Estrategia para recopilar datos
There are four steps in the process of data gathering before registering a substance. Agree with your co-registrants how to divide the work or whether to outsource some, or all of it.
Collect existing study / test results on your substance and assess their quality.
You should also review the available scientific literature and handbooks. Information from literature can often be used for describing physicochemical properties of the substance if there are sufficient independent sources.
Be aware of what information you need for your tonnage band.
The joint part of the registration dossier needs to cover the information requirements from Annex VII up to the highest tonnage band registered by the co-registrants.
Make sure that you consider the most up-to-date testing requirements. Check the REACH text and related legislations.
By comparing information requirements and existing information you should be able to conclude:
- what good quality data are available within your group of co-registrants and need to be shared;
- what information is missing, i.e. data gaps within your group of co-registrants.
Remember that the data needs to be adequate, reliable, relevant and to be considered as fulfilling the information requirement.
Information can be generated from new tests, which may be contracted out to a specialised company (laboratory / contract research organisation). The methodology of the test needs to be appropriate and the test has to be relevant for your substance.
For tests on environmental or human health properties, the test lab needs to be GLP-certified; while for physicochemical characteristics this is not needed.
Importantly, animal tests must only be done as the last resort; other means to generate information need to be considered first (see the Practical guide on “How to use alternatives to animal testing”).
If your existing results show that your substance may pose a risk, you have to investigate further and identify the means you have to gather information beyond the requirements for your tonnage band. Tests described in Annex IX and X to REACH require registrants to submit a testing proposal to ECHA. Only after ECHA has accepted the proposal, can you and your co-registrants go ahead with performing the test.
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