ANALYSIS SIGILLUM: Animal testing on cosmetic products: towards the global ban?

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Animal testing on cosmetic products: towards the global ban?

Cosmetic products can be tested on animals in order to verify their safety for consumer health.This is determined by studying the ingredient toxicity or the irritant or sensitizing capacity of the cosmetic product and / or its ingredients, among others. Animal testing began in the 1940s and became a common practice that peaked in the 1980s. However, its use sparks off strong opposition from animal rights advocates who over the years have criticized the cruelty with which animals are treated for aesthetic purposes only and have questioned their usefulness. Thus, the actions taken by different NGOs, as well as by international committees such as UNESCO, led many countries to adopt a regulatory framework in order to promote the replacement of animal testing by alternative methods. As a result of these measures, numerous alternative methods to animal testing based on in vitro testing, computational models and ethical human volunteer testing have been developed, validated, and accepted over the past few decades. These are more reproducible, scientifically accurate, and even cheaper to perform in some cases. These advances have allowed many countries to adopt strict regulations that prohibit animal testing for cosmetic purposes, as is the case in the European Union; however, other territories only limit its scope or even consider it unavoidable to guarantee product safety. This lack of global harmonization generates great confusion and poses several problems for the cosmetic industry, such as the difficulty of achieving global conformity for its products or, in the case of those brands that opt for animal welfare policies, guaranteeing to their consumers that their products meet the cruelty free requirements. But what is the current situation in the world? The European Union maintains the most restrictive position worldwide and has served as an influence for other countries that have adopted similar measures, such as Australia, Guatemala, India, Iceland, Israel, Norway, New Zealand, Serbia, Switzerland, Taiwan or Turkey. European Regulation (EC) No. 1223/2009 on cosmetic products prohibits animal testing of finished cosmetic products within the Community; in addition, it also prohibits the commercialization within the common market of cosmetic products when the final formulation, or its ingredients, have been subjected to animal testing only for cosmetic purposes. These provisions became fully effective in 2013. Furthermore, in May 2018, the plenary of the European Parliament adopted a resolution calling for a worldwide abolition of animal testing in the cosmetic industry. It also urges to ban the sale of cosmetics that have been subject to animal testing before 2023. On the other hand, the Republic of Korea, since 2017, also prohibits the marketing of cosmetic products when the final formulation, or its ingredients, have been subjected to animal testing. However, unlike the European Union, this jurisdiction admits a series of exceptions that have been harshly criticized by animal rights defenders. For example, animal testing is allowed for some preservatives, dyes, or UV filters, or where animal testing is required to export a cosmetic product or is mandatory in the country of import. Similarly, Taiwan has prohibited the marketing of cosmetic products since 2019 when the final products, or their ingredients have been subjected to animal testing; however, like the Republic of Korea, it also allows some exceptions. In this case, animal testing is still allowed when the ingredient is widely used and cannot be replaced by another to perform the same function; or when the result of an evaluation indicates that the product may be harmful to health and animal tests are required to determine it. As for the United States of America, Canada, Mexico, Japan and ASEAN (ie the Association of Southeast Asian Nations, made up of Malaysia, Indonesia, Brunei, Vietnam, Cambodia, Laos, Burma, Singapore, Thailand and the Philippines), its current legislation neither prohibits nor requires animal testing to demonstrate the safety of cosmetic products; therefore, in many cases, manufacturers continue to use this practice to demonstrate the safety of ingredients or finished products. However, in these territories, the prioritization of alternative test methods to animal testing and replacement, reduction and refinement are advocated. More precisely, the Guidelines published by ASEAN specify that the safety assessment can be obtained from ethical human trials or through the use of alternative methods validated by organizations such as the OECD; Japanese manufacturers are implementing corporate initiatives in line with the global trend to abolish animal testing for cosmetic purposes, and governments in the US, Canada, and Mexico have already introduced bills to ban animal testing for cosmetic purposes. Last but not least, the People’s Republic of China (or Mainland China) is usually cited as an example of a country impervious to the abolition of animal testing on cosmetic products. Currently, its legislation mandates animal testing for all imported cosmetic products. Furthermore, the products manufactured within the national territory, although they do not have to be subjected to animal testing, they are not totally exempt from being analyzed by the competent authorities under this practice. For these reasons, some big brands such as L’Oreal, Estee Lauder or Procter & Gamble have moved part of their manufacturing to China in order to avoid animal testing on part of their cosmetic products, while other brands with strongly defined “cruelty free” policies have decided to avoid this market in despite of being one of the largest consumer markets in the world. However, the pressures that the Chinese legislators receive have had their effect and, on June 29, 2020, China published the final version of the expected updated cosmetic regulation: the Regulation of Supervision and Administration of Cosmetics (CSAR). CSAR, which will replace the existing regulation – Cosmetic Hygiene Supervision Regulations (CHSR), will be implemented from January 2021. This new regulation brings many changes, among which the unification of the notification system for cosmetic products of non-special use (or general cosmetics according to CSAR) manufactured in national territory and imported stands out. In this new Regulation, animal testing is not currently mentioned; however, the Government will also issue a series of standards, supporting documents and administrative rules to complement CSAR and it is likely that animal testing will be covered by this official documents. Specifically, it is expected that these rules contemplate the exemption of animal testing for cosmetic products for non-special use manufactured under certified GMP conditions and whose safety has been evaluated based on alternative methods validated by the European Union, except in some cases, such as, for example, cosmetic products intended for children or those containing ingredients not included in the Inventory of Existing Cosmetic Ingredients in China (IECIC). On the other hand, products for special use (i.e. according to CSAR hair dyes; products for the application of permanent hair; anti-wrinkle products; whitening products; sunscreens; products for hair loss and others cosmetic products with special claims), are not expected to be exempt from animal testing.Thus, are we close to the global ban on animal testing in cosmetic products? Undoubtedly, that is the future; however, the current situation is that around 80% of the countries still allow the commercialization of cosmetic products that have been tested on animals. This situation generates conflicts with those countries that currently prohibit this practice, since some cosmetic products undergo animal testing outside their borders and are analyzed again by alternative methods before being marketed in these countries. In addition, most of the ingredients used in cosmetic products are also used for other purposes, such as pharmaceuticals, detergents, etc; therefore, they may have been tested on animals under the protection of other laws. In short, in this international scenario with diverse and even opposing regulations, the absence of reliable data on animal testing for cosmetic purposes remains a reality. Institutions such as the European Union, facing this situation, urge the formation of coalitions in order to achieve a global ban by 2023. Time will tell whether it is achieved or not.[/vc_column_text][/vc_column][/vc_row]