Cruelty Free Europe: EU chemicals regulation must ‘urgently incorporate’ next-generation, non-animal testing

By Kacey Culliney contact

- Last updated on GMT

Next-gen in vitro and in silico methods have been touted as holding strong potential for non-animal testing in the future (Getty Images)
Next-gen in vitro and in silico methods have been touted as holding strong potential for non-animal testing in the future (Getty Images)

Related tags: Animal testing, ECHA, Regulation, European Green Deal, Risk assessment, Chemicals

The European Union must invest more in next-generation, non-animal chemical safety assessments to achieve its European Green Deal goals, and there are opportunities in in silico methods, says Cruelty Free Europe.

Last week, the European Commission published its European Green Deal​ outlining the over-arching goal to become the first climate-neutral continent by 2050​ and enshrine climate-neutrality into law. Covering a whole range of targets, the deal included steeper emission reductions; single-use plastic elimination; circular business model growth; and the need to protect citizens and the environment from hazardous and very persistent chemicals.

On this latter goal, Dr Katy Taylor, director of science at animal protection network Cruelty Free Europe, said it would be critical the Commission relied on sound science without animal testing to achieve this.

“EU chemicals regulation must urgently incorporate a new generation of modern and powerful non-animal approaches for the evaluation of chemicals and chemical mixtures that is truly meaningful for the protection of citizens and the environment,” ​Taylor said.

“A drive to better understand all the chemicals we are exposed to must be underpinned by investment in scientifically sound non-animal hazard testing methods, exposure monitoring methods and risk assessment strategies.”

Can cosmetics lead next-generation testing?

Animal testing for cosmetics products and ingredients is banned in the EU (Getty Images)
Animal testing for cosmetics products and ingredients is banned in the EU (Getty Images)

While animals, largely mice, remain extensively used for medical research and testing, the European Union implemented a ban on all animal testing for cosmetic products and cosmetics ingredients under its Cosmetics Regulation 1223/2009 ​in 2013. The move followed an initial ban on testing for finished products in 2004 and ingredients in 2009.

However, under the European Chemicals Agency ECHA’s REACH regulation 1907/2006​, certain aspects require or enable animal testing – notably testing for environmental endpoints like aquatic toxicity, the pre-registration of some new chemical substances and registering of chemicals used in non-cosmetic products. Peptides, for example, because used elsewhere may have been subject to animal testing. Although, once these ingredients were integrated into cosmetic formulations, further animal testing was prohibited.

Last month, Amy Beale, scientific liaison officer at medical research charity FRAME, said that despite a clear EU ban on animal testing for cosmetics, it remained a “complex issue”.

“Rather than saying ‘there’s a ban, we can sit back and relax’, we believe there’s still more to be done. …In terms of REACH, there is still animal testing that can occur and it’s just finding out what people know about it,”​ Beale said. FRAME launched an online survey to gauge public and professional knowledge on the matter.

Speaking to CosmeticsDesign-Europe, Dr Mojgan Moddaresi, regulatory expert and director of cosmetics compliance firm Personal Care Regulatory, said when it came to chemical safety assessment within cosmetics, it would be important industry looked to animal alternatives wherever possible.

“My advice is not to go down the easiest and shortest routes. There are plenty of substitute like read-across, computational toxicology, alternative methods and data sharing which may take longer but can lead to using less animal testing,”​ Moddaresi said.

Uptake and acceptance of next-generation methods

Next-generation in vitro assessments should take off in cosmetics (Getty Images)
Next-generation in vitro assessments should take off in cosmetics (Getty Images)

However, she acknowledged that current procedures to validate and approve such alternatives remained “so time consuming”​ it often hindered research efforts in this area.

“If REACH and ECHA would like to reduce animal testing in industry, they should reduce the bureaucracy in approving new alternative methods for evaluating the chemical safety,”​ she said.

Rob Taalman, science and research director of Cosmetics Europe, recently said next-generation in vitro​ safety assessments for cosmetics would see good uptake in the coming years​, though, becoming accepted by regulators and public alike as “robust and powerful”​ alternatives to animal studies.

An international Working Group, of which Taalman was a part of, this year published a report​ and guidance​ outlining nine key principles for next-generation assessment of cosmetics and some examples of novel methods and how they could be used in the cosmetic safety evaluation process.

He said the priority now was to conduct case studies to show these approaches worked – “really important in the whole dialogue of accepting new generation risk assessment”.

A future for in silico​ techniques?

According to Cruelty Free International, in silico methods hold strong promise for cosmetics (Getty Images)
According to Cruelty Free International, in silico methods hold strong promise for cosmetics (Getty Images)

Cruelty Free Europe’s Dr Taylor and her colleague Laura Alvarez recently published a review in Computational Toxicology​* analysing the regulatory drivers of the last 20 years towards use of in silico​ techniques as animal testing replacements for cosmetic-related substances.

The review concluded there had been three pieces of influential legislation: the Directive 2010/63 covering the use of animals for all scientific purposes; the Cosmetics Regulation 1223/2009 which includes a ban on animal testing; and the REACH legislation 1907/2006 which both demands animal tests as well as efforts to avoid conducting them where possible.

“Over the last 20 years, the scientific, ethical and economic limitations of the traditional approach to toxicity testing have become increasingly evident and have resulted in legislative and regulatory drivers towards the use of alternative approaches including ​in silico techniques and particularly for substances relevant to cosmetic products,”​ they wrote.

 “…As public opinion continues to move towards demanding more humane ways of assessing safety, and this is embraced by companies in their corporate and social responsibility policies, we anticipate there to be a continued, accelerating need to employ alternative methods including ​in silico techniques.”

Moddaresi said: “Perhaps we should have a procedure in the regulation to prove that ingredients’ suppliers have reviewed all the available methods and animal testing was the last resort?”

​Source: Journal of Computational Toxicology​, doi: 10.1016/j.comtox.2019.100112, "Regulatory drivers in the last 20 years towards the use of in silico techniques as replacements to animal testing for cosmetic-related substances"

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