List of Acronyms

ABS	Absorption
AC	Article Category
ADME	Absorption, Distribution, Metabolism, and Excretion
ADN	European Agreement concerning the International Carriage of Dangerous Goods by Inland Waterways annexed to resolution No. 223 of the Inland Transport Committee of the Economic Commission for Europe, as amended
ADR	European Agreement concerning the International Carriage of Dangerous Goods by Road under framework Directive 94/55/EC, as amended
AF	Assessment Factor
AS	Allometric Scaling
ATE	Acute Toxicity Estimate: acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as ATEs.
ATP	Adaptation to Technical and Scientific Progress (in this guidance “ATP” refers to an ATP to the CLP Regulation)
AUC	Area Under the Curve; area under the blood/plasma concentration curve vs. time curve, representing the total amount of substance reaching the blood/plasma
BCF	Bio Concentration Factor
BMD	Benchmark Dose; The BMD concept involves fitting a mathematical model to dose-response data. The BMD is defined as the dose causing a predetermined change in response
BMD10	The benchmark-dose associated with a 10% response (for tumours upon lifetime exposure after correction for spontaneous incidence, for other effects in a specified study)
BMDL10	The lower 95% confidence interval of a benchmark-dose representing a 10% response (e.g., tumour response upon lifetime exposure), i.e. the lower 95% confidence interval of a BMD10
BMF	Bio Magnification Factor
BPR	Biocidal Products Regulation: Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products repealing Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market, as amended [OJ L 123, 24.4.98, p. 1], with effect from 1 September 2013
BREF	Best Available Technique Reference Document
BSAF	Biological Soil Accumulation Factor
Bw	Body weight
CAD	Chemical Agents Directive
CAS	Chemical Abstracts Service
CBI	Confidential Business Information
CEN	Comité Européen de Normalisation (European Committee for Standardization)
CGS	Control Guidance Sheets
CLH	Harmonised Classification and Labelling
CLP Regulation	Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006
Cmax	Peak Plasma Concentration
CNS	Central Nervous System
CRF	Child-Resistant Fastening
CSA	Chemical Safety Assessment
CSR	Chemical Safety Report
DLI	Department of Labour Inspection, Cyprus
DMEL	Derived Minimum Effect Level
DNEL	Derived No Effect Level
DPD	Directive 1999/45/EC (Dangerous Preparations Directive, DPD)
DSC	Differential Scanning Calorimetry
DSD	Directive 67/548/EEC (Dangerous Substances Directive, DSD)
DU	Downstream User
DU-CSA	Downstream User Chemical Safety Assessment
DU-TGD	Downstream User Technical Guidance Document
EASE	Estimation and Assessment of Substance Exposure
ECHA	European Chemicals Agency
ED10	Effective dose 10 %; a dose representing an in-creased incidence of 10 % due to a specific exposure (e.g. to a chemical).
EFSA	European Food Safety Authority
EINECS	European Inventory of Existing Commercial Chemical Substances
ELR	Excess Lifetime Risk; additional lifetime risk over the background normal risk (or incidence of disease)
EPIWIN	Estimation Program Interface for Windows
EPL	Exposure Predictor Band Liquid
EPS	Exposure Predictor Band Solid
ERC	Environmental Release Class
ES	Exposure Scenario
ESD	Emission Scenario Document
EU	European Union
EUSES	European System for the Evaluation of Substances
EWL	European Waste List
GCL	Generic Concentration Limit
GCLS	General Chemical State Laboratory of Greece
GDMF	General Decision-Making Framework
GHS	Globally Harmonised System of Classification and Labelling of Chemicals
GLP	Good Laboratory Practice
HBMD10	Human BMD10
HEvE	Human Exposure via Environment
HH	Human health
HSDB	Hazardous Substances Data Bank
HSE	Health Safety Environment
HT25	Human T25
HtLF	High to Low Dose Risk Extrapolation Factor
IC	Industry Category
ICAO	“International Civil Aviation Organisation”, refers to Annex 18 to the Convention on International Civil Aviation “The Safe Transport of Dangerous Goods by Air”
IMDG	“International Maritime Dangerous Goods Code” for the transport of dangerous goods by sea
IPCS	International Programme on Chemical Safety
IPPC	Integrated Pollution Prevention and Control
IRIS	Integrated Risk Information System
ISO	International Standards Organisation
ITS	Integrated Testing Strategy
IUCLID	International Uniform ChemicaL Information Database
IUPAC	International Union of Pure and Applied Chemistry
LC50	Median lethal concentration. The concentration causing 50 % lethality
LCS	Life Cycle Stage
LD50	Median Lethal Dose. The dose causing 50 % lethality
LED10	Lowest Confidence Limit of the ED10
LEV	Local Exhaust Ventilation
LMS	Linear Multistage Model
LOQ	Limit of Quantitation
M/I	Manufacturer / Importer
MMAD	Mass Median Aerodynamic Diameter
MoA	Mode of Action
MoE	Margin of Exposure
MTD	Maximum Tolerated Dose
NACE	Nomenclature générale des activités économiques dans les Communautés Européennes
NAEC	No Adverse Effect Concentration
NAEL	No Adverse Effect Level
NICNAS (Australia)	National Industrial Chemicals Notification and Assessment Scheme
NIOSH (United States)	National Institute of Occupational Safety and Health
NOAEL	No Observed Adverse Effect Level
NOEL	No Observed Effect Level
OC	Operational Condition
OR5	Odds Ratio; the ratio of the odds of an event occurring in one group to the odds of it occurring in another group
ORL	Lowest Confidence Limit of the OR
OSHA (United States)	Occupational Safety and Health Administration
OU	Operational Unit
PBPK	Physiologically-Based Pharmacokinetic Modelling
PBT	Persistent, Bioaccumulative, Toxic
PC	Chemical Product Category
PEC	Predicted Environmental Concentration
PIC Regulation	Prior Informed Consent Regulation; Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals (recast) [OJ L 201 27.07.2012 p 60]
PNEC	Predicted No-Effect Concentration
PPE	Personal Protection Equipment
PPPR	Plant Protection Products Regulation: Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC
PROC	Process Category
(Q)SAR	Qualitative Structure Activity Relationship, mathematical method to predict e.g. biological activity based on chemical structure
QSPR	Quantitative Structure–Property Relationships
RC	Risk Characterization
RCR	Risk Characterization Ratio
REACH Regulation	Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission
RID	Regulation concerning the International Carriage of Dangerous Goods by Rail under framework Directive 96/49/EC [Annex 1 to Appendix B (Uniform Rules concerning the Contract for International Carriage of Goods by Rail) (CIM) of COTIF (Convention concerning international carriage by rail)], as amended
RMM	Risk Management Measure
RR	Relative Risk
RRL	Lower Bound Exposure Value associated with the RR-value of 1.1
RSS	Robust Study Summaries
RTECS	Registry of Toxic Effects of Chemical Substances
RTGD (United Nations)	Recommendations on the Transport of Dangerous Goods
SCL	Specific Concentration Limit
SDS	Safety Data Sheet
SI	The International System of Units
SIEF	Substance Information Exchange Forum
SME	Small and Medium Enterprise
SMR	Standardised Mortality Ratio
SMRL	Lower Bound Exposure Value associated with the SMR-value of 1.1
sRV	Standard Respiratory Volume
STP	Sewage Treatment Plant
SU	Sectors of Use
SVHC	Substances of Very High Concern
T25	The chronic dose rate that will give 25% of the animals’ tumours at a specific tissue site after correction for spontaneous incidence, within the standard life time of that species
TARIC	Tarif intégré des Communautés Européennes
TG	Test Guideline
TTC	Threshold of Toxicological Concern
TWA	Time-Weighted Average Exposure
UC	Use Category
UCN	Use Code Nordic
UDS	Use Descriptor System
UEC	Use and Exposure Categories
UFI	Unique Formula Identifier
UN RTDG	UN Recommendations on the Transport of Dangerous Goods – Model Regulations. It is regularly updated and amended every two years. More information and the latest revision are available at: http://www.unece.org/trans/danger/publi/unrec/rev13/13nature_e.html
UN	United Nations
UN-MTC	The UN Manual of Tests and Criteria contains criteria, test methods and procedures to be used for classification of dangerous goods according to the provisions of Parts 2 and 3 of the United Nations Recommendations on the Transport of Dangerous Goods, Model Regulations, as well as of chemicals presenting physical hazards according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). More information and the latest revision are available at: http://www.unece.org/trans/danger/publi/manual/manual_e.html
UVCB	Substances of unknown or variable composition, complex reaction products or biological materials as defined in the Guidance on substance identification
vPvB	Very Persistent and Very Bioaccumulative
WoE	Weight of Evidence
wRV	Worker Respiratory Volume

Glossary of Terms

Aerosol: aerosol dispenser, any non-refillable receptacle made of metal, glass or plastics and containing a gas compressed, liquefied or dissolved under pressure, with or without a liquid, paste or powder, and fitted with a release device allowing the contents to be ejected as solid or liquid particles in suspension in a gas, as a foam, paste or powder or in a liquid state or in a gaseous state;

Alloy: a metallic material, homogeneous on a macroscopic scale, consisting of two or more elements so combined that they cannot be readily separated by mechanical means; alloys are considered to be mixtures for the purposes of CLP;

Article (Under REACH and CLP): an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition;

Aspiration: the entry of a liquid or solid chemical substances or mixture into the trachea and lower respiratory system directly through the oral or nasal cavity, or indirectly from vomiting;

Carcinogen: a substance or a mixture of substances which induces cancer or increases its incidence

Competent Authority: the authority or authorities or bodies established by the Member States to carry out the obligations arising from the CLP Regulation;

Corrosive to metals: materially damaging, or even destroying, metals by chemical action of a substance or a mixture;

Differentiation: the distinction between hazard classes depending on the route of exposure or the nature of the effects;

Distributor: any natural or legal person established within the Union, including a retailer, who only stores and places on the market a substance, on its own or in a mixture, for third parties;

Downstream user: any natural or legal person established within the Union, other than the manufacturer or the im  porter, who uses a substance, either on its own or in a mixture, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user. A re-importer, exempted pursuant to Article 2(7)(c) of REACH, is regarded as a downstream user;

Explosive article: an article containing one or more explosive substances;

Explosive substance: a solid or liquid substance (or mixture of substances) which is in itself capable by chemical reaction of producing gas at such a temperature and pressure and at such a speed as to cause damage to the surroundings. Pyrotechnic substances are included even when they do not evolve gases;

Eye irritation: the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application;

Fee Regulation: Commission Regulation (EU) No 440/2010 of 21 May 2010 on the fees payable to the European Chemicals Agency pursuant to Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures;

Flammable gas: a gas having a flammable range with air at 20 °C and a standard pressure of 101.3 kPa;

Flammable liquid: a liquid having a flash point of not more than 60°C. Flash point means the lowest temperature (corrected to a standard pressure of 101.3 kPa) at which the application of an ignition source causes the vapours of a liquid to ignite under specified test conditions;

Flammable solid: a solid which is readily combustible, or may cause or contribute to fire through friction;

Gas: a substance which (i) at 50 °C has a vapour pressure greater than 300 kPa; or (ii) is completely gaseous at 20 °C at a standard pressure of 101.3 kPa;

Hazard (sub-)category: the (sub-)division of criteria within each hazard class, specifying hazard severity;

Hazard class: the nature of the physical, health or environmental hazard;

Hazard pictogram (sometimes also referred to as “pictogram” in this document): a graphical composition that includes a symbol plus other graphic elements, such as a border, background pattern or colour that is intended to convey specific information;

Hazard statement: a phrase assigned to a hazard class and category that describes the nature of the hazards of a hazardous substance or mixture, including, where appropriate, the degree of hazard;

Hazardous: fulfilling the criteria relating to physical hazards, health hazards or environmental hazards, laid down in parts 2 to 5 of Annex I of CLP;

Import: the physical introduction into the customs territory of the Union;

Importer: any natural or legal person established within the Union who is responsible for import;

INCHEM: refers to an Internet based tool providing a range of chemical safety related information produced by International Programme on Chemical Safety and the Canadian Centre for Occupational Health;

Intermediate: a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance;

Label element: one type of information that has been harmonised for use in a label, e.g. hazard pictogram, signal word;

Label: an appropriate group of written, printed or graphic information elements concerning a hazardous substances or mixture, selected as relevant to the target sector (s), that is affixed to, printed on, or attached to the immediate container of a hazardous substance or mixture, or to the outside packaging of a hazardous substances or mixture (definition follows chapter 1.2 of the UN GHS);

Liquid: a substance or mixture which at 50 °C has a vapour pressure of not more than 300 kPa (3 bar), which is not completely gaseous at 20 °C and at a standard pressure of 101.3 kPa, and which has a melting point or initial melting point of 20 °C or less at a standard pressure of 101.3 kPa. A viscous substance or mixture for which a specific melting point cannot be determined shall be subjected to the ASTM D 4359- 90 test; or to the test for determining fluidity (penetrometer test) prescribed in section

Manufacturer: any natural or legal person established within the Union who manufactures a substance within the Union;

Manufacturing: production or extraction of substances in the natural state;

M-factor: a multiplying factor. It is applied to the concentration of a substance classified as hazardous to the aquatic environment acute category 1 or chronic category 1, and is used to derive by the summation method the classification of a mixture in which the substance is present;

Mixture: a mixture or solution composed of two or more substances. However, UN GHS Chapter 1.2 includes the phrase, “in which they do not react” at the end of an otherwise identical definition;

Monomer: a substance which is capable of forming covalent bonds with a sequence of additional like or unlike molecules under the conditions of the relevant polymer-forming reaction used for the particular process;

Mutagen: an agent giving rise to an increased occurrence of mutations in populations of cells and /or organisms;

Mutation: a permanent change in the amount or structure of the genetic material in a cell;

Organic peroxide: a liquid or solid organic substance which contains the bivalent -O-Ostructure and may be considered a derivative of hydrogen peroxide, where one or both of the hydrogen atoms have been replaced by organic radicals. The term also includes organic peroxide formulations (mixtures);

Oxidising gas: any gas which may, generally by providing oxygen, cause or contribute to the combustion of other material more than air does;

Oxidising liquid: a liquid which, while in itself not necessarily combustible, may, generally by yielding oxygen, cause, or contribute to, the combustion of other material;

Oxidising solid: a solid which, while in itself not necessarily combustible, may, generally by yielding oxygen, cause, or contribute to, the combustion of other material;

Phase-in substance: a substance which meets at least one of the following criteria: (a) it is listed in the European Inventory of Existing Commercial Chemical Substances (EINECS); (b) it was manufactured in the Union, or in the countries acceding to the European Union on 1 January 1995, on 1 May 2004 or on 1 January 2007, but not placed on the market by the manufacturer or importer, at least once in the 15 years before the entry into force of the REACH Regulation, provided the manufacturer or importer has documentary evidence of this; and (c) it was placed on the market in the Union, or in the countries acceding to the European Union on 1 January 1995, on 1 May 2004 or on January 2007, by the manufacturer or importer at any time between, 18 September 1981 and 31 October 1993 inclusive, and before entry into force of the REACH Regulation it was considered as having been notified in accordance with the first indent of Article 8(1) of Directive 67/548/EEC in the version of Article 8(1) resulting from the amendment effected by Directive 79/831/EEC, but it does not meet the definition of a polymer as set out in the REACH Regulation, provided the manufacturer or importer has documentary evidence of this;

Placing on the market: supplying or making available, whether in return for payment or free of charge, to a third party. Import shall be deemed to be placing on the market.

Polymer: a substance consisting of molecules characterised by the sequence of one or more types of monomer units. Such molecules should be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units. A polymer comprises the following: (a) a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant; and (b) less than a simple weight majority of molecules of the same molecular weight. In the context of this definition a ‘monomer unit’ means the reacted form of a monomer substance in a polymer;

Precautionary statement: a phrase that describes recommended measure(s) to minimise or prevent adverse effects resulting from exposure to a hazardous substance or mixture due to its use or disposal;

Product identifier: details permitting the identification of the substance or mixture;

Pyrophoric liquid: a liquid which, even in small quantities, is liable of igniting within five minutes after coming into contact with air;

Pyrophoric solid: a solid which, even in small quantities, is liable of igniting within five minutes after coming into contact with air;

Pyrotechnic article: an article containing one or more pyrotechnic substances;

Pyrotechnic substance: a substance or mixture of substances designed to produce an effect by heat, light, sound, gas or smoke or a combination of these as the result of nondetonative self-sustaining exothermic chemical reactions;

Registrant: the manufacturer or the importer of a substance or the producer or importer of an article submitting a registration for a substance under the REACH Regulation;

Respiratory sensitiser: a substance that induces hypersensitivity of the airways following inhalation of the substance;

Self-heating substance: a solid or liquid substance, other than a pyrophoric substance, which, by reaction with air and without energy supply, is liable to self-heat; this substance differs from a pyrophoric substance in that it will ignite only when in large amounts (kilograms) and after long periods of time (hours or days);

Self-reactive substance: a thermally unstable liquid or solid substance liable to undergo a strongly exothermic decomposition even without participation of oxygen (air). This definition excludes substances or mixtures classified under CLP as explosive, organic peroxides or as oxidising;

Serious eye damage: means the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance to the anterior surface of the eye, which is not fully reversible within 21 days of application;

Signal word: a word that indicates the relative level of severity of hazards to alert the potential reader of the hazard; the following two levels are distinguished: (a) Danger means a signal word indicating the more severe hazard categories; and (b) Warning means a signal word indicating the less severe hazard categories;

Skin corrosion: the production of irreversible damage to the skin, namely visible necrosis through the epidermis and into the dermis, following the application of a test substance up to 4 hours;

Skin irritation: the production of reversible damage to the skin following the application of a test substance for up to 4 hours;

Skin sensitizer: means a substance that will induce an allergic response following skin contact. The definition for “skin sensitizer” is equivalent to “contact sensitizer”;

Solid: a substance or mixture which does not meet the definitions of liquid or gas;

Substance: a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any identified impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;

Symbol: a graphical element intended to succinctly convey information;

Use: any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation.