Yifan Jiang

Technology Committee of China Oral Care Industry Association, China

Since the EU proposed the concept of banning animal experiment in cosmetic industry[1]in the year of 2003, it had been an issue to every government whether to sacrifice the other creatures on the planet to improve human life. It is a generalized issue of ethics,for human is not the only creature on the planet, and cosmetics, different with foods, drugs and medical instruments, are not essential elements in human life.

Thus, the following discussions in two aspects are provoked: firstly, whether to ban animal tests; and secondly, how to guarantee the safety of cosmetics in case of animal tests are banned, and whether to ban animal tests totally or conditionally.

In the recent decade especially after 2012, more and more countries have banned cosmetic tests on animals with different solutions, for details, see the article below and Table 1.

Status of ban on cosmetic tests on animals in various countries

The UK

The UK is a member of the EU, however, the UK has been staying in leading position compared with the other EU countries on banning animal experiments for cosmetics. Early in 1986, Animals (Scientific Procedures)Act, 1986 (ASPA) had been passed in the UK, which stipulated that for toxicological endpoint with available alternatives, animal tests for finished products and ingredients were forbidden.[2]

Table 1. Current status of ban on cosmetic tests on animals

The principles of 3R for experimental animal protection in the world, were proposed jointly by William Russell, an English zoologist, and Rex Burch,an English microbiologist in 1959[3], which included Replacement, replace conscious vertebrates with unconscious animals and scientific statistical method shall be used whenever possible; Reduction, reduce and control the number of animals under adequate tests and precision; and Refinement, optimize the experimental process to minimize the harm to the animals.

It is considered that the ASPA in the UK is the most rigorous act in the world. Animal tests should be examined and approved, and cost-benefit analysis should be conducted when applying. In the UK, three different licenses should be obtained when conducting an animal experiment, including follows: 1) Project license to check the species and number of experimental animals and method and objective of experiment; 2) Certificate for the institution to verify that there are adequate experimental equipment and staff; 3) Personal license to verify the qualification of each scientist and technician who will take part in the project.

The EU

The EU are the advocates and the most resolute executives of banning cosmetic tests on animals.

The EU prohibition was issued on Feb 27, 2003,with the following timetable: 1) except for repeated dose toxicity, reproduction toxicity and toxicokinetical tests, sales of cosmetics which animal tests for ingredients and finished products had been conducted would be banned from Mar 11, 2009; 2) animal tests,including repeated dose toxicity, reproduction toxicity and toxicokinetical tests, would be totally prohibited from Mar. 11, 2013.

In 2003, the EU was optimistic in development of alternative methods, and believed that the alternative methods for repeated dose toxicity, reproduction toxicity and toxicokinetical tests would be mature after ten years in 2013, however, the advances in technology were far lower than the expectation. In the end of 2012, a further discussion on whether to postpone the animal experiment prohibition in 2013 was held by cosmetics industry and governments in Europe. At that time, a large number of people considered that the prohibition must be postponed and speculated that it would be the eighth amendment of EU Cosmetic Directive 76/768/EEC. However, the final results were surprising that Cosmetics Europe suggested governments on behalf of the industry that the animal experiment prohibition should not be postponed. In other words, animal tests, even repeated dose toxicity,reproduction toxicity and toxicokinetical tests, on cosmetic products and ingredients have already be banned in the EU at present.

It is noteworthy that only animal tests to meet the EU regulations have been prohibited, and for EU enterprises in other countries, animal tests to meet the requirements of government regulations in other countries have not been prohibited.

Furthermore, for ingredients shared by cosmetics,foods and drugs, even if animal tests to meet the requirements of the EU food and drug regulations have been conducted, these ingredients can still be used in cosmetics.

Israel

Israel, which banned animal tests for home-made cosmetics and household cleaning products in 2007, is one of the earliest countries which prohibit cosmetic tests on animals. And new regulation which bans the import of cosmetics and household cleaning products that animal tests have been conducted from Jan 1, 2013 was issued in 2010.[4]

Turkey

In July 2015, Turkey's Pharmaceuticals and Medical Devices Administration made an amendment to the Cosmetic Regulation, which stipulated that animal tests for cosmetics and ingredients would be banned from Jan 2016, including imported products, but except for toxicological endpoint without alternatives.[5]

Brazil

On Jan 23, 2014, Prohibition on Cosmetic Tests on Animals (No. 15316),[6]taking effect on Jan 24, 2014, was passed in Sao Paulo, Brazil. The violators would be fined about 415,000 USD for each animal.

Brazilian Congress passed a bill to prohibit cosmetic tests on animals(Bill 70/2014)[7]in 2014, but animal protection group, which thought there was a major loophole, still expressed protest and dissatisfaction towards the Bill, because only animal tests for finished products were prohibited except for ingredients and imported products.

Proposals to adjust the Bill 70/2014 were formally proposed by some Senators in September 2015,[8]which considered that not only for finished products should be banned, but also for ingredients in three years.

Norway

Cosmetic tests on animals in Norway have also been prohibited since Mar 12, 2013 along with the EU, although it is not an EU country.[9]

New Zealand

In May 2014, New Zealand Parliament voted for the Animal Welfare Amendment Bill,[10]which prohibits cosmetic tests on animals in New Zealand. However, only animal tests conducted in mainland of New Zealand are banned, and the Amendment is not applicable to ones conducted abroad for imported products. The violators will be fined for about 16,600 USD and sentenced to up to 4 months in prison. Furthermore, the Amendment is only applicable to the new products rather than the old ones.

Korea

On November 26 2015, Korea approved a new regulation to prohibit cosmetic tests on animals,[11]according to which animal tests for cosmetic finished products and components would be conditionally banned in 2018.However, Korea took the EU as reference in specific implementation, and following exceptions were listed:

—Animal tests to meet the requirements of other laws and regulations in Korea, for example, Act on the Registration and Evaluation of Chemicals (K-REACH),could still be conducted.

—Animal tests for some specialized components,such as preservatives, colorants, sunscreen agent, etc., are allowed.

—For toxicological endpoint without available alternatives, animal tests are allowed. Industry should only chose those alternatives that approved by MFDS(Ministry of Food and Drug Safety).

—Cosmetics which animal tests had been conducted to meet the requirements of local regulations in other countries could be sold in Korea.

India

There is no doubt that India is the first Asian country to prohibit cosmetic testing on animals. And the Indian government has been taking a firm stood in prohibiting cosmetic tests on animals, which may be because of religiousness of Indian society.

The prohibition of cosmetic tests on animals in India,taking effect on Oct 13, 2014, was issued on May 21, 2014 by Indian FDA.[12]

In order to fully implementation of this regulation,the Indian government issued a special document[13]emphasizing that commitment of not been tested on animals should be made for cosmetics imported after Nov 12, 2014. The Document was also applicable to ingredients.

The USA

The Humane Cosmetics Act was proposed by four senators from four states in June 2015 to prohibit cosmetic tests on animals.[14]Animal protection group claimed that the Act had got the support from at least 140 cosmetics companies, including Lush, Coty, The Body Shop, Overstock, Paul Mitchell, and so on.

Russia

Proposal to prohibit cosmetic tests on animals[15]was proposed by two members of Russian State Duma at the end of August, 2015, which would prohibit animal tests for cosmetic finished products and components in Russia from the year of 2020.

Australia

On Nov 29, 2014, Australian Senate voted for the act to prohibit cosmetic tests on animals,[16]which was proposed by 7 Senators and was a multi-party joint proposal. The Act was first proposed by the Green Party in March 2014, and the following polls by the Labor Party indicated that the Act was backed by approximately 85% of the population. And the Act is supported by the governing party, Liberal-National Party Coalition, and the Labor Party, the second strongest party at present.

Canada

In June 2015, Canadian Senate proposed an act to prohibit cosmetic tests on animals,[17]according to which the sales of cosmetics which ingredients and finished products were tested on animals would be banned. And at the same time, Canadian Senate represented that animal tests led by the government would not be restricted, in other words, government-led animal tests would still be allowed in case of safety concerns of a certain kind of widely-used and irreplaceable product or components.

Compared with the single policy in the EU, the prohibition of animal tests in Canada is apparently more flexible and realistic.

Argentina

In July 2015, Magdalena Odarda, a senator in Rio Negro, proposed a proposal to prohibit cosmetic tests on animals[18]and would take effect in two years to the Congress.

Taiwan, China

FDA in Taiwan issued a document[19]on Apr. 7, 2015,which required using optimal alternatives validated by OECD to test the safety of ingredients of cosmetics.

In May 2015, Wang Yu-Min, the legislator,accompanied with 15 other legislators proposed to revise the “Cosmetics Hygiene Management Act” in order to prohibit animal tests for cosmetics and ingredients,[20]and the transition period for different objects was also given as follows: one year for finished products; two years for semi-finished products, ingredients and excipients; and three years for medical treatment or medicinal cosmetics.Taiwan FDA has already consulted cosmetics industry about the proposal at the beginning of June 2015. The proposal is under discussion at present.

Development of alternatives to animal tests

The EU has been working on alternatives for a long time, but the progress is not optimistic as expected.According to the official report of the EU,[21]five of the seven toxicological endpoints with the deadline in 2009 were successful, including dermal corrosion/irritation,percutaneous absorption and photo-toxicity; mutagenesis/genotoxicity had been improving; and progress on “eye irritation” and “acute toxicity” .

However, for three toxicological endpoints with the deadline in 2013 (repeated dose toxicity such as sensitization and carcinogenesis, reproduction toxicity and toxicokinetics), there were no available verified alternatives.

For chronic toxicity, although research institutions in the EU had been trying to establish six in vitro models for most common target organs (liver, kidney, CNS, lung,cardiovascular system and hematological system), the timetable for the development of concrete methods still could not be predicted.

For sensitization, it is predicted that the establishment of alternatives will be in the year 2017 to 2019.

For genotoxicity, most of in vitro methods are qualitative which cannot provide the data of dose-effect relationship and is commonly used in screenings, at present. Scientists indicate that there is no timetable at all for when the mature alternatives will be developed.

Commonly, reproduction toxicity refers to various adverse effects during genesis cycle when single or repeated exposure to toxic substances, including effects to reproductive ability, sexual behavior, embryo implantation, embryonic/fetal development, parturition, adaptive capacity and growth after birth, and sexual maturity. It is so complicated that toxicologists in Europe have admitted that it will take more than 10 years to complete the development of experimental strategy only.

Toxicokinetics is the science of studying in vivo absorption,distribution, metabolism and elimination of chemical substances. Experts estimated that another 5 to 7 years at least would be needed for the development of experimental methods to simulate renal and bile excretion and pulmonary absorption, and more time would be needed for comprehensive methods.

In general, much progress has been made in the development of alternatives but far behind the expectation.The EU government and toxicologists admitted that both experimental technique and strategy need to further development.

Cosmetic tests on animals are still mandatory in China at present

According to “Cosmetic Hygienic Standard (2007)” and“Regulation of Examination of Administrative Licensing for Cosmetics” issued by SFDA, animal tests for finished products of imported and special-function cosmetics are mandatory (for detailed requirements, see Table 2:Toxicological Test Items for Imported Non-special-use Cosmetics and the Number of Animals Needed, and Table 3:Toxicological Test Items for Imported and Domestic Specialfunction Cosmetics and the Number of Animals Needed[22]),and animal experimental data are also required in application of new ingredients registration.

Currently, animal tests for cosmetics have been prohibited in some countries, and not in most other countries, but it isimportant to note that the animal experimental data are not mandatory in other countries. In other words, China is the only one where animal tests for cosmetics are mandatory at present.

Table 2. Toxicological test items for imported non-special-function cosmetics①②③

Table 3. Toxicological test items for imported and domestic special-function cosmetics①②

According to weight-of-evidence, one of the basic principles in toxicology, the sequence of admitting data should be: human data ＞ animal data ＞ in vitro data ＞ insilico data. Several kinds of data could be used to verify the safety of products and ingredients in the safety assessment,and human data should be adopted prior to animal data.However, only animal data rather than human data are accepted in China, which is not in accordance with the basic principles of safety assessment.

Weigh-of-evidence is the basic principle in safety assessment commonly accepted by international practice.In the EU, weight-of-evidence is well addressed in “EU Cosmetics Regulation EC 1223/2009” chapter 10: an appropriate weight-of-evidence approach is used in the safety assessment for reviewing data from all existing sources.[23]In China, it is not included in “Cosmetic Hygiene Management Rules (1989)” and “Cosmetic Hygienic Standard (2007)” , thus the safety assessment of cosmetics is carried out in the absence of guidance of basic theory.

Recommendation of conditionally prohibit cosmetic tests on animals in our country

At present, there are 8 countries/regions where cosmetic tests on animals have already been prohibited, including the EU (including UK), Brazil, Norway, Turkey, Korea,India, New Zealand and Israel; and 6 are under discussion,including the USA, Russia, Australia, Canada, Argentina,Taiwan of China. It is observed that major economies and markets are included, and most of them are important trading partners of China, such as the EU, North America,Australia, Russia and even Korea, India and Taiwan of China.

There are two models to prohibit cosmetic tests on animals: 1) single policy in the EU and India where animal tests are totally prohibited; 2) according to the development of technology, only toxicology endpoints with alternatives are prohibited considering the actual requirements of safety assessment. There is no doubt that the second model is gradually becoming more popular.

Considering the international trend and combining the actual situation in our country, it is recommended that validated alternatives shall be adopted and animal tests for the same toxicological endpoints shall be prohibited in our country step by step.

Acknowledgements

The author would like to thank Mr. Fu Li-jie, secretary general of China Society of Toxicology (CST) and member of the American Academy of Clinical Toxicology, for his guidance.

[1] EU. Directive 2003/15/EC of the European Parliament and of the Council (2003).

[2] Animals (Scientific Procedures) Act, 1986 (ASPA), Statutory Instruments 1993 No. 2103. The Animals (Scientific Procedures) Act(Amendment) Order 1993. http://www.legislation.gov.uk/uksi/1993/2103/made (Accessed Nov 17).

[3] The Principles of Humane Experimental Technique. William Russell. Rex Burch, 1959. ISBN 0900767782.

[4] Israel Bans Animal-Tested Products, Michelle Kretzer.www.peta.org/blog/israel-bans-animal-tested-products/ (Accessed Nov 17).

[5] Animal Testing for Cosmetics Banned in Turkey. Daily Sabah. www.dailysabah.com/nation/2015/07/27/animaltesting-for-cosmetics-banned-in-turkey (Accessed July 27).

[6] Sao Paulo to Ban Animal Testing for Cosmetics. Premium Beauty Media. www.premiumbeautynews. com/en/saopaulo-to-ban-animal-testing (Accessed Nov 17).

[7] Be Cruelty-Free Brazil Welcomes Historic Bill to Ban Cosmetics Animal Testing but Warns Urgent Improvements Needed to Close Loopholes. Humane Society International.www.hsi.org/news/press_releases/2014/06/brazil-bansanimal-cosmetics-testing-060514.htm (Accessed Nov 17).

[8] Brazil's New Animal Testing Bill Faces Reform. Cosmetics Business.www.cosmeticsbusiness.com/news/article_page/Brazils_new_animal_testing_bill_faces_reform/112303(Accessed Nov 17).

[9] Norway Ban Animal Testing of Cosmetics.The Oslo Times.Aryan.

[10] House of Representatives Supplementary Order Paper Tuesday. Animal Welfare Amendment Bill.SOP No 69. www.loc.gov/lawweb/servlet/lloc_news?disp3_l205404408_text.(Accessed Nov 17).

[11] Cosmetics Animal Testing Faces Restrictions in South Korea. www.chemicalwatch.com/43915/south-korea-passescosmetics-animal-testing-law (Accessed Dec 8).

[12] Ministry of Health and Family Welfare (Department of Health and Family Welfare) Notification,2014, Published by the Controller of Publications, Delhi-110054.

[13] Ministry of Health and Family Welfare (Department of Health and Family Welfare) Notification, 2014, Published by the Controller of Publications, Delhi-110054.

[14] US House Sees Measure To Ban Cosmetic Animal Testing.Chemical Watch. www.chemicalwatch.com/register?o=2427 3&productID=1&layout=main (Accessed Nov 17).

[15] Andrew McDougall+. Bill Proposed to Phase out Animal Testing of Cosmetics in Russia. www.cosmeticsdesigneurope.com/Regulation-Safety/Bill-proposed-to-phase-outanimal-testing-of-cosmetics-in-Russia (Accessed Nov 17).

[16] Catherine. Australia Takes Steps to End Cosmetics Animal Testing. 2014 By www.buyingcrueltyfree.com/australiatakes-steps-to-end-cosmetics-animal-testing/ (Accessed Nov 17).

[17] Bill Banning Cosmetic Animal Testing Introduced in Canada. Chemical Watch. www.chemicalwatch.com/24225/bill-banning-cosmetic-animal-testing-introduced-in-canada(Accessed Nov 17).

[18] Georgina Caldwell. Argentinian Senator Proposes Bill to End Animal Testing for Cosmetics; Brazil Bill Close to Becoming Law. Global Cosmetic News. www.globalcosmeticsnews.com/south-america/1562/argentinian-senator-proposes-billto-end-animal-testing-for-cosmetics-brazil-bill-close-tobecoming-law (Accessed Nov 17).

[19] Amendment to Requirements on Technical Document for Application of Medicinal Cosmetics that Containing New Ingredients, Notification of Taiwan Ministry of Health and Welfare. Notification Number: Bu Shou Shi Zi 1041601904.

[20] Taiwan，Legislation Yuan Act Proposal Document,document number: Yuan Zong 874, proposal number 17628.

[21] Commission Reports on Progress in the Development of Alternative Methods to Animal Testing for Cosmetics. www.aei.pitt.edu/38396/1/COM_(2011)_558_final.pdf (Accessed Sep 13).

[22] Notification on Issuance of Testing Management Rules for Cosmetic Administrative Approval CFDA. www.sda.gov.cn/WS01/CL0055/46154.html.

[23] Regulation (Ec) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on Cosmetic Products. www.ec.europa.eu/growth/tools-databases/cosing/(Accessed Nov 17).