What you need to submit
As a registrant of a substance, you need to compile all the required information in a registration dossier, which has two main components:
- A technical dossier is always required for all substances subject to the registration obligations
- A chemical safety report is required if you manufacture or import a substance in quantities of 10 tonnes or more a year.
Your registration dossier has to be prepared in the IUCLID format. IUCLID implements the harmonised templates developed by the OECD and plays a central role in managing scientific data on chemicals in different regulatory contexts. It is compatible with other chemical legislations around the world.
Your registration dossier has to be submitted to ECHA through REACH-IT.
If you are a manufacturer or importer, you have to collect all existing available information on the intrinsic properties of a substance as well as on its manufacture, uses and exposure.
The technical dossier contains information about:
- The identity of the substance
- Information on the manufacture and use of the substance
- The classification and labelling of the substance
- Guidance on its safe use
- (Robust) study summaries of the information on the intrinsic properties
- Proposals for further testing, if relevant
- For substances registered in quantities between 1 and 10 tonnes a year, as a separate chemical safety assessment is not required, some exposure related information (main use categories, types of use, significant routes of exposure).
The information you need to submit on the properties of a substance varies according to the tonnage you manufacture or import. The higher the tonnage, the more information is required.
The information requirements are described in annexes VI-X of REACH. Under certain circumstances, it may be possible not to perform the test required. This is called an adaptation to the information requirement.
You have to compare the information requirements with the information gathered. You can then identify information gaps and consider how to generate any missing information.
The information gaps can be filled by using different sources of information other than testing on vertebrate animals. You may use a variety of alternative methods such as (Q)SAR and in vitro tests. Grouping of substances and applying read-across are possible adaptations to information requirements. Tests on vertebrate animals are only to be performed as a last resort.
If you identify the need to perform a study listed in Annexes IX or X, you need to include a testing proposal for this test in your registration dossier. The proposal has to evidence that all adaptation possibilities have been considered and justify the need for proceeding to an animal study.
Under certain circumstances, you need to submit a testing proposal also for registrations under 100 tonnes a year. This is the case, for example, if the test performed under Annex VII gives an indication of concern. You then need to verify the concern by performing a test meant for substances produced in higher volumes (covered in Annex IX or X).
If your proposal for testing involves testing on vertebrate animals, ECHA will publish the name of the substance and the property for which vertebrate animal testing is proposed. Third parties can then submit scientifically valid information and studies that address the relevant substance and property as covered in the testing proposal within 45 days.
Taking into account the information received, ECHA will examine the proposal and draft a decision in which it states whether it accepts or rejects the proposal, or requires modification to the conditions under which the test is carried out.
If you manufacture or import a substance at 10 or more tonnes a year, you must conduct a chemical safety assessment to define the conditions of use under which the risks can be controlled. These conditions include operational conditions, such as temperature and risk management measures, for example, the need to use personal protective equipment.
The results of the chemical safety assessment are documented in a chemical safety report (CSR), which you need to submit as part of your registration dossier to ECHA.
The chemical safety assessment has the following steps:
1. Collection and generation of information on intrinsic properties of the substance
2. Human health hazard assessment
3. Physicochemical hazard assessment
4. Environmental hazard assessment
5. Persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) assessment
If, after these steps, you conclude is that your substance is hazardous, the following are also needed:
6. Exposure assessment
7. Risk characterisation
You need to repeat these steps by re-assessing the hazard information and revising the conditions of use, the exposure information or the scope of exposure scenarios until you can conclude that the risks are controlled.
Chesar is a tool developed by ECHA to help you perform your chemical safety assessment and generate your chemical safety report.
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