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

559 A COMPARATIVE EVALUATION OF COSMETIC LEGISLATIONS IN INDIA EU and India, which will not only help in the growth of the cosmetic industry, but also help in the manufacturing of safe and effective cosmetic products in India. REGULATORY BODY OF COSMETIC LEGISTALIONS IN INDIA AND THE EU In India, the CDSCO regulates cosmetic products. The Drugs and Cosmetics Act, 1940, originally known as the Drug Act, was passed by the Indian Parliament on April 10, 1940, with the primary objective to ensure the safety and efficacy of the drug and cosmetic products intended for human use, and conformity to the state quality standards. Later, the Drugs and Cosmetics Rules, 1945 came into the existence, giving the provisions for classification of drugs and cosmetics along with the directions of their manufacturing, storage, sale, and display under different schedules and annexures. Under these rules, the first notification for “Import and Registration of Cosmetics” was introduced on May 19, 2010, but was not implemented until April 1, 2013 (6). More recently, on December 15, 2020, the Ministry of Health and Family Welfare passed the Cosmetics Rules, 2020 with the purpose of regulating the importation and manufacturing of cosmetics separately for sales and distribution in India. The Bureau of Indian Standards (BIS), a national standard body, gives the labeling declarations for cosmetic products. Also, BIS gives the standards and requirements for finished cosmetic products as well as cosmetic ingredients listed under Schedule S of the Drugs and Cosmetics Rules, 1945. The EMA is the regulatory agency of cosmetic products in the EU. The Council Directive 76/768/EEC was the first legislative directive, introduced on July 27, 1976 in the EU, which was formed to govern the composition, labeling, packaging, and distribution of cosmetic products in all 27 EU member countries with the primary objective to protect human health (7). Though Council Directive 76/768/EEC (the old directive) was amended several times, a major amendment was done in January 2003 to ban over 1,100 chemicals in cosmetics on the basis of a safety report provided by the EU Scientific Committee on Consumer Products. On November 30, 2009, the old directive was replaced by a new EU regulation (EC) No. 1223/2009, which was enforced effective July 11, 2013. In comparison to the old directive, new EU regulation included detailed composition and labeling directions, directives on maintenance of product information files (PIF), harmonized notifications, and clearer provisions for the content and format of product safety assessment reports. EU regulation (EC) No. 1223/2009 also included the recent advancements in cosmetic ingredients, such as the use of nanomaterials that were not considered in the old directive (8). DEFINITION OF COSMETIC AS PER INDIAN AND EU LEGISTALTION According to the Drugs and Cosmetics Act 1940, and Rules 2020, cosmetics in India are defined as “any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetics” (9). As per the Cosmetics Directive (EU regulation 1223/2009, Article 2.1.a), cosmetic is defined as “any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips, and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or