Andre Menache BSc(Hons) BVSc Dip ECAWBM (AWSEL) MRCVS
EU law requires as many as eleven toxicity tests for cosmetic products to be marketed, for which there are only four animal-free tests currently available. So our question is: are animals used in the other seven tests? Since animal testing for cosmetics is officially banned, cosmetics manufacturers exploit terminology loopholes to get their required missing data. Most substances in cosmetics are industrial chemicals (which are normally all tested on animals under REACH* regulations), so these chemicals categorised with dual (cosmetics and other industrial) use can still be tested on animals. The cosmetics industry is actually using animal testing under a different legal guise.
*REACH is the EU regulation for: Registration, Evaluation, Authorisation and restriction of CHemicals.
Animal rights activist Henry Spira places a full-page advertisement in 1980 in The New York Times with the caption, « How many rabbits does Revlon blind for beauty’s sake? » (1).
Within a year, Revlon donates $750,000 to a fund to investigate alternatives to animal testing, followed by substantial donations from Avon, Bristol Meyers, Estée Lauder, Max Factor, Chanel, and Mary Kay Cosmetics, donations that led to the creation of the Centre for Alternatives to Animal Testing in the USA (1).
Council Directive 76/768/EEC of 1976 relating to cosmetic products comes into force in the European Union (2).
The 7th amendment of the Cosmetics Directive of 1976 prohibits the testing of finished cosmetic products on animals by 2004 and prohibits the testing of cosmetic ingredients on animals by 2009 (2).
REACH is the European Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force in 2007, replacing the former legislative framework for chemicals in the EU (3).
EU law requires as many as eleven toxicity tests for cosmetic products to be marketed, for which there are only four animal-free tests currently available (4). So our question is: are animals used in the other seven tests? Since animal testing for cosmetics is officially banned, cosmetics manufacturers exploit terminology loopholes
to get their required missing data. Most substances in cosmetics are industrial chemicals (which are normally all tested on animals under REACH regulations), so these chemicals categorised with dual (cosmetics and other industrial) use can still be tested on animals. The cosmetics industry is actually using animal testing under a
different legal guise.
The use of animal tests is even allowed under the Cosmetics directives under some circumstances, for example, to fulfil health and safety requirements for workers in the cosmetics industry (5).
Based on figures published by the European Commission, the number of animal lives spared every year as a result of the Cosmetics Directive is around 5000. This figure represents less than half of one per cent of the roughly 12 million animals used in experiments in the EU annually (6, 7).
A recently published article by a team of scientists in Denmark (1) suggests that animal research is undergoing a « domino effect ». The domino effect refers to the knock-on effect of replacing one species of animal by a different species. largely on the basis of strong public opinion. In this example, Danish scientists chose to use pigs instead of monkeys because they consider pig experiments to be less controversial.
The « domino effect » kicked off on 18 November 2015, when Francis Collins, director of the US National Institutes of Health, announced that his organisation « will no longer fund biomedical research on chimpanzees » (2). The decision to stop funding chimpanzee research was based on public opinion as well as on scientific opinion. After the chimpanzee, the closest animal to humans is the monkey. However, there are already strong indications that public opinion will not tolerate monkey research for much longer. For example, the University of Radboud in the Netherlands recently announced that it would end all primate research in 2017 (3).
Animal researchers in Denmark have seen the writing on the wall and are preparing the pig as a replacement for monkeys. It should be obvious that this decision is not based on science but rather, on fear of public opinion. Humans and monkeys are separated by 25 million years of evolution, which helps to explain why monkeys are genetically so different from people. However, humans and pigs are separated by about 80 million years of evolution.
Instead of continuing to waste valuable resources and animal lives, scientists should focus their attention on human based research methods that are directly applicable to people. This is especially true in the age of the human genome. Society is finally waking up to the fact that billions of euros and millions of animal lives have not provided the hoped-for and much needed answers to important questions of human health and disease. The scientific research community would do well to heed the writing on the wall before the « domino effect » is overtaken by a much more powerful « tsunami » of public opinion.
Antidote Europe responds to the European Commission on the need for non-human primates in biomedical research, production and testing of products and devices.
The European Commission has requested the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER), to update the scientific Opinion on the need for non-human primates in biomedical research, production and testing of products and devices.
I therefore wish to submit the following Scientific Opinion for consideration by the SCHEER on the use of non-human primates (NHPs) in regulatory toxicology in general, and on the use of NHP for the safety testing of breast implants, in particular.
The current SCHEER position is that : “Due to their genetic proximity to humans and highly developed social skills, the use of non-human primates in scientific procedures raises specific ethical questions and practical problems in terms of meeting their behavioural, environmental and social needs in a laboratory environment. Furthermore, the use of non-human primates for scientific purposes is of the highest concern to the citizens. As a result, the use of non-human primates attracted significant attention during the review of the Directive.” (1, 2).
General remarks on the use of NHPs in regulatory toxicology :
As the EC has requested an update concerning Scientific Opinion, future SCHEER position papers should point to the growing debate within the scientific community on whether NHP use is sufficiently evidence based to be a cornerstone of biomedical research and testing (3, 4).
Under general remarks, I would like to include the following document, entitled “Ending the use of non-human primates in toxicity testing” endorsed by 32 medical scientists and researchers, including Professor Michael Balls (past director of the European Centre for the Validation of Alternative Methods) and Dr Shirley McGreal, founder and director of the International Primate Protection League (see pdf).
An analysis of the Bateson Review of research using nonhuman primates
Abstract: An analysis of the use of nonhuman primates in biomedical research in the UK, the Review of Research Using Non-Human Primates (the “Bateson Review”) was released in 2011. The review was applauded, to varying degrees, by most of the stakeholders in the controversy over using nonhuman primates in biomedical research. However, there has not been a scientific analysis of the review. In this paper, the Bateson Review is examined for both methodology and the science relevant to the use of nonhuman primates in biomedical research. The relevant science includes complexity theory, evolutionary biology, genetics, empirical evidence regarding the reliability of interspecies extrapolation, and the value of basic biomedical research in general in making discoveries that lead to human treatments. The authors of this paper conclude that the Bateson Review does not meet the criteria for a scientific assessment, in part, because it fails to consider the current science that impacts on the practice of using animals, in general, and nonhuman primates, specifically, in biomedical research. This lack of scientific consideration has legal and ethical ramifications. Since the Bateson Review fails as a scientific evaluation, the ethical and legal recommendations that are based on science are also suspect (see pdf).
The European Citizens’ Initiative “Stop Vivisection” that was heard in the European Parliament on 11 May 2015 represents the views of more than one million EU citizens. The Initiative “Stop Vivisection” highlights some of the major deficiencies in Directive 2010/63/EU, and most notably the fact that the Directive continues to endorse the animal model paradigm despite overwhelming evidence to the contrary, based on current scientific knowledge (5).
There is no evidence that the use of NHP in research and testing is predictive of human outcome. In contrast, there does exist peer reviewed scientific evidence that the NHP is not predictive of human outcome with respect to drugs and disease (6, 7, 8).
The NIH (National Institutes of Health, USA), the biggest biomedical research organisation in the world “will no longer fund biomedical research on chimpanzees”. This statement by NIH director Francis Collins, made on 18 November 2015 (9) is in response to a scientific report commissioned previously from the Institute of Medicine (IOM, USA) that also included scientific evidence presented by the Physicians Committee for Responsible Medicine (10).
The current view of monkeys as “the next best thing after a chimpanzee” is scientifically untenable. Humans and chimpanzees are separated by about seven million years of evolution, whereas humans and monkeys are separated by about 25 million years of evolution. If the NIH is prepared to stop funding chimpanzee research for ethical as well as scientific reasons, where is the justification to use monkeys ? See for example the following peer reviewed articleÂ : “Commentary : lessons from the analysis of non human primates for understanding human aging and neurodegenerative diseases” (11).
Specific remarks on the use of NHPs or other animals for the safety testing of medical or cosmetic devices, in relation to regulatory toxicology:
“The PIP scandal: an analysis of the process of quality control that failed to safeguard women from the health risks” authored by Victoria Martindale and Andre Menache (published by the Journal of the Royal Society of Medicine (2013)).
The main findings of this paper are that animal testing was, at best, inconclusive :
“The final report acknowledged the conclusion from the European Union’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) but carried out no further investigations: “in the case of PIP implants, when the limited available clinical information is taken together with the findings from tests of the physical and chemical properties of the shell and silicone, and of the inÂ vivo irritancy test, some concerns are raised about the safety of PIP breast implants as the possibility for health effects cannot be ruled out.”
The use of NHPs in biomedical research, production and testing of products and devices has never undergone independent scientific audit. The phasing out of chimpanzees in biomedical research is the result of strong public opinion against their use as living test tubes. It is also the result of a recognition by the scientific community that chimpanzees are no longer essential for the study of human disease and drug development, in an age of the human genome (pharmacogenomics, toxicogenomics), induced pluripotent stem cell technology, bioengineering (as illustrated by the Weiss Institute at HarvardÂ :organ-on-a-chipÂ ; body-on-a-chip), and Integrated Testing Strategies, all of which combine to achieve more reliable and relevant data for humans than animal experiments.
The total replacement of NHPs in research and testing will be greatly accelerated by a paradigm shift in EC spending, away from animal based research and instead towards modern, human based technologies, illustrated by the US National Research Council publication “Toxicity Testing in the 21st Century: a Vision and a Strategy” (12).
Finally, there is an urgent need for the ethical review process relating to animal experiments use to undergo a major transformation, to allow greater public participation and hence greater transparency (13).
Dr Andre Menache BSc(Hons) BVSc Dip ECAWBM (AWSEL) MRCVS