557 Address all correspondence to Shraddha Srivastava, shraddha.2410@gmail.com A Comparative Evaluation of Cosmetic Legislations in India and the European Union SHRADDHA SRIVASTAVA, VIKESH KUMAR SHUKLA, SANDEEP GILL AND ANKIT GOYAL Amity Institute of Pharmacy, Amity University, Noida, Uttar Pradesh, India (S.S.) Associate Professor, Amity Institute of Pharmacy, Amity University, Noida, Uttar Pradesh, India (V.S.) M. Pharma, Birla Institute of Technology and Science, Pilani- Hyderabad campus, Hyderabad, Telangana, India (S.G.) Assistant Professor, Dept. of Dairy Chemistry, Mansinhbhai Institute of Dairy and Food Technology, Mehsana, India (A.G.) Accepted for publication August 23, 2021. Synopsis In current years, cosmetic products have become an important part of human life. The changing lifestyles of customers and an increased awareness for their physical appearance is the main driving force behind the great rise of the cosmetics market worldwide. Though the United States and the European Union are the largest cosmetic markets in the world, India’s cosmetic market has shown a compound annual growth rate of 16.39%, with a value of $13,191.23 million in 2020. There are a number of different ingredients obtained from natural as well as synthetic sources that are used in the manufacturing of cosmetics, some of which might be toxic and may pose a risk to human health. Therefore, it is essential to regulate the manufacturing for the sale and distribution of all cosmetic products worldwide. To ensure the safety and performance of cosmetic products, different countries have formulated their own cosmetic regulations. In India, cosmetics are regulated under the Drugs and Cosmetic Act, 1940 and rules created by the Central Drugs Standard Control Organization under the Ministry of Health and Family Welfare, Government of India. Whereas the European Medicines Agency is the regulatory authority of cosmetic products in the European Union (EU), covering all the 27 EU member states along with Norway, Iceland, and Lichtenstein. Despite all regulating bodies sharing the same objective, the process of cosmetic product registration manufacturing licensing systems for import and distribution labeling and packaging vary from country to country. The present review provides a comparative insight into the cosmetic regulations in the EU and India, which will not only help in the growth of the cosmetic industry, but also will help in the manufacturing of safe and quality cosmetic products in India. Keywords: cosmetic regulations, EU, drugs, rules, heavy metals HISTORY AND INTRODUCTION Cosmetic refers to a range of beauty products intended to alter facial appearance, mask the odor of body parts, and enhance the overall quality of skin and health. The use of cosmetic products is as old as our civilization. It is believed that Egyptians, as early as 10,000 bc, J. Cosmet. Sci., 72, 557–567 (September/October 2021)

558 JOURNAL OF COSMETIC SCIENCE used to apply various natural components, scented oils, ointments and their mixtures on their face and body parts to improve color and odor in several religious activities, group events, and even before burial (1). The English word “cosmetic” is derived from the Greek word kosmetike (tekhnē), equivalent to a Latin word medicamentum, which means “the art of beautifying, art of anointing or decorating the human body” (2). The term cosmetic was not used until the beginning of 17th century and was first used by Sir Francis Bacon (1561– 1626), an author and a scientist (2). It is reported that Egyptians used to live in valleys with natural resources, where they applied the mixtures of olive oil, almond oil, and creams on skin in order to protect it from sunlight and dry winds (3). Kohl, an antimony-based compound and a combination of burned almonds, oxidized copper, and different colored coppers, ores, lead, ash, and ochre, was used by Egyptian women to shape their eye shadow (4). Furthermore, henna, leaf extract from the shrub Lawsoniainermis, was commonly used as a hair dye in North Africa and several Asian countries including India (4). In early Common Era (ce), Romanian people used to apply the paste of barley flour and butter for acne treatment. From 1400 to 1600, Italy and France emerged as main centers of beauty products, and used arsenic and lead-based powders in the preparations of facial powders (5). Later on, toxic, carcinogenic, and deadly lead-based preparations in facial powders were replaced by zinc oxide. Though the new term “makeup” was introduced as a verbal phrase in 1808, it was used as a noun after 1886 (2). In 1920, first liquid nail polish was introduced to the market. Later, Drene® (Procter & Gamble, Cincinnati, Ohio), the first detergent-based shampoo, was introduced into the marketplace in 1934. In 1999, the United States Food and Drug Administration, in association with other country representatives, conducted the first ever Cosmetics Harmonization and International Cooperation (CHIC) meeting in Brussels, Belgium and discussed the safety of cosmetic products, the exchange of data, and an international memorandum of cooperation. In current years, there is an increased interest in cosmetic, beauty, and personal-care products. People are more inclined to use cosmetic products in order to improve their physical appearance, skin softness, body odor, and overall health. As there is a large variety and variability of finished cosmetic products, as well as cosmetic ingredients, their safety to human health is of utmost importance. As previously mentioned, several toxic, carcinogenic components might act as ingredients of cosmetic products that might pose a risk to human health therefore, it is essential to regulate the importation and manufacturing of all cosmetic products worldwide. Although there are several regulating agencies in different countries to regulate the manufacturing, labeling, packaging, importation, and distribution of cosmetic products, the objective is same: ensure the safety of the product in order to protect the consumers’ health. For example, Food and Drug Administration (FDA) is the regulatory body in the US, whereas, the European Medicines Agency (EMA) is the regulatory authority in the EU, covering all 27 EU member states along with Norway, Iceland, and Lichtenstein. In India, cosmetics are regulated by the Central Drugs Standard Control Organization (CDSCO) under the Government of India’s Ministry of Health and Family Welfare. Despite all regulating bodies sharing the same objective, the process of cosmetic product registration manufacturing licensing systems for import and distribution labeling and packaging vary from country to country. Some cosmetic ingredients that are prohibited in one country might be allowed in another country. Similarly, some items that fall under the category of cosmetics in some countries might be categorized as OTC (over the counter) drugs in others. The present contribution provides a comparative insight into the cosmetic regulations in the