The European Union Joint Research Centre for Alternatives to Animal Testing (EURL ECVAM) has issued its 2021 “Status Report on the Development, Validation and Regulatory Acceptance of Alternative Methods and Approaches.”
First off EURL ECVAM, what is this?
It’s the European Union Reference Laboratory on Alternatives to Animal Testing (the individual acronyms stand for: European Union Reference Laboratory and the European Centre for the Validation of Alternative Methods).
EURL ECVAM is an integral part of the Joint Research Centre (JRC), the science and knowledge service of the European Commission and is located at the JRC site in Ispra, Italy.
What do they do?
EURL ECVAM coordinates research and validation studies on alternatives to animal testing within the European Union. It also shares knowledge about and promotes the use of alternative methods, also known as new approach methodologies (NAMs). New approach methodologies including a variety of innovative technologies, such as in vitro methods using 3D tissues and cells, organ-on-chip, computational models (including artificial intelligence) and ‘omics (genomics, proteomics, metabolomics), are developed, evaluated and integrated in assessment frameworks with a view to improve the efficiency and effectiveness of hazard and risk assessment of chemicals and products in a variety of regulatory contexts. Important activities to promote the development and use of non-animal approaches are also pursued in the areas of basic and applied research, where most of the animals are used, as well as for education purposes.
The current activities of EURL ECVAM build on over 30 years of JRC support to the Three Rs and include:
- conducting research and collaborating in EU and international research initiatives;
- coordination and undertaking of validation studies of alternative methods for the safety assessment of chemicals .
- dissemination of information and sharing of knowledge across disciplines and sectors;
- and promotion of alternative methods and the Three Rs in an international context.
EURL ECVAM library of reference chemicals
Over the past years EURL ECVAM have collected a number of resources that can be used to facilitate the validation of test methods by applying good practices and the development of new methods.
The EURL ECVAM library of reference chemicals is a catalogue of chemical lists that can be used to standardise, qualify, characterise or compare in vitro, in chemico and in silico methods and models.
It contains chemical lists used in research and validation projects (including EU-funded, international and JRC projects), proficiency chemicals from OECD test guidelines, and chemicals that have been classified within various regulatory contexts (e.g. pesticides, carcinogenic and endocrine disrupters). Chemical lists are also grouped in toxicological categories such as endocrine disruption, skin corrosion, acute toxicity, developmental toxicity and carcinogenicity.
The chemicals in the lists are well-characterised and for the most part have been selected by domain experts working within chemical selection groups assembled by various projects and studies.
About the report
The report describes research, development, and validation activities, as well as initiatives that promote the regulatory and international adoption and use of alternative approaches and their dissemination.
There are many EU-funded research projects and partnerships focussing on the development of NAMs for chemical risk assessment and proposing new frameworks that do not rely on animal data. Some examples include:
- NAMs have been proven to support chemical grouping and read-across to avoid the generation of new animal data by the EU-ToxRisk project funded under Horizon 2020.
- Development of NAMs to identify chemicals with potential endocrine activity by the EURION cluster
- ASPIS cluster: PrecisionTox – Leveraging evolutionary diversity to reveal the molecular basis of toxicity, Risk Hunt3r – Human-centric chemical safety assessment utilizing systems toxicology
- Ontox – Synthesizing toxicology knowledge to support next-generation risk assessment
- Government-to-government initiative promoting collaboration and dialogue on the scientific and regulatory needs for the application and acceptance of NAMs in regulatory decision making
- Upcoming European Partnership for the Assessment of Risks from Chemicals (PARC) funded under Horizon Europe will support the development and implementation of a research and innovation programme to address current and future needs in chemical risk assessment.
- Exploration of approaches to replace, reduce, or refine animal use for batch testing of vaccines.
- Evaluation of methods to identify potential genotoxins, respiratory and skin sensitisers.
A 2021 breakthrough was the adoption of an OECD guideline that includes three defined approaches (DA) for skin sensitisation that use data derived from combinations of validated chemistry-based and cell-based in vitro tests, and in some cases from computer models. These DAs have comparable or even better performance than the Local Lymph Node Assay (LLNA) using mice.
EURL ECVAM continues to support the work under the United Nations (UN) Globally Harmonized System of Classification and Labelling of Chemicals (GHS) to include criteria for classification based on non-animal methods/approaches.
Progressing its holistic approach for a transformative change, EURL ECVAM also pursued its 3Rs education initiatives by further developing 3Rs education and training resources for primary and secondary school teachers as well as for higher education, and by organising the third edition of its highly successful JRC summer school on non-animal approaches in science, held virtually in 2021.
To read more about EURL ECVAMS work to protect human health and the environment, avoid animal testing, support innovation and competitiveness check out their website.