The Applicant Guide: How do I generate data on residues/consumer exposure ?
What data are used in the assessment of consumer exposure?
Guidance on the data required to address residues and consumer exposure can be found at the following links:
Which applications will require an assessment of consumer exposure?
New products, new uses of existing products and any changes to existing conditions of authorisation or other label claims/recommendation which may affect consumer exposure will require an assessment of consumer exposure. Examples of changes to existing authorisation that may increase exposure include:
- Additional crop types. Changes from indoor to outdoor use or vice versa.
- Increases to the maximum application rate, number of treatments or total dose.
- Changes to the application timing or pre-harvest interval.
- Changes in formulation type.
How will the assessment of consumer exposure be carried out?
Authorisation of new uses
You will need to address consumer exposure arising from the proposed use of the product. This can be done by either the submission of relevant metabolism/residues data or if not available, it may be possible to extrapolate residues data which support a similar use in another formulation (ie show that consumer exposure will be within that previously considered for another product).
Submission of new data
Where new data relating to crop residues have been submitted to support authorisation, the data should be summarised in the format of a draft Registration Report, to include an OECD dossier guidelines Tier I Summary, available at the OECD pesticides registration website.
Submission of reasoned cases
This section of the Application Overview should be used where consumer exposure is being addressed by extrapolation of a previous risk assessment or a reasoned case as to why the consumer risk assessment or a data requirement need not be addressed (ie new data are not submitted with a Tier 1 Summary).
Extrapolation of a previous risk assessment may be most clearly presented as a tabulated comparison between the relevant conditions of use of the approved and proposed formulations, ideally in the form shown below. This example assumes that the proposed product contains two active substances and residues data are to be extrapolated from two products each containing one of those active substances.
|Proposed product (containing active substances 'x' and 'y').||Approved product (containing active substance 'x')||Approved product (containing active substance 'y').|
|Maximum individual dose: (g a.s./ha)|
|Latest time of application|
|Maximum number of treatments (per crop)|
|Maximum total dose (g a.s./ha/crop)|
- Where the formulations of the proposed and authorised products are different, you must explain why extrapolation of data between the formulations is acceptable.
- Where the authorised conditions of either of the authorised products fall outside of those proposed such that the residues data are not relevant, you should address this with a reasoned case or data.
Details of extrapolations which are available between formulation and crop types can be found in Appendix D- Comparability, extrapolation, group tolerances and data requirements. (SANCO 7525/VI/95, 24/3/2011)