The annual status report of the JRC’s EU reference laboratory for alternatives to animal testing (EURL ECVAM) highlights recent EU statistics on animals used for scientific purposes, which show an overall reduction of 5% of animal procedures in the EU and Norway from 2018 to 2022.
In parallel, the biotechnology sector has experienced rapid growth, with cutting edge technologies and innovation transforming many domains including biomedical research, development of medicines and in vitro testing. Data show that in 2021, the global biotechnology market was worth €720 billion with an annual growth rate higher than 18%.
Establishing standards for in vitro biotech innovation
Standards are needed to foster a robust biotech ecosystem and facilitate technology transfer from research to industry.
ECVAM’s work has been instrumental in driving standardisation efforts in the in vitro biotech sector, including contributing to the CEN-CENELEC Focus Group on Organ on Chip. The group delivered a roadmap identifying priorities for standardisation of this disruptive technology, which underpins a new generation of sophisticated non-animal models and methods set to transform research and regulatory testing.
Validation is essential for the development of standard tests using non-animal methods. To ensure an internationally recognised and harmonised approach, ECVAM is co-leading the project to revise the OECD Guidance Document (no. 34) on the validation and international acceptance of new or updated test methods for hazard assessment.
Better protection of workers and consumers from mutagenic chemicals
The UN Globally Harmonized System of Classification and Labeling of Chemicals (GHS) was created by the United Nations to classify chemicals by the hazards they might pose to humans or the environment, such as being corrosive or acutely toxic. The GHS is used worldwide to facilitate trade, and to ensure safe packaging, transport and use.
ECVAM is leading an informal working group to update GHS classification criteria for identifying chemicals that can mutate the DNA of germ cells, which develop into ova in women and sperm in men, and thus can carry over health effects into future generations. This work is also considering options for adapting criteria to make better use of non-animal data and to provide more protection from cancer-causing chemicals.
Supporting EU’s open science policy
Through PRO-MaP, an initiative Promoting Reusable and Open Methods and Protocols, ECVAM has been driving improvements in methodological reporting and transparency in scientific publications, capitalising on innovation and improving health outcomes.
This work has been recently highlighted in an editorial of the journal Nature Methods, recognising the ECVAM Pro Map initiative as very valuable to the field.
Upcoming roadmap on phasing out animal testing
ECVAM is supporting the preparation of the European Commission “Roadmap towards phasing out animal testing for chemical safety assessments”, to be published in 2026. It will serve as an actionable plan for accelerating the path towards replacing animal testing in the safety assessments of chemicals, including pharmaceuticals.
Alternatives in research and education
Finally, ECVAM has also made significant advances in promoting non-animal approaches in research and education, including the launch of its brand new Virtual Reality laboratory.
Other key initiatives include the development of the BioMedical Models Hub (BimmoH), an automated database that collects and organises information on non-animal models used in biomedical research, and the Student Ambassador Project, a self-sustaining movement to spread knowledge across European universities.
Related content
Non-Animal Methods in Science and Regulation – 2024 ECVAM status report
EU Reference Laboratory for alternatives to animal testing (EURL ECVAM)
O artigo foi publicado originalmente em JRC.
