The EURL ECVAM status report 2022 is out
The EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) from the Joint Research Centre (JRC) has recently published its annual status report. This report describes their latest activities regarding the development, use, validation, regulatory application, and uptake of non-animal methods as well as how these methods are promoted for research and educational purposes.
Development of non-animal methods
EURL ECVAM is supporting the development of non-animal methods via several partnerships and projects funded under the EU Framework Programmes for Research and Innovation, Horizon 2020, and Horizon Europe:
- The ASPIS cluster, grouping ONTOX, RISK-HUNT3R and PrecisionTox, which aims to develop an animal-free framework for chemical risk assessment,
- The EURION cluster which works on the development of new test methods for endocrine disruption,
- The European Partnership for the Assessment of Risks from Chemicals (PARC) which aims to tackle current and future needs in chemical risk assessment by generating and sharing data for exposure, hazard, and risk assessment,
- The Virtual Human Platform for Safety Assessment (VPH4Safety) which aims to accelerate the transition from traditional animal-based testing to innovative safety assessment.
EURL ECVAM also supports the development of other promising methods such as physiologically based kinetic models, Adverse Outcome Pathways and in silico medicine, in order to facilitate their progression to practical applications and regulatory acceptance.
In 2022, several test methods were submitted for validation to EURL ECVAM (e.g., LUCS-VALITOX, ProtReact, GENOMARK). In parallel, EURL ECVAM continued to work on the validation of 18 methods related to the thyroid signalling pathway. A complete overview of the submitted methods and the preliminary results of validation studies is available via the Tracking System on Alternative Methods towards Regulatory acceptance (TSAR). In addition, the PARERE network was consulted regarding the chemical risk assessment of respiratory sensitizers. In order to develop a robust and flexible framework to establish scientific confidence in NAMs for regulatory use, EURL ECVAM has collaborated with three US federal agencies (EPA, CPSC, and NIH), the OECD and PETA Science Consortium International. This framework highlights the importance of the following elements: fitness for purpose, human biological relevance, technical characterisation, data integrity and transparency, and independent review.
Several actions were undertaken to increase the development and adoption of NAMs in various fields of biomedical sciences:
- Update of the guidelines on Defined Approaches for skin sensitisation,
- Evaluation of the in vitro battery for developmental neurotoxicity as a tool for chemical assessment,
- Development of an IATA for non-genotoxic carcinogens,
- Development of a new OECD test guidelines describing how to conduct a test using a simple simulated gastric fluid to generate relative metal/metalloid release in massive and powder forms,
- Launch of the OECD Thyroid Disruption Methods Expert Group,
- Establishment of a framework for hazard testing of microbial pesticides using NAMs,
- Launch of OECD webinars on emerging technologies.
The JRC also conducted a survey on the use of NAMs for chemical safety assessment, concluding that companies mainly use NAMs to assess toxicity for simple endpoints such as local toxicity or genotoxicity and not for more complex toxicological endpoints such as carcinogenicity, immunotoxicity and respiratory sensitisation.
In 2022, EURL ECVAM published three new reports on advanced non-animal models to study immunogenicity testing for advanced therapy medicinal products, cardiovascular diseases, and autoimmune diseases. EURL ECVAM also stressed the importance of improving the impact of academic data in risk assessment to bridge the gap between scientific research and clinical practise.
Education and training
New educational resources were made available to share the knowledge on 3Rs with students at primary school, secondary school and at university level. These resources include, amongst others, learning scenarios for primary and secondary school, podcasts of interviews with scientists talking about their work with replacement approaches and other new resources such as slides and games.
Even though a lot of progress has been made in several fields in biomedical research, varying from the development to the actual uptake in a regulatory setting, and going beyond to education and training, the promotion of NAMs needs to remain a high priority for all involved stakeholders in order to achieve a break-through.
You can find our summary video here.
- Link to download the report: https://publications.jrc.ec.europa.eu/repository/handle/JRC132525
- TSAR: https://tsar.jrc.ec.europa.eu/
- JRC report ‘Advanced non-animal models: Immunogenicity testing for advanced therapy medicinal products’: https://publications.jrc.ec.europa.eu/repository/handle/JRC126997
- JRC report ‘Advanced non-animal models: cardiovascular diseases’: https://publications.jrc.ec.europa.eu/repository/handle/JRC130702
- JRC report ‘Advanced non-animal models: Autoimmune diseases’: https://publications.jrc.ec.europa.eu/repository/handle/JRC131505