Feed additives applications: Tools

Environmental risk assessment of feed additives: calculation tool

The EFSA Guidance on the assessment of the safety of feed additives for the environment is structured in two phases: phase I concerns the assessment to determine if a significant environmental effect of the additive is likely; while the aim of phase II is to assess the potential for the additives to affect non‐target species in the environment.

The guidance provides clear definitions for phase I and phase II calculations of exposure (predicted environmental concentrations –PEC – of the additive in different environments) and effect (predicted no effect concentrations – PNEC – of the feed additive on different organisms in different environments). Predictions of exposure to a particular feed additive and its potential environmental effect allow the risk to be characterised.

The Feed additives Environmental Risk Assessment (FERA) calculation tool implements these definitions to provide a standardised instrument to calculate phase I and II exposure levels, and the PNEC of sediment compartment based on the equilibrium partitioning method (PNECsed, EqP) for the environmental risk assessment (ERA) of feed additives. Applicants should use the calculation tool when preparing the data on ERA to be included in the technical dossier. Usage of this tool should also help prevent calculation errors caused, for example, by unit conversion.

Symbols and definitions in the Excel calculator are consistent with those used in the ERA guidance.

How does it work?

The tool is an Excel file with two sheets. The first sheet provides calculations for the ERA of terrestrial animals, while the second one is for aquaculture ERA. Detailed instructions are available to know how to use the calculator. To make the calculation, enter, in the corresponding cells, the physico-chemical properties of the additive and its concentration in feed. The tool will then generate the values of the predicted environmental concentrations to be considered in the ERA.

Feed additives maximum safe concentration in feed for target species calculator

The Feed Additives maximum safe Concentration in feed for Targets Species (FACTS) calculator is a tool for estimating the maximum safe concentration of feed additives in feed for the different animal categories and species.

The safety for the target species can be derived from toxicological studies in laboratory animals. Data from the toxicological studies can be used to derive a maximum safe concentration in feed following the methodology given in the Guidance on the assessment of the safety of feed additives for the target species (see section 4). The no observed adverse effect level (NOAEL) or benchmark dose level (BMDL) from the toxicological studies can be used to derive a safe daily dose in the target species by applying an uncertainty factor (default of 100 to cover intra- and interspecies variation). This safe daily dose in the target species can be translated into a maximum safe concentration in feed by considering the daily feed intake in the animal species/categories.

How does it work?

The tool is an Excel file. Enter the safe dose derived from toxicological studies in the yellow cell. The default uncertainty factor of 100 is shown in an orange cell, which can be modified. The table shows the different target species/categories along with the corresponding default values of daily feed intake scaled to body weight. When the safe dose and the uncertainty factors are inputted, the results for the maximum safe concentration in feed will be automatically displayed. The maximum safe concentration in feed is given per kg feed on as is basis (assuming 88% of dry matter for complete feed and 94.5 % for milk replacers).

Feed additives consumer exposure calculator

The Feed Additive Consumer Exposure (FACE) calculator is a tool for estimating chronic and acute dietary exposure to residues of feed additives and their metabolites present in food of animal origin. It allows users to estimate the exposure for different population groups (e.g., infants, toddlers, adults) in several European countries. This tool implements the exposure methodology recommended by the Guidance on the assessment of the safety of feed additives for the consumer (see section 4.3. Consumer exposure).

FACE relies on food consumption data collected from Member States (stored in the EFSA Comprehensive European Food Consumption Database), which were subsequently disaggregated into raw primary commodities of animal origin (RPC, e.g. milk, meat), using EFSA's RPC model. This disaggregation was applied to the data present in the Comprehensive Database as of March 2018.

How does it work?

You will see a list of raw primary commodities. Enter the estimated residue levels for each relevant food product. These should be expressed as mg/kg whole product.

The tool will then calculate the exposure at individual level and provide summary statistics for the different population groups and European countries. The estimates will be given in terms of mean and high level exposure. The tool will also indicate how the different food commodities contribute to the overall exposure.

To use the tool, you need to register. Send an email to servicedesk [at] efsa.europa.eu with your name, last name, email address and affiliation.