Glossary

The Glossary provides an overview of the key terminology with relevance for the metals industry used in the context of REACH.

 

 

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


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).


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.


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; it is a list of chemicals that have been placed on the European market since September 18, 1981. More than 4500 substances have been notified since then.


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.


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.
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


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.


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).
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).


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.

 


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. Guidance from the Agency to follow.

 


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 guidance and IT tools for implementing REACH. The projects are intended to assist the Agency, industry and Member States’ authorities.

 

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).

 

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

 

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.”

 

SIEF: Substance Information Exchange Forum; 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.

 

Site: 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.

 

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.

 

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.

 

vPvB: Very persistent and very bioaccumulative.