REACH: Short and Simple

Date specified in Annex XIV of the REACH Regulation for each substance from which the placing on the market and the use of that substance shall be prohibited unless an exemption applies or an authorisation is granted, or an authorisation application has been submitted before the application date also specified in Annex XIV, but the Commission decision on the application for authorisation has not yet been taken.

Annex XIV of the REACH Regulation lists all substances which are subject to authorisation under REACH. The use and placing on the market for a use of substances listed in Annex XIV is prohibited from the ‘sunset’ date unless an authorisation has been granted for that use or an exemption applies

Annex XVII of the REACH Regulation lists all restricted substances and the conditions of their restrictions under REACH.

Federal Institute for Occupational Safety and Health in Germany. (= Bundesanstalt für Arbeitsschutz und Arbeitsmedizin).

Any condition for or prohibition of the manufacture, use or placing on the market of a substance. The restrictions established under REACH are included in Annex XVII of the REACH Regulation, which will define the scope and conditions of the restriction

Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (REACH). It came into force on 20 January 2009 and applies across the European Union

Substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction category 1 or 2, in accordance with Directive 67/548/EEC, are substances of very high concern2. They may be included in Annex XIV and by that made subject to authorisation requirement. CMRs may be non-threshold (i.e. it is not possible to define a Derived No-Effect Level (DNEL)) or threshold (i.e. it is possible to define a DNEL).

Agency established by Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 to manage all REACH and CLP tasks by carrying out or co-coordinating the necessary activities, to ensure a consistent implementation at Community level, and to provide Member States and the European institutions with the best possible scientific advice on questions related to the safety and the socio-economic aspects of the use of chemicals. This is achieved by ensuring a credible decision-making process, using the best possible scientific, technical and regulatory capacities and by working independently in an efficient, transparent and consistent manner.

European Database of Export and Import of Dangerous Chemicals. Database which was created by the European commission in order to to implement Council Regulation (EC) 689/2008.

Process in which a given substance or preparation is assigned one of the 15 categories of danger depending on their intrinsic properties in accordance with the criteria specified in Directive 67/548/EEC. If the substance is not found to be dangerous, according to the said criteria, then it is not classified. Under GHS the substance or preparation will be assigned to hazard classes.

An object which during production is given a specific shape, surface or design which determines its function to a greater degree than does its chemical composition.

extended Safety Data Sheet with exposure scenarios.

Member State Committee
A European Chemicals Agency committee responsible for resolving potential divergences of opinion on draft decisions proposed by the Agency or the Member States under the evaluation procedures (Title VI) and proposals for identification of substances of very high concern to be subjected to the authorisation procedure. The MSC consists of one representative appointed by each Member State for a renewable term of three years. The Committee members may be accompanied by advisers on scientific, technical or regulatory matters.

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.

Persistent, bioaccumulative and toxic.
Annex XIII of the REACH Regulation defines criteria for the identification of substances that are Persistent, Bio-accumulative and Toxic (PBTs) and Annex I lays down general provisions for PBT assessment. PBTs are substances of very high concern (SVHC) and may be included in Annex XIV and by that be made subject to authorisation.

Quantitative structure-activity relationship
The relationship between the physical and\or chemical properties of a substance and their ability to cause a particular effect. The goal of QSAR studies in toxicology is to develop whereby the toxicity of a substance can be predicted from its chemical structure by analogy with the properties of other toxic substances of known structure and toxic properties. In practice, QSARs are mathematical models used to predict the properties of substances from their molecular structure.

REACH is a new European Community Regulation on chemicals and their safe use (EC 1907/2006). It deals with the Registration, Evaluation, Authorisation and Restriction of Chemical substances. The new law entered into force on 1 June 2007.
The aim of REACH is to improve the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances. At the same time, innovative capability and competitiveness of the EU chemicals industry should be enhanced. The benefits of the REACH system will come gradually, as more and more substances are phased into REACH.

The submission to the European Chemicals Agency of a technical dossier and, if required, a chemical safety report for a substance being manufactured in or imported into the European Union (and in the European Economic Area (EEA) once implemented in these countries).

The Rotterdam Convention (formally, the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade) is a multilateral treaty to promote shared responsibilities in relation to importation of hazardous chemicals

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.

Substance of very high concern.
In the context of the REACH Regulation are:
1. CMRs category 1 or 2;
2. PBTs and vPvBs meeting the criteria of Annex XIII; and
3. substances – such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of Annex III – for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points 1 and 2 and which are identified on a case-by-case basis in accordance with the procedure set out in Article 59.

After entry into force of REACH, manufacturing and import of substances in quantities > 1 tonne per year can only take place if the substance is registered. However, for substances already on the market (so-called ‘phase-in substances’) a transitional arrangement exists, provided the manufacturer or importer pre-registered their substances between 1 June 2008 and 1 December 2008. Pre-registration allows companies to continue manufacturing and importing their phase-in substances for several years until the registration deadline is reached. A pre-registrant will have to submit a pre-registration dossier to the Agency containing data on the name of the substance, contact details of the pre-registrant, envisaged deadline for registration and tonnage band and name of substances for read-across, grouping or QSAR.

A mixture or solution composed oft wo or more substances

System set up under the REACH Regulation under which the use of substances with properties of very high concern and their placing on the market can be made subject to an authorisation requirement. Such substances are included in Annex XIV of the Regulation, and may not be placed on the market or used without an authorisation after the sunset date. This authorisation requirement ensures that risks from the use of such substances are either adequately controlled or outweighed by socio-economic benefits. An analysis of alternative substances or technologies will be a fundamental component of the authorisation process.