It is a win-win situation: Developing animal-free safety methods and advancing safety science go hand in hand. Today, better safety science without animal testing is a scientific reality in many cases, but obstacles remain. One of them is that chemical regulations are still rooted in former safety science built on animal testing. To truly unlock the full power of existing non-animal safety science, we need regulatory change.
Today’s customers are more astute and more conscious about the products they buy. People want to know what goes into them, where they come from, and what really sits behind the product labels. Is the product packaging environmentally friendly? Are ingredients sourced responsibly? Is a product tested on animals? These are just some of the wide-ranging ethical questions fueling shifts in consumer habits where science is an essential part of the solution.
For more than 40 years, P&G has been working together with experts from academia, animal welfare organizations and industry. We are also partnering with groups like AFSA (Animal Free Safety Assessment Collaboration), EPAA (European Partnership for Alternative Approaches to Animal Testing), and the ICCS (International Collaboration on Cosmetics Safety). This effort enabled us to collectively advance safety science and develop animal-free testing methods, often referred to as New Approach Methodologies (NAMs). These methods often predict human safety more effectively than animal testing, and thanks to their development, we at P&G and the beauty industry now establish the safety of cosmetic products and ingredients without animal testing.
But, while science has progressed, legislative obstacles remain. Chemical safety and the registration laws of many countries, such as the EU’s chemical legislation REACH, are still rooted in older safety science. This approach means that, to determine the safety of ingredients, they still require an adverse effect be established in an animal, rather than utilizing the full power of NAMs that enable a more sophisticated and refined prediction of human safety risks.
For example, REACH requires cosmetic ingredients with fully established safety via NAMs be tested on animals for the safety of workers who may be exposed to the material, undermining the public’s trust in the EU’s Cosmetics Animal Testing ban. Most recently, this issue led to the European Citizens’ Initiative Petition “Save Cruelty Free Cosmetics”, gaining more than one million signatures that included nongovernment organizations (NGOs), private businesses and academics in 2022.
In their recent fifth report on the use of alternatives to testing on animals, the EU’s Chemical Agency, ECHA, in charge of REACH assessments, noted the progress of NAMs and their increased use. However, earlier ECHA representatives have highlighted the general problem in the ‘philosophy’ of the current REACH legislation, stating: “If you want to make them [NAMs] more of use, and more successful, most probably you will need to consider changing the legal framework.”
The U.K. government even went as far as announcing a ban on new licenses for animal testing of cosmetics exclusive ingredients in May 2023, recognizing “the public concern around the testing on animals of chemicals used as ingredients in cosmetics, and the new opportunities available to us to depart from the EU testing regime”.
In partnership with academia, P&G published a peer-reviewed paper outlining the steps required to end animal testing. It also addresses the importance of regulatory change and why we believe it is possible to regulate many chemicals and their safety via NAMs –predicting the biological action and potential effects in humans, rather than demonstrating the adverse outcome in an animal, and extrapolating to humans.
It is clear: REACH, in place for 17 years, needs reform along two paradigm shifts:
- Benchmarking for NAMs needs to be their ability to predict effects in humans, not to mimic effects observed in an animal test. Previous animal research helped develop NAMs to where they are today.This previous animal data will remain important for the entire industry and regulatory community to assess the safety of new ingredients by reading-across data from similar ingredients with an established safety profile. Importantly, animal tests are an attempt to predict what may happen in humans. Unfortunately, the REACH legislation is still rooted in traditional safety science with animal data as the ‘gold standard’ to which all NAMs are benchmarked. Regulators need to acknowledge that NAMs measure different biological effects which can be equivalent to, or even more relevant, for human safety and that there is no one-for-one NAM replacement for animal tests. The chemical management systems in place now will need to be changed to make use of NAMs as more than just supplemental information. Or, to compare it with other technological advancements, when developing the next-generation smartphone, electronics manufacturers follow current consumer needs rather than benchmarking against zero-generation mobile phones from the 1980s. We believe the benchmark for any test should be its ability to predict effects in humans.
- REACH needs to evolve from hazard to safety assessment, by considering the amount of an ingredient, like other regulations do.
“Dosis sola facit venenum — The dose makes the poison”. This basic concept of toxicology is not always considered by REACH. It ignores the amount of a chemical needed to cause harm (i.e., exposure) for which REACH was criticized from the very beginning. Consequently, safe materials such as soap ingredients are to be tested under REACH, not because experts believe these ingredients safely used at certain amounts for decades are of concern, but because their higher production volume requires additional data. Surely, we cannot believe new animal testing of very safe ingredients — for bureaucratic reasons because REACH ignores exposure — will be of any added value for protecting people. Other legislations, like the EU’s Cosmetics Regulation, or food safety regulations, enforce exposure considerations, allowing a much broader use of NAMs. It’s crucial for REACH to evolve toward this approach to bring us closer to an end of animal testing.
We need to work together to reform global chemical legislations. And there is a great opportunity to do so now. In August 2023, global experts from academia, industry, animal welfare NGOs and government officials will come together at the 12th World Congress on Alternatives and Animal Use in the Life Sciences in Canada (WC12), which P&G is sponsoring as we have the past 11 world congresses. A major theme of the WC12 is the ‘Regulatory Acceptance of NAMs’. It is important that we use this opportunity to review regulations, like REACH, for better and more ethical safety science. Only then will we be able to take the next major step to bring us closer to our ultimate goal: A world with better safety science and without animal testing.