Strategy for gathering your data
To gather data for registering your substance, follow these four steps. Agree with your co-registrants how to divide the work or 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 the physico-chemical properties of the substance if there are enough independent sources.
You need to know the requirements which are relevant for your registration. These depend on the volume and properties of the substance you manufacture or import. The bigger the volume, the more information is needed.
Remember that in the SIEF, the information requirements of the highest tonnage band must to be covered in the joint part of the dossier.
Make also sure that you consider the most up-to-date testing requirements.
Check the relevant REACH annexes (VII-X).
By comparing information requirements and existing information you should be able to conclude:
- what good quality data is already available within your SIEF and need to be shared with all registrants of the same substance;
- what information is missing within your SIEF for a compliant registration.
Keep in mind that the data needs to be adequate, reliable, relevant and to fulfil the information requirement.
When you have identified an information gap, you need to find a way to fill it.
Remember that testing on vertebrate animals is always the last resort. So, you first need to consider all other means to generate information. For example, analogue substances or structure-based predictions might be suitable.
See more on the page How to avoid unnecessary testing on animals.
If you conclude that you need to generate information with new testing, consider hiring a specialised company (laboratory/contract research organisation) to do the tests for you. 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 compliant with Good Laboratory Practice (GLP) while for physicochemical characteristics this is not required.
If your results show that your substance may pose a risk, you have to investigate further and identify means to gather information beyond the requirements for your tonnage band.
Keep in mind that before performing tests that are normally required only for substances produced or imported in high volumes (and described in Annexes IX and X of REACH), you first have to submit a testing proposal to ECHA. Only after ECHA has accepted the proposal, you and the co-registrants can go ahead with performing the test.
More in this section
REACH 2018 phases