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REACH

Pre-registration

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 Section 1.7.1.1 – Phase-in substances of the Guidance on

registration at: http://echa.europa.eu/web/guest/support/guidance-on-reach-and-clp-implementation.
What are the duties following from pre-registration?

For each substance you have pre-registered, a pre-SIEF page is set up in REACH-IT. In the pre-SIEF page, you will find the contact information of the other companies that have pre-registered with the same substance identifier (e.g. EC number).

You need to contact each other to see who will be the lead registrant and if your substances are the same.

In the SIEF, you will share the data you have on your substance with your co-registrants, share costs and prepare the joint registration.

The aim of a SIEF is to avoid duplicating the testing of substances and to agree on their classification and labelling. In a SIEF, companies must share animal testing studies to keep these tests to an absolute minimum. They may also share other data relevant for REACH. It is an opportunity to generate and obtain the registration information required by the REACH Regulation in a cost-effective manner.

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 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.

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