All chemical substances manufactured or imported in quantities of one tonne or more per year and falling within the scope of application of the REACH regulation 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 27 European Union (EU) Member States, Iceland, Liechtenstein and Norway.
Where the same substance is intended to be manufactured or imported by more than one company, those companies are required to jointly submit certain information with their registration dossier. This is based on the "one substance, one registration" principle.
Sharing information in this way avoids unnecessary animal testing and reduces registration costs for the companies involved (the registrants).
In the absence of registration, the substance may neither be manufactured nor placed on the European market. This is known as the "no data, no market" principle.
A transitional period has been, under certain conditions, provided for after the REACH regulation's entry into force, so as to allow manufacturers to prepare for the registration process. This concerned so-called "phase-in" substances which had been pre-registered before 1 December 2008. Following the last registration deadline of 2018, this initial transition period ended on May 31, 2018.
Who is concerned
Companies required to submit a registration dossier
Companies operating in the European Economic Area (EEA) (i.e. the 27 EU Member States, Iceland, Liechtenstein and Norway) that manufacture or import substances in quantities of one tonne or more per year are required to submit a registration dossier within the framework of the REACH regulation.
The following have an obligation to register:
- EEA-based manufacturers and importers of one tonne or more per year of substances on their own or contained in preparations;
- EEA-based manufacturers and importers of articles importing a total of more than one tonne of preparations containing the substance per year, if the substance is intended to be released under normal or reasonably foreseeable conditions of use;
- sole representatives appointed by companies that are not established in the EEA but sell chemicals in the EEA.
Downstream users of substances are not subject to the obligation to register the substances they use. They must nevertheless ensure that their suppliers have fulfilled their obligations to register and inform them of how they are using the substances in question.
Registration is mandatory for all chemicals manufactured or imported in quantities of 1 tonne or more per year by a manufacturer, importer or, in some cases, a sole representative.
Nevertheless, some substances which are already subject to other regulations are exempt from registering or considered as already being registered.
Only individual substances must be registered under the REACH regulation, regardless of whether they are used on their own (e.g. hydrochloric acid, white spirit, etc.), in a preparation (e.g. paint, detergent) or contained in an article.
Following the last registration deadline of 2018, the transitional period for phase-in substances pre-registered before 1 December 2008 ended on 31 May 2018. In addition, since 1 January 2020, all pre-registered substances have had their pre-registration revoked.
Thus, any company wishing to manufacture or import, in the EEA, a substance concerned (in a quantity of one tonne or more)
by the REACH regulation must immediately register it before any manufacture or placing on the market of the substance concerned.
In addition, before being able to submit a registration dossier, all potential registrants must submit a prior request for information to ECHA. This request must be made for all substances to be registered.
All registration submissions are subject to a fee. Each member of the SIEF must also pay a fee corresponding to their registered individual tonnage band.
Updates of information submitted to ECHA will in some cases be subject to the payment of a fee.
How to proceed
Within the REACH framework, manufacturers intending to register a substance must share data with other registrants of the same substance. Through this sharing registrants can reduce registration costs and avoid unnecessary testing, in particular on vertebrate animals.
Data sharing was previously carried out through the Substance Information Exchange Forums (SIEFs), which officially ceased operation on 1 June 2018. However, co-registrants still have an obligation to share data when jointly submitting their registration file and are now invited to use informal communication platforms similar to SIEFs.
SIEF members must agree on a fair, transparent and non-discriminatory way to split costs relating to existing and future studies.
In addition, registrants are only obliged to contribute to the cost of information that they must submit to meet the registration requirements applicable to their tonnage band.
Submitting registration files
Depending on the role of the registrant when submitting a registration file, lead registrant or member registrant, the registration file may be prepared in different ways:
- the lead registrant may use:
- IUCLID Cloud for SMEs, if he is a consultant and works for a small or medium-sized enterprise (SME) or if he is an SME and does not frequently use IUCLID, or;
- the IUCLID application, if he manages large amounts of data or if it wants to use all the advanced features.
- the member registrant may use:
- the file creation tool in REACH-IT, if he is a member of a joint submission and he agrees with all the information submitted on his behalf by the lead registrant, or;
- IUCLID Cloud for SMEs, or;
- the IUCLID application.
IUCLID is a free software application that allows users to capture, store, manage and exchange data on the properties and use of chemical substances. It can be downloaded free of charge provided that it is used for non-commercial purposes.
The IUCLID tool also:
- detects any missing information and checking that certain administrative rules are complied with before submission;
- checks which information will be extracted from the file and published by ECHA;
- provides an advance estimate of the registration fee.
To facilitate the process, the "lead registrant" first submits the section of the file prepared jointly by the SIEF members (the "lead dossier"), which includes the classification and labelling of the substance, study summaries, etc.
The other registrants then submit their own separate sections of the file, called their "individual part".
The lead file submitted by the lead registrant must first be accepted before the other members of the SIEF can submit their registration dossiers.
Please note that all registration submissions are subject to a fee. Each member of the SIEF must also pay a fee corresponding to their registered individual tonnage band.
Updating information submitted to ECHA
Registrants must ensure that the information submitted to ECHA is always up-to-date.
As regards information included in the joint part of the file, it is up to the lead registrant to update the registration on behalf of the SIEF members.
Where only administrative information needs to be updated (e.g. the identity of a registrant or the composition of a group of registrants in the case of a joint submission), the change can be made directly via REACH-IT. The IUCLID file does not need to be amended in this case.
The information contained in the individual part of the file must be kept up-to-date by the member concerned. To update their registration data, registrants must amend their IUCLID 5 file and resubmit it to ECHA using the REACH-IT platform.
Note that in some cases updates are subject to a fee.