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Regulations in Cosmetic Industry related to Animal Testing Methods Animal testing regulations are laws or guidelines that permit

and control the use of non-human animals for scientific experimentation. They vary greatly around the world, but most governments aim to control the number of times individual animals may be used; the overall numbers used; and the degree of pain that may be inflicted without anesthetic. China is the only major market where companies must test their mascaras and lotions on animals. Rabbits are killed or ingredients dripped into their eyes during Chinese tests, according to Londonbased animal-rights group Cruelty Free International. Chinas policies create a dilemma for companies like LOreal that want to sell in the country without alienating consumers in markets where public sentiment demands humane treatment of animals. Cosmetics testing on animals is particularly controversial. Such tests, which are still conducted in the U.S., involve general toxicity, eye and skin irritancy, phototoxicity (toxicity triggered by ultraviolet light) and mutagenicity. India banned animal testing for beauty products. The European Union, which has long barred such trials within its borders, this year tightened regulations to also prohibit products tested on animals elsewhere. The EUs new rules further complicate the issue for cosmetic makers. It would be against European rules to sell any product that has been tested on animals in China, so companies would need to reformulate their wares for the two markets. The EUs new rules further complicate the issue for cosmetic makers. It would be against European rules to sell any product that has been tested on animals in China, so companies would need to reformulate their wares for the two markets. The practice is regulated to various degrees in different countries. Cosmetics testing is banned in the Netherlands, Belgium, and the UK, and in 2002, after 13 years of discussion, the European Union (EU) agreed to phase in a near-total ban on the sale of animal-tested cosmetics throughout the EU from 2009, and to ban all cosmetics-related animal testing. France, which is home to the world's largest cosmetics company, L'Oreal, has protested the proposed ban by lodging a case at the European Court of Justice in Luxembourg, asking that the ban be quashed. The ban is also opposed by the European Federation for Cosmetics Ingredients, which represents 70 companies in Switzerland, Belgium, France, Germany and Italy. Europe Experiments on vertebrate animals in the European Union are subject to Directive 86/609/EEC on the protection of Animals used for Experimental and other scientific purposes, adopted in 1986. There is considerable variation in the manner member countries choose to exercise the directive: compare, for example, legislation from Sweden, The Netherlands, and Germany. In November 2010, "Directive 2010/63/EU on the protection of animals used for scientific purposes", which updates and replaces the 1986 Directive 86/609/EEC, was finalized and came into force. Full implementation of the new EU directive starts January 1, 2013 France In France, legislation (principally the decree of October 19, 1980) requires an institutional and project license before testing on vertebrates is carried out. An institution must submit details of their facilities and the reason for the experiments, after which a five-year license may be granted

following an inspection of the premises. The project licensee must be trained and educated to an appropriate level. Personal licenses are not required for individuals working under the supervision of a project license holder. These regulations do not apply to research using invertebrates. United Kingdom The Animals (Scientific Procedures) Act 1986 requires experiments to be regulated by three licenses: a project license for the scientist in charge of the project, which details the numbers and types of animals to be used, the experiments to be performed, and the purpose of them; a certificate for the institution to ensure it has adequate facilities and staff; and a personal license for each scientist or technician who carries out any procedure. In deciding whether to grant a license, the Home Office refers to the Act's cost-benefit analysis, which is defined as "the likely adverse effects on the animals concerned against the benefit likely to accrue as a result of the programme to be specified in the license" (Section 5(4)). A license should not be granted if there is a "reasonably practicable method not entailing the use of protected animals" (Section 5(5) (a)). The experiments must use "the minimum number of animals, involve animals with the lowest degree of neurophysiological sensitivity, cause the least pain, suffering, distress, or lasting harm, and [be the] most likely to produce satisfactory results" (Section 5(5) (b)). Germany The German Animal Welfare Act is designed to enforce the utilitarian principle that there must be good reason for one to cause an animal harm and identifies that it is the responsibility of human beings to protect the lives and well-being of their fellow creatures. There are thirteen sections in the Animal Welfare Act, each containing Articles that go into detail of the specific sections. Japan The system in Japan is one of self-regulation; there are no regulations like Western countries, only the 3Rs principle are written into the Law for Humane Treatment and Management of Animals. This law was amended in June 2005 and enforced in June 2006. The Management of Animals is responsible for administering the newly amended law. The amendment of this law was the conceptual idea of self-regulation and not being restricted by legislative constraints, it was approved by the members of the Japanese Diet who saw that care for laboratory animals and the use of laboratory animals are two different concepts that were concerned with science and animal welfare, respectively. This law requires those using animals to follow the principles outlined in the 3Rs. The principle idea behind the 3Rs (The 3Rs: Replacement, Reduction, and Refinement, which are also known as the standards relating to the care and management of laboratory animals and relief of pain)was to insure that fewer animals were used; by following this principle, minimal distress and suffering could be achieved through monitoring and controlling the animals by the scientist themselves. United States In the United States, animal testing on vertebrates is primarily regulated by the Animal Welfare Act of 1966 (AWA), which is enforced by the Animal Care division of the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA). The AWA contains provisions to ensure that individuals of covered species used in research receive a certain standard of care and treatment, provided that the standard of care and treatment does not interfere with "the design, outlines, or guidelines of actual research or experimentation." Currently, AWA only

protects mammals. In 2002, the Farm Security Act of 2002, the fifth amendment to the AWA, specifically excluded purpose-bred birds, rats, and mice (as opposed to wild-captured mice, rats, and birds) from regulations. Thus, relatively few animals used in research in the U.S. are covered by this legislation. The AWA requires each institution using covered species to maintain an Institutional Animal Care and Use Committee (IACUC), which is responsible for local compliance with the Act. Canada The Canadian Council on Animal Care (CCAC) is setup to act in the interests of the people of Canada to ensure through programs of education, assessment and guidelines development that the use of animals, where necessary, for research, teaching and testing employs optimal physical and psychological care according to acceptable scientific standards, and to promote an increased level of knowledge, awareness and sensitivity to relevant ethical principles. At the inaugural meeting on January 30, 1968, the CCAC adopted the following statement of objective: "to develop guiding principles for the care of experimental animals in Canada, and to work for their effective application". Australia In Australia, Animal Ethics Committees (AECs) determine whether the use of an animal is valid or not. AECs must follow the Code in order to ensure the wellbeing of the animals used for research. The Code emphasizes the responsibilities of investigators, teachers and institutions using animals to: ensure that the use of animals is justified, taking into consideration the scientific or educational benefits and the potential effects on the welfare of the animals; ensure that the welfare of animals is always considered; promote the development and use of techniques that replace the use of animals in scientific and teaching activities; minimise the number of animals used in projects; and refine methods and procedures to avoid pain or distress in animals used in scientific and teaching activities.

Researchers can only conduct their studies once it has approved the validity of the use of the animals and that there is more educational or scientific gain that outweighs the possible effects on the welfare of the animals. The researchers must submit a written proposal to an AEC stating what is to be accomplished, a defense for the study, and the ethical and wellbeing of the animals used reflecting the 3Rs. In China, companies are required to submit samples of their products to be used for tests at local laboratories, according to advocacy group People for the Ethical Treatment of Animals. PETA estimates at least 72 animals are used for each product. Niche brand such as LOreal which refuse to do animal tests, are blocked out of the Chinese cosmetic market. The obstacle to replacing animal tests is that many of these procedures are encouraged, if not required, by national and international laws, regulations, and guidelines. In the United States, few laws actually mandate specific types of animal testing, but some regulations (which implement laws) do specify animal testing. The most common situation, however, is that animal testing is encouraged by a regulatory environment that has historically relied on such testing, thereby developing expectations and biases among regulators as well as corporate toxicologists. Regulators tend to be cautious about switching from methods that seem to be tried and true; anyone who makes such a

switch and then runs into problems is inviting unwelcome scrutiny. For their part, corporate toxicologists and decision-makers worry about corporate liability issues if consumers claim injury following use of a company product that had been tested using alternative techniques; judges will want to know why the company moved away from customary testing practices.