Alternatives to animal testing - what's new in 2016?
This year, the focus is on promoting alternative methods and approaches that are relevant for the information requirements of the 2018 registration deadline. ECHA will publish advice on using the new OECD test guidelines related to serious eye damage/eye irritation and skin corrosion/irritation. For skin corrosion/irritation, the new in vitro tests can, in many cases, fully replace in vivo studies when used either alone or in combination. For serious eye damage/eye irritation, combinations of several alternative test methods may be used to replace in vivo testing.
In mid-2016, the Agency plans to publish an update to the guidance on information requirements (Endpoint specific guidance, (Chapter R.7a) to reflect both the scientific changes and the recent regulatory amendments in the REACH annexes. The updates concern the data requirements for skin corrosion/irritation, serious eye damage/eye irritation, skin sensitisation and acute toxicity.
For skin sensitisation, there will be advice in using newly developed non-animal testing methods within a weight of evidence approach, which may be used to avoid in vivo testing. For acute toxicity, there will also be advice on using a weight of evidence approach, which can lead to avoidance of certain in vivo tests.
These updates favour the use of in vitro methods over the in vivo tests, reinforcing one of the pillars of REACH: animal testing should be used as a last resort. Additional information for registrants is published in the Practical guide: How to avoid unnecessary animal testing.
Help for 2018 registrants
To support registrants ahead of the 2018 deadline, ECHA has developed a roadmap with seven phases. A webinar and web pages for the third phase: 'Get organised with your co-registrants' will be launched in March 2016, providing tips on how to share existing data with registrants of the same substance. Sharing data is an obligation under REACH which helps to avoid unnecessary animal testing.
In July 2016, new material related to the fourth phase 'Assessing hazard and risk' will be launched. A webinar and new web pages on how to fulfil the REACH information requirements with alternative methodologies will be available. A new practical guide on information requirements for low-tonnage chemicals, targeted especially at small and medium-sized companies and business managers, will give further advice.
Read-across is another methodology used to reduce testing on animals. Widely used by REACH registrants, it allows them to use existing information from substances to predict the properties of similar substances where information might be missing. An illustrative example of how to use read-across is available on ECHA's website.
To promote a consistent and correct scientific use of read-across, in 2015 ECHA published a read-across assessment framework (RAAF) targeting human health endpoints. The RAAF explains how ECHA evaluates read-across in registration dossiers. A version covering environmental endpoints will be published in 2017.
Making sure that alternatives are considered first
Before testing on animals (higher tier studies), registrants must first submit a proposal to ECHA. Since September 2015, ECHA has been asking registrants what alternative methods they have considered before submitting their testing proposals. Then the testing proposals and these considerations are published in a public consultation.
During public consultations, everyone can submit relevant information that could be used to avoid tests on vertebrate animals. Registrants can then consider the feedback received to fulfil their REACH information requirements.
Search for data
In January 2016, ECHA revamped its database on chemicals. Users can now access information on chemicals and their properties in three levels: through a simple infocard, a more detailed brief profile and the full source data.
The website also offers access to the OECD's eChemPortal, where registrants can check whether information on animal tests is already available from other authorities.
Using the QSAR Toolbox
In cooperation with the OECD, ECHA develops and manages the QSAR Toolbox, a software for grouping chemicals into categories and filling gaps in (eco)toxicity data. In 2016, ECHA will publish more illustrative examples on the use of QSAR toolbox.
Scientific workshop on new methodologies
To support the development of new alternative methods, ECHA is organising a workshop on new approach methodologies in April 2016. The possible regulatory impacts of the latest scientific developments will be discussed among academics, regulators, industry and other stakeholders.
The new approach methodologies aim to reduce the need for animal testing. To be valid in the regulatory context, the methods should generate information that is reliable enough for risk assessment and classification to protect human health and the environment.
Source: European Chemicals Agency (ECHA)