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

560 JOURNAL OF COSMETIC SCIENCE mainly to cleaning them, perfuming them, changing their appearance and correcting body odors and protecting them or keeping them in good condition.” Any product that is placed in the EU market under this category must comply the requirements of the EU cosmetic regulations irrespective of its place of origin or manufacturing. PREMARKET REQUIREMENTS In India, before placing any locally manufactured cosmetic product in the market, it is mandatory for the manufacturer or responsible person to take preapproval from the State Licensing Authority (SLA). Manufacturers must prepare a dossier file of the product’s information that should contain all the related information such as composition, ingredients, safety data, expiry period, etc. and that must comply the regulations of Cosmetic Rules, 2020 and the Indian Standards as laid down by the BIS. All these details need to be submitted to the SLA along with application form, fees, and other supporting documents. Thereafter, the SLA issues a license for the manufacturing of that cosmetic product for sale or distribution in India. The license shall remain valid in perpetuity, subject to payment of license retention fees before completion of the period of 5 y from the date of issue, unless it is suspended or canceled by the SLA. However, in case of “new cosmetics,” the concept of which has been introduced recently in Cosmetic Rules, 2020, no license shall be granted to a manufacturer by the SLA until the manufacturer takes prior permission from the Central Licensing Authority i.e., the Drugs Controller General of India (9). In the EU, the cosmetics products notification portal (CPNP) is the online notification portal created for the enforcement of Regulation (CE) No. 1223/2009, which requires an online notification before placing a cosmetic product in the market. The online notification includes information on the name and category of the product the name and address of the responsible person including his contact details the country of origin in case of import the first country where the product will be placed on the market the presence of nanomaterials and CMR substances the cosmetic product’s formulation and a compliant label with a photo of the external packaging (if legible). The manufacturer (legal person: individual or company) or responsible person (in case of imported cosmetic product/s) must prepare a PIF. The PIF is a regulatory file that contains the product’s related information such as composition, safety, ingredients, good manufacturing practices (GMP), sampling and analysis, CMR (carcinogenic, mutagenic or toxic for reproduction) substances, nanomaterials, animal testing, and labeling and packaging, and must comply the requirements set by EU cosmetic regulations. Overall, the PIF is divided into two parts: Part A, which contains detailed information of the cosmetic product, and Part B, which is more important and includes the safety assessment information of the cosmetic product. After preparing the PIF, the responsible person shall notify the EU authority online through the CPNP. The product must comply with the Regulation EC No. 1223/2009 and must be safe to human health. Only one notification is required for a product to be marketed in 30 countries controlled by the EU. Any change in composition, unwanted effects after use, recall, etc. must be reported by the responsible person using the CPNP (10). After the notification, the product can be placed into the EU market. REQUIREMENTS FOR IMPORT OF COSMETIC PRODUCTS The licensing process is totally different in the case of imported cosmetic products in India. Unlike locally manufactured cosmetic products for which the SLA issues a license,