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 28 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 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. It is now the companies and not the authorities who must provide proof concerning the assessment of hazards of chemical substances. 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 in the REACH regulation are:
- manufacturer: "any natural or legal person established in the Community and manufacturing a substance in the Community."
- importer: "any natural or legal person established in the Community and responsible for imports".
- downstream user: "any natural or legal person established in the Community, other than a manufacturer or importer, who uses individual substances or mixtures in the context of their professional activities".
The REACH regulation is not only aimed at manufacturers of chemical substances but also applies to importers, users and to sectors such as:
- chemical industry;
- automotive industry;
- plastics industry;
- textile industry;
- cleaning industry;
- paint industry;
- construction industry, etc.
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 fulfill.
The status must be determined for each chemical substance or product purchased. Companies may therefore have one or more statuses depending on their activity.
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 makes available the "Navigator" tool to help businesses identify their obligations and to find the most appropriate guidance documents.
The REACH regulation is focused on 4 procedures:
- registration of chemical substances by the business;
- evaluation of dossiers and chemical substances by the authorities;
- authorisation for substances of very high concern;
- restriction of particular hazardous substances.
All substances manufactured or imported at or above one tonne per year and which are within the scope of application of REACH must be communicated to ECHA through a registration dossier 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 dossier is called a "registrant".
In the absence of registration, the substance may not be manufactured nor placed on the European market. It is the "no data, no market" principle.
The evaluation procedure is a crucial step consisting in 2 separate parts:
- the evaluation of dossiers consists in the compliance check of the dossiers submitted by registrants to ECHA (at least 5 % of all the dossiers received by ECHA per tonnage band are compliance checked). The evaluation also includes the evaluation of the proposals for testing submitted by registrants in order to reduce the amount of testing on vertebrate animals.
- the evaluation of certain prioritised substances, mainly conducted by the Member States although coordinated by ECHA and based on a Community rolling action plan (CoRAP). The results of the evaluation may trigger authorisation or restriction procedures.
The authorisation procedure aims to ensure the good functioning of the internal market all the while guaranteeing that the risks 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 likely to be subject to authorisation are, after several steps, added to 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 procedure may apply whatever the quantities in question and may therefore 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.
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