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” aims to give you an overview of your obligations in a simplified way.
A company planning to register a substance in the EU must submit an inquiry dossier to the European Chemicals Agency (ECHA) in order to find out whether a registration has already been submitted for that substance by someone else. Companies need to wait for the result of the inquiry before submitting a registration. Through the inquiry process, a company intending to register will be put into contact with other companies that may have already registered or intend to register the same substance to facilitate data sharing.
REACH obliges companies who need to register the same substance to come together and to share data in order to avoid duplication of testing, in particular animal testing. Registrants must make every effort to share data on the intrinsic substance properties in a fair, transparent and non-discriminatory way. If the substance you intend to register has already been registered by others, you will need to contact the lead registrant to agree on data and cost sharing and therefore become a member of the joint submission. This means that you may need to buy a “letter of access”.
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. 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, unless you can demonstrate that there are grounds for you undertaking a separate submission. This will however attract a higher fee. Your registration must be prepared in IUCLID and submitted via REACH-IT. The Agency has a period laid down in the regulation in which it can reject the registration; once this period has expired (three weeks), 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 public consultation period before the European Commission makes its decision.
Become a REACHReady member - sign up now. Call us on +44 (0) 20 7901 1444 for more information.
This workshop will provide you with a better understanding of what’s essential to your REACH registration, helping you ensure you don’t end up paying for data you don’t need and helping you to understand how to define your substance and ensure your dossier is of sufficient quality to satisfy UK REACH Agency requirements. ***This workshop will be delivered via MS Teams and split over 2 half day sessions - am Wednesday 26th and am Thursday 27th June 2024***
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