An object which during production is given a special shape, surface or design, which determines its function to a greater degree that does its chemical composition. Examples of articles are a car and a telephone.
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.
European Chemicals Agency (ECHA)
The Agency established for the purposes of managing and in some cases carrying out the technical, scientific and administrative aspects of the REACH Regulation and to ensure consistency at Community level in relation to these aspects. The Agency is located in Helsinki.
The physical introduction into the customs territory.
Any natural or legal person established within the Community who is responsible for import.
A substance that is manufactured solely for the purpose of being transformed into another substance (synthesis) and is used up within this reaction.
(a) non-isolated intermediate: this type of intermediate is not intentionally removed from the equipment used for the synthesis, except for sampling. If the substance is stored after the manufacture in tanks or other vessels, it is not a non-isolated intermediate;
(b) on-site isolated intermediate: an intermediate not meeting the criteria of a non-isolated intermediate and where 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.
The production or extraction of substances.
Any natural or legal person established within the Community who manufactures a substance within the Community.
A substance which is not a phase-in substance, in the meaning of article 3.20. 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.
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, on 1 May 2004 or on 1 January 2007, 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, on 1 May 2004 or on 1 January 2007, 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.
Placing on the market
Supplying or making available, whether in return for payment or free of charge, to a third party. Import shall be deemed to be placing on the market.
A mixture or solution composed of two or more substances.
The manufacturer or the importer of a substance or the producer or importer of an article submitting a registration for a substance.
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 Union (and in Norway, Iceland and Liechtenstein once implemented in these countries).
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.
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.