Extrapolated Trials Permits (ETPs)

You can apply for an Extrapolated Trials Permit (ETP) if the active substance to be used in your experimental work has been considered in a formulation that has been authorised in the UK or another Competent Authority where appropriate. The extrapolations to support the proposed formulations and uses must be fully justified.

Restrictions specified on an Extrapolated Trials Permit

Restrictions may be specified on any ETP. The restrictions specified will depend on the extrapolations that you are using in support of the proposed formulation and uses.

You will need to ensure that each area of the risk assessment is addressed by the submission of data or a reasoned scientific case.

Please note that if the product authorisation on which your ETP relies on is withdrawn for safety reasons, then your ETP may also need to be withdrawn.

The maximum area to be treated

You will need to specify the area which you require for your trials work and provide a full justification for the proposed area. Your permit will specify a maximum area to be treated as a condition of the permit.

For the protection of consumers

If the proposed use for the ETP is on crops intended for human or animal consumption, you must consider the following aspects of the consumer exposure risk assessment.

Acceptable extrapolations for active substances present in plant protection products authorised in the UK

You may be able to place treated crops into the supply chain for human or animal consumption if a new formulation containing an approved active substance is applied within a current UK authorisation in terms of the rates, timings and uses.

The following extrapolations are considered acceptable for active substances approved in the UK:

a new formulation extrapolated from an authorised seed treatment formulation
a new formulation type (except a granule or slow-release formulation) extrapolated from a product authorised as a soil drench or applied pre-emergence to a crop (but excluding all granule or slow release formulations)
a new granule formulation extrapolated from an authorised granule, micro granule, fine granule or macro granule formulation that is applied undiluted
a new water dispersible granule formulation extrapolated from an authorised wettable powder formulation (or vice versa)
a new soluble concentrate formulation extrapolated from an authorised water soluble powder or granule formulation (or vice versa)
a new water-soluble granule formulation extrapolated from an authorised water-soluble powder formulation (or vice versa)
a new formulation extrapolated from an authorised water-based formulation where only the content of the water has increased or decreased in the new formulation
a new suspension concentrate formulation extrapolated from an authorised wettable powder formulation (or vice versa)
a new formulation extrapolated from a formulation of the same type, but where the amount or composition of the co-formulants has been changed
a new formulation which consists of two or more authorised formulations or active substances from authorised formulations combined. It may be possible to submit a reasoned case as to why residue levels will not increase under the new formulation

You may apply for other extrapolations but you will need to submit a reasoned scientific case to support your proposed extrapolation.

Active substances present in plant protection products authorised by another Competent Authority

If the active substance/crop combination on which you wish to carry out your trials work has a Maximum Residue Level (MRL) set in Regulation No. 396/2005, extrapolation can be made from an authorisation by another Competent Authority providing the following conditions can be complied with:

the crop on which you wish to carry out the trials work is authorised and the details are available to HSE
the proposed frequency, rates and timings for the trials work are the same as, or within, those authorised
the situation (for example, field or protected) for the trials work is the same as that authorised
the harvest interval for the trials work is not shorter than that authorised

In addition you will need to submit:

a copy of the authorisation and the authorised product label, and a translation of both documents into English
evidence that an MRL has been set under Regulation No. 396/2005

If your trials permit application is for a microbial ("biological") pest control agent that is authorised, then evidence must be provided to show that the microbial active substance is either included on Annex IV of Regulation No. 396/2005, or that an application has been made to include the microbial active substance on Annex IV of Regulation No. 396/2005.

However, you must still consider whether the use of the microbial pest control agent would result in the generation of secondary metabolites and if so, whether these metabolites would have an impact on the other areas of the safety risk assessment.

We may able to accept applications based on active substances approved by another Competent Authority with a formulation change based on the extrapolations detailed above. A suitable reasoned case to support the proposed extrapolation will need to be submitted.

Rotational crops

You will need to consider the potential for residues in rotational crops based on the nature of the active substance, its persistence in the environment (including bio-available metabolites if appropriate), the uses on which the active substance is currently approved and any differences in the timings, and potentially the climate, between your proposed ETP and the product from which extrapolation is required.

Disposal of treated crops into the supply chain for human or animal consumption

If the conditions and/or data requirements specified above cannot be met or any potential extrapolations are not acceptable then the disposal of treated crops into the supply chain will not be possible and the restrictions specified for Administrative Trials Permits (ATPs) regarding consumer exposure will be specified on your permit.

For the protection of the environment

The same restrictions for the protection of the environment as Administrative Trials Permits (ATPs) will be specified unless the impact of any of these restrictions is to be the subject of your experimental trials work or is unavoidable such as outdoor mesocosm studies. You must submit a reasoned case if you wish to remove any of the restrictions from your permit.

If the active substance is a microbial pest control agent (MPCA) that is not approved under Regulation No. (EC) 1107, and it is not indigenous to the UK, then you will need to submit information that addresses the competitiveness of the MPCA relative to other micro-organisms in any environmental compartment (soil, water or sediment) that may be exposed, and information on the potential for the agent to disperse from the treated area (potential to produce mobile resting stages, spores etc). This is to allow us to carry out an assessment of environmental persistence.

For the protection of operators

The same restrictions will apply as specified for Administrative Trials Permits (ATPs).

How to apply for an Extrapolated Trials Permit

For this type of application you will need to submit:

covering letter explaining your application
completed application form CRD1
relevant correspondence, including any previous advice from CRD and if relevant/available, a copy of any product authorisations
reasoned scientific cases to address the consumer, environmental and operator exposure areas of the risk assessment
reasoned scientific case justifying the maximum area on which you wish to carry out your experimental work