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Bioethics: a look at animal testing in medicine and cosmetics in the UK

Using animals for cosmetics and medical tests has contributed towards a debate based on conflicting interests. Despite the efforts in justifying the value of animals in conducting analyses, this study seeks to elaborate whether or not it is rational to use animals as test subjects in medical and cosmetics fields. The value of animal life is at the core of the emotional conflicts that arise when animals become experimental subjects in medical and cosmetics fields. The aim of this study is to determine if there are ethical differences in the use of animal testing in medicine versus cosmetics. The research, through review and content analysis of the existing literature, compares and provides the outcomes of using animals in medical and cosmetics tests by examining studies conducted in the UK. The findings of this research indicated that animal testing is considered acceptable in the medical field only if there are no other alternatives, but is completely unacceptable in the cosmetics field. The study also provides recommendations in the form of alternatives that protect animals from cruelty and may benefit the different stakeholders and the society at large.

Introduction

Throughout history, animals have been the subject of experimentation to improve our understanding of anatomy and pathology ( 1 ). However, animal testing only became significant in the twentieth century ( 2 ).

Animal experiments are used extensively when developing new medicines and for testing the safety of certain products. Recently, the use of animals for biomedical research has been severely criticized by animal rights and protection groups. Similarly, many nations have established laws to make the practice of animal testing more humane. There are two positions in animal testing. One is that animal testing is acceptable if suffering is minimized and there are human benefits that could not have been achieved using any other means ( 3 ). The second position considers animal testing unacceptable because it causes suffering, and the benefits to human beings are either not proven or could be obtained using other methods.

As such, animal testing is a highly controversial subject that often elicits conflicting emotions from supporters and critics alike. It is also a divisive subject as some people support animal testing only in certain cases and oppose its use in other areas. For example, scientists note that significant medical breakthroughs have only been made possible through drug testing on animals. To them and other like-minded people, such achievements are reason enough to keep using animals in the lab ( 4 ). Animal tests determine if experimental drugs are effective or ineffective on human beings. Eventually, the medicine is tried out on a small group of humans through clinical trials before declaring the medicine safe to use.

Badyal and DesaI ( 5 ) note that these treatments are as beneficial to humans as they are to animals, since some human diseases are found in animals too. Therefore, some who support animal testing only advocate its use for medical (but not cosmetics) purposes, arguing that the advancement in human medicine may lead to advancement in animal medicine.

While a significant population completely disapproves of animal testing, a faction of people only disagrees with the use of animals for cosmetics testing, arguing that it is despicable and cruel to use animal life merely so that humans can advance their beauty technology. The concern extends to animals used for science, and people want animal suffering to be minimized ( 6 ). The discovery of new drugs has for a long time been based on a number of interactions among aspects such as data collected from patients, tissues, organs or cell culture and varied animal species ( 7 ). Those who oppose the use of animal testing for cosmetics believe it is outrageous and cruel to use animal life for the simple reason of making humans look better, and that the benefits to human beings do not validate the harms done to animals ( 7 ).

For such reasons, the use of animals for testing cosmetics products has been banned in the UK and all other member states of the European Union since 2013 ( 8 ). However, other countries like China and the United States of America still continue with the practice ( 9 ). Linzey adds that about 50 - 100 million animals are used for experiments every year, and that over 1.37 million animals were used for drug experimentation in America in the year 2010 ( 9 ). In the meantime, the number of experiments conducted on animals has declined in Britain but is increasing in other countries. While experiments involving vertebrates are regulated in most countries, experiments on invertebrates are not ( 5 ).

The aim of this study is to examine whether or not animal testing is still useful and necessary in the present time, and whether there are ethical differences between animal testing in medical and cosmetics fields. We use the UK as our case study and provide alternatives that can be recommended in place of animal testing.

This review was based on a cross-sectional survey by Clemence and Leaman ( 11 ) that analysed the importance of animal testing from two different aspects: medicine and cosmetics. The population consisted of individuals residing in the UK, and the sample size was 987 (= 0.03). The research included 496 men and 491 women. The report compared public views with the responses from a similar study in 2014 that had 969 participants (477 men and 492 women). The inclusion criteria were based on numerous strata such as gender, social grade definitions (i.e., professionals such as doctors and architects, people with responsible jobs such as professors, middle rank public servants such as nurses and clerics, skilled manual workers, etc.), respondents’ working status (fulltime, part-time, not working), ethnicity (white, non-white), and educational background. This report measured public perception on whether it is ethical to use animal testing for medical or cosmetics purposes. Participants were required to state whether they found it acceptable, mostly unacceptable, unacceptable, or were undecided. Consequently, the same participants were also tasked to indicate whether they saw conducting animal testing for scientific experimentation as completely necessary, somewhat necessary, not very necessary, completely unnecessary, or they did not know.

The study also utilized data from the UK Home Office ( 12 ) to determine which animals were most frequently used for medical and cosmetics research around the world. This report also provided crucial information as to the purposes of animal testing, for instance for medical research, biological testing, regulatory testing, etc.

According to the UK Home Office ( 12 ), in the year 2016, 48.6% of the animal tests in medical research were conducted for genetically oriented studies. Moreover, 28.5% of the medical research involving animal testing was for basic biological research, 13.5% was for regulatory

testing, 8.6% was for translating research from animals to humans, and 0.8% for other trainings. This is summarized in Figure 1 below.

Purposes of Animal Testing in Medicine

Data from the UK Home Office ( 10 ) indicates that the most commonly used animals for medical and cosmetics research are mice and rabbits (72.8%), fish (13.6%), rats (6.3%), birds (3.9%) and other animal species representing 3.4% of the total test animal population, as indicated in Figure 2 below.

Types of Animals Used in Testing

A published report ( 12 ) indicated that 17% of the sampled group viewed animal testing for medical research as ‘mostly unacceptable’ if there were no alternative, 17% as ‘not acceptable’, and 65% as ‘acceptable’. This was in stark contrast with testing for cosmetics purposes, to which an overwhelming 80% of the participants responded as ‘unacceptable’. The summary of the results is provided in Figure 3 and Figure 4 below.

Animal Testing for Medical Research

Animal Testing for Cosmetics Research

 In the same study ( 12 ), the participants were asked about the necessity of conducting scientific experiments on animals, which 38% of the respondents viewed as ‘completely necessary’, 23% as ‘somewhat necessary’, 20% as ‘not very necessary’, and 16% as ‘completely unnecessary’. The results are summarized in Figure 5 below.

Necessity of Conducting Scientific Experiments on Animals

The application of these methods to evaluate the safety of cosmetics was the most detested as stated by about 80% of the people who were interviewed during the investigation. The sensitivity to human life, on the other hand, reduces the strictness towards utilization of animals to find anti-viruses and antibiotics for various diseases.

The outcome portrays the essentiality of using animals to determine materials that would help the population to live healthily ( 13 ). However, in the past few decades, the number of animals used for testing drugs has been steadily decreasing ( 14 ).

The data indicates that most of the medical research processes involving animal testing emanate from genetically oriented studies, which constitute 48.6% of the medical research animal testing. Experimentation on human genetics presents various legal and ethical challenges to medical and biological researchers, alongside problems in creating experimental procedures using human test subjects. These problems occur partially due to the fact that the experimentation processes involved in these types of studies often lead to extensive gene and physiological damages to the test subjects. Such experiments typically involve deliberate presentation of diseases and other gene modifications to the test subjects, usually requiring the euthanizing of the involved subjects ( 15 ). The animal testing experimentations involving genetic processes include studies in gene modification and examine diseases believed to hold genetic components, such as cancer and diabetes ( 16 ). These experimentation processes typically involve some sort of gene modification that can simulate the presentation of genetically based disorders manifested in human beings to allow researchers to better understand those disorders.

The data also indicate that another major application of animal testing in the medical field is in basic research in biological systems and processes, which accounts for 28.5% of the testing categories. This application of animal testing in medical research involves studies in how biological systems function, and the nature and manner of disease transmission in living organisms. The findings accrued through these kinds of studies translate to advancements in the scientific knowledge of human pathology and present opportunities for the derivation and testing of cures, as noted by Festing and Wilkinson ( 17 ).

The findings further present that regulatory testing (13.5%) and animal to human translation research (8.6%) account for significant portions of the application of animal testing in the medical field. The use of animal testing for regulatory testing purposes involves applying new medical findings, procedures and products to animals to see if they meet the thresholds mandated by the medical regulatory bodies. Translation of research findings from animals to humans involves conducting research into the possibility of animal pathogens becoming infectious to humans, and identifying potential ways of applying non-human physiology to the improvement of human health. Other forms of medical and biological trainings and studies that also engage the use of animals in experimentation in the medical field include elements such as basic physiology and pathogen studies, typically conducted in educational institutions.

Animal testing in the field of cosmetics generally involves the use of animal subjects in testing new cosmetics products and ingredients. The practice essentially involves the application or forced ingestion or injection of these substances to various parts of test animals to examine their toxicity, irritation of the eyes and/or skin, ultraviolet light-triggered toxicity, and their potential for causing unwanted gene mutations ( 18 ).

The use of animal testing in the field of cosmetics research and production presents an unethical viewpoint since the findings do not advance human health, and the practice leads to the torture and killing of animals. The Humane Society ( 18 ) also notes that at the conclusion of the experimentation, the animals are usually killed through methods such as decapitation, neck twisting and asphyxiation, often without pain relief.

With regard to the ethical principles of animal testing in both fields, a convincing argument should first be presented to the Institutional Animal Care and Use Committee (IACUC). This is to justify the need for a researcher to conduct animal studies, and to ensure that the research is conducted using the smallest possible number of animals and with minimal suffering. Additionally, Naderi et al. ( 19 ) noted an increased level of legislation on the matter of animal testing, with researchers being required to submit comprehensive proposals to the IACUC to demonstrate procedural compliance with the guiding principles of the organization before conducting animal tests. Furthermore, Holden ( 20 ) highlighted the fact that researchers need to justify to review and ethics committees the use of mice rather than other alternatives in experiments. These issues indicate that researchers should look for alternatives to animal testing before proceeding with animal trials.

The issue then remains on the nature and availability of alternatives to animal testing in the medical research field. Researchers have undertaken measures to introduce some levels of such alternatives in medical studies. The accrued data indicate that a significant number of people agree with animal testing for medical research, especially when compared to those who agree with animal testing for cosmetics purposes. The data obtained from the studies indicate a slow but perceptible shift in the public opinions regarding animal testing for medical research purposes. People are increasingly finding it unacceptable to use animal test subjects even in medical research. However, the majority of the sampled people believed that medical testing procedures should use animal test subjects, but only when there is no other alternative. This indicates that people view animal testing for medical research as ethical, but under certain conditions.

The use of animals in research is still relevant because the process is useful in veterinary medicine as it helps the students understand the physiology and anatomy and improves surgical skills ( 21 ). The study by Badyal and Desai ( 5 ) supports this perception by highlighting the fact that animal use in laboratory investigation will make new discoveries possible. However, researchers should apply ethical concepts to reduce the amount of pain and unnecessary procedures for the animals. Moreover, animal testing to develop new drugs will continue to protect the future existence of humanity. Cheluvappa, et al. ( 22 ) reiterate that animal experimentation will remain essential to testing future medicine because it helps scientists understand the changes of behaviour, embryology and genetics through dissections that are conducted on the genetically produced animals.

Animals play an important role in testing human drugs as they have a large number of medical reactions similar to those of human beings. Specifically, animals such as dogs, mice and rabbits have an identical DNA that cannot be replicated through artificial models. Public concern for the increasing use of animals in terms of ethics and safety provokes anxiety among the population. Conversely, these uncertainties and unavailability of trustable alternatives show the importance of using animals in medical research as the scientists aim to protect the human race ( 23 ).

However, the use of animals to test cosmetics is highly limited due to the availability of alternative sources. For instance, The Laboratory Animals Veterinary Association (LAVA) claims that the UK government prohibits any individual from using animals to determine the suitability of cosmetics to the human body ( 13 , 24 ). In its circular, The European Union states that they have succeeded in developing alternative measures that cosmetics firms can apply to test their products without using laboratory animals ( 25 ).

Recommendations: Alternatives to Animal Testing

To improve business ethics in cosmetics companies, it is necessary for alternatives to be integrated instead of animals. Companies can employ assessment of scientific barriers to find replacements for animal test subjects and to procure the knowledge of correctly using animals for medical and cosmetics tests. Sophisticated tests on human cells or tissues, computer-modelling techniques, and experiments on people who volunteer are some measures that can limit acts of animal cruelty by cosmetics companies. Companies need to integrate tests that minimize involvement of animals in order to limit the possibility of animal cruelty, and consequently improve their business ethics. Some of the recommended alternatives are listed here.

Computer Simulation

The concept was developed by Denis Noble, and the system is currently enrolled in clinical settings. These simulations are used to test heart replacements, and are also applied to explore human behavior. Various scholars provide that this model is more accurate than animal experiments because it uses human data to analyse diseases and make predictions ( 26 ).

Stem cells are proper alternatives to the in vitro systems of disease testing and toxin evaluations ( 27 ). The experiments involve evaluation of embryonic stem cells that can be grown in Petri dishes. The Petri dishes can be placed in the cells, and after that the resulting components are placed under evaluation to help in the discovery of new medications. Stem cells are essential because they can differentiate into human tissues and make it possible to screen the suspected diseases ( 26 ).

These materials are majorly utilized in the cosmetics industry to minimize the number of animals used to test the level of toxicity in a product. Significantly, investigations showed that human tissues developed in laboratories can be used to assess the allergic responses to the available chemicals ( 28 ). These results can then be analysed by comparing reactions, and a bio signature of genes is used to make appropriate interventions.

Notably, scientists can take high-resolution pictures of human tissues, which are then analyzed with the help of various computer systems. The advantage of this model is characterized by its ability to customize the parts of the organism under consideration. Moreover, 3D images also develop prototype designs and materials that can be used to investigate the existing and future ailments ( 29 ).

This study indicates that it is justifiable to use animals in experimentations only when there are no alternatives, and the tests have significant benefits to humans. Many researchers are working towards finding options that will help eliminate the use of animals for medical and cosmetics tests. The different natures of tests conducted on animals in the fields of medicine and cosmetics tend to have clear negative implications. For such reasons, it is imperative for organizations to develop practices that endorse business ethics. Although animal tests are ideal in establishing whether drugs can be effective in treating humans for various ailments, entities that conduct these tests need to be educated about the gravity of the situation. Animals have been extremely useful in conducting genetic studies and for biological systems investigations. However, a comparison between animal tests in medicine and cosmetics reveals that their benefits in the field of medicine outweigh those in cosmetics. Therefore, animals are essential contributors to scientific experiments that are affiliated with the medical industry. The effects that medical products may have on humans make it ethical to carry out the tests on animals first.

After analysing the arguments of both the supporters and opponents involved in the controversial subject of animal testing, it is difficult to determine which direction is right or wrong. However, the agreement is that animal suffering be minimized at all costs. This research concludes that cosmetics companies should adhere to the established laws and principles against the use and abuse of animals in tests and should seek alternative methods to test their products.

Acknowledgements

Citation to this article:

Kabene S, Baadel S. Bioethics: a look at animal testing in medicine and cosmetics in the UK. J Med Ethics Hist Med. 2019; 12: 15.

Conflict of Interests

Authors declare having no conflict of interest.

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About Animal Testing

Humane Society International / Global

What is animal testing?

The term “animal testing” refers to procedures performed on living animals for purposes of research into basic biology and diseases, assessing the effectiveness of new medicinal products, and testing the human health and/or environmental safety of consumer and industry products such as cosmetics, household cleaners, food additives, pharmaceuticals and industrial/agro-chemicals. All procedures, even those classified as “mild,” have the potential to cause the animals physical as well as psychological distress and suffering. Often the procedures can cause a great deal of suffering. Most animals are killed at the end of an experiment, but some may be re-used in subsequent experiments. Here is a selection of common animal procedures:

• Forced chemical exposure in toxicity testing, which can include oral force-feeding, forced inhalation, skin or injection into the abdomen, muscle, etc.
• Exposure to drugs, chemicals or infectious disease at levels that cause illness, pain and distress, or death
• Genetic manipulation, e.g., addition or “knocking out” of one or more genes
• Ear-notching and tail-clipping for identification
• Short periods of physical restraint for observation or examination
• Prolonged periods of physical restraint
• Food and water deprivation
• Surgical procedures followed by recovery
• Infliction of wounds, burns and other injuries to study healing
• Infliction of pain to study its physiology and treatment
• Behavioural experiments designed to cause distress, e.g., electric shock or forced swimming
• Other manipulations to create “animal models” of human diseases ranging from cancer to stroke to depression
• Killing by carbon dioxide asphyxiation, neck-breaking, decapitation, or other means

What types of animals are used?

Many different species are used around the world, but the most common include mice, fish, rats, rabbits, guinea pigs, hamsters, farm animals, birds, cats, dogs, mini-pigs, and non-human primates (monkeys, and in some countries, chimpanzees). Video: Watch what scientists have to say about alternatives to animal testing .

It is estimated that more than 115 million animals worldwide are used in laboratory experiments every year. But because only a small proportion of countries collect and publish data concerning animal use for testing and research, the precise number is unknown. For example, in the United States, up to 90 percent of the animals used in laboratories (purpose-bred rats, mice and birds, fish, amphibians, reptiles and invertebrates) are excluded from the official statistics, meaning that figures published by the U.S. Department of Agriculture are no doubt a substantial underestimate.

Within the European Union, more than 12 million animals are used each year, with France, Germany and the United Kingdom being the top three animal using countries. British statistics reflect the use of more than 3 million animals each year, but this number does not include animals bred for research but killed as “surplus” without being used for specific experimental procedures. Although these animals still endure the stresses and deprivation of life in the sterile laboratory environment, their lives are not recorded in official statistics. HSI believes that complete transparency about animal use is vital and that all animals bred, used or killed for the research industry should be included in official figures. See some animal use statistics .

What’s wrong with animal testing?

For nearly a century, drug and chemical safety assessments have been based on laboratory testing involving rodents, rabbits, dogs, and other animals. Aside from the ethical issues they pose—inflicting both physical pain as well as psychological distress and suffering on large numbers of sentient creatures—animal tests are time- and resource-intensive, restrictive in the number of substances that can be tested, provide little understanding of how chemicals behave in the body, and in many cases do not correctly predict real-world human reactions. Similarly, health scientists are increasingly questioning the relevance of research aimed at “modelling” human diseases in the laboratory by artificially creating symptoms in other animal species.

Trying to mirror human diseases or toxicity by artificially creating symptoms in mice, dogs or monkeys has major scientific limitations that cannot be overcome. Very often the symptoms and responses to potential treatments seen in other species are dissimilar to those of human patients. As a consequence, nine out of every 10 candidate medicines that appear safe and effective in animal studies fail when given to humans. Drug failures and research that never delivers because of irrelevant animal models not only delay medical progress, but also waste resources and risk the health and safety of volunteers in clinical trials.

What’s the alternative?

If lack of human relevance is the fatal flaw of “animal models,” then a switch to human-relevant research tools is the logical solution. The National Research Council in the United States has expressed its vision of “a not-so-distant future in which virtually all routine toxicity testing would be conducted in human cells or cell lines”, and science leaders around the world have echoed this view.

The sequencing of the human genome and birth of functional genomics, the explosive growth of computer power and computational biology, and high-speed robot automation of cell-based (in vitro) screening systems, to name a few, has sparked a quiet revolution in biology. Together, these innovations have produced new tools and ways of thinking that can help uncover exactly how chemicals and drugs disrupt normal processes in the human body at the level of cells and molecules. From there, scientists can use computers to interpret and integrate this information with data from human and population-level studies. The resulting predictions regarding human safety and risk are potentially more relevant to people in the real world than animal tests.

But that’s just the beginning. The wider field of human health research could benefit from a similar shift in paradigm. Many disease areas have seen little or no progress despite decades of animal research. Some 300 million people currently suffer from asthma, yet only two types of treatment have become available in the last 50 years. More than a thousand potential drugs for stroke have been tested in animals, but only one of these has proved effective in patients. And it’s the same story with many other major human illnesses. A large-scale re-investment in human-based (not mouse or dog or monkey) research aimed at understanding how disruptions of normal human biological functions at the levels of genes, proteins and cell and tissue interactions lead to illness in our species could advance the effective treatment or prevention of many key health-related societal challenges of our time.

Modern non-animal techniques are already reducing and superseding experiments on animals, and in European Union, the “3Rs” principle of replacement, reduction and refinement of animal experiments is a legal requirement. In most other parts of the world there is currently no such legal imperative, leaving scientists free to use animals even where non-animal approaches are available.

If animal testing is so unreliable, why does it continue?

Despite this growing evidence that it is time for a change, effecting that change within a scientific community that has relied for decades on animal models as the “default method” for testing and research takes time and perseverance. Old habits die hard, and globally there is still a lack of knowledge of and expertise in cutting-edge non-animal techniques.

But with HSI’s help, change is happening. We are leading efforts globally to encourage scientists, companies and policy-makers to transition away from animal use in favour of 21st century methods. Our work brings together experts from around the globe to share knowledge and best practice, improving the quality of research by replacing animals in the laboratory.

Are animal experiments needed for medical progress?

It is often argued that because animal experiments have been used for centuries, and medical progress has been made in that time, animal experiments must be necessary. But this is missing the point. History is full of examples of flawed or basic practices and ideas that were once considered state-of-the-art, only to be superseded years later by something far more sophisticated and successful. In the early 1900’s, the Wright brothers’ invention of the airplane was truly innovative for its time, but more than a century later, technology has advanced so much that when compared to the modern jumbo jet those early flying machines seem quaint and even absurd. Those early ideas are part of aviation history, but no-one would seriously argue that they represent the cutting-edge of design or human achievement. So it is with laboratory research. Animal experiments are part of medical history, but history is where they belong. Compared to today’s potential to understand the basis of human disease at cellular and molecular levels, experimenting on live animals seems positively primitive. So if we want better quality medical research, safer more effective pharmaceuticals and cures to human diseases, we need to turn the page in the history books and embrace the new chapter—21st century science.

Independent scientific reviews demonstrate that research using animals correlates very poorly to real human patients. In fact, the data show that animal studies fail to predict real human outcomes in 50 to 99.7 percent of cases. This is mainly because other species seldom naturally suffer from the same diseases as found in humans. Animal experiments rely on often uniquely human conditions being artificially induced in non-human species. While on a superficial level they may share similar symptoms, fundamental differences in genetics, physiology and biochemistry can result in wildly different reactions to both the illness and potential treatments. For some areas of disease research, overreliance on animal models may well have delayed medical progress rather than advanced it. By contrast, many non-animal replacement methods such as cell-based studies, silicon chip biosensors, and computational systems biology models, can provide faster and more human-relevant answers to medical and chemical safety questions that animal experiments cannot match.

“The claim that animal experimentation is essential to medical development is not supported by proper, scientific evidence but by opinion and anecdote. Systematic reviews of its effectiveness don’t support the claims made on its behalf” (Pandora Pound et al. British Medical Journal 328, 514-7, 2004).

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Imagine a syringe being forced down your throat to inject a chemical into your stomach, or being restrained and forced to breathe sickening vapours for hours. That’s the cruel reality of animal testing for millions of mice, rabbits, dogs and other animals worldwide.

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Home > Books > Ethics - Scientific Research, Ethical Issues, Artificial Intelligence and Education

Public Awareness of the Impact of Animal Testing in the Cosmetic Industry

Submitted: 03 November 2022 Reviewed: 14 January 2023 Published: 23 February 2023

DOI: 10.5772/intechopen.1001088

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Ethics - Scientific Research, Ethical Issues, Artificial Intelligence and Education

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Animal testing in the cosmetic industry is still practiced daily by several companies across the world subjecting animals to painful and cruel tests. The negative impacts of animal testing not only on animals but also on the environment as well as the cosmetic industry are evident and cannot be concealed. The purpose of this research is to examine the public awareness of the negative impacts of animal testing in the cosmetic industry, particularly with regard to animals, the environment, and the cosmetic industry itself. The data was collected through a survey consisting of a sample of 538 employees from 12 multinational companies working in various kinds of industries in Egypt. Primary data was the major source of data used for the study, while questionnaire was the instrument for data collection. The study revealed the existence of a public awareness of the significant negative impacts of animal testing in the cosmetic industry on animals and the environment. On the other hand, the study unveiled the nonexistence of a public awareness of the significant negative impacts of animal testing on the cosmetic industry.

• animal testing
• cosmetic industry
• environment
• public awareness

Author Information

Sherihan radi *.

• Brandenburg University of Technology, Cottbus – Senftenberg, Germany

*Address all correspondence to: [email protected]

1. Introduction

Human vanity and the desire to purchase favorite scent of deodorant or lipstick put millions of animals as victims to suffering caused by testing several cosmetic products [ 1 ].

Lab testing beauty products on animals has been a common practice for a century in the cosmetic industry in order to determine if these beauty products are safe for human use. Animals such as rabbits, dogs, rodents, or others are used in the testing of skincare, makeup, and hygiene products. These tests are considered a form of animal cruelty due to the harmful side effects they cause to animals [ 2 ].

The debate on the ethics of animal testing has been going on for long years. Although many countries such as Europe banned animal testing for cosmetics, animals are still subject to the testing of the safety of makeup and products all over the whole world. The animals are abused, burned, crippled, and poisoned in labs [ 3 ].

Animal testing should be illegal as it does not only have negative impacts, and it is inhumane, cruel, and against animals’ intrinsic rights [ 4 ].

1.1 Problem statement

Large numbers of animals are killed yearly in cruel tests carried out by the beauty and cosmetic industry in an attempt to assess the hazards of cosmetic products and their ingredients.

Guinea pigs, mice, rats, rabbits, and other animals are the victims of these tests that are administered with the purpose of predicting outcomes in humans.

These tests do not only have evident negative impacts on animals but also on the environment and the cosmetic industry.

This research examines the existence of public awareness of the negative impacts of animal testing on animals, the environment, and the cosmetic industry.

1.2 Research objectives

RO1: To examine the existence of public awareness of the negative impacts of animal testing on animals.

RO2: To investigate the existence of public awareness of the negative impacts of animal testing on the environment.

RO3: To study the existence of public awareness of the negative impacts of animal testing on the cosmetic industry.

1.3 Research questions

How aware is the public of the negative impacts of animal testing on animals?

How aware is the public of the negative impacts of animal testing on the environment?

How aware is the public of the negative impacts of animal testing on the cosmetic industry?

1.4 Research hypotheses

H a1 : The existence of a significant public awareness of the negative impacts of animal testing on animals.

H 01 : The nonexistence of a significant public awareness of the negative impacts of animal testing on animals.

H a2 : The existence of a significant public awareness of the negative impacts of animal testing on the environment.

H 02 : The nonexistence of a significant public awareness of the negative impacts of animal testing on the environment.

H a3 : The existence of a significant public awareness of the negative impacts of animal testing on the cosmetic industry.

H 03 : The nonexistence of a significant public awareness of the negative impacts of animal testing on the cosmetic industry.

2. Literature review

This section will discuss the literature related to the concept of animal testing, the difference between animal testing and animal research as well as the reasons for animal testing. It also discusses types of animal testing and highlights animal testing in the cosmetic industry.

2.1 Concept of animal testing

Animal testing is defined as the use of animals in scientific research such as in testing pharmaceutical products, disease, cosmetics, biology, and others [ 5 ]. It is involved with the experimentation carried on animals [ 6 ].

2.2 Difference between animal testing and animal research

Animal testing is one particular area of animal research with the aim to test the efficiency and safety of new products. On the other hand, animal research is involved with a wide range of scientific research from learning animal behavior in the wild to research occurring in lab to understand diseases in animals. These lab researches have various types and include genetics, physiology, and modeling disease [ 7 ].

2.3 Reasons for animal testing

There are several reasons for the use of animal testing. It is used to understand the way the human body functions as well as to assess both the effectiveness and safety of cosmetics or medication before their distribution. Some products commonly use animal testing such as drugs, cosmetics, supplements, food additives, pesticides, household products, and industrial chemicals [ 6 ]. With the aim of marketing new products, manufacturers use animal testing to ensure product or ingredient safety [ 8 ].

2.4 Types of animal testing

There are various types of animal testing. Some of these tests are summarized in the following paragraph.

One of these tests is skin irritation test which tests a substance and its potential of causing skin damage that includes swelling, itching, and inflammation. Most of the time rabbits are used in these tests where a particular chemical is placed on a shaved patch of their skin. Another test type is acute toxicity testing which has the aim of determining the danger of exposure to a chemical. This can be through inhalation, skin, or mouth and can cause the death of at least half of the animals. Carcinogenicity tests include a substance or mixture of substances that cause cancer or increase cancer. It is carried out through inhaling, placing on the skin or orally. The animals are killed after the test completion, and their organs as well as tissues are examined for any evidence of cancer [ 9 ].

Apart from these above-mentioned tests, the cosmetic industry in particular carries out various tests such as dermal penetration which is also called skin absorption testing with the purpose of determining the effect of a chemical applied to the skin. This test is mostly performed on rats which have their backs shaved and chemicals applied to their bare skin. After that, in order to analyze any changes related to chemicals in their tissue and blood, the rats are killed. Another test is skin absorption test which involves the application of chemicals on the animals’ skin to test the skin response to any allergic reactions that may occur. Draize test is another form of testing that aims at determining the level of irritation to a chemical when exposed to eyes. In this test, where rabbits are mostly used, chemicals are directly placed into the animals’ eyes [ 1 ].

2.5 Animal testing in the cosmetic industry

Several beauty companies test their products on animals in order to examine the product’s safety for human beings. There are main animal-based ingredients used in beauty products. Examples of these ingredients include BEESWAX (CERA ALBA) which is mostly used in the production of moisturizers, soaps, and lip balms to increase the absorption of moisture. Other ingredients include KERATIN which is derived from the horns and hair of different animals and LANOLIN which is taken from sheep’s wool. As for KERATIN, it is used in conditioners and shampoos, while LANOLIN is used to make lip glosses, balms, and lipsticks. Additionally, SHELLAC which is used in nail polishes is from insects, and CARMINE which is used in the production of nail polishes, blushes, and lipsticks comes from crushing insects. Moreover, TALLOW used in foundations, eye makeup, and nail polishes is derived from animal fat [ 10 ].

3. Conceptual framework

Figure 1 demonstrated was constructed according to the study’s objectives.

Public awareness of the negative impacts of animal testing on animals, the environment, and the cosmetic industry. Source: By researcher.

3.1 The negative impacts of animal testing on animals

Animal testing has several negative and harmful physical impacts on animals that are subjected to testing of products.

One of the more evident and obvious impacts is the physical reactions animals experience that begin with the ways animals are quickly identified with a physical indicator which could be tail-clipping or ear-notching. The tests themselves which force the animals to be exposed to chemicals through inhalation or physical application cause effects ranging from mild skin irritation, extreme illness up to death of these animals [ 2 ].

They also cause the suffering of animals which experience pain due to the tests that lead to skin and eye irritation conducted without pain relief by rubbing chemicals on their shaved skin or dripping them into their eyes [ 3 ].

Laboratories that carry out cosmetic testing on animals treat them in an inhumane manner and keep them in cages which cause stress, discomfort, chronic diseases, and even the death of these animals. In addition to that, the placement of different preparations and artificial ingredients on the animals’ skins to test soaps, shampoos, creams, or other products result into allergic reactions and other diseases suffered by these animals. Furthermore, the animals that have been tested suffer from various health problems such as loss of appetite, pain, hair loss, apathy, and other problems [ 11 ].

3.2 The negative impacts of animal testing on the environment

Animal testing results into the environmental exposure to diseases, toxic chemicals, and large amounts of environmental waste. The reason for that is that facilities using animals for testing dispose the animals which did not survive the testing process as well as food waste and dangerous chemicals besides supplies which were used during the process. The disposal process leads to dangerous exposure to radioactive materials and biohazards. Other negative impacts of animal testing on the environment include negative effects on air and water quality. Additionally, it causes environmental damage through the agricultural processes which are the consequence of using so much food to feed millions of animals used in testing [ 12 ].

Disposal of hazardous waste that includes the animal bodies and supplies such as syringes, caging, bedding, and needles creates air pollutants and harmful substances. On the other hand, animal tissues containing toxic chemicals and animal carcasses participate in the production of the most chemically and biologically hazardous waste. As for air pollution, it is produced by the incineration of toxic laboratory supplies and animal carcasses which result into the emission of gases. This causes developmental delays in nearby populations as well as chronic illnesses and extreme harms to human health. Other negative environmental effects include groundwater and soil contamination aggravating the drugs problem in public water supplies. Consequently, public drinking water is infected [ 13 ].

3.3 The negative impacts of animal testing on the cosmetic industry

With regard to the cosmetic industry, animal testing cannot be considered productive whether in relation to the use of resources or time due to the fact that the genetic makeup of animals is not similar to humans. Therefore, animals’ reactions do not mirror human responses. This could cause the existence of significant side effects in human trials which were absent in animal testing and vice versa. Consequently, products could still be harmful to humans showing that these tests are considered a waste of resources, money, and time for the cosmetic industry [ 2 ].

Besides being a costly and long process, animal testing lacks efficiency as it predicts human applications only 40–60% [ 1 ].

4. Methodology

The survey design was adopted in the study. The total population of the study consisted of 5146 employees from 12 selected multinational companies working in different industries. The reason for choosing multinational companies is that the researcher believes based on online searching that they pay higher salaries than domestic firms and sometimes they could even pay above market salaries. This means that employees working in these companies particularly women would afford the purchase of cosmetics and beauty products. At the same time, men and women would also afford the purchase of pets which puts them in the category of people who love and care for animals.

The sample size consisted of 538 employees drawn from the study population.

Questionnaires which are the primary source of this study served as data collection instrument and were self-distributed to the employees in these companies with the consent of the management.

A total of 538 questionnaires were prepared with only 517 questionnaires (96.1%) were filled out and returned. Frequency distribution and percentage table were used to analyze data, while test-retest method was used to determine the instrument reliability. As for the determination of the coefficient of the reliability of the instrument, Spearman’s rank correlation coefficient was used. Since the Spearman’s rank correlation coefficient was very high: r = 0.988, there was a high level of reliability in the survey items.

No personal information was collected from the respondents such as name, contact numbers, and address.

5. Data analysis and findings

5.1 participants demographic information.

Out of the 517 questionnaires returned as mentioned above in the methodology section, 201 (38.9%) were employees who are not pet owners/breeders, while 316 (61.1%) were employees who are pet owners/breeders. 268 (51.9%) of the employees were females with 249 (48.1%) males.

With regard to the employees educational background, 114 (22.1%) are master’s degree holders, 283 (54.7%) bachelor’s degree holders, 69 (13.3%) PhD degree holders, 6 (1.1%) obtained a diploma, and 45 (8.8%) with other educational backgrounds.

5.2 Examining the respondents’ awareness of the negative impacts of animal testing on animals

Table 1 shows the respondents’ awareness of the various negative impacts of animal testing on animals.

Respondents’ awareness of the negative impacts of animal testing on animals.

(Question 1): Does animal testing has a negative impact on animals and how?.

Source: By researcher.

As shown in Table 1 , 1269 (61.4%) respondents strongly agree/somewhat agree. On the other hand, 657 (31.7%) respondents strongly disagree/somewhat disagree. As for the respondents who neither agree nor disagree, they are 142 (6.9%).

Based on the above-mentioned, it is indicated that the majority of the respondents are aware of the negative impacts of animal testing on animals.

The formulated hypotheses in this study as stated in section (1.4) were tested by using regression analysis and Pearson’s product moment correlation.

5.3 Regression model

Y = animals.

X = public awareness.

μ = error term of random variable.

α = a constant amount.

β = effect of X hypothesized to be positive.

Consequently, the regression (predict) equation will be:

The data from the questionnaire has been analyzed by using regression analysis to examine the existence of a significant public awareness of the negative impacts of animal testing on animals. Tables 2 – 4 demonstrate that the regression result reveals the existence of significant result on the variables (R-coefficient = 0.711; p < 0.05). The significant level is 0.002. Therefore, Hypothesis H a1 stating the existence of a significant public awareness of the negative impacts of animal testing on animals is accepted. Consequently, the null Hypothesis H 01 is rejected.

Model summary.

Predictors: (Constant), public awareness.

Dependent variable: animals.

Coefficients. a

5.4 Investigating the respondents’ awareness of the negative impacts of animal testing on the environment

The respondents’ awareness of the various negative impacts of animal testing on the environment is demonstrated in Table 5 .

Respondents’ awareness of the negative impacts of animal testing on the environment.

(Question 2): Does animal testing has a negative impact on the environment and how?.

Table 5 illustrates that 1111 (53.7%) respondents strongly agree/somewhat agree. Furthermore, 832 (40.2%) respondents strongly disagree/somewhat disagree. Only 125 (6.1%) respondents neither agree nor disagree. Derived from the aforementioned, the majority of the respondents are aware of the negative impacts of animal testing on the environment.

The hypotheses data was obtained from the responses in the questionnaires. The validity of the existence of a significant public awareness of the negative impacts of animal testing on the environment was tested by correlation coefficient.

Table 6 illustrates that correlation result reveals the existence of significant result on the variables (r = 0.821; p < 0.05) and the significant level is 0.041. Based on that, Hypothesis H a2 stating the existence of a significant public awareness of the negative impacts of animal testing on the environment is accepted, while the null Hypothesis H 02 is rejected.

Coefficients.

5.5 Investigating the respondents’ awareness of the negative impacts of animal testing on the cosmetic industry

The respondents’ awareness of the various negative impacts of animal testing on the cosmetic industry is demonstrated in Table 7 .

Respondents’ awareness of the negative impacts of animal testing on the cosmetic industry.

(Question 3): Does animal testing has a negative impact on the cosmetic industry and how?.

Based on Table 7 , 946 (45.7%) respondents strongly agree/somewhat agree. Contradictorily, 925 (44.8%) respondents strongly disagree/somewhat disagree. Meanwhile, 197 (9.5%)) respondents neither agree nor disagree. As a result, on the basis of the above-mentioned, the number of the respondents who are not aware of the negative impacts of animal testing on the cosmetic industry exceeds the number of respondents who are aware of this issue.

H 03: The nonexistence of a significant public awareness of the negative impacts of animal testing on the cosmetic industry.

5.6 Regression model

Y = cosmetic industry.

Accordingly, the regression (predict) equation will be:

Regression analysis was used to analyze the data collected from the questionnaires. Tables 8 – 10 demonstrated illustrate that the regression result revels the existence of significant result on the variables (R-coefficinet = 0.124; p < 0.05) with the significant level as 0.051.

Dependent Variable: cosmetic industry.

Dependent variable: cosmetic industry.

In consequence, the null Hypothesis H 03 that states the nonexistence of a significant public awareness of the negative impacts of animal testing on the cosmetic industry is not rejected, while H a3 is not accepted.

In conclusion, the first objective of the study was to examine the existence of public awareness of the negative impacts of animal testing on animals. The findings of the study revealed the existence of a significant public awareness of the negative impacts of animal testing on animals (Hypothesis H a1 ). Not only were the respondents aware that animal testing negatively affects animals, but they are also aware of the various proven negative effects of these tests. The majority of respondents strongly agreed that animals subjected to testing suffer from pain and extreme illness. They also believed that the inhumane treatment of animals subjected to testing causes them stress and chronic diseases. Additionally, they were very much aware of the fact that the tests cause the death of large numbers of these animals. The aforementioned responses are consistent with the negative impacts of animal testing on animals as in section (3.1).

The second objective of the research was to investigate the existence of public awareness of the negative impacts of animal testing on the environment. The findings of the study showed the existence of a significant public awareness of the negative impacts of animal testing on the environment (Hypothesis H a2 ).

Besides being aware of the fact that animal testing has negative impacts on the environment, the majority of respondents strongly affirmed that environmental exposure to diseases is a result of animal testing as well as the pollution of air, groundwater, and soil created by animal testing. In addition to that, the majority of respondents believed that animal testing may result into large amounts of environmental waste and toxic chemical. Further to that, the majority of respondents agreed that the disposal process resulting from animal testing leads to dangerous exposure to biohazards and radioactive materials.

The above-mentioned responses are compatible with the negative impacts of animal testing on the environment as mentioned in section (3.2).

The third and last objective of the research was to study the existence of public awareness of the negative impacts of animal testing on the cosmetic industry. The nonexistence of a significant public awareness of the negative impacts of animal testing on the cosmetic industry (Hypothesis H 03 ) was found out by this study’s findings. It is clear from the responses that the majority of respondents were not aware of the various effects of animal testing on the cosmetic industry. The majority of respondents strongly believed that animal testing is efficient, is not a costly process, and does not lead to significant side effects in human trials. At the same time, they were strongly convinced that animals do not have different genetic makeup than humans.

6. Conclusion

In summary, there is a significant public awareness and a consensus of opinions on the negative impacts of animal testing on both the animals and the environment.

However, there is a lack of a significant public awareness on the negative impacts of animal testing on the cosmetic industry.

Therefore, it is essential to increase public awareness on all the various negative effects of animal testing. This can be achieved through animal cruelty awareness campaigns, social platforms, and media. These are considered powerful and effective ways to raise the public awareness and educate the public on animal rights and welfare as well as the issue of animal testing.

Moreover, people should be more encouraged in these awareness campaigns to purchase makeup, feminine hygiene products, deodorants, and household cleaners from cruelty-free brands that do not test their products on animals. These brands use only national ingredients which do not contain animal products.

Additionally, companies should consider switching to cruelty-free products and use ingredients in their products which have already been proved safe for human use and do not require additional tests.

• 1. Hussain G. www.sentientmedia.org . [Online]. 2021. Available from: https://sentientmedia.org/animal-testing-cosmetics/ [Accessed: October 17, 2022]
• 2. McCoy C. www.altfore.com . [Online]. 2019. Available from: https://altfore.com/blogs/news/the-effects-of-animal-testing-in-the-cosmetic-industry [Accessed: October 15, 2022]
• 3. Otto C. www.sentientmedia.org . [Online]. 2021. Available from: https://sentientmedia.org/why-is-animal-testing-bad/ [Accessed: October 15, 2022]
• 4. Ignacio M. www.honokaastudentnews.com . [Online]. 2021. Available from: https://honokaastudentnews.com/1554/uncategorized-2/the-cruelty-behind-animal-testing/ [Accessed: October 17, 2022]
• 5. Legal Information Institute. www.law.cornell.edu . [Online]. 2022. Available from: https://www.law.cornell.edu/wex/animal_testing [Accessed: October 14, 2022]
• 6. Murnaghan I. www.aboutanimaltesting.co.uk . [Online]. 2021. Available from: https://www.aboutanimaltesting.co.uk/what-animal-testing.html [Accessed: October 14, 2022]
• 7. Speaking of Research. www.speakingofresearch.com [Online]. 2022. Available from: https://speakingofresearch.com/facts/faq-about-animal-research/ [Accessed: October 14, 2022]
• 8. U.S. Food and Drug Administration. www.fda.gov [Online]. 2022. Available from: https://www.fda.gov/cosmetics/product-testing-cosmetics/animal-testing-cosmetics [Accessed: October 14, 2022]
• 9. Leaping Bunny Program. www.leapingbunny.org . [Online]. 2022. Available from: https://www.leapingbunny.org/types-animal-tests [Accessed: October 14, 2022]
• 10. Unsustainable Magazine. www.unsustainablemagazine.com . [Online]. 2021. Available from: https://www.unsustainablemagazine.com/animal-testing-in-the-beauty-industry/#What_is_animal_testing_in_the_beauty_industry [Accessed: October 22, 2022]
• 11. www.products.pcc.eu . [Online]. 2022. Available from: https://www.products.pcc.eu/en/blog/animal-testing-in-the-cosmetic-industry-what-should-you-know/ [Accessed: October 17, 2022]
• 12. Shroff J. www.aishroff.wordpress.com [Online]. 2016. Available from: https://jaishroff.wordpress.com/2016/11/15/the-significant-impact-of-animal-testing-on-the-environment/ [Accessed: October 17, 2022]
• 13. Corbett R. www.faunalytics.org . [Online]. 2019. Available from: https://faunalytics.org/animal-research-an-environmental-perspective/ [Accessed: October 17, 2022]

© The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution 3.0 License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Edited by Miroslav Radenkovic

Published: 02 August 2023

By Lucía Arellano, Pau Alcubilla and Lina Leguízamo

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Bioethics: a look at animal testing in medicine and cosmetics in the UK

Affiliation.

• 1 Faculty of Communication, Arts and Sciences (FCAS), Canadian University Dubai, Dubai, UAE.
• PMID: 32328228
• PMCID: PMC7166243
• DOI: 10.18502/jmehm.v12i15.1875

Using animals for cosmetics and medical tests has contributed towards a debate based on conflicting interests. Despite the efforts in justifying the value of animals in conducting analyses, this study seeks to elaborate whether or not it is rational to use animals as test subjects in medical and cosmetics fields. The value of animal life is at the core of the emotional conflicts that arise when animals become experimental subjects in medical and cosmetics fields. The aim of this study is to determine if there are ethical differences in the use of animal testing in medicine versus cosmetics. The research, through review and content analysis of the existing literature, compares and provides the outcomes of using animals in medical and cosmetics tests by examining studies conducted in the UK. The findings of this research indicated that animal testing is considered acceptable in the medical field only if there are no other alternatives, but is completely unacceptable in the cosmetics field. The study also provides recommendations in the form of alternatives that protect animals from cruelty and may benefit the different stakeholders and the society at large.

Keywords: Animal testing; Bioethics; Cosmetics testing; Medical research.

© 2019 Medical Ethics and History of Medicine Research Center, Tehran University of Medical Sciences. All rights reserved.

Publication types

Unilever Global Change location

Ending animal testing for cosmetics: ten years of progress

Published: 10 March 2023

In March 2013, the EU banned the marketing of cosmetics containing ingredients that had been tested on animals. Here’s how we’ve been partnering for progress over the past decade.

Ten years ago, the EU introduced a total ban on the marketing of cosmetics containing ingredients that had been tested on animals. This was a pivotal moment for animal protection worldwide, and 42 countries now have cosmetics animal testing bans in place.

At Unilever, we’ve been developing and using alternatives to animal testing to assess the safety of products and ingredients since the 1980s. We want to see an end to regulatory requirements for animal testing for cosmetics in every part of the world.

In 2018 we announced our support for a global ban on animal testing for cosmetics and our Dove brand, which reaches tens of millions of consumers every day, was PETA-Approved.

We now have over 25 PETA-Approved brands, including TRESemmé, Simple, Sunsilk and Lakmé. In 2021, Kate Somerville, one of our Prestige Beauty brands, became the first PETA-Approved brand imported into China.

The considerable progress made in the last decade has only been possible due to all stakeholders working together with a shared ambition of ending animal testing. Dr Julia Fentem, Head of Unilever's Safety & Environmental Assurance Centre.

Unilever is also a member of Humane Society International’s (HSI) #BeCrueltyFree movement, supporting its hard-hitting #SaveRalph campaign in 2021, and HSI’s Animal-Free Safety Assessment collaboration (AFSA) , a global coalition working to advance the acceptance and regulatory use of animal-free safety science worldwide.

We are committed to ensuring that our products and the ingredients they contain are safe and sustainable without animal testing – and we take pride in sharing our experience with others. That’s why we’re working with partners to accelerate the use of animal-free safety science beyond our own business.

Read more about alternatives to animal testing at Unilever here

Defending the EU’s ban on animal testing for cosmetics

The progress made by the EU’s ban on animal testing for cosmetics was at risk of being undermined when in 2020 the European Chemicals Agency (ECHA) called for new animal tests on hundreds of commonly used cosmetics ingredients with a long history of safe use.

Dove, working together with PETA, Cruelty Free Europe, The Body Shop and more than 100 animal protection organisations, launched a European Citizens’ Initiative (ECI), inviting EU citizens to show their support for upholding the ban.

More than 1.2 million people signed the ECI, sending EU policymakers a very clear message. Read more about the Save Cruelty Free Cosmetics ECI and what’s happening next here.

We believe that regulators can and should go further to phase out animal tests through implementing non-animal approaches for assessing the safety of all chemical ingredients – not just those used in cosmetics. Last year the EU Commission announced its intention to implement a roadmap to phase out EU regulatory animal testing for chemicals and we look forward to supporting this action through the European Partnership on Alternative Approaches to Animal Testing (EPAA).

Collaborating to advance use of alternatives to animal testing globally

We’ve been developing and using alternatives to animal testing with over 70 partners for more than four decades, publishing approximately 200 scientific research papers in the last ten years alone. Read a summary of our progress here.

One of our key research partners is the Center for Computational Toxicology and Exposure at the US Environmental Protection Agency, who we’ve been working with since 2015 to develop and evaluate our non-animal chemical safety assessment approaches.

We've worked with more than 70 partners to publish around 200 scientific papers on alternatives to animal testing in the past 10 years

We’ve also worked with leading academics, government laboratories and authorities to share our expertise and help build animal-free safety science capability in China for over a decade, both directly and in partnership with the Institute for In Vitro Sciences. In 2021, we were delighted that China introduced a new regulation removing the need for most imported cosmetics to undergo animal testing in Chinese government laboratories.

This year we helped launch the International Collaboration on Cosmetics Safety (ICCS) – a group of more than 35 cosmetics and chemicals companies and animal protection NGOs focused on advancing the adoption of animal-free safety science for cosmetics products and ingredients globally. Read more about our work with the ICCS here.

We’re also investing in the next generation of safety scientists, collaborating with universities and labs around the world to share access to the latest science, technology and new computational tools for assessing safety without animal tests.

And as part of our work to promote the wider use of animal-free safety science, we present our research at scientific conferences and workshops, and make all our research available online as a learning resource. Find out more about SEAC (Unilever’s Safety & Environmental Assurance Centre) here.

“Working together with a shared ambition”

“The considerable progress made in the last decade has only been possible due to all stakeholders working together with a shared ambition of ending animal testing,” says Dr Julia Fentem, Head of SEAC.

“I am extremely proud of the part that the Unilever team continues to play in sharing our non-animal safety approaches and actively collaborating with others. Some strong new partnerships have emerged as powerful contributors to achieving real change, connecting leading-edge animal-free safety science with advocacy to transform regulations to be based on modern science and tools.”

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Safe and sustainable ingredients and products – without animal testing

6 July 2022

The ingredients in our products must be safe for people and the planet – but we don’t need to test on animals to achieve this. Here Dr Julia Fentem, Head of our Safety & Environmental Assurance Centre, explains why we’re calling for chemical regulations to change.

Over 1 million signatures opposing new animal tests. What next?

26 January 2023

More than 1.2 million people signed the European Citizens’ Initiative to save cruelty-free cosmetics and end animal testing. Great news! But what happens now? Here’s what we’re doing…

Unilever joins new collaboration to advance alternatives to animal testing

15 February 2023

We’re a founder member of the International Collaboration on Cosmetics Safety, working with NGOs and industry experts to accelerate global use of animal-free safety science.

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Product Testing of Cosmetics

Cosmetics are required to be safe when consumers use them according to directions in the labeling, or in the customary or expected way. Product testing is just one of the things a manufacturer might do to ensure the safety of a cosmetic product. Sometimes FDA conducts testing when we are investigating possible safety problems with a product or as part of our research program. FDA resources on cosmetic product testing are valuable to consumers and industry alike.  

Who’s Responsible for the Safety of Cosmetics?

• Using Available Safety Data
• Doing Additional Testing

Does “Natural” Mean “Safe”?

• Additional Resources on Product Testing

FDA does not have the legal authority to approve cosmetic products and ingredients (other than color additives) before they go on the market. We also do not have a list of tests required for any particular cosmetic product or ingredient. However, a manufacturer or distributor of a cosmetic is legally responsible for ensuring that a marketed product is safe when consumers use it according to the directions in the labeling or in the customary or expected way. FDA can take action against the manufacturer of a cosmetic on the market if we have reliable information to show that a cosmetic does not meet the legal requirement for safety.

The law treats color additives differently. Unlike other cosmetic ingredients, color additives, other than coloring materials used in coal-tar hair dyes, must be approved by FDA for the specific intended use before they are permitted in any cosmetic. 

Using Available Safety Data to Support the Safety of Your Cosmetic

Manufacturers can use safety data that is already available on individual ingredients and on products with similar formulations. Here are some examples:

• Cosmetic ingredient suppliers often have safety data on their products.
• Safety data may be published in scientific journals (sources include PubMed and TOXNET ). 

Additional Testing

Manufacturers may also need to do toxicological testing to fill in any gaps in the information that’s available. Toxicology or other testing methods may be necessary to determine the safety of each ingredient and the finished product. Animal testing is not a specific requirement for marketing a cosmetic; however, it’s important for all testing to be scientifically sound.

As a government agency, FDA does not provide referrals for private testing labs. However, there are useful resources under “ Trade and Professional Associations of Interest to the Cosmetics Industry .”

Cosmetics do not have to be sterile, but they must not contain any harmful microorganisms, and the number of aerobic microorganisms per gram must be low. To learn more, see “ Microbiological Methods for Cosmetics .”

Many factors can affect how a product may become contaminated, including use by consumers, such as dipping one’s fingers into a jar. If a manufacturer does not have the technical expertise to determine the best way to ensure that a product is protected from contamination, the company may want to work with a consultant.

Choosing ingredients from sources the manufacturer considers “organic” or “natural” is no guarantee that they are safe. Manufacturers are still responsible for making sure their products are safe when used according to the directions in the labeling, or in the customary or expected way. Some testing may still be needed.

For related information, see "Organic" Cosmetics .

Resources on the Safety Substantiation of Cosmetics

• Animal Testing
• Cruelty Free/Not Tested on Animals
• Guidance for Industry: Safety of Nanomaterials in Cosmetic Products
• Investigational New Drug Applications (INDs)-Determining Whether Human Research Studies Can Be Conducted Without an IND
• Potential Contaminants

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Animal Testing in the Cosmetics Industry

Michelle Thew from Cruelty Free International explains why animal testing of cosmetics is still going on and what you can do to campaign against it.

The European Union introduced a ban on the testing of finished cosmetic products (shampoo, make-up, toothpaste, etc.) on animals in 2004. Five years later, it also ended the testing of ingredients, following this up with a ban on the import and sale of new cosmetics tested on animals abroad, in 2013.

But there is also conflicting legislation within the EU which makes the ingredients test ban a bit of a con. The Registration, Evaluation, Authorisation and restriction of Chemicals (REACH) – an EU chemical safety regulation – has been requiring all chemicals used in Europe to be re-tested for safety by June 2018. While the guidelines ask organisations to use available non-animal tests where possible, some of the chemicals that are used in cosmetic products will have been tested on animals for REACH.

Other countries outside the EU have also implemented bans (see below). But 80% of the world still allows cosmetics to be tested on animals.

According to Humane Society International, as many as 500,000 animals are being tested on across the world each year with the largest proportion of these animals – more than 375,000 in 2015 – being used to meet test requirements in China alone. While many of the brands featured in this guide have a commitment not to test on animals, many, like L’Oréal, have a caveat which states “except when required by law”.

Global report – ending animal testing for cosmetics

For over 50 years, animals have been used in tests in an attempt to measure the safety of some chemicals found in cosmetic and household products. Many animals are still subjected to cruel and painful tests across the world to bring a new eyeshadow or cologne to the market. That’s why, for over 20 years, Cruelty Free International has been working tirelessly to end the cruelty and suffering. 

Over the last few years we’ve seen great progress globally as more and more governments introduce legislation that will put a stop to the suffering and death of animals for the testing of cosmetics in particular.

The big breakthrough came in 2004, when – thanks to the 20-year campaign we led in Europe – the European Union introduced a ban on the testing of finished cosmetic products on animals. Five years later, it also ended the testing of ingredients, following this up with a ban on the import and sale of new cosmetics tested on animals abroad in 2013. 

Internationally, over 600 companies are now certified with the Leaping Bunny, making it easier than ever for shoppers to find and buy products that are not animal tested. Cruelty Free International Leaping Bunny-certified companies such as The Body Shop, Liz Earle and the Co-operative have pioneered this move towards cruelty free cosmetics and toiletries. 

Since a Cruelty Free International campaign for a global ban on animal cosmetics testing, the number of animal testing bans that have come into force or been placed on the table continues to grow:

• Norway  now has a testing ban on finished products and ingredients as well as on marketing.
• Last year,  Switzerland  announced it would ban the marketing of cosmetics that have been tested on animals abroad, bringing it closer to the EU ban. 
• Israel  was one of the first countries outside the European Union to introduce testing and marketing bans.
• In August 2015, a bill was introduced in the  Russian  parliament that would phase out all animal testing for cosmetics and their ingredients by 2020. The Cruelty Free International team is lobbying for its passing.
• As of January 2016,  Turkey  banned (apart from in exceptional circumstances) the sale of cosmetic products tested on animals or containing ingredients developed through animal testing.
• In  North America , the USA has legislative proposals for a ban on the table. Cruelty Free International is currently lobbying for the reintroduction of the Humane Cosmetics Act by the Republican-led Congress and Senate.
• Last December, the  Canadian  Cruelty Free Cosmetics Act passed its second reading in the senate and will now be considered in parliamentary committee – a very welcome step forward.
• In  South America , the Brazilian lower house voted, in 2014, to ban many cosmetics tests on animals. Discussions on the future of that bill are ongoing and the Cruelty Free International team is working hard to progress it.
• In  Asia , things have also been moving on. In 2014, India banned the testing of cosmetics on animals and, in the same year,  Vietnam  banned the use of the Draize rabbit eye and skin irritation tests. 
• South Korea , one of Asia’s largest cosmetics producers, is working towards a partial ban on animal testing of cosmetics by 2018. 
• In  Thailand , the Ministry of Public Health has agreed to look at ending cosmetics animal testing, while in  Taiwan , the parliament recently voted to end testing. The legislation will enter into force in October 2019.
• Whilst  China’s  policy has traditionally meant animals are used in cruel tests for imported cosmetics, in January 2017, new regulations were issued which will potentially mean some cosmetics will not now be subject to this requirement. This could be a huge step forward for cruelty free cosmetics.
• In 2015,  New Zealand  passed into law a ban on testing cosmetics ingredients and finished products and, in  Australia , the federal government has also pledged to ban cosmetics cruelty by July 2017.

Until we know that cosmetics animal testing cannot happen anywhere in the world, it is just as vital as ever that ethical consumers look for the Leaping Bunny to ensure your cosmetics and toiletries are cruelty free. 

With our collective determination, together we will end animal testing and make the world a better place for animals.

The EU and REACH, and Brexit

Unfortunately, the EU's ground-breaking ban has been under threat from the EU's regulations on household chemicals (REACH).

With the UK now out of the EU, the picture is even more confusing for companies and citizens. Read more about REACH in our feature article .

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Bioethics: a look at animal testing in medicine and cosmetics in the UK.

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Journal of Medical Ethics and History of Medicine , 12 Nov 2019 , 12: 15 https://doi.org/10.18502/jmehm.v12i15.1875   PMID: 32328228  PMCID: PMC7166243

Abstract 

Free full text , bioethics: a look at animal testing in medicine and cosmetics in the uk.

Using animals for cosmetics and medical tests has contributed towards a debate based on conflicting interests. Despite the efforts in justifying the value of animals in conducting analyses, this study seeks to elaborate whether or not it is rational to use animals as test subjects in medical and cosmetics fields. The value of animal life is at the core of the emotional conflicts that arise when animals become experimental subjects in medical and cosmetics fields. The aim of this study is to determine if there are ethical differences in the use of animal testing in medicine versus cosmetics. The research, through review and content analysis of the existing literature, compares and provides the outcomes of using animals in medical and cosmetics tests by examining studies conducted in the UK. The findings of this research indicated that animal testing is considered acceptable in the medical field only if there are no other alternatives, but is completely unacceptable in the cosmetics field. The study also provides recommendations in the form of alternatives that protect animals from cruelty and may benefit the different stakeholders and the society at large.

Introduction

Throughout history, animals have been the subject of experimentation to improve our understanding of anatomy and pathology ( 1 ). However, animal testing only became significant in the twentieth century ( 2 ).

Animal experiments are used extensively when developing new medicines and for testing the safety of certain products. Recently, the use of animals for biomedical research has been severely criticized by animal rights and protection groups. Similarly, many nations have established laws to make the practice of animal testing more humane. There are two positions in animal testing. One is that animal testing is acceptable if suffering is minimized and there are human benefits that could not have been achieved using any other means ( 3 ). The second position considers animal testing unacceptable because it causes suffering, and the benefits to human beings are either not proven or could be obtained using other methods.

As such, animal testing is a highly controversial subject that often elicits conflicting emotions from supporters and critics alike. It is also a divisive subject as some people support animal testing only in certain cases and oppose its use in other areas. For example, scientists note that significant medical breakthroughs have only been made possible through drug testing on animals. To them and other like-minded people, such achievements are reason enough to keep using animals in the lab ( 4 ). Animal tests determine if experimental drugs are effective or ineffective on human beings. Eventually, the medicine is tried out on a small group of humans through clinical trials before declaring the medicine safe to use.

Badyal and DesaI ( 5 ) note that these treatments are as beneficial to humans as they are to animals, since some human diseases are found in animals too. Therefore, some who support animal testing only advocate its use for medical (but not cosmetics) purposes, arguing that the advancement in human medicine may lead to advancement in animal medicine.

While a significant population completely disapproves of animal testing, a faction of people only disagrees with the use of animals for cosmetics testing, arguing that it is despicable and cruel to use animal life merely so that humans can advance their beauty technology. The concern extends to animals used for science, and people want animal suffering to be minimized ( 6 ). The discovery of new drugs has for a long time been based on a number of interactions among aspects such as data collected from patients, tissues, organs or cell culture and varied animal species ( 7 ). Those who oppose the use of animal testing for cosmetics believe it is outrageous and cruel to use animal life for the simple reason of making humans look better, and that the benefits to human beings do not validate the harms done to animals ( 7 ).

For such reasons, the use of animals for testing cosmetics products has been banned in the UK and all other member states of the European Union since 2013 ( 8 ). However, other countries like China and the United States of America still continue with the practice ( 9 ). Linzey adds that about 50 - 100 million animals are used for experiments every year, and that over 1.37 million animals were used for drug experimentation in America in the year 2010 ( 9 ). In the meantime, the number of experiments conducted on animals has declined in Britain but is increasing in other countries. While experiments involving vertebrates are regulated in most countries, experiments on invertebrates are not ( 5 ).

The aim of this study is to examine whether or not animal testing is still useful and necessary in the present time, and whether there are ethical differences between animal testing in medical and cosmetics fields. We use the UK as our case study and provide alternatives that can be recommended in place of animal testing.

This review was based on a cross-sectional survey by Clemence and Leaman ( 11 ) that analysed the importance of animal testing from two different aspects: medicine and cosmetics. The population consisted of individuals residing in the UK, and the sample size was 987 (= 0.03). The research included 496 men and 491 women. The report compared public views with the responses from a similar study in 2014 that had 969 participants (477 men and 492 women). The inclusion criteria were based on numerous strata such as gender, social grade definitions (i.e., professionals such as doctors and architects, people with responsible jobs such as professors, middle rank public servants such as nurses and clerics, skilled manual workers, etc.), respondents’ working status (fulltime, part-time, not working), ethnicity (white, non-white), and educational background. This report measured public perception on whether it is ethical to use animal testing for medical or cosmetics purposes. Participants were required to state whether they found it acceptable, mostly unacceptable, unacceptable, or were undecided. Consequently, the same participants were also tasked to indicate whether they saw conducting animal testing for scientific experimentation as completely necessary, somewhat necessary, not very necessary, completely unnecessary, or they did not know.

The study also utilized data from the UK Home Office ( 12 ) to determine which animals were most frequently used for medical and cosmetics research around the world. This report also provided crucial information as to the purposes of animal testing, for instance for medical research, biological testing, regulatory testing, etc.

According to the UK Home Office ( 12 ), in the year 2016, 48.6% of the animal tests in medical research were conducted for genetically oriented studies. Moreover, 28.5% of the medical research involving animal testing was for basic biological research, 13.5% was for regulatory

testing, 8.6% was for translating research from animals to humans, and 0.8% for other trainings. This is summarized in Figure 1 below.

Purposes of Animal Testing in Medicine

Data from the UK Home Office ( 10 ) indicates that the most commonly used animals for medical and cosmetics research are mice and rabbits (72.8%), fish (13.6%), rats (6.3%), birds (3.9%) and other animal species representing 3.4% of the total test animal population, as indicated in Figure 2 below.

Types of Animals Used in Testing

A published report ( 12 ) indicated that 17% of the sampled group viewed animal testing for medical research as ‘mostly unacceptable’ if there were no alternative, 17% as ‘not acceptable’, and 65% as ‘acceptable’. This was in stark contrast with testing for cosmetics purposes, to which an overwhelming 80% of the participants responded as ‘unacceptable’. The summary of the results is provided in Figure 3 and Figure 4 below.

Animal Testing for Medical Research

Animal Testing for Cosmetics Research

 In the same study ( 12 ), the participants were asked about the necessity of conducting scientific experiments on animals, which 38% of the respondents viewed as ‘completely necessary’, 23% as ‘somewhat necessary’, 20% as ‘not very necessary’, and 16% as ‘completely unnecessary’. The results are summarized in Figure 5 below.

Necessity of Conducting Scientific Experiments on Animals

The application of these methods to evaluate the safety of cosmetics was the most detested as stated by about 80% of the people who were interviewed during the investigation. The sensitivity to human life, on the other hand, reduces the strictness towards utilization of animals to find anti-viruses and antibiotics for various diseases.

The outcome portrays the essentiality of using animals to determine materials that would help the population to live healthily ( 13 ). However, in the past few decades, the number of animals used for testing drugs has been steadily decreasing ( 14 ).

The data indicates that most of the medical research processes involving animal testing emanate from genetically oriented studies, which constitute 48.6% of the medical research animal testing. Experimentation on human genetics presents various legal and ethical challenges to medical and biological researchers, alongside problems in creating experimental procedures using human test subjects. These problems occur partially due to the fact that the experimentation processes involved in these types of studies often lead to extensive gene and physiological damages to the test subjects. Such experiments typically involve deliberate presentation of diseases and other gene modifications to the test subjects, usually requiring the euthanizing of the involved subjects ( 15 ). The animal testing experimentations involving genetic processes include studies in gene modification and examine diseases believed to hold genetic components, such as cancer and diabetes ( 16 ). These experimentation processes typically involve some sort of gene modification that can simulate the presentation of genetically based disorders manifested in human beings to allow researchers to better understand those disorders.

The data also indicate that another major application of animal testing in the medical field is in basic research in biological systems and processes, which accounts for 28.5% of the testing categories. This application of animal testing in medical research involves studies in how biological systems function, and the nature and manner of disease transmission in living organisms. The findings accrued through these kinds of studies translate to advancements in the scientific knowledge of human pathology and present opportunities for the derivation and testing of cures, as noted by Festing and Wilkinson ( 17 ).

The findings further present that regulatory testing (13.5%) and animal to human translation research (8.6%) account for significant portions of the application of animal testing in the medical field. The use of animal testing for regulatory testing purposes involves applying new medical findings, procedures and products to animals to see if they meet the thresholds mandated by the medical regulatory bodies. Translation of research findings from animals to humans involves conducting research into the possibility of animal pathogens becoming infectious to humans, and identifying potential ways of applying non-human physiology to the improvement of human health. Other forms of medical and biological trainings and studies that also engage the use of animals in experimentation in the medical field include elements such as basic physiology and pathogen studies, typically conducted in educational institutions.

Animal testing in the field of cosmetics generally involves the use of animal subjects in testing new cosmetics products and ingredients. The practice essentially involves the application or forced ingestion or injection of these substances to various parts of test animals to examine their toxicity, irritation of the eyes and/or skin, ultraviolet light-triggered toxicity, and their potential for causing unwanted gene mutations ( 18 ).

The use of animal testing in the field of cosmetics research and production presents an unethical viewpoint since the findings do not advance human health, and the practice leads to the torture and killing of animals. The Humane Society ( 18 ) also notes that at the conclusion of the experimentation, the animals are usually killed through methods such as decapitation, neck twisting and asphyxiation, often without pain relief.

With regard to the ethical principles of animal testing in both fields, a convincing argument should first be presented to the Institutional Animal Care and Use Committee (IACUC). This is to justify the need for a researcher to conduct animal studies, and to ensure that the research is conducted using the smallest possible number of animals and with minimal suffering. Additionally, Naderi et al. ( 19 ) noted an increased level of legislation on the matter of animal testing, with researchers being required to submit comprehensive proposals to the IACUC to demonstrate procedural compliance with the guiding principles of the organization before conducting animal tests. Furthermore, Holden ( 20 ) highlighted the fact that researchers need to justify to review and ethics committees the use of mice rather than other alternatives in experiments. These issues indicate that researchers should look for alternatives to animal testing before proceeding with animal trials.

The issue then remains on the nature and availability of alternatives to animal testing in the medical research field. Researchers have undertaken measures to introduce some levels of such alternatives in medical studies. The accrued data indicate that a significant number of people agree with animal testing for medical research, especially when compared to those who agree with animal testing for cosmetics purposes. The data obtained from the studies indicate a slow but perceptible shift in the public opinions regarding animal testing for medical research purposes. People are increasingly finding it unacceptable to use animal test subjects even in medical research. However, the majority of the sampled people believed that medical testing procedures should use animal test subjects, but only when there is no other alternative. This indicates that people view animal testing for medical research as ethical, but under certain conditions.

The use of animals in research is still relevant because the process is useful in veterinary medicine as it helps the students understand the physiology and anatomy and improves surgical skills ( 21 ). The study by Badyal and Desai ( 5 ) supports this perception by highlighting the fact that animal use in laboratory investigation will make new discoveries possible. However, researchers should apply ethical concepts to reduce the amount of pain and unnecessary procedures for the animals. Moreover, animal testing to develop new drugs will continue to protect the future existence of humanity. Cheluvappa, et al. ( 22 ) reiterate that animal experimentation will remain essential to testing future medicine because it helps scientists understand the changes of behaviour, embryology and genetics through dissections that are conducted on the genetically produced animals.

Animals play an important role in testing human drugs as they have a large number of medical reactions similar to those of human beings. Specifically, animals such as dogs, mice and rabbits have an identical DNA that cannot be replicated through artificial models. Public concern for the increasing use of animals in terms of ethics and safety provokes anxiety among the population. Conversely, these uncertainties and unavailability of trustable alternatives show the importance of using animals in medical research as the scientists aim to protect the human race ( 23 ).

However, the use of animals to test cosmetics is highly limited due to the availability of alternative sources. For instance, The Laboratory Animals Veterinary Association (LAVA) claims that the UK government prohibits any individual from using animals to determine the suitability of cosmetics to the human body ( 13 , 24 ). In its circular, The European Union states that they have succeeded in developing alternative measures that cosmetics firms can apply to test their products without using laboratory animals ( 25 ).

Recommendations: Alternatives to Animal Testing

To improve business ethics in cosmetics companies, it is necessary for alternatives to be integrated instead of animals. Companies can employ assessment of scientific barriers to find replacements for animal test subjects and to procure the knowledge of correctly using animals for medical and cosmetics tests. Sophisticated tests on human cells or tissues, computer-modelling techniques, and experiments on people who volunteer are some measures that can limit acts of animal cruelty by cosmetics companies. Companies need to integrate tests that minimize involvement of animals in order to limit the possibility of animal cruelty, and consequently improve their business ethics. Some of the recommended alternatives are listed here.

Computer Simulation

The concept was developed by Denis Noble, and the system is currently enrolled in clinical settings. These simulations are used to test heart replacements, and are also applied to explore human behavior. Various scholars provide that this model is more accurate than animal experiments because it uses human data to analyse diseases and make predictions ( 26 ).

Stem cells are proper alternatives to the in vitro systems of disease testing and toxin evaluations ( 27 ). The experiments involve evaluation of embryonic stem cells that can be grown in Petri dishes. The Petri dishes can be placed in the cells, and after that the resulting components are placed under evaluation to help in the discovery of new medications. Stem cells are essential because they can differentiate into human tissues and make it possible to screen the suspected diseases ( 26 ).

These materials are majorly utilized in the cosmetics industry to minimize the number of animals used to test the level of toxicity in a product. Significantly, investigations showed that human tissues developed in laboratories can be used to assess the allergic responses to the available chemicals ( 28 ). These results can then be analysed by comparing reactions, and a bio signature of genes is used to make appropriate interventions.

Notably, scientists can take high-resolution pictures of human tissues, which are then analyzed with the help of various computer systems. The advantage of this model is characterized by its ability to customize the parts of the organism under consideration. Moreover, 3D images also develop prototype designs and materials that can be used to investigate the existing and future ailments ( 29 ).

This study indicates that it is justifiable to use animals in experimentations only when there are no alternatives, and the tests have significant benefits to humans. Many researchers are working towards finding options that will help eliminate the use of animals for medical and cosmetics tests. The different natures of tests conducted on animals in the fields of medicine and cosmetics tend to have clear negative implications. For such reasons, it is imperative for organizations to develop practices that endorse business ethics. Although animal tests are ideal in establishing whether drugs can be effective in treating humans for various ailments, entities that conduct these tests need to be educated about the gravity of the situation. Animals have been extremely useful in conducting genetic studies and for biological systems investigations. However, a comparison between animal tests in medicine and cosmetics reveals that their benefits in the field of medicine outweigh those in cosmetics. Therefore, animals are essential contributors to scientific experiments that are affiliated with the medical industry. The effects that medical products may have on humans make it ethical to carry out the tests on animals first.

After analysing the arguments of both the supporters and opponents involved in the controversial subject of animal testing, it is difficult to determine which direction is right or wrong. However, the agreement is that animal suffering be minimized at all costs. This research concludes that cosmetics companies should adhere to the established laws and principles against the use and abuse of animals in tests and should seek alternative methods to test their products.

Acknowledgements

Citation to this article:

Kabene S, Baadel S. Bioethics: a look at animal testing in medicine and cosmetics in the UK. J Med Ethics Hist Med. 2019; 12: 15.

Conflict of Interests

Authors declare having no conflict of interest.

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Let’s End Animal Testing for Cosmetics

Before your shampoo made it to your shower and your lip balm made it to your pocket, there’s a chance their ingredients were tested on animals..

Methods of animal experiments in the cosmetics industry commonly include:

• Eye irritant tests wherein substances are dropped into the eyes of restrained rabbits
• Skin corrosivity tests wherein chemicals are applied directly to the skin of shaved rabbits, rats, mice, and guinea pigs
• “Lethal dose” tests wherein animals are force-fed known or potentially toxic products to determine the amount required to induce death via ingestion

Experiments on animals are unnecessary to determine the safety of cosmetics for human use.

The U.S. Food & Drug Administration (FDA) does not require animal testing to prove cosmetics are safe for human use. In fact, the FDA state they are “a strong advocate of methodologies for the refinement, reduction, and replacement of animal tests with alternative methodologies that do not employ the use of animals.” [ Source ]

Despite no legal requirment for animal testing—and despite the existence of superior alternative research methods—many cosmetics companies continue to test their products or ingredients on animals. Thankfully, a new federal law could change that.

The Humane Cosmetics Act of 2021 ( H.R. 6207 / S. 3357 ) was recently reintroduced to Congress.

If signed into law, this bipartisan bill will prohibit animal testing in the evaluation of cosmetic products and prohibit the sale or transport of cosmetics developed using animal testing.

The precedent for a more humane beauty industry has already been set.

The European Union has already banned animal testing from its cosmetics inductry. Israel, Mexico, Norway, Iceland, Switzerland, and India are among other countries which have also passed similar laws. In all, 41 countries globally have enacted partial or complete bans of this cruel practice.

The United States could be next to save animals if the Humane Cosmetics Act passes legislation.

Right now, we have an opportunity to end cosmetics testing on animals in the U.S. once and for all.

We’ve made it super simple for you to write to your legislators and ask them to co-sponsor the Humane Cosmetics Act. Act now and help save innocent animals!

Take Action Now!

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Cosmetic Animal Testing Is Cruel – But There Are Alternatives

Animal testing is an outdated method of testing the safety of cosmetics. While many companies still rely on it, consumers are demanding cruelty-free alternatives.

Explainer • Animal Testing • Policy

Words by Rachel Graham

While we may think of animal testing for cosmetic products as a thing of the past, it’s a practice that causes the death of 500,000 animals every year , primarily rabbits, guinea pigs, hamsters, rats and mice. These animals have chemicals applied to their skin, injected into their bodies or smeared onto their eyes. They  often  undergo immense physical pain and mental torment just so  companies can produce the very latest lipstick or deodorant. Not only is there significant consumer demand to stop testing cosmetic products on animals, but there are now many alternatives to testing cosmetics on animals that produce more accurate and efficient results — and most importantly, don’t cost lives.

What Products Are Regulated as Cosmetics?

Under U.S. law, the Federal Food, Drug and Cosmetic Act considers cosmetic products to be any “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.” This includes a wide range of products we buy every day, from skin moisturizers to shampoos to deodorants. This also includes any chemicals or substances that a manufacturer is intending to use as an ingredient in one of these products.

When Did Animals Start Being Used to Test Cosmetics?Widespread use of animal testing for cosmetics began in 1938 when the Food, Drug and Cosmetic Act came into law, requiring cosmetic products to be safety tested before being sold to consumers. A key trigger for this was the death of one woman and the blinding of several others from a mascara known as Lash Lure. The product contained p-pheynenediamine, a then untested chemical that caused severe skin damage . 

There’s little debate that cases like this must be prevented, and that cosmetic products need to be safety tested before being applied to human skin — but many feel strongly that testing these products on animals is not the way to do it. In a survey carried out by the organization Cruelty Free International in the U.S. in 2019, 79 percent of respondents would support a federal law that would end animal testing for cosmetics.

Following the widespread introduction of testing cosmetics on animals, it wasn’t long before the Draize irritancy test was introduced and became the “gold standard” for testing cosmetic products on animals. This test was introduced in 1944, and involved the animals’ eyes and/or skin being subjected to harsh chemicals to determine whether or not they were safe enough to be used in cosmetic products. 

Are Cosmetic Products Still Being Tested on Animals? 

Unfortunately, animal testing for cosmetic products is still taking place today. In the U.S., the decision of whether or not to test cosmetics on animals is largely left up to the manufacturing company. In the European Union, conflicting regulations —between requirements on safety testing to protect workers, and a directive to avoid animal testing unless absolutely necessary — mean that animal testing is still used on some substances only for cosmetic products. While China no longer requires cosmetic products to be safety tested on animals, particular products such as hair dyes require a license that can only be granted once data from animal safety tests are submitted. Which Animals Are Used by the Industry for Testing?

Precise numbers of each species used are difficult to ascertain, but animals used to test the safety of cosmetics include rabbits, guinea pigs, mice, rats and hamsters. There is little scientific basis for these species being used;  the animals are often selected instead for their practicality . These animals breed easily, have short gestation periods and therefore reproduce at a rapid rate. They are also cheap to maintain in a laboratory environment, and because they are prey species, are easy for researchers to handle during experiments.

What Products Are Tested on Animals?

In countries where animal testing for cosmetic products is permitted, tests can be carried out on the finalized cosmetic products, or the individual ingredients in them. Testing makeup products on animals is a common example, but cosmetic products also include shampoos, deodorants and moisturizers, just to name a few. Instead of using chemicals and formulas that are already known to be safe for consumers, some companies are still developing new ones that they have no knowledge of the effects of, and testing them out on animals.

What Cosmetics Tests Are Performed on Animals? 

Skin absorption or dermal penetration.

Dermal penetration tests, also known as skin absorption tests, are carried out to determine the rate at which a chemical can penetrate the skin, and what happens to the substance once it is in the body. Animals, typically rats, have their backs shaved and various chemicals spread across their bare skin. The rats are then killed at various times in order to analyze their blood and tissue for changes related to the chemicals. Even if not for their ethical implications, there is no reason for these tests to still be carried out today; the technology exists for in vitro methods to be used instead. These involve models of human skin tissues, or parts of living organisms such as sample of cells.

Skin Sensitization

Skin sensitization tests are similar to dermal penetration tests and also require untested chemicals being smeared on an animal’s skin so that researchers can see how much damage they cause. Just as with dermal penetration tests, there are alternative skin sensitization tests that use in vitro methods and so don’t require lives to be ended. 

Acute Toxicity

Acute toxicity testing involves an animal being exposed to a chemical substance, either orally, through their skin, or by inhaling it. This can involve a single dose or multiple doses, and the animal is observed for 21 days afterwards to assess the substance’s toxicity . 

Draize Test — Chemicals Applied to an Animal’s Eyes

Draize testing involves chemicals being directly placed onto the eyes of the animals to evaluate the damage they can cause. Rabbits are commonly used for draize testing due to their large eyes and how easily they can be handled in the lab.

Skin Irritation

Skin corrosivity and irritation testing is an umbrella term used to refer to a range of methods used to test how a chemical can damage the skin, including the Draize test. These tests have largely fallen out of public favor due to their ineffectiveness in translating to humans , as well as their use of live animals. 

Where Is Cosmetics Testing on Animals Banned?

Animal testing for cosmetics has now been limited or banned in 42 countries around the world. Even in these countries, however, there are often exceptions to the rules that allow companies to still test harmful chemical substances on rabbits, mice and other animals. Campaigns are ongoing for the Humane Cosmetics Act to be passed in the United States so that animal testing for cosmetics here can be limited and eventually banned.

Is Animal Testing for Cosmetics Even Necessary? 

Animal testing is no longer necessary. Not only has scientific advancement provided us with alternative, more ethical methods of safety testing cosmetics, but also with options that are more accurate, efficient and cost-effective . 

 Are There Arguments for Testing on Animals?

The main argument used by those in favor of animal testing is that it allows cosmetic products to be tested on biological tissues before being applied to human skin. In many cases, however, the results they produce are not the same as the results of the chemical being used on human tissue. The absence of a viable argument for testing on animals may slowly but surely inch cosmetics companies closer to an overall end to animal testing .

What Are the Alternatives to Animal Testing? 

Thanks to scientific and technological advances in recent years, there are numerous alternatives to testing cosmetic products on animals. Along with not causing the suffering and deaths of thousands of animals, these alternatives often produce more reliable results and are more efficient to carry out.

Organ on Chip 

Organ on chip technology works by very small tissues being grown within microfluidic chips. These chips control the microenvironment of the cells so that human tissues can be accurately simulated. This technology can be used to mimic single organs or multiple organs, and can be more accurate and cost-effective than the methods that use animal models.

Computer Modeling

Also known as “in-silico modeling,” computer modeling for safety testing of cosmetics involves using computers to predict the toxicity of chemicals in the body. The technology works by using data from chemical substances we know to be similar to the test substance in order to predict how it will interact with certain proteins in the human body, and therefore any harm it might cause.

In Vitro Human Tissue

Instead of chemicals being applied to an animal’s eyes or skin, in vitro tests allow the substances to be applied to models of the human cornea or human epidermis , giving a more accurate picture of the effects of these cosmetics on humans. 

Human Volunteer Research

Chemicals that have unknown effects on human tissue cannot ethically be applied to a human either, so human volunteer testing can’t be considered a complete alternative to animal testing on its own. It can however be used after in vitro safety testing methods have been applied and the product is thought to be safe, to give final confirmation that the cosmetic product does not harm human skin.

Cosmetics Brands That Test on Animals

Despite increasing consumer demand for an end to animal testing and multiple available alternatives, some cosmetic brands still carry out tests on animals. Cosmetics brands that still use animal testing may do so themselves, or by using ingredients that a third party has produced using animal tests. The only way to be sure a product you use has not involved animal testing at any point in its production is if it is certified as “cruelty-free.”

How Do I Know If My Cosmetics Are Cruelty-Free?

Cruelty-free cosmetic products are ones that have not been tested on animals or had any of their ingredients tested on animals. Brands may attempt to get around this, however, by describing their products as being cruelty free when this is not actually the case. 

The best way to determine if a cosmetic product you’re buying is truly cruelty-free is to look for the Leaping Bunny logo . The Leaping Bunny certification program was set up in 1996 by a coalition of several animal protection groups to provide a single standard for brands to be certified as  cruelty-free. In addition to  looking for the Leaping Bunny logo on any cosmetic products you’re considering buying, the program also compiles a list of which brands have recommitted to being cruelty-free each year.

It’s important to note that just because a product is certified as cruelty-free, however, that doesn’t mean it’s vegan. While a Leaping Bunny logo signifies that no animal testing was used, a non-vegan product still has ingredients that are the result of animal confinement or slaughter. 

The Bottom Line

Animal testing is an outdated method of validating the safety of cosmetics. In addition to causing immense amounts of suffering for millions of animals around the world, animal testing isn’t effective nor is it economically viable. Thankfully, increasing demand for cruelty-free cosmetic products that use other methods of safety testing is on the rise, with more and more governments banning the sale of animal-tested products and the use of animal testing for cosmetics.

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Cosmetic testing

Testing cosmetic products and their ingredients on animals was banned in the UK in 1998 and across the EU in 2013.

Recent legal changes have not reintroduced animal testing of cosmetics.

EU legislation banning cosmetics experiments is part of  EU Regulation 1223/2009  (Cosmetics Regulation).

The ban was created because non-animal methods were developed to test the safety of the cosmetics.

Animal testing for cosmetics

In the UK and across the rest of the EU, testing cosmetic products or their ingredients on animals is banned. This means that it is illegal to sell or market a cosmetic product if animal testing has taken place on the finished cosmetic or its ingredients before being sold in the EU.

A ban on animal-tested cosmetic products was first implemented in the UK in 1998 for finished cosmetic products and ‘ingredients intended primarily for “vanity” products’. The EU ban on animal-tested cosmetic products was first passed in 1993 with the full ban taking effect in 2013.

Whilst the UK was a forerunner in banning animal-tested cosmetics this legislation is now part of EU Regulation 1223/2009  (Cosmetics Regulation).

What is a cosmetic product?

The EU defines a cosmetic product as the following 1 :

“any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition”

Therefore everyday hygiene products, such as soap, shampoo, deodorant, and toothpaste, as well as luxury beauty items, including perfumes and makeup, are classified as cosmetic products.

Cosmetic products and animal testing

Cosmetic products for sale in the EU (including the UK) must be deemed safe and it is the responsibility of the manufacturer to ensure that they (and their ingredients) undergo scientific safety assessments to prove that they are not toxic to human health.

Before the ban on animal-tested cosmetics was implemented, safety assessments involving the use of animal studies to determine toxicology endpoint were required. The results gathered from these studies measured the effects the cosmetic and its ingredients had on human health and mainly involved the use of rodents and rabbits. When a safety assessment already existed for an ingredient in a new cosmetic product the animal study for the ingredient would not have to be repeated (the animal study for the finished cosmetic would still be required). However, for a new ingredient where a safety assessment did not previously exist, animal studies had to be conducted.

Due to the development of non-animal techniques, it became apparent that these animal studies were no longer required and a ban on animal-tested cosmetics and their ingredients was introduced.

History of the UK ban

In 1998 the Government announced a policy ban to end the use of animal testing for finished cosmetic products and ingredients. The definition of a cosmetic was in line with the concurrent EU description:

“any substance or preparation intended for placing in contact with the various external parts of the human body (epidermis, hair systems, nails, lops and external genital organs) or with the teeth and the mucous membrane of the oral cavity with a view (exclusively or principally) to cleaning them, perfuming them or protecting them in order to keep them in good condition, change their appearance or correct body odours.”

The definition included toothpaste, sun creams and other products which were considered to be pharmaceuticals outside of Europe at the time.

Whilst the ban in the UK was not part of any legislation, the companies involved with animal testing of cosmetic products relinquished their Home Office licences and were not able to renew them.

History of the EU ban

EU Directive 76/768/EEC (Cosmetics Directive) provided the regulatory framework for the phasing out of animal testing for cosmetics purposes across the EU and established a testing ban i.e. it is prohibited to test a finished cosmetic product and its ingredients on animals in the EU, and a marketing ban i.e. it is prohibited to market a finished cosmetic product or its ingredients in the EU if they are tested on animals.

Between 2007 and 2011 the EU spent €238 million on funding replacements, a testament to how serious they are about animal welfare, the 3Rs and the quest to find non-animal methods.

In 1993 the 6 th Amendment to EU Directive 76/768/EEC was passed and contained a ban on the sale of animal-tested cosmetic products. To make sure that adequate time was given to finding non-animal methods, the deadline for the ban to come into effect was 1 st January 1998.

In 1997 the ban was delayed until 30 th June 2000 due to a lack of alternative methods.

In 2000 the ban was delayed until 30 th June 2002 due to a lack of alternative methods.

In 2003 the 7 th Amendment to EU Directive 76/768/EEC was passed and contained a phased-in ban on animal testing for cosmetics with a deadline of 2013:

Ban animal testing on finished products.

Ban animal testing on cosmetic ingredients.

Ban the marketing of finished products tested on animals.

Ban the marketing of cosmetic ingredients tested on animals.

On 11 th September 2004, the ban on animal-tested cosmetic products came into force. The sale of cosmetic ingredients tested on animals outside the EU using methods that have been replaced within the EU was also banned.

On 11 th March 2009, the ban on animal testing of cosmetic ingredients within the EU was implemented. The sale of cosmetic products containing newly animal-tested ingredients was banned, however animal testing was still allowed for complex human health issues such as repeat dose toxicity, reproductive toxicity and toxicokinetics.

On 11 th March 2013, the full ban came into effect and it is now illegal to market or sell cosmetics in the EU where the finished product or ingredients have been tested on animals.

As of 11 th July 2013, EU Directive 76/768/EEC was replaced by EU Regulation 1223/2009  (Cosmetics Regulation) which contains all the same provisions.

Possible exceptions to the EU ban

REACH is an EU regulation concerning the r egistration,  e valuation, a uthorisation and r estriction of ch emicals and is applied to substances manufactured or imported into the EU in quantities of 1 tonne or more per year.

The hazardous properties of chemicals cannot be sufficiently determined using only non-animal methods therefore animal testing is still required to determine certain human health and environmental data. In order to minimise the use of animals REACH requires companies to share data in order to avoid unnecessary testing.

Those wishing to perform animal tests must obtain approval from the European Chemicals Agency (ECHA) which oversees REACH. Animal testing is to be avoided in favour of non-animal methods and registrants can only carry out tests involving the use of animals when there is no other way.

Read more about REACH here .

Substances that are exclusively used in cosmetics

Animal testing is not needed to meet REACH requirements for human health data, with the exception of tests that are done to assess the risks to workers (those involved with the production or handling of the substance on an industrial site) exposed to the substance. In this situation, animal testing is only required when there is no other way.

Animal testing is required to meet REACH requirements for environmental data when there is no other way. Environmental data is used to determine the safety of a chemical in biological organisms and across ecosystems. Environmental studies required for REACH include the use of fish.

In practice, the requirement for an animal test is most likely to come from a new chemical with an unknown safety profile that a cosmetics manufacturer wants to put in a product, or a chemical that is already in use but is now suspected of being dangerous due to new information.  

Substances that have mixed-use i.e. not solely used in cosmetics

Animal testing is only used to meet REACH requirements for human health and environmental data when there is no other way.

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Cosmetic testing outside the EU

In the USA cosmetics are regulated by the Food, Drug & Cosmetics Act, which prohibits the use of unsafe ingredients in a cosmetic product. The manufacturer has to verify if a cosmetic placed on the market presents any risk to consumer health using methods such as literature reviews, tests on animals or alternative methods, otherwise, the cosmetic must bear the statement ‘the safety of this product has not been determined’. New active ingredients in Over-The-Counter products (anti-acne, anti caries/anti-plaque, anti-hair loss, anti-dandruff, antiperspirant products, skin whiteners, sun protection products) must prove their safety on the basis of animal studies and clinical trials.

Whilst the USA does not prohibit animal testing, the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) was set up in 1997 with the aim to reduce animal testing. Once ICCVAM recommends that an alternative method has been adequately validated and the relevant test recommendations are accepted or endorsed by Federal regulatory agencies, the test becomes available for all toxicology purposes.

A number of products that are qualified as cosmetics in the EU are qualified as quasi-drugs in Japan. This includes hair dyes and de-colourants, anti-hair loss products, hair permanents/straighteners, depilatories, antiperspirants, deodorants, anti-acne, skin whiteners, bath treatment products, and medicinal cosmetics such as anti-dandruff shampoos. These products are subject to the same regulations as pharmaceuticals and a toxicological dossier is required for approval of a new quasi-drug ingredient which includes animal tests when there are no alternatives available.

In China, the control of cosmetic products and new cosmetic ingredients is under the responsibility of the Chinese State Food and Drug Administration and local cosmetics regulators. There are different rules for different sorts of cosmetic, and it can matter whether the product was made in China or is to be sold in China.

If, for instance, it is a general cosmetic such as makeup or toothpaste, does not contain a new chemical, is not intended for children and was manufactured in China, then animal testing would not be required. For a general cosmetic that was not manufactured in China, it is possible to avoid animal tests if the manufacturer can prove the product is safe through non-animal methods.

For special cosmetics like hair dyes and sunscreen, animal testing will be required, even if it was manufactured in China, if it is to be sold in China. If it is only to be sold abroad then animal testing is not needed.   

References and Links:

• http://ec.europa.eu/growth/sectors/cosmetics/index_en.htm
• EU Regulation 1223/2009 (Cosmetics Regulation)
• Interface between REACH and Cosmetics regulations
• The EU's role in cosmetics

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Animal testing for cosmetics

In principle, animal testing for cosmetic products is prohibited in Switzerland. But the situation is different internationally: An estimated 500,000 animals are currently still being used worldwide for torturous tests for cosmetics. And in Switzerland there are loopholes in the law too – unfortunately, the ban is no guarantee for animal-test-free sales shelves.

The legal situation in Switzerland

Since 1.5.2018, according to the Swiss Ordinance on Foodstuffs and Utility Articles, there is a ban on the marketing of cosmetic products or components of these products if they have been tested on animals. However, the ordinance lists exceptions to the ban:

The ban applies only to ingredients exclusively found in cosmetics. However, 90% of all ingredients in cosmetics are also used for medicines, household cleaners or paints – and are therefore also tested on animals.

Only products and ingredients that came onto the market after the ban came into force are affected. Older goods may continue to be on the shelves, even if they have been tested on animals.

Most cosmetic products to be sold in China must be tested on animals. This is required by Chinese legislation. Products that are also sold on the Chinese market are therefore rarely free of animal testing. Nevertheless, they may still be sold in Switzerland.

Why and how are cosmetics tested on animals?

The tests are justified by the need to ensure the safety of humans and the environment from the toxic effects of marketed substances and products. Unfortunately, many circles in science, industry and politics still hold the traditional opinion that animal testing is the only way to prove the safety of substances. However, the transferability of results from animals to humans is often not possible because humans are not mice nor rats. The following are some of the animal tests carried out for safety and compatibility tests for cosmetic products and their ingredients, primarily on rodents:

Acute and chronic toxicity

Ingestion toxicity is tested in rodents by administering different doses over different time periods. Depending on the substance and dose, severe side effects such as convulsions, diarrhea, and bleeding may occur.

Skin, eye, mucous membrane irritation

Testing for skin, eye and mucous membrane irritation of substances can result in painful inflammation and chemical burns in the test animals. The Draize test, which is used to test eye irritation of substances on rabbits and is highly invasive, is particularly controversial. Unfortunately, it has not been fully replaced to date.

Skin allergies

The substance to be tested is injected into the skin of the test animals (often guinea pigs) to stimulate the immune system. The animal is then exposed to the test substance again to test for the occurrence of allergic reactions such as skin inflammation.

Toxic effect of substances under the influence of sunlight (phototoxicity)

After the test animals, usually rodents, have been injected subcutaneously with the test substance, the animals are fixed and exposed to ultraviolet radiation in the wave range 400nm-315nm (= UV-A). Depending on the test substance, massive and painful inflammatory skin irritations may occur.

The last animal experiments reported in Switzerland in the animal experiment statistics in the field of cosmetics were carried out in 2010/2011 to test phototoxicity.

Embryonic malformations (teratogenicity) and impairment of reproductive ability

Pregnant animals are administered the test substance and, in order to assess whether malformations occur in the embryo or the pregnant animal is harmed, pregnant animals are killed at different stages of pregnancy and examined.

Carcinogenicity

It is observed whether the test substance leads to the development of tumors in the animals after administration.

The Cosmetics Guide: Orientation in the Label Jungle

It is not easy to recognize animal-free cosmetics on the shelf. In the meantime, there are numerous certificates and labels available that help consumers to make the right decision. But there are still stumbling blocks: an animal-free product is not necessarily completely free of animal suffering. It may contain animal ingredients and is therefore unsuitable for a vegan lifestyle. Animalfree Research has compiled a guide (in German) that presents the most important labels and their criteria.

Order Cosmetics Guide

You will receive the guide free of charge by mail.

„ * “ zeigt erforderliche Felder an

Testing Cosmetics on Animals: An Idea Who's Time Has Gone

Noah Lewis, Harvard Law School Class of 2005

Submitted in satisfaction of the course requirements for Food and Drug Law

Spring, 2004

Despite tremendous progress in reducing animal testing in the assessment the safety of cosmetic products, it persists and there is no definitive end in sight. The reasons for this are not entirely clear because the major constituents, consumers, animal rights activists, and the corporations engaged in the testing all seem to want it to end. While the government still requires animal testing for drugs and other consumer products, there is no explicit requirement for the animal testing of cosmetics. The time is ripe for these constituencies to join forces and push for an outright ban on the testing of cosmetics on animals.

• Introduction

Animal rights campaigns against cosmetics testing began in earnest in 1980 with a publicity campaign that asked, "how many rabbits does Revlon blind for beauty's sake?" [1] The campaign ended when Revlon and other cosmetics companies helped set up a center for the study of replacements for animal tests. [2] Despite tremendous progress in finding such replacements for animals in cosmetics testing, it persists and there is no definitive end in sight. The reasons for this are not entirely clear because the major constituents, consumers, animal rights activists, and the corporations engaged in the testing all seem to want it to end. While the government still requires animal testing for drugs and other consumer products, there is no explicit requirement for the animal testing of cosmetics. The time is ripe for these constituencies to join forces and push for an outright ban on the testing of cosmetics on animals.

• Opposition to Animal Testing

There are numerous constituencies that actively oppose cosmetics testing on animals or that would be relatively indifferent to a ban.

• The Animals

If nonhuman animals did not oppose testing, there would be no need for a ban on testing cosmetics on them. It seems an obvious point, but it bears repeating: nonhumans do not volunteer for cosmetics testing. [3] There is no informed consent and the animals receive no benefit from their participation. What animals do receive is confinement, oftentimes including immobilization in stocks, isolation from their peers, exposure to corrosive and irritating chemicals. Ultimately they are killed.

Descriptions of what animals endure may seem gratuitous, inconsequential, or designed solely to stir emotions. But animal suffering is easily ignored. It occurs out of the view of the public eye and therefore it is easy to forget, deliberately or otherwise. Here is one description of the lethal dose 50 (LD50) test in which animals are fed a substance until half of them die:

Because most cosmetic products are not especially poisonous, it necessarily follows that if a rat or a dog has to be killed this way, then very great quantities of cosmetic must be forced into their stomachs, blocking or breaking internal organs, or killing the animal by some other physical action, rather than by any specific chemical effect. Of course the procedure of force-feeding—even with healthy food—is itself a notoriously unpleasant procedure, as suffragettes and other prisoners on hunger-strike have testified. When the substance forced into the stomach is not food at all, but large quantities of face powder, makeup or liquid hair dye, then no doubt the suffering is very much greater indeed. If, for the bureaucratic correctness of the test, quantities great enough to kill are involved then clearly the process of dying itself must often be prolonged and agonizing. [4]

Thankfully, this type of test has been largely eliminated and is now confined to testing ingredients, which still involves force feeding and possibly more noxious chemicals. Other once-common tests that persist are the Draize eye and skin irritancy tests that involve placing chemicals in the eyes or on the shaved skin of rabbits or guinea pigs. [5]

B. Animal Rights Activists

Animal rights activists oppose all animal experimentation. The case for animal rights has been thoroughly laid out elsewhere. [6] The basic premise is that animals do not exist for human use. Because animals are sentient beings, they deserve equal consideration of their rights—there are no morally relevant reasons for drawing a line between humans and animals. When it comes to even medical experimentation on animals, animal rights advocates reject placing animals in that position: "[w]e must stop manufacturing conflicts in which we place animals in out hypothetical burning house because we regard them as our property, and then pretend to ask seriously whose interests we should prefer. [7] Once someone decides that animals "have a basic right not to be things, then we must stop thinking about them as our property, our resources." [8] From the animal rights perspective, animals start off as beings worthy of moral consideration and their use in experiments can be no more justified than using a group of despised humans to experiment on—all such instrumental uses of sentient beings are rejected for a very simple reason: you or I would not want to be experimented on without our consent, therefore we should not subject others to that treatment.

C. Animal Welfarists

Unlike animal rights activists, animal welfarists think it is OK to use animals to serve human ends when it is necessary to do so, but the animals must be treated humanely. [9] Most people are welfarists. Even those who exploit animals believe it should be done "humanely." The American Meat Institute, for example states, "[p]eople want animals handled humanely, and we feel we have an ethical obligation to do that." [10] The Foundation for Biomedical Research (FBR), is an industry nonprofit "dedicated to improving human and animal health by promoting public understanding and support for the humane and responsible use of animals in medical and scientific research." [11] FBR notes that researchers are required to "justify their need for animals; select the most appropriate species and use the fewest number of animals possible to answer a specific question." [12] They describe the using animals in research as an "essential need" that provides " invaluable and irreplaceable insights." [13] Another industry group, Americans for Medical Progress, "supports the use of only those animals that are necessary for reliable research results, non-animal research methods when approved for specific types of studies, and the highest standards of animal care, including those for housing, environmental enrichment, research procedures, pain management and euthanasia, among others." [14] The incurably ill For Animal Research (iiFAR) "realizes the importance of Product Safety Testing toward preventing serious injuries and recognizes that tests on animals are necessary. However, iiFAR joins with all concerned parties in encouraging the scientific community to search for additional non-animal methods to help deter-mine the toxicity of new products." [15] Corporations also share welfarist ideals. Johnson & Johnson applies the 3Rs to animal testing: replacement, reduction and refinement. [16] It is their policy to use animals to the "minimum extent necessary" to assess the safety of their products, to treat them "humanely" and to cause no "unnecessary pain." [17] These positions all represent the classic articulation of the welfarist position—humane use of animals when necessary. Given that everyone seems to be opposed to unnecessary use of animals, one must figure out what is necessary.

Conceiving of cosmetics as "necessary" is difficult. Wearing cosmetics may be considered desirable, preferable, or a positive aspect of society, but that does not make it necessary. Some women may consider wearing cosmetics "necessary." Women face enormous social pressure to wear makeup. Their jobs may also depend up wearing makeup. [18] Even if these things are conceded, however, this does not justify testing new cosmetics on animals. There are thousands of cosmetics already on the market and over 3,000 ingredients that can be readily used to formulate new cosmetics. [19] An end to animal testing will, at worst, slow the introduction of new products until replacements for the few remaining animal tests are found.

D. Corporations

Another potential source of "necessity" is corporations. Because corporations have a duty to shareholders to make a profit and attempting to sell women new formulations of cosmetics is traditionally how cosmetics companies increase profits. [20] Corporations could, however, continue to make profits by selling their tried and true formulas, however. This point in time presents another avenue to dramatically increase profits by catering to a large, untapped market—men. Currently sales to men comprise a small percentage of overall sales, but that percentage is growing rapidly. [21]

Moreover, corporations profess a desire to eliminate animal testing. "Unilever is committed to the elimination of animal testing for our business." [22] Proctor & Gamble (P&G) has spent more than $170 million over the past 20 years on replacements for animal tests and currently spends $10-13 million annually. [23] P&G has eliminated animal testing for 80% of its products. [24] Although more costly, the replacement tests "achieve better results." [25]

Advances have yielded impressive progress. "Animal use for skin irritation testing is not necessary today, with currently available and accepted methodology, except for regulatory reasons." [26] Clinical trials on humans represent one advance that not only allows in vitro tests to be validated, but represent a direct product test on the species of concern, humans. [27]

E. Consumers

Many Americans are opposed to using animals in cosmetics testing. Only thirty-one percent of Americans think it is right to test cosmetics on animals. [28] Another poll showed 58% of Americans think "using animals for cosmetics research" should be prohibited by law and another 23% disapprove but don't feel it should be illegal. [29] Among women, 63% oppose animal testing for health and beauty products. [30] Thirty-eight percent of people would support a ban on all product testing on laboratory animals. [31]

In addition to simply being opposed to animal testing in theory, consumers often desire to avoid purchasing products tested on animals. Nine percent of women specifically look for "not tested on animals" claims when buying health and beauty care (HBC) products. [32] Twenty-two percent of women have purchased HBC products because "advertising indicated it was not tested on animals." [33] Moreover, 47% said they would be somewhat or much more likely to buy an HBC product that indicates it has not been tested on animals." [34] This data reveals that the claim "not tested on animals" has power to add value to a product and that consumers make choices based on their beliefs about whether or not a company tests on animals.

In an effort to help consumers make informed choices, several animal rights groups produce guides to companies that do and do not test on animals. [35] To become listed on PETA's "don't test" list, the company must agree not to "conduct or commission any nonrequired animal tests on ingredients, formulations, or finished products and that they pledge not to do so in the future." [36] In 1996 a group of animal protection groups formed the Coalition for Consumer Information on Cosmetics (CCIC) to promote a single comprehensive standard for animal testing claims as well as an internationally recognized "leaping bunny" logo. [37] The standard provides that neither a company or its suppliers conducts animal testing after a fixed cut off date. [38] The program differs from the PETA standard in that it applies to suppliers and requires an annual recommitment. The program is doing well, with 33 new companies being certified in 2004 alone. [39] While a sophisticated consumer might know that CCIC is the gold-standard to look for when purchasing a cruelty-free product, there are a multitude of non-CCIC companies making animal testing claims on their labels.

A survey of 85 cosmetic and soap products that make some type of claim about animal testing on their label highlights the confusing nature of animal testing claims on labels. [40] The results of this survey are presented in a separate spreadsheet. Of the 85 products surveyed, only 19 (22%) appeared on the CCIC list. Seventeen (20%) appeared on the PETA list, but not the CCIC list. Five (6%) appeared on PETA's "do test" list but still carried "don't test" labeling claims. [41] The remaining 44 (52%) appeared on no list at all, thus even a consumer armed with the PETA list and the CCIC list would have no way to evaluate these claims without contacting each company. Taking CCIC as the gold-standard that most consumers think they are purchasing—no new animal testing—these claims are deceptive 78% of the time (66 out of 85).

The labels themselves carry a wide varied of differently worded claims. Here is a sample of some of the different types of claims made on labels:

• Cruelty free
• No animal testing
• Not tested on animals
• Never tested on animals
• We do not test on animals
• This product has not been tested on animals
• Salon tested on people, not animals
• Created without animal testing
• Product and ingredients not tested on animals

In addition to text slogans, the products also featured all manner of bunny logos. Bunnies sitting, bunnies with slashes over them, and bunnies in boxes, triangles and ovals. Not to be left out is one company's "seal" of approval, represented by said sea mammal. [42] Despite the fact that PETA and CCIC both have different official bunny logos, these appeared on only a couple of products. Of the companies entitled to use the CCIC leaping bunny, only one (Jason Natural Cosmetics) used it, perhaps because there is fee associated with using the logo, but not with becoming CCIC certified. [43] The plethora of bunnies can be misleading if consumers think the bunny is some sort of official symbol of approval or have been instructed by animal rights groups to look for the leaping bunny logo and they mistake the bunny on the product for the official CCIC logo, [44] which looks like this:

Labels like those outline above can be misleading—even sophisticated consumers are unable to distinguish between animal testing claims. In one survey, half of consumers though "not tested on animals" meant that neither the product nor the ingredients were tested on animals, although that is seldom the case. [45] The carefully worded labels provide plenty of leeway to hide the fact that a company may be involved in animal testing. This can happen in many ways: 1) Almost all ingredients, including water, have been tested on animals at some point. The Cosmetic, Toiletry & Fragrance Association believes that "not tested on animals" claims are confusing to consumers because of that point. [46] 2) Even if finished products have not been tested on animals, the ingredients may have been. 3) Even if that product was not tested on animals, the company may have tested earlier, very similar products. 4) Some companies use a rolling cut-off date for ingredients. For example, they may not use ingredients that have been tested on animals in the last five years, so they are in effect letting others do the dirty work for them but still profiting from the new ingredients developed through animal testing. [47] 5) The company itself may not conduct tests, but it may contract it out, rely on testing from trade associations, or rely on testing from outside of the US. [48] Given all of these loopholes, disingenuous companies can slap a "not tested on animals" label on its product, attract more customers than a competitor, and face little repercussion because of the difficulty in consumers finding out the specifics of a company's testing policy, and even if they did, there is little legal resource for consumers, as outlined in Section III below.

Europe will ban the testing of cosmetics on animals in 2009. [49] The ban includes a ban on the marketing of cosmetics—final products and ingredients—that have been tested on animals and so will apply to any company wishing to do business in Europe. [50] Corporations perceive the US government's failure to recognize non-animal replacements as a stumbling block for US companies who wish to participate in the European market. [51]

• General Authority to Act

A cosmetic is misbranded if "its labeling is false or misleading in any particular." [52] The FDCA prohibits the introduction of misbranded cosmetics into interstate commerce. [53] The FDA has the authority to seize, detain, or obtain an injunction against the distribution of any such misbranded products. [54] Violations can also result in imprisonment and criminal and civil fines. [55] There is no private right of action of any sort under the federal Food Drug and Cosmetic Act (FDCA). [56] Although there is additional authority to regulate labels under the Fair Packaging and Labeling Act of 1992, that Act applies mainly to things like the identity of the product and the quantity of the product [57] and it is unlikely that claims about animal testing could fit under that law. [58]

The FDCA protects consumers' economic interests as well as health and safety interests. The FDCA has applied to cases of economic adulteration where an ingredient of lesser value has been marketed as one with greater value even if the product itself is not harmful. [59] Because of the FDCA's intention to protect consumers, [60] the standard is not one of the sophisticated consumer or even the reasonable consumer, but rather "a consuming public which includes "the ignorant, the unthinking and the credulous." [61] Similarly, other courts have found that the standard by which misleading statements were be to be judged was not of "overly skeptical buyers," but "actual customers who cannot be presumed to have special expertness or to be unduly cautious." [62] One might argue that animal rights activists are the prime market for cruelty-free products and they are in fact highly skeptical and educated about the subject. Animal rights groups produce numerous guides with which consumers can arm themselves and use to purchase cruelty-free cosmetics. [63] There are several problems with this argument. First, the very fact that guides need to be produced indicates how difficult it is to purchase products that are strictly not tested on animals. Second the guides cannot be comprehensive and they are not as indicated by the large number of products in my survey that made animal testing claims but did not appear on PETA's list. [64] Third, teenage girls often seek out cruelty free products and companies wishing to tap into this large market must pay attention to those preferences. [65] Although some teens probably are much more sophisticated consumers than many adults, it is unfair to hold teenagers to adult scrutiny standards. Finally, it is not just animal rights activists who seek to purchase cruelty-free products. As poll data indicates, up to sixty percent of the public might wish to purchase such products. [66]

The failure to disclose the fact that animal testing has occurred could be considered misleading. In deciding whether a label is misleading, the FDA can take into consideration "the extent to which the labeling or advertising fails to reveal facts material in the light of such representations." [67] Thus if a product is labeled "not tested on animals," but all of the ingredients have been separately tested on animals, the label fails to reveal this material fact and is thus misleading.

By failing to enforce the misbranding portion of the FDCA, the FDA may be abusing its discretion. Because economic harm is part of the statutory mandate and consumers are being harmed, consumers' rights under the FDCA are "'nullified by FDA inactivity." [68]

• Case-by-Case Approach

The FDA could approach the issue on a remedial, case-by-case basis. As shown above, however, the labeling problem is widespread. The FDA could, for example, send a letter to each company notifying them that their product was potentially misbranded and ask for clarification of what the company means by the label along with proof that they comply with their own claim. Virtually every company could come up with a reasonable definition of their claims. If a company merely didn't test the final product on animals, they could say that's all they implied. If a company contracts out the testing of its products, they could claim they were referring to the fact that they themselves did not test on animals. If a company uses a rolling cut-off date for ingredients, they could still claim that the testing was not done to create that product, so it is acceptable to claim there was no animal testing. Some companies might be moved to remove their labeling claims about animal testing, but given all of these ambiguities, they probably feel they could prevail in court that their products are not misbranded. They might also correctly believe that the issue was a low priority for the FDA and the chances of enforcement through a lawsuit were minimal. Absent uniform definitions of these labeling claims, the FDA would be unable to give clear direction as to how to eliminate the risk that their products are misbranded.

• Regulation of Labeling Claims

The FDA could promulgate standards for labeling claims such as "cruelty-free" and "not tested on animals" to ensure that such labels are not misleading consumers. [69] Ideally, the standards would mirror those used by the CCIC. [70] The FDA should allow each company to choose a cut-off date to encourage as many companies as possible to cease animal testing and be able to label their products as such without attempting to go back and remove ingredients tested after a nationwide cut-off date. Such interpretive rules would put companies on notice about what the FDA's position is with respect to misbranding and animal testing claims. The FDA could enforce this by requiring companies to submit their animal testing policies upon request, or make it mandatory for any company wishing to make such a claim on its label.

FDA might lack the authority to promulgate standards, however. In 1974, the FDA promulgated standards that defined "hypoallergenic," but the regulations were struck down as arbitrary and capricious. [71] Given that the FDA received a petition in 1996 on this subject, which it characterized as "through," but did not begin rulemaking proceedings, this seems to indicate that either the FDA lacks the resources to give this issue priority or it does not feel it has authority or a factual basis that would withstand judicial review.

B. Competitor Lawsuits for Unfair Competition

The Lanham Act allows competitors to sue one another for false labeling. [72] There are three elements to a Lanham Act claim: [73] (1) that the advertising in question is conveying a particular message (that the product and/or its ingredients were not tested on animals—this is not mere puffery as polls show people look for it); (2) that the message is false (most ingredients have been tested on animals, or the testing may have been contracted out, etc.); (3) that the plaintiff is likely to be injured as a result of the advertiser's false claim (poll data showing consumers are more likely to choose a product that has not been tested on animals).

Suits could occur in two ways. First, companies that comply with the CCIC standards could sue the companies that claim "no animal testing" but do not comply with CCIC. They could present the arguments made above and show how the competitor is being deceptive and therefore is engaging in unfair competition. Second, this could be used by companies that do not comply with the CCIC and label any of their products as "not animal tested." Corporations like P&G that engage in huge amounts of research on replacements and have substantially reduced the number of animal tests that they perform choose not to label their products because they believe such claims are misleading given the history of animal testing for most ingredients. [74] These corporations could sue companies claiming not to engage in animal testing but who actually do in some form.

States also have various unfair competition laws under which corporations could bring suit. California's even has a private cause of action for any individual harmed by the unfair competition so consumers or animal rights activists could bring suits directly.

C. Additional Possibilities

All of the concerns about labeling, however, are merely a sideshow to the real goal which is, of course, a ban on animal testing of cosmetics. the fda does not explicitly require animal test but it does require a warning label if a product has not been tested. the fda could either eliminate this warning label requirement or clarify that non-animal tests qualify as testing under this requirement and it could foster the validation of replacements in other areas where it does require animal tests..

The FDA lacks statutory authority to outright ban animal tests, so ultimately such a directive would have to come from Congress. In addition to banning animal tests, Congress could increase the FDA's authority over cosmetics regulation and mandate human clinical testing of cosmetics.

Another possibility would be to institute state or local bans on animal cosmetic tests. There is probably no preemption problem given that the FDA does not require animal tests. Similarly, The federal Animal Welfare Act regulates treatment of animals only and does not go to the substance of experiments. [75]

A final way in which Congress could foster an end to animal testing would be to ban the use of animal testing data in product liability suits and to limit liability for unforeseeable harms from cosmetics. This latter solution is not ideal, however, because companies should be encouraged to pursue wider clinical testing.

IV. Conclusion

Due to the limitations of the above-described legal tools, activists cannot rely on the law to create social change. When Spira began his activism in 1979, a ban on cosmetics testing would have been dramatic. Now that replacements for animal tests are in place, particularly in the area of cosmetics, it is time for animal rights advocates to vigorously, publicly call for nothing less than a ban the testing and marketing of any product that uses animal testing after a prescribed cutoff date.

[1] Henry Spria, Should You Take an Activist to Breakfast , 49 Food and Drug Law Journal, 291, 295 & 295 n.8 (1994).

[2] Id. at 295.

[3] Berke Breathed, Night of the Mary Kay Commandos Featuring Smell O-Toons , 1989 (cartoon character Opus visits a cosmetics testing lab in search of his mother. He was initially reassured by his visit to the lab, until he had the a revelation).

[4] Tom Regan, Empty Cages: Facing the Challenge of Animal Rights 168-69 (2004), (quoting Richard Ryder, Victims of Science: The Use of Animals in Research 36 (1975)).

[5] Gary Francione, Introduction to Animal Rights: Your Child or the Dog 45 (2000).

[6] E.g. , Francione, supra note; Joan Dunayer, Speciesism (2004), Tom Regan, Empty Cages: Facing the Challenge of Animal Rights (2004).

[7] Francione, supra note 5 at 157.

[9] Id. at xxii-xxiii.

[10] David Forster, Animal Rights Activists Getting Message Across: New Poll Findings Show Americans More in Tune with "Radical" Views , Chi. Trib. Jan. 26, 1996, at C8.

[11] Foundation for Biomedical Research, About the Foundation for Biomedical Research , Dec. 8, 2003, http://www.fbresearch.org/about.

[12] Foundation for Biomedical Research, FBR's Position on Animal Research , Sept. 5, 2002, http://www.fbresearch.org/about/position.htm.

[14] Americans for Medical Progress, AMP's Statement on Humane Animal Use , http://www.amprogress.org/About/AboutList.cfm?c=9 (last visited May 22, 2005).

[15] incurably ill For Animal Research, About Us - Position Statement: Product Safety Testing , http://www.iifar.org/ps_testing.html (last visited May 22, 2005).

[16] Johnson & Johnson, Statement on Product Safety & Laboratory Research Animal Testing , May 14, 2004, http://www.jnj.com/community/policies/animal_testing/statement.htm.

[17] Johnson & Johnson, Policy on the Humane Care & Use of Laboratory Research Animals , May 14, 2004, http://www.jnj.com/community/policies/animal_testing/policy.htm.

[18] Jespersen v. Harrah's Operating Co., Inc. , 392 F. 3d 1076, 1078 (9th Cir. 2004) (upholding an employee appearance policy requiring that women wear makeup and men do not).

[19] Unwanted Effects

[20] Christina Passariello, Sales to Men Lifts Beauty Market , Wall Street Journal, April 7, 2004, at 1.

[21] Molly Prior, Men's Grooming Moves from Metrosexual to Average Joe , Drug Store News, Mar. 1, 2004 at 38 ("Retail sales of men's skin care products alone have nearly tripled in the last 10 years."); Passariello supra note 20 ("It's a very buoyant market with very fast growth.").

[22] Unilever, Unilever's position on animal testing , http://www.unilever.com/ourvalues/environmentandsociety/issues/animalTesting.asp (last visited May 22, 2005).

[23] Carmen Fleetwood, In Vitro Testing is Coming to Aid, If Not Yet Succeed, the Guinea Pig , Wall Street Journal, Sept. 19, 2004 at 1.

[24] Tonya Vinas, P&G Seeks Alternative to Animal Tests , Industry Week, July 2004 at 60.

[26] Katherine A. Stitzel, Tiered Testing Strategies—Acute Local Toxicity , 43 Institute for Laboratory Animal Research Journal S21 (2002), http://dels.nas.edu/ilar_n/ilarjournal/43_supp/V43suppStitzel.shtml. See also M.K. Robinson et al., Non-animal Testing Strategies for Assessment of the Skin Corrosion and Skin Irritation Potential of Ingredients and Finished Products , 40 Food and Chemical Toxicology 573-592 (2002) (noting that the Draize test for skin irritation and corrosion is incredibly inaccurate and reliable non-animal replacements exist).

[27] Michael K. Robinson, John P. McFadden, and David A. Basketter. Validity and Ethics of the Human 4-h Patch Test as an Alternative Method to Assess Acute Skin Irritation Potential , 45 Contact Dermatitis 1 (2001) (authors include scientists from P&G and Unilever).

[28] Associated Press Poll, Question ID: USAP.945K Q3B 005, Dialog Poll database, Nov. 14, 1995 (Do you think the use of animals to test cosmetics is always right (2%), right under some circumstances (29%), seldom right (21%), or never right (46%)? Don't know: 2%.)

[29] Parents Magazine, Question ID: USKANE.89PM10 R02B 006, Oct. 10, 1989 ("Thinking about specific ways that humans assert their dominance over animals, please tell me if you think each of the following practices is wrong and should be prohibited by law (58%), if you personally disapprove but don't feel it should be illegal (23%), or if it is acceptable to you (13%). Not sure (5%)).

[30] Karyn Snyder, Terms of Ensnarement; Use of Animals in Testing , Drug Topics, Jan. 22, 1996, at 51 (quoting the National Consumers League).

[31] Gallup Poll, Question ID: USGALLUP.03M0005 R37B 004, Dialog Poll database, May 21, 2003 (proposal: "banning all product testing on laboratory animals" 13% strongly support, 25% somewhat support, 31% somewhat oppose, 30% strongly oppose, 1% no opinion.)

[32] Terms of Ensnarement , supra note 30.

[35] E.g. , People for the Ethical Treatment of Animals, Companies That Do/Don't Test on Animals , http://www.caringconsumer.com/searchcompany.asp (last visited May 22, 2005); National Anti-Vivisection Society, Personal Care for People Who Care , http://www.navs.org/ido/index.cfm?ido=product_testing_book&title=Product%20Testing%20Book (last visited May 22, 2005) (this book costs $13.50).

[36] People for the Ethical Treatment of Animals, Companies That Do/Don't Test on Animals , http://www.caringconsumer.com/searchcompany.asp (last visited May 22, 2005).

[37] Coalition for Consumer Information on Cosmetics, About Us , http://www.leapingbunny.org/about_us.htm (last visited May 22, 2005).

[38] Coalition for Consumer Information on Cosmetics, Industry , http://www.leapingbunny.org/industry.php (last visited May 22, 2005).

[39] Coalition for Consumer Information on Cosmetics, Newly Approved Companies , http://www.leapingbunny.org/approved-2004.htm (last visited May 22, 2005).

[40] I conducted this survey in March of 2004 by examining products at a Brooks drug store in Somerville, MA, The Harvest Co-op (a natural foods store) in Cambridge, MA, and a Whole Foods store, Cambridge, MA. The survey includes mostly cosmetics, a few soaps, but no household cleaners. Although soaps are not regulated under the FDA, but fall under the Consumer Product Safety Commission (CPSC), they are included because consumers generally have no knowledge of the different regulatory status of "cosmetics" versus "soaps" and the labeling issues are precisely the same. This paper confines discussion to the FDA, but the same analysis could easily be extended to the CPSC.

[41] This is most likely because the parent company tests on animals or other product lines are tested on animals. For example, Proctor and Gamble appears on PETA's "do test" list, but their Clairol Herbal Essences line is, evidently according to the label, not tested on animals. Perhaps this refers to the final product only.

[42] There are probably no instances of companies testing cosmetics on a seal.

[43] Coalition for Consumer Information on Cosmetics, Frequently Asked Questions , http://www.leapingbunny.org/faq.htm (last visited May 22, 2005).

[44] Coalition for Consumer Information on Cosmetics, welcome page, http://www.leapingbunny.org (last visited May 22, 2005).

[45] Animal Testing Claims Can Confuse , Times-Picayune (New Orleans, LA), Jan. 17, 1996, at E3 (referring to a survey by the National Consumers League).

[46] Terms of Ensnarement , supra note 30.

[47] Terms of Ensnarement , supra note 30.

[49] CNN, EU to ban animal-tested cosmetics, Jan. 15, 2003, http://edition.cnn.com/2003/WORLD/europe/01/15/eu.testing.

[50] Council Directive of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (76/768/EEC), Article 4a, http://pharmacos.eudra.org/F3/cosmetic/Consolidated_dir.htm

[51] W. Richard Ulmer, Invitro's Aspirin Approval , Global Cosmetic Industry, April 2005, at 23 (calling on businesses to "speak with your regulatory agency as soon as you can").

[52] 21 U.S.C.A. § 362(a) (2005).

[53] 21 U.S.C.A. § 331 (2005).

[54] 21 U.S.C.A. § 334 (2005) (seizure and detainment); 21 U.S.C.A. § 332 (2005) (injunctions).

[55] 21 U.S.C.A. § 333 (2005).

[56] National Women's Health Network, Inc. v. A. H. Robins Co., 545 F. Supp. 1177, 1179 (D. Mass 1982) (denying remedial equitable relief in Dalkon Shield case and noting actions for damages or injunctions are also disallowed).

[57] 15 U.S.C.A. § 1453 (2005).

[58] Although the declared policy of the law was to ensure that packaging facilitates "value comparisons," 15 U.S.C.A. 1451 (2005), and claims about animal testing do affect the perceived value of the product for many.

[59] Federal Sec. Adm'r v. Quaker Oats Co., 318 U.S. 218, 230-31 (1943) (noting the FDCA mandated the creation of food identity standards because labeling requirements were insufficient to protect consumers from economic adulteration); United States v. Two Bags, Poppy Seeds , 147 F.2d 123, 127 (6 Cir. 1945) (noting the FDCA was "not designed primarily for the protection of merchants and traders; but was intended to protect the consuming public").

[60] United States v. An Article. . . Consisting of 216 Individually Cartoned Bottles, More or Less, of an Article Labeled In Part: Sudden Change , 409 F.2d 734, 740 n.6 (2nd Cir. 1969) (noting that the legislative history of the FDCA indicates concern about defrauding consumers).

[61] Sudden Change , 409 F.2d at 740 (holding that "face lift" claims made a cosmetic product a drug because consumers would expect it to change the structure of their bodies); United States v. Strauss, 999 F.2d 692, 696-97 (2d Cir. 1993) (applying the same standard to misbranded dog food).

[62] United States v. An Article of Drug Consisting of 47 Bottles, More of Less, Each Containing 30 Capsules of an Article Labeled in Part Jenasol RJ Formula "60" , 320 F. 2d 564, 572 (3rd Cir. 1963) (basing this on the fact that purchasers are "pathetically eager to find some simple cure-all for the diseases with which they are afflicted").

[63] E.g. , Companies That Do/Don't Test supra note 36; National Anti-Vivisection Society, Personal Care for People Who Care , http://www.navs.org/ido/index.cfm?ido=product_testing_book&title=Product%20Testing%20Book (last visited May 22, 2005) (this book costs $13.50).

[64] Companies That Do/Don't Test supra note 36.

[65] Targeting Teens , Chain Drug Review, Feb. 26, 1996 at S3 (noting that teenage girls spent $5.8 billion on cosmetics in 1994); Animal Testing Claims , supra note 45 (noting younger women "are twice as likely as older women to purchase a health and beauty aid with a not-tested-on animals claim on its label").

[66] Supra note 30 and accompanying text.

[67] 21 U.S.C.A. § 321(n) (2005) (emphasis added).

[68] Bryan A. Liang and Kurt M. Hartman, It's Only Skin Deep: FDA Regulation of Skin Care Cosmetics Claims , 8 Cornell J. L. & Pub. Pol'y 249, 276 (1999).

[69] 21 U.S.C.A. § 371 (2005) (granting the FDA rulemaking authority).

[70] Supra note 37 and accompanying text.

[71] Almay v. Califano , 569 F. 2d 674, 675, 683 (DC Cir. 1977).

[72] Thomas C. Morrison, The Regulation of Cosmetic Advertising under the Lanham Act , 44 Food Drug Cosm. L.J. 49, 49 (1989).

[73] Id. at 51.

[74] Proctor & Gamble, Our Commitment Our Approach: Procter & Gamble's Practices, Policy and Progress On Research Involving Animals , at 3, http://www.pg.com/science/Brochure%20on%20Research%20with%20Animals.pdf (last visited May 22, 2005).

[75] But see Larry T. Garvin, Constitutional Limits on the Regulation of Laboratory Animal Research , 98 Yale L.J. 369 (1988).

Replacing Animal Testing with Stem Cell-Organoids : Advantages and Limitations

• Open access
• Published: 19 April 2024

Cite this article

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• Guiyoung Park 1 ,
• Yeri Alice Rim 2 , 3 , 4 ,
• Yeowon Sohn 5 ,
• Yoojun Nam   ORCID: orcid.org/0000-0003-4583-3455 5 , 6 &
• Ji Hyeon Ju 2 , 3 , 4 , 6  

Various groups including animal protection organizations, medical organizations, research centers, and even federal agencies such as the U.S. Food and Drug Administration, are working to minimize animal use in scientific experiments. This movement primarily stems from animal welfare and ethical concerns. However, recent advances in technology and new studies in medicine have contributed to an increase in animal experiments throughout the years. With the rapid increase in animal testing, concerns arise including ethical issues, high cost, complex procedures, and potential inaccuracies.

Alternative solutions have recently been investigated to address the problems of animal testing. Some of these technologies are related to stem cell technologies, such as organ-on-a-chip, organoids, and induced pluripotent stem cell models. The aim of the review is to focus on stem cell related methodologies, such as organoids, that can serve as an alternative to animal testing and discuss its advantages and limitations, alongside regulatory considerations.

Although stem cell related methodologies has shortcomings, it has potential to replace animal testing. Achieving this requires further research on stem cells, with potential societal and technological benefits.

Graphical Abstract

Avoid common mistakes on your manuscript.

Introduction

Historically, animal models have contributed substantially to the advancement and study of vaccines, surgical techniques, and various scientific experiments [ 1 ]. However, owing to the problems associated with animal testing, researchers are now questioning whether animal models and tests are the best options for these procedures. Growing animal testing is ethically concerning amid scientific evolution. According to the Humane Society International Organization, more than 100 million animals are killed annually worldwide for scientific purposes (Humane Society International). The animals used vary depending on their traits and include rats, mice, rabbits, dogs, cats, guinea pigs, zebrafish, swine [ 2 , 3 ].

In December 2022, the U.S. Food and Drug Administration (FDA) announced animal testing is no longer mandatory safety approval of products [ 4 ]. However, products that are used on the human body still require safety testing. In other words, testing for toxicity, compatibility, and safety is compulsory for products; however, animal testing is unnecessary for conducting these tests. In response, research facilities and companies have introduced alternatives such as computer simulations and in silico models. Stem cell therapy has gained popularity throughout the medical field, and various studies are underway to gain deeper knowledge [ 5 ]. With the emergence of this stem cell-based test, alternative methods have also arisen, potentially offering to become a replacement for animal testing.

When comparing test options, alternatives offer more beneficial attributes than animal testing. Non-animal tests are cost-effective, less time-consuming, and simpler procedures than animal tests [ 6 ]. However, most research institutions use animal models. This is because animal testing has been a longstanding experimental approach for decades [ 7 , 8 ]. Efforts are being made to replace animal testing with the use of human cells, as animal testing results often exhibit interspecies differences with humans, thus lacking the ability to reliably predict clinical outcomes. Application of advancing stem cell technology continue, but completely replacing animal experimentation poses significant challenges. Therefore, it is important to conduct further studies to advance the science of alternative testing methods. This review aimed to summarize the use of stem cell technology as an alternative to animal testing and discuss its advantages and limitations.

Current State of Animal Testing

Uses of animal testing.

Animal testing has been used for decades, and in the 21st century, the number of tests has increased considerably [ 2 ]. With approximately 100 million animals used for testing annually worldwide, science has been rapidly evolving. The primary function of animal testing is to test drugs, their toxicity, and their compatibility with the human body to ensure safe use. Hence, pre-launch testing is crucial. Companies and research facilities must subject their products to clinical trials before introducing them to potential customers.

Neurological disorder such as Parkinson’s and Alzheimer’s have also been modeled in animals to understand their mechanisms and to determine suitable treatments [ 9 , 10 , 11 ]. For instance, in the case of Parkinson’s disease, various animal models have been employed, including Caenorhabditis elegans, Zebrafish, and mice. Additionally, genetically modified mice carrying mutations associated with proteins like α-synuclein, Parkin, Pink1, and LRRK2, as well as mice induced with α-Synuclein Pre-Formed Fibril (PFF), are utilized to assess dopaminergic neuronal loss and investigate changes in α-synuclein aggregation. In Alzheimer’s disease, transgenic mice carrying mutations associated with familial Alzheimer’s disease (FAD), such as the 5xFAD model, are commonly used. These models allow for the evaluation of amyloid beta reduction through histological methods and the assessment of drug efficacy using behavioral tests like the Maze, providing insights into underlying disease mechanisms. Animals utilized as disease models contribute significantly to our comprehensive understanding of the mechanisms behind various illnesses, facilitating our grasp of these conditions. Research conducted using these animal disease models has indeed contributed to the discovery and development of treatments. However, it’s scientifically crucial to acknowledge that these animal models often present disparities in lifespans compared to humans and may not entirely mirror the intricate etiology of human diseases. Additionally, while animal experimentation is utilized for various conditions such as cancer, diabetes mellitus, and traumatic brain injury, it’s constrained by its inability to fully capture the nuances of the human immune system and intricate disease mechanisms (Table  1 ).

In addition to modeling diseases, animals are also used to test cosmetics or healing rates of products. In the cosmetics industry, animals are typically used to test skin or eye irritation to assess the safety of these products in humans [ 17 , 18 ]. The Draize test, developed in 1944 to test for such hazards in rabbits [ 19 ], is used to test products such as drugs and balms for wound healing. It involves creating wounds on animals to gauge recovery rates [ 16 ].

Related laws, Guidelines, and Principles

As of 2023, current regulations state that the FDA no longer deems animal tests necessary for evaluating product safety [ 4 ]. This enables companies and research facilities to explore possible non-animal testing when obtaining product approval. Additionally, out of 195 countries worldwide, only 42 have laws or regulations limiting animal testing for products (The Humane Society). Animal testing laws have been implemented by banning animal testing or limiting its use during testing. Europe completely banned cosmetics tested on animal testing in 2013 [ 3 , 20 , 21 ]. This demonstrates a push to limit animal testing; however, the movement remains ineffective because of the absence of laws against animal testing in most countries.

Guidelines for animal experimentation and clinical trials for drug development and safety testing have varied procedures among companies and researchers up to now. So, the Guidance for Industry for Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals from the Center for Drug Evaluation and Research provides guidelines for the safety assessment of products compiled from regulatory standards of several countries. According to these guidelines, preclinical trial researchers should consider factors such as animal species, age, delivery method (dosage, administration, treatment regimen, etc.), and test material stability [ 22 ] (Fig. 1 ).

( A ) Procedure of new drug approval as stated by the Food and Drug Administration (FDA). In the preclinical research stage, small, medium, and large animals are usually used for testing new drugs. ( B ) iPSCs that can replacing animal testing. PBMCs or fibroblasts are reprogrammed to iPSCs and subsequently differentiated into target modeling cells such as neurons, cardiomyocytes, and hepatocytes. ( C ) iPSC-derived 3D organoids enable in vitro efficacy and safety testing. Organ-on-a-chip embedded with organoids used in in vitro tests, created using BioRender

The FDA has also provided a drug development process that includes these steps. The first step in drug development is discovering and researching a new drug (discovery and development stage). The second stage is preclinical research, in which drugs have to undergo a series of animal tests (or alternative tests, if possible) for safety. The FDA strongly suggests that animal preclinical trials follow Good Laboratory Practice (GLP). The main elements of GLP are as follows [ 23 ]: appropriate use of qualified personnel, quality assurance, appropriate use of facility and care for animals, proper operating procedures for animals used in trial, individual animal data collection and evaluation, testing product properly handled and analyzed, study proceeds with an approved protocol, data should be collected as outlined in the protocol, and full report prepared after procedures.

To enhance clinical translation, reproducibility issues in preclinical trials, such as biased allocation, insufficient controls, and lack of interdisciplinary, uncharacterized, or poorly characterized supplies [ 24 ]. The third step involves clinical testing on humans to assess safety and efficacy. The fourth and fifth stages comprise FDA post-market safety monitoring for all approved drugs [ 25 ].

Guidelines also suggest the 3R (replacement, reduction, and refinement) principle, which recommends that scientists follow certain criteria during clinical trials. Replacement involves using other testing methods other than animal testing [ 26 ]. In computer models, tissues, or stem cell research, if alternatives to animal testing exist, researchers should prioritize their use. Reduction involves minimizing the number of animal tests [ 26 ]. Questioning the necessity of animal tests during a particular part of our research and reducing their numbers imbues the concept with meaning. Refinement focuses on minimizing stress and providing the best care to animals [ 26 ], including providing proper food, entertainment, and clean well-maintained shelters.

As International efforts for animal replacement methods, research and development into alternative testing methods is already underway in both Europe and the United States, with each regulatory body establishing its own initiatives. In Europe, the European Center for the Validation of Alternative Methods (ECVAM) was founded in 1992, and since 2013, the sale of cosmetics containing ingredients tested on animals has been completely banned. Moreover, there are plans to expand the scope to include medical devices, health supplements, and pharmaceuticals in the future. In the United States, the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) was established in 2000. The objective is to reduce animal testing by 2025 and eliminate mammalian animal testing entirely by 2035 through innovative advancements in alternative testing methodologies. In 2022, amendments to the Food, Drug, and Cosmetic Act in the United States removed mandatory animal testing requirements in the drug development stage and presented alternative testing methods as viable non-clinical trial options.

Problems/limitations of Animal Testing

A pressing issue with animal testing is the ethical concerns stemming from it. Most studies have demonstrated that these models undergo invasive procedures that often result in pain or even death. Research indicates that animals share pain and emotional capacity with humans [ 27 ]. Thus, sacrificing them for research can appear cruel. Advocates call for equitable treatment, opposing animal testing as inhumane and cruel. Such ethical issues has always followed animal testing and are ongoing [ 28 ].

Moreover, some studies have indicated that animal testing is not an accurate model for medicines or substances, highlighting the need for accurate and efficient testing alternatives that are similar humans. The complexity of human disease mechanisms raises doubts whether animal models can accurately replicate them.

Physiological differences between animals and humans mean a product safe for animals may not guarantee human safety [ 29 ]. Interspecies differences have led to poor results in correlating animal testing with human outcomes, consequently causing several clinical trial failures [ 30 ]. Between 2010 and 2017, clinical trials for drugs had a greater chance of failing phase І, owing to safety and efficacy [ 31 ]. In addition, even if a product passes phase І there is still a 90% rate of failure while undergoing the necessary procedures [ 32 , 33 ]. Prolonged use of animal testing can ultimately endanger humans, as some drugs and products approved through trials were later deemed harmful. Concerns such as high cost and long laborious procedures will be discussed below.

Benefits of Replacing Animal Testing

The main benefits of replacing animal tests with alternatives are as follows: cost-effective, time efficient, less complex testing procedures, and societal benefits.

Stem cell modeling is less expensive than animal testing. The Draize test mentioned before costs approximately $1,800, whereas non-animal testing methods cost considerably less [ 6 ]. Affordable procedures offer renewed chances for past costly research to emerge. A decrease in the cost of procedures would facilitate new drug development, making opportunities for new technologies easier.

Animal testing requires prior preparation that is often complex and time consuming. Several guidelines of various organizations worldwide follow certain principles and procedures. For animal testing, factors such as providing clean and well-maintained shelters, food, necessary supplies for survival, and entertainment are laborious [ 26 ]. Alternatives are time-efficient and less laborious, simpler protocols, and fewer supplies to maintain procedures.

Alternatives to Animal Testing Related to Stem Cells

Organoids are organ-like structures derived from self-organizing stem cells in 3D cell cultures. They exhibit organ-specific characteristics and originate from stem cells undergoing self-organization [ 34 , 35 ]. . They are beneficial over previous 2D cell culture, as they can show near-physiological cellular composition and actions [ 36 ]. Organoids are typically established from embryonic stem cells (ESCs), human pluripotent stem cells (PSCs), and adult stem cells [ 37 , 38 , 39 ]. The potential of organoids as alternatives stems from their correlation with patient reactions to products such as drugs, indicating that they are a promising for rare diseases where clinical trials are impractical [ 39 ]. Organoids have a wide range of applications and are suitable for studies of infectious diseases, hereditary diseases, and toxicity, and can provide personalized medicine for individual patients [ 38 ].

Recent studies have shown that PSC organoids can form complex brain organoids that are useful for modeling traumatic brain injury [ 15 ]. Organoids derived from PSCs are of various types, including stomach, lung, liver, kidney, cerebral, and thyroid, and can contribute to organ failure or dysfunction. Cancer organoids are cultured from thin tumor sections, which are efficient for studying cancer syndromes [ 34 ]. Organoid studies on Alzheimer’s disease highlight the possibility of using familial or sporadic Alzheimer’s disease induced pluripotent stem cells (iPSCs) to model brain activity [ 40 ]. Thyroid follicles derived from hESCs have the potential to be used as organoids to treat hypothyroidism [ 41 ] (Table  2 ). Technology development of 3D bioprinting organoids is underway, promising better productivity. Bioprinting for organoids includes inkjet-based bioprinting, laser-assisted bioprinting, extrusion-based bioprinting, and photo-curing bioprinting [ 42 ]. Ongoing studies are also exploring 3D printing technology using organoids, offering the possibility of creating organs for patient-tailored services and toxicology research.

However, organoids still possess limitations that render them unsuitable tools to replace animal testing. Organoids lack of vasculature structure affects growth and maturation, leading to differences in behavior compared to the original tissue [ 59 ]. This may result in only partial replication, leading to an incomplete disease model [ 38 ]. Moreover, the complexity and heterogeneity of certain organs, such as the brain or immune system, pose challenges for complete replication in organoid models. This inability to replicate such complexity can affect the translatability of findings from organoid studies to clinical applications. Research and experiments involving organoids often require lengthy culture protocols, which can vary depending on the type of organoid being cultivated. In some extreme cases, organoid culture may extend for months or even years, as seen in examples such as intestinal organoids(8 weeks or more), retinal organoids(6 ~ 39 weeks or more), brain organoids(12 weeks or more), and liver organoids(4 ~ 8 weeks or more) [ 60 , 61 , 62 , 63 , 64 ]. Even after going through the lengthy process, there are sometimes a lack of established organoids in sufficient numbers. This limited availability of organoids can hinder the procedure of functional testing, which can lead to insufficient research outcomes. Organoids also lack the intricate network of connections that can be seen in living organisms. Inter-organ communication is crucial when checking metabolic health, and with organoids lacking such an important factor, it is difficult to create treatments for any abnormalities regarding infection and diseases. Organoids also lack a diverse set of cell types, structural organization, and physiological functions in comparison to functioning organs, which limits the ability to accurately replicate disease processes and responses to treatment [ 59 ]. When compared to animal models, organoids fall behind, as animal models offer a broader view of processes for diseases, immune responses, and systemic effects of treatments. Another noteworthy concern arises from the fact that current production technology for organoids under GMP (Good Manufacturing Practice) standards has yet to be established.

Quality Control of Organoid

For organoids to serve as suitable models for diseases or experimental purposes, quality control (QC) is essential. Accuracy and consistency in production lead to more precise results, ensuring better therapeutic treatments or modeling. If quality control for organoids isn’t established sufficiently, problems such as inconsistent test results, misinterpretation of existing data, wastage of valuable resources, reproducibility issues, unreliable models, and ethical concerns regarding biomedical studies could arise.

Organoid structures and functions can be assessed through multiple methods. Structural assessment of organoids can be performed using bright-field imaging for both quantitative and qualitative research. Additionally, methods such as immunofluorescent staining, transmission electron microscopy, and scanning electron microscopy are also utilized [ 65 , 66 ]. The functionality of organoids can be assessed through qPCR and single-cell or bulk cell RNA sequencing, which provide quantitation of marker gene expression, revealing cell identity and composition [ 67 ]. Assay methods like ELISA and colorimetric assays are useful for secretome quantification while Luciferase essays help measure enzyme activity [ 65 , 68 ]. Staining methods such as Glycosaminoglycan (GAG) staining(specifically for synovial mesenchymal stromal cell (SMSC) organoids), immunofluorescence staining, and Alizarin red staining mainly help with visualizing components within the organoid [ 65 , 68 , 69 ]. There are also more direct methods like implantation to test the in vivo functions of organoids [ 65 , 70 ] (Table  3 ).

Extracellular microenvironment, which contain such things as soluble bioactive molecules, extracellular matrix, and biofluid flow, contributes to the growth rate and formation of organoids. Given the variation in extracellular microenvironments across different types of organoids, it is imperative to modulate the extracellular microenvironment accordingly for each organoid type. This ensures the production of organoids with consistent quality across different production batches [ 71 ].

Regulations/Applications Regarding Organoids from the FDA

While there aren’t any specific regulations regarding organoids from the FDA(Food and Drug Administrations) as of in the recent years, there are two categories of applications that include framework for cell related therapies, which include organoids. There are two applications, Biologics License Application (BLA) and the Investigational New Drug (IND) Application. The BLA, as stated in the official website of FDA, is a request for permission to introduce and deliver for a biologic product(vaccines, somatic cells, gene therapy, tissues, recombinant therapeutic proteins, organoids, etc.) into interstate commerce. Requirements for a BLA includes applicant information, product/manufacturing information, pre-clinical studies, clinical studies, and labeling. The IND application is a request for authorization to administer an investigation drug or biological product to humans. IND had three types: Investigator IND, Emergency Use IND, and Treatment IND which could fall into two categories being commercial or non-commercial. The IND application must contain the following broad areas of information: Animal Pharmacology and Toxicology studies, Manufacturing Information, Clinical protocols and Investigator Information.

When examining the current ongoing clinical trials( ClinicalTrials.gov ) in the application of organoids, it can be noted that they are being utilized in refractory cancers, osteosarcoma, high-grade glioma, advanced breast cancer, and colorectal cancer. This pertains to the utilization of the organoid platform to investigate the sensitivity to various drugs (chemotherapy, hormonal therapy, targeted therapy) by exposing them to each individual agent (or combination of agents). It is anticipated and ongoing to aid in clinical decisions regarding the optimal treatment option for each patient.

Organ-on-a-chip

Organoid chips(OoC) can be regarded as the outcome of merging biology and microtechnology, serving as microfluidic cell culture devices [ 72 , 73 ]. OoC has the ability to mimic the cellular environment, which leads to an examination of their effects on cell communication with more accessibility and ease. The chips are generally designed by collecting cells (primary cells, transformed cell lines, human ESC, or iPSCs) using equipment with pumps(that enable fluid flow), incubators, sensors, and microscopes to monitor and examine the cells in the system [ 49 , 74 ] (Fig.  1 ). Depending on the type or cell or method cells can be aggregated in matrix or matrixless conditions [ 75 ].

Various types of human organ chips, including the liver, heart, eyes, kidneys, bones, intestines, and skin, are used to simulate the breathing motion. Single-organ chips such as liver-on-a-chip and lung-on-a-chip are useful for observing individual chemical reactions [ 53 ]. There are also multiple organ-on-chip, which are organ-chips connected to a vast system [ 76 ]. The main purpose of multi-organ-on-chips is to simulate the entire body, recognizing that a single organ does not represent the entire human system. Using multiple organ-on-chips connected to one system allows the analysis of how various organs communicate with each other.

The U.S. Food and Drug Administration (FDA) and the U.S. National Institutes of Health (NIH) have provided project support for tissue chips for drug screening, including lung-on-a-chip. Additionally, efforts are being made globally to advance the utilization of organoid chips, such as the establishment of the European Organ-on-Chip Society in Europe.

A limitation of OoCs is their complex experimental setup [ 77 ], which can be avoided with clear guidelines or protocols. Cell medium changes also raise concerns about chip environments [ 77 ]. There is also the issue of using animal models to validate OoC systems initially [ 78 ]. To address this, OoC experts recommend forming well-established collaborations with developers, toxicologists, and pharmaceutical companies to explore alternative solutions.

iPSCs(Induced Pluripotent stem Cells)

iPSCs are a recent development in the field of disease modeling. Having traits such as self-renewal and pluripotency, iPSCs can transform into various cells within the human body (Fig.  1 ); thus, reprogramming patient cells creates personalized medicine for specific diseases [ 79 , 80 ]. The ability to produce a large batch of iPSCs with only a small number of patient samples is important [ 81 , 82 ]. The objectives of iPSC models closely align with the 3R principle [ 83 ]. Replacing animal models in research while adhering to reduction and refinement principles is expected to be advantageous.

iPSCs are research to find cures for various diseases and are used as broad disease models (Table  2 ). For example, iPSCs from patients with Parkinson’s disease differentiate into midbrain dopaminergic neurons (DAns) in the substantia nigra pars compacta (SNpc), which can be used to model Parkinson’s disease on a cellular basis [ 43 , 44 , 45 ]. For cardiac diseases, which include a decrease in cardiomyocytes that leads to scar formation and ultimately heart function failure, there are existing studies that explore iPSCs for novel therapeutic cures [ 84 ]. iPSC-derived progenitors such as human HCN4 + and human ESC derived ROR2+, CD13+, KDR+, PDGFRα + cells later generate cardiomyocytes [ 47 ]. For cancer modeling using iPSCs, reprogrammed tumor specimens or iPSCs with premalignant or early genetic lesions can show the stages of cancer [ 49 ]. iPSCs from patients that are healthy and those with Alzheimer’s disease differentiate into the main brain cells, modeling the human brain with a functional blood barrier. Further research could drive drug discovery [ 9 ]. Studies of organ failure or dysfunction have shown that human iPSCs are useful. Research on lung regeneration has shown that endogenous and exogenous stem cells mediate therapeutic results [ 50 ]. Another study focused on the use of liver hepatoblasts, which could help alleviate hepatotoxicity through liver development and hepatic differentiation [ 85 ].

However, iPSCs are still in a relatively early developmental phase and have several limitations. Concerns for researchers regarding iPSCs is in vitro culture adaptation and tumorigenicity, the inability to completely reflect in vivo 3D environments, and the variation of differentiated cells depending on the protocol [ 86 , 87 ]. Quality control of differentiated cells and influencing factors are crucial for iPSC researchers, impacting their applicability as medical models or treatments.

Figure 2 Human diagram showing multiple stem cell-related technologies that can be applied to various human organs.

A BioRender diagram depicts diverse stem cell technologies for human organs

Limitations

Stem cell-related methodologies, such as organoids, are a very new technology in the field of animal alternative testing. In the early developmental stage, alternative stem cell models and technologies still require a few years of testing. Animal testing is still used today, owing to its historical role in safety and efficacy assessment. New alternatives have been presented; however, the uncertainty of these methods have caused most researchers to adhere to old protocols. In cases of complex diseases arising from various factors such as cardiovascular, neurodegenerative, and infertility, complete replacement by animal alternative testing methods may still be impractical. In such instances, it is crucial to concurrently employ animal experimentation alongside alternative testing methods utilizing organoids or stem cells to bolster data reliability. As a component of these endeavors, numerous researchers have undertaken disease modeling, such as stroke, utilizing brain organoids and cardiac organoids in in vitro experiments. The solution involves focusing on alternative testing methods [ 88 ]. By transforming old methods and creating alternatives, this shift could be the norm. There has already been a move toward that goal, as the FDA has established a cross-agency working group (The Alternative Methods Working Group) to promote various alternative methods, such as in vivo, in vitro, in silico , or system toxicology modeling [ 89 ]. In the 2021, FDA report titled “Advancing Regulatory Science at FDA,” the most prioritized area is identified as “Advancing Novel Technologies to Improve Predictivity of Non-clinical Studies and Replace, Reduce, and Refine Reliance on Animal Testing.”

Given ongoing research in alternative stem cell-related methods, this appears promising to replace animal testing. These alternatives offer advantages for scientists and the public. However, it is important to acknowledge that iPSCs, organoids, and OoCs each have distinct strengths and limitations. With continued advancements and studies to further understand these issues, these limitations can be avoided.

Data Availability

All data pertaining to this manuscript are included within the article.

Abbreviations

Food and Drug Administration

organ-on-chip

induced pluripotent stem cell

pluripotent stem cell

Embryonic stem cell

Center for Drug Evaluation and Research, GLP, Good Laboratory Practice

Dopaminergic neurons

Substantia Nigra pars compacta

Robinson, N. B., et al. (2019). The current state of animal models in research: A review. International Journal of Surgery , 72 , 9–13.

Article   PubMed   Google Scholar  

Ericsson, A. C., Crim, M. J., & Franklin, C. L. (2013). A brief history of animal modeling. Missouri Medicine , 110 (3), 201–205.

PubMed   PubMed Central   Google Scholar  

Balls, M. (2022). Alternatives to Laboratory animals: Trends in replacement and the three rs. Alternatives to Laboratory Animals , 50 (1), 10–26.

Han, J. J. (2023). FDA modernization Act 2.0 allows for alternatives to animal testing. Artificial Organs , 47 (3), 449–450.

Deinsberger, J., Reisinger, D., & Weber, B. (2020). Global trends in clinical trials involving pluripotent stem cells: A systematic multi-database analysis. Npj Regenerative Medicine , 5 (1), 15.

Article   PubMed   PubMed Central   Google Scholar  

Meigs, L., et al. (2018). Animal testing and its alternatives - the most important omics is economics. Altex , 35 (3), 275–305.

Horejs, C. (2021). Organ chips, organoids and the animal testing conundrum. Nat Rev Mater , 6 (5), 372–373.

Veening-Griffioen, D. H., et al. (2021). Tradition, not science, is the basis of animal model selection in translational and applied research. ALTEX , 38 (1), 49–62.

PubMed   Google Scholar  

Penney, J., Ralvenius, W. T., & Tsai, L. H. (2020). Modeling Alzheimer’s disease with iPSC-derived brain cells. Molecular Psychiatry , 25 (1), 148–167.

Khan, E., Hasan, I., & Haque, M. E. (2023). Parkinson’s Disease: Exploring Different Animal Model Systems . International Journal of Molecular Sciences , 24(10).

Chia, S. J., Tan, E. K., & Chao, Y. X. (2020). Historical Perspective: Models of Parkinson’s Disease . International Journal of Molecular Sciences , 21(7).

Li, Z., et al. (2021). Application of animal models in Cancer Research: Recent progress and future prospects. Cancer Manag Res , 13 , 2455–2475.

Article   CAS   PubMed   PubMed Central   Google Scholar  

Kottaisamy, C. P. D., et al. (2021). Experimental animal models for diabetes and its related complications—a review. Laboratory Animal Research , 37 (1), 23.

King, A. J. (2012). The use of animal models in diabetes research. British Journal of Pharmacology , 166 (3), 877–894.

Ramirez, S. (2021). Modeling traumatic Brain Injury in Human Cerebral organoids . Cells , 10(10).

Grada, A., Mervis, J., & Falanga, V. (2018). Research Techniques made simple: Animal models of Wound Healing. The Journal of Investigative Dermatology , 138 (10), 2095–2105e1.

Article   CAS   PubMed   Google Scholar  

McNamee, P., et al. (2009). A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics: Eye irritation. Regulatory Toxicology and Pharmacology , 54 (2), 197–209.

Macfarlane, M., et al. (2009). A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics: Skin irritation. Regulatory Toxicology and Pharmacology , 54 (2), 188–196.

York, M., & Steiling, W. (1998). A critical review of the assessment of eye irritation potential using the Draize rabbit eye test. Journal of Applied Toxicology , 18 (4), 233–240.

Fentem, J. H. (2023). The 19th FRAME Annual lecture, November 2022: Safer Chemicals and Sustainable Innovation Will be achieved by Regulatory Use of Modern Safety Science, not by more animal testing. Alternatives to Laboratory Animals , 51 (2), 90–101.

Daneshian, M., et al. (2015). Animal use for science in Europe. Altex , 32 (4), 261–274.

Center for Drug Evaluation and, R., R. Center for Biologics Evaluation and, and H. International Conference on, Guidance for industry: S6 preclinical safety evaluation of biotechnology-derived pharmaceuticals (1997). Rockville, MD: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research: Center for Biologics Evaluation and Research.

Centanni, J. M. (2017). Chap. 2 - Preclinical Animal Testing requirements and considerations . Mesenchymal stromal cells (pp. 37–60). Academic. S. Viswanathan and P. Hematti, Editors.

Ioannidis, J. P. A., Kim, B. Y. S., & Trounson, A. (2018). How to design preclinical studies in nanomedicine and cell therapy to maximize the prospects of clinical translation. Nat Biomed Eng , 2 (11), 797–809.

Van Norman, G. A. (2016). Drugs, devices, and the FDA: Part 1: An overview of approval processes for drugs. JACC Basic Transl Sci , 1 (3), 170–179.

Liebsch, M., et al. (2011). Alternatives to animal testing: Current status and future perspectives. Archives of Toxicology , 85 (8), 841–858.

Kiani, A. K., et al. (2022). Ethical considerations regarding animal experimentation. Journal of Preventive Medicine and Hygiene , 63 (2 Suppl 3), E255–E266.

Doke, S. K., & Dhawale, S. C. (2015). Alternatives to animal testing: A review. Saudi Pharm J , 23 (3), 223–229.

Akhtar, A. (2015). The flaws and human harms of animal experimentation. Cambridge Quarterly of Healthcare Ethics , 24 (4), 407–419.

Van Norman, G. A. (2020). Limitations of Animal studies for Predicting toxicity in clinical trials: Part 2: Potential Alternatives to the use of animals in preclinical trials. JACC Basic Transl Sci , 5 (4), 387–397.

Dowden, H., & Munro, J. (2019). Trends in clinical success rates and therapeutic focus. Nature Reviews. Drug Discovery , 18 (7), 495–496.

Takebe, T., Imai, R., & Ono, S. (2018). The current status of Drug Discovery and Development as originated in United States Academia: The influence of Industrial and academic collaboration on Drug Discovery and Development. Clinical and Translational Science , 11 (6), 597–606.

Sun, D., et al. (2022). Why 90% of clinical drug development fails and how to improve it? Acta Pharm Sin B , 12 (7), 3049–3062.

Dutta, D., Heo, I., & Clevers, H. (2017). Disease modeling in stem cell-derived 3D Organoid systems. Trends in Molecular Medicine , 23 (5), 393–410.

Wang, X. (2019). Stem cells in tissues, organoids, and cancers. Cellular and Molecular Life Sciences , 76 (20), 4043–4070.

Li, M., & Izpisua Belmonte, J. C. (2019). Organoids - Preclinical models of Human Disease. New England Journal of Medicine , 380 (6), 569–579.

Rookmaaker, M. B., et al. (2015). Development and application of human adult stem or progenitor cell organoids. Nature Reviews Nephrology , 11 (9), 546–554.

Clevers, H. (2016). Modeling Development and Disease with Organoids. Cell , 165 (7), 1586–1597.

Schutgens, F., & Clevers, H. (2020). Human organoids: Tools for understanding Biology and Treating diseases. Annual Review of Pathology: Mechanisms of Disease , 15 , 211–234.

Article   CAS   Google Scholar  

Barak, M., et al. (2022). Human iPSC-Derived neural models for studying Alzheimer’s Disease: From neural stem cells to cerebral organoids. Stem Cell Reviews and Reports , 18 (2), 792–820.

Romitti, M., et al. (2022). Transplantable human thyroid organoids generated from embryonic stem cells to rescue hypothyroidism. Nature Communications , 13 (1), 7057.

Ren, Y., et al. (2021). Developments and opportunities for 3D Bioprinted Organoids. Int J Bioprint , 7 (3), 364.

Laperle, A. H., et al. (2020). iPSC modeling of young-onset Parkinson’s disease reveals a molecular signature of disease and novel therapeutic candidates. Nature Medicine , 26 (2), 289–299.

Avazzadeh, S. (2021). Modelling Parkinson’s Disease: iPSCs towards Better Understanding of Human Pathology . Brain Sci , 11(3).

Stoddard-Bennett, T., & Reijo Pera, R. (2019). Treatment of Parkinson’s Disease through Personalized Medicine and Induced Pluripotent Stem Cells . Cells , 8(1).

Funakoshi, S., & Yoshida, Y. (2021). Recent progress of iPSC technology in cardiac diseases. Archives of Toxicology , 95 (12), 3633–3650.

Matsa, E., Burridge, P. W., & Wu, J. C. (2014). Human stem cells for modeling heart disease and for drug discovery. Science Translational Medicine , 6 (239), 239ps6.

Hnatiuk, A. P., et al. (2021). Human iPSC modeling of heart disease for drug development. Cell Chem Biol , 28 (3), 271–282.

Papapetrou, E. P. (2016). Patient-derived induced pluripotent stem cells in cancer research and precision oncology. Nature Medicine , 22 (12), 1392–1401.

Aboul-Soud, M. A. M., Alzahrani, A. J., & Mahmoud, A. (2021). Induced Pluripotent Stem cells (iPSCs)-Roles in Regenerative therapies, Disease Modelling and Drug Screening . Cells , 10(9).

Sun, W., et al. (2019). Organ-on-a-Chip for Cancer and Immune organs modeling. Adv Healthc Mater , 8 (15), e1900754.

Wang, Y., et al. (2020). Dantrolene ameliorates impaired neurogenesis and synaptogenesis in Induced pluripotent stem cell lines derived from patients with Alzheimer’s Disease. Anesthesiology , 132 (5), 1062–1079.

Beckwitt, C. H., et al. (2018). Liver ‘organ on a chip’. Experimental Cell Research , 363 (1), 15–25.

Shi, W., et al. (2021). Design and evaluation of an in vitro mild traumatic brain Injury modeling System using 3D printed Mini Impact device on the 3D cultured human iPSC derived neural progenitor cells. Adv Healthc Mater , 10 (12), e2100180.

Lee, J., et al. (2020). Hair-bearing human skin generated entirely from pluripotent stem cells. Nature , 582 (7812), 399–404.

Jung, S. Y., et al. (2022). Wnt-activating human skin organoid model of atopic dermatitis induced by Staphylococcus aureus and its protective effects by Cutibacterium acnes. iScience , 25 (10), 105150.

Risueño, I., et al. (2021). Skin-on-a-chip models: General overview and future perspectives. APL Bioeng , 5 (3), 030901.

Aghmiuni, A. I., & Keshel, S. H. (2023). Chap. 1 0 - Eye-on-a-chip , in Principles of Human Organs-on-Chips , M. Mozafari, Editor. Woodhead Publishing. pp. 315–369.

Andrews, M. G., & Kriegstein, A. R. (2022). Challenges of Organoid Research. Annual Review of Neuroscience , 45 , 23–39.

Pleguezuelos-Manzano, C., et al. (2020). Establishment and culture of human intestinal organoids derived from adult stem cells. Current Protocols In Immunology / Edited By John E. Coligan. [Et Al.] , 130 (1), e106.

Wahle, P., et al. (2023). Multimodal spatiotemporal phenotyping of human retinal organoid development. Nature Biotechnology , 41 (12), 1765–1775.

Kathuria, A., et al. (2020). Comparative transcriptomic analysis of cerebral organoids and cortical neuron cultures derived from Human Induced Pluripotent Stem cells. Stem Cells and Development , 29 (21), 1370–1381.

Zhao, J., et al. (2020). APOE4 exacerbates synapse loss and neurodegeneration in Alzheimer’s disease patient iPSC-derived cerebral organoids. Nature Communications , 11 (1), 5540.

Zhu, X., et al. (2021). Liver organoids: Formation strategies and Biomedical Applications. Tissue Eng Regen Med , 18 (4), 573–585.

Zhao, Z. (2022). Organoids Nat Rev Methods Primers , 2.

Drakhlis, L., et al. (2021). Human heart-forming organoids recapitulate early heart and foregut development. Nature Biotechnology , 39 (6), 737–746.

Broutier, L., et al. (2016). Culture and establishment of self-renewing human and mouse adult liver and pancreas 3D organoids and their genetic manipulation. Nature Protocols , 11 (9), 1724–1743.

Sun, Y., et al. (2021). Generating 3D-cultured organoids for pre-clinical modeling and treatment of degenerative joint disease, in Signal Transduct Target Ther (p. 380). England.

Hemeryck, L., et al. (2022). Organoids from human tooth showing epithelial stemness phenotype and differentiation potential. Cellular and Molecular Life Sciences , 79 (3), 153.

Huch, M., et al. (2013). In vitro expansion of single Lgr5 + liver stem cells induced by wnt-driven regeneration. Nature , 494 (7436), 247–250.

Sullivan, K. M., et al. (2022). Extracellular Microenvironmental Control for Organoid Assembly. Tissue Eng Part B Rev , 28 (6), 1209–1222.

Low, L. A., et al. (2021). Organs-on-chips: Into the next decade. Nature Reviews. Drug Discovery , 20 (5), 345–361.

Bhatia, S. N., & Ingber, D. E. (2014). Microfluidic organs-on-chips. Nature Biotechnology , 32 (8), 760–772.

Leung, C. M., et al. (2022). A guide to the organ-on-a-chip. Nature Reviews Methods Primers , 2 (1), 33.

Olgasi, C., Cucci, A., & Follenzi, A. (2020). iPSC-Derived liver organoids: A journey from Drug Screening, to Disease modeling, arriving to Regenerative Medicine . International Journal of Molecular Sciences , 21(17).

Picollet-D’hahan, N., et al. (2021). Multiorgan-on-a-Chip: A systemic Approach to Model and Decipher Inter-organ Communication. Trends Biotechnol , 39 (8), 788–810.

Wang, H., et al. (2021). 3D cell culture models: Drug pharmacokinetics, safety assessment, and regulatory consideration. Clinical and Translational Science , 14 (5), 1659–1680.

Kang, S., Park, S. E., & Huh, D. D. (2021). Organ-on-a-chip technology for nanoparticle research. Nano Converg , 8 (1), 20.

Kim, C. (2015). iPSC technology–powerful hand for disease modeling and therapeutic screen. Bmb Reports , 48 (5), 256–265.

Qian, L., & Tcw, J. (2021). Human iPSC-Based modeling of central nerve System disorders for Drug Discovery . International Journal of Molecular Sciences , 22(3).

Gómez-Lechón, M. J., & Tolosa, L. (2016). Human hepatocytes derived from pluripotent stem cells: A promising cell model for drug hepatotoxicity screening. Archives of Toxicology , 90 (9), 2049–2061.

Blaszkiewicz, J., & Duncan, S. A. (2022). Advancements in Disease modeling and Drug Discovery using iPSC-Derived hepatocyte-like cells . Genes (Basel) , 13(4).

O’Connor, M. D. (2013). The 3R principle: Advancing clinical application of human pluripotent stem cells. Stem Cell Research & Therapy , 4 (2), 21.

Article   Google Scholar  

Parrotta, E. I. (2020). Modeling Cardiac Disease mechanisms using Induced Pluripotent Stem Cell-Derived cardiomyocytes: Progress, promises and challenges . International Journal of Molecular Sciences , 21(12).

Takebe, T., et al. (2013). Vascularized and functional human liver from an iPSC-derived organ bud transplant. Nature , 499 (7459), 481–484.

Lee, A. S., et al. (2013). Tumorigenicity as a clinical hurdle for pluripotent stem cell therapies. Nature Medicine , 19 (8), 998–1004.

Kramer, N., et al. (2016). Full biological characterization of human pluripotent stem cells will open the door to translational research. Archives of Toxicology , 90 (9), 2173–2186.

Balls, M., Bailey, J., & Combes, R. D. (2019). How viable are alternatives to animal testing in determining the toxicities of therapeutic drugs? Expert Opinion on Drug Metabolism & Toxicology , 15 (12), 985–987.

Administration, U. S. F. D. (2021). Advancing New Alternative Methodologies at FDA . Jan U.S. Food & Drug Administration: FDA website. pp. 1–34.

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This research was supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grant number : HI22C1314).

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Division of Rheumatology, Department of Internal Medicine, Seoul St. Mary’s Hospital, Institute of Medical Science, College of Medicine, The Catholic University of Korea, 4 3, Seoul, 06591, Republic of Korea

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Park, G., Rim, Y.A., Sohn, Y. et al. Replacing Animal Testing with Stem Cell-Organoids : Advantages and Limitations. Stem Cell Rev and Rep (2024). https://doi.org/10.1007/s12015-024-10723-5

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Published : 19 April 2024

DOI : https://doi.org/10.1007/s12015-024-10723-5

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Alternatives to Animal Testing in Cosmetics

From advanced computer modeling to in vitro cell culture, modern cosmetics testing doesn't need to include animals

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Do Alternative Testing Methods Work Better?

The three r’s, in vitro testing, computer modeling, human volunteers, choosing known safe ingredients.

Although several countries —and even some U.S. states —are beginning to create laws that ban or limit the practice of animal testing for cosmetics , the sad reality is that some companies continue to experiment on animals such as mice, rats, guinea pigs, and rabbits for the sake of beauty products.

The good news? Thanks to growing interest in the ethical beauty industry and support for finding humane alternatives to animal testing, scientists and researchers are coming up with new and improved methods for checking the safety of cosmetic products and ingredients.

Many experts believe that testing cosmetics on animals is not only cruel, but unnecessary as well. For one, there are already thousands of cosmetic ingredients that have a long history of safe use in humans that don’t require additional testing. Not to mention, technology has advanced well enough to replace outdated animal tests with methods that are faster, less expensive, and far more reliable, such as computer modeling.

Take the European Union, for example. The ban on testing cosmetic products and their ingredients in the U.K. began in 1998 before spreading across the rest of the EU in 2013—a feat made possible because they’d already developed suitable non-animal methods to test the safety of cosmetics ingredients. That was almost a decade ago, so think about what new developments could be made in the future.

Techniques like cell culture tests can even be more inclusive, since scientists can use pigment-producing cells to create skin samples that resemble human skin from different ethnicities—which isn’t possible with animals like mice or rabbits.

Other in vitro methods can identify severe eye irritants and substances that can cause allergic contact dermatitis.

The development of such methods emerged as a direct result of an “increasing awareness of distinct interspecies-related differences that hamper the effective translation of results from animal models to humans.”

There’s also the issue with animal testing reproducibility—or the ability of a result to be replicated through independent experiments within different laboratories. Researchers have reported more concern about the lack of reproducibility of animal studies over recent years for reasons that include inappropriate study design, errors in conducting the research, and potential fraud.

Alternatives to animal testing that involve more controlled studies and replace animals with computers could make those reproducibility concerns obsolete.

The “Three R’s” refers to replacing, reducing, or refining animal use in research and testing, a concept that was first described over 60 years ago as a response to the growing political and social pressure to develop ethical alternatives to animal testing across all industries.

Testing methods that incorporate the Three R’s are referred to as “new alternative methods.” According to the National Institute of Environmental Health Sciences , the Three R’s are as follows:

Replacing: A test method that substitutes traditional animal models with non-animal systems such as computer models or biochemical or cell-based systems, or replaces one animal species with a less developed one (for example, replacing a mouse with a worm).

Reducing: A test method that decreases the number of animals required for testing to a minimum while still achieving testing objectives.

Refining: A test method that eliminates pain or distress in animals, or enhances animal well-being, such as by providing better housing or enrichment.

In vitro cell culture, which refers to the growth of cells from an animal (or human) in a controlled environment, uses skin cells that have been removed either from the organism directly or from a strain of cells that has previously been established. Healthy and diseased tissues can be donated from human volunteers to provide a more dependable method of studying the effects of cosmetics ingredients.

The human tissue can come from multiple places, such as donated from surgeries like biopsies or even cosmetic surgeries. Skin and eye models made from reconstituted human skin have been used to replace the rabbit irritation tests .

Scientists are also making advances in cultivating cells into 3D structures to create entire organs—which comes in handy when it comes to exploring the long-term effects of ingredients on the human body as a whole.

Artificial skin materials like EpiSkin, EpiDerm, and SkinEthic can imitate the reaction that a product might have to actual human skin, but using UV light can cause it to resemble older skin to create a spectrum of test results.

According to the Physicians Committee for Responsible Medicine , there are over 40 in vitro methods approved by international regulatory bodies that can serve as alternatives for ensuring the safety of cosmetics without testing on animals.

Thanks to the rapid progression of computer science, researchers are able to easily replicate aspects of the human body using computer models of body parts and use them to conduct virtual experiments. Similarly, data mining tools can use existing information about current ingredients to make predictions about new ones that can be more accurate (and efficient) than animal testing.

In 2018, a computer-based system called Read-Across-based Structure Activity Relationship (Rasar) was able to use artificial intelligence to analyze a database on chemical safety that already contains the results of 800,000 tests on 10,000 different chemicals. As Treehugger reported at the time , “Rasar achieved 87% accuracy in predicting chemical toxicity, compared to 81% in animal tests.”

That same year, researchers from the University of Oxford developed computer simulations that were able to outperform animal models in drug trials of a new cardiac drug with an accuracy of 89%–96%. The study proved that computer simulations not only outperform animal models used to test more complicated drugs, but offer a cheaper, faster, and more ethical solution.

Some studies have replaced animal testing with human volunteers even at advanced stages of the testing process. Especially with cosmetics, it’s becoming more common to use humans rather than animals for skin sensitivity tests.

A method called “microdosing,” for instance, involves applying small, one-time doses of a drug that are high enough to cause cellular effects but too low to affect the entire body. There’s already been a large number of drugs investigated using microdosing, with 80% of results corresponding to those observed at therapeutic doses.

Human microdosing can currently only be considered in the earliest phases of a clinical drug trial since the method isn’t developed enough to provide concrete data, but there is plenty of potential there.

There are already thousands of cosmetics products on the market made using ingredients with a long history of safe use and therefore don’t require any additional tests.

In theory, companies can choose from an extensive list of ingredients that have already been used for many years to ensure safety—without the need to test new ones on animals.

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