20 Nov 2023 --- The European Food Safety Authority (EFSA) has unveiled an online platform for modeling and predicting the toxicity of chemicals in food as a pioneering alternative to animal testing. Animal protection groups welcome TKPlate and urge the industry to adopt the open-access software immediately to alleviate animal suffering. 

Historically, safety assessments of chemicals in food and feed have relied on evidence from animal experiments. But, society and scientists are increasingly questioning this practice for ethical and scientific reasons.

Now, alternative tools to generate more representative information about toxicokinetics (how the body manages chemicals) and toxicity/toxicodynamics (what chemicals do to the body) are gaining momentum.

TKPlate was developed by EFSA and several European research organizations. The project was led by two senior EFSA scientists — toxicologist Jean-Lou Dorne and statistician and modeler Jose Cortiñas Abrahantes.

“As far as we are aware, this platform is unique in the food and feed safety area,” says Dorne.

Meanwhile, Cruelty Free International’s director of science and regulatory affairs, Dr. Emma Grange, tells Food Ingredients First the charity is encouraged by developments like TKPlate.

“Such models are a valuable resource in the progression to animal-free evaluation of chemicals, from substances found in food to potentially any type of chemical,” she says.

“It is essential that non-animal approaches such as this gain acceptance across all regulatory frameworks to provide a future wher chemicals are managed in a more ethical and reliable way, based on data which better protects human health and the environment.”

Non-animal transition
According to Dorne and Abrahantes, decision-makers and regulatory authorities, including scientific advisory bodies like EFSA and its international counterparts, generally recognize the need to move to animal-free risk assessment. Regulators increasingly see new models like TKPlate as essential to this transition.

“This platform will be welcomed and, with time and experience, it will become a key tool in future risk assessment work,” the scientists say.

For animal welfare charities like People for the Ethical Treatment of Animals (PETA), animal-free testing methods should be adopted urgently, given the magnitude of animal suffering. According to official statistics, the EU (and Norway) nclick="updateothersitehits('Articlepage','External','OtherSitelink','Beyond animal testing: EFSA pioneers cruelty-free food safety platform with global appeal','Beyond animal testing: EFSA pioneers cruelty-free food safety platform with global appeal','337809','https://www.understandinganimalresearch.org.uk/news/eu-wide-animal-research-statistics-2020', 'article','Beyond animal testing: EFSA pioneers cruelty-free food safety platform with global appeal');return no_reload();">used more than 8.6 million animals for research in 2020 alone, mostly mice, fish, rats and birds (91%).

“We are delighted with the model TKPlate 1.0,” PETA UK’s science policy manager, Dr. Julia Baines, tells us. “Now the model is published, we urge EFSA, member states and the industry as a whole to incorporate TKPlate 1.0 data into risk assessments as soon as possible and continue developing robust tools to modernize regulatory science.”

Although TKPlate is not currently used in EFSA’s assessments, applications for its models are being explored to optimize the platform. The models are being tested and validated for several chemicals, particularly to compare predictions with measured data.

EFSA will then evaluate on a case-by-case basis the context under which TKPlate can be applied in its risk assessments. The organization is providing training to its staff and experts to prepare them for the new testing method.

The TKPlate 1.0 web platform is “up and running,” Dorne and Abrahantes tell us, and requires “no approval process per se.”

Global reach
The project leaders suggest it could be too early to understand TKPlate 1.0’s potential global impact, as different countries and regions have their own scientific advisory bodies with their own regulatory frameworks, risk assessment methodologies and data requirements.

But, EFSA and other regulatory bodies are in regular contact, exchanging experiences and ideas around non-animal testing — for example, work by the US Environmental Protection Agency was critical in the development of TKPlate.

“Some of our partners in EU member states and other regions have already asked for support in using TKPlate in their risk assessments,” say Dorne and Abrahantes.

TKPlate was among the topics discussed at the recent nclick="updateothersitehits('Articlepage','External','OtherSitelink','Beyond animal testing: EFSA pioneers cruelty-free food safety platform with global appeal','Beyond animal testing: EFSA pioneers cruelty-free food safety platform with global appeal','337809','https://www.efsa.europa.eu/en/events/13th-global-summit-regulatory-science-gsrs23', 'article','Beyond animal testing: EFSA pioneers cruelty-free food safety platform with global appeal');return no_reload();">Global Summit on Regulatory Science hosted by EFSA in Parma, Italy. A major advantage of the platform is that it can generate information on kinetics and dynamics for many species within minutes and without testing, allowing researchers to extrapolate in vitro data to in vivo situations.

EFSA’s chief scientist, Carlos Gonçalo das Neves, comments: “We are on the cusp of a new era in chemical risk assessment, which will see not only a welcome reduction in the need for animal testing — much nclick="updateothersitehits('Articlepage','External','OtherSitelink','Beyond animal testing: EFSA pioneers cruelty-free food safety platform with global appeal','Beyond animal testing: EFSA pioneers cruelty-free food safety platform with global appeal','337809','https://ec.europa.eu/commission/presscorner/detail/en/ip_23_3993', 'article','Beyond animal testing: EFSA pioneers cruelty-free food safety platform with global appeal');return no_reload();">requested by our citizens — but also further improvements in the quality and relevance of the data used in our assessments.”

“We can and want to roll out this support to other EU agencies and national authorities.”