Production or extraction of substances in the natural state.

Import

Physical introduction into the customs territory of the Community.

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.

Use

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.

Identified Use

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

Stated Use

Use of a substance on its own or in a preparation, or a use of a preparation, that is intended by a downstream user in the supply chain, including his own use, or that is stated by another downstream user in writing and which is recorded in the chemical safety report conveyed to the downstream users.

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.

Non-Phase-In Substance

Any substance not covered by the description applying to phase-in substances. These are for the most part substances for which proof of registration was presented and which were placed on the market in accordance with Directive 67/548/EEC, including substances brought onto the market for the first time.

Phase-In Substances

A substance which met at least one of the following criteria during the ten year period prior to this Regulation coming into force:

1. The substance was manufactured in or imported into the Community, or the countries acceding to the European Union on May 1, 2004, by a manufacturer or importer and is listed in the European Inventory of Existing Commercial Chemical Substances (EINECS).

2. The substance was manufactured in or imported into the Community, or the countries acceding to the European Union on May 1, 2004, but not placed on the market by the manufacturer or importer.

3. The substance was manufactured in or imported into the Community, or the countries acceding to the European Union on May 1, 2004, between September 18, 1981 and October 31, 1993, placed on the market by the manufacturer or importer and is regarded as being registered in accordance with Article 8 para 1 position one of Directive 67/547/EEC (OJEU L 259 dated 15.10.1979, p. 10) as amended by Directive 79/831/EEC (OJEU L 154 from 5.6.1992, p. 1) but does not correspond to the definition of a polymer stated in Directive 67/548/EEC as amended by Directive 92/32/EEC, provided that the manufacturer or importer can provide documental evidence.

No-Longer Polymer List

Once a more exact definition of the term “polymer” became available in chemical legislation some substances which had previously been regarded as being polymers could no longer be viewed as such (thus: no-longer polymers). “No-longer polymer numbers” were allocated to the substances contained in this list. The numbers have seven digits are are structured as follows: XXX-XXX-X. The list begins at 500-001-0.

Polymer

Any 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 comprises the following:

1. 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

2. Less than a simple weight majority of molecules of the same molecular weight.

Monomer

Any 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.

Preparation

A mixture or solution composed of two or more substances.

Article

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.

Important Abbreviations

CMR Substances

Substances which are carcinogenic (may cause cancer), mutagenic (may cause heritable genetic damage) or reprotoxic (toxic for reproduction).

DNEL

 

“Derived no effect level”

For health reasons humans should not be exposed to substances in concentrations exceeding these levels. The DNEL value is calculated using the lowest valid effect level combined with specific safety factors. For oral and dermal exposures this is stated in either mg per person per day or in mg per body weight and day.

ECHA

 

„European Chemicals Agency“

EINECS Inventory List

"European Inventory of Existing Commercial Chemical Substances"

Former EU directory of substances. This list contains around 100,000 substance entries. All those substances which were on the market when the requirement to identify potential chemical risks was introduced (1981) were recorded in this list.

ELINCS Register

"European List of Notified Chemical Substances"

The ELINCS Register contains new substances registered after completion of the EINECS List (September 18, 1981) in accordance with Directive 67/548/EEC (New Substance Directive). The ELINCS Register is updated regularly.

PNEC

"Predicted No-Effect Concentration“

Value which describes the concentration of a substance in an environmental sphere - i.e. in water, soil, the air etc. - determined and calculated during ecotoxicological testing. When these concentration levels are exceeded adverse effects on organisms can no longer be ruled out. As a rule, data from algae, daphnid and fish toxicity examinations are used for the calculation.

PBT

"Substances that are potentially persistent, bioaccumulative and toxic"

Substances with persistent, bioaccumulative and toxic characteristics. Persistent means that a substance remains stable in the environment and is only slowly biodegradable. Bioaccumulative means that a substance may accumulate in living organisms so that the concentration in tissue material may reach a level which may, in turn, cause toxic effects. Toxic means: harmful to living organisms.

RIP

"REACh Implementation Projects“

European-wide work groups which prepare methods and guidelines for implementing the REACh Regulation; a link to the final reports of the individual RIPs can be found by clicking on REACh Navigator - Guidance Documents.

SDS

„Safety Data Sheet“

Data sheets containing safety tips regarding the handling of hazardous substances. In Europe and many other countries. These data sheets must be supplied by the party placing the dangerous substance or preparation on the market, or by the importer or manufacturer of such, if these contain hazardous substances in amounts exceeding the set levels. In particular cases an extended safety data sheet (eSDB) may be required to include exposure scenarios and risk management measures.

SIEF

"Substance Information Exchange Forum"

A REACh forum is established following pre-registration of a phase-in substance to exchange information on the substance. SIEF participants include all the manufacturers / importers of an identical substance. The aim of the SIEF is to avoid multiple testing.

SVHC

"Substance of Very High Concern“

Substances giving particular cause for concern. These include CMR substances as well as PBT and vPvB substances.

TGD

"Technical Guidance Document“

Technical, non-legally binding guidelines for implementing the REACh Regulation compiled by the RIPs.

UVCB (=SUVC)

"Substances of unknown or variable composition, complex reaction products or biological materials”

UVCB substances are substances of which either the qualitative and/or quantative composition is more or less unknown. UVCB substances, such as complex reaction compounds or extracts, are generally not only defined by way of their exact composition but also by additional parameters.

vPvB

"Substances that are potentially very persistent and very bioaccumulative"

Substances not actually known to be toxic (or which have not yet been tested on their toxicology). On the other hand, they are particularly persistent and extremely bioaccumulative.