Decide if your substance is within the scope of REACH and needs to be registered. The first section of our 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 through your obligations with reference to the legal text.
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. However, a manufacturer or importer who commenced manufacture or import at or above the one tonne per year threshold after 1 December 2008 was able to 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 registration deadline. Thus, the late pre-registration period ended on 31 May 2012 for substances to be registered by 31 May 2013, and on 31 May 2017 for substances to be registered by 31 May 2018.
If pre-registration is not permitted, for example if the substance is non-phase-in, Inquiry and Registration prior to reaching the 1 tpy threshold is required.
A SIEF comprises of manufactures or importers who pre-registered the same phase-in 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 labelling if necessary (click here for further information).
Prepare your dossier to reflect your production quantities and the uses of your substance. You will need to do this in cooperation 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 Approved Service Providers to undertake the work necessary to produce the information for your dossier.
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 has a period laid down in the regulation in which it can reject the registration; once this period has expired the registration process can be regarded as complete. You are then able to continue to manufacture or import the substance in accordance with REACH.
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 be subject to restriction. Safer alternatives to substances on the Authorisation List should be considered as an authorisation may not be renewed if a suitable, safer, substitute is available.
Substances present on an Authorisation List (Annex XIV of REACH) can only be used or placed on the market under special permission ('Authorisation') from the European Commission. There are two routes for Authorisation: the manufacturer, importer or downstream user must be able to demonstrate adequate control of all potential risks associated with a threshold-effect substance or, otherwise, prove that the economic benefits to placing the substance on the market exceeds the risk to human health and the environment given the intrinsic properties of the substance which led to its initial inclusion in the Candidate List. Our Gold subscribers can access detailed information on Authorisation and guidance documents for the socio-economic analysis route for registration.
Annex XVII is a list of substances restricted under REACH. Restriction may come in the form of a total ban for a substance or family of substances in chemical goods and articles, or a restriction on, say, supply to the general public. Restriction can apply to imported articles, mixtures and substances, as well as those made in the EU. A proposal for restriction can be made by any Member State or ECHA and there is normally a six month public consultation period before the European Commission makes its decision.
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