This webpage gives practical information and tools in relation to help in using of existing information and non-test methods (i.e. predictions) as a first step to meeting REACH information requirements. The information presented is based on the available ECHA Guidance and Practical Guides published earlier.
In addition there are also links to other resources that may be of use.
The flowchart below describes the steps listed in Annex VI of REACH which needs to be considered in order to fulfill the information requirements. Note that these steps are not necessarily consecutive but that in practice, it can be seen as an iterative process. Click on the coloured boxes to obtain more detail.
Click on the coloured boxes in the flowchart to obtain more detail and to be guided to relevant resources and tools.
Brief explanations on all the steps in the flowchart are available in the How to use alternatives to animal testing to fulfil your information requirements for REACH registration
Collect all available information
Hazard and risk assessments performed for many chemicals under different national and international regulatory frameworks are available in a number of places. One of most comprehensive on-line databases is eChemPortal, a global portal to information on chemical substances. The eChemPortal allows a simultaneous search of multiple databases and provides clearly described sources and quality of data.
This portal will assist registrants to collect existing data on the substance or on similar substances including information on use, exposure and risk management that should be considered in the assessment of information.
Available information from assessments carried out under other international and national programmes should be included in the chemical safety report to be submitted for registration purposes under REACH.
In all cases, registrants are reminded that according to the Article 10 second paragraph of REACH Regulation, they should be in the 'legitimate possession' of the information submitted.
Consider Read across and grouping approaches
Read across and grouping approaches (chemical categories) can be very helpful when collecting and evaluating data also in a Weight of Evidence approach. Read across and chemical categories rely on the fact that the substances physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity. Data on analogous substances, if 'read across' or membership of a 'chemical category' is possible, should also be considered by contacting SIEFs with related substances.
A valuable tool to consider when building categories or considering read across is the OECD QSAR Toolbox. It facilitates the practical application of grouping and read across approaches for data gap filling. The Toolbox incorporates information and tools from various sources (including a link to the eChemPortal) into a logical workflow and also allows the prediction of a number of properties related to (eco)toxicological properties. The Toolbox software is available for download free of charge along with additional information materials and guidance for installation and use.
A public discussion forum for users of the QSAR Toolbox is also available and users can:
- Exchange experience on using the software (tips and tricks)
- Seek guidance
- Exchange databases
- Exchange user defined profilers and QSARs
- Make suggestions for improvements
- QSAR Toolbox discussion forum
- The Toolbox software download
- Available information on the conditions that need to be fulfilled in order to apply read across and grouping when collecting data for substances:
Consider QSAR analyses/estimations
The collection of all available information should include the search for suitable QSAR models. QSAR predictions are assessed for adequacy and if appropriate they can be considered for risk assessment and/or classification and labelling. (Q)SAR models are non-test methods that can assist on data generation but also on data interpretation.
The international activities on (Q)SARs are coordinated by the OECD.
The Institute for Health and Consumer Protection (IHCP), a scientific institute of the European Commission's Joint Research Centre (JRC), provides additional resources with respect to QSAR tools and their use for regulatory purposes. Users of QSAR models are advised to look at these resources and use them when relevant.
Harmonised templates for summarising and reporting key information on QSAR models, QSAR model reporting formats as well access to the QSAR model database are available on the IHCP website.
Additional important information sources that relate to the QSAR models are also available on the IHCP website.
The principles on when and how (Q)SAR can be used for REACH registration purposes:
Assessment of information
All available information (existing data on the substance, similar substances or derived with the use of non-test methods (QSAR, read across and grouping)) should be assessed for validity and adequacy. Consider the information in a Weight of Evidence approach in order to make decisions on the need for additional information. The resources and tools used in order to gather information could also be used to decide which tests are the most appropriate for data gap filling.
When deciding what type of test is needed to fulfil REACH information requirements, in vitro tests and non-test data should be considered first in order to avoid unnecessary animal testing.
Additional information on how to use weight of evidence:
In vitro methods
Data generated from in vitro test methods (validated and pre-validated) can be used under REACH provided that the information for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment. Such information can be used either as stand-alone to fill in a data gap or as part of a Weight of Evidence approach.
The European Centre for Validation of Alternative Methods (ECVAM) provides a database on alternatives to animal testing which has useful information on in vitro methods that could be considered during information gap analysis for REACH registration purposes. The database contains information on methods that are in use or under development as well as those validated and/or accepted for regulatory purposes.
In addition, tracking system for alternative test methods review (TSAR) is another source of information to be considered when deciding whether in vitro tests could provide the information needed for data gap filling or in a Weight of Evidence approach.
Detailed information on the conditions under which in vitro tests can be used for REACH registration purposes:
The following links provide access to products developed by the OECD and WHO for risk assessment purposes.
- OECD Environmental Risk Assessment Toolkit: Gives access to practical tools on environmental risk assessment and management of chemicals. It describes the work flow of environmental risk assessment and management with links to relevant OECD products that can be used in each step of the work flow.
- WHO Human Health Risk Assessment Toolkit: Aims to make the international tools available on chemical risk assessment more readily accessible in the form of a "toolkit" and develops related training materials including case study examples of use of the tools.