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Consumer Exposure

The following page is intended to provide guidance to applicants on how to conduct consumer risk assessments to meet the requirements which apply under Regulation (EC) No 1107/2009. 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 acceptable dietary intakes derived from toxicological studies. At its most basic level, if estimates of long and short-term intake are less than the acceptable daily intake (ADI) and the acute reference dose (acute RfD), respectively, then the risks to the consumer may be regarded as acceptable.

Consumer risk assessment is a vital part of the approval process and it is in the applicant's interest to estimate potential intakes since intake estimates can assist in assessing whether further information is required.

The following intake models are available:

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

This model has been developed by CRD and is in the form of an Excel workbook consisting of consumption data for ten consumer groups: adults, infants, toddlers, children (further split into 4-6 year old, 7-10 year old, 11-14 year old and 15-18 year old), vegetarians, elderly (own home), elderly (residential). The consumption data has been provided by the UK Food Standards Agency (FSA) as a result of the National Dietary and Nutrition Surveys of 1986, 1992/93, 1994/95, 1997 & 2001.

The model uses the consumption data, residues inputted by the user, and taking account of average bodyweight for each consumer group and unit weights of commodities returns a deterministic intake estimate (a NESTI). This NESTI can then be compared to an acute reference dose for a specific active substance to assess the suitability of any proposed use.

The user also has the option to refine the risk assessment by incorporating a processing factor or adjusting the variability factor.

The NESTI model (version 1.1, 5th January 2006) and associated guidance are available for download:

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

This model has been developed by CRD and is in the form of an Excel workbook consisting of consumption data for ten consumer groups: adults, infants, toddlers, children (further split into 4-6 year old, 7-10 year old, 11-14 year old and 15-18 year old), vegetarians, elderly (own home), elderly (residential). The consumption data has been provided by the UK Food Standards Agency (FSA) as a result of the National Dietary and Nutrition Surveys of 1986, 1992/93, 1994/95, 1997 & 2001.

The NEDI model assesses long term intake for comparison against an acceptable daily intake.

The NEDI model (version 1.1, 23rd January 2006) and associated guidance are available for download:

PRIMo – Pesticide Residue Intake Model

The PRIMo model has been developed by EFSA and is based on national food consumption figures and unit weights provided by Member States which it uses to estimate the short term and long term exposure of consumers.

The PRIMo model is available from the EFSA website.

For UK approvals consumer risk assessments with both EU (PRIMo) and UK models (short and long term exposure) are required.

Updated 2016-10-05e -->