REACH Glossary

12 Years Rule—Data protection applies for 12 years.  The period begins from the moment when the information is submitted to the relevant authorities.  The rule also applies to data on substances submitted as part of a notification in accordance with Directive 67/548/EEC on the classification, packaging and labeling of dangerous substances, although the date of the original submission still applies (e.g. data submitted in January 2000 will cease to be protected in January 2013).

Actor in the Supply Chain—All manufacturers and/or importers and/or downstream users in a supply chain.

Additive—A compound that has been added during the manufacturing process to stabilze the substance.

Agency—The European Chemicals Agency, based in Helsinki, Finland, is the “public face” of the REACH system. It primary tasks include: managing the registration process, ensuring consistency in evaluations, providing criteria to guide Member States’ selections of substances for evaluation and providing opinions and recommendations on the authorisation and restriction procedures.

Alloy—A metallic material, homogenous on a macroscopic scale, consisting of two or more elements combined in such a fashion that they cannot be readily mechanically separated.

Article—An object which during production is given a specific shape, surface or design, which determines its function to a greater degree than its chemical composition.

Authorisation—Pre-market approval procedure for substances of very high concern (SVHCs) listed in Annex XIV REACH. It may apply to category 1 or 2 carcinogens, mutagens, substances classified as toxic for reproduction (CMRs), PBTs, vPvBs, and other substances of equivalent concern (e.g. endocrine disruptors).

CAS Number—(Chemical Abstracts Service index number) It is a unique 9 digit numeric identifier that has no chemical significance. It provides a way to identify a chemical substance or molecular structure where there are many possible systemic, generic, proprietary or trivial names. (CAS is a division of the American Chemical Society.)

CBI—Confidential Business Information 

Chemical Safety Assessment—Considers the use of the substance on its own (including any major impurities and additives), in a preparation and in an article, as defined by the identified uses. It must consider all stages of the life-cycle of the substance resulting from the manufacture and identified uses and is based on a comparison of the potential adverse effects of a substance with the known or reasonably foreseeable exposure of man and/or the environment to that substance taking into account implemented and recommended risk management measures and operational conditions. Annex I of REACH provides general provisions for assessing substances.

Chemical Safety Report—Provides the information collected in the chemical safety assessment (see above); Annex I of REACH provides general provisions for preparing the report.

CMR—Carcinogenic, mutagenic or toxic for reproduction.

Competent authority—The entity (i.e. authority or body) established by each Member State to carry out obligations on the national level.

Component—A substance intentionally added to form a preparation.

Constituent—Any single species present in a substance that can be characterized by its unique chemical identity.

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

Downstream user—Natural or legal person established in the European Community, (but not the manufacturer or importer) who uses the 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 who has been exempted will be regarded as a downstream user.

EINECS—The European Inventory of Existing Commercial Chemical Substances; it is a list of existing chemical substances that have been commercially available in the European Community between January 1, 1971 and September 18, 1981 (approximately 100,000 entries).

ELINCS— (European List of Notified Chemical Substances) consists of all chemical substances notified within the European Community under Directive 67/548/EEC on classification, packaging and labelling of dangerous substances.  It is updated regularly.

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. These exposure scenarios may cover one specific process or use or several processes or uses as appropriate.

Full study report—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.

GLP— (Good Laboratory Practice) 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.  The principles of good laboratory practice, which were created in the OECD, are annexed to Directive 2004/10/EC on the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances.

GHS— (Globally Harmonised System of classification and labelling of chemicals) A system that focuses on the classification of chemicals by types of hazard and proposes harmonized hazard communication elements (such as safety data sheets) is being developed and will be implemented in Community legislation.  It will substitute currently valid criteria for classification and labelling.

Identified use—A substance’s use (on its own or in a preparation) or a preparation’s use, 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.

Import—The physical introduction into the customs territory of the European Community.

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

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

Intermediate—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: 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 excludes tanks or other vessels in which the substance(s) are stored after the manufacture.

      (b) on-site isolated intermediate: an intermediate not meeting the criteria of a non-isolated intermediate (above) and 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: an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites.

IUCLID 5—International Uniform Chemical Information Database is software for the submission of dossiers, which will be used by industry, the European Chemical Agency and Member States’ authorities.

IUPAC—The International Union of Pure and Applied Chemistry, which is the world authority on inter alia chemical nomenclature, terminology, standardized methods for measurement, and atomic weights.  It issues recommendations on how to name compounds or what symbol to use for a specific quantity.

Joint registration—A group of companies formed together for the purpose of joint submission of registration in accordance with Article 11.

Lead Registrant—A company that 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 members of the joint registration decide, the lead registration may also submit information on safe use and the CSR on behalf of the others.  After the joint registrant submits the information, other members of the joint registration submit the remaining information individually.

Manufacturer—Any natural or legal person established within the European Community who manufactures a substance within the European Community.

Manufacturing—Production or extraction of substances in the natural state.

Main constituent—A constituent, which is not 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.

Monomer—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.

• A monomer unit is the reacted form of a monomer substance in a polymer.

Not chemically modified substance—A substance whose chemical structure remains unchanged, even if it has undergone a chemical process or treatment, or a physical mineralogical transformation (e.g. to remove impurities).

Notified substance—A substance for which a notification has been submitted and which could be placed on the market in accordance with Directive 67/548/EEC (which relates to the classification, packaging and labelling of dangerous substances).

Only representative—A natural or legal person, with a sufficient background in the practical handling of substances and the information related to them, who is established in the Community, which is appointed by a non-Community producer to assume the obligations imposed on importers of the non-Community producer’s products.

PBT—Persistent, bioaccumulative and toxic.

Per year—In general, it is per calendar year. For phase-in substances (see below) that have been imported or manufactured for at least three consecutive years, quantities per year shall be calculated on the basis of the average production or import volumes for the three preceding calendar years.

Phase-in substance—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 European Community (including new Member States) but not placed on the market by the manufacturer or importer, at least once since 1 June 1992 (provided the manufacturer or importer has documentary evidence of this);

      (c) it was placed on the European Community market (including new Member States’ markets) before 1 June 2007 by the manufacturer or importer and was notified under Article 8(1), first indent, of Directive 67/548 (7th amendment), which relates to the classification, packaging and labelling of dangerous substances. However, the substance does not meet the definition of a polymer (see below), (provided the manufacturer or importer has documentary evidence of this).

In July 2007, due to the accession of Bulgaria and Romania, the Commission had to submit a proposal to ensure that the definition of phase-in substances applied to substances manufactured or marketed in these two new Member States before their accession to the EU in the same fashion as substances manufactured or marketed in the other Member States.  It is highly probable that this measure will be adopted without modification.

Placing on the market—Supplying or making available, for payment or free of charge, to a third party. Import (see above) falls under this definition.

Polymer—A substance consisting of molecules characterised by the sequence of one or more types of monomer units. The molecules must be distributed over a range of molecular weights, with the differences in the molecular weight being 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.

      “Monomer unit” means the reacted form of a monomer substance in a polymer.

Polymer molecule—A molecule that contains a sequence of at least three monomer units (see above), which are covalently bound to at least one other monomer unit or other reactant.

Preparation—Mixture or solution composed of two or more substances (see below).

Producer of an article—Any natural or legal person who makes or assembles an article (see above) within the European Community.

Product and Process Oriented Research and Development (PPORD)—Any scientific development relating to product development or the further development of a substance (on its own, in preparations or in articles) that involves a pilot plant or production trials to develop the production process and/or to test the fields of application of the substance.

QSAR—Quantitative Structure Activity Relationship; results of such relationships may be used instead of testing when certain conditions are met.

Recipient of a substance/ preparation—A downstream user or a distributor supplied with a substance or a preparation.

Recipient of an article—An industrial or professional user, or a distributor, supplied with an article. This does not include consumers.

Registrant—The manufacturer or the importer of a substance or the producer or importer of an article who submits a registration for a substance.

Registrant’s own use—An industrial or professional use (see below) by the registrant.

Registration—Any manufacturer or importer of a substance (on its own or in one more preparations, including substances in articles if intentionally released) in quantities of 1 tonne or more must follow the procedure under Title II of REACH, which requires submitting information to the Agency. Certain exemptions apply.

Restriction—Any condition imposed or prohibition on manufacturing, using or placing on the market.

RIPs—REACH Implementation Projects; seven individual projects are being conducted to develop guidances and IT tools for implementing REACH. The projects are intended to assist the Agency, industry and Member States’ authorities.

RMM— (risk management measures) Measures in the control strategy for a substance that reduces the emission and exposure to a substance, thereby reducing the risk to human health or the environment.

Robust Study Summary—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 (see above).

Safety Data Sheet—The document includes the following: identity of the substance/preparation, uses, classification, composition, handling and storage requirements, first aid/fire measures to be taken, accidental release measures, exposure controls and personal protection and means of disposal. Annex II of REACH provides the “Guide to the Completion of Safety Data Sheets.”

Scientific Research and Development—Any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than 1 tonne/year.

Sequence—A continuous string of monomer units within the molecule that are covalently bonded to one another and are uninterrupted by units other than monomer units.  This continuous string of monomer units can possibly follow any network within the polymer structure.

SIEF—Substance Information Exchange Fora; all potential registrants, downstream users and third parties who have pre-registered phase-in substances or whose substances have been regarded as registered due to applicable plant protection/biocidal products legislation, or registrants who have submitted a registration before the applicable phase-in substance deadline, become participants in a substance-specific SIEF. Participants in respective SIEF are subject to data sharing/data generation obligations.

SIEF Facilitator—A potential registrant (i.e.  a party that has pre-registered) who oversees pre-SIEF and/or SIEF activities including organizing the exchange of information on the identity of the substance. 

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

SME—Small and medium-sized enterprises as defined in the Commission Recommendation of 6 May 2003.

Study Summary—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—Chemical element and its compounds, in the natural state or obtained by any manufacturing process, including any additives necessary to preserve its stability and any impurity deriving from the process used. It does not include any solvent which may be separated without affecting the stability of the substance or changing its composition.

Substances which occur in nature—A naturally occurring substances; it may be unprocessed or processed. If it is processed, it may only be processed manually, mechanically, by gravitational means, by dissolution in water, by floatation, by extraction with water, by steam distillation, by heating solely to remove water, or, it may be extracted from the air by any means.

Super User—One user that is attached to several legal entities of the same organisation, which submits pre-registrations on behalf of each legal entity, although each pre-registrations remains specific to each of the entities.

Supplier of a substance or a preparation—Any manufacturer, importer, downstream user or distributor who places a substance (on its own or in a preparation) or preparation on the market (see above).

Supplier of an article—Any producer or importer of an article, distributor or other actor in the supply chain who places an article on the market (see above).

SVHCs—Substances of very high concern.

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 utilization.

Use and exposure category—An exposure scenario covering a wide range of processes or uses, where the processes or uses are communicated, at least as a brief general description of use.

UVCB substances— (Substances of Unknown or Variable composition, Complex reaction products or Biological materials) Substances that cannot be sufficiently identified based on the composition.  Different identification and naming rules can be found in RIP 3.10 Technical Guidance Document on substance identification.

vPvB—Very persistent and very bioaccumulative.

Well defined substances—Substances with a defined qualitative and quantitative composition that can be sufficiently identified based on the identification parameters of REACH Annex IV, Section 2.  Rules for identification and naming differ for “well defined substances” with one main constituent (in principle greater than 80%), a mono-constituent substance and for substances with more than one main constituent (in principle each constituent is greater than 10%), a  multi-constituent substance.