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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;

General Guidance on Generating Data and Submitting Applications.
Application or Situation Specific Guidelines.
Crop Safety Guidelines.
Crop Specific Guidelines.
Pest/Disease/Weed specific Guidelines.
Chemical and Control Specific Guidelines.
Other efficacy guidelines.

Latest Update: 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.

307 Quality Parameters - Cereals.

Details quality data required for cereals.

603 Fungicide Resistance: label advice and restrictions.

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

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

Further to Regulatory Update 17/2007, in which PSD announced the amended labelling requirements for DMI fungicides with recommendations for control of Septoria tritici, CRD now announces proposals for dealing with the declining field performance amongst this group of fungicides. The guidance "Re-registration of triazole uses on cereals: fungicide resistance issues" (v1.0, 9 July 2009) provides further background information and outlines what additional data may be required to support continued claims for certain diseases. The guidance has been sent separately to the CPA for comment. Comments from other interested parties are hereby invited and should be sent to paul.ashby@hse.gsi.gov.uk. The guidance should be considered at this stage as a draft proposal.

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.org). 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 containing Existing Active Substances after Inclusion in Annex I.	-
104	Guidance for Efficacy Sifting of New Active Substance Submissions.	-
110	Official recognition of efficacy testing organisations.	-
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.
-	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.	Draft Published December 2007 -please send any comments to environment@hse.gsi.gov.uk.

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 2006.
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 115)	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	Draft issued 9 July 2009. Please send comments to paul.ashby@hse.gsi.gov.uk
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 the document Groundwater metabolites - guidance on efficacy aspects (issued 21 July 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.