The Applicant Guide: Extrapolated and Assessed Trials Permits

Extrapolated Trials Permits

What do I need to consider for an Extrapolated Trials Permit?

The restrictions specified on an Extrapolated Trials Permit (ETP) will depend on the extrapolations that you are using from either another formulation that has been authorised in the UK or another Competent Authority (where possible and appropriate) 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Please note that if the product authorisation on which your ETP relies on is withdrawn for safety reasons, then your ETP may also need to be withdrawn.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:

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:

In addition you will need to submit:

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 specified for 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 (eg 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 ATPs.

How do I apply for an Extrapolated Trials Permit?

For information on how to apply for an ETP please see the guidance documents on requirements for trials permits.

Consumer-Assessed Trials Permits

What do I need to consider for a Consumer-Assessed Trials Permit?

The maximum area to be treated

The maximum total area for all crops for a Consumer-Assessed Trials Permit (CATP) is 10 hectares per year. If you require a larger area then you will need to apply for either an Extrapolated Trials Permit (see above) or a Fully-Assessed Trials Permit (see below).

For the protection of consumers

You will need to submit the following mammalian toxicology data to allow us to carry out a consumer exposure risk assessment:

Where the Limit of Quantification (LOQ) for residue levels in the crop at harvest exceeds 0.01 mg/kg, or where the potential consumer exposure may be greater than 1 µg/kg bw/day the following further data are also required to set an (Acceptable Consumer Exposure (ACE) value:

You will also need to submit a residues data package to allow us to carry out a consumer exposure risk assessment consisting of the following data (go to Data Requirements for Residues for guidance):

Microbial pest control agents (MPCAs)

For MPCAs, taking account of the proposed conditions of use and the biological characteristics of the MPCA, you will need to consider:

If the residue levels in crops which have been subject to experimentation are within the appropriate current MRL, and there is no risk to consumers (human or animal), then treated crops can be placed into the supply chain for human and/or animal consumption.

However, if there is no current MRL, or (for a microbial pest control agent active substance) the substance is not included on Annex IV of Regulation No 396/2005, or the current MRL for the proposed use is exceeded, then the permit will carry a restriction for treated crop material to be destroyed and this restriction will apply until a suitable MRL is in place and no unacceptable risk to consumer health has been demonstrated.

For the protection of the environment

The same restrictions as detailed for ATPs will be specified unless the impact of any of these restrictions is to be the subject of your trials work or is unavoidable (eg 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 MPCA that is not approved 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 ATPs.

How do I apply for a Consumer-Assessed Trials Permit?

For information on how to apply for a CATP please see the guidance on requirements for consumer-assessed trials permits.

Fully-Assessed Trials Permits

What do I need to consider for a Fully-Assessed Trials Permit (FATP)?

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. If your application is successful then your permit will specify a maximum area to be treated as a condition of the permit.

For the protection of consumers

You will need to address the same data requirements as detailed above.

For the protection of the environment

You will need to submit the appropriate data in the following situations:

For all other situations, no specific data are required. However, if you wish to use a plant protection product or active substance outside of the restrictions stated as in (a), (b) and (c) in the appropriate guidance for ATPs, advice should be sought from our Ecotoxicology Branch via an enquiry (go to the contact details page). You must submit a reasoned case if you wish to remove any of the restrictions from your permit. If the active substance is a biological control agent (MPCA) that is not approved 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

You will need to submit the following data so that we can set a health-based temporary Operator Exposure Limit (OEL):

You should also be aware of the following:

How do I apply for a Fully-Assessed Trials Permit?

For information on how to apply for a FATP please see the guidance on requirements for fully-assessed trials permits.

Further information

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Updated 2021-08-09