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REACH guide

REACH is one of the largest single pieces of European legislation ever.  It is therefore understandable that most people get confused about the various terms and phrases associated with REACH, let alone understand how to comply.

We have put together this guide covering:

• REACH compliance plan
• Useful information sheets
• REACH key dates
• REACH glossary and abbreviations

Useful information sheets

REACH key dates

REACH glossary and abbreviations

Article 
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 (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. (See Title VII)

C&L 
Classification and Labelling

CA 
Competent Authority

CMR 
Carcinogen, Mutagen, Reproductive toxin

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 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; 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
click here to see how NCEC can help with GHS

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 in order to be transformed into another substance (Article 3.15)

IUCLID 
International Uniform Chemical Information Database

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 means production or extraction of substances in the natural state (Article 3.8)

M/I 
Manufacturer/Importer

MS 
Member State

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) 
Product and process orientated research and development 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 (Article 3.22)

QSAR 
Quantitative Structure Activity Relationship model

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 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