Actors in the supply chain | All manufacturers and/or importers and/or downstream users in a supply chain. |
Agency | European Chemicals Agency ECHA as established by the Regulation |
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; |
Competent Authority | The Authority or Authorities or Bodies established by the Member States to carry out their obligations arising from this Regulation |
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 |
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. A re-importer exempted pursuant to Article 2(7) (c) shall be regarded as a downstream user |
Exposure Scenario: (ES) | 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 or the environment. These exposure scenarios may cover one specific process or use or several processes or uses, as appropriate |
Import | The physical introduction into the customs territory of the Community |
Importer | Any natural or legal person established within the Community who is responsible for import |
Intermediate | A substance that is manufacture for and consumed in or used for chemical processing in order to be transformed into another substance (hereinafter referred to as synthesis); |
Manufacturing | Production or extraction of substances in the natural state |
Manufacturer | Any natural or legal person established within the Community who manufactures a substance within the Community |
Non-isolated intermediate | Any 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 substances(s) pass(es) during a continuous flow or batch process as well as the pipe-work for transfer from one vessel to another for the purpose of the next reaction step, but it excludes tanks or other vessels in which the substance(s) are stored after the manufacture |
An Only Representative (OR) | An Only Representative (OR) is a person established within the EU who represents a non-EU manufacturer of a substance that is imported into the EU by one or more importers. The OR must have sufficient background in the practical handling of substances and the information relating to them. |
Phase-in substance | A substance which meets at least one of the following criteria: - It is listed in the European Inventory of Existing Commercial Chemical Substances
- It was manufactured in the Community, or in the countries ascending to the EU on 1st January 1995 or on 1st May 2004, but not placed on the market by the manufacturer or importer at lease once in the 15 years before the entry into force of this Regulation provided the manufacturer or importer has documentary evidence of this.
- It was placed on the market in the Community, or in the countries ascending to the European Union on 1st January 1995 or on 1st May 2004, before entry into force o 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.
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Preparation | A mixture or solution composed of two or more substances |
Producer of an article | Any natural or legal person who makes or assembles an article within the community |
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 |
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 |