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 28 European Union (EU) Member States, Iceland, Liechtenstein and Norway.
When a single substance is (or will be) manufactured or imported by more than one company, these companies are required to submit some information together in a joint registration dossier.
Sharing information in this way allows unnecessary animal testing to be avoided and reduces registration costs for the companies involved (the registrants).
In the event of failure to respect the registration deadline, the substance may not be manufactured or placed on the European market. This is the "no data, no market" principle.
A transitional period, under certain conditions, was provided for when the REACH regulation entered into force, so as to allow industrials to prepare for the registration process. This concerns phase-in substances which were pre-registered.
Who is concerned
Companies required to submit a registration dossier
Companies operating in the European Economic Area (EEA), i.e. the 28 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, where a total of more than one tonne of the substance is imported per year, if the substance is intended to be released under normal or reasonably foreseeable conditions of use;
- companies not established in the EEA but which sell chemical products in the EEA. They must appoint an exclusive representative ("only representative") based in the EEA to fulfil their obligations to register.les entreprises qui ne sont pas établies dans l’EEE mais y vendent des produits chimiques, doivent nommer un représentant exclusif établi dans l’EEE, qui s’acquiterra des obligations d’enregistrement.
Downstream users of substances are not subject to the obligation to register the substances used. 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 compulsory for all chemical substances manufactured or imported in quantities of one tonne or more per year per manufacturer or importer.
Nevertheless, some substances which are already subject to other regulations are exempt from registering or considered to be already 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.
If they do not already have one, registrants must create a REACH-IT account which they will then use to submit their registration dossier.
In addition, registrants must submit their registration dossier in IUCLID format.
IUCLID is a free software application that allows you 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.
Companies which, for the first time after 1 December 2008, manufacture or import phase-in substances (namely substances benefiting from a transitional regime) may still submit a late pre-registration until 31 May 2017, if the quantity of the substance concerned totals one tonne or more per year.
Potential registrants who have not submitted a pre-registration must submit an inquiry to ECHA before being authorised to register the substance(s) concerned.
All companies wishing to manufacture or import, in the EEA, a substance covered by the REACH regulation must immediately register said substance before manufacturing said substance or placing it on the market.
That said, companies which pre-registered their substances before 2008 benefit from a transitional period (2010, 2013 and 2018) depending on the hazardousness and tonnage of the substance concerned.
Companies wishing to manufacture or import phase-in substances can still benefit from an extended registration deadline until 31 May 2018, provided that they submit a late pre-registration of the substance in question before 31 May 2017.
How to proceed
Forming a Substance Information Exchange Forum (SIEF)
Within the framework of REACH, industrials intending to register a substance must share data with other registrants of the same substance. Data is shared through Substance Information Exchange Fora (SIEF) which are set up through the REACH-IT platform. There is one SIEF for each substance.
ECHA puts SIEF members in contact with each other through REACH-IT but has no input into how the fora are run. It is up to the SIEF members themselves to decide how their cooperative group will be organised.
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 dossiers
Registration dossiers must be submitted via the REACH-IT platform in IUCLID 5 format. This tool has several plug-ins for:
- detecting any missing information and checking that certain administrative rules are complied with before submission;
- checking which information will be extracted from the dossier and published by ECHA;
- providing an advance estimate of the registration fee.
To facilitate the process, the "lead registrant" first submits the section of the dossier 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 dossier, called their "individual part".
The lead dossier submitted by the lead registrant must first be accepted before the other members of the SIEF can submit their registration dossiers.
Each member of the SIEF must also pay a fee corresponding to their registered individual tonnage band.
Companies who want to submit an individual registration dossier
In some cases, a company may wish to submit their own individual registration of a substance, independently of a SIEF.
This option is only available under certain conditions and only if no animal testing is required in order to obtain the necessary data.
In this case, the business must collect all the data required for their tonnage band on their own so as to put together the technical dossier.
Individual registration dossiers must also be submitted using the REACH-IT platform.
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 dossier, 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 5 dossier does not need to be amended in this case.
The information contained in the individual part of the dossier must be kept up-to-date by the member concerned. To update their registration data, registrants must amend their IUCLID 5 dossier and resubmit it to ECHA using the REACH-IT platform.
Note that in some cases updates are subject to a fee.