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Silva, R.J.;  Tamburic, S. Phasing-Out of Animal Testing in Cosmetics. Encyclopedia. Available online: https://encyclopedia.pub/entry/27255 (accessed on 11 July 2025).
Silva RJ,  Tamburic S. Phasing-Out of Animal Testing in Cosmetics. Encyclopedia. Available at: https://encyclopedia.pub/entry/27255. Accessed July 11, 2025.
Silva, Rita José, Slobodanka Tamburic. "Phasing-Out of Animal Testing in Cosmetics" Encyclopedia, https://encyclopedia.pub/entry/27255 (accessed July 11, 2025).
Silva, R.J., & Tamburic, S. (2022, September 16). Phasing-Out of Animal Testing in Cosmetics. In Encyclopedia. https://encyclopedia.pub/entry/27255
Silva, Rita José and Slobodanka Tamburic. "Phasing-Out of Animal Testing in Cosmetics." Encyclopedia. Web. 16 September, 2022.
Phasing-Out of Animal Testing in Cosmetics
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This entry is adapted from the peer-reviewed paper 10.3390/cosmetics9050090

Almost a decade after the stipulated deadline in the 7th amendment to the EU Cosmetics Directive, which bans the marketing of animal-tested cosmetics in the EU from 2013, animal experimentation for cosmetic-related purposes remains a topic of animated debate.

alternatives to animal testing in silico/in vitro/in vivo safety testing of cosmetics OECD guidance

1. Introduction

A 1936 publication entitled ‘American Chamber of Horrors: The Truth about Food and Drugs’ [1] highlighted the many instances where consumer goods led to injury or even death of the user. Consumer safeguarding, and subsequent animal testing, became a legal requirement in the United States shortly after [2], and thus, the first target for the modern animal rights movement was created. Global campaigning efforts culminated in 2009, with the phasing out of animal testing in cosmetics within European Union (EU) member states, despite representing only 0.05% of total animal use [3]. The 3Rs principle of replacement, reduction, and refinement, introduced by Russel and Burch [4], was reduced to a single R approach (replacement), making the cosmetics industry a major propellant of innovation in the field of alternative testing methods [5][6].
From March 2013, and for the purpose of cosmetics, the term ‘New Approach Methodology’ (NAM) has been adopted to refer to any non-animal technique, methodology, approach, or combination thereof that may be utilised to give data on chemical hazard and risk assessment [6][7]. NAMs are comprised of traditional in vivo/ex vivo tests, alongside in chemico methods (which provide physicochemical data on the test chemical), in silico ‘non-testing methods’ (utilising computational models such as structure-activity relationship and read-across), and physiologically-based toxicokinetics modelling. These must be combined with in vitro/ex vivo testing methodologies through a Weight of Evidence (WoE) approach, historical animal data (performed prior to legislative deadlines), and when available, data from human research, such as clinical trials and human biomonitoring [6][8].
Great efforts have been made to promote the development and regulatory acceptance of NAMs, both in science [6][9] and through initiatives championed by Non-Governmental Organizations (NGOs), trade associations, and cosmetic companies [10][11][12]. This has led to great advances in NAM development that have recently been highlighted in the literature [13]. Nevertheless, consumers and brands continue to focus on optics, such as cruelty-free certifications [14], over important milestones in NAM implementation. For example, a survey of 1011 British adults found that only 23% of participants knew that animal research is only allowed to be carried out when there is no alternative [15].
Since the 2013 cut-off-date for the phasing-out of animal testing, no novel compounds for exclusive use in cosmetics have been announced to the EU market. To remove this barrier, additional approaches and out-of-the-box thinking for the safety evaluation of new chemicals are needed [6].

2. Drivers for the Phasing-Out of Animal Testing in Cosmetics

According to NGOs, the timeline for the reduction of the use of animals in scientific experiments did not start until the early 1980s, with ethics-centred actions spearheaded by advocate Henry Spira [16]. However, prior to the birth of this global social justice movement, and the adoption of cruelty-free certificates by the personal care industry, the concept of lessening the use of animals in clinical testing was already being discussed in science [4][17].
Russel and Burch [4] were the first scientists to explore the limitations of animal models in scientific experimentation as a way of incentivising the development of alternative methods. They were also the first in literature to explore the concept of efficiency in animal experimentation, specifically the length and cost of animal studies when compared to alternative methods. They went on to state that, at the time, some in vitro methods (e.g., those employing bacteria cultures) were already proving to be cheaper than keeping live animals in laboratories. Overall, their work helped make a case for the reduction, refinement, and replacement of animal experimentation that went beyond ethical rules. However, ethical considerations must not be ignored, as they were, effectively, the fuel for the formation of the modern Animal rights movement [18][19].
The following three major drivers of innovation in the field of clinical research, including the testing of cosmetics, can be identified: ethical considerations, the lack of effective extrapolation, and economic efficiency. These emerged from an intersection between healthcare and social sciences, alongside the inescapable economic requirements of modern society.

2.1. Ethical Considerations

Henry Spira, who was a major catalyst for the modern animal rights movement, was a USA journalist for left-wing publications, which led him to emulate other social movements (such as the civil rights movement) and identify one single big success against what he called “systems of oppression” [19]. His first target was the American Museum of Natural History (AMNH), which culminated with the Museum ceasing their research on laboratory-bred and domesticated animals [19]. Spira’s next target was the cosmetics industry, specifically the Draize test [19], which signified the birth of the modern Animal rights movement.

2.2. The Lack of Effective Extrapolation

The use of animal models to obtain human-relevant data requires extrapolation, i.e., the conversion of dose-related toxicity of chemicals from animal models to humans [20]. A major motivation for the development of alternative methods is the fact that animal models can differ structurally and physiologically from humans in ways that render the study unsatisfactory [21]. In a recent analysis of 100 systematic reviews on animal experiments, 75% of reviews were found to present significant limitations when trying to predict human disease outcomes or safety through animal data [22]. These were associated with one or more of the following factors: discrepancies between species, lack of clinical translation, unsuitable methodology, inconsistencies, and publication bias, which led to an exaggeration of the benefits of animal use.
One such study that lacked in concordance was the Draize test, a method using rabbit models to study irritation and toxicity of substances applied topically to the skin and mucous membranes [23]. The efficacy of the Draize test was already being questioned by scientists and singled out as a good contender for the creation of an alternative method [19][21]. Spira’s campaign against the Draize test, which culminated in 1980, led to Revlon’s Board of Directors agreeing to provide the Rockefeller University with $750,000 in funding to support research into non-animal safety tests. Revlon then went to call on other major corporations in the personal care space to join in as research program partners. The Cosmetic, Toiletry, and Fragrance Association (CTFA) set up a fund for this purpose, which gradually gained supporters, including Avon, Bristol-Myers, Estée Lauder, Max Factor, Mary Kay Cosmetics, and others [19].

2.3. Economic Efficiency

The economic efficiency of animal testing has often been questioned [24], hence the alternative approaches were explored as a way of saving time and money, while also addressing animal welfare concerns [25]. A good example of the application of the reduction principle of the 3Rs was the abolition of the classical Lethal dose test (LD50) in 2002, which at the time used a minimum of 20 animals per test. Post-abolition, the OECD approved three new in vivo tests: the ‘Fixed-Dose Procedure Test’ (FDP; OECD TG 420), the ‘Acute Toxic Class Method Test’ (ATC; OECD TG 423), and the ‘Up-and-Down Procedure’ (UDP; OECD TG 425). These tests are performed in a sequence, in which the outcome of the previous step/dosage defines the next dose to be tested; this allows for a significant reduction in the number of animals utilised for each test, to a minimum of five animals per test [26][27][28][29][30].
Bottini and Hartung [3] were the first to explore the economic aspects of animal testing and identified the lack of new developments in this field as a suppressor of innovation and economic growth. One such inhibitory factor was precautionary, hyper-sensitive animal testing leading to the acceptance of false positives; this would then make companies discard substances at late (and expensive) stages of development. Gabbert and van Ierland [31] applied the concept of Cost-Effectiveness Analysis (CEA) to a short-term mutagenicity testing and found that, to achieve superior sensitivity to that of an in vivo test, a combination of tests would have to be used (Ames test, OECD TG 471, and Gene Mutation in Mammalian Cells, OECD TG 476), leading to an increased cost. However, when considering substances that will be marketed towards the EU cosmetics industry, where animal testing has been prohibited since 2013, in vitro testing may be the only option, and therefore the most economically viable.
Recently, Meigs et al. [5] expanded on the work of Bottini and Hartung [3], concluding that the NAMs lead to greater productivity and turnover in different industries. This work highlighted the unique position in which the cosmetic industry found itself due to regulatory changes in Europe.

References

  1. Lamb, R.D. American Chamber of Horrors: The Truth about Food and Drugs; Farrar & Rinehart, Incorporated: New York, NY, USA, 1936.
  2. Zurlo, J.; Rudacille, D.; Goldberg, A.M. Animals and Alternatives in Testing: History, Science, and Ethics; Mary Ann Liebert: New York, NY, USA, 1994.
  3. Bottini, A.A.; Hartung, T. Food for thought... on the economics of animal testing. ALTEX 2009, 26, 3–16.
  4. Russel, W.M.S.; Burch, R.L. The Principles of Humane Experimental Technique; Universities Federation For Animal Welfare (UFAW): Hertfordshire, UK, 1959.
  5. Meigs, L.; Smirnova, L.; Rovida, C.; Leist, M.; Hartung, T. Animal testing and its alternatives—The most important omics is economics. ALTEX 2018, 35, 275–305.
  6. Rogiers, V.; Benfenati, E.; Bernauer, U.; Bodin, L.; Carmichael, P.; Chaudhry, Q.; Coenraads, P.J.; Cronin, M.T.D.; Dent, M.; Dusinska, M.; et al. The way forward for assessing the human health safety of cosmetics in the EU—Workshop proceedings. Toxicology 2020, 436, 152421.
  7. ICCVAM. A Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States. Available online: https://ntp.niehs.nih.gov/go/iccvam-rdmp (accessed on 29 April 2022).
  8. SCCS. SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 11th ed.; SCCS/1628/21; SCCS: 2021. Available online: https://ec.europa.eu/health/system/files/2021-04/sccs_o_250_0.pdf (accessed on 29 April 2022).
  9. Adler, S.; Basketter, D.; Creton, S.; Pelkonen, O.; van Benthem, J.; Zuang, V.; Andersen, K.E.; Angers-Loustau, A.; Aptula, A.; Bal-Price, A.; et al. Alternative (non-animal) methods for cosmetics testing: Current status and future prospects-2010. Arch. Toxicol. 2011, 85, 367–485.
  10. Culliney, K. ‘Unique’ for Cosmetics: Animal-Free Safety Assessment New Science Programme to Launch in 2022. Available online: https://www.cosmeticsdesign-europe.com/Article/2021/06/15/Cosmetics-industry-unveils-animal-free-safety-assessment-New-Science-Programme-set-to-launch-2022 (accessed on 22 May 2022).
  11. Culliney, K. Beauty Majors Sign Joint Statement Claiming EU Animal Testing Ban is ‘Being Undermined’ by ECHA. Available online: https://www.cosmeticsdesign-europe.com/article/2020/11/10/humane-international-society-and-beauty-brands-claim-echa-is-undermining-eu-animal-testing-ban (accessed on 28 April 2022).
  12. Culliney, K. Cosmetics industry Calls on EU Institutions to Uphold Animal Testing Ban ‘As Intended’. Available online: https://www.cosmeticsdesign-europe.com/article/2020/12/02/eu-ban-on-animal-testing-for-cosmetics-must-be-upheld-by-european-commission-parliament-and-council-says-industry (accessed on 28 April 2022).
  13. Barthe, M.; Bavoux, C.; Finot, F.; Mouche, I.; Cuceu-Petrenci, C.; Forreryd, A.; Chérouvrier Hansson, A.; Johansson, H.; Lemkine, G.F.; Thénot, J.-P. Safety Testing of Cosmetic Products: Overview of Established Methods and New Approach Methodologies (NAMs). Cosmetics 2021, 8, 50.
  14. Sheehan, K.B.; Lee, J. What’s cruel about cruelty free: An exploration of consumers, moral heuristics, and public policy. J. Anim. Ethics 2014, 4, 1–15.
  15. IPSOS. Public Attitudes to Animal Research in 2018. Available online: https://www.ipsos.com/en-uk/public-attitudes-animal-research-2018 (accessed on 21 May 2022).
  16. Humane Society of the United States Timeline: Cosmetics Testing on Animals. Available online: https://www.humanesociety.org/resources/timeline-cosmetics-testing-animals (accessed on 28 May 2022).
  17. Doke, S.K.; Dhawale, S.C. Alternatives to animal testing: A review. Saudi Pharm. J. 2015, 23, 223.
  18. Singer, P. Animal Liberation; New York Review: New York, NY, USA, 1975.
  19. Singer, P. Ethics into Action: Learning from a Tube of Toothpaste; Rowman & Littlefield: Lanham, MD, USA, 1998.
  20. Voisin, E.M.; Ruthsatz, M.; Collins, J.M.; Hoyle, P.C. Extrapolation of animal toxicity to humans: Interspecies comparisons in drug development. Regul. Toxicol. Pharmacol. 1990, 12, 107–116.
  21. Sharpe, R. The Draize test—Motivations for change. Food Chem. Toxicol. 1985, 23, 139–143.
  22. Ram, R. Extrapolation of Animal Research Data to Humans: An Analysis of the Evidence. In Animal Experimentation: Working Towards a Paradigm Change; Herrmann, K., Jayne, K., Eds.; Brill: Boston, MA, USA, 2019; Volume 22, pp. 341–375.
  23. Draize, J.H.; Woodard, G.; Calvery, H.O. Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J. Pharmacol. Exp. Ther. 1944, 82, 377–390.
  24. Imai, K.; Ariumi, H.; Matsushita, T.; Hasegawa, T.; Yoshiyama, Y. History and Social Duties in Future of the AATEX: Alternatives to Animal Testing and Experimentation. AATEX 2013, 18, 53–57.
  25. Ukelis, U.; Kramer, P.; Olejniczak, K.; Mueller, S.O. Replacement of in vivo acute oral toxicity studies by in vitro cytotoxicity methods: Opportunities, limits and regulatory status. Regul. Toxicol. Pharmacol. 2008, 51, 108–118.
  26. OECD Test No. 420: Acute Oral Toxicity—Fixed Dose Procedure. In OECD Guidelines for the Testing of Chemicals, Section 4; OECD Publishing: Paris, France, 2002; Available online: https://www.oecd-ilibrary.org/environment/test-no-420-acute-oral-toxicity-fixed-dose-procedure_9789264070943-en (accessed on 19 April 2022).
  27. OECD Test No. 423: Acute Oral toxicity—Acute Toxic Class Method. In OECD Guidelines for the Testing of Chemicals, Section 4; OECD Publishing: Paris, France, 2002; Available online: https://www.oecd-ilibrary.org/environment/test-no-423-acute-oral-toxicity-acute-toxic-class-method_9789264071001-en (accessed on 19 April 2022).
  28. OECD Test No. 425: Acute Oral Toxicity: Up-and-Down Procedure. In OECD Guidelines for the Testing of Chemicals; OECD Publishing: Paris, France, 2008; Available online: https://www.oecd-ilibrary.org/environment/test-no-425-acute-oral-toxicity-up-and-down-procedure_9789264071049-en (accessed on 19 April 2022).
  29. Norlen, H.; Worth, A.P.; Gabbert, S. A tutorial for analysing the cost-effectiveness of alternative methods for assessing chemical toxicity: The case of acute oral toxicity prediction. Altern. Lab. Anim. 2014, 42, 115–127.
  30. Andrew, D.J. Acute Systemic Toxicity: Oral, Dermal and Inhalation Exposures. In Reducing, Refining and Replacing the Use of Animals in Toxicity Testing; Allen, D.G., Waters, M.D., Eds.; The Royal Society of Chemistry: London, UK, 2014; pp. 183–214.
  31. Gabbert, S.; von Ierland, E.C. Cost-Effectiveness Analysis of Chemical Testing for Decision-Support: How to Include Animal Welfare? Hum. Ecol. Risk Assess. Int. J. 2010, 16, 603–620.
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