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REACH definitions

Below, you will find the key terms used in the REACH Regulation with a brief definition, taken from the different parts of the REACH legislation:

 

Annex I of Directive 67/548/EEC:

Annex I of Directive 67/548/EEC contains a list of harmonised classifications and labellings for substances or groups of substances, which are legally binding within the EU.
The list is regularly updated through Adaptations to Technical Progress. Revised and new classifications inserted into the list are put forward by DG ENV and agreed by a Member State vote.
The DG ENV proposal is based on advice from the Commission Working Group on Classification and Labelling with the participation of experts from Member States. Their meetings are prepared, chaired and followed-up by the ECB.

 

Annex XIV:

Annex XIV of REACH lists all substances which are subject to authorisation under REACH.

 

Annex XV:

Annex XV of the REACH Regulation lays down general principles for preparing Annex XV dossiers to propose and justify
(a) harmonised classification and labelling of CMRs, respiratory sensitisers and other effects
(b) the identification of a substance as a CMR, PBT, vPvB or a substance of equivalent concern
(c) restrictions on the manufacture, sale or use of a substance within the Community.
Proposals for restrictions and identification of substances of very high concern can be prepared by a Member State Competent Authority or by ECHA on a request from the Commission. Proposals for harmonised classification and labelling can be prepared by a Member State Competent Authority.

 

Annex XV dossier:

A dossier produced in accordance with Annex XV.
The dossier consists of two parts, an Annex XV technical dossier and the Annex XV report.

 

Article:

An article 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.

 

Authorisation:

The REACH Regulation sets up a system under which the use and sale of substances with properties of very high concern can be made subject to an authorisation requirement. This authorisation requirement ensures that risks from the use of such substances are either adequately controlled or outweighed by socio-economic benefits, having taken into account the available information about alternative substances or technologies. Substances requiring authorisation will be included in Annex XIV of the Regulation.

 

Chemical Safety Assessment (CSA):

A Chemical Safety Assessment is the process to determine the risk posed by a substance and which, as part of the exposure assessment, develops exposure scenarios including risk management measures. Annex I contains general provisions for performing a CSA. A CSA consists of the following steps:
- Human health hazard assessment
- Human health hazard assessment of physicochemical properties
- Environmental hazard assessment
- PBT and vPvB assessment
If, as a result of this hazard assessment, the registrant concludes that a substance meets the criteria for classification as dangerous according to Directive 67/548/EEC (for substances), or that it has PBT/vPvB properties, this triggers further steps in the CSA:
- Exposure assessment
- Risk characterisation.

 

Chemical Safety Report (CSR):

A Chemical Safety Report documents the Chemical Safety Assessment for a substance on its own, in a preparation or in an article or a group of substances.
In other words, a CSR is a document which details the process and results of a CSA. Annex I of the REACH Regulation contains general provisions for performing CSAs and preparing CSRs.

 

Classification:

Classification is the process via which a given substance or preparation is assigned to one of the 15 categories of danger, depending on its intrinsic properties, in accordance with the criteria specified in Directive 67/548/EEC. If, according to these criteria, the substance is not found to be dangerous, then it is not classified. Under the GHS (Globally Harmonised System), the substance or preparation will be assigned to the relevant class.

 

CMR:

Carcinogenic, Mutagenic or toxic to Reproduction.
This is a substance of very high concern that is carcinogenic (causes cancer), mutagenic (causes damage to genes) or toxic to reproduction (causes either a decrease in fertility or problems with foetal development).

 

Distributor:

Any natural or legal person established within the Community, including a retailer, who only stores and sells a substance, either on its own or in a preparation, for third parties.

 

Downstream user: 

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 their industrial or professional activities. A distributor or a consumer is not a downstream user.

 

Evaluation:

There are three types of evaluation within REACH:
- Dossier evaluation performed by the ECHA.
- Compliance check: to examine whether all the required information is included in the registration dossier and whether this information is adequate.
- Checking testing proposals: to evaluate whether the testing proposals submitted in the registration dossier by the registrant are adequate, or whether further testing is necessary for information specified in Annex IX and X of the Regulation.

- Substance evaluation performed by a Member State: to clarify any grounds for considering that a substance constitutes a risk to human health or the environment
Member States can also evaluate registered intermediates.

 

Existing chemicals:

These are chemicals that were reported to be on sale in 1981, when the requirement to notify new chemicals came into force. There are about 100,000 existing chemicals. According to estimates, some 30,000 of them will need to be registered under REACH.

 

Exposure assessment:

The aim of exposure assessment is to make a quantitative or qualitative estimate of the dose / concentration of a substance to which humans and the environment are, or may be, exposed. Exposure assessment under REACH consists of two steps. The first is the development of exposure scenarios. The second is exposure estimation. These have to be repeated until it can be concluded that the resulting exposure scenarios would ensure adequate control of risks upon implementation.

 

Exposure scenario:

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 a manufacturer or importer controls, or recommends that downstream users control, its exposure to humans and the environment. These exposure scenarios may cover one specific process or use or several processes or uses as appropriate.

 

Identified use:

Use of a substance on its own or in a preparation, or use of a preparation, that is intended by a player in the supply chain, including his own use, or that is made known to him in writing by an immediate downstream user.

 

Importer:

Any natural or legal person established within the Community who is responsible for importing.

 

Information requirement:

Information requirements refer to the information needed in a registration dossier (see article 10 and Annexes VI to XI). These include information about the inherent properties of the substance, as well as some information about its manufacture, use and exposure.

 

Intermediate:

A substance that is manufactured for, and consumed in or used for, chemical processing in order to be transformed into another substance.

 

IUCLID:

International Uniform Chemical Information Database.
This is the basic data collection and evaluation tool within the framework of the European Risk Assessment Programme on Existing Substances.

 

Manufacturer:

Any natural or legal person established within the Community who manufactures a substance within the Community.

 

Manufacturing:

The production or extraction of substances in their natural state.

 

New chemicals:

Chemicals that have been placed on sale since 1981. These have to be notified to the Competent Authorities under the current EU chemical legislation. There are around 3,400 'new' chemicals currently on the market.

 

Notified substance:

A substance for which a notification has been submitted and which could be sold in accordance with Directive 67/548/EEC. Notified substances were also previously called 'new substances'.

 

PBT:

Persistent Bioaccumulative and Toxic.
PBT pollutants are toxic chemicals which persist in the environment and bioaccumulate in food chains, and thus pose risks to human health and ecosystems. The biggest worries about PBTs are that they transfer relatively easily through air, water and land, and that they are not restrained by programmes, geography and generations.

 

Phase-in substance:

This is a substance which is already available in the EU.

 

Preparation:

A mixture or solution composed of two or more substances.

 

Pre-registration:

After REACH comes into force, the manufacture and import of substances in quantities > 1 tonne per year can only take place if the substance is registered. However, a transitional arrangement exists for substances already available (known as phase-in substances), provided that the manufacturer or importer pre-registers 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 ECHA containing data about the name of the substance, contact details of the pre-registrant, the envisaged deadline for registration, and the tonnage band and name of the substances for read-across, grouping or QSAR.

 

Producer of an article:

Any natural or legal person who makes or assembles an article within the Community.

 

QSAR:

Quantitative Structure Activity Relationship.

 

Registrant:

The manufacturer or importer of a substance or an article submitting a registration for a substance.

 

Registration:

Registration is the submission of a technical dossier to the ECHA and, if required, a Chemical Safety Report for a substance being manufactured in, or imported into, the EU.

 

Registration dossier:

Manufacturers or importers of substances on their own or in preparations, or producers or importers of articles will, in certain circumstances, have to provide a registration dossier to the ECHA. This consists of a technical dossier and, when required, a Chemical Safety Report.

 

Safety Data Sheet (SDS):

The Safety Data Sheet is the main tool used in industry for communicating information about the hazards of dangerous substances and preparations through the supply chain. Annex II of REACH is based on the Annex to the Safety Data Sheet Directive (91/155/EEC) and explains what information should be included under each of the 16 Safety Data Sheet headings.

 

SIEF:

Substance Information Exchange Forum.

 

Substance:

A chemical element and its compounds, either in its 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 in articles:

Hazardous substances that are released from articles as part of their function will generally have to be registered. If the release is not intentional, the substances may have to be notified.

 

Technical dossier:

The primary meaning of the term under REACH is documentation, which contains all the information required for registration, as specified in Article 10(a). The format of the technical dossier is IUCLID.
In addition, the term technical dossier is also used to refer to one of the two parts of the Annex XV dossier. It supports the Annex XV report.

 

vPvB:

Very Persistent and very Bioaccumulative.
Substances of very high concern that are very persistent (very difficult to break down), very bioaccumulative (very likely to accumulate in human bodies). Subject to Authorisation.

The REACH Regulation:

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REACH definitions