The European Chemicals Agency as established by the REACH Regulation (EC/1907/2006)

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)

Biocides are defined in Article 2 (1) of the Biocidal Products Directive (98/8/EC) as:
"Active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means."

Note, however, that many substances or preparations which meet this definition are excluded from the Biocidal Products Directive on the basis of being covered by other legislation such as the Plant Protection Products Directive (91/414/EEC) and many other Directives relating to veterinary medicines, proprietary medicinal products etc. Therefore, for a complete definition of a biocidal products you should consult the Biocidal Products Directive and its associated guidance.

In general terms, the scope of the BPD is very wide, covering 23 different product types. This includes disinfectants for home and industrial use; preservatives for manufactured and natural products; non-agricultural pesticides for use against insects, rodents and other vertebrates and specialised products such as embalming/taxidermist fluids and antifouling products. A full list of product types is in Annex V of the BPD.

Under Article 15 (2) of the REACH Regulation, active substances which are regulated as biocides are regarded as being already registered under REACH

Carcinogenic, mutagenic or toxic to reproduction

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)

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)

The dossier evaluation performed by the Agency to assess testing proposals made by the registrant or to check that the registration dossiers comply with the requirements to ensure no unnecessary animal testing takes place

Within the REACH regulation, the term evaluation is used in relation to several key processes in the registration process, including:
- The Agency's examination of testing proposals for further testing of a substance in accordance with the information requirements for substances manufactured or imported in quantities of 100 tonnes or more
- The Agency's examination of technical dossiers submitted for substance registration to verify that the information requirements have been met and that any adaptations to these requirements are appropriate
- Evaluation of a substance by a Member State
- Evaluation of an intermediate by a Member State

The Agency will co-ordinate substance evaluation, which will be conducted by the Member States to investigate chemicals of concern

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 (Article 3.27)

Any natural or legal person established within the Community who is responsible for import (Article 3.11)

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):
 (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 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;
 (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; and

(c)  transported isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites

Any natural or legal person established within the Community who manufactures a substance within the Community (Article 3.9)

Means production or extraction of substances in the natural state (Article 3.8)

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)

The submission of specific information to the Agency in accordance with a legislative requirement. The REACH Regulation requires actors in the supply chain (manufacturers, importers, downstream users) to submit the following types of notifications, under certain circumstances:

• Notification of a substance in an article
• Notification of classification and labelling
• Notification of substances for the purposes of product and process orientated research and development
• Notification of restart of use by downstream user

Further information on notification obligations can be found in the relevant guidance document.
Notification may also refer to substances notified under Directive 67/548/EEC

A natural or legal person established outside the Community who manufactures a substance on its own, in preparations or in articles, formulates a preparation or produces an articles imported into the Community may by mutual agreement appoint a natural or legal person established in the Community to fulfil, as his only representative, the obligations on importers regarding the registration of substances. The representative shall also comply with all other obligations of importers under the Regulation
The non-Community exporter must inform the importer(s) within the same supply chain of the appointment. These importers are regarded as downstream users to the only representative for the purposes of Registration (Article 8)

Persistent, bioaccumulative and toxic

Substances of very high concern that are Persistent (difficult to break down), Bio-accumulative in living organisms and Toxic. Annex XIII defines criteria for the identification of PBTs and Annex I lays down general provisions for PBT assessment. PBTs may be included in Annex XIV and by that be made subject to authorisation requirements

A substance which meets at least one of the following criteria (Article 3.20):
(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 REACH 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 the REACH Regulation (EC/1907/2006), provided the manufacturer or importer has documentary evidence of this 

Plant Protection Products are defined in Article 2 of the Plant Protection Products Directive (91/414/EEC) as:
"Active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to:
1) protect plants or plant products against all harmful organisms or prevent the action of such organisms, in so far as such substances or preparations are not otherwise defined below;
2) influence the life processes of plants, other than as a nutrient, (e.g. growth regulators);
3) preserve plant products, in so far as such substances or products are not subject to special Council of Commission provisions on preservatives;
4) destroy undesired plants; or
5) destroy parts of plants, check or prevent undesired growth of plants."
Under Article 15 (1) of the REACH Regulation, active substances which are used and regulated as Plant Protection Products are regarded as being already registered under REACH.
Other uses are not exempted from REACH registration

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 compromises the following (Article 3.5):
(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.

Polymers are currently outside the scope of REACH

A mixture or solution composed of two or more substances (Article 3.2)

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 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)

Registration is the submission to the Agency of a technical dossier and, if required, a chemical safety report for a substance being manufactured in or imported into the European Economic Area (EEA)

Manufacturers or Importers of substances on their own or in preparations or Producers or importers of articles will have in certain circumstances to provide a registration dossier to the European Chemicals Agency according to Articles 10, 11, 12, 17 and 18. It consists of a technical dossier and, when required, a Chemical Safety Report. Annexes VI to XI set out the minimum requirements for information on the substance to be registered

Any condition for or prohibition of the manufacture, use or placing on the market (Article 3.31)

Small and medium-sized enterprise: An enterprise that employs < 250 people which has either a turnover of ≤ €50 million or a balance sheet total of ≤ €43 million (Commission Recommendation of 6 May 2003)

any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than 1 tonne per year (Article 3.23)

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)

SIEF stands for Substance Information Exchange Forum. SIEF is a forum, formed after the pre-registration phase, to share data and other information on a given phase-in substance. Participants of a SIEF are potential registrants having pre-registered, early registrants and data holders. Data holders can be a natural or legal entity holding data for the phase-in substance like downstream users, manufacturers or importers of < 1 tonne/year or reserach organizations.
The principal aims of a SIEF are to:
 i) facilitate data sharing for the purposes of registration;
 ii) agree on the classification and labelling of the substance where there is a difference between the the potential registrants

SVHC for the purposes of the REACH Regulation are:
1. CMRs category 1 or 2;
2. PBTs and vPvBs meeting the criteria of Annex XIII; and
3. substances which give raise to equivalent level of concern as the above such as those having endocrine disrupting properties or those having PBT or vPvB properties, which do not fulfil the criteria CMRs PBTs or vPvBs - for which there is scientific evidence of probable serious effects to human health or the environment and which are identified on a case-by-case basis in accordance with the procedure set out in Article 59

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)

Substances of very high concern, which are very persistent (very difficult to break down) and very bio-accumulative in living organisms. vPvBs may be included in Annex XIV and by that be made subject to authorisation requirements. Annex XIII defines criteria for the identification of vPvBs and Annex I lays down general provisions for their assessment..