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Definitions

Glossary of definitions for terms used in the context of REACH. 

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z  

Actors in the supply chain 1 - All manufacturers and/or importers and/or downstream users in a supply chain. 

Acute- Short term or immediate.

Acute aquatic toxicity - means the intrinsic property of a material to cause injury to an aquatic organism in a short-term exposure

Additive2- Used in REACH to specify a substance that has been intentionally added to stabilise a substance.  Under other legislation an additive can have other functions, e.g. colouring agent or antistatic.  

Adverse effects - is a harmful and undesired effect resulting from a medication or other intervention such as chemotherapy or surgery.

Agency 1- The European Chemicals Agency as established by the REACH Regulations. 

Alloy 1- A metallic material, homogenous on a macroscopic scale, consisting of two or more elements so combined that they cannot be readily separated by mechanical means. 

Article 1 - 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.

Authorisation- The REACH process by which a registered substance (of very high concern) may be authorised for use under specified conditions, which may not otherwise be used.  The Commission is responsible for deciding which substances will require authorisation and for maintaining a list of such substances in Annex XIV of REACH. 

BCF- Bioconcentration Factor is the accumulation of a chemical in living organisms (biota) compared to the concentration in water.

Biocides / Biocidal products3- Active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means.

Biodegradation -  is the process by which organic substances are broken down by living organisms. The process depends on certain microorganisms, such as bacteria, yeast, and fungi, which break down molecules for sustenance.

CAS Number -Chemical Abstracts Service Registry Number. A CAS number includes up to 9 digits separated into 3 groups by hyphens. The first part of the number, starting from the left, has up to 6 digits; the second part has 2 digits. The final part consists of a single check digit.

Chemical Degradation- Chemical decomposition.

Chemical Safety Assessment -The Chemical Safety Assessment (CSA) is a risk assessment which looks at hazard information and exposure scenarios to arrive at risk management strategies for the control of the substance.

Chemical Safety Report - The documented, robust summary of a chemical safety assessment(CSA). The CSA is a risk assessment which looks at hazard information and exposure scenarios to arrive at risk management strategies for the control of the substance.

Chronic- Long term Classification & Labelling Inventory - An inventory of substance classifications, to be establish by ECHA, and based on classification and labelling notifications submitted by substance manufacturers/importers.  The inventory will be made publically available once compiled.

Classification & Labelling Inventory11 - The Classification and labelling inventory is a database maintained by the Agency containing the classification of all substances submitted either in registration dossiers or in notification of classification and labelling, including in PPORD notifications. Information from this inventory, which includes substance name and classification and labelling is made publicly available in accordance with the provisions of Article 119 of the REACH Regulation.

CMR Cat 1 & 2- Shorthand term used to describe substances which have been classified as a carcinogen, mutagen or reprotoxic, category 1 & 2, in accordance with Directive 67/548/EEC5. 

Competent Authority 1- The authority or authorities or bodies established by the Member states to carry out the obligations arising from this Regulation. 

Component 2- Substance intentionally added to form a preparation  

Consortium- A group of manufacturers/importers or other interested parties of the ‘same’ substance(s), who come together with the intention of generating, collating and sharing data for registration purposes.

Constituent 2- Any single species present in a substance that can be characterised by its unique chemical identity.  

D

Dangerous Substance Directive 67/548/EEC- Pre-REACH legislation providing for the classification and labelling of dangerous substances, and the notification of ‘new’ substances.  As a directive this legislation was enforced under national legislation in each Member State. 

Dangerous Preparations Directive  1999/45/EC- Pre-REACH legislation providing for the classification and labelling of dangerous preparations, and the concentrations at which classifications should be applied.  As a directive this legislation was enforced under national legislation in each Member State. 

Derived No-Effect Level (DNEL) 11 - A DNEL is the level of exposure to the substance below which no adverse effects are expected to occur. It is therefore the level of exposure to the substance above which humans should not be exposed. DNEL is a derived level of exposure because it is normally calculated on the basis of available dose descriptors from animal studies such as No Observed Adverse Effect Levels (NOAELs) or benchmark doses (BMDs).

Distributor 1- Any natural or legal person established within the Community, including a retailer, who only stores or places on the market a substance, on its own or in a preparation, for third parties. 

Domain of a (Q)SAR - is the group of substances for which the model is valid. This group of substances can be defined by structural rules such as alcohol, acids or parameters ranges such as log Kow.

Downstream user 1- Any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a preparation, 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) shall be regarded as a downstream user.  

EC Inventory 2 - The three European lists of substances from the previous EU chemicals regulatory framework, EINECS, ELINCS and the NLP-List, in combination are called the EC Inventory.  The EC Inventory is the source for the EC Number as an identifier of substances.

EC Number - is a term used to replace the outmoded “EINECS/ELINCS number” designation.  All of these numbers have the form XXX-XXX-X where X = a digit.

Endocrine disruptor - A substance that interferes with the hormonal system of an organism.

End User - User of a substance on its own or in a preparation without further supplying it on its own or in a preparation to customers.  That is, the substance is either consumed in the activity or incorporated in an article.

End point - Refers to any physicochemical, biological or environmental effect that can be measured.

Endocrine disruptors - are restricted to chemicals (naturally-occurring and man-made) that interfere with the endocrine system and are suspected of causing adverse effects on development, growth, reproduction and behaviour of human beings and wildlife.

European chemical Substances Information System (ESIS)11 - an IT System developed by the European Chemicals Bureau which provides you with information on chemicals, related to:
- EINECS (European Inventory of Existing Commercial chemical Substances),
- ELINCS (European List of Notified Chemical Substances),
- NLP (No-Longer Polymers),
- HPVCs (High Production Volume Chemicals) and LPVCs (Low Production Volume Chemicals), including EU Producers/Importers lists,
- C&L (Classification and Labelling), Risk and Safety Phrases, Danger etc...,
- IUCLID Chemical Data Sheets, IUCLID Export Files, OECD-IUCLID Export Files, EUSES Export Files,
- Priority Lists, Risk Assessment process and tracking system in relation to Council Regulation (EEC) 793/93 also known as Existing Substances Regulation (ESR).

Expert systems: are computer programs that guide hazard assessment and that are able to predict toxicity endpoints of certain chemical structures based on the available information. These systems can be used to provide an indication of the potential toxic activity of chemicals, for either screening or assessment purposes.

Exposure- Contact with a substance by humans or the environment either deliberately or otherwise, and by any route.  

Exposure assessment11 - Exposure assessment aims to make a quantitative or qualitative estimate of the dose / concentration of the substance to which humans and the environment are or may be exposed. Exposure assessment under REACH consists of two steps: 1) Development of Exposure Scenarios and 2) Exposure Estimation, which have to be iterated until it can be concluded that the resulting exposure scenarios would ensure adequate control of risks upon implementation

Exposure scenario 1- The set of conditions, including operational conditions and risk management measures, that describes how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment.  These exposure scenarios may cover one specific process or use or several processes or uses as appropriate.  

Full study report 1 - A complete and comprehensive description of the activity performed to generate the information.  This covers the complete scientific paper as published in the literature describing the study performed or the full report prepared by the test house describing the study performed. 

Good Laboratory Practice11 - Good Laboratory Practice (GLP) is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.

Hazard- The ability or potential for something to cause harm.  

Hazard assessment11 - Hazard assessment consists in using the information about the intrinsic properties of the substance to make an assessment of hazard in the following areas:
1) Human health hazard assessment
2) Human health hazard assessment of physicochemical properties
3) Environmental hazard assessment
4) PBT and vPvB assessment

High Production Volume11 - High Production Volume (HPV) is a term that was used in previous European chemicals legislation for substances manufactured annually in volumes of more than 1,000 tonnes. The term is no longer relevant under REACH regulation, but it is currently still use for the global risk assessment of chemicals e.g. by the Organisation for Economic Co-operation and Development (OECD).

Identified use 1- A use of a substance on its own or in a preparation, or a use of a preparation, that is intended by an actor in a supply chain, including his own use, or that is made known to him in writing by an immediate downstream user. 

Import 1 -The physical introduction into the customs territory of the Community. 

Importer 1 -Any natural or legal person established within the Community who is responsible for import. 

Impurity 2- An unintended constituent present in a substance as produced.  It may originate from the starting materials or be the result of secondary or incomplete reactions during the production process.  While it is present in the final substance it was not intentionally added.  

Industry Category11 - The Industry Category indicates in which sectors of economy (including private household and public domain) the substance is used. This descriptor is based on the NACE system

In silico - is an expression used to mean "performed on computer or via computer simulation.

Intermediate 1 - A substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (hereinafter referred to as “synthesis”:
a) non-isolated intermediate: means an intermediate during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place. Such equipment includes the reaction vessel, its ancillary equipment, and any equipment through which the substance(s) pass(es) during a continuous flow or batch process as well as the pipe work for transfer from one vessel to another for the purpose of the next reaction step, but it excludes tanks or other vessels in which the substance(s) are stored after the manufacture;
b) on-site isolated intermediate ; means an intermediate not meeting the criteria of a non-isolated intermediate and where the manufacture of the intermediate and the synthesis of (an)other substance(s) from that intermediate takes place on the same site, operated by one or more legal entities;

c) transported isolated intermediate; means an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites.

Intrinsic property (of a substance) 11 - An intrinsic property of a chemical substance is a characteristic of the substance which can be used to determine its fate or to identify potential hazards.

In Vitro testing-Testing carried out on cells in an artificial environment e.g. a test tube. 

In Vivo testing-Testing performed on living organisms    

IUCLID 5- IUCLID 5 (International Uniform Chemical Information Database) is a data management software that allows registrants to enter, manage, store and exchange information on their substances. It is based upon the Harmonised Templates developed by the OECD (Organisation for Economic Cooperation and Development). 

IUPAC NameInternational Union of Pure and Applied Chemistry refers to standardized nomenclature of organic chemistry.   

J

K

Kow - octanol/water partition coefficient is defined as the ratio of a chemical’s concentration in octanol divided by its concentration in water.

L  

LD50 - A statistically derived expression of a single dose of a chemical that can be expected to kill 50% of animals in the experimental group

Lowest Observed Adverse Effect Concentration (LOAEC) 11 - the lowest tested concentration at which there are statistically significant increases in frequency or severity of adverse effects between the exposed population and an appropriate control group.

Lowest Observed Adverse Effect Level (LOAEL) 11 - the lowest tested dose or exposure level at which there are statistically significant increases in frequency or severity of adverse effects between the exposed population and an appropriate control group.

Lowest Observed Effect Concentration (LOEC) 11 - the lowest tested concentration at which, in a study, a statistically significant effect is observed in the exposed population compared with an appropriate control group.

Lowest Observed Effect Level (LOEL) 11 - the lowest tested dose or exposure level at which, in a study, a statistically significant effect is observed in the exposed population compared with an appropriate control group.

Main Constituent2- A constituent, not being an additive or an impurity, in a substance that makes a significant part of that substance and is therefore used in substance naming and detailed substance identification. 

Manufacturer 1- Any natural or legal person established within the Community who manufactures a substance within the Community. 

Manufacturing 1- Production or extraction of substances in the natural state. 

Mixture- Two or more substances which are mixed, but have not reacted with each other. Mono-constituent substance2 - As a general rule, a substance, defined by its composition, in which one main constituent is present to at least 80% (w/w). 

Mono-constituent substance2 - As a general rule, a substance, defined by its composition, in which one main constituent is present to at least 80% (w/w).

Monomer 1- 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. 

Monomer unit 4- The reacted form of a monomer substance in a polymer. Multi-constituent substance2 - As a general rule, a substance, defined by its composition, in which more than one main constituent is present in a concentration ≥ 10% (w/w) and < 80% (w/w). 

Multi-constituent substance2 - As a general rule, a substance, defined by its composition, in which more than one main constituent is present in a concentration ≥ 10% (w/w) and < 80% (w/w).

Mutagen- A physical or chemical agent that has the ability to change genetic information leading to mutation. Other terms include: mutagenic, mutagenicity, mutatoxic, mutatoxicity.   

Normal Conditions of Use5- The conditions associated with the intended end use function (usually of an article).  

Naturally occurring substance(cf. Substance which occurs in nature)1 - A substance which occurs in nature as such, unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water, or which is extracted from air by any means. 

No-Longer Polymer 11 - An NLP is a substance which was considered as notified under Article 8 (1) of the 6th amendment of Directive 67/54/EEC (and hence did not have to be notified under that Directive), but which does not meet the REACH definition of a polymer (which is the same as the polymer definition introduced by the 7th amendment of Directive 67/548/EEC).

No Observed Adverse Effect Concentration (NOAEC) 11 - the highest tested concentration at which there are no statistically significant increases in the frequency or severity of adverse effects between the exposed population and an appropriate control group, some effects may be produced at this level, but they are not considered adverse or precursors of adverse effects.

No Observed Adverse Effect Level (NOAEL)11 - the highest tested dose or exposure level at which there are no statistically significant increases in the frequency or severity of adverse effects between the exposed population and an appropriate control group, some effects may be produced at this level, but they are not considered adverse or precursors of adverse effects.

No Observed Effect Concentration (NOEC) 11 - the highest tested concentration at which, in a study, no statistically significant effect is observed in the exposed population compared with an appropriate control group.

No Observed Effect Level (NOEL) 11 - the highest tested dose or exposure level at which, in a study, no statistically significant effect is observed in the exposed population compared with an appropriate control group.

Non-phase-in substance - A new substance, or an existing substance which does not meet the REACH criteria for  phase-in. Non-phase in substances do not qualify for transitional registration deadlines provided for phase-in substances under REACH and have to be registered before manufacture or import above 1 tonne per year can begin. 

Manufacturers and Importers of phase-in substances which have not been pre-registered under REACH and do not qualify for late pre-registration under REACH, must also register there substances as non-phase-in substances.

Not chemically modified substance 1 - A substance whose chemical structure remains unchanged, even if it has undergone a chemical process or treatment, or a physical mineralogical transformation, for instance to remove impurities.

Notification 11 - The submission of specific information to the Agency in accordance with a legislative requirement. The REACH Regulation requires actors in the supply chain (manufacturers, importers, downstream users) to submit the following types of notifications, under certain circumstances:
- Notification of a substance in an article
- Notification of classification and labelling
- Notification of substances for the purposes of product and process orientated research and development
- Notification by downstream user of use within the conditions of authorisation granted to an actor up his supply chain
- Notification of restart of use by downstream user
Notification may also refer to substances notified under Dir. 67/548/EEC

Notified Substance 1- A substance for which a notification has been submitted and which could be placed on the market in accordance with Directive 67/548/EEC. 

Only Representative- A natural or legal person based within the EU, who has been appointed by a non-EU manufacturer/supplier to fulfil the registration duties of EU importers. 

Persistent Organic Pollutants (POPs)- Chemicals which persist and bioaccumulate in the environment, which have the potential to cause harm to human health and the environment. 

Per year 1- Per calendar year, unless stated otherwise, for phase-in substances that have been imported or manufactured for at least three consecutive years, quantities per year shall be calculated on the basis of the average production or import volumes for the three preceding calendar years. 

Phase-in substance12 - A substance which meets at least one of the following criteria:

a) it is listed in the European Inventory of Existing Commercial Chemical Substance (EINECS);

b) it was manufactured in the Community, or in the countries acceding to the European Union on 1 January 1995, on 1 May 2004 or on 1 January 2007, but not yet placed on the market by the manufacturer or importer, at least once in the 15 years before entry into force of REACH, provided the manufacturer or importer has documentary evidence of this;

c) it was placed on the market in the Community, or in the countries acceding to the European Union on 1 January 1995, on 1 May 2004 or on 1 January 2007, before entry into force of REACH by the manufacturer or importer and was considered as having been notified in accordance with the first indent of Article 8(1) of directive 67/548/EEC but does not meet the definition of a polymer as set out in REACH, provided the manufacturer or importer has documentary evidence of this. 

Placed on the market - Supplied or made available, whether in return for payment or free of charge, to a third party, including importation.

Placing on the market 1- 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. 

Plant Protection Products6 - Active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to:

  • protect plants or plant products against all harmful organisms or prevent the action of such organisms, in so far as such substances or preparations are not otherwise defined below;
  • influence the life processes of plants, other than as a nutrient, (e.g. growth regulators);
  • preserve plant products, in so far as such substances or products are not subject to special Council of Commission provisions on preservatives;
  • destroy undesired plants; or
  • destroy parts of plants, check or prevent undesired growth of plants;

Polymer 1- A substance consisting of molecules characterised by the sequence of one or more types of monomer units.  Such molecules must 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 (over 50%) of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant;

b)      less than a simple weight majority (over 50%) 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. 

Polymer molecule 4- A molecule that contains a sequence of at least 3 monomer units, which are covalently bound to at least one other monomer unit or other reactant. 

Predicted No-Effect Concentration (PNEC) 11 - Concentration of the substance below which adverse effects in the environmental sphere of concern are not expected to occur.

 

Preparation 1- A mixture or solution composed of two or more substances. 

Producer of an article1- Any natural or legal person who makes or assembles an article within the Community. 

Product and process orientated research and development (PPORD) 1- Any scientific development related to product development or the further development of a substance, on its own, in preparations, or in articles in the course of which pilot plant or production trials are used to develop the production process and/or to test the fields of application of the substance

QSARs are quantitative models yielding a continuous or categorical result.

 

(Q)SAR model - is the quantification of the (Q)SAR method through for example the derivation of a mathematical equation describing the activity for a specific class of substance.  

R50⁄537 - ‘May cause long-term adverse effects in the aquatic environment’. (Risk phrase)

REACH IT - On-line software tool allowing companies to submit information to ECHA, and to facilitate the sharing of information with industry and Member State Competent authorities.

Reaction mass 11 - A multi-constituent substance is named as a reaction mass of two or more main constituents. The generic naming format is: "Reaction mass of [names of the main constituents]"

Reasonable foreseeable conditions of use5 - Conditions of use outside the use originally intended by the article producer (normal use) but which may be foreseen because of the form, shape or function (of an article). 

Recipient of an article 1- An industrial or professional user, or a distributor, being supplied with an article, but does not include consumers. 

Recipient of a substance or a preparation 1- A downstream user or a distributor being supplied with a substance or a preparation

Registrant 1- The manufacturer or the importer of a substance or the producer or importer of an article submitting a registration for a substance

Registrant’s own use 1- An industrial or professional use by the registrant

Relative binding affinity (RBA)- This compares how strongly the compound binds to the estrogen receptor to how strongly estradiol binds, the primary endogenous estrogen.

Reprotoxic- A toxic substance that can cause adverse effects on the reproduction and the reproductive system in animals or humans. Other terms include: Reprotoxicity. 

Restriction 1- Any condition for or prohibition of the manufacture, use or placing on the market. 

Retailer 10 - Actor who stores and places on the market substances, preparations or articles to final consumers and/or professional users in retail stores.

Risk - The likelihood or probability that a hazard will cause harm.

Risk Management Measures- Measures which the manufacturer or importer recommends to be implemented by the downstream user to reduce or avoid exposure of humans (including workers and consumers) and the environment to the substance.

Risk phrase / R-phrase 11 - Under Directive 67/548/EEC these are standard phrases indicating the special risks arising from the dangers involved in using the substance or preparation. For example "Danger of very serious irreversible effects", "Limited evidence of a carcinogenic effect". When the current provisions are repealed and GHS enters into force, the R-phrases will be replaced by "hazard statements".

Robust study summary 1- A detailed summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an independent assessment of the study minimising the need to consult the full study report

S  

SARs - are qualitative relationships in the form of structural alerts that incorporate molecular substructures.

Safety phrase / S-phrase 11 - Standard phrases relating to the safe use of a substance. For example "Keep container tightly closed" or "avoid contact with skin" or "do not empty into drains". When the current provisions are repealed and GHS enters into force, the S-phrases will be replaced by "precautionary statements".

Scientific research and development (SR&D) 1- Any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than 1 tonne per year

Site  1- A single location, in which, if there is more than one manufacturer of (a) substance(s), certain infrastructure and facilities are shared. 

SME 1,  8- Small and medium-sized enterprises as defined in the Commission Recommendations 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises.  An SME is a company employing less than 250 persons, with an annual turnover not exceeding EUR 50 million, and/or an annual balance sheet not exceeding EUR 43 million.  This is further divided into medium, small and micro-sized enterprises as shown in the table below. 

CategoryNo of employeesAnnual TurnoverorBalance sheet
Medium< 250≤ 50 million Eurosor≤ 43 million Euros
Small< 50≤ 10 million Eurosor≤ 10 million Euros
Micro< 10≤ 2 million Eurosor≤ 2 million Euros

Criteria for classification as medium, small or micro-sized enterprise  

SMILES - is Simplified Molecular Input Line Entry System which is a molecular text code of displayed STRUCTURE.

Study summary 1 - A summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an assessment of the relevance of the study. 

Substance1- 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 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. 

Substances of very high concern (SVHC)- Substances which are deemed very hazardous with respect to human health and the environment and will come under scrutiny for authorisation or restriction under REACH.  Human health concerns includes cancer causing agents (Carcinogens Cat 1 &2), substances which can cause adverse affects to reproduction and genes (Reprotoxic and Mutatoxic Cat 1 & 2), and substances with can interfere with the hormone system (endocrine disruptors).  Substances which are of high concern to the environment include those which are persistent and bioaccumulate in the environment (PBTs, vPvBs).  Any substance which carries a R50/53 classification (Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment), may be treated as a suspected PBT/vPvB until proven otherwise. 

Substance which occurs in nature 1- A naturally occurring substance as such, unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water, or which is extracted from air by any means. 

Sunset date 11 -  Annex XIV (list of substances subject to Authorisation) will specify for each substance included in that Annex the date (called 'the sunset date") from which the placing on the market and the use of that substance shall be prohibited unless an authorisation is granted or an authorisation application has been submitted before the application date also specified in Annex XIV.

Supplier of a substance or a preparation 1- Any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in preparation, or a preparation

Supplier of an article 1- Any producer or importer of an article, distributor or other actor in the supply chain placing an article on the market.  

T

Tentative Exposure Scenario 11 - The tentative ES forms the starting point for the exposure estimate and risk characterisation. A tentative ES is a set of assumptions (using the determinants of exposure) on how a process is conducted and which risk management measures are used or should be implemented. The tentative ES may have to be adapted during the iterative Chemical Safety Assessment until it is shown that risks are controlled. The resulting ESs shall be implemented for own manufacture/use and/or communicated to Downstream Users (DU) as annex to the Safety Data Sheet

Tetrogenic- A toxic substance that can cause adverse effects on the development of embryos and foetuses leading to birth defects.  Other terms include: tetrogenicity.  

U

Use  1- 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. 

Use and exposure category 1- An exposure scenario covering a wide range of processes or uses, where the processes or uses are communicated, as a minimum, in terms of the brief general description of use. 

V

W

Waste 9- Any substance or object which the holder discards or intends or is required to discard. 

X

Y

Z

Acronyms/abbreviations

Glossary of acronyms and abbreviations commonly used in the chemical industry and REACH literature. 

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

A

B

BCF             Bioconcentration factor

C

CAS            Chemical Abstracts Service

C&L            Classification & Labelling

CA              Competent Authority

CBI             Confidential Business Information

CMR                 Carcinogen, Mutagen or Reproductive toxicant

CoMFA         Comparative molecular field analysis

CSA                 Chemical Safety Assessment

CSR                  Chemical Safety report  

D

DEREK         Deductive Estimation of Risk from Existing

DNEL               Derived No-Effect Level (human health)

DU                   Downstream User·

DSD                 Dangerous Substances Directive 67/548/EEC

DPD                 Dangerous Preparations Directive 1999/45/EC

E

EC                   European Commission 

ECB                 European Chemicals Bureau

ECHA               European CHemicals Agency

ED              Endocrine Disruptor

EEA                 European Economic Area

EFTA               European Free Trade Agreement

EIF                   Entry Into Force

EINECS            European Inventory of Existing Chemical Substances

ELINCS             European LIst of Notified Chemical Substances

EPA              Environmental Protection Agency 

ER               Estrogen receptor

ES                    Exposure Scenario

ESIS                 European chemical Substances Information System

EU                    European Union·

G

GLP                  Good Laboratory Practice

GHS                 Globally Harmonised System for classification and labelling·

H

HPV                 High Production Volume (as in OECD HPV programme)

HPVC               High Production Volume Chemical

HSE                 Health & Safety Executive (UK)·

I

 IC                    Industry Category

IP                     Intellectual Property

IUCLID 5          International Uniform ChemicaLs Information Database - version 5       

IUPAC              International Union of Pure and Applied Chemistry          ·

J

JRC                  Joint Research (Council of the EU)

K

L

LOAEC         Lowest observed adverse effect concentration

LOAEL         Lowest observed adverse effect level

LOEC          Lowest observed effect concentration

LOEL           Lowest observed effect level 

Log P           Logarithm of the octanol/water partition   

M

M⁄I                    Manufacturer/Importer

MSCA               Member State Competent Authority

MSDS              Material Safety Data Sheet·

MULTICASE  Multiple Computer Automated Structure

N

NGO                 Non-governmental organisations

NLP                  No Longer Polymer·

NOAEC            No observed adverse effect concentration

NOAEL             No observed adverse effect level

NOEC              No observed effect concentration

NOEL              No observed effect level

NONS               Notification of New Substances (under Directive 67/548/EEC)

O

OC                   Operational Conditions

OECD               Organisation for Economic Co-operation and Development·

OEL                   Occupational exposure level

P

PBT                 Persistant, Bioaccumulative & Toxic

PEC                 Predicted Environmental Concentration

PNEC               Predicted No-Effect Concentration

PPORD             Product and Process orientated Research and Development·

PPP                  Plant Protection Product

Q

(Q)SAR            (Quantitative) Structure-Activity Relationships·

R

RBA            Relative binding affinity

REACH             Registration, Evaluation, Authorisation and restriction of CHemicals

RIP                   REACH Implementation Project

RMM                Risk Management Measures·

S

SAR             Structure activity relationship

SEA             Socio-Economic Analysis

SDS                 Safety Data Sheet

SIDS                Screening Information Data Set (as in OECD SIDS)

SIEF                 Substance Information Exchange Forum

SME                 Small and Medium sized Enterprises

SMILES            Simplified Molecular Input Line Entry Specification

SR&D               Scientific Research & Development

SVHC               Substance(s) of Very High Concern·

T

TG               Test Guideline

TGD                 Technical Guidance Document

TSCA                Toxic Substance Control Act (USA)

T⁄yr                   Tonnes per year·

U

UC                     Use Category 

UUID                 Universal Unique Identifier (REACH-IT)

UVCB               Substance of Unknown or Variable Composition, Complex reaction products, or Biological materials·

V

VAS                 Vertebrate Animal Study

vPvB               Very Persistent, Very Bioaccumulative·

W

w⁄w                   Weight by weight

X

Y

Z              

 

References

Reference sources for definitions.

  1. 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)
  2. TGD: Guidance for naming and identification of substances under REACH, European Chemicals Agency, June 2007.
  3. Directive of the European Parliament and of the Council 98/8/EC of 16 February 1998 concerning the placing of biocidal products on the market, Art 2(1) (a).
  4. TGD: Guidance for monomers and polymers, European Chemicals Agency, March 2008.
  5. RIP 3.8 Final Report draft TGD, May 2006. available at  http://ecb.jrc.it/documentation
  6. Council Directive 91/44/EEC of 15 July 1991 concerning the placing of plant protection products on the market, Art 1(1-5).
  7. Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances
  8. Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises.     
  9. Directive of the European Parliament and of the Council 2006/12/EC of 5 April 2006 on waste
  10. TGD: Guidance for downstream users, European Chemicals Agency, January 2008
  11. EUROPEAN CHEMICAL AGENCY. REACH Guidance, Glossary [Online]. Available at http://reach.jrc.it/public-2/glossary.htm?lang=en [Accessed 16 June 2008]
  12. Council Regulation (EC) No 1354/2007 of 15 November 2007 adapting Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), by reason of the accession of Bulgaria and Romania.
Last Updated ( Friday, 28 November 2008 )
 
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