Consumer-Assessed Trials Permits
You can apply for a Consumer-Assessed Trials Permit (CATP) if you do not need more than 10 hectares per year to carry out your work. You will need to submit data so that we can carry out a consumer exposure risk assessment. If the submitted data are acceptable we will not specify a restriction for the treated crop material to be destroyed on your permit.
Restrictions specified on an a Consumer-Assessed Trials Permit
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 or a Fully-Assessed Trials Permit .
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:
- a full technical specification for the active substance(s)
- details of the method of manufacture and method of analysis for the active substance(s)
- 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
- an in vitro mutagenicity test on the active substance(s)
- 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:
- a thirteen-week feeding study on the active substance in one species along with additional information (for example the results from dose ranging experiments or preliminary studies) on a second species to indicate the potential for inter species variability
- 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)
- a complete teratogenicity study in one species along with relevant information (such as the results from dose ranging experiments or preliminary studies) in a second species to indicate the potential for inter-species variability
- a mammalian metabolism study may be required to assess the toxicological significance of any metabolites found in crops or derived from domestic animals, like 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:
- if appropriate, data on plant metabolism
- suitable methods of analysis
- 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
- 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
- if appropriate, residues in rotational crops
More information on Data Requirements for Residues
How to apply for a Consumer-Assessed 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
- mammalian toxicology and residues data requirements to allow a consumer exposure risk assessment to be carried out
- if appropriate, reasoned scientific cases to remove any of the standard restrictions that will be specified for the protection of the environment and the operator