All manufacturers and importers of chemicals must identify and manage risks linked to the substances they produce and market. For substances manufactured or imported in quantities of one tonne or more per year, per company, this must be demonstrated in a registration dossier submitted to the European Chemicals Agency (ECHA).
This obligation applies to substances on their own and in mixtures. A special registration regime applies for substances in articles (e.g. manufactured goods such as cars, textiles, and electronic chips). However, certain substances are exempted from registration under REACH (see ECHA/Guidance on registration - Chapter 2.2.2), 2 MB).
Without registration, substances cannot be manufactured or imported into the EU.
Companies that intend to register the same substance are required to form a so called 'Substances Information Exchange Forum' (SIEF). Activities and practices in SIEFs must respect EU competition law.
The responsible services of the Commission (DG Competition, DG Internal Market, Industry, Entrepreneurship & SMEs, and DG Environment) have developed a document on competition issues in the context of REACH and SIEFs (188 kB) which provides answers to the most frequent questions in this area.
The European Chemicals Agency (ECHA) may check that registration dossiers comply with the Regulation. It must also evaluate testing proposals to ensure that the assessment of the chemical substances will not result in unnecessary testing, especially on animals, and that adequate information is provided.
Authorities may also select substances for a broader substance evaluation to further investigate substances of concern.
More information on the evaluation of chemicals (ECHA)
REACH includes an authorisation requirement to ensure that the risks from substances of very high concern (SVHCs) are properly controlled and that those substances are progressively replaced by suitable alternative substances or technologies. Substances subject to authorisation are listed in Annex XIV to the REACH Regulation. Once included in this Annex, a substance cannot be placed on the market for a use or used after a given date (the so-called 'sunset date') unless the companies concerned are granted an authorisation for the specific use(s).
Authorisations are granted by the Commission, after obtaining the opinion of the Committee for Risk Assessment (RAC) and the Committee for Socio-economic Analysis (SEAC) of the European Chemicals Agency (ECHA). An authorisation may be granted if either the risks from the use of the substance are adequately controlled or the socio-economic benefits outweigh the risks to human health or the environment.
EU countries or the European Commission (via ECHA) may propose EU-wide restrictions on the manufacture, use, or placing on the market of substances causing an unacceptable risk to human health or the environment.
Restrictions are designed to manage unacceptable risks that are not addressed by the other REACH processes or by other EU legislation. Restrictions are listed in Annex XVII to the REACH Regulation.
National authorities are responsible for enforcing REACH through inspections as well as handing out penalties in case of non-compliance. They exchange information and coordinate activities related to enforcement through the Forum for Exchange of Information on Enforcement (the Forum).
A Forum, set up by ECHA, formally brings together national enforcement authorities to:
Since 2007, many projects and documents have been generated.
National authorities are responsible for enforcing REACH. Each EU country has already designated the authority to deal with REACH enforcement.
The REACH review communication (February 2013) highlighted that a strong and harmonised approach towards enforcement in the Member States is vital for delivering the objectives of the REACH and CLP Regulations. This is challenging and so Member States are actively cooperating within the Forum to enhance compliance. To ensure more consistent enforcement at EU level, REACH established the Forum for Exchange of Information on Enforcement within ECHA. This Forum is recognised as a useful collaboration platform. The Communication also highlights, among other things, that the Commission will develop enforcement indicators, in liaison with the Forum.
The Commission contracted a study to develop enforcement indicators. The objective of the study was to propose a set of indicators that could be used to monitor and measure the performance of the enforcement of the REACH and CLP regulations.
The Commission used these indicators. See the first results of the application of EU level enforcement indicators:
REACH regulations dictate that EU countries must determine the penalties that would apply to the infringement of REACH provisions and must take all measures necessary to ensure that they are implemented:
A comparative study of the penalties that were communicated by EU countries by the first deadline (December 2008) was completed in 2009/2010.
REACH in its Article 2, paragraph 3, states that “Member States may allow for exemptions from REACH Regulation in specific cases for certain substances, on their own, in a mixture or in an article, where necessary in the interests of defence”.
The Ministries of Defence of the Member States coordinated by the European Defence Agency (EDA) have developed a Code of Conduct on REACH Defence exemption and associated technical framework that is of relevance for companies that want to benefit from such exemption.
REACH requires that companies pay for certain services delivered by the European Chemicals Agency (ECHA). This includes:
A number of guidance documents can be found on the ECHA website. They aim to support industry and authorities in fulfilling their obligations under REACH and to assist in its implementation.
EU countries have established national helpdesks to assist industry in understanding its role and obligations under REACH.
The ECHA helpdesk also provides support to all companies registering substances.
In addition, there is a helpdesk on using IUCLID5, the software tool through which companies are required to submit their registrations under REACH.
For more information, including the contact details of national helpdesks, please consult the helpdesk section on the ECHA website.
For more on the history of REACH, see here (70 kB).