Consumer Exposure

The following page provides guidance to applicants on how to conduct consumer risk assessments to meet the requirements which apply under Regulation (EC) No 1107/2009 (there are data requirements under the regulation). In addition to consulting the below guidance and resources applicants should check that their applications are complete using the Consumer Exposure section of the common omissions checklist.

Residue studies enable estimates of pesticide intake to be made in order to compare potential consumer dietary exposure with toxicological reference values derived from toxicological studies. If estimates of long and short-term intake are less than the acceptable daily intake (ADI) and the acute reference dose (ARfD), respectively, then the risks to the consumer may be regarded as acceptable. Where a pesticide product contains more than one active substance an assessment of combined risk is necessary.

The consumer risk assessment is a vital part of the approval/authorisation process. Submissions should include both long term and short term estimates of dietary intake using UK models (NEDI and NESTI) and PRIMo.

The National Estimate of Short Term Intake (NESTI) model for short term consumer intake calculations

The NESTI model is an Excel workbook containing consumption data for 10 consumer groups: adults, infants, toddlers, children (further split by age group, 4 to 6 year old, 7 to 10 year old, 11 to 14 year old and 15 to 18 year old), vegetarians, elderly (own home) and elderly (residential). The consumption data is taken from the National Dietary and Nutrition Surveys of 1986, 1992/93, 1994/95, 1997 & 2001, and has been provided by the Food Standards Agency (FSA).

The model uses the consumption data and inputted residues values to calculate a deterministic intake estimate (NESTI) which considers the average bodyweight for each consumer group and the unit weights of commodities. This NESTI can then be compared to an acute reference dose for a specific active substance to assess the acceptability of any proposed use.

Users have the option to refine the risk assessment by incorporating a processing factor or adjusting the variability factor. Any processing or variability factors used in submissions should be fully justified.

The NESTI model (version 1.1, 5 January 2006) and associated guidance can be downloaded here:

• NESTI model (version 1.1, 5th January 2006)
• NESTI model guidance. (pdf, 14 pages)

The National Estimate of Dietary Intake (NEDI) model for long term consumer intake calculations

The NEDI model is an Excel workbook containing consumption data for 10 consumer groups: adults, infants, toddlers, children (further split by age group, 4 to 6 year old, 7 to 10 year old, 11 to 14 year old and 15 to 18 year old), vegetarians, elderly (own home) and elderly (residential). The consumption data is taken from the National Dietary and Nutrition Surveys of 1986, 1992/93, 1994/95, 1997 & 2001, and has been provided by the UK Food Standards Agency (FSA).

The NEDI model assesses long term intake of residues and compares this with the ADI.

The NEDI model (version 1.1, 23 January 2006) and associated guidance can be downloaded here:

• NEDI model (version 1.1 23rd January 2006)
• NEDI model guidance (pdf, 12 pages)

PRIMo – Pesticide Residue Intake Model

The PRIMo model is used to estimate short term and long-term residue exposure of consumers. It is based on national food consumption figures and unit weights provided by EU Member States it was developed by EFSA and is available on the EFSA website.

GB Toxicological Reference Value Database

The GB toxicological reference value (TRV) database contains the toxicological reference values relevant to consumer exposure assessment within GB.

It is provided as a tool to help applicants with GB approvals, authorisations and Maximum Residue Levels (MRLs).