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Definitions

REACH has introduced a number of terms which may differ from their use under previous legislation. The following are the terms that are fundamental for understanding the REACH Regulation:

ECHA: The European Chemical Agency

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.

PREPARATION: means a mixture or solution composed of two or more substances.

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.

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.

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.

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.

NON PHASE-IN SUBSTANCE: All substances that are not fulfilling of the criteria for phase-in substances are considered non-phase in substances. Non phase-in substances do not benefit from the transitional regime provided for phase-in substances and need to be registered before they can be manufactured, imported or placed on the market in the EU in a quantity of 1 tonne/year or more, unless they have already been notified under Directive 67/548/EEC.

MANUFACTURER: means any natural or legal person established within the Community who manufactures a substance within the Community.

IMPORTER: means any natural or legal person established within the Community who is responsible for import.

REGISTRATION DOSSIER: the set of information submitted ECHA for the registration of a substance. The Registration Dossier consists of a Technical Dossier and, if the quantity concerned is 10 tonne/year or more, a Chemical Safety Report.

TECHNICAL DOSSIER: the set of information identifying the manufacturer/importer, defining the substance and detailing its intrinsic properties. The data requirements of the Technical Dossier are set out in Annexes VII to XI of REACH.

CHEMICAL SAFETY REPORT (CSR): the documentation of the chemical safety assessment for a substance. The Chemical Saftey Report contains a detailed summary of the information on the environmental and human health hazard properties of the substance, together with an assessment of the exposure and risk in each proposed use.

SUBSTANCE INFORMATION EXCHANGE FORUM (SIEF): A communication mechanism to allow pre-registrants of phase-in substances to share data. Rules for the communication and data sharing in the SIEF are set out by ECHA.

CONSORTIUM: A legal accord under which 2 or more companies unite for the purposes of creating a Lead Registration Dossier.

LEAD REGISTRATION DOSSIER: the registration dossier submitted by the Lead Registrant on behalf of a group of companies sharing data in a SIEF or consortium.

JOINT REGISTRATION  DOSSIER: the registration dossier submitted by a Joint Registrant which refers to information shared in a Lead Registration Dossier under a "Letter of Access" (LoA).

LETTER OF ACCESS (LoA): a legal document or token under which a legal entity has a right to refer to information a Lead Registration Dossier.

LEAD REGISTRANT: the legal entity submitting the Lead Registration Dossier to ECHA.

JOINT REGISTRANT: a legal entity submitting a Joint Registration Dossier.

INQUIRY: The first stage in the process of making a registration for a non phase-in substance in which the data requirements for a dossier are established.

Further definitions can be found in Chapter 2, Article 3 of the REACH Regulation.

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