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Actor in the supply chain
All manufacturers and/or importers and/or downstream users in a supply chain of a substance.
Any object that has been given a specific shape, surface or design which determines its function to a greater degree than does its chemical composition (e.g. manufactured goods such as cars, batteries, telephones, textiles, electronic chips, furniture, books, toys, kitchen equipment). The same requirements apply to new and used imported articles. For further details see the ECHA overview on articles.
Chemicals (Hazard Information and Packaging for Supply) Regulations 2002, also known as CHIP 3. This is the legislation under which chemicals are classified and labelled.
CAS registry numbers are unique numerical identifiers for chemical compounds, polymers, biological sequences, mixtures and alloys. They are also referred to as CAS numbers, CAS RNs or CAS #s.
Chemical Abstracts Service (CAS), a division of the American Chemical Society, assigns these identifiers to every chemical that has been described in the literature. The intention is to make database searches more convenient, as chemicals often have many names. Almost all molecule databases today allow searching by CAS number.
Chemical Safety Assessment. This should address all the identified uses of a substance on its own (including any major impurities and additives), in a preparation and in an article. The assessment shall consider all stages of the life-cycle of the substance resulting from the manufacture and identified uses. The chemical safety assessment shall be 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.
Chemical Safety Report. A CSR should be completed for all substances subject to registration in quantities of 10 tonnes or more per year per registrant, this is a documentation of the chemical safety assessment (see above).
The authority or authorities or bodies established by the Member States to carry out the obligations arising from the REACH Regulation.
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.
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 (Article 3(13)). A distributor or a consumer is not a downstream user.
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 (Article 3(24)).
EINECS & ELINCS
European Inventory of Existing Chemical Substances, it is a list of all the so called "existing substances." The EINECS number is a registry number given to each chemical substance commercially available in the European Union between 1 January 1971 and 18 September 1981. The inventory was created by Directive 67/548/EEC concerning the labeling of dangerous substances: the EINECS number(s) must appear on the label and the packaging of dangerous substances.
As from 19 September 1981, the inventory has been replaced by the European List of Notified Chemical Substances (ELINCS). All "new" substances brought on to the European market are allocated an ELINCS number after their notification to the European Chemicals Bureau. The ELINCS number is also obligatory on labels and packaging.
And the No-Longer Polymers (NLP): Substances to be included in this list have been on the EU market between September 18, 1981, and October 31, 1993 and satisfy the requirement that they were considered to be polymers under the reporting rules for EINECS but are no longer considered to be polymers under the 7th amendment. Therefore to create the no-longer polymer list industry was asked to submit their candidates. The attached list is based on these submissions.
The term EC number is now preferred to the outmoded "EINECS/ELINCS/NLP number" designations.
The terms EC-No and EC# refer to the seven-digit code (sometimes called the EC number) that has been allocated by the Commission of the European Communities for commercially available chemical substances within the European Union.
The "EC#" designation supersedes the outmoded EINECS and ELINCS designations, and the EC# codes include those on the so-called No-longer Polymers List, a list of substances that were on the European market between 18 September 1981 and 31 October 1993 and at the time were regarded as polymers, but are no longer regarded as such.
Existing Substances Regulations
European Chemicals Agency (ECHA)
The Agency established for the purposes of managing and in some cases carrying out the technical, scientific and administrative aspects of the REACH Regulation and to ensure consistency at Community level in relation to these aspects. The Agency is in Helsinki.
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.
The physical introduction into the customs territory of the Community (Article 3(10)). According to the legal definition of “placing on the market” (Article 3(12)), import is considered to be placing on the market.
Any natural or legal person established within the Community who is responsible for import.(Article 3(11)).
The production or extraction of substances in the natural state (Article 3(8)). It is a case by case decision to establish which steps of the synthesis of the end product lead to substances which need to be registered (e.g. different purification or distillation steps).
Any natural or legal person established within the Community who manufactures a substance within the Community (Article 3(9)).
Natural or legal person
A natural person is an individual person or includes self-employed people, sole traders or people in partnerships. A legal person is not a specific individual but something with a legal personality such as limited companies, trusts, charities etc.
A substance that is manufactured solely for the purpose of being transformed into another substance (or synthesis) and is used up within this reaction. This type of intermediate is not intentionally removed from the synthesising equipment (except for sampling). NOTE: this equipment does not include tanks or other vessels in which the substances is stored after manufacture.
Non Phase-in substance
A new substance, one not covered by the definition of a phase in substance.
Notification of New Substances Regulations.
On-site isolated intermediate
A substance manufactured for or used for chemical processing in order to be transformed into another substance, the synthesis of which takes places on the same site which is operated by one or more legal entities.
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 (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 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.
Placing on the market
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.
A mixture or solution composed of two or more substances (Article 3(2)).
Typical examples of preparations include paints, varnishes, inks. Preparations can contain several substances. Preparations are not the same as multi-constituents substances. The difference between preparation and multi-constituent substance is that a preparation is gained by blending of two or more substances without any chemical reaction occurring, whereas a multi-constituent substance is the result of a chemical reaction. REACH obligations apply individually to each of those substances depending on whether the individual substances are within the scope of REACH. Within the Globally Harmonised System for classification and labelling (GHS), a preparation is named a "mixture".
Product and Process Orientated Research and development (PPORD)
Any scientific development of a product, 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.
The manufacturer or the importer of a substance or the producer or importer of an article submitting a registration for a substance.
Safety Data Sheet
The Safety Data Sheet provides a mechanism for transmitting appropriate safety information on classified substances and preparations, including information from the relevant Chemical Safety Report down the supply chain to the immediate downstream users. The information provided in the Safety Data Sheet shall be consistent with the information in the Chemical Safety Report, where one is required.
Further information on SDSs is available on the ECHA site.
Scientific research and development
Any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than a tonne a year.
Substance Information Exchange Fora. SIEF participants should include all relevant actors submitting information to the Agency on the same substance.
A chemical element and its compounds. The term substance includes both substances obtained by a chemical manufacturing process (for example formaldehyde or methanol) and substances in their natural state. The term substance also includes its additives and impurities where these are part of its manufacturing process, but excludes any solvent which can be separated without affecting the stability of the substance or changing its composition.
For substance identification, the distinction is made between the three following types of substances:
Mono-constituent substances, multi-constituent substances and UVCB substances.
- A mono-constituent substance is a substance, defined by its quantitative composition, in which one main constituent is present to at least 80% (w/w).
- A multi-constituent substance is a substance, defined by its quantitative composition, in which more than one main constituent is present in a concentration ≥ 10% (w/w) and < 80% (w/w). A multi-constituent substance is the result of a chemical reaction in a manufacturing process. A multi-constituent substance is named as a reaction mass of two or more main constituents.
- A UVCB substance (substances of Unknown or Variable composition, Complex reaction products or Biological materials) cannot be sufficiently identified by its chemical composition, because: the number of constituents is relatively large and/or the composition is, to a significant part, unknown and/or the variability of composition is relatively large or poorly predictable. As a consequence, UVCB substances require other types of information for their identification, in addition to what is known about their chemical composition.
The following example is a UVCB as a residue of a specific reaction:
EC number: 293-693-6
EC Name: Soybean meal, protein extn. Residue
EC Description: By-product, containing primarily carbohydrates, produced by an ethanolic extraction of defatted soybean.
Any manufacturer, importer or downstream users or distributor placing on the market a substance, on its own, in a preparation or in an article.
Transported isolated intermediate
A substance manufactured for or used for chemical processing in order to be transformed into another substance, the synthesis of which is transported between or supplied to other sites.
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