Under the REACH regulation, all chemical substances manufactured or imported in quantities of one tonne or more per year and falling within its scope of application must be registered with the European CHemicals Agency (ECHA) before being manufactured or placed on the market in the European Economic Area (EEA), i.e. the 28 European Union (EU) Member States, Iceland, Liechtenstein and Norway.
A system of pre-registration was provided for when the REACH regulation entered into force. It allowed potential registrants of substances to benefit from an extended registration deadline subject to certain conditions.
The pre-registration deadline was 1 December 2008. However, companies may still benefit from late pre-registration if they plan to manufacture or import, for the first time and in the EU, phase-in substances (substances eligible for the transitional regime) in quantities of one tonne or more per year.
Late pre-registration allows them to:
- continue manufacturing or importing these substances until the expiry of the registration deadlines, and;
- benefit from an extended deadline to arrange for the collection and selection of available data, the sharing of existing data and the production of missing data required under the REACH regulation.
Who is concerned
Late pre-registration is available to potential registrants established in the EEA which, for the first time after 1 December 2008, manufacture or import phase-in substances (namely substances benefiting from a transitional regime) on their own or contained in preparations or articles in quantities of one tonne or more per year.
Late pre-registration is only obligatory for companies wishing to benefit from extended registration deadlines. Companies can also decide to register their phase-in substances immediately.
Potential registrants are not obliged to submit a late pre-registration if the quantities concerned are below one tonne per year. However, they may opt to submit a late pre-registration if they intend to manufacture or import the substance in quantities of one tonne or more per year in the future.
Companies who cannot or do not wish to benefit from late pre-registration must submit an inquiry and then a registration dossier before being authorised to manufacture or import a substance on the European market.
Substances fulfilling at least one of the following three criteria may be considered as phase-in substances in accordance with the REACH regulation:
- substances listed in the European INventory of Existing Commercial Chemical Substances (EINECS);
- substances manufactured at least once since 31 May 1992 in a country which is today an EU Member State, but not placed on the EU market by the manufacturer or importer;
- substances that qualify as "no-longer polymer'' (NLP), i.e. substances that are no longer included in the list of polymers as they do not meet the definition of a polymer. A non-exhaustive list of these substances is available on the European Commission's website.
Before submitting the late pre-registration, potential registrants must:
- identify the substance concerned;
- check whether the substance concerned is a phase-in substance;
- determine the exact quantity of the substance to be registered, given that late pre-registration is only available for substances manufactured or imported in quantities of one tonne or more per year. Echa has published a Guidance on Registration to help registrants calculate the exact quantities.
Registrants must be able to prove that they manufactured or imported the substance for the first time after 1 December 2008.
Late pre-registrations have to be submitted within 6 months of the manufacturing or importing of the substance that exceeds the one-tonne threshold and no later than 12 months before the registration deadline corresponding to the tonnage band manufactured or imported.
The last registration deadline still open for phase-in substances is 31 May 2018. The last deadline for submitting a late pre-registration is therefore 31 May 2017.
How to proceed
To submit a late pre-registration, registrants must have or create an account on the REACH–IT platform. Information must be submitted to ECHA using this platform.
Once the dossier has been processed, ECHA will attribute a pre-registration number to the potential registrant.
After the pre-registration, potential registrants who are registering the same substance must join a Substance Information Exchange Forum (SIEF) so as to submit a joint registration dossier for the substance in question.