NORMAN

Accepted reference value

A value that serves as an agreed-upon reference for comparison, and which is derived as:

1. a theoretical or established value, based on scientific principles;
2. an assigned or certified value, based on experimental work of some national or international organisation
3. a consensus or certified value, based on collaborative experimental work under the auspices of a scientific or engineering group

when a), b) and c) are not available, the expectation of the (measurable) quantity, i.e. the mean or the median of a specified population of measurements

Accreditation (of laboratories)

Procedure where an independant authority body acknowledges that an organisation or a person is competent to carry out specified tasks. Accreditation relies on criteria or procedures to assess the technical competencies. Accreditation acknowledges the conformity of the quality system as well as the competencies of the staff.

Accuracy

The closeness of agreement between a test result and the accepted reference value.
NOTE: The term accuracy, when applied to a set of test results, involves a combination of random components and a common systematic error or bias component.

Adaptation

Deliberate modification of a test method with the aim to extend its scope or applicability, e.g. to make it applicable for a new matrix or organism

Analyte

The substance subject to analysis

Analytical method

Any fully documented and validated method describing procedures that enable the amount or concentration of a parameter to be determined to a stated uncertainty

Analytical run

To be defined (sub project validation)

Applicability

To be defined (sub project validation)

Bias

The difference between the expectation of the test results and an accepted reference value.
NOTE: Bias is the total systematic error as contrasted to random error. There may be one or more systematic error components contributing to the bias. A larger systematic difference from the accepted reference value is reflected by a larger bias value

Biomarker

A change in biological response, ranging from molecular through cellular and physiological responses to behavioural changes, which can be related to exposure to or toxic effects of environmental chemicals

Blank

To be defined (sub project validation)

Calibration

Operation establishing the relation between quantity values provided by measurement standards and the corresponding indications of a measuring system, carried out under specified conditions and including evaluation of measurement uncertainty.

Calibration laboratory

A laboratory producing standards of known composition and uncertainty which are then used by other laboratories for calibration purposes

Certification

Third party, independent process confirming compliance to specified requirements

Certified Reference Material

Reference material, accompanied by a certificate, one or more whose property values are certified by a procedure, which establishes its traceability to an accurate realisation of the unit in which the property values are expressed, and for which each certified value is accompanied by an uncertainty at a stated level of confidence

European Topic Centre

Institutions/organisations contracted by the EEA to execute tasks identified in the multiannual work programme. They are designated by the management board after a competitive expertise/capacity selection process. Guiding principles for selection should be the cost-efficient use of existing and potential capacities in the member countries and avoidance of duplication of work and capacities.

Community Reference Laboratory (CRL)

Community Reference Laboratories" (CRLs) with scientific and technical expertise within the areas of animal health, public health and zootechnics have been designated in different Community Decisions, Directives and Regulations. Within the framework of Council Decision N° 90/424/EEC on expenditure in the veterinary field of 26 June 1990, these laboratories may receive a Community financial aid for fulfilling tasks and functions specified in legislation.

Comparability

Property of measurement results enabling them to be compared because they are metrologically traceable to the same stated metrological reference

Contact Point

Expert from leading institutes / organisations / research centres to be identified in the different European countries in order to collaborate with the NORMAN network for:

• the exchange of information about research initiatives, monitoring programmes and analytical needs for emerging environmental pollutants
• the dissemination of information in their own countries regarding NORMAN activities.

Contaminant

Any physical, chemical, biological, or radiological substance or matter that has an adverse effect on air, water, or soil.

Control Chart

To be defined (sub project validation)

Criteria

General definition: a descriptive factor / a measure

Criteria of accreditation

Internationally recognised requirements as described in ISO 17025

Criteria for Contact Points

A Contact Point should meet the following criteria:

• Recognised experience in the field of emerging substances demonstrated via scientific publications or a related national / international institutional role;
• Expertise in at least one of the following sectors of activity:
  • research on emerging substances (chemical analyses and/or bio-monitoring using bio-assays and biomarkers, etc.)
  • risk assessment
  • monitoring of emerging pollutants
  • participation in national / international projects / work programmes dealing with emerging substances.

A Contact Point should be committed to carry out the following tasks:

• Support the NORMAN network in creating links to the key research centres, reference laboratories, institutions, etc. and providing first-contact information about the on-going research activities, projects, monitoring programmes and other initiatives relating to emerging substances
• Help to disseminate information about NORMAN reports, workshops and activities to relevant institutions / organisations.

Criteria for analytical laboratory

• Demonstration by the lab of the performance of a method in the concentration range of interest
• Limit of quantification (1/5 of the concentration level of interest)
• Regular blank control and spiking experiments or analysis of control sample (if available certified reference material)
• Successful participation of inter-laboratory studies (relevant matrixes)
• Accreditation (ISO 17025) to ensure the application of analytical quality assurance

Criteria for expert laboratory

1. Activities in the policy area:
   • Participation in European Working Groups (policy development and implementation)
2. Activities in the standardisation area:
   • Participation in CEN, ISO working groups/ technical committees
   • Participation in accreditation and/or certification working groups
3. Activities in the research area:
   • Publications (number and citation by other publications, participation in national / international research projects, participation and communication in internationally recognised congress (posters, presentations…)
4. Activities in the public domain:
   • Technical support to public authorities

Criteria for research laboratory

1. Activities in the research area
   • Publications (number and citation by other publications, participation in national / international research projects, participation and communication in internationally recognised congress (posters, presentations…)
   • Publications (prime journals), participation in national / international research projects. Number of citations by other publications.
2. Activities in the public domain:
   • Technical support to public authorities

Criteria for national reference laboratory

Competencies:

• capable of interacting with research labs
• capable of interacting with organisations and institutional bodies in charge of QA/QC systems
• capable of interacting with standardisation bodies
• capable of interacting with routine analysis laboratories.

Missions:

• developing, validating and testing methods and protocols dealing with sampling, transport, storage, preparation of samples, in situ measurements and laboratory analyses (with particular emphasis on the validation of chemical and biological methods necessary for obtaining reliable and comparable data for the determination of emerging substances)
• providing technical support to the laboratories for the implementation of these methods (in terms of QA/QC procedures) via the development of books /guidelines / manuals, and / or the organisation of national working groups
• providing technical support to competent authorities for the definition of the performance targets to be achieved by the monitoring labs which are authorised to apply these methods (and the evidence to be provided for the demonstration of the achievement of these targets)
• auditing of monitoring labs (at the request of the competent authorities)
• organising PT exercises for routine laboratories at national level and being a reference point for routine labs in its particular country in order to inform and encourage them to take part in inter-laboratory tests available at the national or EU level
• taking part in the activities (technical committees) of standardisation bodies, accreditation and certification bodies at national and/or European / international level
• running a scientific and technological watch (observatory) in order to advise authorities and anticipate research needs regarding emerging pollutants and new methods
• being involved in research programmes and ensuring, through its participation in these programmes, the transfer and added value of the research findings

Development

In this guide, development is used in the meaning of extending the applicability of a method, e.g. to a new matrix, compound or organism.

Emerging pollutants

A substance currently not included in routine environmental monitoring programmes and which may be candidate for future legislation due to its adverse effects and / or persistency.

Emerging substance

A substance that has been detected in the environment, but which is currently not included in routine monitoring programmes and whose fate, behaviour and (eco)toxicological effects are not well understood

Expert laboratory

Laboratory judged by one’s peers and recognised as expert on a specific area, field or theme. Besides activities in the research area, it may be involved in activities related to policy development and / or implementation, standardisation, certification, accreditation.
Could be academic centre, university, research institute, private or public organisation.

Fitness for Purpose

Degree to which data produced by a measurement process enables a user to make technically and administratively correct decisions for a stated purpose

National Focal Point

National Focal Points (NFPs) are appointed and funded by member countries and are in charge of national co-operation with the EEA and national co-ordination of activities related to the EEA work programme.

Indicator (Environmental Indicator)

A concise measure of cumulative effects and ecosystem vulnerability.

Interference

To be defined (sub project validation)

Intermediate precision (within-lab reproducibility)

Precision under conditions where independent test results are obtained with the same method on identical test items in the same laboratory by different operators using different equipment on different days.

Internal Standard

To be defined (sub project validation)

LC 50/Lethal Concentration

Median level concentration, a standard measure of toxicity. It tells how much of a substance is needed to kill half of a group of experimental organisms in a given time. (See: LD 50.)

LD 50/ Lethal Dose

The dose of a toxicant or microbe that will kill 50 percent of the test organisms within a designated period. The lower the LD 50, the more toxic the compound.

Limit of Detection

The lowest concentration of analyte in a sample that can be detected with stated level of confidence, but not necessarily quantitated under the stated conditions of the test.

Limit of Quantitation (or Limit of Quantification)

The lowest concentration of an analyte that can be determined with acceptable precision under the stated conditions of the test

Linearity

The ability of the response of the method (signal, colour density…) to obtain test results proportional to the concentration of analyte.
NOTE: The linear range is by inference the range of analyte concentrations over which the method gives test results proportional to the concentration of the analyte

Lower Limit Of Applicability

The lowest concentrations for which a method has been validated with specified accuracy

Matrix

To be defined (sub project validation)

Matrix effect

To be defined (sub project validation)

Measurand

Quantity intended to be measured

Measurement

Process of experimentally obtaining information about the magnitude of a quantity

Measurement Uncertainty

Parameter that characterises the dispersion of the quantity values that are being attributed to a measurand, based on the information used.

Metadata

Data about data, e.g. Date and location of sampling are metadata for concentration data measured at a given site

Method, Test method

To be defined (sub project validation)

Monitoring (under WFD)

The three modes of monitoring specified in the WFD include

1. surveillance monitoring aimed at assessing long-term water quality changes and providing baseline data on river basins allowing the design and implementation of other types of monitoring,
2. operational monitoring aimed at providing additional and essential data on water bodies at risk or failing environmental objectives of the WFD, and finally
3. investigative monitoring aimed at assessing causes of such failure when they are unknown

Monitoring (Bio-monitoring)

Monitoring (Risk monitoring)

Process of following up the decisions and actions within risk management in order to ascertain that risk containment or reduction with respect to a particular hazard is assured.

Negative Control

To be defined (sub project validation)

Optimisation

Deliberate modification of a test method with the aim to improve its performance, e.g. with respect to lower limits of quantitation, smaller measurement uncertainty or better selectivity

Outlier

A member of a set of values which is inconsistent with the other members of that set.
NOTE: ISO 5725-2 specifies the statistical tests and the significance level to be used to identify outliers in trueness and precision experiments

Pollutant

Generally, any substance introduced into the environment that adversely affects the usefulness of a resource or the health of humans, animals, or ecosystems.

Positive Control

To be defined (sub project validation)

Precision

The closeness of agreement between independent test results obtained under stipulated conditions.
NOTES:
Precision depends only on the distribution of random errors and does not relate to the true value or the specified value. The measure of precision is usually expressed in terms of imprecision and computed as a standard deviation of the test results. Less precision is reflected by a larger standard deviation.
"independent test results" means results obtained in a manner not influenced by any previous result on the same or similar test object. Quantitative measures of precision depend critically on the stipulated conditions. Repeatability and reproducibility conditions are particular sets of extreme conditions.

Proficiency Testing

A periodic assessment of the performance of individual laboratories and groups of laboratories that is achieved by the distribution by an independent testing body of typical materials for unsupervised analysis by the participants

Primary procedure

Measurement procedure used to realise the definition of a measurement unit and obtain the quantity value and measurement uncertainty of a primary measurement standard.

Quality Assurance

Planned activities designed to ensure that the quality control activities are being properly implemented.

Quality control

A planned system of activities designed to provide a quality product.

Quantity

Property of a phenomenon, body, or substance, to which a magnitude can be assigned

Quantity values

Magnitude of a quantity represented by a number and a reference

Range

The difference between the largest and the smallest observed value of a quantitative characteristic

Recovery

If a known amount of analyte is added to a test sample and the test sample is then analysed for that analyte by a particular method, the recovery is that fraction of the amount of analyte added which is found by the method

National Reference centre

National reference centres (NRCs) are not mentioned in the regulation, but have been defined subsequently as a special set of main component elements . National reference centres are therefore also nationally funded institutions/organisations which may be nominated by member countries to play a role in technical co-ordination within their countries and cooperate with the European topic centre established to cover various topics.

National Reference laboratories

Nationally-funded institutes/ organisations, designated by the competent authorities to offer technical and scientific support in specific fields. The designation and the organisation of their missions may vary from one country to another in the EU (certain countries have permanently designated one or more NRLs, other competent authorities have chosen to select NRLs from their current operating "contractors"). As a common denominator their role and tasks include:

• being directly involved in research programmes
• provide technical support to public bodies as regards the implementation of national and EU legislation by:
  • Implementing a quality system in the laboratory
  • Improving measurement systems (instruments, laboratories, networks)
  • Ensuring the traceability of the measurements at national level, by providing/certifying reference materials to networks, organising PT schemes, etc.
  • Participating in EU QA/QC programmes
  • Exchanging information through the organisation of training sessions, workshops and conferences.

Reference Material

Material or substance one or more of whose property values are sufficiently homogeneous and well established to be used for the calibration of an apparatus, the assessment of a measurement method, or for assigning values to materials

Repeatability

Precision under repeatability conditions, i.e. conditions where independent test results are obtained with the same method on identical test items in the same laboratory by the same operator using the same equipment within short intervals of time

Research laboratory

Laboratory judged by one’s peers and recognised as expert on a specific area, field or theme.
Could be academic centre, university, research institute, private or public organisation.

Reproducibility

Precision under reproducibility conditions, i.e. conditions where test results are obtained with the same method on identical test items in different laboratories with different operators using different equipment.

Residual

Difference between the observed response and that predicted by a calibration function.

Robustness

The robustness of an analytical procedure is a measure of its capacity to remain unaffected by small, but deliberate variations in method parameters and provides an indication of its reliability during normal usage

Routine analysis laboratory

"Any laboratory undertaking analysis of a parameter, whether as part of a legislative need or requirement, or not as the case may be, and where the result is generated using a fully validated and documented method with established performance characteristics such as precision and bias produced within that laboratory".
This definition, whist broad in its approach, enables a wide range of laboratories to be included in the proposed network.

Sample

The totality of a homogeneous analysis material having an identical composition or quality (similar to term batch)

Sample — Field Sample

For example, the bulk of water collected from the river

Sample — Laboratory Sample

Primary sample material delivered to the laboratory

Sample — Subsample

A defined portion of a sample obtained by suitable sample division and identical in terms of composition

Sample — Test sample

The aliquot of the laboratory sample taken for processing into a test portion

Sample — Test portion

The portion of the laboratory sample taken for analysis or testing

Sample handling

The manipulation to which samples are exposed during the measurement process, from the selection from the original material through to the disposal of all samples

Sample preparation

The procedures followed to select the test portion from the sample (or sub-sample). These include in-laboratory processes such as: homogenisation, mixing, and filtering. It often includes chemical operations such as: extraction, separation, derivatisation, and concentration

Selectivity

The ability of a method to determine accurately and specifically the analyte of interest in the presence of other components in a sample matrix under the stated conditions of the test

Sensitivity

The change in the response of a measurand divided by the corresponding change in the stimulus

Specificity

The ability of a method to measure only what it is intended to measure

Stability

Ability of a measuring system to maintain its metrological characteristics constant with time

Standard

Realisation of the definition of a given quantity, with stated value and measurement uncertainty, used as a reference.

Test laboratory

See routine analysis laboratory

Toxicity

The degree to which a substance or mixture of substances can harm humans or animals.

Acute toxicity

The ability of a substance to cause severe biological harm or death soon after a single exposure or dose. Also, any poisonous effect resulting from a single short-term exposure to a toxic substance.

Chronic toxicity

The ability of a substance or mixture of substances to cause harmful effects over an extended period, usually upon repeated or continuous exposure sometimes lasting for the entire life of the exposed organism.

Sub-chronic toxicity

The ability of the substance to cause effects for more than one year but less than the lifetime of the exposed organism.

Toxicity test

Determination of the effect of a substance on a group of selected organisms under defined conditions

Tracability

Property of the result of a measurement or the value of a standard whereby it can be related with a stated uncertainty, to stated references, usually national or international standards (i.e. through an unbroken chain of comparisons all having stated uncertainties)
NOTE: The standards referred to here are measurement standards rather than written standards

Trueness

The closeness of agreement between the average value obtained from a large series of test results and an accepted reference value.
NOTE: The measure of trueness is usually expressed in terms of bias.

Uncertainty of measurement

See Measurement uncertainty

Validation

Confirmation through examination of a given item and provision of objective evidence that it fulfils the requirements for a stated intended use.

Working range

The interval between the upper and lower concentration (amounts) of analyte in the sample for which it has been demonstrated that the analytical procedure has a suitable level of uncertainty.