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 A subdivision of the genus, a species is a group of closely related and similar-looking organisms; for example, in the case of Homo sapiens (humans), the second part of the name (sapiens) represents the species in the environment.
The guidance provides clear definitions for phase I and phase II calculations of exposure Concentration or amount of a particular substance that is taken in by an individual, population or ecosystem in a specific frequency over a certain amount of time (predicted environmental concentrations –PEC – of the additive in different environments) and effect (predicted no effect concentrations – PNEC – of the feed additive Product intentionally added to animal feed to improve: i) the quality of the feeds ii) the quality of the food products obtained from animals; iii) animal performance and health 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 A specialised field of applied science that involves reviewing scientific data and studies in order to evaluate risks associated with certain hazards. It involves four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation ( ERA Environmental risk assessment (ERA) is the process of assessing potential harm to the environment caused by a substance, activity or natural occurrence. This may include the introduction of GM plants, the use of pesticides, or the spread of plant pests) 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 three sheets. The first two sheets provide calculations for ERA of terrestrial animals: one provides calculations for Phase I ERA and the other for Phase II ERA. The third 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 A change in the health, growth, behaviour or development of an organism that impairs its ability to develop or survive level ( NOAEL The no observed adverse effect level (NOAEL) is the greatest concentration or amount of a substance at which no detectable adverse effects occur in an exposed population) or benchmark dose The minimum dose of a substance that produces a clear, low level health risk, usually in the range of a 1-10% change in a specific toxic effect such as cancer induction level (BMDL) from the toxicological studies can be used to derive a safe daily dose The total amount of a substance (e.g. a chemical or nutrient) given to, consumed or absorbed by an individual organism, population or ecosystem in the target species by applying an uncertainty Scientific concept used in risk assessment to describe all types of limitations in available knowledge at the time an assessment is conducted, with the agreed resources, that affect the probability of possible outcomes to the assessment 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 The amount of a substance (e.g. nutrient or chemical) that is ingested by a person or animal via the diet 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 For the purposes of risk assessment, measurement of the amount of a substance consumed by a person or animal in their diet that is intentionally added or unintentionally present (e.g. a nutrient, additive or pesticide) to residues of feed additives and their metabolites present in food of animal origin. It allows users to estimate the exposure for different population Community of humans, animals or plants from the same species 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.
Dietary data from the UK were included in FACE when the UK was a member of the European Union.
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@efsa.europa.eu with your name, last name, email address and affiliation.