A bill (see definitinon) that has become law, in USA legislation

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, according to REACH (see definition).

BCF = Bioconcentration factor-parameter (L/kg) that gives an indication of the accumulation potential of a substance in an organism.Can either be expressed as the ratio of the concentration of a substance to the concentration in water once a steady state has been achieved (static BCF), or, on a non-equillibrium basis, as the quotient of the uptake and depuration rate constants (dynamic BCF).

The dose causing a predetermined change in response.The BMD concept involves fitting a mathematical model to dose-response data.

Document under consideration prior to becoming an act (see definition) in the USA legislation system.

A property causing the substances to build up (accumulate) in the body. Such substances build up in fat tissue in the body and can not be excreted by the body.

Binding Occupational Limit Value (Bindender Arbeitsplatzgrenzwert)

Chemical Agents Directive 98/24/EG

A list of substances within REACH meeting the criteria of Substances of Very High Concern, and proposed by either the European Commission or the EU Member states. These substances are candidates for REACH Authorisation.

A carcinogenic substance causes cancer.

Chemical Abstracts Services registration number. A unique number assigned to each substances submitted to CAS. Used world wide to positively identify chemicals.

A chemical is another word for substance or compound. Identified by a unique CAS or EC-number.

Siehe auch

• CAS Nummer

Regulation on classification, labelling and packaging of substances and mixtures (CLP-Regulation, Regulation (EC) No. 1272/2008).

Cancerogen and Mutagen Directive 2004/37/EG

The abbreviation for Carcinogenic, Mutagenic and toxic to Reproduction, chemicals with inherent properties which can cause cancer, alter DNA and damage reproductive systems. Part of the REACH Substances of Very High Concern.

Process of bringing together a EU legislative act and all its amendments in a single new act. The new act passes through the full legislative process and replaces the acts being codified.

if not specified otherwise) = European Commission is the executive body of the European Union responsible for proposing legislation, implementing decisions, upholding the Union’s treaties and the general running of the Union.The Commission is divided into departments known as Directorates-General (DGs) e.g. DG Environment.

Combining in a single EU legislative text the provisions of a basic instrument and all subsequent amendments. Consolidated texts are used for practical reasons only, they have no legal value.

Legislative act of the European Union, which requires Member States to achieve a particular result without dictating the means of achieving that result.

The Derived Minimal Effect Level. For non-threshold effects, the underlying assumption is that a no-effect-level cannot be established and a DMEL expresses an exposure level corresponding to a low, possibly theoretical, risk, which should be seen as a tolerable risk.

The Derived No-Effect Level is the level of exposure to the substance below which no adverse effects are expected to occur. It is the level above which humans should not be exposed. DNEL is a derived level of exposure because it is normally calculated on the basis of available dose descriptors from animal studies such as No Observed Adverse Effect Levels (NOAELs) or benchmark doses (BMD).

A user of a chemical produced by a manufacturer. This can be a formulator, article manufacturer or a consumer.

European Commission registration number. The unique number under which a substance is registered in the European Union.

The European Chemicals Agency in Helsinki, Finland, established to oversee and implement the REACH Regulation and the Biocidal Products Regulation.

Endocrine Disruptor Chemical. A substance that disrupts or alters the hormonal systems in the body, causing widespread effects throughout the organism. These effects can be observed at extremely low doses.

Electrical and electronical equipment: the functionality of the equipment depends on electrical current or electromagnetic fields or the equipment is used to generate, transfer and measure electrical current or electromagnetic fields.

European Inventory of Existing Commercial Chemical Substances, which lists reported substances on the EU market before 18^th September 1981.

European List of Notified Chemical Substances. ELINCS is comprehensive of all notified substances, concluded by expiry of the Directive 67/548/EEC on 31^st May 2008. On 1^st June 2008 the notification scheme was replaced by Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).

A substance that disrupts or alters the hormonal systems in the body causing widespread effects throughout the organism. These effects can be observed at extremely low doses.

The safety net of the REACH regulation for substances which do not automatically fall into the categories CMR, PBT or vPvB but is of equivivalent level of concern in terms of the potential damage it may cause.

European chemical Substances Information System, available until end of 2012. A former IT System with information on chemicals related to Biocidal Products, on PBT or vPvB substances, on Classification and Labelling etc. Since 2008, most information is available in the database of the European Chemicals Agency (ECHA).

Reactive substances consisting of Fluorine, Chlorine, Bromine, Iodine or Astatine.

Intrinsic property of a substance which is always present. See also Risk.

High Production Volume chemical, manufactured/imported at more than 1000 tonnes/year.

Testing within a living organism.

Indicative Occupational Exposuer Limit Value

Octanol-Water Partition Coefficient is a coefficient representing the ratio of the solubility of a compound in octanol to its solubility in water. The higher the K_OW, the more soluble is the compound in  non-polar, organic solvents. Log K_OW is generally used as a relative indicator of the tendency of an organic compound to adsorb to soil. Log K_OW values are generally inversely related to aqueous solubility and directly proportional to molecular weight.

The Lowest Observed Adverse Effect Concentration is the lowest tested concentration at which there are statistically significant increases in frequency or severity of adverse effects between the exposed population and an appropriate control group.

The Lowest Observed Adverse Effect Level is the lowest tested dose or exposure level at which there are statistically significant increases in frequency or severity of adverse effects between the exposed population and an appropriate control group.

The Lowest Observed Effect Level is the lowest tested dose or exposure level at which, in a study, a statistically significant effect is observed in the exposed population compared with an appropriate control group.

Low Production Volume chemical, manufactured/imported at more than 100 tonnes/year.

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

Production or extraction of substances in the natural state

A solution composed of two or more substances.

Member State Competent Authority. The authority in each EU Member state which monitors REACH and other chemical issues.

Causes irreparable mutations in the DNA which will be transferred on to the next generation.

No Observed Adverse Effect Level is the highest tested dose or exposure level at which there are no statistically significant increases in the frequency or severity of adverse effects between the exposed population and an appropriate control group.

No Observed Effect Concentration  is the highest tested concentration at which, in a study, no
statistically significant effect is observed in the exposed population compared with an appropriate control group.

No Observed Effect Level is the highest tested dose or exposure level at which, in a study, no statistically significant effect is observed in the exposed population compared with an appropriate control group.

Organic substances including the halogen elements Fluorine, Chlorine, Bromine, Jodine.

Substances that are Persistent, Bioaccumulative and Toxic are substances that do not easily break down, instead they build up in nature and in eg. the fatty tissue of mammals, with a potential to cause serious and long-term irreversible effects. Part of the REACH Substances of Very High Concern.

A persistent substance will not break down or degrade in humans, animals or nature. This means that they will stay for a very long time once produced.

a substance which meets at least one of the following criteria: a) it is listed in EINECS; (b) was manufactured in the Community, or in countries that acceded EU up to 2004, but was not placed on the market in the 15 years before the entry into force of REACH c) was placed on the market in the Community, or in countries that acceded to EU up to 2004, before entry into force of REACH and was considered notified in accordance with the Directive 67/548/EEC, but does not meet the REACH definition of a polymer.

Predicted No-Effect Concentration: Concentration of a substance below which adverse effects in the environmental sphere of concern are not expected to occur.

Persistent Organic Pollutant. POPs are organic substances which persist for a long time in nature. They are tackled globally through the provision of the Stockholm Convention.

The Persistent Organic Pollutants Review Committee within the Stockholm Convention.

see Mixture

Regulation for Registration, Evaluation, Authorisation and Restriction of Chemicals, the EU chemical regulation entered into force in 2007.

Legislative act of the European Union that becomes immediately enforceable as law in all Member States simultaneously.

A legal act by which the regulations, directives and decisions are formally repealed and their validity is terminated.

Combination of “Hazard”, probability and exposure. See also Hazard.

EU Directive 2002/95/EC on the Restriction of the use of certain Hazardous Substances in electrical and electronic equipment. Came into force in 2006 and restricting six substances and groups of substances in electrical and electronic equipment.

In the EU Commission's Chemicals Strategy for Sustainability (published on 14 October 2020), this term is used to complement the existing concept of "safe-by-design" with considerations of sustainability. The exact criteria of this concept for "safe" and "sustainable" are currently being discussed and developed with experts, stakeholders and authorities in the EU.

"Safe-by-design (SbD)" refers to the forward-looking analysis of substances, materials, processes and products throughout the R&DI process (e.g. by technology assessment/risk assessment). The aim is to avoid and prevent hazards to humans and the environment through specific risk management measures (built-in safety). An extension of the concept is "safer-by-design", which recognises that absolute safety cannot always be achieved by design alone. Further measures (e.g. according to the basic measures and the hierarchy of measures in occupational safety and health (T - technical measures, O - organisational measures, P - personal protective equipment)) may be necessary to ensure application safety.

The Strategic Approach to International Chemicals Management was adopted in 2006 providing an overarching framework for global action on chemical hazards and enable governments and other stakeholders to collaborate more effectively on reducing toxic risks.

One single chemical substance identified by its unique Chemical Abstracts Services (CAS) or European Community (EC) registration number.

The most hazardous substances according to article 57 of REACH. These are substances that are Carcinogenic, Mutagenic and toxic to Reproduction (CMR), Persistent, Bioaccumulative and Toxic (PBT), very Persistent and very Bioaccumulative (vPvB) or substances of Equivalent level of Concern.

See Substances of Very High Concern

The general aim of the principle of subsidiarity is to guarantee a degree of independence for a lower authority in relation to a higher body or for a local authority in relation to central government. It therefore involves the sharing of powers between several levels of authority, a principle which forms the institutional basis for federal states.

When applied in the context of the EU, the principle of subsidiarity serves to regulate the exercise of the Union’s non-exclusive powers. It rules out Union intervention when an issue can be dealt with effectively by Member States themselves at central, regional or local level. The Union is justified in exercising its powers only when Member States are unable to achieve the objectives of a proposed action satisfactorily and added value can be provided if the action is carried out at Union level.

European Parliament on the principle of subsidiarity

Intrinsic property of a substance rendering it to harm, impair or elsehow damage living organisms.

A substance which is toxic for reproduction will impair the ability to get children or cause irreversible harm to the offspring itself.

process by which the European Union’s Member States give force to a directive by passing appropriate implementation measures.

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.

Substances of Unknown or Variable Composition, Complex Reaction products and Biological materials

Substances that are very Persistent and very Bioaccumulative but do not need to be toxic as defined today. However they persist in the environment and accumulate in the food chain for such a long period of time that they are also considered to be Substances of Very High Concern according to REACH.

Considering the strengths and weaknesses of various pieces of information in reaching a conclusion concerning a property of the substance