Actor in the supply chain
All manufacturers and/or importers and/or downstream users in a supply chain of a substance.
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. Examples of articles are a car, a battery and a telephone.
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.
Chemical Safety Assessment. This is carried out for all registered substances manufactured or imported at 10 tonnes per year or greater. It 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 and 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. A distributor or a consumer is not a downstream user.
European Inventory of Existing Commercial Chemical Substances, it is a list of all the so called “existing substances”
Existing Substances Regulation. This is one of the pieces of EU legislation replaced by REACH.
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, Finland.
The set of conditions, including operational conditions and risk management measures, that describe how a 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.
Any natural or legal person established within the Community who is responsible for import.
The production or extraction of substance in the natural state.
Any natural or legal person established within the community who manufactures a substance within the Community.
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.
'No Longer Polymers' are a group of substances that were once considered to be polymers (and so not listed on EINECS) and were also not notified under the original (6th Amendment) NONS legislation. The introduction of a new polymer definition in 1993 led to these substances losing their polymer status, however they remained exempt from notification under NONS. To qualify as a NLP a substance must have been on the market between September 18th 1981 and October 31st 1993 (inclusive) and satisfy the requirement that they were considered polymers under the reporting rules for EINECS, but were no longer considered polymers under the 7th Amendment (92/32/EEC).
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. This is one of the pieces of EU legislation replaced by REACH.
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.
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.
(Quantitative) Structure Activity Relationships are computer based models which are designed to predict the physico-chemical properties, human health and environmental effects of a substance from knowledge of its chemical structure. Some models are qualitative and give an indication of a likely effect rather than try to quantify that effect.
Read-across is a method of filling in data gaps for a substance by using surrogate data from another substance. Read-across can be between two substances or through a group or category of chemicals. The groups are selected on the assumption that the properties of a series of chemicals with common structural features will show similar trends in their physico-chemical properties and in their toxicological effects or environmental fate properties.
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.
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 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.
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.