#REACH Definitions & REACH Acronyms
 
A
Actors in the supply chain :
  means all manufacturers and/or importers and/or downstream users in a supply chain.  
Acute Reference Dose (ARfD) :
  The Acute Reference Dose is an estimate of a chemical substance, expressed on a bodyweight basis, to which a human population (including sensitive subgroups) can be exposed over a short period of time (24 hours or less), without an appreciable risk of deleterious effects during a lifetime.  
Additive :
  Within the context of REACH, an additive is a compound that has been intentionally added during the manufacturing process to stabilise the substance. Under other legislation additive can have other functions, e.g. pH-regulator or colouring agent.
In REACH the term 'additive' can also have other meanings outside the context of substance identification, for instance in relation to food or feed additives (See article 2).
 
Adverse effect :
  Change in morphology, physiology, growth, development or lifespan of an organism which results in impairment of its functional capacity or impairment of its capacity to compensate for additional stress or increased susceptibility to the harmful effects of other environmental influences.  
AF :
  Assessment Factor.  
Agency :
  means the European Chemicals Agency as established by this Regulation.  
Alloy :
  means 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.  
Animal testing :
  Testing carried out on research animals, mainly mice and rats, in order to predict the potential effects of a substance in humans or animals .  
Annex I of Directive 67/548/EEC :
  Annex I of Directive 67/548/EEC contains a list of harmonised classifications and labellings for substances or groups of substances, which are legally binding within the EU.
The list is regularly updated through Adaptations to Technical Progress. Revised and new classifications inserted to the list are proposed by DG ENV and agreed by a Member State vote.
The DG ENV proposal is based on advice from the Commission Working Group on Classification and Labelling with participation of experts from the Member States. Their meetings are prepared, chaired and followed-up by the ECB.
 
Annex XIV :
  Annex XIV of REACH lists all substances which are subject to authorisation under REACH. The use and placing on the market for a use of substances listed on Annex XIV is prohibited from the "sunset" date unless an authorisation has been granted for that use or unless an exemption appliesr.  
Annex XV :
  Annex XV of the REACH regulation lays down general principles for preparing Annex XV dossiers to propose and justify
(a) harmonised classification and labelling of CMRs, respiratory sensitisers and other effects
(b) the identification of a substance as a CMR, PBT, vPvB or a substance of equivalent concern
(c) restrictions of the manufacture, placing on the market or use of a substance within the Community.
Proposals for restrictions and identification of substances of very high concern can be prepared by a Member State Competent Authority or by the Agency on a request from the Commission. Proposals for harmonised classification and labelling can be prepared by a Member State Competent Authority.
 
Annex XV dossier :
  A dossier produced in accordance with Annex XV.
The dossier consists of two parts, an Annex XV technical dossier and the Annex XV report.
 
ARfD :
  Acute Reference Dose.  
Article :
  means 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.  
ATP :
  Adaptation to Technical Progress.
Adaptation to Technical Progress (ATP) of EU Directive 67/548/EEC on the classification, packaging and labelling of dangerous substances.
A proposal for a new ATP is given by the Commission (DG ENV) to the Technical Progress Committee in order for member states (MS) to adopt the ATP at certain TPC-meetings. A new ATP is then finally confirmed by the Commission before it is published in the Official Journal (OJ).
The ATP number for a specific substance in the database refers to the last time the substance was included in a ATP. For example, if a substance has the ATP number 25, this means that the substance was included in a new ATP when the Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances was adapted to technical progress for the 25th time.
 
Authorisation :
  The REACH Regulation sets up a system under which the use of substances with properties of very high concern and their placing on the market can be made subject to an authorisation requirement. This authorisation requirement ensures that risks from the use of such substances are either adequately controlled or outweighed by socio-economic benefits, having taken into account the available information on alternative substances or technologies. Substances requiring authorisation will be included in Annex XIV of the Regulation.  
B
BCF :
  Bioconcentration Factor.  
Business impact assessment (BIA) :
  carried out for the Commission to estimate the costs of REACH.  
Biocide (Biocidal product) :
  Biocides are defined in Article 2 (1) of the Biocidal Products Directive (98/8/EC) as:
"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."
Note, however, that many substances or preparations which meet this definition are excluded from the Biocidal Products Directive on the basis of being covered by other legislation such as the Plant Protection Products Directive (91/414/EEC) and many other Directives relating to veterinary medicines, proprietary medicinal products etc. Therefore, for a complete definition of a biocidal products you should consult the Biocidal Products Directive and its associated guidance.
In general terms, the scope of the Biocidal Products Directive is very wide, covering 23 different product types. This includes disinfectants for home and industrial use, preservatives for manufactured and natural products, non-agricultural pesticides for use against insects, rodents and other vertebrates and specialised products such as embalming/taxidermist fluids and antifouling products. A full list of product types is in Annex V of the BPD.
Under Article 15 (2) of the REACH Regulation, active substances which are regulated as biocides are regarded as being already registered under REACH.
 
Bioconcentration factor :
  A Bioconcentration factor (L/kg) can either be expressed as the ratio of the concentration of a substance in an organism to the concentration in water once a steady state has been achieved (static BCF), or, on a non-equillibrium basis, as the quotient of the uptake and depuration rate constants (dynamic BCF). Static and dynamic BCFs can be equally used for regulatory purposes. The parameter gives an indication of the accumulation potential of a substance.B86.  
Bw :
  Body weight / Bw, b.w.  
C
C & L :
  Classification and Labelling.  
CA :
  Competent Authority.  
Candidate list :
  The candidate list refers to the list of substances which will eventually be included in Annex XIV (list of substances subject to authorisation) is established in accordance with Article 59(1).  
CAS :
  Chemical Abstract Service.  
CAS#, CAS-No. :
  Chemical Abstract Service index number.
It is a unique numeric identifier, designates only one substance, has no chemical significance, is a link to a wealth of information about a specific chemical substance.
It includes up to 9 digits which are 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 and the final part consists of a single check digit.
The CAS Number may be written in a general form as:
   N...NN-NN-R
   i...43-21-0

In which R represents the check digit and N represents a fundamental sequential number. The check digit is derived from the following formula:
   iN + ... + 4N + 3N + 2N + 1N        R
   ---------------------------- = Q + --
                 10                   10

In which Q represents an integer which is discarded.
For example, CAS# 107-07-3, the validity is checked as follows:
   (5x1) + (4x0) + (3x7) + (2x0) + (1x7)   33        3
   ------------------------------------- = -- = 3 + --
                     10                    10       10

Q = 3 is discarded and R (the check digit) = 3.
 
Category of Danger :
  Categories of danger describe the nature of hazard posed by a substance or preparation. Under Directive 67/548/EEC there are 15 categories of danger. Substances and preparations may be: (a) explosive: (b) oxidizing (c) extremely flammable (d) highly flammable (e) flammable (f) very toxic (g) toxic (h) harmful (i) corrosive (j) irritant (k) sensitizing (l) carcinogenic (m) mutagenic (n) toxic for reproduction, (o) dangerous for the environment. Under GHS these categories will be replaced by hazard classes.  
CBI :
  Confidential Business Information.  
CCE :
  Commission of the european communities.  
CE :
  European commission.  
CEC :
  Commission of the European Communities.  
CEFIC :
  European Chemical Industry Council.  
CEN :
  Adaptation-to.  
CEPE :
  European Committee for Paints and Inks.  
Chemical Abstracts Service :
  Chemical Abstracts Service maintains the most comprehensive list of chemical substances. Each substance registered in the CAS Registry is assigned a CAS Registry Number. The CAS Registry Number (commonly referred to as CAS number) is widely used as a unique identifier of chemical substances.

Further Information:
http://www.cas.org

 
Chemical category of substances :
  In the context of REACH a category of substances is a group of substances whose physicochemical, toxicological and/or ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.
The similarities may be based on the following:
a) common functional group(s) (e.g. aldehyde, epoxide, ester, specific metal ion)
b) common constituents or chemical classes, similar carbon range numbers. This is frequently the case with complex substances often known as "substances of Unknown or Variable composition, Complex reaction products or Biological material" (UVCB substances)
c) an incremental and constant change across the category (e.g. a chain-length category), often observed in physicochemical properties, e.g. boiling point range
d) the likelihood of common precursors and/or breakdown products, via physical or biological processes, which result in structurally similar chemicals (e.g. the "metabolic pathway approach" of examining related chemicals such as acid/ester/salt).
 
Chemical Safety Assessment (CSA) :
  Chemical Safety Assessment is the process aimed at determining the risk posed by a substance and, as part of the exposure assessment, develop exposure scenarios including risk management measures to control the risks. Annex I contains general provisions for performing a CSA. The CSA consists of the following steps:
- Human health hazard assessment
- Human health hazard assessment of physicochemical properties
- Environmental hazard assessment
- PBT and vPvB assessment
If, as a result of this hazard assessment, the registrant concludes that the substance meets the criteria for classification as dangerous according to Directive 67/548/EEC (for substances) or has PBT/vPvB properties, this triggers further steps in the chemical safety assessment:
- Exposure assessment
- Risk characterization.
 
Chemical Safety Report (CSR) :
  The chemical safety report documents the chemical safety assessment for a substance on its own, in a preparation or in an article or a group of substances.
In other words the chemical safety report (CSR) is a document, which details the process and the results of a chemical safety assessment (CSA). Annex I of the REACH Regulation contains general provisions for performing CSAs and preparing CSRs.
 
Classification :
  Classification is the process in which a given substance or preparation is assigned one of the 15 categories of danger depending on their intrinsic properties in accordance with the criteria for specified in directive 67/548/EEC. If the substance is not found to be dangerous, according to the said criteria, then it is not classified. Under GHS the substance or preparation will be assigned to hazard classes.  
Classification and labelling inventory :
  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 :
  Carcinogenic, mutagenic or toxic to reproduction.
Substance of very high concern that is carcinogenic (causes cancer), mutagenic (causes damage to genes) or reproductively-toxic (causes either a decrease in fertility or problems with development of the foetus). CMRs category 1 and 2 are subject to authorisation.
 
Company :
  The producer or importer of the chemical.
Where Name, is the corporate name of the company,
Town, is the city where the company is located,
Country, is the country where the company is located.
 
Competent authority :
  means the authority or authorities or bodies established by the Member States to carry out the obligations arising from this Regulation.  
Complex :
  Reaction products or Biological material.  
Component :
  Substance intentionally added to form a preparation.  
Conditions of use :
  Conditions of use refer to the Operational Conditions and Risk Management Measures as described in an Exposure Scenarios.  
Constituent :
  Any single chemical species present in a substance that can be characterised by its unique chemical identity.  
CSA :
  Chemical Safety Assessment.  
CSR :
  Chemical Safety Report.  
CSTEE :
  Scientific committee on toxixcity, ecotoxicity and the environment.  
Customs territory :
  The Customs Territory of the Community is defined at http://ec.europa.eu/...glossary/customs/index_en.htm#C
D
d :
  Day(s).  
d.wt :
  Dry weight / dw.  
Danger symbols :
  According to current classification and labelling provisions danger symbols are pictograms which are placed on the package of dangerous substances and preparations. The design of the danger symbols shall comply with those laid down in Annex II of Directive 67/548/EEC. The symbol shall be printed in black on an orange-yellow background. After the GHS enters into force, current danger symbols shall no longer be used and will be replaced by a new set of GHS symbols.  
DBMS :
  Data Base Management System.
A complex set of programs that control the organization, storage and retrieval of data for many users; extensively used in business environments. Data is organized in fields, records and files. A database management system must also control the security of the database. Examples of database management systems are Oracle, Sybase, and Datacom.
 
Derived No-Effect Level (DNEL) :
  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).  
DG :
  Directorate General.  
Distributor :
  means any natural or legal person established within the Community, including a retailer, who only stores and places on the market a substance, on its own or in a preparation, for third parties.  
DNEL :
  Derived No-Effect Level.  
Dose response assessment :
  A dose-response assessment is the estimation of the relationship between the dose, or level of exposure to a substance, and the incidence and severity of an effect.  
Downstream user :
  means 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.  
Draft RAR :
  Draft of the Comprehensive Risk Assessment Report.  
DT50 :
  Period required for 50 percent dissipation (define method of estimation).  
DT50lab :
  Period required for 50 percent dissipation, under laboratory conditions (define method of estimation).  
DT90 :
  Period required for 90 percent dissipation (define method of estimation).  
DT90field :
  Period required for 90 percent dissipation under field conditions (define method of estimation).  
DU :
  Downstream User.  
E
EC :
  European Commission.  
EC Inventory :
  The EC Inventory is composed of three combined European lists of substances from the previous EU chemicals regulatory framework: EINECS, ELINCS and the NLP-list (no-longer polymers).  
EC#, EC-No :
  EC number, number allocated by the Commission of the European Communities as a term used to replace the EINECS / ELINCS / NLP number designation.
This number is a seven-digit system, separated into 3 groups by hyphens of the type XXX-XXX-X.
Which starts by:
- 2 or 3 (2XX-XXX-X or 3XX-XXX-X) for chemical substances belonging to EINECS (Exiting Chemicals),
- 4 (4XX-XXX-X) for chemical substances belonging to ELINCS (New Chemicals),
- 5 (5XX-XXX-X) for chemical substances belonging to NLP (No-Longer Polymers).
 
EC50  :
  Median effective concentration.  
ECB :
  European Chemicals Bureau.  
ECHA :
  European Chemicals Agency.  
ECT :
  European Community Treaty.  
EEA :
  European Economic Area.  
EEC :
  European Economic Community.  
EFTA :
  European Free Trade Agreement.  
EIF :
  Entry Into Force (of the REACH Regulation): 1st June 2007.  
EINECS :
  European INventory of Existing Commercial chemical Substances.
It lists and defines all chemical substances that were on the European Community market between 1 January 1971 and 18 September 1981. (Einecs, OJ No C 146A, 15.6.1990).

Inventaire Européen des Substances chimiques Commerciales Existantes.
Inventaire des substances chimiques "existantes" commercialisies sur le marché européen entre le 1er janvier 1971 et le 18 septembre 1981. (Einecs, JO No C 146A, 15.6.1990).

 
EINECS (IS) :
  European INventory of Existing Commercial chemical Substances Information System.
An online IT Information System which provides, trough the EINECS inventory (100 204 chemical substances), general information like CAS number, EINECS number, Substance Name and Molecular formula.
 
EINECS#, EINECS-No. :
  European INventory of Existing Commercial chemical Substances index number.
This number is a seven-digit system, separated into 3 groups by hyphens of the type XXX-XXX-X which starts at 200-001-8 for formaldehyde.
The first part of the number, starting from the left, has 3 digits; the second part has 3 digits and the final part consists of a single check digit.
The EINECS Number may be written in a general form as:
   NNN-NNN-R
   123-456-0

In which R represents the check digit and N represents a fundamental sequential number. The check digit is derived from the following formula:
   1N + 2N + 3N + 4N + 5N + 6N        R
   --------------------------- = Q + --
                 11                  11

In which Q represents an integer which is discarded.
Example, EINECS# 300-015-5, the validity is checked as follows:
   (1x3) + (2x0) + (3x0) + (4x0) + (5x1) + (6x5)   38        5
   --------------------------------------------- = -- = 3 + --
                          11                       11       11

Q = 3 is discarded and R (the check digit) = 5.
 
ELINCS :
  European LIst of Notified Chemical Substances, this list is periodically updated as an Official Journal.  
ELINCS#, ELINCS-No :
 
European LIst of Notified Chemical Substances index number.
This number is a seven-digit system of the type XXX-XXX-X.
Which starts at 400-010-9 for tetrasodium 3,3'-[piperazine-1,4-diyl-bis[(6-chloro-1,3,5-triazine-2,4-diyl)amino(2-acetylamino-4,1-phenylene)azo]]bis(naphthalene-1,5-disulfonate.
 
Endocrine disrupters :
  Substances of very high concern that mimic or inhibit the effects of hormones. Identified on a case-by-case basis and subject to authorisation. Many of these substances are also CMRs.  
Endpoint :
  An endpoint is an observable or measurable inherent property of a chemical substance. It can for example refer to a physical-chemical property like vapour pressure or to degradability or to a biological effect that a given substance has on human health or the environment, e.g. carcinogenicity, irritation, aquatic toxicity.  
Epidemiological studies :
  Studies of public or occupational health. Cohort studies compare the health status of a group of people that have been exposed to the same environmental factor (e.g. a chemical) with a control group. Case-control-studies look at a group of people that have developed certain symptoms (e.g. a specific kind of cancer) to establish whether they have been exposed to certain environmental factors to a greater extent than other people.  
ES :
  Exposure Scenario.  
ESIS :
  ESIS (European chemical Substances Information System), is 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).

Further Information:
http://ecb.jrc.it/esis/
ESR :
  Existing Substances Regulation.  
EU :
  European Union.  
EURATS :
  EUropean Risk Assessment Tracking System.  
European Chemicals Bureau :
  A part of the Joint Research Centre (JRC) in Ispra in Italy, doing a lot of the Commission's scientific-technical work under the current legislation. Will prepare the ground for the new Agency that will then manage the REACH system.  
EUSES :
  European Union System for the Evaluation of Substances.  
Evaluation :
  There are three types of evaluation within REACH:
- Dossier evaluation performed by the Agency :
- Compliance check: to examine whether all required information is included in the registration dossier and whether this information is adequate.
- Checking of testing proposals: to evaluate whether the testing proposals submitted in the registration dossier by the registrant in case further testing is necessary for information specified in Annex IX and X or the Regulation are adequate.
- Substance evaluation performed by a Member State: to clarify any grounds for considering that a substance constitutes a risk to human health or the environment
Member States can also evaluate registered intermediates.
 
Existing chemicals :
  Chemicals that were reported to be on the market in 1981, when the requirement to notify new chemicals entered into force. There are about 100,000 existing chemicals. According to estimations, some 30,000 of them will be subject to registration in REACH.  
Exposure :
  To come into contact with a substance. The amount of a substance someone comes into contact with is often modelled on a computer.  
Exposure assessment :
  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 :
  means the set of conditions, including operational conditions and risk management measures, that describe 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.  
F
Final RAR :
  Final Risk Assessment Report.  
foc :
  Organic carbon factor (compartment depending).  
Full study report :
  means 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.  
G
g :
  Gram(s).  
GHS :
  "Globally Harmonized System of Classification and Labelling of Chemicals" developed by the United Nations.  
GLP :
  Good Laboratory Practice.  
Good Laboratory Practice :
  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.  
gw :
  Gram weight.  
H
h :
  Hour(s).  
ha :
  Hectares / h.  
Harmonised classification and labelling :
  A Harmonised classification is one which is agreed at Community level. It is included in Annex I of Directive 67/548/EEC.
Any Member States can propose an harmonised classification and labelling by submitting an Annex XV dossier.
 
Hazard :
  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 Volume :
  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).  
HPLC :
  High Pressure Liquid Chromatography.  
HPV :
  High Production Volume.  
HPVC :
  HPVC (High Production Volume Chemical).
A HPVC, is a chemical which is defined as being produced or imported in quantity of at least 1000 tonnes per year in EU by at least one Industry.
 
HPV-LPV (IS) :
  HPV-LPV Chemicals Information System.
An online IT Information System which provides information on the HPVCs (High Production Volume Chemicals) and the LPVCs (Low Production Volume Chemicals), where data have been reported by Industry.
The content has been extracted from the IUCLID (International Uniform Chemical Information Data Base).
 
I
IARC :
  International Agency for Research on Cancer.  
IC :
  Industry Category.  
IC50 :
  Median immobilisation concentration or median inhibitory concentration 1.  
Identified use :
  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 the supply chain, including his own use, or that is made known to him in writing by an immediate downstream user.  
IFCS :
  Intergovernmental Forum on Chemicals Safety.
Intermediates: Chemicals that are used up in the process of making other chemicals.
 
Import :
  means the physical introduction into the customs territory of the Community.  
Importer :
  means any natural or legal person established within the Community who is responsible for import.  
Impurity :
  An unintended constituent present in a substance as manufactured. It may, for example, 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. In most cases impurities constitute less than 10% of the substance.  
In vitro testing :
  In vitro literally stands for "in glass", or "in test tube", taking place outside the body of an organism. It refers to studies in the laboratory usually involving isolated organs, tissues, cells or biochemical systems.  
Index# (for Annex I of the Directive 67/548/EEC) :
  Entries (i.e. substance/substances indicated by the same Index number) in Annex I of the EU Directive 67/548/EEC are listed according to the atomic number of the most characteristic element of the substances' properties.
The Index number for each substance is in the form of a digit sequence of the type ABC-RST-VW-Y, where:
- ABC is either the atomic number of the most characteristic chemical element (preceded by one or two zeros to make up the sequence) or the usual class number for organic substances (cf. Appendix I),
- RST is the consecutive number of the substance in the series ABC,
- VW denotes the form in which the substance is produced or placed on the market, and
- Y is the check-digit calculated in accordance with the ISBN (International Standard Book Number) method.
 
Indications of danger (in Classification & Labelling) :
  In the existing provisions on classification and labelling, laid out in Directive 67/548/EEC, the indications of danger are words which are included on the packaging of the substance or the preparation together with the danger symbol. Indication of danger describes the type of danger associated with the symbol. Examples are: "Toxic", "Harmful", "Irritant", "Highly flammable".  
Industry Category :
  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.  
Information requirement :
  Information requirements refer to the information needed in a registration dossier (see article 10 and Annexes VI to XI). These include information on inherent properties of the substance as well as some information on manufacture, use and exposure. The term is sometimes used to exclusively refer to the intrinsic properties of a substance in support of a registration.
Specifically for the information requirements on inherent properties: The amount and type of information required is principally dependant on the tonnage threshold but can also be affected by other factors like its use and exposure characteristics. For substances manufactured or imported in quantities between 1 and 10 tonnes the specific information requirements can also be affected by whether the substance is classed as 'phase-in'.
The standard information requirements for each tonnage band are presented in Annexes VII to X of the Regulation.
 
Intermediate :
  means 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 that 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 pipework 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 take 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) :
  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 order to register a substance under REACH, the registrant must submit specific information about the intrinsic properties of the substance in each of the following areas:
- physical/chemical properties
- human toxicological information
- ecotoxicological information
Data on the intrinsic properties of a substance are categorised into endpoints. For instance, "carcinogenicity" is a human toxicological endpoint.
 
IPPC :
  Integrated Pollution Prevention and Control.  
IS :
  Information System.  
ISO :
  International Standards Organisation.  
IT :
  Information Technology.  
IUCLID :
  International Uniform ChemicaL Information Database.
Is the basic tool for the data collection and evaluation in the frame of the European Risk Assessment Programme on Existing Substances.
 
IUCLID 5 :
  IUCLID (International Uniform ChemicaL Information Database) is a database including a tool for data collection on chemical substances. In particular IUCLID5 enables to prepare a registration dossier as well as to prepare other types of REACH dossiers (PPORD dossiers, C&L notifications, notifications of substances in articles, DU reports and Annex XV dossiers) as well as dossiers for other EU and international jurisdictions. REACH requires that registration dossiers are submitted to the Agency following IUCLID format.
IUCLID5 is built using internationally harmonized formats for reporting data on intrinsic properties of chemicals that were prepared and accepted by many national and international regulatory authorities within the OECD.
 
IUPAC :
  International Union for Pure Applied Chemistry.
Union internationale de chimie pure et appliquée.
 
J
   
K
kg :
  Kilogram(s).  
Koc :
  Organic carbon adsorption coefficient.  
Kow :
  Octanol-water partition coefficient.  
Kp :
  Solid-water partitioning coefficient of suspended matter.  
kPa :
  Kilo Pascals.  
L
l :
  Litre(s) / L.  
L(E)C50 :
  Lethal concentration, median.  
Lead Registrant :
  A company which submits registration information to the Agency on behalf of other members of a joint registration. The information submitted by the lead registrant concerns classification and labelling, study summaries, test proposals and, if necessary, indication which of the information was reviewed by an assessor. If the members of the joint registration so decide, the lead registrant may also submit information on safe use and the CSR on behalf of the others. After the lead registrant submits the information, the other members of the joint registration submit the remaining information individually.  
LOAEL :
  Lowest Observed Adverse Effect Level.  
LOEC :
  Lowest Observed Effect Concentration.  
LOEL :
  Lowest Observed Effect Level.  
log :
  Logarithm to the basis 10.  
Lowest Observed Adverse Effect Concentration (LOAEC) :
  The Lowest Observed Adverse Effect Concentration is 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) :
  The Lowest Observed Adverse Effect Level is 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.

Further Information:
European Environment Agency after WHO. 1994. Assessing human health risks of chemicals: Derivation of guidance values for health-based exposure limits. Environmental health criteria 170. World Health Organization, Geneva. http://glossary.eea.europa.eu/EEAGlossary/L/lowest-observed-adverse-effect_level

 
Lowest Observed Effect Concentration (LOEC) :
  The Lowest Observed Effect Concentration is 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) :
  The Lowest Observed Effect Level is 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.  
LPVC :
  LPVC (Low Production Volume Chemical).
A LPVC, is a chemical which has been produced or imported in EU with a tonnage >10t/y but never more than 1000 t/y.
By definition a LPV Chemical is a chemical which is not a HPV Chemical.
 
M
m :
  Meter.  
M/Is :
  Manufacturers/Importers.  
Main constituent :
  A constituent, not being an additive or impurity, in a substance that makes a significant part of that substance and is therefore used in substance naming and detailed substance identification. For substances defined as mono-constituent, the main constituent has a concentration in the substance of ? 80%. For multi-constituent substances, the main constituents all have a concentration in the range between ? 10% and <80%.  
Manufacturer :
  means any natural or legal person established within the Community who manufactures a substance within the Community.  
Manufacturing :
  means production or extraction of substances in the natural state.  
mg :
  Milligram(s).  
Molecular Formula :
  The formula of a compound in which the subscripts give the actual number of atoms of each element in the formula.
For example, CH2O for formaldehyde, benzene is a molecule composed of six carbon and six hydrogen atoms and has a formula C6H6.
Note: two different materials may share the same molecular formula. For example, both acetone (also called 2-propanone) and propanal (also called 1-propanone) share the same molecular formula of C3H6O, but have different arrangements of atoms in the molecules. These are called structural isomers. Structural isomers usually have different chemical and physical properties.
 
Mono-constituent substance :
  As a general rule, a substance, defined by its composition, in which one main constituent is present to at least 80% (w/w).  
Monomer :
  means 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.  
MOS :
  Margins of safety.  
MS :
  Member State.  
N
NCD :
  New Chemicals Database.  
New chemicals :
  Chemicals that have been placed on the market since 1981. These have to be notified to the Competent Authorities under the current EU chemical legislation. There are around 3,400 'new' chemicals currently on the market.  
NGO :
  Non-Governmental Organisation.  
NLP :
  No-Longer Polymers.
As polymers were not reportable and therefore not included in EINECS, in many cases it had to be decided whether a substance is a polymer or not by a desk examination of the submitted documents.
A widely used definition of polymers refers to the need for both a high molecular weight (more than 10.000) and a molecular weight distribution. In contrast, for decisions on the inclusion or otherwise in EINECS, the molecular weight of a substance was not taken into account.
Following the definition of the 7th Amendment a polymer is beside the molecular weight distribution also characterised "by the sequence of one or more types of monomer units and comprising 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 consists of less than a simple weight majority of molecules of the same molecular weight" (Directive 92/32/EEC, Art. 2, 1 c)).
The information available in the primary processing of substances reported for EINECS was not always sufficient to distinguish a polymer from a non polymer. In particular only the name and the CA registry number was known for substances reported on the A or B forms used for reporting. The first decision on whether a compound was a polymer or not had therefore to rely on the name and on the classification of the compounds in the Chemical Abstract Registry System. Whenever a substance based on the information available was suspected of being a polymer, a problem letter was issued, and the submitter was asked to supply more detailed information on the size and distribution of the molecular weight.
Therefore decisions taken for the inclusion of submitted substances in EINECS did not follow general rules without any exception. In some cases decisions were only based on the name of the submitted substance.
The no-longer polymer list contains only substances not included in EINECS. For legal reasons the definitions depend on the EINECS definitions and hence decisions on the notification status of e.g. a post-reacted NLP can be inferred by considering for this purpose an equivalence with EINECS rules. Further requests on declaration of substances as no-longer polymers have to be based on the rejection of a submission to EINECS (ref.: correspondence).
NLP-Nos and name descriptions take precedence. The CAS# given are to be treated as indicative and for a use as a searching tool.
 
No Observed Adverse Effect Concentration (NOAEC) :
  The No Observed Adverse Effect Concentration is 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) :
  The No Observed Adverse Effect Level is 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) :
  The No Observed Effect Concentration is 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) :
  The No Observed Effect Level is the hightst tested 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.  
NOAEL :
  No observed adverse effect level.  
NOEC :
  No observed effect concentration.  
NOEL :
  No observed effect level.  
Not chemically modified substance :
  means 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.  
No-Longer Polymer :
  A 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).  
Notified substance :
  Means a substance for which a notification has been submitted and which could be placed on the market in accordance with Directive 67/548/EEC. Notified substances also used to be termed 'new substances'.  
O
OCDE :
  Organisation de Coopération et de Développement économiques.  
OECD :
  Organisation for Economic Co-operation and Development.  
OEL :
  Occupational Exposure Limit.  
OJ :
  Official Journal.  
OJ Recomm. :
  Official Journal Commission Recommendation.  
Only representative :
  According to Article 8 of the REACH Regulation, a natural or legal person established outside the Community who manufactures a substance on its own or in preparations, formulates a preparation or produces an articles imported into the Community may by mutual agreement appoint a natural or legal person established in the Community to fulfil, as his only representative, the obligations on importers regarding the registration of substances. The only representative shall also comply with all other obligations of importers under REACH.
The non-Community exporter must inform the importer(s) within the same supply chain of the appointment. These importers are regarded as downstream users for the purposes of REACH.
 
ORACLE :
  A relational database management system for many computer platforms from Oracle Corporation, Redwood Shores, California.  
ORATS (IS) :
  Online EUropean Risk Assessment Tracking System.
An online IT Information System which provides information on 4 European Priority Lists and the progress of implementation of Council Regulation (EEC) 793/93 also known as Existing Substances Regulation (ESR).
It tells how far in the assessment process a substance has progressed including an overview of the conclusions reached, statistics and testing requirements.
 
P
Pa :
  Pascal unit(s).  
PBT :
  Persistent Bioaccumulative and Toxic.
PBT pollutants are chemicals that are toxic, persist in the environment and bioaccumulate in food chains and, thus, pose risks to human health and ecosystems. The biggest concerns about PBTs are that they transfer rather easily among air, water, and land, and span boundaries of programs, geography, and generations.
 
PEC :
  Predicted environmental concentration.  
Per year :
  means 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.  
Persistent, Bio-accumulative and Toxic (PBT) :
  Annex XIII defines criteria for the identification of substances that are Persistent, Bio-accumulative and Toxic (PBTs) and Annex I lays down general provisions for PBT assessment. PBTs are substances of very high concern (SVHC) and may be included in Annex XIV and by that be made subject to authorisation.  
pH :
  Potential hydrogen -logarithm (to the base 10) of he hydrogen ion concentration {H+}.  
Phase-in substance :
  means 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 Community, or in the countries acceding to the European Union on 1 January 1995 or on 1 May 2004, but not placed on the market by the manufacturer or importer, at least once in the 15 years before the entry into force of this Regulation, 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 or on 1 May 2004, before entry into force of this Regulation 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 this Regulation, provided the manufacturer or importer has documentary evidence of this.

 
pKa :
  Logarithm (to the base 10) of the acid dissociation constant.  
pKb :
  Logarithm (to the base 10) of the base dissociation constant.  
Placing on the market :
  means 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 Products :
  Plant Protection Products are defined in Article 2 of the Plant Protection Products Directive (91/414/EEC) as:
"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:
1) 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
2) influence the life processes of plants, other than as a nutrient, (e.g. growth regulators)
3) preserve plant products, in so far as such substances or products are not subject to special Council of Commission provisions on preservatives
4) destroy undesired plants or
5) destroy parts of plants, check or prevent undesired growth of plants."
Under Article 15 (1) of the REACH Regulation, active substances which are used and regulated as Plant Protection Products are regarded as being already registered under REACH.
 
PNEC(s) :
  Predicted no effect concentration(s).  
PNECwater :
  Predicted no effect concentration in water.  
Polymer :
  means 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 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 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.

 
POPs :
  Persistent (difficult to break down) organic pollutants, banned under UNEP's Stockholm Convention.  
ppm :
  Parts per million
This is a way of expressing very dilute concentrations of substances. One ppm is equivalent to 1 milligram of something per litre of water (mg/l) or 1 milligram of something per kilogram soil (mg/kg).
 
PPORD :
  Plant Protection Product.  
PPP :
  Plant Protection Product.  
Predicted No-Effect Concentration (PNEC) :
  Concentration of the substance below which adverse effects in the environmental sphere of concern are not expected to occur.  
Preparation :
  means a mixture or solution composed of two or more substances.  
Pre-registration :
  After entry into force of REACH, manufacturing and import of substances in quantities > 1 tonne per year can only take place if the substance is registered. However, for substances already on the market (so-called phase-in substances) a transitional arrangement exists, provided the manufacturer or importer pre-register their substances between 1 June 2008 and 1 December 2008. Pre-registration allows companies to continue manufacturing and importing their phase-in substances for several years until the registration deadline is reached. A pre-registrant will have to submit a pre-registration dossier to the Agency containing data on the name of the substance, contact details of the pre-registrant, envisaged dead-line for registration and tonnage band and name of substances for read-across, grouping or QSAR.  
Priority List :
  In 1993 the Council adopted Council Regulation (EEC) 793/93 or the Existing Substances Regulation (ESR), thereby introducing a comprehensive framework for the evaluation and control of "existing" chemical substances.
Article 8 of the Regulation states that the Commission, in consultation with the Member States, will regularly draw up lists of priority substances which require immediate attention because of their potential effects to man or the environment. The Commission and Member States utilise the information collected during step I of the regulation (Data Collection) as a basis for selecting priority substances.
Since 1994, 4 such priority lists have been published with a total of 141 substances.
 
Producer of an article :
  means any natural or legal person who makes or assembles an article within the Community.  
Product and process orientated research and development (PPORD) :
  means 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.  
Q
QSAR :
  Quantitative Structure Activity Relationship.  
Quantitative Structure Activity Relationship :
  It is the relationship between the physical and\or chemical properties of a substance and their ability to cause a particular effect. The goal of QSAR studies in toxicology is to develop whereby the toxicity of a substance can be predicted from its chemical structure by analogy with the properties of other toxic substances of known structure and toxic properties. In practice QSARs are mathematical models used to predict the properties of substances from their molecular structure.  
R
R & D :
  Research and development.  
RAR :
  Risk Assessment Report.  
RAR Status :
  Risk Assessment Report Status.  
RDBMS :
  Relational Database Management System.
A system for database management of a relational database.
A Relational database is a database in the form of tables which have rows and columns to show the relationships between items, and in which information can be cross-referenced between two or more tables to generate a third table. A query language is used to search for data. If data is changed in one table, it will be changed in all related tables. A database that has only one table is called a flat file database.
 
REACH :
  Registration, Evaluation and Authorisation of CHemicals.
On 29 October 2003, the European Commission adopted a proposal for a new EU regulatory framework for chemicals, COM (2003) 644. Under the proposed new system called REACH (Registration, Evaluation and Authorisation of CHemicals), enterprises that manufacture or import more than one tonne of a chemical substance per year would be required to register it in a central database.
The aims of the proposed new Regulation are to improve the protection of human health and the environment while maintaining the competitiveness and enhancing the innovative capability of the EU chemicals industry. REACH would furthermore give greater responsibility to industry to manage the risks from chemicals and to provide safety information on the substances. This information would be passed down the chain of production.
 
Reaction mass :
  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]".  
Recipient of a substance or a preparation :
  means a downstream user or a distributor being supplied with a substance or a preparation.  
Recipient of an article :
  means an industrial or professional user, or a distributor, being supplied with an article but does not include consumers.  
Registrant :
  means 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 :
  means an industrial or professional use by the registrant.  
Registration :
  Registration is the submission to the Agency of a technical dossier and, if required, a chemical safety report for a substance being manufactured in or imported into the European Union (and in the European Economic Area (EEA) once implemented in these countries).  
Registration dossier :
  Manufacturers or Importers of substances on their own or in preparations or Producers or importers of articles will have in certain circumstances to provide a registration dossier to the European Chemicals Agency according to Articles 10, 11, 12, 17 and 18. It consists of a technical dossier and, when required, a Chemical Safety Report.  
REGISTRATION#, REGISTRATION-No. :
  This number is used for new chemicals also known as Notified Chemical Substances. It (chronological per member state) is unique to each notification, allocated by a Competent Authority. For multiple notifications of the same substance, the original dossier isdesignated file leader.
The registration number has standard format: xx-xx-xxxx. The first two digits represent year of notification, the next two indicate country of notification, and the last four digits allow sequential numbering of individual dossiers respective of the country.
The two digit country codes refer to member states (and Norway) as follows:
   01. France (FR)         10. Greece (GR)         19. Cyprus (CY)
   02. Belgium (BE)        11. Spain (ES)          20. Latvia (LV)
   03. Netherlands (NL)    12. Portugal (PT)       21. Lithuania (LT)
   04. Germany (DE)        13. Finland (FI)        22. Hungary (HU)
   05. Italy (IT)          14. Austria (AT)        23. Malta (MT)
   06. United Kingdom (UK) 15. Sweden (SE)         24. Poland (PL)
   07. Ireland (IE)        16. Norway (NO)         25. Slovenia (SI)
   08. Denmark (DK)        17. Czech Rebublic (CZ) 26. Slovakia (SK)
   09. Luxembourg (LU)     18. Estonia (EE)
.
 
Restriction :
  means any condition for or prohibition of the manufacture, use or placing on the market.  
RIP :
  REACH Implementation Project.  
Risk :
  Risk is the probability that some adverse effect (e.g., skin irritation or cancer) will result from a given exposure to a chemical. The risk posed by a substance depends both on the intrinsic properties of the substance (hazard) and of exposure.  
RMM :
  Risk Management Measures.  
Risk characterisation :
  Final step in chemical safety assessment, it consists of estimation of the incidence and severity of the adverse effects likely to occur in a human population or environmental compartment due to actual or predicted exposure to a substance. It may include a "risk estimation", i.e. the quantification of that likelihood. Risk characterisation is made for each exposure scenario and for each target population or compartment.  
Risk management measures :
  Measures in the control strategy for a substance that reduce the emission and exposure to a substance, thereby reducing the risk to human health or the environment.  
Robust study summary :
  means 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.  
R-phrases :
  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".  
S
Safety data sheet (SDS) :
  The safety data sheet is the main tool used in industry for communicating information on the hazard of dangerous substances and preparations through the supply chain. Annex II of REACH is based on the Annex to the safety data sheet Directive (91/155/EEC) and explains what information should be included under each of the 16 safety data sheet headings.  
SAICM :
  The Strategic Approach to International Chemical Management.  
Scientific research and development :
  means any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than 1 tonne per year.  
SDS :
  Safety Data Sheets.  
SEA :
  Socio-economic Analysis.  
SIAP :
  SIDS Initial Assessment Profile (OECD Existing Chemicals Programme)
Further Information:
http://www.oecd.org/document/7/0,2340,en_26...
 
SIAR :
  SIDS Initial Assessment Report (OECD Existing Chemicals Programme).  
SIDS :
  Screening Information DataSets.
Is a voluntary cooperative international testing program operated under the auspices of the Organization for Economic Cooperation and Development (OECD).
The IUCLID software is the preferred tool for entering data and developing a SIDS Dossier for High Production Volume Chemicals in the OECD HPV Chemicals Programme. The SIDS Dossiers, together with the SIDS Initial Assessment Reports (SIAR), once they are agreed upon by Member countries are published by UNEP Chemicals.
 
SIEF :
  Substance Information Exchange Forum.  
Site :
  means a single location, in which, if there is more than one manufacturer of (a) substance(s), certain infrastructure and facilities are shared.  
Small and medium enterprises (SMEs) :
  Small and medium-sized enterprises as defined in the Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium sized enterprises.  
SME :
  Article 2 (2003/361/EC): Staff headcount and financial ceilings determining enterprise categories

1. The category of micro, small and medium-sized enterprises (SMEs) is made up of enterprises which employ fewer than 250 persons and which have an annual turnover not exceeding EUR 50 million, and/or an annual balance sheet total not exceeding EUR 43 million.

2. Within the SME category, a small enterprise is defined as an enterprise which employs fewer than 50 persons and whose annual turnover and/or annual balance sheet total does not exceed EUR 10 million.

3. Within the SME category, a microenterprise is defined as an enterprise which employs fewer than 10 persons and whose annual turnover and/or annual balance sheet total does not exceed EUR 2 million.

Reference: The Commission Recommendation of 6 May 2003 (2003/361/EC) concerning the definition of micro, small and medium-sized enterprises .
 
SMILES :
  SMILES is an acronym for Simplified Molecular Input Line Entry System. It is a simplified chemical notation that allows a user to represent a 2 dimensional chemical structure in linear textual form for easy entry into a computer application.  
S-phrases :
  Standard phrases relating to the safe use of the 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".  
SPORT :
  Strategic Partnerships on REACH Testing.  
SQL :
  Structured Query Language.
A language used to create, maintain, and query relational databases.
 
SR&D :
  Scientific research and development.  
STP :
  Sewage Treatment Plant.  
Structure Activity Relationship (SAR) :
  A structure-activity relationship (SAR) is a (qualitative) association between a chemical substructure and the potential of a chemical containing the substructure to exhibit a certain biological effect.  
Study summary :
  means 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.  
Substance Name :
  Substance name, chemical name or IUPAC name.
Generally this is the name of the substance according to the rules of the International Union of Pure and Applied Chemistry (IUPAC). If it is not possible to allocate a precise chemical name (e.g. if the substance is not completely defined), a name has been allocated according to the rules defined for the identification of such chemical substances in the EINECS. Some chemical names listed in the ELINCS were amended according to the notification and the IUPAC nomenclature rules.
(e.g. formaldehyde for EINECS# 200-001-8, CAS# 50-00-0).
 
Substance :
  means 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 in articles :
  Hazardous substances that are released from articles as part of their function will generally have to be registered. If the release is not intentional, the substances may have to be notified.  
Substance identification :
  Substance identification is a process by which a substance can be identified and distinguished from other substances. An element of substance identification is the naming of the substance, which follows specific criteria, as set out in the Guidance document on substance identification.  
Substance Information Exchange Forum (SIEF) :
  SIEF stands for Substance Information Exchange Forum. A SIEF is a forum, formed after the pre-registration phase, to share data on a given phase-in substance.
The principal aims of a SIEF are to:
i) facilitate data sharing for the purposes of registration
ii) agree on the classification and labelling of the substance where there is a difference of interpretation between the potential registrants.
 
Substance of Very High Concern (SVHC) :
  SVHC in the context of the REACH Regulation are:
1. CMRs category 1 or 2
2. PBTs and vPvBs meeting the criteria of Annex XIII and
3. substances - such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of Annex III - for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points 1 and 2 and which are identified on a case-by-case basis in accordance with the procedure set out in Article 59.
 
Substances which occur in nature :
  means 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.  
Substitution :
  Avoiding use of a hazardous substance by replacing it with another substance (a substitute) or by changing production methods.  
Summary RAR :
  Summary Risk Assessment Report.  
Sunset date :
  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 :
  means any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a preparation, or a preparation.  
Supplier of an article :
  means any producer or importer of an article, distributor or other actor in the supply chain placing an article on the market.  
Sustainable development :
  Development that meets the needs of the present without jeopardising the needs of future generations. Sustainable development includes striking the right balance between environmental, social and economic concerns.  
SVHC :
  Substance of Very High Concern.  
T
TCS :
  Toxicology and Chemical Substances.  
Technical dossier :
  The primary meaning of the term under REACH is documentation, which contains all information required for registration, as specified in Article 10(a). The format of the technical dossier is IUCLID.
In addition, the term technical dossier is also used to refer to one of the two parts of the Annex XV dossier. It supports the Annex XV report.
 
Technical Expert Working Groups :
  Eight working groups consisting of stakeholder experts were convened in the winter of 2001/2002 to discuss and investigate technical issues.  
Tentative Exposure Scenario :
  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 manfacture/use and/or communicated to Downstream Users (DU) as annex to the Safety Data Sheet.  
Testing proposal :
  A proposal made by a registrant or a Downstream User for further testing in accordance with Annexes IX and X of the Regulation.  
TGD :
  Technical Guidance Document.  
TM :
  Technical Meeting.  
TMs :
  Testing Methods.  
Tonnage threshold :
  Volume based criteria for different requirements under REACH, formulated as "X tonnes/year per manufacturer/importer". In addition, the tonnage threshold will affect registration deadlines for phase-in substances.  
Toxicity :
  Property of chemical causing adverse effects on humans, animals or plants (e.g. causes cancer or death).  
Trade Name(s) :
  All names under which the substance is marketed within the Community market.  
U
UC :
  Use Category.  
UEAPME :
  European Association of Craft, Small and Medium-sized Enterprises.  
UICPA :
  Union Internationale de Chimie Pure et Appliquée.
International union for pure applied chemistry.
 
UNEP :
  United Nations Environment Programme.  
Use and exposure category :
  means 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.  
UUID :
  Universal Unique Identifier.  
Use :
  means 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.  
UV :
  Ultraviolet region of spectrum.  
UVCB :
  Unknown or Variable composition.  
V
v/v :
  Volume per volume ratio.  
very Persistent and very Bioaccumulative (vPvB) :
  Substances of very high concern, which are very persistent (very difficult to break down) and very bio-accumulative in living organisms. Annex XIII defines criteria for the identification of vPvBs and Annex I lays down general provisions for their assessment. vPvBs may be included in Annex XIV and by that be made subject to authorisation.  
VOLUME :
  The produced or imported volume of the chemical.  
vPvB :
  Very Persistent and very Bio-accumulative.
Substances of very high concern that are very persistent (very difficult to break down), very bioaccumulative (very liable to accumulate in our bodies). Subject to Authorisation.
 
W
w/w :
  Weight per weight ratio.  
WTO :
  World Trade Organisation.  
X
     
Y
   
Z
   
Other
°C :
  Degrees Celsius (centigrade).  
µg :
  Microgram(s).