Definitions and Terms

Definitions | Abbreviations

Some definitions associated with REACH are provided below.

Actors in the supply chain: means all manufacturers and/or importers and/or downstream users in a supply chain.

Agency: means the European Chemicals Agency ECHA as established by the Regulation;

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;

Competent Authority: The authority or authorities or bodies established by the Member States to carry out their obligations arising from this Regulation;

Downstream user: means 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;

Distributor: means 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;

Exposure Scenario: (ES) means 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: means the physical introduction into the customs territory of the Community;

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

Intermediate: means 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: means production or extraction of substances in the natural state;

Manufacturer: means any natural or legal person established within the Community who manufactures a substance within the Community;

Non-isolated intermediate: means 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

Phase-in substances: means a substance which meets at least one of the following criteria:

1. It is listed in the European Inventory of Existing Commercial Chemical Substances
2. 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.
3. 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.

Preparation: means a mixture or solution composed of two or more substances;

Producer of an article: means any natural or legal person who makes or assembles an article within the community

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;

Use: means 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.

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Abbreviations

• CAS number - the Chemicals Abstracts Service number for a chemical
• CSA- Chemical Safety Assessment
• CMR - Carcinogens, Mutagens, Toxic to Reproduction
• EINECS - the European Inventory of Existing Commercial Chemical Substances and is a list of all chemical substances on the EU market up to 1981
• ELINICS -  the European List of Notified Chemical Substances and is a list of substances which have been notified in the EU in accordance with Directive 67/548/EEC
• GHS: Globally Harmonised System for classification and labelling of chemicals, agreed under the auspices of the United Nations
• PBT -Persistent, Bioaccumlative and Toxic
• POPs- Persistent (difficult to break down) organic pollutants, banned under UNEP‘s Stockholm Convention
• PPORD-Product and process orientated research and development: Substances used in PPORD will have time limited exemptions from testing requirements
• SIEF Substance Exchange Information Forum
• SMEs: Small and medium sized enterprises. A definition of SME is contained in Commission Recommendation 2003/361/EC: "The category of micro, small and medium-sized enterprises (SMEs) is made up of enterprises which employ fewer than 250 persons and which have an annual turnover not exceeding EUR 50 million, and/or an annual balance sheet total not exceeding EUR 43 million."
• SvHC - substances of very high concern
• vPvB - very persistent and very bioaccumulative (vPvBs)