Glossary

ADI

Acceptable daily intake. The ADI is an estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight and day and applies to chemical substances such as food additives, pesticide residues and veterinary drugs.

ADME

An abbreviation for “absorption, distribution, metabolism and excretion”, the four key processes which describe how drugs and chemicals get into the body, what happens to them while they are there, and how they are eliminated

AIC

Akaike Information Criterion.

AOP

Adverse Outcome Pathways. An AOP is a structured representation of biological events leading to adverse effects and is considered relevant to risk assessment.

ARfD

Acute reference dose. Estimate of the amount of a substance in food and/or drinking water, normally expressed on a body weight basis, that can be ingested in a period of 24 h or less without appreciable health risk to the consumer on the basis of all known facts at the time of the evaluation.

AU

Agricultural Use.

BBN

Beta binomial normal model.

BMD

Benchmark dose. A dose or concentration that produces a predetermined change in response rate of an adverse effect (called the benchmark response or BMR) compared to background.

BMDL

Benchmark dose lower confidence limit.

BMDU

Benchmark dose upper confidence limit.

BMI

The body mass index is a measurement that expresses the relationship between an individual’s weight and height. BMI is calculated by dividing weight in kilograms by height in metres squared (i.e. height x height). Used to assess whether someone’s weight is appropriate.

BMR

Benchmark response.

BREAM

Bystander and resident exposure assessment model for plant protection products.

BROWSE

Bystanders, residents, operators and workers exposure models for plant protection products.

BW

Body weight.

CA

Concentration Addition. This model is based on a dilution principle, and was designed for chemicals with a similar mechanism of action.

CAG

Cumulative assessment group. A group of chemicals that could plausibly act by a common mode of action, not all of which will necessarily do so. Membership of a CAG can usually be refined (reduced) by application of successively higher tiers of assessment.

ConsExpo

Consumer exposure model.

CRA

Cumulative risk assessment. Risk assessment for combined exposure to two or more chemicals by all relevant pathways and routes.

DA

Dose addition. A process to establish the response of organisms to a mixture of chemicals with similar toxicity. This involves adding up their individual effects to predict the likely impact of the overall mixture.

DR

Dose response. The relationship between the amount of a substance to which an individual organism, population or ecosystem is exposed and the way in which it responds (e.g. in terms of toxicity).

E/H

Risk characterisation ratio (Exposure/Hazard).

FA

Food additive. A substance deliberately added to foods or beverages for beneficial technological reasons (e.g. to preserve, flavour, colour or ensure a particular texture). Food additives are not normally consumed by themselves nor used as typical ingredients in food.

FC

Focal commodity. A commodity for which an MRL is to be set or for which a high residue event has been monitored, and which is therefore the focus of an exposure assessment.

GAP

Good agricultural practice. GAP is a certification system for agriculture, specifying procedures (and attendant documentation) that must be implemented to create food for consumers or further processing that is safe and wholesome, using sustainable methods.

HBM

Human biomonitoring. A direct measurement of the level of toxic chemical compounds present in the body. Often, these measurements are made using blood and urine.

HBGV

Health based guidance value. HBGV is a science-based recommendation for the maximum (oral) exposure to a substance that is not expected to result in an appreciable health risk, taking into account current safety data, uncertainties in these data, and the likely duration of consumption.

HC

Hazard characterisations is a generic term for any reference value for a substances at a chosen biological target level (external or internal) beyond which exposure is associated with potential adverse health effects. Hazard characterisations can be specified as external values (e.g., a human based guidance value, such as an ADI or ARfD) or are based on a point of departure (POD), such as BMDs from dose-response models or externally specified points of departure (NOAEL, LOAEL, MDS). The computation may involve assessment factors, e.g., for inter-species conversion, intra-species variation or additional sources of uncertainty. The calculation may also use kinetic models or absorption factors to convert external doses to internal doses or vice versa.

HCPs

House Cleaning Products.

HI

The hazard index is the sum of all hazard quotiens (HQ) of the substances that are associated with the same potential adverse health effect.

HQ

The hazard quotient is the ratio of the exposure to a substance and the reference level at which no adverse effects are expected (i.e., exposure divided by the reference level). A HQ smaller than 1 is associated with no expected adverse health effect and a HQ larger than 1 is associated with possible adverse health effects. The HQ is closely related to the MOE, which can be seen as the inverse metric.

HR

Highest residue. The HR is the highest residue level (expressed as mg/kg) in a composite sample of the edible portion of a food commodity when a pesticide has been used according to maximum GAP conditions. The HR is estimated as the highest of the residue values (one from each trial) from supervised trials conducted according to maximum GAP conditions, and includes residue components defined by the JMPR for estimation of dietary intake.

H/E

Risk characterisation ratio (Hazard/Exposure).

ICED

Individual critical effect dose.

In silico

Research theoretical method, particularly involving computer models, to predict the likely toxicological, or other, effects of substances.

In vitro

Research method which involves testing cells or tissues extracted from living organisms.

In vivo

Research method which involves testing individual live animals or populations of live animals.

IVIVE

In vitro to in vivo extrapolation. Refers to the qualitative or quantitative transposition of experimental results or observations made in vitro to predict phenomena in vivo, biological organisms.

JRC

Joint Research Centre

Lipid

Fat and fat-like substance.

LNN

Logistic normal normal model.

LOAEL

Lowest observed adverse effect level.

LOD

Limit of detection. Lowest concentration of a pesticide residue in a defined matrix where positive identification can be achieved using a specified method (IUPAC, 2006).

LOQ

Limit of quantification. Lowest concentration of a pesticide residue in a defined matrix where positive identification and quantification measurement can be achieved using a specified analytical method (IUPAC, 2006).

LOR

Limit of reporting. Practical limit of residue quantification at or above the LOQ. The conservative limit of quantification for a defined matrix and method which may vary between laboratories or within the one laboratory from time to time because of different equipment, techniques, and reagents. Commonly either the lower limit of the calibrated range of the method or the lowest level at which quantitative recovery of the analyse has been demonstrated (IUPAC, 2006).

MCR

Maximum cumulative ratio.

MCRA

Monte Carlo Risk Assessment.

MIE

Molecular initiating event.

MoA

Mode of Action.

MOE

The margin of exposure (MOE) is the ratio between the reference level at which no adverse effects are expected to the exposure to a substance (i.e., reference level divided by exposure). Commonly, the reference level is assumed to be a point of departure (POD) based on animal studies that does not incorporate all factors to translate to a human reference value. A MOE is therefore typically compared to a uncertainty/safety factor (UF) composed of the product of the uncertainty factors. An MOE is smaller than the UF is associated with risk. A MOE larger than the UF is associated with no expected adverse health effects.

MOET

The harmonic sum of all individual MOEs.

MRA

Mixture risk assessment.

MRL

Maximum residue level. Maximum concentration of a residue that is legally permitted or recognized as acceptable in,or on, a food, agricultural commodity, or animal feedstuff as set by Codex or a national regulatory authority(IUPAC, 2006).

MV

Missing value

NAMs

New approach methodologies. The term NAM has been emerged as a descriptive reference to any non-animal-based approaches that can be used to provide information in the context of chemical hazard and risk assessment

NMF

Non-negative Matrix Factorization

NOAEL

No observed adverse effect level is the greatest concentration or amount of a substance at which no detectable adverse effects occur in an exposed population.

NOEC

No observed effect concentration.

OIM

Observed Individual Means approach. An approach for estimating longer term exposures by taking each individual’s observed mean consumption over the duration of a dietary survey.

OP

Occurence pattern

PACEM

Probabilistic Aggregate Consumer Exposure Model. PACEM evaluates aggregate exposure in a population considering individual use and co-use patterns as well as variation in product composition. Product usage data is included on personal care products (PCPs) and household cleaning products (HCPs).

PARC

Partnership for the Assessment of the Risk of Chemicals

PBK

Physiologically based kinetic models

PBPK

Physiologically based pharmacokinetic/toxicokinetic models

PCPs

Personal care products

POCE

The probability of critical exposure (PoCE) is the proportion of the HI distribution above the threshold (or of the generalised MOE below the threshold) is the probability of critical exposure in the particular (sub)population. The threshold value can be 1 if all assessment factors have already been accounted for in the calculation of HI or MOE.

POD

A point of departure is defined as a point on a toxicological dose-response curve obtained from a dose dose-response experiment in the region at which the curve transitions from no effects to effects. It is used as the base value for deriving toxicological reference values, or hazard characterisations. Common PODs are the no-observed adverse effect level (NOAEL) and benchmark dose (BMD).

PPP

Plant protection products. Products used to protect, preserve or influence the growth of desirable plants or to destroy or control the growth of unwanted plants or parts of plants.

PRIMo

EFSA pesticide residue intake model.

QSAR

Quantitative structure activity relationship. The quantitative/qualitative structure activity relationships are a set of methods by which the effects of different compounds are related to their molecular structures. It allows the likely adverse or beneficial effects of a particular chemical to be predicted by comparing it with others which have similar structures.

RA

Response Addition. An approach to the risk assessment of mixtures of substances in which responses to each of the individual components are determined and added together in order to predict the response to the mixture as a whole. This approach is only valid if the individual components do not interact with each other, i.e. their effects are completely independent.

RAC

Raw agricultural commodity. Part of a crop used as a food or feed commodity directly from the harvested crop without processing.

RIVM

Rijksinstituut voor Volksgesondheid en Milieu (Dutch National Institute for Public Health and the Environment). (Dutch) National Institute for Public Health and the Environment.

RPF

Relative potency factor. The ratio of the toxic potency of a given chemical to that of an index chemical in the Cumulative Assessment Group (CAG). Relative potency factors are used to convert exposures of all chemicals in the CAG into their exposure equivalents of the index chemical.

RSExpo

Modelling tool developed by ANSES, to estimate aggregate internal systemic exposures from multiple sources and routes using absorption factors

SA

Standard action

SBML

Systems Biology Markup Language

SG

Specific gravity of urine

SNMU

Sparse Nonnegative Matrix Underapproximation

SRA

Standard Regulatory Action

SSC

Source/Substance Combination

SSD

EFSA Standard sample description.

TDS

Total diet study. A study designed to estimate the likely consumption of harmful or beneficial substances in the diet. When undertaking such a study, commonly-consumed foods are purchased from shops in a particular country before being analysed.

TDI

Tolerable daily intake. Is an estimate of the amount of a substance in food or drinking water which is not added deliberately (e.g contaminants) and which can be consumed over a lifetime without presenting an appreciable risk to health.

TEF

Toxic equivalency factor.

TK

Toxicokinetics. The study of the processes by which potentially toxic substances are handled in the body. This involves an understanding of the absorption, distribution, metabolism and excretion of such substances ADME.

TP

Thermal paper.

TTC

Threshold of toxicological concern. A screening tool that provides conservative exposure limits in the absence of sufficient chemical-specific toxicological data. It is a science-based approach for prioritising chemicals with low-level exposures that require more data over those that can be presumed to present no appreciable human health risk.

The tolerable weekly intake is the maximum intake of substances in food, such as nutrients or contaminants, that can be consumed weekly over a lifetime without risking adverse health effects.