The REACH Regulation – short for Registration, Evaluation, Authorisation, and Restriction of Chemicals – aims to ensure a high level of protection for human health and the environment against the risks posed by chemical substances, while at the same time promoting competitiveness and innovation within the European Union.
The provisions of REACH apply to the manufacture, placing on the market, or use of substances on their own, in the form of mixtures, or incorporated in articles.
In this context, it is essential to distinguish clearly between the concepts of substance, mixture, and article. A substance is a chemical element and its compounds, either occurring naturally or obtained through an industrial process. A mixture is a blend or solution composed of two or more substances. An article is an object which, during its manufacture, is given a specific shape, surface, or design that determines its function to a greater extent than its chemical composition.
REACH applies to all chemical substances, whether used in industrial processes or in everyday life. The Regulation is founded on the principle that manufacturers, importers, and downstream users are responsible for managing the risks associated with the substances they handle and for passing on appropriate safety information to users along the supply chain.
REACH seeks to achieve earlier and more effective identification of hazardous chemicals. Where the risks associated with a particular substance cannot be adequately controlled, the authorities may prohibit its use, restrict it, or make it subject to authorisation.
Compliance with REACH is an ongoing process that involves several distinct stages, which are outlined below.
Registration
Manufacturers and importers of substances on their own or in the form of mixtures in quantities equal to or exceeding 1 tonne per year are required to submit a registration. The same obligation applies to manufacturers and importers of articles containing substances intended to be released under normal or reasonably foreseeable conditions of use, where such substances are present in quantities exceeding 1 tonne per year. This registration must be submitted to the European Chemicals Agency, ECHA.
Depending on the tonnage band and the potential hazards, the registration dossier must include information relating to the substance identity, its physicochemical and toxicological properties, its uses, anticipated volumes, and a proposed classification and labelling. It must also include an assessment of exposure scenarios and associated risks, among other relevant data.
Only substances (whether on their own, in the form of mixtures, or incorporated in articles) that have been duly registered may be manufactured and placed on the market in the European Economic Area.
Evaluation
At this stage, ECHA, together with the EU Member States, carries out a rigorous evaluation of the data submitted. Testing proposals are reviewed, and the substances and their associated risks are assessed. The quality of the registration dossiers is also verified, which may lead to requests for additional information from the registrants.
Priority is given to registration dossiers for substances that exhibit, or are suspected of exhibiting, bioaccumulative, persistent, toxic, sensitising, carcinogenic, mutagenic, or reprotoxic properties. Particular consideration is also given to substances classified as hazardous in quantities of more than 100 tonnes per year, where their uses give rise to widespread and diffuse exposure.
Authorisation
The authorisation procedure is intended to ensure that the risks arising from substances of very high concern (SVHC) are properly controlled. It also aims to promote their progressive substitution with economically and technically viable alternatives.
Substances that may be identified as substances of very high concern (SVHCs) are those exhibiting one or more of the following properties:
Where a Member State, or ECHA acting at the request of the Commission, proposes the identification of a substance as a substance of very high concern and that proposal is accepted, the substance is subsequently included in the Candidate List for authorisation. ECHA periodically reviews this list to determine, on the basis of properties, uses, and volumes, which substances should be given priority for inclusion in the Authorisation List, and submits its recommendations to the European Commission.
SVHCs included in the list of substances subject to authorisation (Annex XIV of REACH) may neither be placed on the market nor used, unless a specific use is exempt from authorisation or an authorisation has been granted for that specific use.
All manufacturers, importers, and downstream users applying for authorisation are required to demonstrate that the risks arising from the substance are adequately controlled. The application must also include an assessment of the availability of alternatives, together with the technical and economic feasibility of substitution.
Restriction
Any Member State, ECHA, or the European Commission may propose the adoption of restrictions where an unacceptable risk to human health or the environment arises from a substance and needs to be addressed at EU level.
Restrictions are typically used to limit or prohibit the manufacture, placing on the market (including import), or use of a substance. In certain cases, however, they may also impose specific conditions, such as technical measures or labelling requirements.
A restriction may apply to any substance, whether on its own, in the form of a mixture, or incorporated in an article, including those not subject to registration, such as substances manufactured or imported in quantities below 1 tonne per year. In adopting such measures, the socio-economic implications of the restriction are taken into account, as well as the availability of suitable alternatives.
The list of restrictions is set out in Annex XVII to REACH.
Information in the Supply Chain
To ensure the safe use of substances, the various actors in the supply chain are required to communicate relevant information.
In the case of articles, where they contain any substance of very high concern from the Candidate List in a concentration exceeding 0.1% (weight by weight), suppliers must provide professional customers with sufficient information to allow safe use of the article, including, as a minimum, the name of the substance.
REACH requires companies to take responsibility for identifying and managing the risks associated with the chemical substances they manufacture, import, or use, promoting transparent communication and the substitution of hazardous substances.
As of the date of publication, Unex products do not contain substances of very high concern, in accordance with the Candidate List for authorisation updated by ECHA on 4 February 2026.
If you need further information on the REACH compliance of our products, please contact us.