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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 halogens

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.

Phase-in substance

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.

Safe-and-sustainable-by-design (SSbD)

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(r)-by-design (SbD)

"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.

Substances of Very High Concern

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 principle of subsidiarity

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

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