Glossary - Support to accomplish the requirements of the REACH regulation

Term / Abbreviation

Explanation / Interpretation

BauA

Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (Federal Institute for Occupational Safety and Health)

BDI

Bundesverband der Deutschen Industrie e.V. (Federal Association of German Industry e.V.)

BfR

Bundesinstitut für Risikobewertung (Federal Institute for Risk Assessment)

BImSchG

Bundesimmissionsschutzgesetz (Federal Control of Pollution Act)

Bioaccumulative

Characteristic of particularly hazardous chemicals for the environment. Substances accumulate in living organisms (plants, animals, humans), whereby tissue concentrations could be reached, which in turn can trigger toxic effects.

C&L

Classification and Labelling

CAS

Often short name for the "Registry Number (RN)" of the "Chemical Abstracts Service" of the "American Chemical Society (ASC)", Suchmaschine (search engine)

CMR

Carcinogenic, Mutagenic or Toxic for Reproduction Chemicals, classified under Directive 67/548/EWG

CSA

Chemical Safety Assessment

CSR

Chemical Safety Report

CSTEE

Previously: Scientific Committee on Toxicology, Ecotoxicology and Environment -

Now: SCHER (Scientific Committee on Health and Environmental Risks).

DDT

Dichlordiphenyltrichlorethane - Illegal insecticide

DMEL

Derived Maximum Exposure Level

DNEL

Derived No-Effect Level - The DNEL-value is calculated from the lowest value in combination with certain safety factors. It is used for oral and dermal exposure in mg per day per person or body weight mg per day.

Downstream User

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. Any industrial/professional user of substance/preparation who is not a manufacturer or importer. A re-importer shall be deemed to be a "Downstream User".

DPD

Dangerous Preparation Directive

DU

Downstream User

E&K

Einstufung und Kennzeichnung – Classification and Labelling (C&L)

EAK

Europäischer Abfallkatalog (European Waste Catalogue)

EBW

Exposure-Based Waiving

ECB

European Chemicals Bureau - established in Italy, Establishment of the Commission of the European Communities

EChA

European Chemicals Agency

ECVAM

JRC's European Centre for the Validation of Alternative Methods -  Establishment of the Commission of the European Communities

EESC

The Economic and Social Committee (EESC) is a body of the European Union (EU) established in 1957. It is a consultative assembly composed of employers, employees and representatives of various other interests. It is similar to the Committee of the Regions, with whom it shares the Delors building in Brussels as its seat.

EINECS

European Inventory of Existing Chemical Substances - European directory of former substances: Substances, which have been brought on the market between 1.1.1971 and 18.9.1981 in the European Economic Area.

ELINCS

European List of Notified Chemical Substances -ELINCS  contains new substances, which have been and will be declared after conclusion of the EINECS-List (18.9.1981) according to 67/548/EWG. The ELINCS directory will be updated constantly.

EINECS-List / regulation 67/548/EWG

EMEA

European Medicines Agency - Establishment of the Commission of the European Communities

EmS

Erzeugnis

Product = According to Art. 3, No 3, "Article, which receives a specific shape, surface and design and, in a greater extent than the chemical composition, affects its function.

ES

Exposure scenario - 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 exposure of humans and the environment. These exposure scenarios may cover one specific process or use or several processes or uses as appropriate. REACH Article 3 (37).

eSDB

Safety Data Sheet extended by annexed exposure scenario

eSDS

Safety Data Sheet extended by annexed exposure scenario

ESIS

European Chemical Substance Information System

EuGH

Europäischer Gerichtshof (European Court)

EUSES

European Union System for the Evaluation of Substances

F&E

Forschung und Entwicklung – Research and Development (R&D)

FAO

Food and Agriculture Organization of the United Nations

GHS

Globally Harmonised System of Classification and Labelling - The Commission Draft for an EC regulation for the GHS is available since 27.6.2007. Initial information can be obtained from the Directorate-General for Enterprise (Generaldirektion Unternehmen).

GLP

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.

H/I

Hersteller/Importeur - Manufacturer/Importer (M/I)

HCB

Hexachlorbenzol (Hexachlorobenzene)

HPLC

High Pressure Liquid Chromatography

HPVC

High Production Volume Chemicals

IARC

International Agency for Research on Cancer

ICCA

International Council of Chemical Associations

Identifizierte Verwendung

Identified application according to Art. 3, No 26 "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. REACH Article 3 (26)

IFCS

Internationales Forum für Chemiekaliensicherheit (International Forum on Chemical Safety)

ILO

International Labour Organization

In vitro-testing

Studies done with cell or tissue cultures - 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.

In vivo-testing

Studies done with live animals or testing within a living organism.

IOMC

Inter-Organization Programme for the Sound Management of Chemicals

IRPTC

International Register of Potentially Toxic Chemicals

ISO

International Standards Organisation

IUCLID

International Uniform Chemical Information Database - Database system, which contains data according the regulation (EC) Nr. 793/93 (former substances) for the evaluation and control of environmental risks of former chemical substances, which have been collected and registered by the European Industry

IUCLID 5

IUCLID 5 is a software, which is used by companies (incl. consultants) as well by national/international authorities and the agency for the execution of the registration, evaluation and authorisation under REACH. 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 - International association for pure applied chemistry. Institute for binding recommendation of nomenclature, symbols, terminology, standardised measurement methods, etc. in chemistry.

JRC

Joint Research Centre - Common Research Centre, Establishment of the Commission of the European Communities

K_ow

Octanol-water partition coefficient – A dimensionless partition coefficient, which describes the proportion of concentrations of a chemical in a two-phase-system of n-octanol and water. It is a model for the polarity or the solubility of water or fat of the chemical. The higher the coefficient, the stronger the trend of the substance, to accumulate in the adipose tissue of organisms.

KMU

Kleine und mittlere Unternehmen (Smaller and medium-sized enterprises)

LC

lethal concentration

LCA

Life Cycle Assessment

LD

lethal dose

LD₅₀

Median lethal concentration of a substance, on this concentration 50% of the tested organisms died.

Legierung

Alloy, according to Art. 3, No. 41, means"a metallic material, on a macroscopic scale consisting of two or more elements, so combined that they can not be readily separated by mechanical means.

Letter of access

Access and use authorisation

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.

LRI

Legal Resource Index

LVP

Low Production Volume Chemicals

M/I

Manufacturer/Importer - Hersteller/Importeur (H/I)

MOS

Margin of safety

NCD

New Chemicals Database

NLP

No-Longer Polymers – a NLP is a substance, which was considered as notified under Article 8 (1) of the 6^th amendment of Directive 67/548/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 7^th amendment of Directive 67/548/EEC). (List for No-Longer Polymers)

NOAEL

No observed adverse effect level - 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.

NOEC

No observed effect concentration - 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.

NOEL

The No Observed Effect Level is 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-Stoff

A substance which is not a phase-in substance, in the meaning of Article 3. No. 20. Those non-phase in substances do not benefit from the transitional regime provided for phase-in substances under REACH and therefore have to be registered before manufacture or import starts. 

Substance, which is no Phase-in substance means

a) substance is not mentioned in the European directory for the on market-chemical substances (EINECS),

b) the manufacturer or importer can not prove, that the substance has not been placed on the market by him in the EC (according members of 1.5.2004: Belgium, Denmark, Germany, Estonia, Finland, France, Greece, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Austria, Poland, Portugal, Sweden, Slovakia, Slovenia, Spain, Czech Republic, Hungary, United Kingdom, Cyprus) 15 years before REACH (1.6.2007) coming into effect

c) substance (except polymers) has not been registered bevore 1.6.2007 in a country inside the European Community

(list of members 1.5.2004) acc. regulation 67/548/EWG.

OECD

Organization for Economic Cooperation and Development

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. 

OPS

Overarching Policy Strategy

Opt-out

Non-participation in a consortium for registration

ORATS

Online European Risk Assessment Tracking System

OSOR

One Substance, One Registration

OSPAR

Oslo-Paris Convention for the Protection of the Marine Environment of the North East Atlantic

PBT

Persistent, Bio-Accumulative and Toxic - Annex XIII defindes criteria for the identification of substances that are Persistent, Bio-accumulative and Toxic (PBT) 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.

PCB

Polychlorinated biphenyls, heavily polluting and toxic chemical compound for insulation and hydraulic fluids.

PCDD/F

Polychlorinated dibenzodioxins and -furans

PEC

Predicted Environmental Concentration

Persistent

Characteristic of particularly hazardous chemicals for the environment. Persistent substances are stable in the environment, they are non-degradable or only very slow degradable and can be accumulated in the environment.

Phase-in-Stoff

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 (67/548/EWG) 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.

PIC

Prior Informed Consent, the Rotterdam Convention of Prior Informed Consent sets up a system to control international trade in certain hazardous substances

PNEC

Predicted No-Effect Concentration - Concentration of the substance below which adverse effects in the environmental sphere of concern are not expected to occur. (REACH Annex I 3.0.1). The French institute INERIS made a database for PNEC-values available.

POP

Persistent organic pollutants (POPs) are toxic chemicals that adversely affect human health and the environment around the world. Because they can be transported by wind and water, most POPs generated in one country can affect people and wildlife far from where they are used and released. They persist for long periods of time in the environment and can accumulate and pass from one species to the next through the food chain. To address this global concern, the United States joined forces with 90 other countries and the European Community to sign a groundbreaking United Nations treaty in Stockholm, Sweden, in May 2001. Under the treaty, known as the Stockholm Convention, countries agree to reduce or eliminate the production, use, and/or release of 12 key POPs. known as the 'dirty dozen’.

POPs

Persistent Organic Pollutants

PPORD

Product and Process Oriented Research and Development

Pre-SIEF

Preparatory phase for the establishment of a SIEF for the declaration of the substance identity

Produzent eines Erzeugnisses

Acc. to Art.3 , No. 4 "a natural or legal person, who manufactures or composes a product in the European community."

Pro Jahr

Per year – means per calender 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 calender years.

PRTRs

Pollution Release and Transfer Registers

PSM

Plant Protective Agent (Pflanzenschutzmittel)

QSAR

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 know structure and toxic properties.

RA

Risk Assessment

RAR

Risk Assessment Report

R&D

Research and Development - Forschung und Entwicklung (F&E)

REACH

Registration, Evaluation, Authorisation and Restriction of Chemicals

REACH-IT

REACH-IT is the central online workflow-system of the European Chemicals Agency (EChA). The homepage allows companies to easily sign-up online, submit dossiers and other required information on chemical substances to the Agency. And will be also used for the pre-registration (1.6.2008 – 1.12.2008).

Read across

Transmission of substance characteristics from one substance to another per analogy by conclusion (e.g. by reference of valid data, without accomplishing separate tests.)

Registrant

Registrant means the manufacturer or the importer of a substance or the producer or importer of an article submitting a registration for a substance.

RIP

REACH Implementation Project – Project for the implementation of REACH. Information and current news can be found at ECB.

RMM

Risk Management Measure

SAICM

Strategic Approach to International Chemicals Management

SAR

Structure Activity Relationship

SCHER

Scientific Committee on Health and Environmental Risks

SCOEL

Scientific Committee on Occupational Exposure Limits

SDB

Sicherheitsdatenblatt - Safety data sheet

SDS

Safety data sheet – Sicherheitsdatenblatt

SEA

Socio-economic analysis

SIEF

Substance Information Exchange Forum – a SIEF is a forum, formed after pre-registration phase, to share data on a given phase-in substance. The principal aim of a SIEF are to:

i) facilitate data sharing for the purpose of registration

ii) agree on the classification and labelling of the substance where there is a difference of interpretation between the potential registrants.

SIEF facilitator

SME

Small and medium-sized enterprises

SPORT

Strategic Partnership on REACH Testing

Stoff

Substance – a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any 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.

SVHC

Substance of Very High Concern

TA-Luft

Technische Anleitung zur Reinhaltung der Luft (Technical Instructions for Clean Air)

TGD

Technical Guidance Document – These documents will be currently compiled in the REACH Implementation Projects (RIP). Information about the updated workings are offered by the ECB. A series of technical guidelines is partly finished by now and available on the website of the European Chemicals Agency (EChA).

TRA

Targeted Risk Assessment

TSCA

Toxic Substance Control Act

UBA

Umweltbundesamt - Federal Environment Agency

UEC

Use and exposure category – Verwendungs- und Expositionskategorie (VEK)

Umfassender Studienbericht

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.

UN

United Nations

UNEP

United Nations Environment Programme

UNITAR

United Nations Institute for Training and Research

UVCB

Substances of unknown variable composition, complex reaction products or biological materials.

VEK

Verwendungs- und Expositionskategorie - Use and Exposure Category (UEC)

VOC

Volatile Organic Compound

vPvB

Very persistent, very bio-accumulative

Waiving

Omission of tests

WHO

World Health Organization

WTO

World Trade Organisation