Tag Archives: substances
REACH and registration

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
Registration requirements only apply to substances that are manufactured or imported in quantities of 1 tonne or more per year per registrant. However, if a substance is manufactured or imported at less than 1 tonne per-year-per-registrant, other obligations under REACH may still apply. These obligations, which may apply irrespectively of the volume, include obligations concerning: a) use of the substance, b) restrictions, c) authorizations and d) communication in the supply chain.
Registration must take place when a person who is the member of the EEA:
- manufactures a substance within the EEA in quantities of 1 tonne or more per year
- is responsible for import into the EEA of quantities of 1 tonne or more per year or
- has been appointed as an only representative according to Article 8 of the REACH Regulation
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.
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.