May pre-registered substances that are manufactured or imported before the relevant registration deadline be placed on the market after this deadline without a registration?

REACH imposes registration obligations only on manufacturers or importers (and, in specific cases, on producers or importers of articles). The registration obligation does not apply to downstream users or distributors. Therefore, the registration obligation does not apply to you if you have:

  • manufactured or imported pre-registered substances before the registration deadline; and
  • completely ceased such activities and only used the substances and/or supplied them after that.

For example, importers for whom the last batch of the substance was imported on 31 May 2018, at the latest, may continue to use and/or supply that substance after the deadline without a registration, without time-limitation. Since the pre-registered substance has not been registered, there is no obligation to notify ECHA of the cessation of manufacture/import. Article 50(2) and (3) of the REACH Regulation does not apply to this situation.

If you have not ceased your activities before the registration deadline, you have an obligation to register the substance according to Article 6 of REACH.

If you are a downstream user (or any other actor down the supply chain) who is not subject to the registration obligation, you can continue to use, without time-limitation, and/or supply quantities of the substance that were manufactured or imported before the registration deadline.

For the obligations of a downstream user or distributor and whether they are obliged to check the registration status of the substances on their own or in a mixture, please see Q&A 155

What are phase-in substances?

Substances that fulfil at least one of the following criteria may be considered as phase-in substances in accordance with Article 3(20) of the REACH Regulation:

  • Substances listed in the European Inventory of Existing Commercial chemical Substances (EINECS);
  • Substances that have been manufactured in the EU (including accession countries on 1 January 2007) but have not been placed on the EU market after 1 June 1992;
  • Substances that qualify as a so-called ‘no-longer polymer’.

Detailed information can be found in the Guidance on registrationSection 2.3.1. – Phase-in substances vs non phase-in substances.

Where can I find the list of substances that have been pre-registered?
ECHA publishes the list of pre-registered substances at: https://echa.europa.eu/information-on-chemicals/pre-registered-substances.
Information published will include:
  • Substance EINECS and CAS number (if available) and other identity codes;
  • The first envisaged registration deadline;
  • The names and other identifiers of related substances that pre-registrants have, i.e. those for which the available information may be relevant for performing adaptation of testing requirements using read across, (Q)SARs and/or grouping of substances.
The list published by ECHA does not show the identity of the pre-registrants. Thus, to find out whether a substance has been pre-registered in a particular supply chain, downstream users should ask their suppliers or other actors further up their own supply chain.
This information is also visible in REACH-IT to those who have pre-registered the same substance and those who have pre-registered related substances for read-across
What should I do if nobody in the pre-SIEF replies to my emails?

A pre-SIEF might have many participants, but it is possible that most of them are undecided about registration or have decided not to register. The status ‘Inactive’ in the pre-SIEF indicates that the company will not register, but not all companies use it.

If companies do not reply to your emails, you might want to try contacting them in another way (if their email address is outdated). You might limit this to companies you are familiar with and who you think might be registering.

It will also be helpful to download the pdf file of pre-registrants at regular intervals to see if any changes to contact details have been made. Please note that communications might be filtered out as spam.

If further communication attempts remain unanswered, document the attempts made and prepare to register your substance alone. Communicate your progress by email to the others in the pre-SIEF. Think about becoming the SIEF Formation Facilitator (SFF) so you can indicate in the pre-SIEF how others can contact you.

If your substance is a complex substance, consider the possibility that other manufacturers/importers of the substance used other identifiers for the substance and are in a different pre-SIEF. Look in the list of pre-registered substances for pre-SIEFs you could potentially merge with.

What is the status of pre-registrations?

The pre-registrations are not valid as of 1 January 2020 following the Commission Implementing Regulation (EU) 2019/1692.

Companies must register substances that they manufacture or import in quantities of more than one tonne per year in the EU/EEA before they start these activities, unless the substances are exempt from registration.