Regulatory Compliance

REACH glossary

A list of terms and abbreviations used in and associated with the Registration, Evaluation, Authorisation and restriction of Chemicals (REACH) regulation.

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

 Article – an object which, during production, is given a special shape, surface or design that determines its function to a greater degree than does its chemical composition. (Article 3.3)

Authorisation – the system whereby restrictions are made on the placing on the market of substances of very high concern as identified by Annex XIV of REACH. (Title VII)

 C&L – Classification and Labelling

CA – Competent Authority

CMR –carcinogens, mutagens and substances toxic to reproduction'

CSA – Chemical Safety Assessment

CSR - Chemical Safety Report

 Distributor
– 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. (Article 3.14)

DNEL – Derived No Effect Level

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. A distributor or a consumer is not a downstream user.

DU – Downstream User

 ECHA – European Chemicals Agency

EINECS – European Inventory of Existing Chemical Substances

ELINCS – European List of Notified Chemical Substances

ES – Exposure Scenario

ESDS or extSDS – Extended Safety Data Sheet (with Exposure Scenario Annex)

EUSES – European Union System for the Evaluation of Substances

Evaluation – within the REACH regulation, the term ‘evaluation’ is used in relation to several key processes in the registration process, including evaluation of testing proposals for further testing of a substance; examination of technical dossiers submitted for substance registration; evaluation of a substance by a Member State; and evaluation of an intermediate by a Member State.

Exposure Scenario – 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. (Article 3.27)

 GHS – Globally Harmonised System of Classification and labelling of Chemicals

GLP – Good Laboratory Practice

 HPV – High Production Volume

 Importer – any natural or legal person established within the Community who is responsible for import. (Article 3.11)

Intermediate – a substance that is manufactured for and consumed in or used for chemical processing to be transformed into another substance. (Article 3.15)

IUCLID – International Uniform Chemical Information Database

 Legal Person – a person that is not necessarily a human being but still has rights and obligations ( a company, partnership, etc).

LOAEL – Lowest-Observed-Adverse-Effect Level

 Manufacturer – any natural or legal person established within the Community who manufactures a substance within the Community. (Article 3.9)

Manufacturing
– production or extraction of substances in the natural state. (Article 3.8)

M/I – Manufacturer/Importer

MS – Member State

 Natural Person – a human being.

NOAEL – No Observed Adverse Effect Level

NLP – No Longer Polymer

Notification – the submission of specific information to the Agency in accordance with a legislative requirement, including 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 of restart of use by downstream user.

 Only Representative – a natural or legal person established outside the Community who manufactures a substance on its own, in preparations or in articles, 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 representative shall also comply with all other obligations of importers under the Regulation. (Article 8)

OR – Only Representative

OSOR – One Substance One Registration

 PBT – Persistent, Bioaccumulative, Toxic

PEC – Predicted Environmental Concentration

Phase-in Substance – a substance which meets at least one of the criteria in Article 3.20. Companies pre-registering their Phase-in Substances will be able to take advantage of the transitional provisions in Article 23.

PNEC – Predicted No-Effect Concentration

PPORD – Product and Process Oriented Research and Development

Preparation
– a mixture or solution composed of two or more substances. (Article 3.2)

Pre-registration – pre-registration allows companies registering products already on the market (phase-in-substances) to take advantage of transitional arrangements for several years until the appropriate registration deadline is reached.

Product and process orientated research and development (PPORD)
– 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. (Article 3.22)

 QSAR – Quantitative Structure-Activity Relationship model

 Registration – 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 Economic Area (EEA).

REACH – Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation (EC) 1907/2006

Restriction – any condition for or prohibition of the manufacture, use or placing on the market. (Article 3.31)

RIP – REACH Implementation project

RMM – Risk Management Measures

RSS – Robust Study Summary

 SAR – Structure Activity Relationship

SDS – Safety Data Sheet

SEG – Stakeholder Expert Group

SIA – Substances in Articles

SIEF – Substance Information Exchange Forum
 
SME – Small or Medium Enterprise

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. (Article 3.1)

SVHC – Substance of Very High Concern

 TDI – Tolerable Daily Intake

TGD – Technical Guidance Document

TPR – Third Party Representative

 UC – Use Category

UDS – Unscheduled DNA Synthesis

Use – any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation. (Article 3.24)

UVCB – (Substance of) Unknown or Variable Composition, Complex Reaction Products and Biological Materials
 
vPvB – Very Persistent, very Bioaccumulative

 WF – Workflow