Registration & Data Sharing
Joint registration and data sharing
This is the principle that for any one substance, a single set of information on its intrinsic properties is produced that is shared by all those companies that manufacture or supply that substance. Business specific (e.g. company name) and business sensitive (e.g. how it is used) information is submitted separately by each company. The Companies will work together to get an agreement on information sharing through a Substance Information Exchange Forum (SIEF). The details of how this information is shared is the responsibility of the businesses involved in the SIEF. A role for national authorities in this aspect of REACH is not foreseen.
Companies who submit joint registrations via a SIEF benefit from a reduced registration fee.
One of the key objectives in REACH is to obtain and share information about the properties of substances being manufactured, supplied and used in the EU. This ensures that registrations use existing data rather than commissioning new studies. REACH prohibits the duplication of animal testing. Datasharing is achieved using one of two mechanisms, SIEFs or the Article 26 Inquiry. The SIEF is the data sharing forum used for phase-in substances that have been pre-registered. For non-phase-in (new) substances, the main data sharing process is the Article 26 Inquiry. This process allows prospective registrants to be put in touch with any existing registrants so that data sharing can be organised. In some cases, data can be made freely available for registration purposes.
Dossier preparation and submission
Dossiers are created using the IUCLID software system. This is available free of charge from ECHA. For each substance the data is divided into separate sections, e.g., company information, substance identity information, toxicological information, etc. IUCLID is then used to create the file that will be sent to ECHA using their REACH-IT system. There are two main components to a registration dossier, the technical dossier required in all cases and a chemical safety report (CSR) which is only required for substances registered at 10 tonnes or more per annum. The amount of information you need to add to your dossier will depend on your registration tonnage band and, as requirements are cumulative, more data will be required at higher tonnages. All registrants need a certain minimum amount of data, but those who are part of a joint submission can exclude certain sections as this information will be provided in the main dossier of the Lead Registrant. The CSR is added as an attached stand-alone document.
All registration activity with ECHA is done through their REACH-IT system and will be done through your REACH-IT account.
After Submission of Dossier
ECHA will contact you within a set time from the date of submission and either issue a registration number or provide information on why they do not consider the dossier complete. The time for a response is usually 3 weeks, but if the registration is submitted within 2 months of a registration deadline, then this response limit is extended to 3 months. The submission works on a default acceptance principle, and if you do not receive anything to the contrary within the times given above, then you can assume the dossier has been accepted. If your dossier is not considered complete you will be given a deadline to submit the missing information. If again the information is found lacking the registration will be rejected and you risk losing your registration fee. Once you have a registration in place, it is your responsibility to ensure it is kept up to date.
If you are part of a joint registration, the Lead Registrant will issue a security token to grant you access to the data in the lead dossier. It is important that you maintain good communications between Lead and Member Registrants, including for the issuing and acceptance of these tokens.
ECHA have issued a Technical Completeness Check tool (TCC tool) available for download and use within IUCLID. You are strongly advised to download this and use it to check your dossier prior to submission.
NO REGISTRATION = NO MARKET!
PHARMEGIC HEALTHCARE LIMITED has a proven track record of conducting audits and certifying manufacturers of substances, mixtures or articles for REACH compliance and based upon “gap analysis” advising clients how to achieve REACH compliance, alleviating EU importers concerns on regulatory compliance.
Supply chains can often be complex with substances sourced from own manufacture, worldwide suppliers directly and indirectly from distributors and agents.
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Pharmegic Healthcare Limited provides Pharma & Chemical regulatory compliance and product safety solutions globally. Pharmegic Healthcare Limited has its headquarter in Ireland and offices in India & China.