Companies are responsible for collecting information on the properties and uses of the substances they manufacture or import above one tonne a year. They also have to assess the hazards and potential risks presented by the substance.
This information is communicated to ECHA through a registration dossier containing the hazard information and, where relevant, an assessment of the risks that the use of the substance may pose and how these risks should be controlled.
Registration applies to substances on their own, substances in mixtures and certain cases of substances in articles. Chemical substances that are already regulated by other legislations such as medicines, or radioactive substances are partially or completely exempted from REACH requirements.
Registration is based on the "one substance, one registration" principle. This means that manufacturers and importers of the same substance have to submit their registration jointly. The analytical and spectral information provided should be consistent and sufficient to confirm the substance identity.
For substance registration a fee is usually charged.
Substances to be registered
There is a special transitional regime for substances which were already manufactured or placed on the market before REACH entered into force. Such substances are called phase-in substances.
Companies benefit from the transitional regime if they pre-registered their substances by 1 December 2008 (or in certain circumstances, made a later pre-registration before the relevant registration deadline).
Substances that fulfil at least one of the following criteria may be considered as phase-in substances in accordance with REACH:
- Substances listed in the European Inventory of Existing Commercial Chemical Substances (EINECS)
- Substances that have been manufactured in the EU (including the countries that joined on 1 January 2007) but have not been placed on the EU market after 1 June 1992
- Substances that qualify as "no-longer polymer''
For these substances, the REACH Regulation sets the following registration deadlines:
30 November 2010
Deadline for registering substances manufactured or imported at 1 000 tonnes or more a year; substances that are carcinogenic, mutagenic or toxic to reproduction above 1 tonne a year; and substances dangerous to aquatic organisms or the environment above 100 tonnes a year.
31 May 2013
Deadline for registering substances manufactured or imported at 100-1 000 tonnes a year.
31 May 2018
Deadline for registering substances manufactured or imported at 1-100 tonnes a year.
All substances that do not fulfil any of the criteria for phase-in substances are considered as non-phase-in substances. Normally, non-phase-in substances have not been manufactured, placed on the market or used in the EU before 1 June 2008, (unless they were notified under the Dangerous Substances Directive (67/548/EEC)).
Potential manufacturers and importers of non-phase-in substances have to submit an inquiry to ECHA and subsequently register the substance before they can manufacture or import the substance.
All substances notified under the Dangerous Substances Directive (also called NONS) are considered to be registered under REACH and ECHA has assigned registration numbers to all the notifications. The owners of the notifications can claim the registration numbers from ECHA.
You need to register if you are an:
- EU manufacturer or importer of substances on their own or in a mixture
- EU producer or importer of articles meeting the criteria explained in the Guidance on requirements for substances in articles
- "Only representative" established in the EU and appointed by a manufacturer, formulator or article producer established outside the EU to fulfil the registration obligations of importers