followed for all products completing their 91/414 re-registration in the UK. First issued in 2005, it has been updated in 2012 not only to clarify the procedures now that (EC)1107/2009 has been implemented, but also to reflect the experience gained since re-registration started.

The following draft guidelines are available and comments are invited.

Regulatory Update 15/2010: Efficacy considerations relating to the current 91/414 Directive, and introduction of the New Regulation (EC 1107/2009)

There are various new developments affecting the way in which evaluations of for plant protection products are conducted, both now and in the future. Central to this is the new Regulation (EC 1107/2009) for placing plant protection products on the market (replacing Directive 91/414/EEC), which applies from the 14th June 2011. One of the key new provisions is zonal authorisations, with the EU divided into three zones. The UK is included as part of the 'Central' zone.

Draft Registration Report (dRR) Guidance and Template

Following on from Regulatory Update 15/2010, proposed amendments to the dRR guidance and template documents to provide further guidance on future efficacy zonal assessments are now available.

220 Data Requirements and Trials Design for Mating Disruption Pheromone Products.

603 Fungicide Resistance: label advice and restrictions.

Restrictions on fungicide use and label advice and warnings required to support resistance management.

These guidelines are published as drafts to allow any further comments, and if you wish to do so please e-mail environment@hse.gsi.gov.uk.

Efficacy guidelines

The following guidelines on the generation of efficacy data are available in pdf format from this site.

Applicants should also be aware of the EPPO standards on Efficacy Evaluation of Plant Protection Products. These EPPO standards are available as a web-based database from the European and Mediterranean Plant Protection Organisation (EPPO) (http://pp1.eppo.int/). All general standards can be accessed free of charge. Access to specific standards is provided for an annual fee. Our guidelines marked 'EPPO Standard n/nnn' in the notes column have either been superseded or adopted and published in a revised form as EPPO standards.

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.

102

Guidance on the preparation of an Efficacy Overview.

Historical - use 101 for dossier preparation.

103

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

Revised July 2012

104

Guidance for Efficacy Sifting of New Active Substance Submissions.

110

Official Recognition of Efficacy Testing Organisations.

Revised July 2012

111

Guideline on statistical analysis of efficacy data.

Also see EPPO Standard 1/152.

112

Guidance on Conducting User Trials.

113

Requirements for an Efficacy Assessment and Availability of Relevant Guidance.

Revised May 2008
EPPO Standard 1/223.

114

Guidance on the status and use of EPPO guidelines for the efficacy evaluation of plant protection products.

115

Guidance on Numbers of Trials in Target Crops for Demonstration of Efficacy and Crop Safety.

EPPO Standard 1/226.

116

Minimum effective dose.

EPPO standard 1/225;
Note this was previously guideline 605.

117

Groundwater metaboilites - guidance on efficacy aspects

118

Soil texture and pesticides

Issued September 2012

Climate Comparability Guidance.

EPPO standard 1/241.

Application or Situation Specific Guidelines.

Number

Title

Notes

201

Fabric treatments with residual insecticides.

202

Fumigants for the control of insect and mite pests of stored products.

203

Pesticides for admixture with stored cereals to control insects and mites.

204

Space treatments – against flying insects.

205

Larvicides in animal rearing units.

206

Baits for the control of houseflies in animal rearing units.

207

Hand held aerosols and ready for use sprays against crawling insects.

208

Seed treatments – Efficacy and physical/mechanical data requirements.

209

Propagule fungicide/insecticide treatments data requirements – Efficacy and physical/mechanical data requirements.

210

Simulation of aerial application to field crops using ground based sprayers.

211

Efficacy Data Requirements for Home Garden Products.

220

Data Requirements and Trials Design for Mating Disruption Pheromone Products.

Crop Safety Guidelines

Number

Title

Notes

301

Guidance on Taint Testing

Updated Jan 2005.

EPPO Standard 1/242.

302

Cleaning Application Equipment – Efficacy Aspects

303

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

304

Transformation Processes

EPPO Standard 1/243.

305

Cleaning Application Equipment – Small scale jar test protocol

306

Plant parts for propagation

307

Quality Parameters – Cereals

Crop Specific Guidelines

Number

Title

Notes

401

Efficacy testing of Apple and Pear Fungicide and Insecticides.

Updated April 2008.

402

Guidance document on Trials Requirements for a Potato Haulm desiccant.

403

Provision of information on tree canopy size in efficacy and residue trials in apple orchards.

(HDC tree fruit dosing leaflet).

Updated Jan 2013.

404

Data requirements for PGR products in pome fruit (pre-harvest, post-harvest and ‘in store’ applications).

405

Data requirements Oilseed Rape and Brassica pests, diseases and weeds.

EPPO are developing guidance for Vegetable Brassica extrapolations as part of Standard 1/257.

406

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

Pest/Disease/Weed specific Guidelines

Number

Title

Notes

510

Evaluation of Molluscicides.

530

Requirements for a new late blight fungicide for potatoes.

Updated August 2008.

590

Guidelines on Efficacy Tests for Rodenticides.

591

Guidelines on efficacy testing of mammal and bird repellents.

592

Requirements for products used for mole control.

Chemical and Control Specific Guidelines

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.gsi.gov.uk.

604

Efficacy Data Required For Tank Mixtures and Sequences of Pesticides.

605 (now 116)

Minimum Effective Dose.

EPPO standard 1/225.

606

Resistance risk analysis and use of resistance management strategies.

Revised May 2008.

607

Insecticide Mixtures: Justification for use and implications for resistance management in the United Kingdom.

Issued June 2007.

608

Using Non-toxic Slug Traps when Assessing Slug Activity and the Risk of Damage in Winter Wheat and Oilseed Rape.

Issued February 2009.

Was regulatory update 21/2006.

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.

630

Data requirements for Aqueous Dispersions of Sulphur.

Other efficacy guidelines

Efficacy considerations relating to the current 91/414 Directive and introduction of the new regulation (EC 1107/2009).

There are various new developments affecting the way in which evaluations of plant protection products are conducted, both now and in the future. Central to this is the new Regulation (EC 1107/2009) for placing plant protection products on the market (replacing Directive 91/414/EEC), which applies from the 14th June 2011. One of the key new provisions is zonal authorisations, with the EU divided into three zones. The UK is included as part of the 'Central' zone. Guidance has been issued under Regulatory Update 15/2010

CPA paper on climate comparability.

A justification for climate comparability to allow the use of efficacy trials data from defined areas of continental Europe in support of applications for authorisation of plant protection products in the UK.

Note: This has now been superseded by EPPO standard 1/241 and should be read in conjunction with AAHL 11/03.

Formulation comparability.

Efficacy requirements for demonstration of comparability of pesticide formulations.

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).

Extrapolation proposals.

EC Project Report - Proposals for extending and harmonizing efficacy and crop safety extrapolations to reduce the need for efficacy trials on minor crops.

If you have any comments on these guidelines or suggestions for improvements or for additional guidelines please contact:

Tony Fisher,
E-mail: environment@hse.gsi.gov.uk

Further Information

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