Documents and glossary

Definition of terms and acronyms used in EU-LCI documents

AFSSET: Agence Francaise de Sécurité Sanitaire de l’Environment et du Travail (French agency for environmental and occupational health and safety; now ANSES).

ANSES: Agence nationale de sécurité sanitaire de l’alimentation, de l’environment et du travail (French agency for food, environmental and occupational health and safety).

AgBB: Ausschuss zur gesundheitlichen Bewertung von Bauprodukten (Committee for Health-related Evaluation of Building Products).

Assessment Factor: A numerical factor (multiplier) used at various stages of the extrapolation from an experimentally determined toxicological point-of-departure to the estimated level of exposure below which an adverse effect is unlikely to occur. Sometimes referred to as an ‘uncertainty factor’ or, historically, a ‘safety factor’.

ATSDR: [US] Agency for Toxic Substances and Disease Registry.

BMD: Benchmark Dose – The dose or exposure of a compound associated with a specified low incidence of risk, generally in the range of 1% to 10%, of a health effect, or the dose associated with a specified measure or change of a biological effect. Thus BMD10, for example, is the dose of the test material that leads to a 10% increase in effect. The BMD approach provides a more quantitative alternative to the first step in the dose-response assessment than the NOAEL/LOAEL process for non-cancer health effects.

Category 1A and 1B carcinogens and mutagens: Compounds that are classified in accordance with the provisions of Regulation (EC) No 1272/2008 as a carcinogen or mutagen category 1A or 1B (based on the Globally Harmonized System). A Category 1 compound is known or presumed to have carcinogenic/mutagenic potential for humans. For Category 1A the assessment is based primarily on human evidence; for Category 1B the assessment is based primarily on animal evidence.

CEN/TC 351 horizontal standard: Horizontal testing procedure developed by the CEN/TC 351 working group 2 and published as EN 16561 for the determination of emissions into indoor air of regulated dangerous substances from construction products that can be used for all types of substances and construction products deemed relevant under the essential requirements of the Construction Products Regulation (Regulation (EU) No. 305/2011).

CLI: Concentration Limite d’Intérêt– the French (Afsset/Anses) LCI.

CLP: Classification, Labelling and Packaging. The classification, labeling and packaging of substances in the EU is regulated under EU Regulation 1272/2008 on Classification, Labelling and Packaging and, until 1st June 2015, Directive 67/548 EEC on Classification, Labelling and Packaging.

CMR: Carcinogenic, mutagenic or toxic to reproduction – meeting the criteria for classification in category 1 or 2 in accordance with Directive 67/548/EEC. This directive was recently replaced by the new EU regulation (EC) No 1272/2008 on classification, labelling and packaging of chemical substances and mixtures, the so-called CLP Regulation. According to the new CLP Regulation these substances shall be classified as 1A or 1B (see definition above).

CPD: The ‘Construction Products Directive’ 89/106/EEC of 21 December 1988 on the approximation of laws, regulations and administrative provisions of the member states relating to construction products. The ‘Construction Products Directive’ (CPD) aims to ensure the free movement of all construction products within the European Union by introducing a common technical language, consisting of harmonised standards and European technical approvals, in which manufacturers can express the performance of the products that they place on the market. This Directive will be replaced by the Construction Products Regulations (CPR) on 1st July 2013. Page 79

CPR: The Construction Products Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC. This regulation aims to ensure reliable information on construction products in relation to their performance. This is achieved by providing a “common technical language" offering uniform assessment methods of the performance of construction products. The Construction Products Regulation entered into force on the 24th of April 2011 and will replace the Construction Products Directive (CPD) completely on 1st July 2013.

Critical effect: The first adverse effect that appears when the threshold (critical) concentration or dose is reached in the critical organ.

Critical dose: The dose of a substance at and above which adverse functional changes, reversible or irreversible, occur in a cell or an organ. In the EU-LCI process it may also refer to the lowest dose or exposure level at which the identified important (critical) toxic effect occurs in the chosen study(ies).

CSR: Chemical Safety Report (produced as part of the substance registration process under REACH).

DG ENTR: The European Commission’s Directorate General for Enterprise and Industry.

DG JRC: The European Commission’s Joint Research Centre.

DG SANTE: The European Commission’s Directorate-General for Health and Food Safety(Formerly known as DG SANCO: Directorate General for Health and Consumers until 2014).

DIBT: Deutsches Institut für Bautechnik (German Institute for Building Technology).

DNEL: Derived No-Effect Level – in REACH, the level of exposure below which no adverse effects are expected to occur and therefore the level above which humans should not be exposed. A DNEL is a derived level of exposure because it is normally calculated on the basis of available dose descriptors such as NOAELs or BMDs from animal studies.

ECETOC: European Centre for Ecotoxicology and Toxicology of Chemicals.

ECHA: The European Chemicals Agency.

EFSA: The European Food Safety Agency.

EGDS: The DG Enterprise Expert Group on Dangerous Substances.

Emission rate: The mass of chemical emitted from a specific unit area of product surface per unit time – [mg/m2/h] or [mg/item/h].

Endpoint: In biological and clinical research, a disease, symptom or sign that constitutes one of the target outcomes of the experiment or trial.

EU-LCI: The EU-LCI value for a compound (‘ascribed interim’, ‘derived interim’, ‘with derivation pending’) agreed by the EU-LCI working group or formally endorsed by the EU Member States (‘confirmed’).

EU-LCI ‘ascribed’ value: The EU-LCI value given to a compound that, for whatever reason, has identical or very similar (differing by 20% or less) LCI values in the ANSES and AgBB lists.

EU-LCI ‘candidate’ compound: A compound under consideration for inclusion into the EU-LCI master list and subsequent evaluation (e.g. compounds identified by EU national authorities).

EU-LCI ‘derived’ value: The EU-LCI value of a compound derived de novo using the EU-LCI protocol.

EU-LCI ‘interim’ value: This term may be used to describe the ‘ascribed’ or ‘derived’ EU-LCI value in the EU-LCI master list that is to be used as the harmonised value by the EU Member States until such time as a formal process is in place to transform it into a ‘confirmed’ EU-LCI value.

EU-LCI ‘with derivation pending’: The EU-LCI value (for compounds with different LCI values in AgBB and ANSES lists) for which de novo derivation (by applying the EU-LCI protocol) has not been initiated.

EU-LCI WG: The expert group (established by the European Commission’s DG JRC in the context of the PILOT INDOOR AIR MONIT administrative arrangement with DG SANCO) responsible for developing the EU-LCI framework, deriving EU-LCI values and preparing the EU-LCI master list.

EU-LCI master list: a list comprising compounds with ‘confirmed’ and ‘interim’ EU-LCI values, EU-LCI values ‘with derivation pending’ and EU-LCI ‘candidate’ compounds.

EU-RAR: European Union Risk Assessment Report. These reports were produced in accordance with Council Regulation (EEC) 793/93 on the evaluation and control of the risks of “existing” substances - chemical substances in use within the European Community before September 1981 and listed in the European Inventory of Existing Commercial Chemical Substances.

HEC: The human equivalent concentration represents the equivalent human exposure concentration adjusted to a continuous basis.

IAQG: Indoor Air Quality Guideline(s).

LOAEL: Lowest Observed Adverse Effect Level - the lowest dose or exposure level at which there is a statistically or biologically significant increase in the frequency or severity of an adverse effect compared with the unexposed control group.

LCI: Lowest Concentration of Interest - The LCI concept was first developed by the ‘European Collaborative Action on ‘Indoor Air Quality and its Impact on Man’ when considering the best way to evaluate emissions from solid flooring materials. It was defined (see ECA Report No.18, 1997) as “the lowest concentration above which, according to best professional judgement, the pollutant may have some effect on people in the indoor environment”.

Molar adjustment: The multiplicative factor, based on relative molecular weight, applied to the value derived by read-across, generally from a smaller molecular entity to a larger molecule, assuming the same active moiety. When applying molar adjustment in a homologous series of compounds, the molar adjustment factor rapidly increases. It is considered appropriate, therefore, to apply a cap or ‘cut-off’ (e.g. 1.5 x base value; two CH2 group per aliphatic chain) to limit the maximum adjustment made and achieve an appropriate level of safety in the risk assessment procedure.

MRL (Chronic Minimal Risk Level): An estimate of daily human exposure to a dose of a chemical that is likely to be without an appreciable risk of adverse noncancerous effects over a lifetime of exposure (based on chronic studies of 365 or more days). Used by ATSDR.

NIK: Niedrigste Interessierende Konzentration – the German (AgBB) LCI.

NOAEL: No Observed Adverse Effect Level - An exposure level at which there are no statistically or biologically significant increases in the frequency or severity of adverse effects compared to those observed in the control group; some effects may be produced at this level, but they are not considered as adverse or precursors to adverse effects. The NOAEL is thus generally taken as the highest exposure without adverse effect.

OECD: Organization for Economic Co-operation and Development.

OEL: Occupational Exposure Limit.

PBPK: Physiologically based pharmacokinetic [modelling] - Mathematical modeling of the kinetic behavior of a substance in the body, based on measured physiological parameters (Also known as physiologically based toxicokinetic modelling).

Point-of-departure (POD): The point on a toxicological dose-response curve established from experimental data generally corresponding to an estimated low effect level, based for example on the benchmark dose or a LOAEL or NOAEL.

Primary emission: The release of volatile compounds contained in the material from manufacture in free form. The rate of emission will normally decay continuously up to and beyond the standard 28-day chamber testing period.

QSAR: Quantitative Structure-Activity Relationship - The relationship between the physical and/or chemical properties of a substance and its ability to cause a particular effect. ‘QSARs’, as commonly referred to, are the mathematical models developed to predict the properties of a substance from its molecular structure. In toxicology the aim of QSARs is to predict the toxicity of a substance by analogy with the properties of other toxic substances of known structure and toxic properties.

R-Value: R is the sum of the ratio of individual VOCi concentrations to their respective LCIi values, i.e. R = S (Ci/LCIi) of assessable VOCs. In both the AgBB scheme and the ANSES protocol, the limit value of “exposure concentration” is R ≤ 1 after 28 days.

Read-across: The technique used to predict endpoint information for one chemical by using data on the same endpoint from another chemical which is considered to be similar - e.g. on the basis of structural similarity and similar properties and/or activities. The approach can be qualitative or quantitative.

REACH: Registration, evaluation, authorisation and restriction of chemicals – the European regulatory framework for chemicals (Regulation (EC) No 1907/2006).

RfC (Reference Concentration)/RfD (Reference Dose): An estimate of the daily exposure concentration/dose to/of a substance for a human population, including sensitive subgroups, that is likely to be without an appreciable risk of deleterious effects during a lifetime.

RIVM: Rijksinstituut voor Volksgezondheid en Milieu (Dutch national institute for public health and the environment).

Risk value (inhalation): A concentration of chemical (usually expressed as μg/m.) that for noncancer toxicity is generally considered to be without adverse effects in populations of humans (including sensitive subpopulations) for the duration of exposure specified. Examples include: MRL, RfC, TC, TCA, WHO Air quality guidelines, DNEL).;

SCOEL: EC Scientific Committee on Occupational Exposure Limits

Secondary emission: The release of volatile compounds formed by a continuous process (sometimes only after induction by an external influence) – for example by oxidation, hydrolysis or other chemical reaction – after the material is produced. This can result in an unusually prolonged emission phase or even an increase in emissions during the 28-day chamber testing period.

SVOC: Semi-Volatile Organic Compound – An organic compound whose boiling point is in the range from (240 °C to 260 °C) to (380 °C to 400 °C). [This classification has been defined by the World Health Organization. Boiling points of some compounds are difficult or impossible to determine because they decompose before they boil at atmospheric pressure. Vapour pressure is another criterion for classification of compound volatility that may be used for classification of organic chemicals].

TC (TCA): Tolerable Concentration (or Tolerable Concentration in Air), used by Health Canada and RIVM.

TRV: Toxicological Reference Value (or "reference dose"); see RfD.

TVOC: Total Volatile Organic Compounds – TVOC is a simple parameter that summarizes on Tenax TA adsorbed VOCs following GC elution between the C6 to C16 chromatographic retention window. TVOC is determined as the total integrated peak area, calibrated with use of toluene as reference compound.[Alternatively, the sum of VOCs (TVOCSUM) may be determined by summing the individual concentrations of every identified and unidentified component eluting between n-hexane and n-hexadecane inclusively, at a concentration above 5 μg.m-3, after subtracting non-interfering VOC artefacts].

UBA: Umweltbundesamt – the German Federal Environment Agency

VOC: Volatile Organic Compound – An organic compound whose boiling point is in the range from (50 °C to 100 °C) to (240 °C to 260 °C).

VVOC: Very Volatile Organic Compound – An organic compound whose boiling point is in the range from <0 °C to (50 °C to 100 °C).

WHO: World Health Organization