Tag Archives: substances

REACH and registration

You need to register if you are an:

  1. EU manufacturer or importer of substances on their own or in a mixture
  2. EU producer or importer of articles meeting the criteria explained in the Guidance on requirements for substances in articles
  3. “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:

  1. manufactures a substance within the EEA in quantities of 1 tonne or more per year
  2. is responsible for import into the EEA of quantities of 1 tonne or more per year or
  3. 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:

  1. Substances listed in the European Inventory of Existing Commercial Chemical Substances (EINECS)
  2. 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
  3. 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.