Testing times for cosmetics legislation, conflicting rules for consumers, workers

Animal testing is still being used for cosmetic products in the EU. The ban on animal testing for cosmetic products is not holding; chemicals used in cosmetics must be tested under REACH regulations to protect workers.

German flavour and fragrance company Symrise discovered the rule impact when it had to meet REACH regulations for testing homosalate and 2-ethylhexyl salicylate in the exposure of its workers. An appeal of the European Chemicals Agency’s (ECHA) decision was denied.

“The thing that is difficult for me to understand, as a toxicologist, is you have workers and consumers; they're the same people, workers are consumers - workers aren’t a different species, it's not like there's different physiology and biology between workers and consumers,” says Jay Ingram, director of chemicals, Humane Society International (HSI).

“If the cosmetic regulation is saying that actually, we can be satisfied without resorting to animal testing for the safety of a cosmetic product that's going to be used every single day by people, perhaps for their whole lives,”

Ingram added: “Whereas for other humans, we have to conduct animal testing to be able to say that they're going to be okay in their factories - without really understanding the level of exposure in the factory or in the supply chain that they're going to experience; without really any analysis and exploration into that - it's just confusing, and there's a lot of tension,” he explained.

“It doesn't really seem to me like that's prioritising pragmatic steps towards assessment of health and safety. It really is just we need to tick the box because the box is there,” he said.

Conflicting legislation

MEP Tilly Metz, chair of the Parliament’s Animals in Science working group and vice chair of the Sub-committee on Public Health, explained in a recent Euractiv op-ed, “The two conflicting pieces of legislation, REACH and the Cosmetic Products Regulation, need revising to implement the animal testing ban effectively while ensuring robust human health and environmental protection.”

“Investment in non-animal methods must be bolstered, and the European Commission must offer transparency to consumers by acknowledging the alarming erosion of the ban on animal testing for cosmetics. The European Commission must include REACH and the Cosmetics Products Regulation in its upcoming work programme - a move that is already two years overdue.”

A quick look at ALURES, the Animal Use Reporting EU System, shows the alarming number of animals still being used relating to research, testing, routine production and education and training purposes in the EU, in 2022, 838,397 animals were used in testing in some form or another.

With regards to the testing of chemicals, a review of REACH, the regulation of the European Union adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, and its last resort requirement for animal testing by the Animal Free Safety Assessment (AFSA) Collaboration points out the regulatory framework around ‘last resort’ isn’t necessarily the last resort.

Poison for progress?

“These animal models can't really provide us with the information that we need to understand human biology and toxicity, and we can't put all of our faith in these animal models - is it worth putting a living sentient creature through that amount of pain, and that amount of poisoning, for something that actually we can't rely on, or we don't know if we can rely on it or not?” asks Ingram.

An example of one animal test which advocates argue needs to be left in the past is the LD50 test, which is the Lethal Dose 50% toxicity test. It’s used to measure acute toxicity and will kill 50% of the test animals for a result - it has also been proven that the results can provide questionable data and prove unrelatable when used in the human world.

But is there a call for an immediate stop to animal testing?

“Not immediately because it's very difficult, and at the minute there are still gaps in the scientific knowledge - we want to make sure that what we are doing benefits animals, but also benefits the wider society and that includes humans, it includes our ecosystems and the environment that we live and interact with as well,” said Ingram.

The alternatives

Non-animal methods or new approach methodologies (NAMs) include in vitro methods such as organ-on-a-chip solutions or 3D cell culture. There is also testing which can be done with computer code.

With advances in technology and the full-scale adoption of artificial intelligence, there are viable solutions; the next step is securing trust.

Industry stakeholders are keen to incorporate NAMS into the testing regulations, but there is a sticking point where data from these methods is not accepted within the current framework and confidence in the improved methods, which do not involve animal testing, is low.

“When it comes to the lack of confidence today, it's fair to say it's about training, capacity building, and validating these new methods and alternatives to animal testing to ensure they are fit for purpose and can be integrated into regulatory frameworks,” says Dr. Katia Lacasse Senior advisor of product stewardship at Cefic, the European Chemical Industry Council.

“It is also essential that this validation happens at the international level to avoid disconnects between what is developed in the EU and globally. You don’t want to generate data that isn’t accepted in other parts of the world and vice versa,” she explained.

Cefic’s Long-Range Research Initiative supports the 3R principles (refinement, reduction and replacement of animal testing), developing NMAs from biosciences and medicine.

The area Lacasse is most active in is the regulatory framework, particularly around REACH and also the European Chemical Agency’s CLP (Classification, Labelling and Packaging Regulation).

“The real challenge is how we can move toward a new paradigm, abandoning the tick-box approach and adopting a more tiered system that considers where testing is needed and how it can be done more meaningfully,” she says.

The ECHA has set out the key areas of regulatory challenge, for the sake of the mice, let’s hope the stakeholders find their ‘how’.

[Edited By Brian Maguire | Euractiv's Advocacy Lab ]