If you have chemical registration 2013 duties under REACH, then you need to know what you should be doing and by when.
When talking about the need to register, attention generally focuses on the need for data review, new testing, deciding on classification and filling in all those fields in IUCLID. Even when considering the Chemical Safety Report (CSR) and Exposure Scenarios (ES), guidance is presented as if the reader needs to start from scratch. Most of the guidance and what is presented at meetings is based on the assumption that registrant is a potential lead registrant or is at least taking an active role in the proceedings.
In reality, many registrants will have a minor role in a SIEF that is run by larger organisations or pre-existing consortia. These (majority of) registrants will only need to do conduct the minimal work to be part of a joint registration process. And of course pay data holders for access.
What is the registration requirement ?
Registration requires manufacturers, importers and Only Representatives (ORs) (registrants) to collate information on the substances they manufacture or import. Where appropriate, they use that information to assess the potential hazards. With this information on the properties of the substance, and by working with others in the supply chain, the registrant can, when appropriate, assess any risks to human health and/or the environment and develop appropriate risk management measures for the various uses of the substance. This information is sent to the European Chemicals Agency (ECHA) as an electronic summary file (a IUCLID 5 registration dossier).
Steps to Registration
A – Data-sharing
One of the key objectives in REACH is to gain information about the properties of substances being manufactured, supplied and used in the EU. However, this should be achieved by using the minimum number of animal tests. One of the main ways to reduce the amount of animal testing is through the mandatory sharing of animal test data. Depending on the type of substance (phase-in or non-phase-in) and whether it has been pre-registered (where applicable), this data-sharing is achieved through one of two mechanisms: Substance Information Exchange Forums (SIEFs) or Article 26 Inquiry.
The Substance Information Exchange Forum (SIEF)
This data-sharing mechanism is used for phase-in substances that have been pre-registered. All the companies that pre-register a substance will be members of the Substance Information Exchange Forum (SIEF) for that substance and can benefit from the phased registration deadlines.
The members of the SIEF should communicate with each other, pool the existing information available to them and decide on how to fill any information gaps.
For a SIEF to operate effectively somebody will need to coordinate its activity and initiate communications, organise meetings, etc. One or more members of the SIEF may indicate that they wish to be the SIEF Formation Facilitator (SFF). This is not a formal role in REACH, but may offer a way to get things started. Once the SIEF is active, a ‘Lead Registrant’ can be identified. The SFF does not need to be the same as the Lead Registrant.
The Lead Registrant’s role is to produce the ‘Lead dossier’ to which the other joint registrants will refer. That is, the Lead Registrant will submit a complete dossier containing all the required data for physico-chemical, toxicological end environmental properties. Joint registrants submit ‘partial dossiers’ containing information specific to their company; for example, information about their identified uses, their production volumes or their ‘version’ of the substance (e.g., to account for different impurities). In these joint submissions, instead of test summaries, they simply refer back to the lead dossier.
It is possible to appoint a Third Party Representative (TPR) to represent you in the SIEF. This can be for commercial confidentiality reasons or to provide expertise in negotiating the data-share. However, the TPR does not register on your behalf and you retain legal liability for the registration.
B – Information requirements
There are two main components to the registration dossier, a technical dossier and a chemical safety report (CSR). A CSR is only required for substances registered in the 10 tonne/annum tonnage band or above.
C – Submitting your registration
The technical dossier must be compiled using the IUCLID 5 software. This is available to download (free of charge) from http://iuclid.eu. Details of how to install and use the software are available on the IUCLID website. You should use the appropriate structured template in IUCLID for the tonnage band involved. If the tonnage of your substance is 10 tonnes per year or greater, and a chemical safety report is required, this should be a stand-alone document, which you should attach to the IUCLID 5 dossier.
All dossier submissions and correspondence regarding the registration will occur via your REACH-IT account. More information is also available on the Registration section of “Dossier Submission Tools” part of the ECHA website.
D – What happens next?
Once ECHA receives your registration dossier, they will assign a submission number and communicate this to you. This is just an acknowledgement number and is NOT your registration number. It should be used as a reference in all correspondence relating to this registration until a registration number is assigned.
ECHA will then check the dossier for completeness. Part of this is an automated check to ensure that all the required sections have been completed. The second part is a check for financial completeness to ensure the appropriate fees have been paid on time. REACH registration fees are payable to ECHA and the precise fee payable depends on the registration tonnage band and company size (for details see the REACH Fees Regulations). At least 5% of all registrations will also be selected to undergo a full compliance check. This is a rigorous check that the information required is present, scientifically valid and of the appropriate quality.
E – Updating a registration
Once you have a registration in place for your substance, it is your responsibility to ensure that it is kept up to date.
You may wish to update your registration for various reasons, such as your substance composition has changed, tonnage band has increased, because you have additional information (e.g., about classification & labelling) or because the company information has changed. This new information should be submitted to ECHA without undue delay. For some types of update a fee is charged. You may also need to update your registration because of a decision that has been made by ECHA; for example, following the submission of testing proposals. In this case, ECHA will issue a deadline for completion of the update.
You will also be informed by ECHA if a new registrant for your substance submits new information, you will then be expected to consider this information and update your registration if appropriate.
When submitting an update, this should also be done via REACH-IT on the ECHA website. You should submit the entire dossier again, including all the new information in the appropriate sections.
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