Pesticide product trials permits 

Overview

If you wish to carry out experimental/research and development work on an:

• approved or unapproved active substance
• authorised or unauthorised plant protection product

you must apply for a Permit for Trials Purposes or "Trials Permit", previously known as an Experimental Approval, which will allow storage and use of the active substance or product for the experimental work.

You must apply for a Trials Permit if you wish to carry out research and development work involving the release into the environment of an approved or unapproved active substance or plant protection product that is not authorised for the proposed experimental trials use.

Types of trial permit

There are 4 different types of trials permit.

• Administrative Trials Permits
• Extrapolated Trials Permits (ETPs)
• Consumer Assessed Trials Permits
• Fully-Assessed Trials Permits

General conditions

There are a number of general conditions that apply to all Trials Permits:

• you must ensure that the pesticide is stored, handled, applied and disposed of in accordance with the Code of Practice for Using Plant Protection Products
• the material to be used in the experimental work, and for which you have received your permit, must only be stored, supplied or used by the permit holder or your agent. You must advise your agent in writing of all the conditions which relate to the use of the active substance or plant protection product under the permit. The number of agents used must be kept to a minimum
• you must ensure that the person who carries out the trials work possesses a recognised certificate of competence and that the appropriate application equipment is used
• you must keep full records of all applications carried out under the permit and keep these for at least ten years following treatment. These records must include details of the specific sites that are treated and their Ordnance Survey grid references
• you must ensure that the material to be used in the trials work is accompanied by adequate information to ensure it can be used and disposed of safely. This information must be presented in line with 'The Labelling Handbook Volume 4 (Requirements for Labels of Products used under Permits for Trials Purposes)' and comply with the regulation requirements
• you must avoid direct or indirect post-treatment exposure of humans or animals wherever possible
• Trials Permits are generally granted for a period of three years and you may carry out your experimental work at any time in that period
• you must submit immediately, any new information on the potentially dangerous effects of the active substance or plant protection product for which you have received your permit. These effects relate to human or animal health and any effects on ground water or the environment. You are obligated to inform us of any wildlife casualties that occur following treatment
• you cannot use your permit for performing research and development work on genetically-modified crops without consulting us beforehand
• all Trials Permits will specify a restriction to protect groundwater

Leaching

You are prohibited to carry out experimental work on soils with high leaching potential and (in England and Wales) to areas within a 'Zone 1' Groundwater Source Protection (GSP) Zone or within 50 metres of other sources of groundwater used to supply drinking water.

Details of the leaching potential of soils in England and Wales are given on Groundwater Vulnerability Maps available from the Stationery Office (for major and minor aquifers) and from the Environment Agency (for non-aquifer areas). In Scotland a limited number of groundwater vulnerability maps are available from the Scottish Environment Protection Agency (SEPA). Details of GSP Zones in England and Wales are available from the Environment Agency (there are currently no GSP Zones in Scotland).

If the statutory conditions cannot be complied with then you may gain agreement from the Environment Agency or SEPA on using a particular site to carry out your trials work. For further advice on avoiding leaching then you may wish to contact your local Environment Agency or SEPA office.

Exemptions to trials permit requirements

Research and development work with an active substance or plant protection product must be conducted under a Trials Permit unless one of the following exemptions applies:

• none of the research material (including the experimental active substance or plant protection product) is released into the environment. For example where trials are conducted exclusively in laboratories and where all treated materials are destroyed in an appropriate manner
• the experimental trials will be performed within the conditions of use of a currently authorised plant protection product
• taint testing where a COSHH assessment is required

Farmer demonstration trials may be performed under a Trials Permit. However, the results of such trials work must not be advertised. Permits for trials purposes are not issued for the purposes of advertisement.

Research and development work on more than one formulation

You may apply for a Trials Permit to carry out research and development work on a range of similar formulations under one application. The formulations must have the same active substance and be of the same basic type, with only minor changes in the amounts of constituents. You may use different co-formulants if they perform the same function such as surfactants but you must submit all the appropriate Safety Data Sheets and full details of the formulation ranges or individual formulation details where these can be specified.

If you submit any data in support of your application it must be based on all the formulations for which you wish to receive a Trials Permit unless you submit reasoned scientific cases to extrapolate the submitted data across all of the formulations.

Research and development work that will require the submission of additional data and/or information

If you wish to carry out research and development work on the following types of active substances then you should contact us for advice in the first instance:

• genetically modified organisms
• microbial pest control agents (including viruses, bacteria, fungi, protozoa and mycoplasmas). Some information is included in the appropriate sections below
• vertebrate control agents (excluding repellents)
• active substances that have previously been evaluated and for which approval has been refused
• banned or severely restricted pesticides
• products for aerial application (note that the aerial use of experimental substances is not permitted under Administrative Trials Permits unless a previous, relevant risk assessment has been performed)
• products for use in or near water (where the statutory restrictions to protect aquatic life cannot be adhered to)
• products for use on land openly accessible to the public and accessible to companion or grazing animals (like public parks, common land, moor and heathland)

In addition, you must consult us before making an application for a Trials Permit for the use of an active substance or plant protection product on crops genetically-modified for tolerance to that active substance, as these will require an additional risk assessment.

Renewal of a trials permit

You cannot:

• apply to renew an administrative trials permit - you must apply for a new permit.
• use an admin application to renew a trials permit if it has a data requirement for renewal - you will need to submit a technical application

Otherwise, you can use an admin application to renew a trials permit.

Trials permits are usually issued for 3 years. You can apply to renew your existing trials permit for an additional 3 years if you do not wish to change any of the conditions or restrictions specified on the existing permit.

Provide the following with your admin application:

• a covering letter fully explaining your request and detailing the requirements below
• completed application form CRD2
• letters of access to third party data
• any previous relevant correspondence for example a copy of the parent product authorisation, previous authorisation/trials permit/EAMU as appropriate or any written advice previously provided by HSE

Regulation

Permits for trials uses are issued under Article 54 of assimilated Regulation No 1107/2009 (legislation.gov.uk).