Brexit: Transition period
The UK has now left the EU. Your health and safety responsibilities have not changed in the transition period.
The Efficacy pages are currently under re-development to update and reflect the requirements under Regulation 1107/2009. A brief summary of relevant efficacy information is provided below. This 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 historical UK specific guidance. A copy of which can still be accessed via Efficacy Data Requirements Handbook chapter on National Archive.
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 made 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 on their website:
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).
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. Included are guides and information on UK crops/situations, with details of relevant UK targets; and UK resistance management and labelling. This may assist applicants in trials planning, summarising data and supporting UK label claims. Please note that non-UK generated efficacy data may be used to support UK uses, provided there is an appropriate case for relevance to UK agronomic conditions. In this regard, EPPO PP 1/278 provides a key overview of the relevant issues on generating and using regional data packages. In future a range of comprehensive crop guides will be produced.
General Guidance on Generating Data and Submitting Applications
- 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
- 211 - Efficacy Data Requirements for Home Garden Products.
- 212 - Efficacy guidelines for labelling of amateur use products.
Crop Safety Guidelines
Crop Specific Guidelines
- 403 - Provision of information on tree canopy size in efficacy and residue trials in apple orchards.
(HDC tree fruit dosing leaflet).
Updated Jan 2013.
- 405 - Data requirements for Oilseed Rape and Vegetable Brassicas.
- 406 - Data requirements for Turf Fungicides, Herbicides, Insecticides and Plant Growth Regulators.
- 407 - Data requirements for Cereals and Maize.
- Crop Guide -
UK Crop Guide on Potato.
- Working Document -
A summary of the major UK Pests for various crops.
- 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.
- 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
- '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