The REACH regulation provides for the Registration, Evaluation, Authorisation and Restriction of Chemical substances.
The scope of application of the REACH regulation extends to the countries of the European Economic Area, i.e. all 27 EU Member States as well as Iceland, Liechtenstein and Norway (defined as the "European Union", "EU" or "Community" within the framework of the REACH regulation).
The implementation of REACH has enabled a significant amount of data on the chemical substances that are manufactured in or imported into the European Union to be collected.
The purpose of the REACH regulation is to improve the protection of human health and of the environment, including the promotion of alternative methods for assessing the hazards of chemicals while enhancing competitiveness and innovation.
The innovative element of the REACH regulation is that it places the burden of proof on companies. The burden of proof concerning the assessment of hazards of chemical substances therefore now lies with manufacturers rather than with the authorities. This means that it is up to companies to prove that the substances can be manufactured, used or destroyed without impacting human health and the environment.
The European Chemicals Agency (ECHA) is responsible for implementing the REACH regulation and for providing a framework for the procedures so as to facilitate its uniform implementation within the EU.
The provisions of the REACH regulation apply to the manufacture, import, placing on the market or use of individual substances, mixtures or finished products.
The obligations of companies under the REACH regulation depend on the status of said companies which is determined by their role in the supply chain.
The main statuses as defined by the REACH regulation are:
The REACH regulation is not only aimed at manufacturers of chemical substances but also applies to importers, users and to sectors such as:
It is important to determine the company status in accordance with the REACH regulation ("manufacturer", "importer" or "downstream user"), as the status determines the obligations that the business must fulfil.
This status needs to be determined for all chemical substances, mixtures and articles purchased. Companies may therefore have one or more statuses depending on their activity or their substances.
The first step is to draft an inventory of chemical substances purchased. To help you achieve this, you may use the "REACH EXCEL Tool" and the associated guidance document offered by the REACH & CLP Helpdesk Luxembourg.
ECHA also provides the "Navigator" tool which helps businesses identify their obligations and to find the most appropriate guidance documents.
The REACH regulation is focused on 4 procedures:
All substances manufactured or imported at or above one tonne per year by one company, and which are within the scope of application of REACH, must be communicated to ECHA through a registration file before said substances can be manufactured or placed on the market in the EU.
Registration applies to substances on their own, substances in mixtures and, in certain cases, substances in articles. The company that submits a registration file referred to as "registrant".
In the absence of registration, the substance may neither be manufactured nor placed on the European market. This is known as the "no data, no market" principle.
The evaluation procedure is a crucial step consisting in 2 separate parts:
The authorisation procedure aims to ensure the good functioning of the internal market all the while guaranteeing that the risks arising from Substances of Very High Concern (SVHC) are properly controlled and that these substances are progressively replaced by suitable alternative substances or techniques where these are economically and technically viable.
Substances which are subject to authorisation are listed in Annex XIV of the REACH regulation.
Once they have been added to annex XIV of the REACH regulation, said substances become subject to authorisation before they can be used. After a transitional period, these substances may no longer be placed on the market or used without prior authorisation issued by the European Commission.
The purpose of the authorisation procedure is to ensure that the risks from these substances of very high concern are controlled and that said substances are replaced.
The authorisation obligation applies whatever the quantities in question are and may therefore also be applied to substances, which have not been registered and are used in quantities of less than one tonne per year.
The restriction process enables Member States or the Commission to limit the manufacture, use or placing on the market of substances which pose an unacceptable risk to human health or the environment.
When a manufacturer intends to place a substance subject to restriction on the market, he must first consult the list of restrictions (annex XVII of the REACH regulation) and comply with the conditions listed. These conditions may lead to a pure and simple ban on the manufacture and use of the substance.