The Registration Process
1. Data Sharing
Data sharing is a core principle of REACH, with the aim of avoiding unnecessary animal testing and reducing registration costs. REACH requires multiple registrants of the same substance to share data and to jointly submit their registration dossier. For phase-in substances, all potential registrants that have pre-registered the same substance will be part of a Substance Information Exchange Forum (SIEF). Each SIEF allows registrants to come together, share information, agree on classification and labelling and submit the registration dossier jointly. To allow the SIEF to run smoothly, a SIEF Formation Facilitator (SFF) may be appointed to coordinate activities and communications, etc.
As indicated, multiple registrants of the same substance are required to jointly submit information on the intrinsic properties of the substance. This will involve data and cost sharing, agreement on what studies are available and what tests need to be carried out. A lead registrant must be nominated and this lead registrant submits the joint part of the dossier first, well ahead of any registration deadline. The joint registrants then only have to submit their own specific information as part of their member dossier.
For further information on SIEF formation and data sharing, include cost sharing and disputes, see ECHA's registration and data sharing guidance in a nutshell documents.
2. Information requirements
There are 2 main components to the registration dossier: a technical dossier and a chemical safety report (CSR). A CSR is only required for substances registered at greater than 10 tonnes per annum.
The technical dossier will contain information as follows:
- The identity of the substance
- Information on manufacture and use
- Classification and labelling
- Guidance on safe use
- (Robust) study summaries of the information on the intrinsic properties
- Proposals for further testing, if relevant
- For substances registered in quantities between one and ten tonnes, the technical dossier also contains exposure related information for the substance (main use categories, type of uses, significant routes of exposure)
In preparing the dossier, registrants should collect all available information. This information should then be compared to the information requirements that are outlined in annexes VI to X of REACH, which specify the information requirements for the different tonnage bands. In the case where testing is required to fulfil information requirements, for information required by annexes VII or VIII, this information should be generated. For information requirements for annexes IX and X, registrants must submit a testing proposal to ECHA. This testing proposal will be evaluated by ECHA as part of dossier evaluation. Testing can only begin once a decision is issued to the registrant by ECHA.
The chemical safety report (CSR) is the document resulting from the chemical safety assessment undertaken as part of the registration process and is the key source from which the registrant provides information to all users of chemicals through the exposure scenarios. The chemical safety assessment is carried out to demonstrate that the risks from the exposure to a substance, during its manufacture and use, are controlled when specific operational conditions and risk management measures are applied. These conditions of use of a substance constitute the exposure scenario, which is an essential component of the chemical safety report. The 3 main steps in preparing the chemical safety assessment are hazard assessment, exposure assessment and risk characterisation.
An exposure scenario is a set of conditions that describe how a substance is manufactured or used, and the measures necessary to control exposure to humans and releases to the environment. For substances registered at and above ten tonnes per year, which meet the classification criteria, each identified use of a substance should have an exposure scenario that will document all the relevant routes of exposures and releases associated with that use. The relevant exposure scenarios will be communicated to downstream users via the extended safety data sheets.
The CSR can be submitted separately by registrants, or jointly covering all uses. Information on the manufacturing process (EU) and all identified uses will be required to complete the CSR.
For further information on information requirements and CSRs, see ECHA’s guidance. ECHA also has formats for the CSR.
3. Preparing and submitting the registration dossier
The registration dossier has to be prepared using the latest version of IUCLID 6 software application. Once the dossier has been created with IUCLID 6, it has to be submitted to ECHA through REACH-IT. Member registrants creating and submitting their dossier for the first time, are not required to use IUCLID 6 and can register directly in REACH-IT. Registrants are encouraged to become familiar with the preparation and submission processes and the necessary tools. The following steps in dossier preparation are outlined on ECHA’s website:
- Read the relevant manuals on ECHA’s website:
- Data Submission Manual 4: How to Pass Business Rule Verification ("Enforce Rules")
- Data Submission Manual 5: How to complete a Technical Dossier for Registrations and PPORD Notifications
- Data Submission Manual 18: How to report the substance identity in IUCLID 5 for registration under REACH
- Enter the required information in IUCLID 6 to complete the substance dataset
- Use Chesar tool to carry out the chemical safety assessment and to generate the chemical safety report (CSR), if relevant. Alternatively, the CSR plug-in in IUCLID 6 or the CSR template can be used
- When the substance dataset is complete, the final registration dossier can be created following the Dossier Creation wizard in IUCLID 6. After that, the dossier can be exported to a computer
- Use the IUCLID 6 technical completeness check plug-in to detect any missing information and pre-check certain ‘Business Rules'
- Use the IUCLID 6 dissemination plug-in to check what information from the dossier will be published by ECHA
- Apply the IUCLID 6 fee calculation plug-in to estimate the fee associated with the registration
- Export the dossier from IUCLID 6 and submit it via REACH-IT.
Step by step instructions on how to submit the dossier are available in the Industry User Manual - Part 6: Dossier Submission, on ECHA’s website. In addition, the links below to all of the relevant documents, user manuals and IUCLID plug-ins are taken from ECAH’s website:
IUCLID 6 plugins
4. Following submission
Once ECHA receives a dossier, a submission number is assigned. This number is NOT a registration number – it is used as a reference in all correspondence relating to this registration until a registration number is assigned. All dossiers undergo administrative checks, called ‘‘Business Rules'' checks, to ensure that the dossiers fulfil the pre-requisites for ECHA to handle them. Passing the business rules only confirms that the dossier is accepted for processing, and does not mean that the registration is finalised yet. If there is a business rules failure, the registrant needs to correct the dossier and submit it again. After the dossier has been accepted for processing, the next step is the technical completeness check. At this stage, the dossier is checked to certify that all the required information is included. If there is any missing information, the registrant will be given a reasonable deadline to re-submit a complete dossier, with only one additional submission attempt allowed. In parallel to the technical completeness check, the invoice is sent to the registrant via REACH-IT and must be paid within the given due dates.
Once the technical completeness check is successful and the invoice is paid, the dossier is considered complete and a registration number is assigned. If there is a second completeness check failure or a failure in paying the relevant fee, the dossier is rejected.
Publication of registration information
ECHA publishes information included in the registrations dossiers on its website. The information published covers the identity of the substance, the results of studies on its intrinsic properties and hazard profiles, the levels where no adverse effects are expected for human health or the environment, its classification and labelling, as well as guidance on its safe use. If not claimed confidential by the registrant, ECHA will also publish information on the degree of purity essential for classification and labelling, total tonnage band, (robust) study summaries, information in the safety data sheet and the trade name. Under certain circumstances, the IUPAC name can be claimed confidential. In these cases, the registrant must provide a public name that ECHA can use for dissemination purposes.
Before submitting their dossiers, registrants have the opportunity to request that certain data be kept confidential and to check what information will be publicly available. All confidentiality requests will be assessed by ECHA.
Communication in the supply chain
Companies that supply registered substances need to include the registration number and exposure scenarios in the safety data sheets that are to be provided to their customers.
5. Updating registrations
Registrants have a responsibility to keep their dossiers updated. Reasons to update a registration include a change of the substance composition, an increase of the tonnage band or the availability of additional information, for example, related to classification and labelling. For some types of update a fee is charged.
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