Glossary & Official Texts
Glossary and Official Texts
Use the links below to find official texts and detailed information. To understand the REACH jargon, use the glossary of most REACH terms, both official and not and even non-existing terms. The many REACH acronyms are also listed.
Learn more: • Useful links • Official REACH terms and definitions • Non-Existing REACH Terms • Acronyms_______________________________________________________________________________________________________________________________________ The Glossary has to a large extent been taken from the Automotive Industry’s Guideline on REACH (Version 2.0, January 2008). Thanks are due to the authors of that guideline. _______________________________________________________________________________________________________________________________________
For official texts and detailed information: • ECHA (European Chemicals Agency) • REACH Official text (Choose ‘Consolidated Version’) • REACH Annex IV and V (Specific exemptions) • REACH Guidance to Annex V • Technical Guidance Documents
• ESIS (EU database with substance information) • ECHA Fees regulation • CLP regulation (Classification, Labelling and packaging) • ORO (Only Representatives Organisation) • ECHA’s REACH FAQ’s • National REACH Helpdesks
Actors in the supply chain: means “all manufacturers and/or importers and/or downstream users in a supply chain” (Article 3.17 REACH). Agency: means “the European Chemicals Agency as established by this Regulation” (Article 3.18 REACH). 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” (Article 3.3 REACH). For more detail see technical Guidance Document on Substances in Articles. Downloadable from the ECHA web site Candidate list: List of substances of very high concern for potential inclusion in Annex XIV REACH, which itself lists substances subject to authorisation (Article 59 REACH). The establishment of the candidate list is subject to specific procedures described in Article 59 REACH. Certificate of REACH Compliance: Document issued by a supplier or REACH Service Provider certifying REACH compliance for a certain product or producer. Demanded by purchasers of products or customs authorities in some EU Member States. Competent authority: means “the authority or authorities or bodies established by the Member States to carry out the obligations arising from this Regulation” (Article 3.19 REACH). 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” (Article 3.14 REACH) 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” (Article 3.13 REACH). Exposure scenario: means “the set of conditions, including operational conditions and risk management measures, that describe how the substance is manufactured or used during its lifecycle 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” (Article 3.37 REACH). First-time Manufacturer or Importer: is a Manufacturer or Importer who manufactures or imports a substance in quantities of 1 tonne or more for the first time after 1 December 2008 (The original pre-registration deadline). Identified use: means “a use of a substance on its own or in a preparation, 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” (Article 3.26 REACH). Import: means “the physical introduction into the customs territory of the Community” (Article 3.10 REACH). Please note: The customs territory of the Community includes its airspace and territorial waters. Importer: means “any natural or legal person established within the Community who is responsible for import” (Article 3.11 REACH). Please note: It is not always clear who exactly is the importer. Guidance does not exist. It is often wise to appoint in writing the first EU based legal owner of the imported goods as the importer under REACH Intended to be released under normal or reasonably foreseeable conditions of use: means “that the release is essential for the sufficient function of the article” (without the release the article would not work properly) Intermediate: means “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"): Article 3.15 REACH: (a) non-isolated intermediate: means 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 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; (b) on-site isolated intermediate: means 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: means an intermediate not meeting the criteria of a non isolated intermediate and transported between or supplied to other sites Manufacture or import for the first time: means the manufacture or import for the first time after the entry into force of REACH. Manufacturer: means “any natural or legal person established within the Community who manufactures a substance within the Community” (Article 3.9 REACH) Manufacturing: means “production or extraction of substances in the natural state” (Article 3.8.REACH) 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” (Article 3.6.REACH) Mixture: means “a mixture or solution composed of two or more substances” (Article 3.2 REACH), No Longer Polymers: Some substances which were considered to be polymers under the reporting rules when the EINECS was being established are no longer considered to be polymers, due to a revised definition of "polymer" within directive 92/32/EEC. More detailed information and the No-Longer Polymers List can be found on the ECHA website Non phase-in substance: means “a substance which does not meet the criteria of phase-in substance” (defined above), that is, a substance which was not manufactured or marketed or put on the market prior to the entry into force of REACH. Notified substance: means “a substance for which a notification has been submitted and which could be placed on the market in accordance with Directive 67/548/EEC” (Article 3.21 REACH).
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 (Article 3.20 REACH). Placing on the market: means “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 (Article 3.12 REACH). Preparation: Old REACH Term. Now replaced by ‘Mixture’, See there. Producer of an article: means “any natural or legal person who makes or assembles an article within the Community” (Article 3.4 REACH). 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”. (Article 3.5. REACH) 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; Product and process orientated research and development (PPORD): means “any scientific development related to product development or the further development of a substance, on its own, in preparations or in articles in the course of which pilot plant or production trials are used to develop the production process and/or to test the fields of application of the substance” (Article 3.22 REACH). REACH: Registration Evaluation and Authorisation of Chemicals. The popular name for Regulation No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals Recipient of an article: means “an industrial or professional user, or a distributor, being supplied with an article but does not include consumers” (Article 3.34 REACH). Re-import: Import of a substance on its own or in a preparation that was manufactured and registered in EU/EEA. Re-imported substances do not need to be registered again. Registrant: means “the manufacturer or the importer of a substance or the producer or importer of an article submitting a registration for a substance” (Article 3.7.REACH). Registrant's own use: means “an industrial or professional use by the registrant” (Article 3.25 REACH). Scientific research and development: means “any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than 1 tonne per year“ (Article 3.23 REACH). Site: means “a single location, in which, if there is more than one manufacturer of (a) substance(s), certain infrastructure and facilities are shared” (Article 3.16 REACH) 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” (Article 3.1 REACH), Substance ID: The description of a substance, including the possible ranges of impurities that determined the validity of the registration dossier. Substances of very high concern (SVHC): the following substances are considered as of very high concern according to Article 57 REACH: (a) Substances meeting the criteria for classification as carcinogenic, mutagenic, toxic for reproduction according to Directive 67/547/EEC (“CMR-substances”) category 1 or 2. (b) Substances which are persistent, bioaccumulative and toxic according to Annex XIII REACH (“PBT-substances”). (c) Substances which are very persistent and very bioaccumulative according to Annex XIII REACH (“vPvB-substances”). (d) Substances which have endocrine disrupting, persistent, bioaccumulative and toxic or very persistent and very bioaccumulative properties, which give rise to an equivalent level of concern to those of other substances listed in points (a-c) and which are identified on a case-by-case basis in accordance with the procedures set out in Article 59 REACH. Sunset date: means “the date(s) from which the placing on the market or the use of the substance shall be prohibited unless an authorisation is granted which should take into account, where appropriate, the production cycle specified for that use” (Article 58.1 REACH). Supplier of a substance or a preparation: means “any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a preparation, or a preparation” (Article 3.32 REACH). Supplier of an article: means “any producer or importer of an article, distributor or other actor in the supply chain placing an article on the market” (Article 3.33 REACH). 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 utilization” (Article 3.24 REACH). Use and exposure category: means “an exposure scenario covering a wide range of processes or uses, where the processes or uses are communicated, as a minimum, in terms of the brief general description of use” (Article 3.38 REACH).
These terms are found to be used as Internet search words, but have no unambiguous meaning. Possible alternatives search terms are provided. REACH Data pads: try ‘REACH Lists’ REACH Directive: The incorrect name sometimes given to the REACH Regulation. (Before it applies, an EU Directive must first be transposed into national legislation, whereas a Regulation applies directly)
REACH Letter: try ‘Certificate of REACH Compliance’ REACH Report: try ‘Registration’ REACH Statement: try ‘Certificate of REACH Compliance’
CAS: Chemical Abstracts Service. The CAS number is a means to identify the substance. CMR: Carcinogenic, Mutagenic, Toxic for Reproduction CSR: Chemical Safety Report DU: Downstream User ECHA: European Chemical Agency. ECHA has a very comprehensive web site regarding REACH: http://echa.europa.eu/ EEA: EU 27 plus Norway, Iceland and Liechtenstein. Switzerland is not a member of EEA. EINECS: European Inventory of Existing Commercial Chemical Substances that is the list of substances on the EC market between 1 January 1971 and 18 September 1981. The EINECS list can be consulted at http://esis.jrc.ec.europa.eu. ELINCS: European List of Notified Chemical Substances, that is, the list of substances marketed as of 18 September 1981 and notified under Directive 67/548/EEC. The ELINCS list can be consulted at http://esis.jrc.ec.europa.eu. The substances listed in ELINCS are regarded as registered (see also Article 24 REACH). GHS: Globally Harmonized System for classification and labelling of chemicals. http://ec.europa.eu/enterprise/reach/ IUCLID: International Uniform Chemical Information Database
NGO: Non Governmental Organisation OSOR: One Substance, One Registration PBT: Persistent, Bio-accumulative and Toxic. PPORD: Product and Process Oriented Research and Development PRTR: Pollution Release and Transfer Register (Q)SAR : Qualitative or Quantitative structure-activity relationship; Results obtained from valid (Q)SARs may indicate the presence or absence of a certain dangerous property. Results of (Q)SARs may be used instead of testing when certain conditions are met. REACH: Registration, Evaluation, Authorisation (and Restriction) of Chemicals. Read-across approach: Information on intrinsic properties of substances may be generated by means other than tests, in particular from information from structurally related substances. RMM: Risk Management Measures. Instructions for safe storage, handling and use that will appear in new Safety Data Sheets SDS: Safety Data Sheet SIEF: Substance Information Exchange Forum SVHC: Substance of Very High Concern. TGD: Technical Guidance Document. TGD’s may be downloaded from the ECHA web site: http://echa.europa.eu/ vPvB: very Persistent and very Bioaccumulative