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Editor-in-chief: Maurizio Roncaccia
Editors: Paul Trouth and Päivi Jokiniemi
Article related to: People and perspectives
Guest column: Change of mindset needed to increase use of non-animal methodologies for safety assessment
When it comes to safety assessment of chemicals, we need to find a balance between ethics and science. We need to make sure that the pace of development, acceptance of new methodologies by regulators and promotion of education all go hand-in-hand to make most of the momentum started in Europe that is being embraced worldwide.
Europe has pioneered the promotion of alternative approaches to testing on animals. European regulations were the first to require fewer animal tests for assessing safety and no in vivo tests at all if alternatives are available. In fact, the EU invests massively in developing, validating and accepting new alternative approaches. I am very proud to have been one of the founders of the European Partnership for Alternative Approaches to Animal Testing (EPAA) in 2005, which is a public private partnership between companies and the European Commission.
Charles Laroche. Image: Charles Laroche.
The goal of the EPAA is to share information on alternatives to accelerate their validation and acceptance. For instance, our current portfolio includes six projects covering different endpoints and industry sectors.
One of the largest is the skin sensitisation project that focuses on comparing new in vitro skin sensitisation models based on 3D-epidermis with a set of difficult to test reference chemicals. Since the first step in safety evaluation of chemicals and cosmetics is the assessment of the skin sensitisation potential (hazard identification), finding ways to do this without using animals has been the focus of intensive work in industry and academia. Developments here would have a significant effect on the numbers of animals needed.
This work has resulted in validated non-animal tests that are accepted as OECD Test Guidelines. The REACH Committee has approved a revision of Annex VII to REACH with the result that validated non-animal test results are now the default information requirement for assessing the skin sensitisation potential of chemicals.
In addition, three in chemico/in vitro methods based on cell culture and/or aqueous media have been validated by the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) and have also been adopted by the OECD. However, these methods still have limitations in terms of predicting potency, which is a key element for risk assessment and to test certain types of substances.
Therefore, further work on these models is needed. For example, 3D skin tissue models are being developed to better mimic the skin’s structure and how it works allowing the substances to be applied to this more accurate skin model. The objective of this EPAA project is to evaluate the three most advanced 3D skin models for their reliability for skin sensitisation prediction for substances that are difficult to test. We are expecting to have the preliminary results of this project ready within the coming months.
These European regulations and developments are inspiring many similar initiatives overseas, which is a great thing. Meanwhile, the EPAA partners will further work to strengthen the European lead in more effective assessment for safer products while bringing benefits for animal welfare.
Mr Charles Laroche is the Head of the International Fragrance Association (IFRA) Europe as well as the Industry Chair and Founder of the European Partnership for Alternative Approaches to Animal Testing (EPAA).
EPAA is a voluntary collaboration between the European Commission, European trade associations and companies from seven industry sectors. The partners work to speed up the development, validation and acceptance of alternative approaches to animal use in regulatory testing.