Identify the need to register

Decide if your substance is within the scope of REACH and needs to be registered. Our first section of the Basics page “Should you be worried about REACH” gives you an overview of your obligations and our REACHScope tool is designed to further guide you with your obligations with reference to legal text.

Assemble and submit information for pre-registration

Gather information to be submitted to the European Chemical Agency (ECHA). Information requirements for pre-registration can be found as a separate note: click here. Pre-registration allows manufacturers and importers to benefit from phased-in deadlines for full registration depending on the properties of the substance and the production volume. The 6-month pre-registration period for “phase-in" substances closed on 1 December 2008. A manufacturer or importer who commences manufacture or import at or above the one tonne annual threshold after 1 December 2008 may still take advantage of the longer deadline concession, providing the company submits a late pre-registration within six months after the manufacturing or importing of the substance and at least 12 months before the expiry of the registration deadline. Therefore, the late pre-registration period ends on 31 May 2012 for substances to be registered by 31 May 2013, and 31 May 2017 for substances to be registered by 31 May 2018.

Formation of Substance Information Exchange Forum (SIEF)

A SIEF comprises of manufactures or importers who pre-registered the same substance and exists to fill data gaps through the sharing of information, thereby avoiding the duplication of testing, in particular, any animal testing. You will need to identify the data you are missing in order to complete your registration dossier and develop proposals for sharing the results of testing, which may mean accessing pre-existing data that is owned by another SIEF participant. You may also need to revise classification and labeling if necessary (click here for further information).

Registration preparation

Prepare your dossier to reflect your production quantities and the uses of your substance. You will need to do this in co-operation with your customers (click here for further information). The information required for registration is dependent on tonnage threshold. This can quickly become a very complex process as tonnage increases. Our Matchmaker service can help you to find suppliers to undertake the work necessary to produce the information for your dossier.

Registration submission

You are obliged to submit your completed registration dossier as part of a joint registration (click here for further information), unless you can demonstrate that there are grounds for you undertaking a separate submission for pre-registered phase-in substances (REACHReady Gold subscribers can download our data sharing guidance document from our website for details). Your registration must be prepared in IUCLID and submitted via REACH-IT.

Depending on the time of submission, the Agency will have a specific period in which to reject the registration, once this period has expired the registration process can be regarded as complete. You are then able to manufacture or import the substance in accordance with REACH.

Registration review

It is important to establish a review procedure to maintain knowledge of your substance and its uses to ensure that your registration is updated as new information emerges. Once registered, a substance can be subject to regulatory review under Evaluation. In addition to registration, certain substances of very high concern (SVHC) may require a use-specific authorisation or restriction. Safer alternatives to authorised substances should be considered as an authorisation may not be renewed if a suitable, safer, substitute is available.

Authorisation

Substances present on an authorisaion list (Annex XIV of REACH) can only be used or placed on the market under restricted conditions. There are two routes for authorisation: the manufacturer or importer must be able to demonstrate adequate control of all potential risks associated with the substance or prove that the economic benefits to placing the substance on the market exceeds to environmental cost. Our ‘gold subscribers’ can access detail information on authorisation and guidance documents for the socio-economic analysis route for registration.

Restriction

Annex XVII is a list of substances restricted for use under specific conditions under REACH. This means that these substances cannot be used or placed on the EU market. A proposal for restriction can be made by any Member State or ECHA and there is normally a 6 month public consultation period before the European Commission makes a decision.