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Please note that if the product authorisation on which your ETP relies on is withdrawn for safety reasons, then your ETP may also need to be withdrawn.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

  1. A new formulation extrapolated from an authorised seed treatment formulation.
  2. 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).
  3. A new granule formulation extrapolated from an authorised granule, micro granule, fine granule or macro granule formulation that is applied undiluted.
  4. A new water dispersible granule formulation extrapolated from an authorised wettable powder formulation (or vice versa).
  5. A new soluble concentrate formulation extrapolated from an authorised water soluble powder or granule formulation (or vice versa).
  6. A new water soluble granule formulation extrapolated from an authorised water soluble powder formulation (or vice versa).
  7. 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.
  8. A new suspension concentrate formulation extrapolated from an authorised wettable powder formulation (or vice versa).
  9. A new formulation extrapolated from a formulation of the same type, but where the amount or composition of the co-formulants has been changed.
  10. 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 in another Member State

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

  1. The crop on which you wish to carry out the  trials work has authorisation in the other MS; and,
  2. The proposed frequency, rates and timings for the trials work are the same as, or within, those authorised in the other MS; and,
  3. The situation (eg field or protected) for the  trials work is the same as that authorised in the other MS; and,
  4. The harvest interval for the trials work is not shorter than that authorised in the other MS; and,

In addition you will need to submit:

  1. A copy of the authorisation and the authorised product label from the other MS and a translation of both documents into English; and,
  2. Evidence that a MRL has been set by the European Commission (EC) under Regulation (EC) No. 396/2005.

If your trials permit application is for a microbial ("biological") pest control agent that is authorised in another MS, then evidence must be provided to show that the microbial active substance is either included on Annex IV of Regulation (EC) No. 396/2005, or that an application has been made to the Commission to include the microbial active substance on Annex IV of Regulation (EC) 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 in another MS 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 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 included in Annex I of Directive 91/414/EEC/Approved under Regulation (EC) 1107/2009, 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 (ETP, see above) or a Fully-Assessed Trials Permit (FATP, 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:

  1. A full technical specification for the active substance(s);
  2. Details of the method of manufacture and method of analysis for the active substance(s);
  3. An acute oral toxicity study on the active substance(s) in one mammalian species. If the active substance is for a microbial pest control agent then information on infectivity and pathogenicity must be provided;
  4. An in vitro mutagenicity test on the active substance(s);
  5. Material Safety Data Sheets for all the co-formulants.

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:

  1. A thirteen week feeding study on the active substance in one species along with additional information (eg the results from dose ranging experiments; preliminary studies) on a second species to indicate the potential for inter‑species variability;
  2. A mutagenicity package in accordance with the Committee on Mutagenicity guidelines (two in vitro studies may suffice where the results are satisfactory and exposure can be argued to be minimal);
  3. A complete teratogenicity study in one species along with relevant information (eg the results from dose ranging experiments; preliminary studies) in a second species to indicate the potential for inter-species variability;
  4. A mammalian metabolism study may be required to assess the toxicological significance of any metabolites found in crops or derived from domestic animals eg in milk.

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 (see Data Requirements for Residues for guidance):

  1. If appropriate, data on plant metabolism;,
  2. Suitable methods of analysis;
  3. If appropriate, residues data (a minimum of two trials representing a worst case situation and not necessarily the exact proposed treatment regime with a reasoned case as to the suitability of the data may be sufficient, but see the guidance in the Data Requirements Handbook from the link above);
  4. Animal metabolism data where there are significant residue levels in any crop that will be consumed by animals. Transfer studies may be necessary if estimation of the residue levels in products of animal origin is not possible from the metabolism study;,
  5. If appropriate, residues in rotational crops.

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:

  1. Whether or not the MPCA would result in the generation of secondary metabolites and/or toxins, and if so, whether these metabolites would impact on the area of consumer risk assessment; and,
  2. Whether the MPCA could be pathogenic to humans and animals and whether the proposed use of the MPCA could result in a residues in the edible portion of the treated crop; and,
  3. Taking into account persistence in the soil, whether there is the potential for residues in rotational crops.

If the residue levels in crops which have been subject to experimentation are within the appropriate current EU 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 EU MRL or (for a microbial pest control agent active substance), the substance is not included on Annex IV of Regulation (EC) No 396/2005, or the current EU 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 microbial pest control agent (MPCA) that is not approved in the EU 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 document on requirements for 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:

  1. For pellets, granules and seed treatments; data on the acute and dietary avian toxicity of the active substance(s) in one species.
  2. For rodenticides; for outdoor use, data on the acute and dietary avian toxicity of the active substance(s) and the residue of the active substance(s) in treated rodents from laboratory studies; for indoor use, a reasoned scientific case regarding the risk from primary and secondary consumption.
  3. For the use of a sprayed product which may be applied to a crop which is likely to be grazed by birds at the time of application; data on the acute and dietary avian toxicity of the active substance(s) in one bird species.
  4. For the use of a sprayed product which may be applied to a crop or situation in which bees are actively foraging; an acute oral and contact toxicity of the active substance(s) to the honeybee.
  5. For an application that may lead to the contamination of water:
    • An aquatic toxicity data set to include acute toxicity of the active substance(s) to one species of fish, Daphnia magna and one algal species;
    • A reasoned scientific case to address the fate and behaviour of the active substance(s) in water so that we can make a preliminary assessment of the risk to aquatic life. The information required will depend on the properties of the active substance(s) involved and advice should be sought from our Environmental Fate and Behaviour Branch via an enquiry to Defra Helpline (see our Contact Details page for further information).
    • If there is containment and appropriate disposal of any effluent or contaminated water or an 18 metre buffer zone is left between treated areas or surface waters or ditches, then no data are required. However, you will not be able to contaminate surface waters or ditches with chemical or used container, and you must not carry out your trials work on soils obviously vulnerable to leaching or above groundwater reserves.

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 to Defra Helpline: see 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 in the EU 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):

  1. A full technical specification for the active substance(s);
  2. Material Safety Data Sheets for all the co-formulants;
  3. A thirteen week feeding study on the active substance(s) in one species along with additional information (eg the results from dose ranging experiments; preliminary studies) on a second species to indicate the potential for inter‑species variability;
  4. A mutagenicity package in accordance with the Committee on Mutagenicity guidelines (two in vitro studies may suffice where the results are satisfactory and where it can be argued that exposure will be minimal);
  5. A complete teratogenicity study in one species along with relevant information from a second species (eg the results from dose ranging experiments; preliminary studies) to indicate the potential for inter-species variability;
  6. Skin sensitisation data on the active substance(s) and the formulation, and acute oral and acute dermal toxicity, skin and eye irritancy data on the formulation.

You should also be aware of the following:

  1. The same restrictions as specified for ATPs will apply.
  2. Where a FATP has been recommended for more than 10 hectares per year but where insufficient data and/or information have been submitted to perform a full operator exposure risk assessment, we may restrict the area allowed for your trials work to 10 hectares per year for any one operator.

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

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

Further information

Updated 2016-08-03