Actors in the supply chainmeans all manufacturers and/or importers and/or downstream users in a supply chain;

Agency means the European Chemicals Agency as established by this Regulation;

Alloy means a metallic material, homogenous on a macroscopic scale, consisting of two or more elements so combined that they cannot be readily separated by mechanical means.

Competent authority means the authority or authorities or bodies established by the Member States to carry out the obligations arising from this Regulation;

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;

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.

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 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 means 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 means a use of a substance on its own or in a preparation, or a use of 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;

Intended release of substances Release of substances from products is intended when:

  • the release is essential for the end use function of the product or when the product would not work sufficiently without the release, (e.g. release of ink from felt tip pens, release of detergents from cleaning wipes)
  • the release contributes to a quality or minor function of the product, i.e. the release contributes to an added value of the product, which is not directly connected to the end use
    function, e.g release of perfume from a perfumed eraser or dishwasher tablet {mospagebreak}

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 manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (hereinafter referred to as "synthesis"):

  • 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 pipework 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;
  • 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;
  • transported isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites;

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

Manufacturing means production or extraction of substances in the natural state;

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;

Normal condition of use means the conditions associated with the intended end use function.

Normal conditions of use may be deductible by common sense (imagining someone using the product as it is supposed to be used) or can be derived from user manuals or instructions for use.

Normal conditions of use for products used by industrial or professional users may differ significantly from conditions that are “normal” for consumers. This may particularly be true for the frequency and duration of normal use as well as temperature, air exchange rates or conditions related to water contact.

Recommendations on avoiding specific conditions during normal use or explicitly excluding a certain use may be given by the product producer or importer as part of the instructions for use. Those uses and connected conditions of use are not considered “normal use” if the product producer or importer clearly states this in writing, e.g. in the instructions or on the label of the product.

Examples of the exclusion of specific conditions of use are care labels in textiles “do not wash above 30°C” and warning statements such as “keep out of children's reach” or “do not expose to high temperatures”.{mospagebreak}

Not chemically modified substance means a substance whose chemical structure remains unchanged, even if it has undergone a chemical process or treatment, or a physical mineralogical transformation, for instance to remove impurities;

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;

Per year means per calendar year, unless stated otherwise, for phase-in substances 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 means a substance which meets at least one of the following criteria:

  • it is listed in the European Inventory of Existing Commercial Chemical Substances (EINECS);
  • 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;
  • 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 Product 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 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;

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. A polymer comprises the following:

  • 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;
  • 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;{mospagebreak}

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

Producer of a product means any natural or legal person who makes or assembles an product within the Community;

Product and process orientated research and development means any scientific development related to product development or the further development of a substance, on its own, in preparations or in products 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;

Product 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;

Reasonably foreseeable conditions of use means conditions of use outside the use originally intended by the product producer (normal use) but which may be foreseen because of the form, shape or function of that product .
The following conditions are considered reasonably foreseeable:

  • “Accidents” of high likelihood, e.g. breakage of a fragile container releasing all of the content (wording is dependent on the product definition). These are to be considered as worst-case situations.
  • Uses not in accordance with the function but which can be anticipated because function and appearance of the product also suggests other uses than the intended ones
  • Extremely intensive use (e.g. ‘a consumer' working with a tool 12 hours a day for three months when building his own house)
    Excluded from reasonably foreseeable conditions in situations of professional and industrial uses are:
  • Uses, which are clearly and noticeably excluded by the product producer or importer. These uses are to be regarded as use deliberately against the intention
  • Uses, which have been clearly advised to be avoided by means of product design or warning labels 
  • Clear misuse. Children are a good example to illustrate how reasonably foreseeable conditions of use can be identified: It is commonly known that children do not always know the function of an product but still use it for any of their purposes and in a way that suits them best. Especially small children put any-thing into their mouth or, if the object is too big, bite it or lick it.
    Therefore, when defining conditions of reasonable foreseeable uses of an product, children's access to the product should be assessed.

The assessment of reasonably foreseeable conditions of use for products solely used by industrial or professional users can mainly focus on evaluating the likelihood of breakage/accidents as uses not foreseen by the product function can normally (but not al-ways) be excluded.

The assessment of reasonably foreseeable conditions of ‘use' should be targeted only to those situations where an increased exposure or an exposure via different pathways (inhalation, dermal contact or ingestion) as compared to the normal conditions of use occurs.{mospagebreak}

Recipient of a product : means an industrial or professional user, or a distributor, being supplied with an product but does not include consumers;

Recipient of a substance or a preparation : means a downstream user or a distributor being supplied with a substance or a preparation;

Registrant means the manufacturer or the importer of a substance or the producer or importer of an product submitting a registration for a substance;

Registrant's own use means an industrial or professional use by the registrant;

Restriction means any condition for or prohibition of the manufacture, use or placing on the market;

Robust study summary means 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;

Scientific research and development means any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than 1 t per year;

Site means a single location, in which, if there is more than one manufacturer of (a) substance(s), certain infrastructure and facilities are shared;

SME means small and medium-sized enterprises as defined in the Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises1;

Study summary means 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 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;

Substances of Very High Concern CMR 1&2, PBTs, vPvBs:

  • Substances meeting the criteria for classification as carcinogenic category 1or 2
  • Substances meeting the criteria for classification as mutagenic category 1 or 2
  • Substances meeting the criteria for classification as toxic for reproduction category 1 or 2
  • Substances which are persistent, bioaccumulative and toxic
  • Substances which are very persistent and very bioaccumulative
  • Substances having endocrine disrupting properties
  • Current existing detailed lists from Directive 67/548/EEC and other EU legislations can be used as an interim /start base till EU commission has published candidates list and later develops final list.

Substances which occur in nature means a naturally occurring substance as such, unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water, or which is extracted from air by any means;

Supplier of a product means any producer or importer of an product, distributor or other actor in the supply chain placing an product on the market;

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;

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;

Use means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an product or any other utilisation.