Efficacy evaluations and guidelines
This guidance is to help you complete the efficacy section of a pesticide application.
What efficacy is
Efficacy can be defined as determining the effectiveness of a substance, including identifying the appropriate dose and mode of action, and identifying any adverse or unintended negative impacts.
In regulatory assessments, the relevant claims of the proposed product must be supported by data. These data are generated from appropriately conducted trials, following relevant guidance and are provided to address regulatory requirements.
Efficacy assessments for plant protection products (PPP)
HSE’s Efficacy Team considers:
- whether the claims made on the product labels are supported by data
- the relevance of the proposed uses to Great Britain (GB) and Northern Ireland (NI) effectiveness, risk to the crop and resistance issues
- whether there is a demonstrated benefit (to the crops or in non-crop situations) and put into context with any identified adverse impacts (for example damage caused to the crop)
- the directions on the label to ensure they are appropriate to the use of the product - this contributes to using the product in a targeted, responsible manner optimising its' use as part of integrated control programmes with other measures, but ensuring it is the minimum required
Data requirements and accompanying guidance
Data supporting GB and NI authorisations for a PPP should follow the appropriate guidance (EPPO, see below) and address the relevant data requirements for the active substance and the formulated product.
European Plant Protection Organisation (EPPO)
EPPO is an international organisation responsible for cooperation and harmonisation in plant health and protection within the European and Mediterranean region.
HSE provides expertise on a number of PPP related panels and expert working groups.
EPPO produce standards on how to approach efficacy evaluations, which are recognised in regulatory regimes, including GB, NI, EU, FAO and OECD. These range from general standards addressing regulatory data requirements (such as Phytotoxicity (PP 1/135)) to standards describing the conduct of individual efficacy trials (such as aphids on cereals (PP 1/020)).
Data generated outside GB and NI
You may use data generated outside GB and NI to support GB and NI products, provided there is an appropriate case for relevance to GB and NI agronomic conditions.
EPPO PP 1/278 'Principles of zonal data production and evaluation' provides a comprehensive overview of the relevant issues when generating and using regionally based data.
Further information is provided in Efficacy Guideline 106.
In some situations, where guidance is not harmonized via EPPO or in a limited number of GB and NI specific situations, additional GB and NI guidance is relevant and must be followed (for example, for resistance management).
GB and NI additional guidance
Refer to the guidance below when applying for uses in GB and NI.
Included are guides and information on:
- crops and situations
- details of relevant targets
- resistance management and labelling
This may help in trials planning, summarising data and supporting GB and NI label claims.
Please note that efficacy data generated in other countries may support GB and NI authorisations, provided there is an appropriate case for relevance to GB and NI agronomic conditions. EPPO PP 1/278 provides a overview of the relevant issues on generating and using regional data packages.
Go to EPPO PP 1/278 (on the EPPO website).
In future, a range of comprehensive crop guides will be produced.
General guidance on generating data and submitting applications
Efficacy Guideline:
- 101 - UK Efficacy Guidance for the Preparation of a Biological Assessment Dossier (BAD)
Revised August 2020. Also see EPPO Standard 1/181. - 105 - UK Efficacy Guidance on Plant Protection Product (PPP) formulation changes, and Use of EPPO PP 1/307
Revised January 2021 - 106 - General Principles on Conducting Efficacy Trials to Support Registration of Plant Protection Products (PPP) in GB and NI
Revised January 2022 - 110 - Efficacy Official Recognition of Efficacy Testing Organisations
Revised July 2020 - 117 - Groundwater metabolites - Guidance on Efficacy aspects
Revised July 2020 - 119 - Rainfastness of foliar applications
New January 2022
Application or Situation Specific Guidelines
- 211 - Home Garden Products
Revised October 2020 - 212 - Amateur product labelling – Efficacy aspects
Revised October 2020
Crop safety guidelines
303 - Effects on Non-Target Crops of Highly Active Herbicides – Including Mixtures and Sequences
Revised July 2020
Crop specific guidelines
- 403 - Provision of information on tree canopy size in efficacy and residue trials in apple orchards
Revised October 2020 - 405 - Data requirements for Oilseed Rape and Vegetable Brassica Pests, Diseases and Weeds
Revised 2019 - 406 - Data requirements for Turf Fungicides, Herbicides, Insecticides and Plant Growth Regulators.
Revised 2019 - 407 - Cereal and maize pests – trial numbers.
New 2019 - CG01 - Crop Guide: Potato
New 2019 - CG02 - Crop Guide: Grassland
Revised January 2021 - Working Document -
Summarising UK major ‘pests (diseases, pests and weeds) on a range of UK crops
New 2019
Chemical and control specific guidelines: resistance management and tank mixtures/sequences
- 601 - Resistance Warnings on Labels of Insecticide and Acaricide Products.
Revised October 2010. - 602 - Resistance Warnings and Restrictions on Labels of Professional Herbicide Products.
Revised November 2010. - 603 - Fungicide Resistance: label advice and restrictions.
Revised December 2014. - 604 - Efficacy Data Required For Tank Mixtures and Sequences of Plant Protection Products
Revised July 2020. - 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.
Revised July 2020. - 617 - Re-registration of Triazole uses in cereals: fungicide resistance issues
Revised July 2020.
Other efficacy related guidance
- Reduced efficacy requirements for low-risk plant protection products
- GB and NI efficacy advice and product labelling
Applicants are advised to use a draft Registration Report (dRR) when submitting an Efficacy data to support a PPP application. This annotated version of Part B, Section 3 of the dRR includes relevant advice on addressing the data requirements for authorisation in GB and NI as well as guidance on efficacy related labelling requirements. Use it in conjunction with the information and examples provided in the dRR template and guidance notes for ‘Part B Section 3’, which illustrate relevant approaches when summarising data from the BAD into the dRR. - Tank-mix recommendations on pesticide product labels
- Groundwater metabolites
Further to SANCO/221/2000-rev.10 (EC website), 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.